AQUAMANTYS PUMP GENERATOR SYSTEM

K052859 · Tissuelink Medical, Inc. · GEI · Oct 25, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K052859
• Device Name: AQUAMANTYS PUMP GENERATOR SYSTEM
• Applicant: Tissuelink Medical, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Oct 25, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Aquamantys™ Bipolar Pump Generator is an electrosurgical generator with a rotary peristaltic pump which is intended for hemostatic sealing of soft tissue and bone at the operative site. It is intended for, but not limited to, hemostatic sealing of orthopaedic, spine and thoracic surgery. The device is not intended for contraceptive tubal coagulation (permanent female sterilization). For use only by qualified medical personnel properly trained in the use of electrosurgical equipment, technology and techniques.

Device Story

Aquamantys Pump Generator System is a shelf-top electrosurgical unit featuring a rotary peristaltic pump and bipolar generator. System includes generator, cart, and disposable bipolar sealer wands (6.0 and 2.3 models). Wands feature plastic handles with tubing that interfaces with the peristaltic pump. Device delivers simultaneous saline irrigation and radiofrequency (RF) energy to tissue; saline acts as a conductive medium to distribute heat. Used in OR settings by surgeons to achieve hemostasis in soft tissue and bone during orthopaedic, spine, and thoracic procedures. Output is controlled via front panel settings (20-200 watts; high/medium/low flow). Benefits include effective coagulation of oozing tissue compared to conventional electrosurgical devices.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Shelf-top electrosurgical generator with integrated rotary peristaltic pump. Sheet metal housing. Bipolar RF energy source. Adjustable power (20-200W) and flow rates. Disposable hand-held wands (6.0 and 2.3 models) with tubing interface. Software-controlled flow and power integration. Class II device (21 CFR 878.4400).

Indications for Use

Indicated for hemostatic sealing of soft tissue and bone during orthopaedic, spine, and thoracic surgery. Contraindicated for contraceptive tubal coagulation. For use by trained medical personnel.

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

• Söring GmbH MBCTM Series (K024059)
• TissueLink BPS 6.0 (K020574)
• TissueLink BPS 6.0 (K022532)
• TissueLink BPS 2.3 (K032132)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for TissueLink. The logo consists of the word "TissueLink" in a bold, sans-serif font, with a stylized graphic to the right. Below the word "TissueLink" is the tagline "Simply Better Surgery" in a smaller, sans-serif font. The graphic to the right of the word "TissueLink" appears to be a stylized representation of two interlocking shapes.

OCT 25 2005

K052859

Page 1 of 2

# 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: | September 29, 2005 |
|-------------------|-----------------------------------------------------|
| Submitter: | TissueLink Medical Inc. |
| Address: | One Washington Center Suite 400<br>Dover, NH 03820 |
| Contacts: | Vicki S. Anastasi<br>Director of Regulatory Affairs |
| Telephone Number: | [phone] ext. 210 |
| FAX Number: | [phone] |

### Device Information:

| Trade Name: | Aquamantys Pump Generator System, Aquamantys 6.0 Bipolar Sealer,<br>and Aquamantys 2.3 Bipolar Sealer |
|----------------------|-------------------------------------------------------------------------------------------------------|
| Common Name: | Electrosurgical Bipolar Generator |
| Classification Name: | Electrosurgical cutting and coagulation device and accessories - 21CFR<br>878.4400 |

#### Predicate Devices:

Claim of Substantial Equivalence of the Aquamantys Pump Generator System is made to:

| Name: | Söring GmbH MBCTM Series |
|-------------------|-----------------------------------------------------------------------|
| 510(k) Number | K#024059 |
| Regulation Number | 878-4400 Device, Electrosurgical, Cutting & Coagulation & Accessories |
| Product Code | GEI |
| Decision Date | January 8, 2003 |

Claim of Substantial Equivalence of the Aquamantys 6.0 and 2.3 Bipolar Sealer devices are made to:

TissueLink BPS 6.0 K20574 and K022532 TissucLink BPS 2.3 K032132

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Special 510(k): Part A TissueLink Medical, Inc. – Aquamantys Pump Generator System

K052859

## Device Description-Pump Generator

Page 2 of 2

The Aquamantys Pump Generator is a shelf top unit consisting of a sheet metal housing, front control i he Aqualifantys i unip Generator is a show top until consing resides a main circuit board, a displayers of the panel and side mounted purific within the neasing reasure would more on any more any software integrates the flow to the desired power setting and flow level selected. The punip generator can be set from 20 to 200 watts and has high, medium and low flow rate settings.

The Aquamantys system includes the pump generator, cart and specified Aquamantys disposable devices of The Aquamantys BPS 6.0 and the Aquanantys BPS 2.3 are hand held "wand" like devices that consist of The Aqualifaniys DF S o.o allo the Aqualiantys DF B 2.5 art one end that interface with the operative a plastic handle with two need they of the plugs into the pump generator and have a section of pump tubing that clamps into the peristaltic pump.

Compared to most conventional electrosurgical devices and generators. TissueLink bipotent that in Compared to most conventional clectrosurgiour delivery, as well as the reatment of tissue that is based on simulaticous same in gation and ter pover detroity are oozing blood at a slow but steady rate.

A complete Aquamantys System diagram is shown on the following page.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" in a circular arrangement.

OCT 2 5 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K052859

Trade/Device Name: TissueLink Aquamantys Pump Generator System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: October 7, 2005 Received: October 11, 2005

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 cnactment 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- 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/industry/support/index.html.

Sincerely yours.

Curbare Prelud
for

Mark N. Melkerson Acting 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): Part A TissueLink Medical, Inc. - Aquamantys Pump Generator System

| | K052859 |
|---------------------------|-------------------------------|
| | Indications for use Statement |
| | Page ______ of ______ |
| 510(k) Number (if known): | K0528859 |

Device Name:

TissueLink Aquamantys Pump Generator System

Indications for Use:

The Aquanantys™ Bigolar Pump Generator is an electrosurgical generator with a rotary peristaltic pump whic I he Aquamantys a jor assethly with rightmastatic sealing of soft tissue and hone at the operative site. It is intended for, but not encier with same join tembrant beating of orthopaedic, spine and thoracic surgery. The device is not intended for contraceptive tubal coagulation (permanent female sterilization). for contraceptive land coaghtause only by qualified medical personnel properly trained in the use of electrosurgical equipment, technology and techniques.

Preseription Use

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Over-The-Counter Use

(Per 21 CFR 801.109)

Optional Format 1

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

Concurrence of CDRH. Office of Device Evaluation (ODE)

Barbara Oneill

and Neurological Devices

**510(k) Number** K052857

Tissuel mi, Miedical Inc