da Vinci Xi Surgical System

K153276 · Intuitive Surgical, Inc. · NAY · Aug 7, 2016 · Gastroenterology, Urology

Device Facts

• Record ID: K153276
• Device Name: da Vinci Xi Surgical System
• Applicant: Intuitive Surgical, Inc.
• Product Code: NAY · Gastroenterology, Urology
• Decision Date: Aug 7, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic, Real-World Evidence, Pediatric

Real-World Evidence

Submission	Device	Sponsor	RWD Sources	RWE Use Summary	Key Tags
K153276 · Aug 7, 2016	da Vinci Xi Surgical System	Intuitive Surgical, Inc.	Published clinical literature (retrospective, comparative, and single-arm studies)	The sponsor utilized published clinical data from routine surgical practice to demonstrate substantial equivalence for additional representative procedures (Lobectomy, Mediastinal Mass Resection, Thymectomy, Segmentectomy, Wedge Resection, and Lymphadenectomy) under the existing thoracoscopic surgical indications.	Retrospective studies; Comparative studies; Single-arm studies; Thoracoscopic surgery; Lobectomy; Thymectomy

Clinical Evidence

Study Design	Population	Comparator	Key Endpoints
Lobectomy Umbrella Procedure Literature Review; Retrospective, comparative, and single-arm studies	Patients undergoing lobectomy; Sample Size: Varies by study (e.g., da Vinci N=2,498 in Paul 2014)	Open surgical procedures and VATS	Mortality, complications, blood transfusion rates, length of hospital stay, operative time, conversion rates
Mediastinal Mass Resection Umbrella Procedure Literature Review; Retrospective, comparative, and single-arm studies	Patients undergoing mediastinal mass resection; Sample Size: Varies by study (e.g., da Vinci N=75 in Cerfolio 2012)	Open surgical procedures	Mortality, operative times, complication rates, length of hospital stay, conversion rates, transfusion rates
Thymectomy Umbrella Procedure Literature Review; Retrospective, comparative, and single-arm studies	Patients undergoing thymectomy; Sample Size: Varies by study (e.g., da Vinci N=125 in Keijzers 2014)	Open surgical procedures and VATS	Mortality, complication rates, length of hospital stay, transfusion rates, operative times, conversion rates

Indications for Use

The Intuitive Surgical Endoscopic Instrument Control System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, 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 system translates surgeon hand movements at the console into precise movements of EndoWrist instruments and endoscopes inside the patient. Used in operating rooms by trained physicians, the system facilitates complex procedures like lobectomy, thymectomy, and mediastinal mass resection. It provides high-definition visualization and ergonomic control, potentially reducing patient trauma and recovery time compared to traditional open surgery. This submission specifically expands the cleared indications to include additional thoracic procedures.

Clinical Evidence

Clinical evidence consists of a literature review of 40 publications covering 'umbrella' procedures (Lobectomy, Mediastinal Mass Resection, Thymectomy). Studies included retrospective, comparative, and single-arm designs. Results indicate da Vinci-assisted procedures have comparable or lower mortality, complication rates, and lengths of stay compared to open or VATS procedures. Operative times were variable, sometimes longer than VATS, but did not correlate with increased mortality. Animal data from 20 animals supported lung resection and lobectomy use.

Technological Characteristics

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

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, dissection, suturing, and ablation probe placement.

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.

In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls: 1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following: 1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures. 2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use. 3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use. 2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes. 3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches 4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error. 5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program. (6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms. (7) Labeling must include: (i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified; (ii) A statement in the labeling that the 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 the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA; (iii) Identification of compatible devices; (iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification; (v) Reprocessing instructions for reusable components; (vi) A shelf life for any sterile components; (vii) A description of the device-specific use training program; (viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and (ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance. (8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include: (i) Device motion accuracy and repeatability; (ii) System testing; (iii) Instrument reliability; (iv) Crosstalk; (v) Table motion control; (vi) Thermal effects on tissue; (vii) User-device interface performance; (viii) Workspace access testing; and (ix) Performance testing with compatible devices. (9) Software verification, validation, and hazard analysis must be performed. (10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed. (11) Performance data must demonstrate the sterility of all patient-contacting device components. (12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life. (13) Performance data must validate the reprocessing instructions for the reusable components of the device. (14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible. (15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic. (16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information: (i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and (ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.

