October 24, 2018 Intuitive Surgical, Inc Domecus Consulting ...Principal, Domecus Consulting...

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U.S. Food & Drug Administration 10903 New Hampshire Avenue Doc ID# 04017.03.00 Silver Spring, MD 20993 www.fda.gov October 24, 2018 Intuitive Surgical, Inc ℅ Cindy Domecus Principal, Domecus Consulting Services, LLC/ISI Chief Regulatory Advisor Domecus Consulting Services LLC 1171 Barroihet Drive Hillsborough, California 94010 Re: K182140 Trade/Device Name: da Vinci Xi Surgical System, da Vinci X Surgical System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: NAY Dated: October 8, 2018 Received: October 10, 2018 Dear Cindy Domecus: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

Transcript of October 24, 2018 Intuitive Surgical, Inc Domecus Consulting ...Principal, Domecus Consulting...

Page 1: October 24, 2018 Intuitive Surgical, Inc Domecus Consulting ...Principal, Domecus Consulting Services LLC Chief Regulatory Advisor to Intuitive Surgical Telephone: 650.343.4813 Fax:

U.S. Food & Drug Administration 10903 New Hampshire Avenue Do c ID# 0 4 0 1 7 . 0 3. 0 0 Silver Spring, MD 20993 www.fda.gov

October 24, 2018 Intuitive Surgical, Inc ℅ Cindy Domecus Principal, Domecus Consulting Services, LLC/ISI Chief Regulatory Advisor Domecus Consulting Services LLC 1171 Barroihet Drive Hillsborough, California 94010 Re: K182140

Trade/Device Name: da Vinci Xi Surgical System, da Vinci X Surgical System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: NAY Dated: October 8, 2018 Received: October 10, 2018

Dear Cindy Domecus: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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Page 2 - Cindy Domecus K182140

801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([email protected]) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device EvaluationCenter for Devices and Radiological Health

Enclosure

ely,

Jennifer R. Stevenson -S3

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510(k) Summary - Page 1 of 6

510(k) Summary (21 CFR § 807.92(c))

I. SUBMITTER INFORMATION

Submitter: Intuitive Surgical, Inc. 1266 Kifer Road Sunnyvale, CA 94086 Contact: Cindy Domecus, R.A.C. (US & EU) Principal, Domecus Consulting Services LLC Chief Regulatory Advisor to Intuitive Surgical Telephone: 650.343.4813 Fax: 650.343.7822 Email: [email protected] Date Summary Prepared: October 23, 2018 II. SUBJECT DEVICE INFORMATION Device Trade Name: da Vinci® Xi and X Surgical Systems, Model IS4000 and Model IS4200 Common Name: System, Surgical, Computer Controlled Instrument Classification Name: Endoscope and Accessories (21 CFR §876.1500) Regulatory Class: II Product Code: NAY Submission Type: Traditional 510(k) III. PREDICATE DEVICE INFORMATION: Predicate Device: Intuitive Surgical da Vinci Xi and X Surgical Systems, Models IS4000 and

IS4200 (K131861, K152578, K153276, K161178, K170713, K171632, K171294 K172643, K173842, K173585)

Intuitive Surgical da Vinci Si Surgical System, Model IS3000 (K081137, K123463, K090993)

IV. DEVICE DESCRIPTION:

This 510(k) is for a labeling modification only, to include the following additional representative, specific

procedure under the cleared “general laparoscopic surgical procedures” Indication for Use of the da

Vinci Xi Surgical System, Model IS4000 (K131861) and the da Vinci X Surgical System, Model IS4200

(K171294) and the associated labeling claims: Gastrectomy. There are no changes to the technological

characteristics of the cleared da Vinci Xi or X Surgical Systems (Models IS4000 and IS4200) proposed in

this submission. The da Vinci Xi and X Surgical Systems, Models IS4000 and IS4200, are software-

controlled, electro-mechanical systems designed for surgeons to perform minimally invasive surgery.

