The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endloscopic dissectors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, 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 procedures under the cleared "gynecologic laparoscopic surgical procedures" general indication for the da Vinci Xi Surgical System (K131861): Hysterectomy (Radical, Hysterectomy for Benign Disease 1), Salpingectomy, Oophorectomy, Lymphadenectomy, Myomectomy, Sacrocolpopexy, Endometriosis Resection, Adnexectomy, Omentectomy, Parametrectomy, Cyst Removal, and Lysis of Adhesions. There are no changes to the technological characteristics of the cleared da Vinci Xi Surgical System proposed in this submission. The da Vinci Xi Surgical System, Model IS4000 is a software-controlled, electromechanical system designed for surgeons to perform minimally invasive surgery. The Model IS4000 Surgical System consists of a Surgeon Console, a Patient Side Cart (PSC), and a Vision Side Cart (VSC) and is used with an Endoscope, EndoWrist Instruments, and Accessories.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study that demonstrates the device meets these criteria, based on the provided text:

Device: da Vinci® Surgical System, Model IS4000

Acceptance Criteria and Reported Device Performance

The clinical studies for the da Vinci® Surgical System, Model IS4000, do not present a clear table of predefined numerical acceptance criteria. Instead, the studies demonstrate substantial equivalence by comparing the outcomes of da Vinci-assisted procedures to open and laparoscopic surgical procedures, focusing on comparable or superior safety and effectiveness metrics.

The reported device performance, in comparison to traditional methods (open and laparoscopic surgery), is summarized for "umbrella procedures" (Hysterectomy (Radical) Salpingectomy, Oophorectomy, Lymphadenectomy, Myomectomy and Sacrocolpopexy) across various publications:

Metric	da Vinci-assisted vs. Open Procedures	da Vinci-assisted vs. Laparoscopic Procedures
Complications	Comparable or fewer complications. For Myomectomy, comparable outcomes. For Sacrocolpopexy, comparable or lower.	Comparable or fewer complications. For Myomectomy, comparable outcomes. For Sacrocolpopexy, comparable or lower.
Blood Transfusions	Comparable or fewer transfusions. For Myomectomy, comparable or lower (with some exceptions noted for more challenging cases). For Sacrocolpopexy, comparable.	Comparable or fewer transfusions. For Myomectomy, comparable or lower (with some exceptions noted for more challenging cases). For Sacrocolpopexy, comparable.
Length of Hospital Stay	Shorter length of hospital stay. For Myomectomy, comparable or shorter. For Sacrocolpopexy, comparable or shorter.	Comparable or shorter length of hospital stay. For Myomectomy, comparable or shorter. For Sacrocolpopexy, comparable or shorter.
Operative Time	Increased operative times, but this increase did not correlate with an increase in reported complication rates.	Comparable operative times (with some exceptions such as Sacrocolpopexy where increased operative times were noted, but without correlating increase in complications).
Conversion Rates	Not directly compared to Open procedures in terms of conversion rates since Open is a primary approach.	Comparable or lower conversion rates.

The overall acceptance is based on the demonstration that the da Vinci-assisted procedures are associated with comparable or improved outcomes (fewer complications, less blood loss, shorter hospital stays) compared to traditional methods, despite potentially longer operative times in some cases. The increased operative time was deemed acceptable as it did not lead to increased complication rates.

Study Details

The provided document describes a labeling modification for the da Vinci Xi Surgical System (Model IS4000) to include additional specific gynecologic laparoscopic surgical procedures. The performance data presented is a summary of existing pre-clinical and clinical studies that have previously been used to support the clearance of the device.

