Da Vinci Surgical System (IS5000)

K251213 · Intuitive Surgical, Inc. · NAY · Jul 23, 2025 · Gastroenterology, Urology

Device Facts

• Record ID: K251213
• Device Name: Da Vinci Surgical System (IS5000)
• Applicant: Intuitive Surgical, Inc.
• Product Code: NAY · Gastroenterology, Urology
• Decision Date: Jul 23, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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, 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, 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. 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.

Device Story

Da Vinci Surgical System (IS5000) is a software-controlled, electro-mechanical system for minimally invasive surgery. System comprises console, robot, and tower; used with endoscopes, instruments, and accessories. Modification adds 'force gauge' GUI element providing visual representation of forces applied during tasks with existing da Vinci Force Feedback instruments. Operated by trained physicians in operating room. Visual output assists surgeon in monitoring applied forces during tissue manipulation, potentially improving precision and safety. System maintains core principles of operation of predicate. No changes to force feedback instruments themselves.

Clinical Evidence

Bench testing only. Software verification and validation performed at unit, subsystem, and system levels. Human factors validation conducted via comparative task analysis (CTA) and use-related risk analysis (URRA) for impacted critical tasks, following FDA guidance for HF Submission Category 3.

Technological Characteristics

Electro-mechanical endoscopic instrument control system. Software-controlled. Includes console, robot, and tower. Modification adds software-based force gauge GUI element. Enhanced documentation level software. Human factors category 3.

Indications for Use

Indicated for adult patients undergoing urologic, general laparoscopic, gynecologic laparoscopic, and general thoracoscopic surgical procedures. Contraindicated for use of force feedback needle drivers in hysterectomy and myomectomy.

Regulatory Classification

Identification

An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Special Controls

*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.

Predicate Devices

• Da Vinci Surgical System, Model IS5000 (K232610)

Reference Devices

• da Vinci Force Feedback Instruments (K243641)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

July 23, 2025

Intuitive Surgical, Inc.
Jennifer Karafin
Senior Regulatory Affairs Specialist
1266 Kifer Road
Sunnyvale, California 94086

Re: K251213
Trade/Device Name: Da Vinci Surgical System (IS5000)
Regulation Number: 21 CFR 876.1500
Regulation Name: Endoscope And Accessories
Regulatory Class: Class II
Product Code: NAY
Dated: June 24, 2025
Received: June 24, 2025

Dear Jennifer Karafin:

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.

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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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).

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 QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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-reporting-combination-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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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 the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-

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K251213 - Jennifer Karafin
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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,

Mark
Trumbore - S
Digitally signed by Mark Trumbore-S
Date: 2023.07.23 14:46:14 -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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Da Vinci Surgical System
Page 9 of 33

| Indications for Use | | |
| --- | --- | --- |
| Please type in the marketing application/submission number, if it is known. This
textbox will be left blank for original applications/submissions. | K251213 | ? |
| Please provide the device trade name(s). | | ? |
| Da Vinci Surgical System (IS5000) | | |
| Please provide your Indications for Use below. | | ? |
| 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, 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, 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.

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. | | |
| Please select the types of uses (select one or both, as
applicable). | ☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? |

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K251213
Traditional 510(k)
Da Vinci Surgical System, Model IS5000
Page 1 of 2

# 510(k) Summary

510(k) Owner:
Intuitive Surgical, Inc.
1266 Kifer Road
Sunnyvale, CA 94086-5304 USA

Contact:
Jennifer Karafin
Senior Regulatory Affairs Specialist
Intuitive Surgical, Inc.
1266 Kifer Road
Sunnyvale, CA 94086-5304 USA
Phone: [phone]
Email: [e-mail]

Date Summary Prepared: April 16, 2025
Trade Name: Da Vinci Surgical System, Model IS5000
Common Name: Endoscopic instrument control system
Classification: Class II, 21 CFR 876.1500, Endoscope and Accessories
Product Code: NAY (System, Surgical, Computer Controlled Instrument)
Review Panel: General & Plastic Surgery
Predicate Devices: Da Vinci Surgical System, Model IS5000 (K232610)

## Device Description:

The da Vinci Surgical System, Model IS5000 (da Vinci 5) is a software-controlled, electro-mechanical system designed to enable complex surgery using a minimally invasive approach. The system consists of a Console, Robot, and Tower and is used with an endoscope, instruments, and accessories.

The basis for this submission is a modification to the da Vinci Surgical System, Model IS5000, cleared under K232610. The device software has been modified to include a new “force gauge” graphical user interface element, which provides a visual representation of forces applied while completing tasks with the da Vinci Force Feedback instruments.¹ The modification also includes changes to the device labeling.

## 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, 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, gynecologic laparoscopic surgical procedures and general thoracoscopic surgical procedures. The system is indicated for adult use.

¹ The da Vinci Force Feedback Instruments are force sensing endoscopic instruments that are compatible with the da Vinci Surgical System, Model IS5000. These existing devices, most recently cleared under K243641, have not been modified for the subject device changes.

INTUITIVE
©2025 Intuitive Surgical, Inc. All rights reserved. Product names are trademarks or registered trademarks of their respective holders.

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K251213
Traditional 510(k)
Da Vinci Surgical System, Model IS5000
Page 2 of 2

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 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.

## Technological Characteristics:

The subject da Vinci Surgical System, Model IS5000 (da Vinci 5) is technologically similar to its predicate device. The overall technological characteristics such as principles of operation are unchanged. The change that is the basis for this submission includes a software modification to enable the new force gauge graphical user interface element.

## Performance Data:

The following performance data demonstrates substantial equivalence to the predicate device. All testing passed and supports the subject device changes:

**Software Verification and Validation:** Software verification and validation have been conducted at the unit, subsystem integration, and system level to confirm that the subject device continues to meet design specifications and user needs. Software documentation has been provided in accordance with recommendations for Enhanced Documentation Level in FDA Guidance Content of Premarket Submissions for Device Software Functions, issued on June 14, 2023.

**Human Factors Information:** Human factors information has been provided in accordance with recommendations for HF Submission Category 3 in FDA Draft Guidance Content of Human Factors Information in Medical Device Marketing Submissions, issued on December 9, 2022. Based on the results of a comparative task analysis (CTA) and use-related risk analysis (URRA), human factors validation has been conducted for impacted existing critical tasks.

## Summary:

Based on the intended use, indications for use, technological characteristics, and performance data, the subject da Vinci Surgical System, Model IS5000 (da Vinci 5) is substantially equivalent to and is as safe, as effective, and performs as well as its predicate device.

INTUITIVE
©2025 Intuitive Surgical, Inc. All rights reserved. Product names are trademarks or registered trademarks of their respective holders.