The Model IS4000 and Model IS4200 Surgical Systems consist of a Surgeon Console, a Patient Side Cart

(PSC), and a Vision Side Cart (VSC) and are used with an Endoscope, EndoWrist Instruments, and

Accessories.

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510(k) Summary - Page 2 of 6

V. INDICATIONS FOR USE

The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System, Models: lS4000

and IS4200) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments

including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups,

needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of

tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery,

suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories,

during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic

surgical procedures, general thoracoscopic surgical procedures and thoracoscopically-assisted

cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform

coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric

use. It is intended to be used by trained physicians in an operating room environment in accordance

with the representative, specific procedures set forth in the Professional Instructions for Use.

Precaution for Representative Uses

The demonstration of safety and effectiveness for the representative specific procedures was based on

evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the

treatment of cancer (overall survival, disease-free survival, local recurrence) or treatment of the

patient’s underlying disease/condition. Device usage in all surgical procedures should be guided by the

clinical judgment of an adequately trained surgeon.

VI. COMPARISON OF INTENDED USE, INDICATIONS FOR USE AND TECHNOLOGICAL CHARACTERISTICS

WITH THE PREDICATE DEVICE

There are no changes to the technological characteristics for the subject devices compared to the

cleared predicate devices, da Vinci Xi Surgical System, Model IS4000 (K131861) and the da Vinci X

Surgical System, Model IS4200 (K171294). This 510(k) is for a labeling modification to include

Gastrectomy as a labeled use under the cleared “general laparoscopic surgical procedures” Indication

for Use of the cleared predicate devices, da Vinci Xi Surgical System, Model IS4000 and the da Vinci X

Surgical System, Model IS4200. The subject devices differ from the predicate devices by this

modification to the labeling. Results of clinical data from literature demonstrated that the subject

devices have the same intended use as the predicate devices.

VII. PERFORMANCE DATA

There were no technological changes to the subject devices, thus no bench testing, electromagnetic

compatibility testing, sterilization testing or biocompatibility testing was required.

Clinical Study Data

Published clinical data were provided to support use of the da Vinci Xi and X Surgical Systems (Models

IS4000 and IS4200) in “Gastrectomy” procedures to demonstrate that the intended use of the devices is

the same as the predicate devices. Sixteen (16) publications were identified for this procedure based on

specific search criteria and filters. These publications included two (2) randomized controlled trials (1b),

ten (10) systematic reviews/meta-analysis (2a), and four (4) database studies (2c) comparing da Vinci-

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510(k) Summary - Page 3 of 6

assisted procedures with laparoscopic and/or open cohorts. A detailed summary of the published clinical

data on this procedure is provided in Tables 1A and 1B below.

The findings from the Gastrectomy publications show that da Vinci-assisted procedures as compared to

laparoscopic procedures are associated with:

• Mortality: comparable mortality rates;

• Estimated Blood Loss (EBL): comparable or lower1 EBL volumes;

• Blood Transfusion: comparable blood transfusion rates;

• Lengths of Hospital Stay (LOS): comparable or shorter2 lengths of hospital stay;

• Intraoperative Complication Rates: comparable intraoperative complication rates;

• Postoperative Complication Rates: comparable postoperative complication rates;

• Conversion Rates: comparable conversion rates;

• Reoperation Rates: comparable reoperation rates;

• Readmission Rates: comparable readmission rates;3

• Anastomotic Leak Rates: comparable anastomotic leak rates;

• Anastomotic Stenosis Rates: comparable anastomotic stenosis rates; and,

• Operative Time: comparable or longer operative times. However, this increase was not associated

with an increase in the mortality or complication rates.

