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.

Device Description

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

The basis for this submission is the modification of the da Vinci Surgical System, Model IS5000, cleared under K232610. The device software is being modified to include a new feature called "Networked Central Configuration Management" which enables Intuitive technical support to remotely push configuration data to a system connected to the network for user to update the system. The configuration data includes customer site preference settings and system feature enabling or disabling. The modification also includes changes to the device labeling.

AI/ML Overview

The provided FDA 510(k) clearance letter for the da Vinci Surgical System (IS5000), K251202, describes a submission for a modification to an already cleared medical device, not a completely novel device. The core of this submission revolves around software changes, specifically the addition of a "Networked Central Configuration Management" feature and associated cybersecurity updates.

As such, the detailed information typically found for a new device's performance study (MRMC, expert ground truth, extensive sample sizes for training/test sets, etc.) is not present in this type of 510(k) submission. The FDA clearance is based on demonstrating that the modifications do not adversely affect the device's safety and effectiveness and that the new features function as intended without introducing new risks.

Therefore, the response below will focus on what can be inferred or reasonably assumed from the provided document regarding performance criteria and how the device meets them in the context of this specific modification.

Acceptance Criteria and Device Performance for da Vinci Surgical System (IS5000) K251202

Given that this 510(k) submission (K251202) is for a modification to an already cleared device (K232610), the performance data provided focuses on verifying the safety and functionality of the changes rather than re-establishing the fundamental efficacy of the surgical system itself. The core acceptance criteria revolve around ensuring that the new software feature ("Networked Central Configuration Management") and associated cybersecurity updates do not introduce new risks or degrade the existing performance of the device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Inferred from Submission Type)	Reported Device Performance (as per 510(k) Summary)
Software Functionality	The "Networked Central Configuration Management" feature enables remote pushing of configuration data and updates settings as intended.	Software verification and validation conducted at unit, integration, and system levels confirmed the subject device continues to meet design requirements and user needs.
Software Safety	The software changes do not introduce new hazards or adverse events related to device operation.	Software verification and validation confirmed the device continues to meet design requirements and user needs. (Implying safety)
Cybersecurity	The device is resilient against identified cybersecurity threats; risk controls are adequate.	Cybersecurity verification and validation conducted confirmed risk control measures based upon the cybersecurity threat model are adequate.
Unchanged Performance	The fundamental surgical capabilities (accurate control of instruments, tissue manipulation, etc.) remain unaffected.	"The principles of operation are unchanged." The submission implies no degradation of the original device's performance due to the software modifications.
Labeling Accuracy	Device labeling accurately reflects the modified features and any associated warnings/contraindications.	"The modification also includes changes to the device labeling." (Implies accuracy and completeness have been addressed).

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

Test Set Sample Size: The document does not specify a quantitative "sample size" in terms of patient cases or surgical procedures for the performance testing of these software modifications. This is typical for software-only changes. Instead, testing would involve a comprehensive set of software validation tests, unit tests, integration tests, and system-level tests for the new functionalities and cybersecurity.
Data Provenance: Not specified in terms of country of origin. The testing would have been performed by the manufacturer (Intuitive Surgical, Inc.) in a controlled development and testing environment. The data is retrospective in the sense that it's derived from internal validation activities, not a prospective clinical trial for these specific changes.

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

Number of Experts: Not explicitly stated. For software and cybersecurity validation, "experts" would likely be:
- Software engineers and quality assurance (QA) testers experienced in medical device software.
- Cybersecurity experts (e.g., ethical hackers, penetration testers, network security specialists).
- Clinical subject matter experts (e.g., surgeons, clinical engineers) might be involved in reviewing use cases and validating clinical workflows impacted by the new features, but this is not detailed.
Qualifications of Experts: Not specified. It's assumed they would possess relevant engineering, software development, cybersecurity, and potentially clinical experience for their respective roles in the verification and validation process.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable or specified. For software and cybersecurity testing, "adjudication" typically refers to the process of resolving discrepancies in expert interpretations of data (e.g., image reads). In software testing, the "ground truth" is adherence to design specifications and user requirements, as well as absence of bugs and security vulnerabilities. Test results are compared against expected outcomes, not expert consensus.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

MRMC Study: No, an MRMC study was not performed. MRMC studies are typically conducted to evaluate the impact of a new diagnostic imaging AI algorithm on human reader performance (e.g., radiologists improving detection rates). This 510(k) is for a surgical system's software modification, not a diagnostic AI.