Predicate Devices

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

Submission Summary (Full Text)

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

August 7, 2016

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

Re: K153276

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: July 15, 2016 Received: July 18, 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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,

Christopher J. Ronk -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

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## Indications for Use

510(k) Number (if known) K153276

#### 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 IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, 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> | <span></span> Prescription Use (Part 21 CFR 801 Subpart D) |
|---------------|------------------------------------------------------------|
| <span></span> | <span></span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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# 510(k) Summary (21 CFR § 807.92(c))

#### I. SUBMITTER INFORMATION

| Submitter: | Intuitive Surgical, Inc.<br>1266 Kifer Road<br>Sunnyvale, CA 94086 |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Cindy Domecus, R.A.C. (US & EU)<br>Principal, Domecus Consulting Services LLC<br>Chief Regulatory Advisor to Intuitive Surgical<br>Telephone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Date Summary Prepared: | August 1, 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: | |

#### Intuitive Surgical da Vinci Surgical System, Model IS4000 (K131861, Predicate Device:

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 "thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures" general indication for the da Vinci Xi Surgical System (K131861): Lobectomy, Mediastinal Mass Resection, Thymectomy, Segmentectomy, Wedge Resection 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 delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic

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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 three (3) evaluations in a total of twenty (20) animals demonstrating use of da Vinci Xi Surgical System in Lung Resection and Lobectomy procedures. These data were also submitted in support of clearance of two (2) Xi EndoWrist Staplers (K140553 and K152421).

## 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 "thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures" 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: Lobectomy, Mediastinal Mass Resection and Thymectomy. Forty (40) publications were identified for these umbrella procedures based on specific search criteria and filters. These publications included retrospective, comparative and single arm studies. A detailed summary of the published clinical data on these procedures is provided in Tables 1-3 below.

The findings from the Lobectomy publications show that da Vinci-assisted procedures are associated with comparable or lower mortality rates; comparable complications; comparable or lower blood transfusion rates; and comparable or shorter lengths of hospital stay as compared to both open and VATS surgical procedures. Five (5) studies reported comparable or shorter operative times for da Vinci

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assisted procedures as compared to VATS procedures. Thirteen (13) publications noted increased operative times in the da Vinci-assisted procedures as compared to open and VATS procedures; however, this increase did not correlate with an increase in the reported mortality rates. Lastly, these publications report comparable or lower conversion rates for da Vinci-assisted procedures as compared to VATS procedures.

Outcomes reported in the Mediastinal Mass Resection comparative publications demonstrate that da Vinci-assisted procedures are associated with comparable mortality rates and operative times, comparable or lower complication rates and comparable or shorter lengths of hospital stay as compared to open surgical procedures. Data from five (5) publications reporting on single-arm studies using the da Vinci System for mediastinal mass resection procedures demonstrate that use of the da Vinci System can be accomplished with no reports of mortality and low complication rates. Intraoperative complications were < 1% in two (2) of the single-arm publications and post operative complication rates were ≤ 14% in all five (5) publications. Two (2) of the single-arm publications reported on conversion rates (0.65% and 4.3%) and three (3) publications reported low transfusion rates (0 – 1.4%). Operative times in the singlearm publications ranged from 85.9 minutes to 210.0 minutes and length of stay ranged from 1.0 to 12.8 days.

The data provided in the Thymectomy comparative publications show that da Vinci-assisted procedures are associated with comparable mortality rates; comparable or lower complication rates; comparable or shorter lengths of hospital stay; and comparable or lower transfusion rates/estimated blood loss as compared to both open and VATS surgical procedures. Operative times were comparable or longer in the do Vinci-assisted procedures as compared to open and VATS procedures, however, this increase did not correlate with higher mortality rates. Data from ten (10) publications reporting on single-arm studies using the da Vinci System for thymectomy procedures demonstrate that use of the da Vinci System in such procedures can be accomplished with no reports of mortality and low complication rates. No intraoperative complication rates were reported in eight (8) of the single-arm publications; two (2) of the publications reported intraoperative complication rates of 1.3% and 15.4%. Postoperative complication rates in the single-arm publications ranged from 3.6% - 15.4% and conversion rates ranged from 0% - 15.4%. Operative times in the single-arm publications ranged from 85.2 minutes to 155 minutes and length of stay ranged from 2.0 to 5.0 days.

