Vessel Sealer Extend 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 vessels up to 7 mm in diameter and tissue bundles that fit in the jaws of the instrument. Vessel Sealer Extend 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 Extend is a sterile, single-use (disposable), 8 mm instrument with an integrated cord that connects to the instrument housing and an Erbe VIO dV generator. The Vessel Sealer Extend 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 IESU. 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.

Modifications from the predicate include a labeling change to remove references to using a specific electrosurgical generator (ERBE VIO dV electrosurgical generator) from the Indications for Use Statement that is listed as compatible with the Vessel Sealer Extend instrument. Additionally, "EndoWrist", has been removed from the Indications for Use for product branding reasons.

AI/ML Overview

This 510(k) premarket notification (K183107) for the Intuitive Surgical Vessel Sealer Extend received FDA clearance based on its substantial equivalence to a predicate device (K173337). This submission did not involve new performance studies because the changes were limited to labeling. Therefore, the information typically requested about acceptance criteria, study design, and performance metrics for a new device study is largely absent.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document as no new performance studies were conducted for this specific 510(k) submission. The document explicitly states:

"There were no design changes made to the subject Vessel Sealer Extend instrument as a result of the labeling change. Thus, the previously submitted bench testing reports and explanations demonstrating that the cleared predicate device (K173337) meet design specifications and performance requirements, apply to the subject device."

Therefore, the acceptance criteria and reported device performance would refer to those established and met by the predicate device (K173337). To obtain detailed information on those criteria and performance, one would need to review the K173337 submission.

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided for this specific submission as no new test set was generated. The previous testing for K173337 would contain this detail.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

This information is not provided for this specific submission as no new ground truth was established. This would be relevant to the K173337 submission's performance data.

4. Adjudication Method for the Test Set

This information is not provided for this specific submission as no new test set adjudication was performed. This would be relevant to the K173337 submission's performance data.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size of AI Improvement

This type of study is not applicable to this device. The Intuitive Surgical Vessel Sealer Extend is a surgical instrument, not an AI-powered diagnostic or assistive technology for human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study was Done

This type of study is not applicable to this device. It is a surgical instrument, not a standalone algorithm.

7. The Type of Ground Truth Used

This information is not provided for this specific submission. For a surgical instrument like this, ground truth in performance testing typically involves objective measurements from bench testing (e.g., burst pressure, seal integrity, tissue transection effectiveness), which would have been established for the predicate device (K173337).

8. The Sample Size for the Training Set

This information is not applicable as this device does not involve a training set as would be found in machine learning or AI algorithm development.

9. How the Ground Truth for the Training Set was Established

This information is not applicable for the same reason as above.

Summary of the K183107 Substantial Equivalence Determination:

The FDA's review of K183107 focused on the modifications from the predicate device (K173337), which were limited to:

Removal of references to a specific electrosurgical generator (ERBE VIO dV) from the Indications for Use, meaning it is now compatible with "a compatible electrosurgical generator."
Removal of "EndoWrist" from the Indications for Use for branding reasons.

Since there were no design changes that would impact the safety or effectiveness of the instrument, Intuitive Surgical leveraged the existing performance data from the predicate device (K173337). The FDA determined that the device is substantially equivalent based on the unchanged fundamental scientific technology, intended use, and existing performance data (from the predicate).

Summary

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December 11, 2018

Intuitive Surgical, Inc. Mr. Kunal Gunjal Regulatory Affairs Specialist 1266 Kifer Road Sunnyvale, California 94086

Re: K183107

Trade/Device Name: Intuitive Surgical Vessel Sealer Extend Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: NAY Dated: November 7, 2018 Received: November 8, 2018

Dear Mr. Gunjal:

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 (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 located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmr/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.

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

For Binita S. Ashar, M.D., M.B.A., F.A.C.S Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2020

See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

510(k) Number (if known)

K183107

Device Name Intuitive Surgical Vessel Sealer Extend

Indications for Use (Describe)

Vessel Sealer Extend 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 dissue and for bipolar coagulation and mechanical transection of vessels up to 7 mm in diameter and tissue bundles that fit in the jaws of the instrument. Vessel Sealer Extend has not been shown to be effective for tubal coagulation for sterilization for sterilization procedures and should not be used for these procedures.

Type of Use (Select one or both, as applicable)

X 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

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FORM FDA 3881 (7/17)

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Intuitive Surgical Vessel Sealer Extend

Traditional 510(k)

7 510(k) Summary

510(k) Owner:	Intuitive Surgical, Inc.1266 Kifer RoadSunnyvale, CA 94086
Contact:	Kunal GunjalRegulatory Affairs SpecialistPhone Number: 408-523-8017Fax Number: 408-523-8907Email: Kunal.Gunjal@intusurg.com
Date Summary Prepared:	November 7, 2018
Trade Name:	Intuitive Surgical Vessel Sealer Extend
Common Name:	System, surgical, computer controlled instrument
Classification:	Endoscope and accessories, 21 CFR 876.1500, NAY
Predicate Device:	Intuitive Surgical EndoWrist® Vessel Sealer Extend (K173337)

Image /page/3/Picture/5 description: The image contains the logo for Intuitive Surgical. The word "INTUITIVE" is in a larger, sans-serif font, with a yellow dot above the "I". Below that, in a smaller font, is the word "SURGICAL" followed by the registered trademark symbol. The text is light gray against a white background.

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Intuitive Surgical Vessel Sealer Extend

Traditional 510(k)

Device Description: The Vessel Sealer Extend is a sterile, single-use (disposable), 8 mm instrument with an integrated cord that connects to the instrument housing and an Erbe VIO dV generator. The Vessel Sealer Extend 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 IESU. 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.

Indications for Use:

Technological Characteristics:

The subject Intuitive Surgical Vessel Sealer Extend is very similar to its predicate device originally cleared under K173337 for use with the da Vinci Xi system and da Vinci X system. It has the same intended use, same fundamental scientific technology, and similar technological characteristics as the predicate device.

Performance Data:

There were no design changes made to the subject Vessel Sealer Extend instrument as a result of the labeling change. Thus, the previously submitted bench testing reports and explanations demonstrating that the cleared predicate device (K173337) meet design specifications and performance requirements, apply to the subject device.

Image /page/4/Picture/11 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in all caps and in a light gray color. Below that, the word "SURGICAL" is also in all caps and in a smaller font size, with the registered trademark symbol next to it.

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Intuitive Surgical Vessel Sealer Extend

Traditional 510(k)

Summary: Based on the intended use, technical characteristics, and performance data, the Intuitive Surgical Vessel Sealer Extend is equivalent to the predicate device in terms of safety, effectiveness, and performance.

Image /page/5/Picture/4 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in all caps and in a light gray color. Below that, the word "SURGICAL" is also in all caps and in a smaller font size. There is a yellow dot above the "I" in Intuitive.

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.