The findings from the Gastrectomy publications show that da Vinci-assisted procedures as compared to

open procedures are associated with:

• Mortality: comparable mortality rates;

• Estimated Blood Loss (EBL): lower EBL4 volumes;

• Blood Transfusion: comparable blood transfusion rates;

• Lengths of Hospital Stay (LOS): comparable or shorter5 lengths of hospital stay;

• Intraoperative Complication Rates: comparable intraoperative complication rates;

• Postoperative Complication Rates: comparable postoperative complication rates;

• Reoperation Rates: comparable reoperation rates;

• Readmission Rates: comparable readmission rates;6

• Anastomotic Leak Rates: comparable anastomotic leak rates;

1Nine (9) publications reported EBL data. One (1) publication (Reference #9) reported comparable values between the da Vinci and laparoscopic cohorts; seven (7) publications reported lower EBL values for the da Vinci cohort as compared to the laparoscopic cohort (References #1, 3, 8, 10, 11, 13, 15); and, one (1) publication reported higher EBL values for the da Vinci cohort as compared to the laparoscopic cohort (Reference #6). The higher EBL value in the da Vinci cohort was not associated with increased blood transfusion, complication or mortality rates. EBL values are provided in Table 1A. 2Eleven (11) publications reported LOS data. Three (3) publications (References #1, 9, 11) reported shorter LOS values for the da Vinci cohort; and, seven (7) publications reported comparable LOS values (References #5, 6, 8, 10, 12, 13, 15) for the da Vinci and laparoscopic cohorts. One publication (Reference #4) reported comparable LOS values for the da Vinci, laparoscopic and open cohorts. LOS values are provided in Table 1A. 3One (1) publication (Reference #4) reported comparable readmission rates for the da Vinci, laparoscopic and open cohorts. 4Six (6) publications reported EBL data. All six (6) publications reported lower EBL values (References #2, 3 ,6, 7, 14, 15) for the da Vinci cohorts as compared to the open cohorts. EBL values are provided in Table 1A. 5Eight (8) publications reported LOS data. Five (5) publications (References #2, 6, 7, 14, 15) reported shorter LOS values for the

da Vinci cohort as compared to the open cohort; and, two (2) publications reported comparable LOS values (References #5, 12) for the da Vinci and open cohorts. One publication (Reference #4) reported comparable LOS values across the da Vinci, laparoscopic and open cohorts. LOS values are provided in Table 1A. 6One (1) publication (Reference #4) reported comparable readmission rates for the da Vinci, laparoscopic and open cohorts.

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510(k) Summary - Page 4 of 6

• Anastomotic Stenosis Rates: comparable anastomotic stenosis rates; and,

• Operative Time: longer operative times. However, this increase was not associated with an increase

in the mortality or complication rates.

VIII. CONCLUSION

The da Vinci Xi and X Surgical Systems (models IS4000 and IS4200) have the same intended use as the

predicate devices, as demonstrated by the clinical data from literature to support the safety and

effectiveness for the new labeled use of Gastrectomy procedures under the “general laparoscopic

surgical procedure” indications compared to the predicate devices. In addition, the subject devices have

the same technological characteristics as the predicate devices. Therefore, the da Vinci Xi and X Surgical

Systems (Models IS4000 and IS4200) are substantially equivalent to the cleared predicate devices.

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510(k) Summary - Page 5 of 6

TABLE 1A: da Vinci vs. Open and da Vinci vs. Laparoscopic Gastrectomy Procedures

Author

Study Size (N) Operation Time (minutes)

EBL (ml) Length of Stay (days)

Transfusion Rate (%)

Intraop Comp

Rate (%)

Postop Comp

Rate (%)

Mortality (in-hospital - 30

days %)

Reoperation Rate (%)

Conversion Rate (%)

1. Pan 2017 Robotic 102 153.11 41.27 3.75 Not Reported

4.9 0 Not Reported

0

Lap 61 151.97 83.69 5.36 19.7 0 0 2. Wang 2016 Robotic 151 242.7 94.2 5.7 0.66 Not

