da Vinci Xi Surgical System

K161178 · Intuitive Surgical, Inc. · NAY · Jan 19, 2017 · Gastroenterology, Urology

Device Facts

• Record ID: K161178
• Device Name: da Vinci Xi Surgical System
• Applicant: Intuitive Surgical, Inc.
• Product Code: NAY · Gastroenterology, Urology
• Decision Date: Jan 19, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

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, 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 laparosopic 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 Story

The da Vinci Xi Surgical System (Model IS4000) is a computer-controlled, electro-mechanical system for minimally invasive surgery. It comprises a Surgeon Console, Patient Side Cart, and Vision Side Cart. The surgeon operates the system from the console, controlling EndoWrist instruments and endoscopes to perform complex tissue manipulation. The system translates surgeon hand movements into precise instrument actions at the surgical site. It is used in operating rooms by trained physicians. This submission specifically expands the labeled representative procedures under the existing urologic indication to include radical/partial prostatectomy, nephrectomy, and cystectomy, among others. The system provides enhanced visualization and instrument dexterity, potentially reducing blood loss, hospital stay, and complication rates compared to traditional open or laparoscopic approaches.

Clinical Evidence

Clinical evidence consists of a systematic review of 61 published studies (prospective RCTs, meta-analyses, database studies) comparing da Vinci-assisted procedures to open and laparoscopic techniques for 'umbrella' procedures (radical prostatectomy, nephrectomy, cystectomy). Results consistently show da Vinci-assisted procedures have comparable or lower mortality, blood transfusion rates, and hospital stays. Complication rates were generally comparable, with some studies noting increased operative times that did not correlate with adverse clinical outcomes. Data for 'covered' procedures were extrapolated from these umbrella procedure findings.

Technological Characteristics

Software-controlled, electro-mechanical system. Components: Surgeon Console, Patient Side Cart, Vision Side Cart, EndoWrist instruments, and rigid endoscopes. No changes to materials or hardware from predicate. Connectivity: System-integrated. Sterilization: Compatible with standard surgical instrument sterilization protocols.

Indications for Use

Indicated for adult and pediatric patients undergoing urologic, general laparoscopic, gynecologic laparoscopic, general thoracoscopic, and thoracoscopically-assisted cardiotomy procedures, including coronary anastomosis via adjunctive mediastinotomy. Used for tissue manipulation (grasping, cutting, dissection, approximation, ligation, electrocautery, suturing) and delivery of ablation probes.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• da Vinci Surgical System, Model IS4000 (K131861, K152578)
• da Vinci Surgical System, Model IS3000 (K081137, K123463, K090993)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are rendered in a dark color, creating a sense of depth and unity. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

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

January 19, 2017

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

Re: K161178

Trade/Device Name: Da Vinci Xi Surgical System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: NAY Dated: April 22, 2016 Received: April 26, 2016

Dear Ms. 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 of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

{1}------------------------------------------------

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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

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

Sincerely yours,

# Jennifer R. Stevenson -S

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

{2}------------------------------------------------

# DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

# 510(k) Number (if known)

K161178

#### 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, 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 laparosopic 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)

| <span></span> | Prescription Use (Part 21 CFR 801 Subpart D) |
|---------------|----------------------------------------------|
|---------------|----------------------------------------------|

| <span></span> | 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:

> 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."

{3}------------------------------------------------

# 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: [phone] |
| | Fax: [phone] |
| | Email: [e-mail] |
| Date Summary Prepared: | January 18, 2017 |
| 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, K152578) Intuitive Surgical da Vinci 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 procedures under the cleared "urologic surgical procedures" general indication for the da Vinci Xi Surgical System (K131861): Prostatectomy (Radical), Nephrectomy (Partial, Radical), and Cystectomy (Radical, Partial), Donor Nephrectomy, Cyst Removal, Ureteral Implantation, Lysis of Adhesions and Lymphadenectomy. 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, electro-mechanical 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.

