The TissueLink SS4.0 bipolar sealer is a sterile, single-use bipolar electrosurgical device intended to be used in conjunction with the Aquamantys Pump Generator for delivery of RF energy and saline for hemostatic sealing and coagulation of soft tissue and bone at the operative site. It is intended for but not limited to orthopaedic, spine, endoscopic procedures, abdominal and thoracic surgery, and epidural vein-sealling during surgery. The device is not intended for contraceptive tubal coagulation (permanent female sterilization.)

Device Description

Aquamantys SS4.0 Bipolar Sealer

AI/ML Overview

This document is a 510(k) Summary of Safety and Effectiveness for the TissueLink Aquamantys SS4.0 Bipolar Sealer and an FDA clearance letter. It describes the device and its intended uses, and claims substantial equivalence to a predicate device.

However, the provided text does not contain any information regarding acceptance criteria or a study that proves the device meets specific performance criteria.

Therefore, I cannot fulfill the request for the following information:

A table of acceptance criteria and the reported device performance
Sample size used for the test set and the data provenance
Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Adjudication method for the test set
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size
If a standalone performance study was done
The type of ground truth used
The sample size for the training set
How the ground truth for the training set was established

This type of information is typically found in a clinical study report or a more detailed section of a 510(k) submission, not in the summary provided. The 510(k) summary focuses on demonstrating substantial equivalence based on indications for use, technological characteristics, and safety and effectiveness, often by comparison to a predicate device rather than presenting new clinical study data with acceptance criteria for a new device.

Summary

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Traditional 510(k) TissueLink Medical, Inc. – Aquamantys SS4.0

. I I

TISSUELINK
Simply Better Surgery

K063639

FEB 2 2 2007

510(k) Summary of Safety and Effectiveness

This summary of 510(k)-safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

Application Information:

Date Prepared:	December 6, 2006
Submitter:	TissueLink Medical Inc.
Address:	One Washington Center Suite 400
	Dover, NH 03820
Contacts:	Vicki S. Anastasi
	Director of Regulatory Affairs
Telephone Number:	(603) 742-1515 ext. 210
FAX Number:	(603) 742-1488

Device Information:

Trade Name:	Aquamantys SS4.0 Bipolar Sealer
Common Name:	Electrosurgery Bipolar Sealer
Classification Name:	Electrosurgical cutting and coagulation device and accessories21CFR 878.4400

Predicate Devices:

Claim of Substantial Equivalence of the Aquamantys SS4.0 Bipolar Sealer is made to:

Name:	Aquamantys 2.3 Bipolar Sealer
510(k) Number	K#052859
Regulation Number	878-4400 Device, Electrosurgical, Cutting & Coagulation &Accessories
Product Code	GEI
Decision Date	October 25, 2005

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/1/Picture/2 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized image of an eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The eagle is drawn in black and white, and the text is in all capital letters.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

TissueLink Medical, Inc. % Ms. Vicki S. Anastasi Director Regulatory Affairs One Washington Center, Suite 400 Dover, New Hampshire 03820

FEB 2 2 2007

Re: K063639

Trade/Device Name: TissueLink Aquamantys SS4.0 Bipolar Sealer Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: December 6, 2006 Received: December 8, 2006

Dear Ms. Anastasi:

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. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Vicki S. Anastasi

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Traditional 510(k) TissueLink Medical, Inc. - Aquamantys SS4.0

	Indications for use Statement
	Page ___ of ___
510(k) Number (if known):	K063639
Device Name:	TissueLink Aquamantys SS4.0 Bipolar Sealer
Indications for Use:

Prescription Use Usé

Over-The-Counter

(Per 21 CFR 801.109)

Optional Format 1-

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Milken

(Division Sign-Division of General, Bestorative, and Neurologi 510(k) 1

TissueLink Medical, Inc.

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.