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| Publications | Sample Size (N) | Operative Time (minutes)~ | Transfusions (%) and/or EBL (ml) | Length of Stay (days)~ | Complications (%) | |
|-----------------------------|-----------------|---------------------------|-----------------------------------|------------------------|-------------------|------------------|
| 1. Cerfolio (2011) | da Vinci | 106 | 132.0 | 30 ml | 2.0 | 26.4 |
| | Open | 318 | 90.0 | 90 ml | 4.0 | 37.8 |
| 2.Veronesi (2010) | da Vinci | 54 | 236.0 | 0 | 5.0 | 20.4 |
| | Open | 54 | 154.0 | 6.0 | 6.0 | 20.4 |
| 3. Kent (2013) | da Vinci | 430 | NR | NR | 4.0 | 44.4 |
| | Open | 20,238 | NR | NR | 6.0 | 55.1 |
| | VATS | 12,427 | NR | NR | 5.0 | 43.6 |
| 4. Oh (2013) | da Vinci | 43 | 217.0 | 100 ml | 4.0 | 28.0* / 2.0^ |
| | Open | 88 | 168.0 | 200 ml | 10.0 | 24.0* /3.0^ |
| 5. Adams (2014) | da Vinci | 120 | 241.5 | 0.9 / 0.9# | 4.7 | 5.2** / 0.9^^ |
| | Open | 5,913 | 175.5 | 5.0 / 7.8# | 7.3 | 10.8** / 1.1^^ |
| | VATS | 4,612 | 179.8 | 1.4 / 3.8# | 5.3 | 8.9** / 1.0^^ |
| 6. Deen (2014) | da Vinci | 57 | 223.0 | NR | 4.6 | 32.0 |
| | Open | 69 | 180.0 | NR | 5.5 | 30.0 |
| | VATS | 58 | 202.0 | NR | 4.8 | 31.0 |
| 7. Farivar (2014) | da Vinci | 181 | 199.2 | 0 / 0# | 3.2 | 6.1** |
| | Open | 5,913 | 243.7 | 4.8 / 7.8# | 7.3 | 10.7** |
| | VATS | 4,612 | 239.0 | 1.3 /3.7# | 5.3 | 8.9** |
| 8. Augustin (2013) | da Vinci | 26 | 215.0 | NR | 11.0 | 42.3 |
| | VATS | 26 | 183.0 | NR | 9.0 | 38.4 |
| 9. Bodner (2011) | da Vinci | 26 | 228.0 | NR | 11.0 | 11.5 |
| | VATS | 114 | 183.0 | NR | 9.5 | 7.0 |
| 10. Jang (2011) | da Vinci | 40 | 240.0 | 219.0 ml | 6.0 | 10.0 |
| | VATS | 40 | 257.0 | 374.0 ml | 9.0 | 32.5 |
| 11. B. Lee (2012) | da Vinci | 100 | 209.0 | NR | 6.3 | 9.0 |
| | VATS | 100 | 157.0 | NR | 8.9 | 21.0 |
| 12. Louie (2012) | da Vinci | 45 | 213.0 | 154.0 ml | 4.0 | 43.5 |
| | VATS | 35 | 207.0 | 134.0 ml | 4.5 | 35.3 |
| 13. B. Lee (2014) | da Vinci | 35 | 161.0 | 0 | 3.0 | 11.0 |
| | VATS | 34 | 128.0 | 0 | 3.0 | 18.0 |
| 14. Swanson (2013) | da Vinci | 295 | 269.4 | NR | 6.1 | 16.95++/ 36.95++ |
| | VATS | 295 | 253.8 | NR | 5.8 | 18.98++/ 38.31++ |
| 15. Paul (2014) | da Vinci | 2,498 | NR | NR | 5.0 | 50.1~ |
| | VATS | 37,595 | NR | NR | 5.0 | 45.2~ |
| 16. Spillane (2014) | da Vinci | 22 | 261.0 | 143 ml | 4.4 | 9.0 |
| | VATS | 22 | 159.0 | 223 ml | 5.5 | 22.0 |
| 17. B Lee (2015) | da Vinci | 53 | 161.0 | NR | 3.0 | 11.0 |
| | VATS | 158 | 123.0 | NR | 3.0 | 24.0 |
| 18. Mahieu (2015) | da Vinci | 28 | 190.0 | 100 ml | 6.0 | 50.0 |
| | VATS | 28 | 185.0 | 200 ml | 7.0 | 42.8 |
| Publications | Sample Size (N) | Operative Time (minutes)* | Transfusions (%) and /or EBL (ml) | Length of Stay (days)* | Complications (%) | |
| 1. Balduyck (2011) da Vinci | 14 | 224.2 | NR | 9.6 | 21.4 | |
| Open | 22 | 243.8 | NR | 11.8 | 22.5 | |
| 2. Seong (2014) da Vinci | 34 | 157.2 | NR | 2.7 | 0 | |
| Open | 34 | 139.3 | NR | 5.5 | 14.7 | |
| 3. Cerfolio (2012) da Vinci | 75 | 95.0 | NR | 1.0 | 12.0 | |
| 4. Huang (2014) da Vinci | 48 | 85.9 | NR | 3.9 | 2.0 | |
| 5. Melfi (2012) da Vinci | 69 | 124.3 | 1.4 | 4.3 | 7.2 | |
| 6. Nakamura (2014) da Vinci | 52 | 142.6 – 184.3 | 0 | 7.7 – 12.8 | 5.8 | |
| 7. Seder (2013) da Vinci | 19 | 210.0 | 0 | 2.0 | 14.0 | |