Sample size used for the test set and the data provenance:
- Pre-Clinical Animal Study Data: Provided results from 7 evaluations in a total of 27 animals.
  - Provenance: Not specified, but implied to be prospective experimental data from animal studies.
- Clinical Study Data: This refers to a review of 21 published clinical data publications. These publications included randomized controlled trials, meta-analyses, systematic reviews, Health Technology Assessments, and comparative studies.
  - Provenance: This is retrospective data analysis from various published clinical studies. The country of origin for these studies is not specified in this summary but would be diverse given the nature of published literature.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Pre-Clinical Animal Study Data: For the animal studies, the "ground truth" would be established by the researchers conducting the experiments and analyzing the physiological outcomes and histological findings. The number and qualifications of these experts are not specified in the summary.
- Clinical Study Data: For the retrospective clinical data, the "ground truth" is derived from the reported outcomes and statistical analyses within the 21 identified publications. The experts involved would be the authors of those publications (surgeons, statisticians, researchers, etc.). The specific number and exact qualifications of these experts for all 21 publications are not provided in this summary. However, it's inherent that these would be medical professionals experienced in conducting and reporting clinical trials.
Adjudication method for the test set:
- Pre-Clinical Animal Study Data: Not specified. Adjudication methods are typically outlined in the study protocols of animal research, but are not detailed here.
- Clinical Study Data: For the aggregate of 21 publications, the adjudication method is essentially the peer-review process inherent to scientific publications. This submission itself represents an internal review and synthesis of these published findings by the manufacturer and the FDA. No specific external adjudication panel beyond this is mentioned for this particular 510(k) submission.
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, an MRMC comparative effectiveness study was not done. This device (da Vinci Surgical System) is a surgical robot that assists human surgeons, not an AI diagnostic tool that human readers interpret. The studies compare robotic assistance (human with robot) versus traditional surgery (human without robot for the specific robotic tasks). Therefore, the concept of "human readers improving with AI vs without AI assistance" in the context of interpretation accuracy doesn't directly apply. The comparison is related to surgical outcomes.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, a standalone study was not done because the da Vinci Surgical System is designed to be a human-in-the-loop system. It is a tool that enhances a surgeon's capabilities, not an autonomous system. The indication states: "It is intended to be used by trained physicians in an operating room environment."
The type of ground truth used:
- Pre-Clinical Animal Study Data: Based on anatomical observations, physiological measurements, and histopathological findings in animals.
- Clinical Study Data: Based on clinical outcomes data from human patients, including complications (e.g., adverse events), blood transfusions, length of hospital stay, operative time, and conversion rates, as reported in published peer-reviewed medical literature. This is essentially patient outcomes data.
The sample size for the training set:
- Not applicable / Not specified in this context. This 510(k) is for a labeling modification and relies on previously submitted performance data and published literature. The da Vinci Surgical System is an electro-mechanical system controlled by a surgeon, not an AI algorithm that learns from a training set in the conventional sense of machine learning. The "training" for such a system would involve engineering development, testing, and validation against design specifications and performance requirements, rather than a data-driven machine learning training set. Surgeons are also "trained" to use the system.
How the ground truth for the training set was established:
- Not applicable. As explained above, for this type of medical device, the concept of a "training set" with associated "ground truth" as typically defined for AI/ML algorithms does not directly apply. The development and validation of the device rely on engineering principles, verification, and validation testing, and clinical evaluations where "ground truth" is defined by standard medical endpoints and established surgical practices.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human profile.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 30, 2016

Intuitive Surgical, Inc. % Ms. Cindy Domecus Chief Regulatory Advisor, Intuitive Surgical Domecus Consulting Services, LLC 1171 Barroilhet Drive Hillsborough, California 94010

Re: K152578

Trade/Device Name: da Vinci Surgical System, Model IS4000 Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: NAY Dated: March 21, 2016 Received: March 23, 2016

Dear Ms. 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. 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 801); medical device reporting (reporting of medical device

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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Jennifer R. Stevenson -A

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

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K152578

Device Name

da Vinci Surgical System, Model IS4000, and EndoWrist Instruments and Accessories

Indications for Use (Describe)

The Intuitive Surgical Endoscopic Instrument Control System, Model 184000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endloscopic dissectors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, 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.

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)

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

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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:	March 29, 2016
II. SUBJECT DEVICE INFORMATION
Device Trade Name:	da Vinci® Surgical System, Model IS4000
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 Surgical System, Model IS4000 (K131861) Intuitive Surgical da Vinci Surgical System, Model IS3000 (K081137, K123463, K090993)

IV. DEVICE DESCRIPTION:

V. INDICATIONS FOR USE

4 "Hysterectomy" was previously cleared as a representative, specific procedure for the da Vinci Xi Surgical System under K131861.

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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.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

There are no changes to the technological characteristics of the cleared do Vinci Xi Surgical System (IS4000) proposed in this submission.

VII. PERFORMANCE DATA

Pre-Clinical Animal Study Data

Animal performance data were provided in this premarket notification, including the results from 7 evaluations in a total of 27 animals demonstrating use of da Vinci Xi Surgical System in the following procedures: Hysterectomy and Salpingectomy/Oophorectomy (Adnexectomy), Pyeloplasty, Nephrectomy, Nissen Fundoplication, Colectomy and Mitral Valve Repair. These data were previously submitted in support of clearance of the da Vinci Xi Surgical System and the da Vinci Xi Vessel Sealer (K131861 and K140189) and also support inclusion of the additional representative specific procedures.

