(99 days)
No.
The device description and testing details do not mention any AI, DNN, or ML models. The functionalities described are electrosurgical and mechanical, controlled by standard surgical system components.
Yes
The device is intended for "bipolar coagulation and mechanical transection of blood vessels... lymphatic vessels, and tissue bundles," which are direct therapeutic interventions.
No
Explanation: The device is described as a surgical instrument for grasping, dissecting, coagulating, and transecting tissue and vessels. Its "Intended Use" and "Device Description" clearly outline therapeutic functions (sealing and cutting) rather than diagnostic ones (identifying or detecting conditions).
No
The device is a physical, electrosurgical instrument with mechanical components (distal wristed end effector, proximal housing, tubular shaft, integrated cord, electrode sealing surface, cutting blade). It performs physical actions like grasping, dissection, coagulation, and transection. While it mentions "Software Verification" in its testing, this refers to verification of integrated software controlling the physical device, not the device itself being solely software.
No.
The device is an electrosurgical instrument used for grasping, dissecting, coagulating, and transecting tissue and blood vessels, which are invasive surgical procedures performed directly on the human body, not on samples taken from the body.
N/A
Intended Use / Indications for Use
The Vessel Sealer Curved is a bipolar electrosurgical instrument for use with a compatible da Vinci Surgical System and a compatible electrosurgical generator. It is intended for grasping and blunt dissection of tissue, and for bipolar coagulation and mechanical transection of blood vessels (veins and arteries) up to 7 mm in diameter, lymphatic vessels, and tissue bundles that fit in the jaws of the instrument. The Vessel Sealer Curved has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.
Product codes
NAY
Device Description
The Vessel Sealer Curved is a sterile, single-use (disposable), 8 mm instrument with an integrated cord that connects to the instrument housing. The Vessel Sealer Curved device consists of a distal wristed end effector and a proximal housing connected by a tubular shaft. The housing contains mechanisms to actuate the end effector when attached to a compatible da Vinci Surgical System. An integrated cord attached to the housing is connected to a receptacle in the Intuitive Electrosurgical generator, E-200. An electrode sealing surface and a cutting blade within the jaws of the instrument enable sealing of vessels and cutting of sealed vessels and other tissues. The sealing and cutting functions are controlled using the compatible da Vinci Surgical System foot pedals.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
blood vessels (veins and arteries), lymphatic vessels, and tissue bundles
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing was performed with a compatible da Vinci surgical systems and Generator. Testing included design verification, compatibility verification, transit and shelf-life verification, biocompatibility, and design validation. The successful completion of testing demonstrated that the Vessel Sealer subject design outputs meets design inputs.
Design Verification: Bench testing was performed to verify that functional design outputs met the functional design inputs. This addressed:
- Mechanical bench testing
- Reliability Testing
- Force to Jaw Failure
- Software Verification
- Testing in accordance with IEC60601-1 and IEC60601-1-2
- Usability Testing
Shelf-Life Verification: Device shelf-life verification testing was performed in accordance with ASTM F1980 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices.
Transit Verification: Transit testing was performed in accordance with ASTM D4169-16, Standard Practice for Performance Testing of Shipping Containers and Systems.
Biocompatibility: Biocompatibility testing was completed in accordance with FDA Guidance: Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process", issued September 2020 and ISO 10993-1:2018 Biological evaluation of medical devices.
Design Validation: Animal testing was performed to validate that the product specifications meet the user's needs and intended use. These included:
- Design Validation
- Burst Pressure Testing
- Thermal Spread on Vessels
- Chronic Animal Study
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
FDA 510(k) Clearance Letter - Vessel Sealer Curved
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
June 13, 2025
Intuitive Surgical, Inc.
Meirav Harsat
Regulatory Affairs Lead
1266 Kifer Road
Sunnyvale, California 94086
Re: K250674
Trade/Device Name: Vessel Sealer Curved (480522)
Regulation Number: 21 CFR 876.1500
Regulation Name: Endoscope And Accessories
Regulatory Class: Class II
Product Code: NAY
Dated: [NOTE: Use date of most recent supplement]
Received: May 15, 2025
Dear Meirav Harsat:
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.
