(96 days)
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.
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.
The provided FDA 510(k) clearance letter and summary for the Da Vinci Surgical System (IS5000) focuses on a software modification, specifically the addition of a "force gauge" graphical user interface (GUI) element. The document does not provide detailed information about clinical performance studies with acceptance criteria in the sense of diagnostic accuracy or clinical outcomes directly tied to the new GUI feature.
Instead, the performance data presented is related to software verification and validation and human factors. This is typical for device modifications where the core functionality of the device remains unchanged, and the modification primarily affects the user interface or internal software operations.
Here's a breakdown of the requested information based only on the provided text, recognizing the limitations of this type of submission:
1. Table of Acceptance Criteria and Reported Device Performance
Since the primary modification is a software change and the addition of a GUI element, the acceptance criteria are not clinical performance metrics but relate to the software's adherence to design specifications and usability.
| Acceptance Criteria Category | Reported Device Performance (Summary) |
|---|---|
| Software Verification & Validation | All testing passed; continues to meet design specifications and user needs. Software documentation provided according to FDA guidance. |
| Human Factors Validation | Based on Comparative Task Analysis (CTA) and Use-Related Risk Analysis (URRA), human factors validation conducted for impacted critical tasks. All testing passed. |
2. Sample Size Used for the Test Set and Data Provenance
- Software Verification & Validation: The document states "unit, subsystem integration, and system level" testing. This typically involves internal testing by engineers. It does not specify a "sample size" in terms of patient data or clinical cases. The provenance is internal development and testing.
- Human Factors Validation: While a "human factors validation" was conducted, the document does not specify the number of users (the "test set" in this context) involved in these studies. The provenance would be from internal usability testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable in the context of this software modification submission. The "ground truth" for software verification is adherence to design specifications and functional requirements. For human factors, it relates to usability and safety of interaction, which is assessed through user testing and expert review of the interface. The document does not specify the number or qualifications of "experts" involved in establishing this ground truth.
4. Adjudication Method for the Test Set
Not applicable for the types of testing described. Adjudication methods like "2+1" typically apply to diagnostic studies where multiple readers interpret cases and a consensus or tie-breaker is needed to establish ground truth.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not explicitly mentioned or implied to be done for this submission. The submission focuses on verification of the software change and human factors, not on comparing clinical effectiveness with and without the AI assistance (which the force gauge isn't explicitly defined as, but rather a new GUI element for an existing force feedback instrument).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable. The force gauge is a graphical user interface element that provides visual feedback to the human operator using the Da Vinci Surgical System. It inherently functions "with human-in-the-loop."
7. The Type of Ground Truth Used
- Software Verification & Validation: The "ground truth" is the design specifications and functional requirements of the software. The tests verify that the software performs as designed.
- Human Factors Validation: The "ground truth" is adherence to usability principles and mitigation of use-related risks, assessed through task analysis and user studies against established human factors engineering principles.
8. The Sample Size for the Training Set
Not applicable. This submission concerns a modification to an existing surgical system's software GUI. It does not describe an AI/ML algorithm that requires a "training set" in the conventional sense for model development. The "force gauge" is a visual representation of existing force feedback data, not a new predictive or analytical algorithm trained on data.
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/ML model.
Summary of Device and Study Context:
The Da Vinci Surgical System (IS5000) submission (K251213) is a Traditional 510(k) for a software modification to an already cleared device (K232610). The modification adds a "force gauge" graphical user interface (GUI) element that visually represents forces applied by existing Da Vinci Force Feedback instruments.
The study described is not a clinical effectiveness trial but rather a set of engineering verification and validation activities to ensure the software modification is safe and functions as intended, and that the new GUI element does not introduce new use-related risks. The FDA's clearance is based on the determination that the modified device is substantially equivalent to its predicate device, and the performance data provided (software V&V, human factors) supports this equivalence for the specific modification.
U.S. Food & Drug Administration 510(k) Clearance Letter
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.08.00
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.
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 and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Page 2
K251213 - Jennifer Karafin 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-
Page 3
K251213 - Jennifer Karafin 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 -S Digitally signed by Mark Trumbore -S Date: 2025.07.23 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
Page 4
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)
Da Vinci Surgical System Page 9 of 33
Page 5
510(k) Summary
Traditional 510(k) Da Vinci Surgical System, Model IS5000 Page 1 of 2
©2025 Intuitive Surgical, Inc. All rights reserved. Product names are trademarks or registered trademarks of their respective holders.
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: +1-315-447-6522
Email: jennifer.karafin@intusurg.com
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.
Page 6
Traditional 510(k) Da Vinci Surgical System, Model IS5000 Page 2 of 2
©2025 Intuitive Surgical, Inc. All rights reserved. Product names are trademarks or registered trademarks of their respective holders.
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.
§ 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.