Clinical Study Data

Published clinical data support use of the da Vinci Xi Surgical System for the representative, specific procedures that fall under the cleared "gynecologic laparoscopic surgical procedures" general Indication for Use. Clinical data were not provided for all of the representative, specific procedures. Instead, clinical data were provided only for the more complex/higher risk representative, specific procedures (referred to as "umbrella" procedures). The published data on these "umbrella" procedures were deemed sufficient to cover the less complex/lower risk procedures (referred to as "covered" procedures), so published clinical data on the covered procedures were not provided.

Umbrella Procedures

Published clinical data were provided for the following umbrella procedures: Hysterectomy (Radical) Salpingectomy, Oophorectomy, Lymphadenectomy, Myomectomy and Sacrocolpopexy. Twenty-one (21) publications were identified for these umbrella procedures based on specific search criteria and filters. These publications included randomized controlled trials, meta-analyses, systematic reviews or Health Technology Assessments and comparative studies. A detailed summary of the published clinical data on these procedures is provided in Tables 1-3 below.

The findings from the Hysterectomy, Salpingectomy, Oophorectomy and Lymphadenectomy publications show that dd Vinci-assisted procedures are associated with comparable or fewer complications and blood transfusions and a shorter length of hospital stay as compared to both open and laparoscopic surgical procedures. These publications also noted increased operative times in the da Vinci procedures as compared to open procedures. However, this increase did not correlate with an increase in the reported complication rates. Additionally, these publications report comparable operative times and comparable or lower conversion rates for da Vinci-assisted procedures as compared to laparoscopic procedures.

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Outcomes reported in the Myomectomy publications demonstrate that da Vinci-assisted procedures are associated with comparable complication rates; comparable or lower blood transfusion rates (Two publications reported a higher transfusion rate in the da Vinci-assisted cohorts as compared to the laparoscopic groups. However, Barakat noted that the cases completed with the laparoscopic approach were less challenging than those completed with do Vinci assistance and Gargiulo noted that the majority of transfusions in the da Vinci-assisted procedures were planned pre-operatively.); and comparable or shorter length of hospital stays as compared to both open and laparoscopic surgical procedures. These publications also noted increased operative times in the da Vinci procedures as compared to open procedures. However, this increase did not correlate with an increase in the reported complication rates. Additionally, these publications report comparable conversion rates for da Vinci-assisted procedures as compared to laparoscopic procedures.

The data provided in the Sacrocolpopexy publications show that da Vinci-assisted procedures are associated with comparable or lower complication rates; comparable blood transfusion rates and comparable or shorter length of hospital stays as compared to both open and laparoscopic surgical procedures. These publications also noted increased operative times in the da Vinci procedures as compared to open and laparoscopic procedures. However, this increase did not correlate with an increase in the reported complication rates. Additionally, these publications reported comparable conversion rates for da Vinci-assisted procedures as compared to laparoscopic procedures.

					Oophorectomy, Lymphadenectomy
Publications		Operative Time(minutes)	Transfusions(%)	Length of Stay(days)	Complications(%)
1. Gaia (2010)	da Vinci	207 – 219	1.7 - 2.6	1.2 - 1.4	2.0 - 3.8
(Simple Total)	Open	130	7.2	3.9	14.5
	Lap	209	5.0	1.9	3.8
2a. Reza (2010)	da Vinci	177 - 283	0 - 5	1.0-2.3	7.1 - 8.3
(Simple Total)	Open	79 - 146.5	1.5 - 15	3.2 - 5.3	27.0
	Lap	171.1 - 255	2.5 - 10	1.2 - 2.0	13.0
2b. Reza (2010)	da Vinci	144 - 290	0 - 7.5	1.0-3.7	13.9 - 30.4
(Radical)	Open	114 - 247.8	8.2 - 35.7	3.2 - 5.6	19.4
	Lap	132 - 220.4	0	2.3 - 2.4	30.2
3. O'Sullivan (2011)	da Vinci	173 - 231	6	1.5 - 1.9	18
(Simple Total, Radical)	Open	181	27	4.4	36
	Lap	161	10	1.9	26
4a. O'Neill (2012)	da Vinci	242	5	3.7	21
(Simple Total)	Open	79 - 187.9	0 - 42.9	3.0 - 10.8	13.2 - 33.0
	Lap	82.9 - 287.0	0 - 16	1.2 - 7.7	2.5 - 21.9
4b. O'Neill (2012)	da Vinci	202	4	1.7	11
(Radical)	Open	114 - 283	8.2 - 42.5	2.8 - 9.5	4.7 - 70.8
	Lap	132 - 300	0	2.2 - 8.0	23.5 - 85.7
5. Ran (2015)	da Vinci	96.7 - 331.8	1.0-3.8	1.0 - 7.9	8.4 - 13.2
(Simple Total)	Open	79 - 187.9	10.0	4.0 - 10.8	35.6
	Lap	80 - 287	1.7	1.2 - 8.1	13.2
6. Geetha (2012)	da Vinci	253.6	2.1	3.1	3.9~
(Radical)	Open	219.7	25.2	8.4	18.2~
	Lap	259.7	5.3	5.6	6.6~
7. Shazly (2015)	da Vinci	144 - 383	3.4 - 4.0	1.7 - 13.5	17.1 - 22.4
(Radical)	Open	114 - 302.9	17.3	4.0 - 16.9	16.8
	Lap	132 - 364.2	6.6	2.0 - 10.0	20.2