Page 2
K250674 - Meirav Harsat
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
K250674 - Meirav Harsat
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: 2025.06.13 07:55:49 -04'00'
Mark Trumbore Ph.D.
Assistant Director, THT4A1: Robotically-Assisted Surgical Devices Team
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)
K250674
Device Name
Vessel Sealer Curved (480522)
Indications for Use (Describe)
The Vessel Sealer Curved is a bipolar electrosurgical instrument for use with a compatible da Vinci Surgical System and a compatible electrosurgical generator. It is intended for grasping and blunt dissection of tissue, and for bipolar coagulation and mechanical transection of blood vessels (veins and arteries) up to 7 mm in diameter, lymphatic vessels, and tissue bundles that fit in the jaws of the instrument. The Vessel Sealer Curved has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.
Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Page 5
Vessel Sealer Curved Traditional 510(k)
CONFIDENTIAL
Page 1 of 3
510(k) Summary
Submitter: Intuitive Surgical, Inc.
1266 Kifer Road
Sunnyvale, CA 94086
Official Contact: Meirav Harsat
Regulatory affairs Lead
Phone number: 650-862-4942
Email: Meirav.harsat@intusurg.com
Date Prepared: March 4, 2025
I. Subject Device:
Trade Name: Vessel Sealer Curved
Common Name: System, surgical, computer controlled instrument
Classification: Class II, Endoscope and accessories, 21 CFR 876.1500, NAY
II. Predicate Device:
Vessel Sealer Extend K183107
III. Device Description:
The Vessel Sealer Curved is a sterile, single-use (disposable), 8 mm instrument with an integrated cord that connects to the instrument housing. The Vessel Sealer Curved device consists of a distal wristed end effector and a proximal housing connected by a tubular shaft. The housing contains mechanisms to actuate the end effector when attached to a compatible da Vinci Surgical System. An integrated cord attached to the housing is connected to a receptacle in the Intuitive Electrosurgical generator, E-200. An electrode sealing surface and a cutting blade within the jaws of the instrument enable sealing of vessels and cutting of sealed vessels and other tissues. The sealing and cutting functions are controlled using the compatible da Vinci Surgical System foot pedals.
IV. Indications for Use:
The Vessel Sealer Curved is a bipolar electrosurgical instrument for use with a compatible da Vinci Surgical System and a compatible electrosurgical generator. It is intended for grasping and blunt dissection of tissue, and for bipolar coagulation and mechanical transection of blood vessels (veins and arteries) up to 7 mm in diameter, lymphatic vessels, and tissue bundles that fit in the jaws of the instrument. The Vessel Sealer Curved has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.
Page 6
Vessel Sealer Curved
Traditional 510(k)
510(k) Summary
Submitter: Intuitive Surgical, Inc.
1266 Kifer Road
Sunnyvale, CA 94086
Official Contact: Meirav Harsat
Regulatory affairs Lead
Phone number: 650-862-4942
Email: Meirav.harsat@intusurg.com
Date Prepared: March 4, 2025
I. Subject Device:
Trade Name: Vessel Sealer Curved
Common Name: System, surgical, computer controlled instrument
Classification: Class II, Endoscope and accessories, 21 CFR 876.1500, NAY
II. Predicate Device:
Vessel Sealer Extend K183107
III. Device Description:
The Vessel Sealer Curved is a sterile, single-use (disposable), 8 mm instrument with an integrated cord that connects to the instrument housing. The Vessel Sealer Curved device consists of a distal wristed end effector and a proximal housing connected by a tubular shaft. The housing contains mechanisms to actuate the end effector when attached to a compatible da Vinci Surgical System. An integrated cord attached to the housing is connected to a receptacle in the Intuitive Electrosurgical generator, E-200. An electrode sealing surface and a cutting blade within the jaws of the instrument enable sealing of vessels and cutting of sealed vessels and other tissues. The sealing and cutting functions are controlled using the compatible da Vinci Surgical System foot pedals.