## TABLE 1: Comparison of da Vinci vs. Open and VATS Lobectomy

~Mean or median reported; *Air leak > 24 hours; ^Return to OR; *Intraoperative values; **Air leak > 5 days; ^^Bleeding requiring reoperation; Major Complications; *Authors reported all complications which included latrogenic Complications (i.e., Intraoperative Complications)

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#### TABLE 2: Comparison of da Vinci vs. Open and Single Arm Mediastinal Mass Resection Procedures

*Mean or median reported

## TABLE 3: Comparison of da Vinci vs. Open and VATS and Single Arm Thymectomy Procedures

| Publications | Sample Size (N) | Operative Time (minutes)* | Transfusions (%) and/or EBL (ml) | Length of Stay (days)* | Complications (%) |
|-------------------------------|-----------------|---------------------------|----------------------------------|------------------------|-------------------|
| 1. Weksler (2011) da Vinci | 15 | 130.0 | 41.67 ml | 1.0 | 6.7 |
| Open | 35 | NR | 151.43 ml | 4.0 | 57.1 |
| 2. Ye (2014) da Vinci | 23 | 97.0 | 0% / 61.3 ml | 3.7 | 4.3 |
| Open | 51 | 214.5 | 0% / 466.1 ml | 11.6 | 3.9 |
| 3. Renaud (2013) da Vinci | 6 | 189.2 | <10 ml | 5.0 | 0 |
| Open | 15 | 55.0 | 24.6 ml | 8.7 | 15.0 |
| 4. Ye (2013) da Vinci | 21 | 96.2 | 0% / 58.6 ml | 3.7 | 4.8 |
| VATS | 25 | 103.6 | 4.0% / 86.8 ml | 6.7 | 4.0 |
| 5. Ruckert (2010) da Vinci | 75 | 187.0 | NR | NR | 2.7 |
| VATS | 79 | 198.0 | NR | NR | 2.5 |
| 6. Jun (2014) da Vinci | 56 | 139.8 | NR | 7.18 | 10.7 |
| VATS | 60 | 121.07 | NR | 7.23 | 6.66 |
| 7. Freeman (2011) da Vinci | 75 | 113.0 | NR | 2.2 | 5.3 |
| 8. Goldstein (2010) da Vinci | 26 | 127.0 | NR | 2.0 | 15.4 |
| 9. Huang (2013) da Vinci | 23 | 85.2 | NR | 3.6 | 4.3 |
| 10. Keijzers (2014) da Vinci | 125 | 123.0 | NR | 3.0 | 7.2 |
| 11. Marulli (2012) da Vinci | 79 | 155.0 | 1.2% | 3.0 | 12.7 |
| 12. Marulli (2013) da Vinci | 100 | 120.0 | 3.0% | 3.0 | 6.0 |
| 13. Mussi (2011) da Vinci | 14 | 139.0 | NR | 4.0 | 14.2 |
| 14. Rea (2011) da Vinci | 108 | 120.0 | 1.8% | 3.0 | 3.6 |
| 15. Schneiter (2013) da Vinci | 20 | NR | NR | 5.0 | 10.0 |

*Mean or median reported

#### Covered Procedures

The published data on the above cited umbrella procedures were used to support clearance of the following covered procedures: Segmentectomy, Wedge Resection 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 "thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures" previously cleared Indications for Use is substantially equivalent to the predicate devices: Lobectomy, Mediastinal Mass Resection, Thymectomy, Segmentectomy, Wedge Resection and Lymphadenectomy.