da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke Evacuation

K232610 · Intuitive Surgical, Inc. · NAY · Mar 14, 2024 · Gastroenterology, Urology

Device Facts

• Record ID: K232610
• Device Name: da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke Evacuation
• Applicant: Intuitive Surgical, Inc.
• Product Code: NAY · Gastroenterology, Urology
• Decision Date: Mar 14, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic, Real-World Evidence

Real-World Evidence

Submission	Device	Sponsor	RWD Sources	RWE Use Summary	Key Tags
K232610 · Mar 14, 2024	da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke Evacuation	Intuitive Surgical, Inc.	Retrospective review of robotic cases	Retrospective clinical data from previous robotic cases was used as a comparator to assess the safety profile of the new device, specifically identifying an increased risk of vaginal bleeding in certain gynecological procedures.	Retrospective review; Safety comparison; Gynecological surgery

Clinical Evidence

Study Design	Population	Comparator	Key Endpoints
Retrospective review of robotic cases; Retrospective review	Patients undergoing robotic-assisted surgical procedures by participating surgeons	Prospective clinical investigation of the da Vinci Surgical System, Model IS5000	Safety outcomes (unplanned hospital readmission, adverse events)

Indications for Use

The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System, Model IS5000) shall assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures and general thoracoscopic surgical procedures. The system is indicated for adult use. It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use. The da Vinci Insufflator with compatible tube sets is intended for use in diagnostic and/or therapeutic endoscopic and thoracoscopic procedures to distend a cavity by filling it with gas. Intended cavities for this device include abdominal and thoracic cavities in adult and bariatric patients. The Intuitive da Vinci 5 endoscope tray is intended for use to encase and protect compatible da Vinci endoscopes for sterilization in any of the following sterilization machines and cycles: STERRAD 100NX sterilization system using the Flex, Express, and DUO cycles; STERIS V-PRO maX 2 using the Non Lumen, Flexible, or Lumen cycles; STERIS V-PRO maX using the Non Lumen, Flexible, or Lumen cycles; STERIS V-PRO 1 Plus using the Non Lumen or Lumen cycles; STERIS V-PRO 1 using the V-PRO/Lumen cycle.

Device Story

da Vinci IS5000 is a software-controlled, electromechanical robotic surgical system; consists of Surgeon Console, Patient Side Cart, and Vision Tower. Surgeon operates via console hand controls; system translates inputs to robotic instruments for tissue manipulation (grasping, cutting, suturing, etc.). Features new force feedback instruments with sensors transmitting directional forces back to surgeon hand controls. Includes integrated insufflator for cavity distension and updated 4K vision system. Used in OR by trained physicians. Output provides real-time visualization and precise instrument control, enhancing surgical accuracy. System includes stainless steel tray for endoscope sterilization. Benefits include minimally invasive access with haptic feedback for improved surgical performance.

Clinical Evidence

Prospective, multi-center, single-arm study (N=53) across general, thoracic, urologic, and gynecologic specialties. Primary endpoints assessed safety and performance. Results showed 9 adverse events in 8 subjects; 2 readmissions and 1 reoperation occurred in the gynecology cohort. Qualitative comparison to retrospective robotic data indicated increased vaginal bleeding risk with force feedback needle drivers in specific procedures, leading to a contraindication. Human factors testing confirmed safe use without serious errors.

Technological Characteristics

Electromechanical robotic system; stainless steel endoscope tray. Sensing: Force feedback sensors in instruments. Energy: Integrated electrosurgical unit (K223039) and insufflator. Connectivity: Networked system components (Console, Tower, Robot). Sterilization: Tray compatible with STERRAD and STERIS V-PRO cycles. Software: Enhanced documentation level; includes UI features like instrument tracking and digital swap.

Indications for Use

Indicated for adult patients undergoing urologic, general laparoscopic, gynecologic laparoscopic, and general thoracoscopic surgical procedures. Insufflator indicated for adult and bariatric patients for cavity distension. Contraindicated: Force feedback needle driver use in hysterectomy and myomectomy due to vaginal bleeding risk.