# V. INDICATIONS FOR USE

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 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

{4}------------------------------------------------

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 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 eight (8) evaluations in a total of 31 animals demonstrating use of do Vinci Xi Surgical System in the following procedures: Nephrectomy, Pyeloplasty, Hysterectomy and Salpingectomy/Oophorectomy (Adnexectomy), Nissen Fundoplication, Colectomy and Mitral Valve Repair. These data were previously submitted in support of clearance of the da Vinci Xi Surgical System, the da Vinci Xi Vessel Sealer, the da Vinci Xi Stapler 30 and the da Vinci Xi labeling modification to add specific procedures under the gynecologic laparoscopic surgical procedures general indication and the general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures general indication (K131861, K140189, K152241, K152578 and K153276) 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 "urologic 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: Prostatectomy (Radical), Nephrectomy (Partial, Radical), and Cystectorny (Radical). Sixty-one (61) publications were identified for these umbrella procedures based on specific search criteria and filters. These publications included

{5}------------------------------------------------

prospective randomized controlled trials, meta-analyses, systematic reviews, Health Technology Assessments (HTAs), large database studies and comparative studies. A detailed summary of the published clinical data on these procedures is provided in Tables 1-4 below.

The findings from the Prostatectomy (Radical) publications show that da Vinci-assisted procedures are associated with comparable or lower mortality rates; comparable or lower blood transfusion rates and EBL volumes; comparable or shorter lengths of hospital stay; comparable or lower intraoperative and postoperative complication rates; comparable rates of positive surgical margins; comparable or higher potency and continence rates; and, comparable or shorter operative times as compared to both open and laparoscopic surgical procedures. Several 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 mortality or complication rates. Additionally, these publications report comparable or lower conversion rates for da Vinci-assisted procedures as compared to laparoscopic procedures. One publication reported a higher intraoperative complication rate for da Vinci-assisted procedures as compared to open procedures'; one publication reported a higher postoperative complication rate for da Vinci-assisted procedures as compared to laparoscopic procedures '; and one publication reported a higher surgical margin rate for da Vinci-assisted procedures as compared to laparoscopic procedures.3

Outcomes reported in the Nephrectomy (Partial) publications demonstrate that da Vinci-assisted procedures are associated with comparable or lower mortality rates; comparable or lower blood transfusion rates and EBL volumes; comparable or shorter lengths of hospital stay; comparable or lower intraoperative and postoperative complication rates; comparable rates of positive surgins; comparable or shorter warm ischemia times; and, comparable or shorter operative times as compared to both open and laparoscopic surgical procedures. Several 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 mortality or complication rates. Additionally, these publications report comparable or lower conversion rates for da Vinci-assisted procedures as compared to laparoscopic procedures. Two publications reported higher warm ischemia times for da Vinci-assisted procedures as compared to open procedures.4

^ี With regards to the higher intraoperative complication rate, "Univariate analysis confirmed pre- and postoperative risk category, surgical technique and annual caseload to be significant contributors to intraoperative complication rate; however, only laparoscopic technique was significant on multivariate analysis [hazard ratio (HR) 2.45, 95% Cl 1.65-3.62, P < 0.001]."

^´ The authors note, "We can say that once the learning curve is completed, LRP (laparoscopic radical prostatectorny) and RALP (robot-assisted radical prostatectomy) can be performed without a significations and with better results than RRP (retropubic radical prostatectomy)."

^ី The PSM rate was higher for the robotic cohort, however, the rates were similar (22.5% R vs. 22.2% L), and there was no difference in <=pT2 rates or >=pT3 rates, and no difference in biochemical recurrence (OR 1.15, p=0.9).

^&quot; The robotic cohort had a WIT of 18.9 minutes. Hadjipavlou, et al (B10) states: "The strongest surgical risk factor for CKD is ischaemia time; current data supports safe warm ischaemia time to be less than 20 minutes and cold ischaemia time up to 2 hours". The WIT reported for the robotic cohort was within the safe WIT of < 20 minutes. "Our primary analysis showed that OPN had the shorter WIT compared with RAPN. However, the sensitivity analysis showed no significant difference. Furthermore, there was no difference between the two groups regarding postoperative eGFR decline. Although WIT is an important predictor of postoperative renal function, it certainly is not the only factor. In experienced hands and appropriate patient selection, the WIT of RAPN can be controlled to less than 20 minutes. So the marginal difference of WIT between RAPN and OPN may not have much clinical significance for patients with adequate renal reserve."

