The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Xi Surgical System Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, 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.

The Intuitive Surgical Endoscopic Instrument Control System (da Vinci X Surgical System Model IS4200) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, 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.

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 softwarecontrolled, 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.

AI/ML Overview

The provided document describes a 510(k) submission for a labeling modification of the da Vinci Xi and X Surgical Systems (Models IS4000 and IS4200) to include "Gastrectomy" as a recognized procedure under the existing "general laparoscopic surgical procedures" indication for use. This is explicitly stated as a labeling modification only, with no changes to the technological characteristics of the cleared devices. As such, the "acceptance criteria" and "device performance" in a traditional sense (e.g., diagnostic accuracy, sensitivity, specificity) for a novel device or AI algorithm are not applicable here.

Instead, the study aims to demonstrate that adding "Gastrectomy" to the labeling does not introduce new safety or effectiveness concerns compared to the already cleared general laparoscopic indications, and that the da Vinci systems are substantially equivalent for this new labeled use.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a labeling modification and not a new device or AI algorithm with specific performance metrics like accuracy, sensitivity, or specificity, there are no predefined numerical acceptance criteria or typical "device performance" values.

Instead, the "acceptance criteria" can be inferred as demonstration of comparable safety and effectiveness outcomes for Gastrectomy procedures performed with the da Vinci system when compared to laparoscopic and/or open procedures, based on literature review.

Metric (Comparison Group)	Acceptance Criteria (Inferred)	Reported Device Performance Statement for da Vinci (vs. Laparoscopic)	Reported Device Performance Statement for da Vinci (vs. Open)
Mortality	Comparable mortality rates	Comparable mortality rates	Comparable mortality rates
Estimated Blood Loss (EBL)	Comparable or lower EBL volumes	Comparable or lower EBL volumes	Lower EBL volumes
Blood Transfusion Rates	Comparable blood transfusion rates	Comparable blood transfusion rates	Comparable blood transfusion rates
Lengths of Hospital Stay (LOS)	Comparable or shorter lengths of hospital stay	Comparable or shorter lengths of hospital stay	Comparable or shorter lengths of hospital stay
Intraoperative Complication Rates	Comparable intraoperative complication rates	Comparable intraoperative complication rates	Comparable intraoperative complication rates
Postoperative Complication Rates	Comparable postoperative complication rates	Comparable postoperative complication rates	Comparable postoperative complication rates
Conversion Rates	Comparable conversion rates	Comparable conversion rates	Not explicitly stated for open, but relevant for comparing da Vinci to other minimally invasive approaches.
Reoperation Rates	Comparable reoperation rates	Comparable reoperation rates	Comparable reoperation rates
Readmission Rates	Comparable readmission rates	Comparable readmission rates	Comparable readmission rates
Anastomotic Leak Rates	Comparable anastomotic leak rates	Comparable anastomotic leak rates	Comparable anastomotic leak rates
Anastomotic Stenosis Rates	Comparable anastomotic stenosis rates	Comparable anastomotic stenosis rates	Comparable anastomotic stenosis rates
Operative Time	Comparable or longer operative times, without an increase in mortality or complication rates	Comparable or longer operative times; this increase was not associated with an increase in mortality or complication rates.	Longer operative times; this increase was not associated with an increase in mortality or complication rates.

2. Sample Size Used for the Test Set and the Data Provenance

Sample Size for the Test Set:
The study is a literature review, not a primary clinical trial with a "test set" in the traditional sense of a prospectively collected cohort. The sample sizes are derived from the N values reported in the individual studies included in the meta-analysis/systematic review. For example, some studies reviewed had sample sizes for Robotic Gastrectomy ranging from 53 to 1830 patients, for Laparoscopic Gastrectomy from 61 to 4123 patients, and for Open Gastrectomy from 145 to 8585 patients.
Data Provenance: The data provenance is stated as "Published clinical data from literature." The document extensively cites 16 publications. No specific countries of origin are mentioned, but based on typical medical literature, these would likely be international. The studies cited include:
- Two (2) randomized controlled trials (level 1b evidence)
- Ten (10) systematic reviews/meta-analysis (level 2a evidence)
- Four (4) database studies (level 2c evidence)
  The nature of these studies (e.g., retrospective database analyses, prospective RCTs within the included literature) would vary.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This type of study does not involve "experts establishing ground truth" for individual cases in a test set. The "ground truth" here is the aggregated clinical outcomes reported in published studies, which are considered evidence-based medical conclusions. The experts involved would be the authors of the 16 published clinical studies (surgeons, statisticians, researchers, etc.) who conducted the original research and established their findings. Their specific qualifications are not detailed in this 510(k) summary, but are implicitly assumed based on the peer-reviewed nature of the published literature.

