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.

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.

AI/ML Overview

Based on the provided FDA 510(k) clearance letter and summary for the "Vessel Sealer Curved" device, it is important to note that this document pertains to a surgical instrument (hardware), not a medical device with an AI/software component that would involve "acceptance criteria" and "studies" as typically understood for AI-based diagnostic or prognostic devices.

The information requested in the prompt (acceptance criteria for AI, sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable to this type of device submission. The 510(k) summary clearly outlines the types of testing performed: mechanical, reliability, software (presumably related to the electrosurgical generator and da Vinci system, not AI), biocompatibility, shelf-life, transit, and animal studies focusing on functional performance like burst pressure and thermal spread.

Therefore, I cannot extract the information requested in the format provided because the device and its clearance process do not involve AI performance evaluation. The "study that proves the device meets the acceptance criteria" in this context refers to the engineering and preclinical validation tests detailed in Section VI "Performance Data" (Design Verification, Shelf-Life, Transit, Biocompatibility, Design Validation via animal testing).

Here's how to address the prompt given the nature of the device:

Acknowledgement of Device Type:
The Vessel Sealer Curved is a physical surgical instrument (bipolar electrosurgical instrument) used with a compatible da Vinci Surgical System and an electrosurgical generator. It is not an AI/software-based diagnostic or imaging device.

Why the Requested Information is Not Applicable:
The majority of the questions in the prompt (e.g., acceptance criteria for AI, sample sizes for test/training sets for AI, expert ground truth, MRMC studies, standalone AI performance) are relevant to the regulatory pathway for AI/Machine Learning-enabled medical devices. Since the Vessel Sealer Curved is a hardware device focused on mechanical and electrosurgical performance, these metrics are not part of its 510(k) submission.

Information that is relevant and can be inferred from the document:

The acceptance criteria for a device like this would be tied to its functional performance, safety, and substantial equivalence to a predicate device.

Overall Goal: To demonstrate substantial equivalence to the predicate device (Vessel Sealer Extend K183107) in terms of intended use, technological characteristics, safety, and performance.
Key Performance Indicators (Acceptance Criteria): While not explicitly stated in a table format with specific percentages for AI performance, the document implies the following types of performance criteria based on the tests conducted:
- Mechanical Integrity: The device must withstand expected forces and remain functional (e.g., ability to grasp, dissect, and transect tissue).
- Reliability: Consistent performance over its intended lifespan/usage.
- Sealing Effectiveness: Ability to seal vessels up to 7mm effectively, preventing burst at a certain pressure (Burst Pressure Testing).
- Controlled Thermal Spread: Minimizing unintended thermal damage to surrounding tissue (Thermal Spread on Vessels).
- Compatibility: Seamless function with the da Vinci Surgical System and E-200 electrosurgical generator.
- Biocompatibility: No adverse biological reactions when in contact with tissues.
- Shelf-Life and Transit Stability: Maintaining sterility and functional integrity throughout its shelf-life and during shipping.

Study Proving Device Meets Criteria (Based on Document):

The performance data listed in Section VI outlines the studies conducted:

Design Verification:
- Mechanical bench testing
- Reliability Testing
- Force to Jaw Failure
- Software Verification (likely for the control system, not AI)
- Testing in accordance with IEC60601-1 and IEC60601-1-2 (electrical safety)
- Usability Testing
Shelf-Life Verification: In accordance with ASTM F1980.
Transit Verification: In accordance with ASTM D4169-16.
Biocompatibility: In accordance with ISO 10993-1 and FDA guidance.
Design Validation (Animal Testing):
- Burst Pressure Testing
- Thermal Spread on Vessels
- Chronic Animal Study

Addressing Specific Prompt Questions (as far as applicable):

A table of acceptance criteria and the reported device performance:
- As explained, specific quantitative acceptance criteria for AI performance are not relevant here. The acceptance criteria would be successful completion of the listed engineering and preclinical tests, demonstrating that the device's functional outputs meet design inputs and that it performs safely and effectively comparable to the predicate. The document states, "The successful completion of testing demonstrated that the Vessel Sealer subject design outputs meets design inputs."
Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated for bench or animal testing in this summary and would vary by test (e.g., number of units tested mechanically, number of animals in the design validation study, number of vessels sealed).
- Data Provenance: Not specified regarding country of origin. The studies are described as engineering bench tests and animal studies. These are prospective experiments conducted to validate the device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the AI sense. Ground truth for a surgical instrument would be established through direct measurement of physical performance (e.g., pressure at which a seal bursts, precise measurements of thermal spread, visual inspection for mechanical integrity), and observation of physiological effects in animal models by veterinary or surgical experts. These wouldn't be "experts establishing ground truth for an AI assessment."
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as it's not an AI-based diagnostic assessment. Performance is measured objectively.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is for evaluating AI assistance in diagnostic tasks, which is not the function of this device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is a surgical instrument operated by a human surgeon via the da Vinci system. Its "performance" is inherently tied to human use.
The type of ground truth used:
- The "ground truth" for this device's performance is based on direct physical measurements (e.g., force, pressure, temperature, electrical parameters), observational data from preclinical animal studies (e.g., successful vessel sealing, lack of adverse tissue reactions, long-term tissue response in chronic studies), and adherence to established engineering and biocompatibility standards.
The sample size for the training set:
- Not applicable. This device is not an AI model that undergoes "training."
How the ground truth for the training set was established:
- Not applicable.

In summary, the provided document details the regulatory clearance for a conventional surgical instrument, not an AI-enabled device. Therefore, the performance criteria and validation methods are entirely different from those required for AI software.

Summary

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.

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K250674 - Meirav Harsat
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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-

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K250674 - Meirav Harsat
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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)

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:

IV. Indications for Use:

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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:

IV. Indications for Use:

CONFIDENTIAL
Page 1 of 3

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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:

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Vessel Sealer Curved
Traditional 510(k)

V. Comparison of Technological Characteristics:

VI. Performance Data:

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

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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.

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.