{6}------------------------------------------------

The data provided in the Nephrectomy (Radical) publications show that da Vinci-assisted procedures are associated with comparable or lower mortality rates; comparable or lower blood transfusion rates; comparable EBL volumes; comparable or shorter lengths of hospital stay; and, comparable or lower intraoperative and postoperative complication rates; and, comparable or shorter operative times as compared to both open and/or laparoscopic surgical procedures. Additionally, these publications report comparable operative times and conversion rates for da Vinci-assisted procedures as compared to laparoscopic procedures. One publication reported a higher blood transfusion rate for da Vinci-assisted procedures as compared to open and laparoscopic procedures ; one publication reported a longer length of stay and a higher "any" complication rate for da Vinci-assisted procedures as compared to laparoscopic procedures.6

The findings from the Cystectomy (Radical) publications show that da Vinci-assisted procedures are associated with comparable or lower mortality rates; comparable or lower blood transfusion rates and EBL volumes; comparable or shorter lengths of hospital stay; comparable or lower intraoperative and postoperative complication rates; comparable rates of positive surgical margins; and, comparable operative times as compared to both open and laparoscopic surgical procedures. Several 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 mortality or complication rates. One publication reported conversion rates for da Vinci-assisted procedures as compared to laparoscopic procedures. One publication reported a higher post operative 90-day complication rate for da Vinci-assisted procedures as compared to open procedures. '

^້ The authors state, "The higher transfusion rate of nephrectorny with RALS (robotic assisted laparoscopic surgery) may be related to the relative infrequency of use compared with RALS for the other 3 procedures and to the overall nephrectomy volume, which may reflect a learning curve effect." (Note: this publication reported results from four (4) procedures: 1) Nephrectomy; 2) Radical Prostatectomy; 3) Partial Nephrectomy; and, 4) Pyeloplasty).

⁶ The higher "any" complication rate for the robotic cohort was not associated with higher mortality or transfusion rates. 7 The higher 90 day "any" complication rate reported in Leow for the da Vinci cohort did not result in a higher 90 day mortality rate; the mortality rate for the da Vinci cohort was significantly lower.

{7}------------------------------------------------

| TABLE 1: da Vinci vs. Open and da Vinci vs. Laparoscopic Prostatectomy (Radical) | | | |
|----------------------------------------------------------------------------------|--|--|--|
|----------------------------------------------------------------------------------|--|--|--|