Reported 9.3 0

Not Reported Open 145 192.4 152.8 6.4 0.69 10.3 0

3. Eom 2016* Robotic 53 268.4 74.2 Not Reported Lap 541 227.3 137.7

Open 2654 200.4 272.4 4. Glenn 20156 Robotic 223

Not Reported

12.2

Not Reported

33.6*** 4.9

Not Reported Lap 789 12.1 27.8*** 1.9 Open 8585 13.0 31.7*** 2.6

5. Greenleaf 20176 Robotic 223 Not Reported

8 Not Reported

Not Available1, 2 Not

Reported

7.6 Lap 1487 8 Not Reported 19

Open 4717 9 Not Available1,2 N/A 6. Parisi 2017 Robotic 151 365.44 117.91 8.85 2.6/8.6** 1.3 17.9 0 1.3 4.6

Lap 151 220.37 95.93 9.07 4.6/8.6** 2.0 11.9 0 3.3 5.3

Open 302 198.67 127.26 12.68 3.0/6.3** 1.7 19.5 0 3.6 N/A 7. Caruso 2017 Robotic 689 226 - 415.9 30.3 - 208.2 5.1 - 11.3

Not Reported 12.77 0.44 Not

Reported 1.4

Open 5434 126.7 - 331.8 78.8 - 564.6 6.4 - 16.5 11.94 0.64 N/A 8. Chen 2017 Robotic 1830 202.1 - 439 30.3 - 176.6 5.1 - 14

Not Reported 10.60 0.84 1.9 0.57

Lap 4123 166.7 - 361 34 - 212.5 5.9 - 15 10.11 0.52 1.11 0.73 9. Chuan 2015 Robotic 551 226 - 361 30.3 - 130.48 5.1 - 12.1

Not Reported 12.70

Not Reported Lap 1245 176 - 345 44.7 - 131.3 6.5 - 17.3 13.01

10. Duan 2017 Robotic 993 202 - 439 30.3 - 131.3 5.1 - 12.1 Not Reported

12.22 Not Reported

Lap 2510 170.7 - 345 44.7 - 173.45 6.5 - 17.3 12.68 11. Hu 2016 Robotic 1096 178 - 439 47 - 171.3 4.5 - 11

Not Reported UK 0.26 Not

Reported 1.91

Lap 2484 137.6 - 319.8 87.1 - 152.8 5.7 - 13.2 UK 0.60 1.30

12. Kostakis 2017 Robotic 85 Not Reported

9.6 Not Reported

10.71 3.45 3.45 0 – 18.2 Lap 1281 8 - 16.9 7.99 3.06 5.98 0 – 27.7 Open 11194 11.5 - 24 5.83 5.35 4.04 N/A

13. Wang 2017 Robotic 1134 202.1 - 415.9 30.3 - 214.2 4.5 - 12.1 Not Reported

11.7 Not Reported

Lap 2610 173.5 - 362.2 44.7 - 212.5 4.3 - 17.3 10.7 14. Yang 2017 Robotic 606 Not Available1,3 Not Available1,4 Not Available1,5

Not Reported 12.71

Not Reported Open 5364 Not Available1,3 Not Available1,4 Not Available1,5 12.08

15. Zong 2014 Robotic 520/997 202 - 344 30.3 – 197.6 5.1 - 10.5

Not Reported

11.54 0.50 – 0.58

Not Reported Lap 2207 134 - 235 39.5 -173.45 6.2 - 11.9 12.01 0.32 Open 5260 126.7 - 222 78.8 – 386.1 6.7 - 13.4 11.50 0.67

16. Guerra 2018 Robotic 570 206.4 - 439.0 Not Reported

6.75 - 10.5 Not Reported

Lap 1456 167.1 - 361.0 6.7 - 13.0 *Data reported for “total” gastrectomy procedures herein. Authors reported similar results for “distal” gastrectomy procedures; **Intra-op and post-op reported; ***In-hospital overall complication rate. 1Absolute rates/means not available; 2OR 1.07 [0.42, 2.75]; 3WMD 63.72 [33.83, 93.61]; 4WMD 129.74 [-178.31, -81.16]; 5WMD -2.39 [-2.92, -1.87] 6The years 2010, 2011 and 2012 overlap between the two (2) databases used in the Glenn and Greenleaf publications. As such, there is a possibility of data overlap in the reported

results.

