(140 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, 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 orPSC), and a Tower (Vision Side Cart or VSC) and is used with an endoscope, instruments, and accessories.
The basis for this submission is the initial submission of the da Vinci Surgical System, Model IS5000, cleared under K232610. The device software is being modified to include compatibility support of Harmonic ACE™ Curved Shears. Harmonic ACE™ Curved Shears was previously cleared to be used with da Vinci Surgical Systems Model IS4000 under K143132. This modification does not change the Harmonic ACE™ Curved Shears. It changed the da Vinci Surgical System Model IS5000 software to allow Harmonic ACE™ Curved Shears to be used with the IS5000 system. This modification also includes changes to the da Vinci Surgical System, Model IS5000 device labeling for instruments and accessories.
N/A
FDA 510(k) Clearance Letter - da Vinci Surgical System (IS5000)
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue Doc ID # 04017.08.00
Silver Spring, MD 20993
www.fda.gov
September 8, 2025
Intuitive Surgical, Inc.
Changxin Xu
Senior Regulatory Affairs Specialist
1266 Kifer Road
Sunnyvale, California 94086
Re: K251227
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: August 6, 2025
Received: August 11, 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.
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"
Page 2
K251227 - Changxin Xu Page 2
(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-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).
Page 3
K251227 - Changxin Xu Page 3
Sincerely,
Mark Trumbore -S Digitally signed by Mark Trumbore -S Date: 2025.09.08 11:53:49 -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. | K251227
Please provide the device trade name(s).
da Vinci Surgical System, Model 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)
Page 5
da Vinci Surgical System, Model IS5000 Traditional 510(k) K251227
510(k) Summary (21 CFR § 807.92)
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: August 6, 2025
I. 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
II. Predicate Device Information
Predicate Device: da Vinci Surgical System, Model IS5000 (K232610)
Reference Device: IS4000 8mm Harmonic ACE™ Curved Shears (K143132)
III. 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 initial submission of the da Vinci Surgical System, Model IS5000, cleared under K232610. The device software is being modified to include compatibility support of Harmonic ACE™ Curved Shears. Harmonic ACE™ Curved Shears was previously cleared to be used with da Vinci Surgical Systems Model IS4000 under K143132. This modification does not change the Harmonic ACE™ Curved Shears. It changed the da Vinci Surgical System Model IS5000 software to allow Harmonic ACE™ Curved Shears to be used with the IS5000 system. This modification also includes changes to the da Vinci Surgical System, Model IS5000 device labeling for instruments and accessories.
Page 6
da Vinci Surgical System, Model IS5000 Traditional 510(k) K251227
IV. 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.
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.
V. 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 the updated system software that extended existing instrument control to support Harmonic ACE Shears in the subject device.
VI. 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.
Electrical Safety and Electromechanical Compatibility
For electrical safety, the Harmonic ACE instrument is only subjected to the temperature test since it is a non-energy mechanical instrument which achieves its intended clinical action by the mechanical vibration of the cutting surface. The Harmonic ACE instrument is connected to an Ethicon generator, which is connected to the Tower of the da Vinci Surgical System. The Ethicon generator is a 3rd party device and maintains its own safety certificate. Underwriters Laboratories (UL) evaluated the Harmonic ACE instrument when the IS5000 was introduced and determined no additional testing of the Harmonic ACE
Page 7
da Vinci Surgical System, Model IS5000 Traditional 510(k) K251227
was needed. This result was recorded in 841016-02 Rev D as part of the UL report submitted in K232610.
For EMC testing, both the IS5000 system and the Ethicon Generator are compliant with the current EMC standard IEC 60601-1-2. No new system level testing is required per Clause 8.5 and Clause 7.1.4 of IEC 60601-1-2.
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 June 27, 2025.
Human Factors Information
Human factors information has been provided in accordance with recommendations for HF Submission Category 2 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), there are no new critical tasks introduced and no impacted existing critical tasks. Furthermore, the Summary of Known Use Problems (also referred to as Summary of Known Use Errors) report did not reveal any usability issues that may impact existing risk assessments. As a result, no human factors validation testing was needed.
VII. Conclusion
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.
§ 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.