(165 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 (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.
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.
The provided FDA 510(k) clearance letter for the da Vinci Surgical System, IS5000 (K250442) describes modifications to an existing device, focusing on software and labeling updates for new features: Focused Mode, 3D Model Viewer, and Video Review. As such, the study described is primarily focused on demonstrating that these new features do not raise new questions of safety or effectiveness and that the modified device remains substantially equivalent to its predicate.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a "table of acceptance criteria" with specific quantitative thresholds. Instead, it states that "All testing performed met its predetermined acceptance criteria and supports the subject device changes." The acceptance criteria are broadly described by the types of testing conducted and the regulatory guidance followed. The reported device performance is that these tests were met.
| Acceptance Criteria Category (Implied from document) | Reported Device Performance (Implied from document) |
|---|---|
| Software Verification and Validation | Met design requirements and user needs at unit, integration, and system levels. Complied with FDA Guidance "Content of Premarket Submissions for Device Software Functions." |
| Human Factors Information | Addressed per recommendations for HF Submission Category 3 in FDA Draft Guidance "Content of Human Factors Information in Medical Device Marketing Submissions." Human factors validation testing was performed for impacted critical tasks. |
| Cybersecurity Testing | Demonstrated adequacy of implemented cybersecurity controls. Complied with FDA Guidance "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions." |
| Substantial Equivalence | Device is substantially equivalent to the predicate device based on indications for use, device characteristics, and technological characteristics. The new features do not raise new questions of safety or effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a sample size for any of the testing conducted. It also does not specify the data provenance (e.g., country of origin, retrospective/prospective). The testing appears to be primarily focused on internal verification and validation of the software and human-device interaction rather than a clinical study involving patients or patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not specify the number of experts used or their qualifications for establishing ground truth associated with the test set. For "Human Factors Information," it mentions that "human factors validation testing was performed for impacted critical tasks," which would typically involve user testing with representative users (e.g., surgeons). However, details about the number or qualifications of these users/experts are not provided.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the test set. Given the nature of the testing described (software V&V, human factors, cybersecurity), a formal adjudication process akin to clinical trial endpoint determination is generally not applicable or described in this type of submission summary.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not conducted. The submission focuses on modifications to an existing surgical system and primarily addresses safety and effectiveness through software, human factors, and cybersecurity testing, rather than comparative clinical outcomes with human readers or AI assistance. The new features (Focused Mode, 3D Model Viewer, Video Review) are enhancements to the user interface and functionality, not diagnostic aids or AI-driven decision support tools that would typically warrant an MRMC study.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance Study
A standalone performance study of an algorithm without human-in-the-loop performance was not conducted or described. The da Vinci Surgical System is, by definition, a human-in-the-loop system controlled by a surgeon. The new features described are intended to assist the surgeon (e.g., displaying 3D models, reviewing video) rather than operate autonomously.
7. Type of Ground Truth Used
The type of "ground truth" used is not explicitly specified in terms of clinical outcomes, pathology, or expert consensus on a test set. Instead, the "ground truth" for the testing performed likely refers to:
- Design Requirements: For software V&V, the "ground truth" is that the software performs according to its specified requirements and user needs.
- Usability Objectives: For human factors testing, the "ground truth" is that critical tasks can be performed safely and effectively by intended users without unacceptable use errors.
- Security Standards: For cybersecurity testing, the "ground truth" is adherence to established cybersecurity best practices and the mitigation of identified vulnerabilities.
8. Sample Size for the Training Set
The document does not specify a sample size for any training set. As the modifications described are for software features (Focused Mode, 3D Model Viewer, Video Review) that enhance the control system but do not appear to involve machine learning models that require a "training set" in the traditional sense, this information is not applicable or provided.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set in the document, information on how its ground truth was established is not provided. The system enhancements are described as software functionalities rather than machine learning algorithms that would typically rely on labeled training data and an associated ground truth establishment process.
FDA 510(k) Clearance Letter - da Vinci Surgical System, IS5000
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.08.00
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).
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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K250442 - Justin Florence
Page 3
Sincerely,
Mark Trumbore, Ph.D.
Digitally signed by Mark Trumbore -S
Date: 2025.07.29 13:28:11 -04'00'
Mark Trumbore, Ph.D.
Assistant Director
DHT4A: Division of General Surgery Devices
OHT4: Office of Surgical and Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
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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.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
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Traditional 510(k) K250442 - Da Vinci Surgical System, Model IS5000
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: joyce.zhong@intusurg.com
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.
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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 Deviceda Vinci Surgical System, IS5000 | Predicate Device (K232610)da Vinci Surgical System, IS5000 |
|---|---|---|
| Regulation Number | 21 CFR §876.1500 | Identical |
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| Description | Subject Deviceda 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.
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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.
§ 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.