TISSUELINK FLOATING BALL MODEL 23-201-1

K032132 · Tissuelink Medical, Inc. · GEI · Aug 20, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K032132
• Device Name: TISSUELINK FLOATING BALL MODEL 23-201-1
• Applicant: Tissuelink Medical, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Aug 20, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The TissueLink BPS bipolar sealer is a sterile, single use electrosurgery device intended to be used in conjunction with an electrosurgical generator for delivery of radiofrequency current and saline for hemostatic sealing and coagulation of soft tissue and bone at the operative site. It is intended for, but not limited to, endoscopic and open abdominal, orthopaedic, spine and thoracic surgery. The device is not intended for contraceptive tubal coagulation (permanent female sterilization).

Device Story

The TissueLink Bipolar Sealer 2.3 is a sterile, single-use electrosurgical device designed for use with an electrosurgical generator. It delivers radiofrequency (RF) current and saline to the operative site to achieve hemostatic sealing and coagulation of soft tissue and bone. The device is utilized in endoscopic and open surgical procedures, including abdominal, orthopaedic, spine, and thoracic surgeries. It is operated by surgeons to control bleeding and seal tissues during operations. The device functions by combining RF energy with saline irrigation to facilitate tissue coagulation, providing a benefit of improved hemostasis in various surgical environments.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Bipolar electrosurgical device; utilizes radiofrequency energy and saline irrigation for tissue coagulation. Sterile, single-use form factor. Designed for integration with standard electrosurgical generators.

Indications for Use

Indicated for hemostatic sealing and coagulation of soft tissue and bone during endoscopic and open abdominal, orthopaedic, spine, and thoracic surgery. Contraindicated for contraceptive tubal coagulation.

Regulatory Classification

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.

Predicate Devices

• TissueLink Bipolar Floating Ball

Submission Summary (Full Text)

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# AUG 2 0 2003

Special 510(k): Device Modification -- TissueLink Medical, Inc. - Bipolar Floating Ball

K032132 P31/1

## 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: | February 3, 2003 |
|----------------------|-----------------------------------------------------------------------------------|
| Submitter: | TissueLink Medical Inc. |
| Address: | One Washington Center Suite 400<br>Dover, NH 03820 |
| Contacts: | Vicki S. Anastasi<br>Directory Regulatory Affairs |
| Telephone Number: | [phone] |
| FAX Number: | [phone] |
| | Roberta L. Thompson<br>Vice President, Clinical, Regulatory and Quality |
| Telephone Number: | [phone] ext. 106 |
| Fax Number: | [phone] |
| Device Information: | |
| Trade Name: | TissueLink Bipolar Sealer 2.3 (Bipolar Floating Ball) device |
| Common Name: | Electrosurgery Bipolar Sealer |
| Classification Name: | Electrosurgical cutting and coagulation device and accessories, 21CFR<br>878.4400 |

### Predicate Devices:

Claim of Substantial Equivalence of the TissueLink Bipolar Floating Ball (Bipolar Sealer 2.3) device is made to:

TissueLink Bipolar Floating Ball

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized human figure with three faces in profile, connected by flowing lines, and a star above the figures.

AUG 2 0 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K032132

Trade/Device Name: TissueLink Bipolar Sealer 2.3 (Bipolar Floating Ball) device Regulation Number: 21 CFR 878.4400 * Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: July 11, 2003 Received: July 28, 2003

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Sincerely yours,

Mark N Milken

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure ·

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Special 510(k): Device Modification – TissueLink Medical, Inc. – Bipolar Floating Ball

## Indications for use Statement

Page

510(k) Number (if known):_KO32132

Device Name:

TissueLink Bipolar Sealer 2.3 (Bipolar Floating Ball) device

Indications for Use:

The TissueLink BPS bipolar sealer is a sterile, single use electrosurgery device intended to be used in conjunction with an electrosurgical generator for delivery of radiofrequency current and saline for hemostatic sealing and coagulation of soft tissue and bone at the operative site. It is intended for, but not limited to, endoscopic and open abdominal, orthopaedic, spine and thoracic surgery. The device is not intended for contraceptive tubal coagulation (permanent female sterilization).

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

Concurrence of CDRH, Office of Device Evaluation (ODE) OR Prescription Use Over-The-Counter Use Optional Format 1 -(Per 21 CFR 801.109) eral. Restorative

510(k) Number.

TissueLink Medical, Inc.

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