4. Adjudication Method for the Test Set

No adjudication method is applicable here as this is a review of published literature, not a study involving individual case assessments by reviewers. The "adjudication" is inherent in the peer-review process of the published articles and the methodology of systematic reviews and meta-analyses.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC comparative effectiveness study was done. This submission is for a surgical system, not an AI diagnostic/interpretive tool requiring human reader performance evaluation.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

No standalone algorithm performance study was done. The da Vinci Xi and X Surgical Systems are electro-mechanical systems intended to assist surgeons (human-in-the-loop), not standalone algorithms. The submission explicitly states "The Intuitive Surgical Endoscopic Instrument Control System...is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments...It is intended to be used by trained physicians in an operating room environment..."

7. The Type of Ground Truth Used

The ground truth used is clinical outcomes data (e.g., mortality, EBL, LOS, complication rates, reoperation rates, etc.) collected and analyzed in previously published clinical studies (Randomized Controlled Trials, Systematic Reviews/Meta-analyses, and Database Studies).

8. The Sample Size for the Training Set

This submission does not involve a "training set" in the context of an AI/ML algorithm. The "training data" for making the determination about substantial equivalence for the new indication are the 16 published clinical studies. The sum of patients across all studies' da Vinci cohorts, laparoscopic cohorts, and open cohorts constitutes the entirety of the evidence base reviewed. These numbers are substantial, with individual studies reporting hundreds to thousands of patients (e.g., Robotic 1830, Lap 4123, Open 8585 in some studies).

9. How the Ground Truth for the Training Set Was Established

Since there is no "training set" in the AI/ML sense, the question refers to how the evidence for the labeling modification was established. The "ground truth" (i.e., the clinical outcomes and conclusions) in the selected 16 publications was established through:

Clinical Research Methodologies: Randomized controlled trials, systematic reviews, meta-analyses, and database studies.
Data Collection: Gathering patient data on various clinical outcomes (e.g., EBL, LOS, complications, mortality) from surgical procedures.
Statistical Analysis: Rigorous statistical methods applied by the authors of the original publications to analyze and interpret the collected data, leading to the reported conclusions regarding comparability or differences in outcomes between da Vinci, laparoscopic, and open surgical approaches.
Peer Review: The scientific rigor of these publications being accepted into peer-reviewed journals.

Summary

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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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801); medical device 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.html; 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Image /page/1/Picture/5 description: The image shows the closing of a letter with the word "Sincerely,". Below that is the name "Jennifer R. Stevenson-S3". The following line says "For Binita S. Ashar, M.D., M.B.A., F.A.C.S.". The last line says "Director".

Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K182140

Device Name

Intuitive Surgical® da Vinci® Xi Endoscopic Instrument Control System

(da Vinci Xi System, Model IS4000) and Endoscopic Instruments and Accessories

Indications for Use (Describe)

Type of Use (Select one or both, as applicable):

✘ Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Indications for Use

510(k) Number (if known)

K182140

Device Name

Intuitive Surgical® da Vinci® X Endoscopic Instrument Control System

(da Vinci X System, Model IS4200) and Endoscopic Instruments and Accessories

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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510(k) Summary (21 CFR § 807.92(c))

I. SUBMITTER INFORMATION

Submitter:	Intuitive Surgical, Inc.1266 Kifer RoadSunnyvale, CA 94086
Contact:	Cindy Domecus, R.A.C. (US & EU)Principal, Domecus Consulting Services LLCChief Regulatory Advisor to Intuitive SurgicalTelephone: 650.343.4813Fax: 650.343.7822Email: domecusconsulting@comcast.net
Date Summary Prepared:	October 23, 2018
II. SUBJECT DEVICE INFORMATION
Device Trade Name:	da Vinci® Xi and X Surgical Systems, Model IS4000 and M

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:

Intuitive Surgical da Vinci Xi and X Surgical Systems, Models IS4000 and Predicate Device: 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:

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V. INDICATIONS FOR USE

The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System, Models: IS4000 and IS4200) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, 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, do 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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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 lower2 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 shorter 1engths 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, 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.

3 One (1) publication (Reference #4) reported comparable readmission rates for the da Vinci, laparoscopic and open cohorts. "Six (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.