| Publications | | Sample Size<br>(N) | Operative Time<br>(minutes) | Transfusions (%)<br>or EBL (ml) | Length of Stay<br>(days) | PostOp Complications<br>(%) | | | | | | | |
|-----------------------------|----------|--------------------|-----------------------------|---------------------------------|--------------------------|-----------------------------|--|-----|-----|-----|--|--|-----|
| A1. Pan (2014) | da Vinci | 798 | 220.0 - 330.0 | 0.94 - 16.88% | | 1.4 / 5.8* | | | | | | | |
| | Open | 1571 | 151.0 - 289.0 | 1.99 - 65.0% | Not Reported | 2.6 / 12.2* | | | | | | | |
| A2. Trinh (2013) | da Vinci | 11,889 | | 1.95% | 12.86%** | 0.36 / 8.20 | | | | | | | |
| | Open | 7389 | Not Reported | 7.74% | 39.56% | 0.99 / 11.14 | | | | | | | |
| A3. Davis (2013) | da Vinci | 27,348 | 264.0 | 2.3% | 2.2 | 10.6 | | | | | | | |
| | Open | 30,124 | 204.0 | 11.5% | 3.4 | 15.8 | | | | | | | |
| A4. Pilecki (2013) | da Vinci | 4,374 | 212.3 | 1.87% | | 5.62 | | | | | | | |
| | Open | 1,097 | 174.0 | 17.68% | Not Reported | 23.2 | | | | | | | |
| A5. Ellimoottil<br>(2014) | da Vinci | 5,503 | | 2.2% | 19.4%^ | 2.1 / 16.6 | | | | | | | |
| | Open | 3,605 | Not Reported | 11.2% | 46.3%^ | 3.5 / 21.6 | | | | | | | |
| A6. Asimakopoulos<br>(2011) | da Vinci | 64 | Not Reported | 0% | Not Reported | 8 | | | | | | | |
| | Lap | 64 | | 5% | | 15 | | | | | | | |
| A7. Porpiglia<br>(2012) | da Vinci | 60 | 147.6 | 202.0 ml | 4.6 | 16.6 | | | | | | | |
| | Lap | 60 | 138.1 | 234.1 ml | 4.8 | 11.6 | | | | | | | |
| A8. Robertson<br>(2013) | da Vinci | 6,768 | 225 | 3.5% | Not Reported | 0.5 - 3.9** | | | | | | | |
| | Lap | 4,952 | 239 | 5.0% | | 0.8 - 7.2** | | | | | | | |
| A9. Novara (2012) | da Vinci | 2,446/977 | 153.0 - 330.0 | 0 - 13.33% | 1.9 | 1.89 - 41.67 | | | | | | | |
| | Open | 2,843 | 127.0 - 289.0 | 1.67 - 80.65% | 5.5 - 17.0 | 0.97 - 83.87 | | | | | | | |
| | Lap | 903 | 159.5 - 267.0 | 0 - 48.57% | 2.6 - 16.4 | 7.06 - 74.29 | | | | | | | |
| A10. Tewari (2012) | da Vinci | 62,389 | | 1.8% | 1.4 | 7.8 | | | | | | | |
| | Open | 167,184 | Not Reported | 16.5% | 3.1 | 17.9 | | | | | | | |
| | Lap | 57,303 | | 4.7% | 2.1 | 11.1 | | | | | | | |
| A11. DeCarlo<br>(2014) | da Vinci | 4,044 | 187.91 | 4.66% | 5.87 | 18.52 | | | | | | | |
| | Open | 7,047 | 179.03 | 19.93% | 7.87 | 23.2 | | | | | | | |
| | Lap | 2,841 | 236.54 | 6.3% | 9.02 | 13.42 | | | | | | | |
| A12. Moran (2013) | da Vinci | 1,581 | 160 - 341 | 0 - 20.0% | 1.0-8.0 | 2.13 - 22.86 | | | | | | | |
| | Open | 1,365 | 127.2 - 330 | 0-90.0% | 1.3 - 17.0 | 4.79 - 40.0 | | | | | | | |
| | Lap | 2,166 | 160.0 - 264.0 | 0-9.8% | 1.76 - 6.1 | 6.34 - 9.02 | | | | | | | |
| A13. Yu (2012) | da Vinci | 11,506 | | 1.6% | 1.7 | 8.4 | | | | | | | |
| | Open | 9,694 | Not Reported | 5.2% | 2.4 | 10.1 | | | | | | | |
| | Lap | 611 | | ≤ 1.8% | 2.0 | 14.5 | | | | | | | |
| A14. Laird (2015) | da Vinci | 424 | | 0% | 2.5 | 10.3 | | | | | | | |
| | Open | 558 | Not Reported | 2.7% | 4.7 | 8.8 | | | | | | | |
| | Lap | 1181 | | 0.4% | 2.9 | 14.6 | | | | | | | |
| A15. Gandaglia<br>(2014) | da Vinci | 3476 | Not Reported | 1.9% | 1 | 22.2 | | | | | | | |
| | Open | 2439 | | 8.9% | 2 | 23.8 | | | | | | | |
| A16. Hyams<br>(2013) | da Vinci | 1499 | | Not Reported | 1.7 | Not Reported | | | | | | | |
| | Open | 2565 | | | 1.9 | | | | | | | | |
| A17. Kim (2013) | da Vinci | 20,424 | | Not Reported | 1 | 8.2 | | | | | | | |
| | Open | 9413 | | | 2 | 11.3 | | | | | | | |
| A18. Lundstrom<br>(2016)## | da Vinci | 7256 | | Not Reported | | 0.07, 0.08, 0.06 | | | | | | | |
| | Open | 9787 | | | | 0.01, 0.02, 0 | | | | | | | |
| A19. Monn<br>(2016) | da Vinci | 9248 | 210 | | 1 | | | | | | | | |
| | Open | 3206 | 162 | Not Reported | 2 | Not Reported | | | | | | | |
| A20. Pearce (2016) | da Vinci | 73,131 | | | 11.6%~ | | | | | | | | |
| | Open | 23,804 | | Not Reported | 39.0%~ | Not Reported | | | | | | | |
| A21. Seo (2016) | da Vinci | 15,766 | 32 - 341 | 0 - 20.0 | 1 – 9 | | | | | | | | |
| | Open | 16,628 | 74 – 289 | 1.7 - 90 | 1 - 17 | Not Reported | | | | | | | |
| A22. Yaxley (2016) | da Vinci | 157 | 202.03 | 0.6 | 1.55 | 3.8 | | | | | | | |
| | Open | 151 | 234.34 | 4.0 | 3.27 | 9.3 | | | | | | | |
| A23. Huang<br>(2016) | da Vinci | 4114 | 145.5 - 280.8 | 0 – 7.6 | 2.2 - 6.4 | 3.6 - 21.0 | | | | | | | |
| | Lap | 5064 | 118.1 - 283.2 | 0 - 25.1 | 2.2 - 6.6 | 6.0 - 42.6 | | | | | | | |
| A24. Weiner<br>(2015) | da Vinci | 82,338 | | | | | | | | | | | |
| | Lap | 5077 | | | Not Reported | | | | | | | | |
| A25. Anderson<br>(2012) | da Vinci | 12,588 | | | 1.7 (vs. O), 1.9 (vs. L) | | | | | | | | |
| | Open | 8968 | | Not Reported | 2.5 | Not Reported | | | | | | | |
| | Lap | 547 | | | 1.8 | | | | | | | | |
| A26. Basto (2016) | da Vinci | 233 | | 0% | 1.4 | | | | | | | | |
| | Open | 882 | Not Reported | 6% | 3.6 | Not Reported | | | | | | | |
| | | Lap | Lap | 233 | 233 | | | 15% | 15% | 4.8 | | | 4.8 |
| A27. Stolzenburg | da Vinci | 2495 | | 2.6% | | 4.6 | | | | | | | |
| (2016) | Open | 14,741 | Not Reported | 12.4% | Not Reported | 5.4 | | | | | | | |
| | Lap | 2831 | | 3.8% | | 3.9 | | | | | | | |