TABLE 1: da Vinci vs. Open and da Vinci vs. Laparoscopic Hysterectomy (Radical), Salpingectomy,

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Publications		Operative Time(minutes)	Transfusions(%)	EBL(mL)	Length of Stay(days)	Complications(%)
8. Pundir (2013)	da Vinci	181 – 231.4	0 – 5	100 – 370	0.5 – 1.5	0 – 11.1
	Open	92.5 – 161.7	6.4 – 14.3	NA^^	3.0 – 3.6	0.3 – 13.0
	Lap	115 – 203	0 – 0.9	85.3 – 420	1.0 – 3.0	0.9 – 2.5
9. Barakat (2011)*	da Vinci		2.2	100
	Lap		0	150
10. Bedient (2009)*	da Vinci		4.8	100
	Lap		5.0	250
11. Gargiulo (2012)*	da Vinci		5.7	112.2
	Lap		0.9	85.3
12. Nezhat (2008)*	da Vinci		0	370
	Lap		0	420
13. Hsaio (2013)*	da Vinci		20	175
	Lap		14	200
14. Pluchino (2013)*	da Vinci		0	125.8
	Lap		4.6	222.1
15. Gobern (2013)*	da Vinci		6	100
	Lap		12	100
16. Gocmen (2013)*	da Vinci		NotReported^	101.33
	Lap			119.78
17. Behera (2011)*	da Vinci		0	NotReported
	Lap		0	Reported

TABLE 2: da Vinci vs. Open and da Vinci vs. Laparoscopic Myomectomy

TABLE 3: da Vinci vs. Open and da Vinci vs. Laparoscopic Sacrocolpopexy

Publications		Operative Time(minutes)	Transfusions(%)	Length of Stay(days)	Complications(%)
18. Serati (2014)	da Vinci	265	0.9	1.5	17.1
	Open	212	<1	3.0	27.6
	Lap	206	1.4	1.2	12.6
19. Paraiso (2011)	da Vinci	265	Not Reported	43 hours	Not Reported**
	Lap	199	Not Reported	34 hours
20. Anger (2014)	da Vinci	202.8	Not Reported	Not Reported	15
	Lap	178.4	Not Reported	Not Reported	26
21. Flack (2015)	da Vinci	Not Reported	Not Reported	1.0	8.0
	Lap	Not Reported	Not Reported	2.0	7.0

^Rates reported are for "Infectious" complications; Non-infectious complication rates were 7.8%, 19.4% and 18.3% for the da Vinci-assisted, open and lap cohorts, respectively.

*Transfusion and/or EBL (estimated blood loss) data only were provided for this publication.

**Not Reported but publication states that there were no differences in intraoperative complications. ^Transfusion rates not reported.

^^EBL volumes not provided. Author states "Pooled results showed that the mean EBL was significantly lower in the RLM group compared with the AM group."

Covered Procedures

The published data on the above cited umbrella procedures were used to support clearance of the following covered procedures: Endometriosis Resection, Adnexectomy, Omentectomy, Lysis of Adhesions, Cyst Removal and Parametrectomy.

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VIII. CONCLUSION

Based on the information provided in this premarket notification, the inclusion of the following additional representative, specific procedures under the da Vinci Xi Surgical System "gynecologic laparoscopic surgical procedure" general indication is substantially equivalent to the predicate devices: Hysterectomy (Radical, Hysterectomy for Benign Disease2), Salpingectomy, Oophorectomy, Lymphadenectomy, Myomectomy, Sacrocolpopexy, Endometriosis Resection, Adnexectomy, Omentectomy, Parametrectomy, Cyst Removal, and Lysis of Adhesions.

The demonstration of safety and effectiveness was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to treatment of cancer (overall survival, disease-free survival, local recurrence).

2 "Hysterectomy" was previously cleared as a representative, specific procedure for the do Vinci Xi Surgical System under K131861.

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.