The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Xi and X Surgical Systems, Models IS4000 and IS4200) is intended to 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, general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric 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.

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

Device Description

The da Vinci Xi/X Surgical Systems, Models IS4000/IS4200, are software-controlled, electro-mechanical systems designed to enable complex surgery using a minimally invasive approach. The systems consist of a Surgeon Console, a Patient Side Cart (PSC), and a Vision Side Cart (VSC) and are used with an endoscope, instruments, and accessories.

The basis for this submission is the modification of the da Vinci Xi/X Surgical Systems, Models IS4000/IS4200, cleared in K240723. 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, including 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 pertains to the da Vinci Xi/X Surgical Systems (IS4000/IS4200). This document primarily focuses on a software modification, specifically the "Networked Central Configuration Management" feature, and does not describe a clinical study comparing device performance against specific acceptance criteria in the manner typically seen for diagnostic or AI-driven devices.

Here's a breakdown of the requested information based on the provided text:

Key Takeaway: The submission is for a software modification to an already cleared device, not a new device requiring extensive clinical performance studies against defined acceptance criteria. Therefore, many of the requested data points (like sample size for test sets, expert consensus, MRMC studies, standalone performance with ground truth) are not applicable in this context.

1. Table of Acceptance Criteria and Reported Device Performance

Not directly applicable as described for clinical performance. This submission is for a software modification to an existing, already cleared device. The "performance data" discussed relates to software and cybersecurity testing, not clinical outcomes against specific performance metrics for diagnosis or treatment efficacy in patients compared to a predicate or ground truth.

Acceptance Criterion Type	Description from Document	Reported Device Performance
Software Functionality	Device software meets design requirements and user needs.	"Software verification and validation have been conducted at the unit, integration, and system level to confirm that the subject devices continue to meet design requirements and user needs."
Cybersecurity	Risk control measures based on the cybersecurity threat model are adequate.	"Cybersecurity verification and validation have been conducted to confirm that the risk control measures based upon the cybersecurity threat model are adequate."

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

Not applicable. The document describes software and cybersecurity testing, not a clinical test set with patient data for performance evaluation. Therefore, there is no mention of a sample size for a test set or data provenance (country of origin, retrospective/prospective).

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. Ground truth in the context of clinical performance is not relevant for a software update related to configuration management and cybersecurity. Software testing would involve software engineers and cybersecurity experts, but their roles are not defined as "establishing ground truth" in the clinical sense.

4. Adjudication Method

Not applicable. Adjudication methods (e.g., 2+1, 3+1) are used in clinical studies, particularly for diagnostic devices, to resolve disagreements among experts in establishing ground truth. This is not mentioned as it's a software modification submission.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC study was not done. The document does not mention any clinical studies, and therefore no MRMC comparative effectiveness study was performed to evaluate human reader improvement with or without AI assistance. The da Vinci system is a surgical robot, not an AI diagnostic tool for image interpretation or similar tasks that would typically involve MRMC studies.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

Not applicable. The da Vinci Xi/X Surgical Systems are surgical robots intended to be used with human surgeons (human-in-the-loop). A standalone performance evaluation in the absence of human involvement would not be relevant for this device. The software update is for configuration management, not an autonomous function.

7. Type of Ground Truth Used

Not applicable in the clinical sense. The "ground truth" for software testing would be the predefined functional requirements and specifications, and for cybersecurity, it would be adherence to security protocols and protection against identified threats. This is different from clinical ground truth such as pathology, expert consensus on imaging, or patient outcomes data.

8. Sample Size for the Training Set

Not applicable. The document refers to software modifications and testing for an existing device. There is no mention of a "training set" in the context of machine learning or AI model development which would require such a set. The "training" implied is for the system's internal functions, not for a learning algorithm.

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

Not applicable. As there is no mention of a training set for an AI/machine learning model, the method for establishing its ground truth is not discussed.

Summary

FDA 510(k) Clearance Letter - da Vinci Xi/X Surgical Systems

Page 1

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

Doc ID # 04017.07.05

April 1, 2025

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

Re: K242427
Trade/Device Name: da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200)
Regulation Number: 21 CFR 876.1500
Regulation Name: Endoscope And Accessories
Regulatory Class: Class II
Product Code: NAY
Dated: February 28, 2025
Received: February 28, 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.

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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K242427 - Jennifer Karafin
Page 2

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

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K242427 - Jennifer Karafin
Page 3

Sincerely,

Mark Trumbore -S
Digitally signed by Mark Trumbore -S
Date: 2025.04.01 14:17:32 -04'00'

Mark Trumbore, PhD
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

Page 4

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

Indications for Use

Submission Number (if known)
K242427

Device Name
da Vinci Xi Surgical System (IS4000);
da Vinci X Surgical System (IS4200)

Indications for Use (Describe)

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:

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Page 5

da Vinci Xi/X Surgical Systems, Models IS4000/IS4200
Traditional 510(k)
Page 1 of 2

510(k) Summary (21 CFR § 807.92)

I. Submitter Information

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

Contact Person: Jennifer Karafin
Senior Regulatory Affairs Specialist
Phone: +1-315-447-6522
Email: jennifer.karafin@intusurg.com

Date Prepared: August 12, 2024

II. Subject Device Information

Trade Name: da Vinci Xi Surgical System, Model IS4000
da Vinci X Surgical System, Model IS4200

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 Devices: da Vinci Xi Surgical System, Model IS4000 (K240723)
da Vinci X Surgical System, Model IS4200 (K240723)

IV. Device Description

Page 6

da Vinci Xi/X Surgical Systems, Models IS4000/IS4200
Traditional 510(k)
Page 2 of 2

V. Intended Use/Indications for Use

Intended use and indications for use for the subject da Vinci Xi/X Surgical Systems, Models IS4000/IS4200, are unchanged from their predicate devices.

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 Xi and X Surgical Systems, Models IS4000 and IS4200) is intended to 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, general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric 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 Xi/X Surgical Systems, Models IS4000/IS4200, are technologically similar to their predicate devices. 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 devices continue 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

Based on the intended use, indications for use, technological characteristics, and performance data, the subject da Vinci Xi/X Surgical Systems, Models IS4000/IS4200, are substantially equivalent to and are as safe, as effective, and perform as well as their predicate devices.

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.