da Vinci Surgical System, IS5000

K250442 · Intuitive Surgical, Inc. · NAY · Jul 29, 2025 · Gastroenterology, Urology

Device Facts

• Record ID: K250442
• Device Name: da Vinci Surgical System, IS5000
• Applicant: Intuitive Surgical, Inc.
• Product Code: NAY · Gastroenterology, Urology
• Decision Date: Jul 29, 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

Software-controlled, electromechanical system for minimally invasive surgery; consists of Surgeon Side Console, Patient Side Cart, and Vision System Cart. Surgeon operates console to control endoscopic instruments; system provides visualization and tissue manipulation. New features: Focused Mode (GUI menu), 3D Model Viewer (displays/manipulates 3D models and 2D images on console), and Video Review (records, bookmarks, and reviews surgical video intraoperatively). Used by trained physicians in operating rooms. Output displayed on surgeon console GUI; assists in surgical decision-making and visualization during procedures.

Clinical Evidence

No clinical data. Evidence consists of software verification and validation (unit, integration, system levels), human factors validation testing (comparative task analysis and use-related risk analysis), and cybersecurity verification/validation.

Technological Characteristics

Software-controlled, electromechanical system. Host hardware: general-purpose computer. Features: Focused Mode, 3D Model Viewer, Video Review. Connectivity: System-integrated GUI. Sterilization: Not specified (system-level).

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)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

July 29, 2025

Intuitive Surgical Inc.
Justin Florence
Senior Regulatory Affairs Specialist
1266 Kifer Road
Sunnyvale, California 94086

Re: K250442
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 29, 2025
Received: June 30, 2025

Dear Justin Florence:

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).

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

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K250442 - Justin Florence
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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-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).

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K250442 - Justin Florence
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Sincerely,

Mark Trumbore
-S

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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FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services [phone]
EF

| DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K250442 | |
| Device Name da Vinci Surgical System (IS5000) | |
| Indications for Use (Describe) 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. | |
| 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 [e-mail] | |
| "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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Traditional 510(k) K250442
Da Vinci Surgical System, Model IS5000
Page 1 of 4

# 510(k) Summary: K250442

## 1. SUBMITTER

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

Contact: Joyce Zhong
Regulatory Affairs Lead
Phone Number: 626-592-1164
Email: [e-mail]

Date Prepared: June 27, 2025

## 2. SUBJECT DEVICE INFORMATION

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 and Plastic Surgery

## 3. PREDICATE DEVICE INFORMATION

Predicate Device: da Vinci Surgical System, Model IS5000 (K232610)
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 and Plastic Surgery

## 4. DEVICE DESCRIPTION

The da Vinci Surgical System Model IS5000 (also referred to as dV5) 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.

This submission is based on the software and labeling modification to the da Vinci Surgical System, Model IS5000, previously cleared under K232610. The IS5000 system software has been modified to enable features including Focused Mode, 3D Model Viewer, and Video Review. The Device Labeling of the da Vinci Surgical System, Model IS5000, is also modified to reflect the additional features.

INTUITIVE

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Traditional 510(k) K250442
Da Vinci Surgical System, Model IS5000
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Focused Mode is a new menu mode within the da Vinci Surgical System IS5000 Graphical User Interface (GUI) that allows users to access and interact with 3D Model Viewer and Video Review.

3D Model Viewer (3DMV) is a software feature that enables the da Vinci Surgical System IS5000 system to display and manipulate 3D Models and 2D image files directly on the da Vinci Surgeon Console graphical user interface.

Video Review is a software feature that allows the surgeon to record surgical case video on the da Vinci Surgical System IS5000, create bookmarks, and review the video and bookmarks intraoperatively.

## 5. INTENDED USE/INDICATIONS FOR USE

The intended use and indications for use for the subject da Vinci Surgical System, Model IS5000, remain unchanged from those of the predicate device.

### Intended Use:

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

### Indication 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. 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.

## 6. TECHNOLOGICAL CHARACTERISTICS

The subject da Vinci Surgical System, Model IS5000, is technologically similar to the predicate device. The principles of operation remain unchanged.

The technological differences that form the basis for this submission are limited to updates in the system software that enables Focused Mode, 3D Model View and Video Review features in the subject devices.

| Description | Subject Device
da Vinci Surgical System, IS5000 | Predicate Device (K232610)
da Vinci Surgical System, IS5000 |
| --- | --- | --- |
| Regulation Number | 21 CFR §876.1500 | Identical |

INTUITIVE

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Traditional 510(k) K250442
Da Vinci Surgical System, Model IS5000
Page 3 of 4

| Description | Subject Device
da Vinci Surgical System, IS5000 | Predicate Device (K232610)
da Vinci Surgical System, IS5000 |
| --- | --- | --- |
| Classification | Class II | Identical |
| Product Code | NAY | Identical |
| Prescription use | Rx only | Identical |
| Host Hardware | General-purpose computer hardware | Identical |
| Intended population | Adult patients | Identical |
| Intended Users | Healthcare Professionals | Identical |
| Technological Characteristics | Software-controlled,
electromechanical system. The
technological differences are limited
to updated system software to enable
Focused Mode, 3D Model Viewer and
Video Review features in the subject
devices. | Similar |

# 7. PERFORMANCE DATA

The following performance data support the determination of substantial equivalence between the subject device and the predicate device. All testing performed met its predetermined acceptance criteria and supports the subject device changes:

**Software Verification and Validation**: Software verification and validation were conducted at the unit, integration, and system levels to confirm that the subject device continues to meet design requirements and user needs. Software documentation has been provided in accordance with 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 testing was performed for impacted critical tasks.

**Cybersecurity Testing**: The cybersecurity information has been provided in accordance with the FDA's Guidance Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions issued in September 2023. The cybersecurity verification and validation test results demonstrate the adequacy of the implemented cybersecurity controls.

INTUITIVE

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Traditional 510(k) K250442
Da Vinci Surgical System, Model IS5000
Page 4 of 4

# CONCLUSION

The subject device, da Vinci Surgical System IS5000 with 3D Model Viewer, Video Review and Focused Mode, is substantially equivalent to the predicate device, the da Vinci Surgical System IS5000, based on a comparison of indications for use, device characteristics, and technological characteristics.

The addition of 3D Model Viewer, Video Review and Focused Mode features does not raise new questions related to safety or effectiveness.

INTUITIVE
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