{8}------------------------------------------------

| Publications | | Sample Size<br>(N) | Operative Time<br>(minutes) | Transfusions (%)<br>or EBL (ml) | Length of Stay<br>(days) | PostOp Complications<br>(%) |
|---------------------------|-----------------|--------------------|-----------------------------|---------------------------------|--------------------------|-----------------------------|
| A28. Sugihara<br>(2014)^^ | <i>da Vinci</i> | 2126 | 322 | Auto: 12.2% Homo: 0.7% | 11 | 0.8 |
| | Open | 7202 | 268 | Auto: 82.6% Homo: 7.3% | 14 | 5.3 |
| | Lap | 2483 | 329 | Auto: 41.8% Homo: 2.3% | 11 | 3.9 |
| A29. Wen (2014) | <i>da Vinci</i> | 61,656 | Not Reported | Not Reported | Odds Ratio 0.4# | Not Reported |
| | Open | 111,361 | Not Reported | | | |

*Complication rates reported for: Bladder Neck Dissection / Inguinal Hernia; ^Percentage of cases with prolonged length of stay > 2 days reported; **Range includes complications reported for Clavin I – IV; ^^Sugihara reports anesthesia time and postoperative complications. "Wen, et al reports odds ratio only; * Rates reported for abdominal wall defects, wound dehiscence surgery and peritoneal drainage. ; " Percentage of patients with LOS of 2 or more days