් Eight (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.

رَ One (1) publication (Reference #4) reported comparable readmission rates for the da Vinci, laparoscopic and open cohorts.

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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. The da Vinci Xi and X Surgical Systems (Models IS4000 and IS4200) are substantially equivalent to the cleared predicate devices.

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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 (%)	Author	Study Size (N)	Positive SurgicalMargin Rate (%)	Proximal resectionmargin (cm)	Distal resectionmargin (cm)	Lymph Node Yield (n)	AnastomoticLeak Rate (%)	Anastomotic StenosisRate (%)
1. Pan 2017	Robotic 102Lap 61	153.11151.97	41.2783.69	3.755.36	Not Reported		4.919.7	00	Not Reported	00	1. Pan 2017	Robotic102Lap61	Not Reported			36.0630.03	03.3	Not Reported
2. Wang 2016	Robotic 151Open 145	242.7192.4	94.2152.8	5.76.4	0.660.69	Not Reported	9.310.3	00	Not Reported		2. Wang 2016	Robotic151Open145	Not Reported	$5.3 \pm 1.5$	$5.5 \pm 1.7$	30.129.1	2.62.1	Not Reported
3. Eom 2016*	Robotic 53Lap 541Open 2654	268.4227.3200.4	74.2137.7272.4		Not Reported						3. Eom 2016*	Robotic53Lap541Open2654	Not Reported	Not Reported		Not Reported	Not Reported	Not Reported
4. Glenn 20156	Robotic 223Lap 789Open 8585	Not Reported		12.212.113.0	Not Reported		33.6*27.831.7**	4.91.92.6	Not Reported		4. Glenn 20156	Robotic223Lap789Open8585	Not Reported	Not Reported		Not Reported	Not Reported	Not Reported
5. Greenleaf 20176	Robotic 223Lap 1487Open 4717	Not Reported		889	Not Reported			Not Available1,2Not ReportedNot Available1,2	Not Reported	7.619N/A	5. Greenleaf 20176	Robotic223Lap1487Open4717	5.810.914.6	Not Reported	Not Reported	129/223 (57.8%)791/1487 (53.2%)2352/4717 (49.9%)**	Not Reported	Not Reported
6. Parisi 2017	Robotic 151Lap 151Open 302	365.44220.37198.67	117.9195.93127.26	8.859.0712.68	2.6/8.64.6/8.63.0/6.3**	1.32.01.7	17.911.919.5	000	1.33.33.6	4.65.3N/A	6. Parisi 2017	Robotic151Lap151Open302	2.04.05.0	Not Reported	Not Reported	27.7824.5825.82	2.62.63.6	0.70.70.3
7. Caruso 2017	Robotic 689Open 5434	226 - 415.9126.7 - 331.8	30.3 - 208.278.8 - 564.6	5.1 - 11.36.4 - 16.5	Not Reported		12.7711.94	0.440.64	Not Reported	1.4N/A	7. Caruso 2017	Robotic689Open5434	Not Reported	Not Reported	Not Reported	22 - 41.125.2 - 43.3	3.01.6	Not Reported
8. Chen 2017	Robotic 1830Lap 4123	202.1 - 439166.7 - 361	30.3 - 176.634 - 212.5	5.1 - 145.9 - 15	Not Reported		10.6010.11	0.840.52	1.91.11	0.570.73	8. Chen 2017	Robotic1830Lap4123	Not Reported	2.6 - 5.92.9 - 5.7	4 - 7.43.8 - 7.7	23.1 - 47.220 - 46.5	Not Reported	Not Reported
9. Chuan 2015	Robotic 551Lap 1245	226 - 361176 - 345	30.3 - 130.4844.7 - 131.3	5.1 - 12.16.5 - 17.3	Not Reported		12.7013.01		Not Reported		9. Chuan 2015	Robotic551Lap1245	Not Reported	3.8 - 5.63.68 - 5.7	7.3 - 12.46.21 - 11.6	32.8 - 44.332.6 - 43.2	2.552.68	Not Reported
10. Duan 2017	Robotic 993Lap 2510	202 - 439170.7 - 345	30.3 - 131.344.7 - 173.45	5.1 - 12.16.5 - 17.3	Not Reported		12.2212.68		Not Reported		10. Duan 2017	Robotic993Lap2510	Not Reported	Not Reported	Not Reported	25 - 44.326 - 43.2	Not Reported	Not Reported
11. Hu 2016	Robotic 1096Lap 2484	178 - 439137.6 - 319.8	47 - 171.387.1 - 152.8	4.5 - 115.7 - 13.2	Not Reported		UKUK	0.260.60	Not Reported	1.911.30	11. Hu 2016	Robotic1096Lap2484	Not Reported	UKUK	UKUK	25.3 - 4420.7 - 40	Not Reported	Not Reported
12. Kostakis 2017	Robotic 85Lap 1281Open 11194	Not Reported		9.68 - 16.911.5 - 24	Not Reported		10.717.995.83	3.453.065.35	3.455.984.04	0 - 18.20 - 27.7N/A	12. Kostakis 2017	Robotic85Lap1281Open11194	04.638.07	Not Reported	Not Reported	Not Reported	0-3.40-5.60-5.8	02.4 - 5.60 - 1.4
13. Wang 2017	Robotic 1134Lap 2610	202.1 - 415.9173.5 - 362.2	30.3 - 214.244.7 - 212.5	4.5 - 12.14.3 - 17.3	Not Reported		11.710.7		Not Reported		13. Wang 2017	Robotic1134Lap2610	Not Reported	range (3.8 - 5.8)range (3.68 - 5.7)	range (5.1 - 12.4)range (5.6 - 11.6)	25 - 44.326 - 43.2	2.42.3	0.501.20
14. Yang 2017	Robotic 606Open 5364	Not Available1,3	Not Available1,4	Not Available1,5	Not Reported		12.7112.08		Not Reported		14. Yang 2017	Robotic606Open5364	Not Reported	Not Available1,2Not Available1,2	Not Available1,3Not Available1,3	Not Available1,4Not Available1,4	3.01.6	Not Reported
15. Zong 2014	Robotic 520/997Lap 2207Open 5260	202 - 344134 - 235126.7 - 222	30.3 - 197.639.5 - 173.4578.8 - 386.1	5.1 - 10.56.2 - 11.96.7 - 13.4	Not Reported		11.5412.0111.50	0.50 - 0.580.320.67	Not Reported		15. Zong 2014	Robotic520/997Lap2207Open5260	Not Reported	Not Reported	Not Reported	25 - 42.826 - 42.731.7 - 43.3	2.71.62.3	Not Reported
16. Guerra 2018	Robotic 570Lap 1456	206.4 - 439.0167.1 - 361.0	Not Reported	6.75 - 10.56.7 - 13.0	Not Reported			Not Reported	Not Reported		16. Guerra 2018	Robotic570Lap1456	Not Reported	Not Reported	Not Reported	Not Available1,5Not Available1,5	Not Reported	Not Reported