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, K141077, K151794, K152892, K161271, K191529, K152578, K153276, K161178, K170713, K171632, K171699, K172086, K172643, K173585, K173842, K182140, K183086, K202834, K211784, K223080, K231224)
• World of Medicine Pneumoclear Insufflation System (K201361)
• Endoscope Sterilization Tray (K183139)

Reference Devices

• Senhance Surgical Robotic System (K171120)
• AirSeal iFS System (K190303)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

March 14, 2024

Intuitive Surgical, Inc. Melissa Gonzalez Project Manager, Regulatory Affairs 1266 Kifer Road Sunnyvale, California 94086

# Re: K232610

Trade/Device Name: da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke Evacuation

Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: NAY Dated: February 9, 2024 Received: February 12, 2024

# Dear Melissa Gonzalez:

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 (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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approvals in the device master record (21 CFR 820.181).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.70) and document changes and

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-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803). please go to https://www.fda.gov/medical-device-safety/medical-device-reporting-mdr-howreport-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and -CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatorythe DICE website assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

> Sincerely, Digitally signed by Mark Mark Trumbore -S Trumbore -S Date: 2024.03.14
> 09:52:43 -04'00' Mark Trumbore, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K232610

#### Device Name

da Vinci Surgical System, Model IS5000

#### Indications for Use (Describe)

The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System, Model ISS000) shall assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gyneologic laparoscopic surgical procedures and general thoracoscopic surgical procedures. The system is indicated for adult 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.

Contraindication:

Use of the force feedback needle driver is contraindicated in hysterectomy and myomectorny due to the risk of vaginal bleeding requiring hospital readmission and/or the need for additional procedures. The use of non-force feedback needle drivers is recommended for suturing in these procedures.

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| <div> <span> </span> <span>Prescription Use (Part 21 CFR 801 Subpart D)</span> </div> | <div> <span> </span> <span>Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> |

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# Indications for Use

510(k) Number (if known) K232610

#### Device Name

da Vinci Insufflator and Tube Set with Smoke Evacuation

Indications for Use (Describe)

The da Vinci Insufflator with compatible tube sets is intended for use in diagnostic and/or therapeutic endoscopic and thoracoscopic procedures to distend a cavity by filling it with gas. Intended cavities for this device include abdominal and thoracic cavities in adult and bariatric patients.

> Prescription Use (Part 21 CFR 801 Subpart D)

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

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

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

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

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

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

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# Indications for Use

510(k) Number (if known) K232610

#### Device Name

Stainless Steel Endoscope Reprocessing Tray, 8mm, Gen5

Indications for Use (Describe)

The Intuitive da Vinci® 5 endoscope tray is intended for use to encase and protect compatible da Vinci endoscopes for sterilization in any of the following sterilization machines and cycles:

- · STERRAD 100NX sterilization system using the Flex, Express, and DUO cycles
- · STERIS V-PRO maX 2 using the Non Lumen, Flexible, or Lumen cycles
- · STERIS V-PRO maX using the Non Lumen, Flexible, or Lumen cycles
- · STERIS V-PRO 1 Plus using the Non Lumen or Lumen cycles
- · STERIS V-PRO 1 using the V-PRO/Lumen cycle

The sterilization-cycle parameters of the sterilizers are preset by the manufacturers and are not adjustable. The maximum product load per tray is one da Vinci 5 endoscope. The da Vinci 5 endoscopes is approximately 600 mm an the diameter of the shaft is 8.8 mm. The maximum weight of the tray and endoscope is 13 lbs. The endoscope tray is not intended to maintain sterility; it is intended to be used in conjunction with a legally-marketed, FDA-cleared STERRAD and STERIS V-PRO compatible sterilization wrap in order to maintain sterility of the enclosed medical instrument.

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------|---------------------------------------------------------------------------------|
| <input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | <input checked="" type="checkbox"/> 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."

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# 5 510(k) Summary

| 510(k) Owner: | Intuitive Surgical, Inc.<br>1266 Kifer Road<br>Sunnyvale, CA 94086 |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Melissa S. Gonzalez<br>Project Manager, Regulatory Affairs<br>Intuitive Surgical, Inc.<br>1266 Kifer Road, Sunnyvale, CA 94086<br>Ph: [phone]; Email: [e-mail] |
| Date Summary<br>Prepared: | March 12, 2024 |
| Trade Name: | da Vinci Surgical System Model IS5000/Gen5<br>da Vinci Insufflator and Tube Set with Smoke Evacuation<br>da Vinci Endoscope Tray |
| Common Name: | Endoscopic instrument control system, endoscopic instruments and accessories<br>Insufflator, laparoscopic |
| Classification: | Class II, 21 CFR 876.1500, Endoscope and Accessories<br>Class II, 21 CFR 884.1730, Insufflator, Laparoscopic |
| Product Code: | NAY (System, Surgical, Computer Controlled Instrument)<br>HIF (Insufflator, Laparoscopic)<br>GCJ (Laparoscope, General & Plastic Surgery)<br>KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories) |
| Classification Advisory<br>Committee: | General and Plastic Surgery<br>Obstetrics and Gynecology<br>General Hospital |
| Predicate Devices: | Intuitive Surgical da Vinci Surgical System, Model IS4000 (K131861, with<br>subsequent clearances for additional features, instruments, accessories -<br>K141077, K151794, K152892, K161271, K191529; and representative uses -<br>K152578, K153276, K161178, K170713, K171632, K171699, K172086, K172643,<br>K173585, K173842, K182140, K183086, K202834, K211784, K223080, K231224)<br>World of Medicine Pneumoclear Insufflation System (K201361)<br>Endoscope Sterilization Tray (K183139) |
| INTUITIVE | ©2024 Intuitive Surgical, Inc. All rights reserved. Product names |