|--|

| Publications | | Sample Size (N) | Operative Time (minutes) | Transfusions (%) or EBL (ml) | Length of Stay (days) | PostOp Complications (%) |
|----------------------------|----------|-----------------|--------------------------|------------------------------|-----------------------|----------------------------------|
| B1. Aboumarzouk<br>(2012) | da Vinci | 313 | 152.17 – 233 | 122.4 – 368 ml | 2.51 – 6.2 | 0 – 33.3 |
| | Lap | 404 | 117.5 – 226.05 | 136.7 – 580 ml | 2.2 – 5.3 | 0 – 33.3 |
| B2. Choi (2015) | da Vinci | 1,152 | 140 – 376 | 93.3 – 368 ml | 2 – 6.2 | 10.91 – 37.03*<br>2.67 – 11.11** |
| | Lap | 1,088 | 156 – 293 | 100 – 400 ml | 2 – 6.9 | 6.67 – 30.56*<br>0 – 15.56** |
| B3. Froghi (2013) | da Vinci | 101 | 153.2 – 242 | 139.2 – 355.7 ml | 2.8 – 6.2 | 8.53 – 18.52 |
| | Lap | 155 | 117.5 – 256 | 146.3 – 456.3 ml | 2.95 – 5.3 | 0 – 20.34 |
| B4. Mir (2011) | da Vinci | 477 | 188 | Not Reported | 2.6 | Not Reported |
| | Lap | 2,220 | 200 | Not Reported | 3.2 | Not Reported |
| | Open | 2,745 | 193 | Not Reported | 5.9 | Not Reported |
| B5. Zhang (2013) | da Vinci | 425 | 151.17 – 233 | 122.40 – 323.00 ml | 2.51 – 6.20 | 0 – 22.22 |
| | Lap | 341 | 117.50 – 226.50 | 146.30 – 387.50 ml | 2.71 – 6.80 | 0 – 31.11 |
| B6. Zhang (2014) | da Vinci | 705 | 152 – 376 | 100 – 368 ml | 2 – 6.2 | 0.78 – 26.63*<br>2.67 – 7.75** |
| | Lap | 835 | 117.5 – 361 | 150 – 400 ml | 2 – 14 | 2.54 – 30.56*<br>1.33 – 11.76** |
| B7. Wu (2014) | da Vinci | 757 | 168 – 231.8 | 3.81 – 7.91% | 2.5 – 6.2 | 9.52 – 40.66 |
| | Open | 2661 | 123 – 238.8 | 4.7 – 10.61% | 4.5 – 18 | 13.79 – 54.21 |
| B8. Ghani (2014)^ | da Vinci | 9095 | Not Reported | 5.8% | 12.4% | 22.1 |
| | Lap | 3508 | Not Reported | 7.1% | 17.6% | 24.9 |
| | Open | 25,461 | Not Reported | 10.6% | 34.8% | 30.5 |
| B9. Kates (2015) | da Vinci | 1078 | Not Reported | | 2.51 | Not Reported |
| | Lap | 282 | Not Reported | | 3.0 | Not Reported |
| B10. Hadjipavlou<br>(2016) | da Vinci | 83 | 179 | 272 mL | | 16.0 |
| | Lap | 192 | 159 | 322 mL | Not Reported | 16.3 |
| | Open | 412 | 126 | 335 mL | Not Reported | 18.5 |
| B11. Leow (2016) | da Vinci | 2671 | 108 – 376 | 88 – 490 ml | 2.51 – 10.9 | 0 – 30.8 |
| | Lap | 2238 | 111 – 361 | 61 – 626 ml | 2.0 – 14.0 | 4.8 – 27.8 |
| B12. Xia (2016) | da Vinci | 1216 | 122.3 – 263.0 | 0 – 14.5% / 57.5-322ml | 1.51 – 9.67 | 0 – 25.5 |
| | Open | 2335 | 123.0 – 288.7 | 0 – 37.8% / 183.33-653.6ml | 2.47 – 18.0 | 0 – 30.1 |

*Minor complications; **Major complications; ^Ghani reports prolonged length of stay.

# TABLE 3: da Vinci vs. Open and da Vinci vs. Laparoscopic Nephrectomy (Radical)

| Publications | Sample<br>Size (N) | Operative Time<br>(minutes) | Transfusions<br>(%) | Length of Stay<br>(days) | PostOp Complications<br>(%) |
|------------------------|--------------------|-----------------------------|---------------------|--------------------------|-----------------------------|
| C1. Yu (2012) | da Vinci<br>327 | Not Reported | 23.5 | 5.2 | 29.9 |
| | Lap<br>2,601 | | 7.4 | 4.2 | 33.8 |
| | Open<br>11,287 | | 14.1 | 5.9 | 37.4 |
| C2. Yang (2014) | da Vinci<br>7,787 | Not Reported | Not Reported | 3.0, IQR* 2-4 | 11.0 |
| | Lap<br>16,525 | | | 3.0, IQR* 2-5 | 12.0 |
| C3. Kates (2015) | da Vinci<br>376 | Not Reported | Not Reported | 3.52 | 4.0^ |
| | Lap<br>1,098 | | | 4.0 | 4.0^ |
| C4. Boger (2010) | da Vinci<br>13 | 168.0 | Not Reported | 2.0 | 15.4 |
| | Lap<br>46 | 171.0 | | 2.0 | 2.2 |
| C5. Weinberg<br>(2016) | da Vinci<br>5,849 | Not Reported | 4.5 | 2.12 | 27.8 |
| | Lap<br>18,329 | | 4.7 | 2.04 | 26.4 |
| | Open<br>100,284 | | 7.1 | 3.89 | 35.3 |
| C6. Park (2012) | da Vinci<br>20 | Not Reported | Not Reported | 6 | Not Reported |
| | Lap<br>20 | | | 7.4 | |
| | Open<br>20 | | | 8 | |

*IQR = Interquartile Range; ^Readmission rates provided in study publication.