*Data reported for "total" gastrectorny proced sinilar results for "listal" gastrectory procedures; ** Intra-op and post-op reported; *** M-hopital overal complication rate. ¹Absolute rates/means not available; ²OR 1.07 [0.42, 2.75]; ³WMD 129.74 [-178.31, -81.16]; ³WMD -2.39 [-2.92] -1.87]

"The years 2010, 2011 and 202 overlap the two (2) databases used in the Glenn and Greenleaf publications. As such, the eported results.

{9}------------------------------------------------

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

*Data reported for "total" gastrectory procedures her results for "distal" gastrectomy procedures, ** V reported for cases with > 15 UV

¹Absolute rates/means not available; ׳WMD 0.10 [-0.43, 0.64]; ³WMD 0.52 [-0.76, 1.79); 'WMD -1.36 [-3.69, 0.97]; ³MD 2.92 [0.32, 5.53]

"The years 2010, 2011 and 2012 verləp between the Glenn and Greenleaf publications. As such, there is a possibility of data overlap in the eported results.

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.

Dear Cindy Domecus:

Indications for Use

510(k) Number (if known)

K182140

Device Name

Indications for Use (Describe)

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Indications for Use

510(k) Number (if known)

K182140

Device Name

Indications for Use (Describe)

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510(k) Summary (21 CFR § 807.92(c))

I. SUBMITTER INFORMATION

III. PREDICATE DEVICE INFORMATION:

IV. DEVICE DESCRIPTION:

V. INDICATIONS FOR USE

Precaution for Representative Uses

VI. COMPARISON OF INTENDED USE, INDICATIONS FOR USE AND TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

VII. PERFORMANCE DATA

Clinical Study Data

VIII. CONCLUSION

§ 876.1500 Endoscope and accessories.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW

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