are trademarks or registered trademarks of their respective holders.

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Reference Device: K171120 Senhance Surgical Robotic System (force feedback instruments) K190303 AirSeal iFS System

# Device Description:

da Vinci Surgical System, Model IS5000:

The da Vinci Surgical System Model IS5000/Gen5 is a software-controlled, electromechanical system designed for surgeons to perform minimally invasive surgery. It consists of a Surgeon Side Console (Console), a Patient Side Cart (Robot), and a Vision System Cart (Tower) and is used with an Endoscope, EndoWrist Instruments, and Accessories.

The da Vinci Surgical System Model IS5000/Gen5 is a modification to the da Vinci Xi Surgical System Model IS4000 with the same core features. The IS5000 System further integrates supporting surgical devices, such as an updated electrosurgical generator (E-200) and an integrated insufflator. The instruments and accessories compatible with the IS4000 System are also compatible with the IS5000 System, with an additional set of force feedback instruments designed specifically for the IS5000 System. These Force Feedback instruments (including Large Needle Driver, MegaSutureCut Needle Driver, Cadiere Graspers, Fenestrated Bipolar Forceps, and Maryland Bipolar Forceps) are similar to the Xi instruments with the addition of a sensor that translates directional forces at the instrument back to the surgeon through the hand controls on the Console.

## da Vinci Insufflator

The da Vinci Insufflator is a pneumatic device, integrated into the system Tower, which connects to house or tank CO2 gas through the Tower insufflation manifold. It is operated through controls and indicators on each of the Tower, Console, or Robot touchscreens.

#### Endoscope Tray

The endoscope tray is a stainless steel sterilization tray to encase and protect da Vinci endoscopes during reprocessing.

#### Intended Use:

# da Vinci Surgical System, Model IS5000

To assist in the accurate control of endoscopic instruments during minimally invasive surgery.

# da Vinci Insufflator and Tube Set with Smoke Evacuation

To distend the abdominal and/or thoracic cavity during diagnostic and/or therapeutic endoscopic and thoracoscopic procedures.

#### da Vinci Endoscope Tray

To encase and protect da Vinci endoscopes for sterilization

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# Indications for Use:

## da Vinci Surgical System, Model IS5000

The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System, Model IS5000) shall assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures and general thoracoscopic surgical procedures. The system is indicated for adult use.

lt 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.

## Contraindication:

Use of the force feedback needle driver is contraindicated in hysterectomy and myomectomy due to the risk of vaginal bleeding requiring hospital readmission and/or the need for additional procedures. The use of non-force feedback needle drivers is recommended for suturing in these procedures.

#### da Vinci Insufflator and Tube Set with Smoke Evacuation

The da Vinci Insufflator with compatible tube sets is intended for use in diagnostic and/or therapeutic endoscopic and thoracoscopic procedures to distend a cavity by filling it with gas. Intended cavities for this device include abdominal and thoracic cavities in adult and bariatric patients.

#### da Vinci Endoscope Tray

The Intuitive da Vinci 5 endoscope tray is intended for use to encase and protect compatible da Vinci endoscopes for sterilization in any of the following sterilization machines and cycles:

- STERRAD 100NX sterilization system using the Flex, Express, and DUO cycles
- STERIS V-PRO maX 2 using the Non Lumen, Flexible, or Lumen cycles
- STERIS V-PRO maX using the Non Lumen, Flexible, or Lumen cycles
- · STERIS V-PRO 1 Plus using the Non Lumen or Lumen cycles
- · STERIS V-PRO 1 using the V-PRO/Lumen cycle

The sterilization-cycle parameters of the sterilizers are preset by the manufacturers and are not adjustable. The maximum product load per tray is one da Vinci 5 endoscope. The length of the da Vinci 5 endoscopes is approximately 600 mm and the diameter of the shaft is 8.8 mm. The maximum weight of the tray and endoscope is 13 lbs. The endoscope tray is not intended to maintain sterility; it is intended to be used in conjunction with a legally-marketed, validated, FDA-cleared STERRAD and STERIS V-PRO compatible sterilization wrap in order to maintain sterility of the enclosed medical instrument.