6. If a Standalone (Algorithm Only) Performance Study Was Done

Standalone Performance Study: Not in the traditional sense of an AI algorithm's diagnostic performance (e.g., sensitivity/specificity for a disease). However, the "Software Testing" and "Cybersecurity Testing" sections represent the standalone performance evaluation of the new software feature and its security aspects in isolation from the full clinical context. This involves testing the software's ability to correctly manage configurations, push updates, and maintain data integrity and security, independent of a specific surgical procedure.

7. The Type of Ground Truth Used

Type of Ground Truth: For this type of submission, the ground truth is established by:
- Design Specifications and User Requirements: The software is tested against whether it correctly implements the defined functionalities (e.g., "Networked Central Configuration Management" remotely pushes data, updates settings as specified).
- Cybersecurity Threat Models: The security measures are validated against identified threats and vulnerabilities to ensure they provide adequate protection.
- Existing Validated Performance: The ground truth for the core surgical system's performance is assumed from its prior clearance (K232610), and the current testing aims to ensure this performance is not degraded.

8. The Sample Size for the Training Set

Training Set Sample Size: Not applicable. The "Networked Central Configuration Management" feature is a conventional software function, not a machine learning or AI algorithm that requires a "training set."

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

Ground Truth for Training Set Establishment: Not applicable, as there is no training set for a machine learning model in this submission.

Summary

FDA 510(k) Clearance Letter - da Vinci Surgical System (IS5000)

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

Doc ID # 04017.08.00

July 16, 2025

Intuitive Surgical, Inc.
Changxin Xu
Senior Regulatory Affairs Specialist
1266 Kifer Road
Sunnyvale, California 94086

Re: K251202
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: April 16, 2025
Received: April 18, 2025

Dear Changxin Xu:

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.

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K251202 - Changxin Xu Page 2

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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K251202 - Changxin Xu Page 3

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,

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

Digitally signed by Mark Trumbore -S
Date: 2025.07.16 09:34:04 -04'00'

Enclosure

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FORM FDA 3881 (8/23) Page 1 of 1

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): K251202

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:
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
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"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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da Vinci Surgical System, Model IS5000 Traditional 510(k)

510(k) Summary (21 CFR § 807.92)

I. Submitter Information

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

Contact Person: Changxin Xu
Senior Regulatory Affairs Specialist
Phone: +1-408-218-9360
Email: Changxin.xu@intusurg.com

Date Prepared: April 16, 2025

II. Subject Device Information

Trade Name: da Vinci Surgical System, Model IS5000
Common Name: System, Surgical, Computer Controlled Instrument
Classification Name: Endoscope and Accessories (21 CFR § 876.1500)
Regulation Medical Specialty: Gastroenterology/Urology
Review Panel: General and Plastic Surgery
Product Code: NAY
Classification: Class II

III. Predicate Device Information

Predicate Device: da Vinci Surgical System, Model IS5000 (K232610)
Reference Device: da Vinci Surgical System, Model IS4000 and IS4200 (K242427)

IV. Device Description

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V. Intended Use/Indications for Use

Intended use and indications for use for the subject da Vinci Surgical System, Model IS5000, are unchanged from the predicate device.

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

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.

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.

VI. Technological Characteristics

The subject da Vinci Surgical System, Model IS5000, is technologically similar to the predicate device. The principles of operation are unchanged. The technological differences that are the basis for this submission are limited to updated system software that enables the Networked Central Configuration Management feature in the subject devices.

VII. Performance Data

Software Testing
Software verification and validation have been conducted at the unit, integration, and system level 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.

Cybersecurity Testing
Cybersecurity verification and validation have been conducted to confirm that the risk control measures based upon the cybersecurity threat model are adequate. Cybersecurity documentation has been provided in accordance with FDA Guidance Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions, issued on September 27, 2023.

VIII. Conclusion

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

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.