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

| Publications | | Study Size<br>(N) | Operative Time<br>(minutes) | Transfusions(%)<br>or EBL (ml) | Length of Stay<br>(days) | PostOp Complications<br>(%) |
|-------------------|----------|-------------------|-----------------------------|--------------------------------|--------------------------|-----------------------------|
| D1. Ishii (2014) | da Vinci | 461 | 252 - 455 | 2-40 | Not Reported | 25.0 - 66.34 |
| | Open | 287 | 211 - 393 | 19 - 50 | | 25.0 - 61.54 |
| D2. Li (2013) | da Vinci | 364 | 252 - 606 | 2 - 52.63 | 4.4 - 40.2 | 33.33 - 66 |
| | Open | 598 | 210-420 | 24 - 71.43 | 5.3 - 37.0 | 50 - 73.33 |
| D3. Novarra | da Vinci | 565/ 62 | 308 - 638 | 4.17 - 57.14 | 8.0 - 40.2 | 15.38 - 83.33 |
| (2015) | Open | 943 | 259 - 507 | 24.0 - 86.96 | 8.0 - 37.0 | 16.67 - 78.57 |
| | Lap | 78 | 316-419 | 25.9 - 70.0 | 9.4 - 16 | 55.0 - 81.0 |
| D4. Tang (2014) | da Vinci | 382 | 252 - 638 | 0-53.85 | 5.0 - 40.2 | 15.38 - 66.0 |
| | Open | 510 | 211.2 - 507 | 30.30 - 86.96 | 6.0 - 27.0 | 16.67 - 85.00 |
| D5. Xia (2015) | da Vinci | 787 | 285.5 - 606 | 4.0 - 52.53 | 5.5 - 28.9 | 40.96 - 66 |
| | Open | 992 | 222 - 500.6 | 24.0 - 80.95 | 8 - 27.1 | 58.65 - 73.33 |
| D6. Bochner | da Vinci | 60 | 456 | 516 ml | 8.0 | 62.0 |
| (2014) | Open | 58 | 329 | 676 ml | 8.0 | 66.0 |
| D7. Messer (2014) | da Vinci | 20 | 300 | 40% / 400 ml | 6.0 | 25.0 |
| | Open | 20 | 285.5 | 50% / 800 ml | 6.0 | 25.0 |
| D8. Fonseka | da Vinci | 728 | 252 - 638 | 212 – 422 ml | 5.1 - 40.2 | 28.0 |
| (2015) | Lap | 276 | 300 - 419 | 331 - 653 ml | 9.13 - 16.1 | 72.1 |
| | Open | 1100 | 211 - 507 | 398 - 1790 ml | 6-37.0 | 47.2 |
| D9. Khan (2015) | da Vinci | 20 | 389 | 585 ml | 11.96 | 55 |
| | Lap | 19 | 301 | 460 ml | 9.7 | 26 |
| | Open | 20 | 293 | 808 ml | 14.4 | 70 |
| D10. Bagi (2016) | da Vinci | 348 | Not Reported | | 8 - 15.5 | Not Reported |
| | Open | 1509 | | | 9 - 32 | |
| D11. Hu (2016) | da Vinci | 439 | Not Reported | RR 0.97 (0.96 - 0.98) | 10.1 | Not Reported |
| | | Open | | | 7308 | |
| D12. Leow (2014) | da Vinci | 2667 | 386 | Not Reported | 10.2 | Any 90d: 59.7 |
| | | Open | 40,980 | | 338 | 11.8 |
| D13.Mantulewicz | da Vinci | 2397 | Not Reported | | | |
| (2016) | Open | 9639 | | | | |
| D14. Monn (2014) | da Vinci | 3733 | Not Reported | | 7 | Any in-hospital: 33.2 |
| | | Open | | | 25,986 | 8 |

#### TABLE 4: da Vinci vs. Open and da Vinci vs. Laparoscopic Cystectomy (Radical)

# Covered Procedures

The published data on the above cited umbrella procedures were used to support clearance of the following covered procedures: Cystectomy (Partial), Donor Nephrectomy, Cyst Removal, Ureteral Implantation, Lysis of Adhesions and Lymphadenectomy.

# 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 "urologic surgical procedure" general indication is substantially equivalent to the predicate devices: Prostatectomy (Radical), Nephrectomy (Partial, Radical), and Cystectomy (Radical, Partial), Donor Nephrectomy, Cyst Removal, Ureteral Implantation, Lysis of Adhesions and Lymphadenectomy.