IV. Indications for Use:
The Vessel Sealer Curved is a bipolar electrosurgical instrument for use with a compatible da Vinci Surgical System and a compatible electrosurgical generator. It is intended for grasping and blunt dissection of tissue, and for bipolar coagulation and mechanical transection of blood vessels (veins and arteries) up to 7 mm in diameter, lymphatic vessels, and tissue bundles that fit in the jaws of the instrument. The Vessel Sealer Curved has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.
CONFIDENTIAL
Page 1 of 3
Page 7
Vessel Sealer Curved
Traditional 510(k)
CONFIDENTIAL
Page 2 of 3
V. Comparison of Technological Characteristics:
The Vessel Sealer Curved has the same intended use and fundamental scientific technology as its predicate device. It is similar to its predicate device in terms of its indication for use and technological characteristics. Differences between the predicate and the subject device include the addition of specific vessels to the indication for use, changes in design and materials at the end effector (jaw), and modifications to the electrical cable at the distal end. These changes do not substantively change the safety and performance of the subject device relative to the function of the predicate device.
VI. Performance Data:
Testing was performed with a compatible da Vinci surgical systems and Generator. Testing included design verification, compatibility verification, transit and shelf-life verification, biocompatibility, and design validation. The successful completion of testing demonstrated that the Vessel Sealer subject design outputs meets design inputs.
Design Verification
Bench testing was performed to verify that functional design outputs met the functional design inputs. The design verification in this section addressed the following:
- Mechanical bench testing
- Reliability Testing
- Force to Jaw Failure
- Software Verification
- Testing in accordance with IEC60601-1 and IEC60601-1-2
- Usability Testing
Shelf-Life Verification
Device shelf-life verification testing was performed in accordance with ASTM F1980 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices.
Transit Verification
Transit testing was performed in accordance with ASTM D4169-16, Standard Practice for Performance Testing of Shipping Containers and Systems.
Biocompatibility
Biocompatibility testing was completed in accordance with the following standards and guidance documents:
Page 8
Vessel Sealer Curved
Traditional 510(k)
V. Comparison of Technological Characteristics:
The Vessel Sealer Curved has the same intended use and fundamental scientific technology as its predicate device. It is similar to its predicate device in terms of its indication for use and technological characteristics. Differences between the predicate and the subject device include the addition of specific vessels to the indication for use, changes in design and materials at the end effector (jaw), and modifications to the electrical cable at the distal end. These changes do not substantively change the safety and performance of the subject device relative to the function of the predicate device.
VI. Performance Data:
Testing was performed with a compatible da Vinci surgical systems and Generator. Testing included design verification, compatibility verification, transit and shelf-life verification, biocompatibility, and design validation. The successful completion of testing demonstrated that the Vessel Sealer subject design outputs meets design inputs.
Design Verification
Bench testing was performed to verify that functional design outputs met the functional design inputs. The design verification in this section addressed the following:
- Mechanical bench testing
- Reliability Testing
- Force to Jaw Failure
- Software Verification
- Testing in accordance with IEC60601-1 and IEC60601-1-2
- Usability Testing
Shelf-Life Verification
Device shelf-life verification testing was performed in accordance with ASTM F1980 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices.
Transit Verification
Transit testing was performed in accordance with ASTM D4169-16, Standard Practice for Performance Testing of Shipping Containers and Systems.
Biocompatibility
Biocompatibility testing was completed in accordance with the following standards and guidance documents:
CONFIDENTIAL
Page 2 of 3
Page 9
Vessel Sealer Curved
Traditional 510(k)
CONFIDENTIAL
Page 3 of 3
- FDA Guidance: Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process", issued September 2020
- ISO 10993-1:2018 Biological evaluation of medical devices
Design Validation
Animal testing was performed to validate that the product specifications meet the user's needs and intended use. These included:
- Design Validation
- Burst Pressure Testing
- Thermal Spread on Vessels
- Chronic Animal Study
VII. Conclusions:
Based on the intended use, technological characteristics, and performance data, the subject Vessel Sealer Curved is substantially equivalent to the Vessel Sealer Extend predicate device.