Image /page/7/Picture/19 description: The image shows the word "INTUITIVE" in blue font. There is a small blue circle above the letter "U". The font is sans-serif and the letters are evenly spaced. The background is white.

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# Technological Characteristics:

The da Vinci Surgical System, Model IS5000 based on the da Vinci Xi Surgical system and therefore is technologically similar to the da Vinci Xi Surgical System, Model IS4000. Both systems have a Console, Tower and Robot. The Robot architecture is identical and therefore, the Model IS5000 is compatible with a subset of the Model IS4000 instruments and accessories. The new Force Feedback instruments are modifications of the iS4000 instruments to include force feedback sensor technology. The IS5000 includes a new integrated insufflator and like the IS4000 also has an Electrical Surgical Unit on the Tower.

The System software has been updated to include new UI features (i.e. head-in menu, digital swap, instrument tracking, and new system menu) as well as support for hardware design changes.

All system Carts contain updated electronics to include the latest technology. In addition, the Console and Tower have updated form factor.

The Surgeon Console is identical to the predicate in core functions and similar in design. The 3D viewer is smaller and more maneuverable and the MTMs have been modified to enable the ability to transmit haptic feedback from the Force Feedback instruments to the user.

The Tower has an updated 4K overhead monitor, new front touchscreen, integrated Electro Surgical Unit (cleared separately under K223039), integrated Insufflator and associated High Flow Insufflator Tube Set, and modified endoscope connector on the Endoscope System Controller (ESC).

The Model IS5000 Endoscopes have a modified connector to accommodate the modified ESC hardware and a tip heater.

A set of six (6) Force Feedback enabled instruments have been added to the existing IS4000 instruments which are now compatible with the da Vinci Surgical System, Model IS5000. The Force Feedback instruments are only compatible with the IS5000 System, they are not backward compatible with the IS4000 System.

Two 8mm Cannulas (standard and long) are also being introduced to support the High Flow Insufflator Tube Set. The only modification to the cannulas is hexagonal tip geometry which alters the airflow through the cannulas.

# Performance Data:

The following performance testing was conducted to demonstrate substantial equivalence to the predicate devices.

Bench testing demonstrates that the subject devices design output meets the design input requirements and that the devices perform as intended. The testing conducted consisted of dimensional measurements, mechanical and functional verification, and simulated use in animal and cadaver models.

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Electrical Safety and Electromagnetic Compatibility testing was conducted using a third-party lab in accordance with the current versions of IEC 60601-1 (basic safety and essential performance), IEC 60601-1-2 (Electromagnetic disturbances), IEC 60601-2-18 (Endoscopic equipment interactions, IEC 60601-2-2 (high frequency surgical equipment) and IEC 60825-1 (laser safety).

Software verification and validation testing was performed following the same software development processes and test methodology used for the predicate device. In consideration of the device risk, the software documentation level is classified as a "Enhanced" and documentation was provided as recommended in FDA's Guidance for Industry and FDA Staff "Content of Premarket Submissions for Device Software Functions".

Cybersecurity information demonstrating compliance with section 524B of the FD&C Act consistent with current "FDA Guidance: Cybersecurity in Medical Devices - Quality System Considerations and Content of Premarket Submissions" was provided in this submission.

Human Factors data assessed the use-safety and effectiveness of the da Vinci Surgical System, Model IS5000 for the intended uses, user groups and use environments. Surgeon and OR Staff participants were observed to determine their ability to safely complete simulated surgical tasks and high-risk use scenarios related to Critical Tasks. Results of this study, including observed performance and subjective feedback, demonstrate that the da Vinci Surgical System, Model IS5000 is safe and effective for its intended uses, users and use environment.

Pre-clinical surgical equivalence studies (Acute and Chronic Animal data) were performed directly comparing the safety and performance of the Intuitive Surgical da Vinci Surgical System, Model IS5000 and the Intuitive Surgical da Vinci Xi Surgical System, Model IS4000. Surgeon participants performed urologic, thoracic and colorectal surgical procedures using either canine or porcine models. Surgical safety and performance were assessed via metrics collected during testing and by veterinary pathologists' review of histology from excised tissue.

