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.

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 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.

AI/ML Overview

Acceptance Criteria and Device Performance for da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke Evacuation, and da Vinci Endoscope Tray

This document describes the acceptance criteria and supporting studies for the Intuitive Surgical da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke Evacuation, and da Vinci Endoscope Tray.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document doesn't explicitly state quantitative acceptance criteria or detailed reported device performance in a summary table. However, it outlines the types of testing conducted to demonstrate substantial equivalence to predicate devices and overall safety and effectiveness. Based on the "Performance Data" section, the implicit acceptance criteria are that the devices meet design input requirements, perform as intended, and are safe and effective for their intended uses.

Acceptance Criteria Category	Implicit Criteria	Reported Device Performance
Design & Functionality	- Design output meets design input requirements. - Devices perform as intended. - Compatibility with existing instruments and accessories (for IS5000). - Integrated features (e.g., insufflator, ESU) function correctly.	- Bench testing demonstrated that design output meets design input requirements and devices perform as intended. - Mechanical and functional verification were conducted. - Simulated use in animal and cadaver models showed intended performance. - IS5000 compatible with a subset of IS4000 instruments and accessories. - Force Feedback instruments are designed specifically for IS5000. - IS5000 includes new integrated insufflator and ESU.
Safety - Electrical & Electromagnetic	- Compliance with relevant electrical safety and electromagnetic compatibility standards.	- Electrical Safety and Electromagnetic Compatibility testing conducted in accordance with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18, IEC 60601-2-2, and IEC 60825-1.
Software	- Software verification and validation performed following established processes and methodologies. - Compliance with FDA guidance for device software functions. - Cybersecurity compliance.	- Software verification and validation testing performed following the same processes and test methodology as for the predicate device. - Software documentation classified as "Enhanced" and provided as recommended by FDA guidance. - Cybersecurity information demonstrating compliance with Section 524B of the FD&C Act and FDA guidance was provided.
Usability & Human Factors	- Safe and effective use by intended users (surgeons, OR staff) in intended use environments. - No use errors leading to serious patient or user harm.	- Human Factors data assessed use-safety and effectiveness for intended uses, user groups, and environments. - Surgeon and OR Staff participants safely completed simulated surgical tasks and high-risk use scenarios. - Results showed no use errors resulting in serious patient or user harm. - Confirmed safety, effectiveness, and usability for robotic-assisted surgical procedures.
Clinical Performance (Safety & Effectiveness)	- Comparable safety and performance to predicate device in a clinical setting. - Acceptable adverse event rates. - No remarkable differences in outcomes compared to predicate (except for specific contraindication). - Specific finding: Acknowledge and address any identified risks, such as increased unplanned hospital readmission due to vaginal bleeding with force feedback needle driver in specific procedures.	- Clinical Investigation: 53 subjects across 4 specialties followed for 30 days. - Qualitatively compared to a retrospective review of robotic cases using the predicate device. - Identified increase in unplanned hospital readmission due to vaginal bleeding when using the force feedback needle driver in hysterectomy and myomectomy (leading to a contraindication). - No other remarkable differences between the data from the two groups were observed. - Clinical results show low numbers of adverse events, conversions, deaths, readmissions (2 in gynecology, related to vaginal bleeding), and re-operations.
Sterilization (for Endoscope Tray)	- Ability to encase and protect compatible endoscopes for sterilization in specified sterilization machines and cycles. - Compatibility with specific sterilization wraps.	- Intended for use with STERRAD 100NX (Flex, Express, DUO cycles) and STERIS V-PRO maX 2, maX, and 1 Plus/1 (Non Lumen, Flexible, or Lumen cycles). - Intended to be used with legally-marketed, validated, FDA-cleared STERRAD and STERIS V-PRO compatible sterilization wrap. - Maximum product load: one da Vinci 5 endoscope. - Maximum weight of tray and endoscope: 13 lbs.

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

The primary clinical test set information is from a prospective, multi-center, single-arm confirmatory clinical investigation.

Sample Size: 53 subjects.
- General Surgery: 20 subjects
- Thoracic: 6 subjects
- Urology: 6 subjects
- Gynecology: 21 subjects
Data Provenance: The document does not explicitly state the country of origin. Given the FDA submission, it is likely the data was collected in the United States, but this is not explicitly confirmed. The study was prospective, as stated.
Bench and Pre-clinical studies: Involved animal (canine or porcine) and cadaver models, but specific sample sizes for these are not detailed.

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

The document does not explicitly provide details on the number or qualifications of experts used to establish a "ground truth" for the clinical test set in the sense of independent adjudication of outcomes.

For the pre-clinical surgical equivalence studies, veterinary pathologists were involved in the review of histology from excised tissue. Their specific qualifications (e.g., years of experience) are not mentioned.