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510(k) Summary - Page 6 of 6

TABLE 1B: da Vinci vs. Open and da Vinci vs. Laparoscopic Gastrectomy Procedures

Author

Study Size (N) Positive Surgical Margin Rate (%)

Proximal resection margin (cm)

Distal resection margin (cm)

Lymph Node Yield (n) Anastomotic Leak Rate (%)

Anastomotic Stenosis Rate (%)

1. Pan 2017 Robotic 102 Not Reported

36.06 0 Not Reported

Lap 61 30.03 3.3

2. Wang 2016 Robotic 151 Not Reported

5.3 ± 1.5 5.5 ± 1.7 30.1 2.6 Not Reported

Open 145 5.1 ± 1.9 5.3 ± 1.5 29.1 2.1

3. Eom 2016* Robotic 53 Not Reported Lap 541

Open 2654

4. Glenn 20156 Robotic 223 Not Reported Lap 789

Open 8585

5. Greenleaf 20176 Robotic 223 5.8

Not Reported

129/223 (57.8%)**

Not Reported Lap 1487 10.9 791/1487 (53.2%)**

Open 4717 14.6 2352/4717 (49.9%)**

6. Parisi 2017 Robotic 151 2.0

Not Reported

27.78 2.6 0.7

Lap 151 4.0 24.58 2.6 0.7

Open 302 5.0 25.82 3.6 0.3

7. Caruso 2017 Robotic 689 Not Reported

22 - 41.1 3.0 Not Reported

Open 5434 25.2 - 43.3 1.6

8. Chen 2017 Robotic 1830 Not Reported

2.6 - 5.9 4 - 7.4 23.1 - 47.2 Not Reported

Lap 4123 2.9 - 5.7 3.8 - 7.7 20 - 46.5

9. Chuan 2015 Robotic 551 Not Reported

3.8 - 5.6 7.3 - 12.4 32.8 - 44.3 2.55 Not Reported

Lap 1245 3.68 - 5.7 6.21 - 11.6 32.6 - 43.2 2.68

10. Duan 2017 Robotic 993 Not Reported

25 - 44.3 Not Reported

Lap 2510 26 - 43.2

11. Hu 2016 Robotic 1096 Not Reported

UK UK 25.3 - 44 Not Reported

Lap 2484 UK UK 20.7 - 40

12. Kostakis 2017 Robotic 85 0

Not Reported

0 -3.4 0

Lap 1281 4.63 0-5.6 2.4 - 5.6

Open 11194 8.07 0-5.8 0 - 1.4

13. Wang 2017 Robotic 1134 Not Reported

range (3.8 - 5.8) range (5.1 - 12.4) 25 - 44.3 2.4 0.50

Lap 2610 range (3.68 - 5.7) range (5.6 - 11.6) 26 - 43.2 2.3 1.20

14. Yang 2017 Robotic 606 Not Reported

Not Available1,2 Not Available1,3 Not Available1,4 3.0 Not Reported

Open 5364 Not Available1,2 Not Available1,3 Not Available1,4 1.6 15. Zong 2014 Robotic 520/997

Not Reported

25 - 42.8 2.7

Not Reported Lap 2207 26 - 42.7 1.6 Open 5260 31.7 - 43.3 2.3

16. Guerra 2018 Robotic 570 Not Reported

Not Available1,5 Not Reported

Lap 1456 Not Available1,5 *Data reported for “total” gastrectomy procedures herein. Authors reported similar results for “distal” gastrectomy procedures; **N reported for cases with > 15 LN 1Absolute rates/means not available; 2WMD 0.10 [-0.43, 0.64]; 3WMD 0.52 [-0.76, 1.79}; 4WMD -1.36 [-3.69, 0.97]; 5MD 2.92 [0.32, 5.53]

6The years 2010, 2011 and 2012 overlap between the two (2) databases used in the Glenn and Greenleaf publications. As such, there is a possibility of data overlap in the reported

results.