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Clinical Data was collected via a prospective, multi-center, single-arm confirmatory clinical investigation. The study enrolled 53 subjects across four (4) specialties treated by surgeons with a range of experience. A summary of the baseline demographics for subjects in each of the specialties is provided in Table 1.

| Variable Name | General Surgery<br>(N=20) | Thoracic<br>(N=6) | Urology<br>(N=6) | Gynecology<br>(N=21) |
|------------------------|---------------------------|-------------------|------------------|----------------------|
| Age (years) | | | | |
| Mean (SD) | 49.2 (12.77) | 53.5 (17.72) | 66.0 (3.79) | 52.6 (16.02) |
| Median | 49.0 | 54.5 | 67.0 | 51.0 |
| 95% CI | (43.17, 55.13) | (34.91, 72.09) | (62.02, 69.98) | (45.33, 59.91) |
| Sex n (%) | | | | |
| Male | 14 (70.0%) | 1 (16.7%) | 6 (100.0%) | 0 (0%) |
| Female | 6 (30.0%) | 5 (83.3%) | 0 (0%) | 21 (100.0%) |
| Race n (%) | | | | |
| White | 15 (75.0%) | 5 (83.3%) | 4 (66.7%) | 16 (76.2%) |
| Black/African American | 3 (15.0%) | 0 (0%) | 1 (16.7%) | 3 (14.3%) |
| Other* | 2 (10.0%) | 1 (16.7%) | 1 (16.7%) | 2 (9.5%) |
| Ethnicity n (%) | | | | |
| Hispanic or Latino | 2 (10.0%) | 1 (16.7%) | 2 (33.3%) | 3 (14.3%) |
| Not Hispanic or Latino | 18 (90.0%) | 5 (83.3%) | 4 (66.7%) | 18 (85.7%) |

#### Table 1:IS5000 IDE Subject Demographics by Specialty

* Other for General Surgery includes: (1) Not Specified, (1) Hispanic. Other for Thoracic includes: (1) Not specified. Other for Urology includes: (1) Not Specified. Other for Gynecology includes: (1) Unknown.

Subjects were followed for 30 days. This data was qualitatively compared to a retrospective review of robotic cases done by participating surgeons. There was an increase in unplanned hospital readmission due to vaginal bleeding for the subject device compared to the predicate device. There were no other remarkable differences between the data from the two (2) groups.

In the absence of conclusive safety and effectiveness data, the following contraindication has been added to the labeling.

Contraindication: Use of the force feedback needle driver is contraindicated in hysterectomy and myomectomy due to the risk of vaginal bleeding requiring hospital readmission and/or the need for additional procedures. The use of non-force feedback needle drivers is recommended for suturing in these procedures.

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The summary of the clinical investigation data is provided in Table 2.

| | Number of<br>Subjects | Number of<br>Adverse<br>Events | Number of<br>Subjects<br>with an<br>Adverse<br>Event | Number of<br>Conversions | Number of<br>Deaths | Number of Re-<br>admissions | Number of re-<br>operations |
|--------------------|-----------------------|--------------------------------|------------------------------------------------------|--------------------------|---------------------|-----------------------------|-----------------------------|
| General<br>Surgery | 20 | 3 | 3 | 0 | 0 | 0 | 0 |
| Thoracic | 6 | 0 | 0 | 0 | 0 | 0 | 0 |
| Urology | 6 | 1 | 1 | 0 | 0 | 0 | 0 |
| Gynecology | 21 | 5 | 4 | 0 | 0 | 2 | 1 |
| Total | 53 | 9 | 8 | 0 | 0 | 2 | 1 |

#### Table 2: Clinical Results

In addition to the clinical assessments, human factors assessments were performed. The results of those assessments were that there were no use errors that resulted in serious patient or user harm. The study confirmed safety, effectiveness, and usability of the Intuitive Surgical da Vinci Surgical System, Model IS5000 in performing robotic-assisted surgical procedures.

## Summary:

Based on the intended use, indications for use, technological characteristics and performance data, the Intuitive Surgical da Vinci Surgical System, Model IS5000, and da Vinci Insufflator and Tube Set with Smoke Evacuation are substantially equivalent to their respective predicate devices, the Intuitive Surgical da Vinci Xi Surgical System, Model IS4000, the World of Medicine Pneumoclear Insufflation System and the endoscope sterilization tray.

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