For the human factors study, Surgeon and OR Staff participants were observed, implying their expertise was leveraged, but they were the users being studied, not necessarily establishing a separate "ground truth".

The clinical investigation involved surgeons with a range of experience performing procedures, and outcomes were tracked. The document doesn't indicate a separate panel of experts for post-hoc ground truth establishment for clinical events. Adverse events, readmissions, etc., would typically be derived directly from patient records and assessed by the study investigators/clinicians.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (like 2+1 or 3+1 consensus) for establishing ground truth for the clinical outcomes. Adverse events, readmissions, surgeries, etc., appear to be directly measured results from the clinical investigation. The document mentions "clinical assessments" and "qualitative comparison" to retrospective data, suggesting a direct observation and comparison approach rather than a multi-expert adjudication of each case for a specific "ground truth."

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

No, an MRMC comparative effectiveness study involving human readers and AI assistance was not done based on the provided text. The device described, the da Vinci Surgical System, Insufflator, and Endoscope Tray, are surgical tools, not AI-driven diagnostic or assistive technologies that would typically involve "human readers" to interpret data (like images) with or without AI assistance. The clinical study compares the new system to a predicate system (IS4000) based on surgical outcomes.

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

This question is not applicable to the device described. The da Vinci Surgical System is an instrument control system that assists surgeons; it is not a standalone algorithm performing tasks independently. While it is software-controlled, its performance is always in conjunction with a human surgeon. Bench testing and pre-clinical studies evaluate the device's technical performance and safety aspects without direct human patient involvement, which could be considered "standalone" in that context, but this isn't an "algorithm-only" performance evaluation.

7. The Type of Ground Truth Used

Clinical Investigation: Clinical outcomes (e.g., adverse events, conversions, deaths, readmissions, re-operations) observed directly from patient follow-up data. The identified issue with the force feedback needle driver in specific procedures resulting in vaginal bleeding was likely a direct observation within the study data.
Pre-clinical Studies: Veterinary pathologists' review of histology from excised tissue to assess surgical safety and performance in animal models.
Bench Testing: Engineering measurements, mechanical and functional verification against design input requirements.
Human Factors: Observation of user performance and subjective feedback from surgeons and OR staff.

8. The Sample Size for the Training Set

The document does not refer to a "training set" in the context of machine learning or AI models being developed for the device's core functionality. The da Vinci Surgical System as described is a robotic surgical platform, not an AI diagnostic or predictive tool that would undergo a typical machine learning training and testing paradigm. "Training set" might refer to data used during software development, but it's not specified.

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

As there is no explicit mention of an "AI training set" for the device's core surgical assistance function, the method for establishing its ground truth is not provided. Any software development would rely on traditional software verification and validation processes against specified requirements, rather than a machine learning ground truth establishment.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

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:

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

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

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

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

da Vinci Insufflator and Tube Set with Smoke Evacuation

Indications for Use (Describe)

Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

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

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

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

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

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

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

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

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5 510(k) Summary

510(k) Owner:	Intuitive Surgical, Inc.1266 Kifer RoadSunnyvale, CA 94086
Contact:	Melissa S. GonzalezProject Manager, Regulatory AffairsIntuitive Surgical, Inc.1266 Kifer Road, Sunnyvale, CA 94086Ph: (408) 523-8684; Email: melissa.gonzalez@intusurg.com
Date SummaryPrepared:	March 12, 2024
Trade Name:	da Vinci Surgical System Model IS5000/Gen5da Vinci Insufflator and Tube Set with Smoke Evacuationda Vinci Endoscope Tray
Common Name:	Endoscopic instrument control system, endoscopic instruments and accessoriesInsufflator, laparoscopic
Classification:	Class II, 21 CFR 876.1500, Endoscope and AccessoriesClass II, 21 CFR 884.1730, Insufflator, Laparoscopic
Product Code:	NAY (System, Surgical, Computer Controlled Instrument)HIF (Insufflator, Laparoscopic)GCJ (Laparoscope, General & Plastic Surgery)KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories)
Classification AdvisoryCommittee:	General and Plastic SurgeryObstetrics and GynecologyGeneral Hospital
Predicate Devices:	Intuitive Surgical da Vinci Surgical System, Model IS4000 (K131861, withsubsequent clearances for additional features, instruments, accessories -K141077, K151794, K152892, K161271, K191529; and representative uses -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)
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:

da Vinci Insufflator

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

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.

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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(N=20)	Thoracic(N=6)	Urology(N=6)	Gynecology(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 ofSubjects	Number ofAdverseEvents	Number ofSubjectswith anAdverseEvent	Number of Re-admissions	Number of re-operations
GeneralSurgery	20	3	3	0	0
Thoracic	6	0	0	0	0
Urology	6	1	1	0	0
Gynecology	21	5	4	2	1
Total	53	9	8	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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Regulation Number and Section

§ 876.1500 Endoscope and accessories.

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