ATRICURE TRANSPOLAR SYSTEM

K052893 · AtriCure, Inc. · GEI · Oct 25, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K052893
• Device Name: ATRICURE TRANSPOLAR SYSTEM
• Applicant: AtriCure, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Oct 25, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The AtriCure Transpolar System is intended to ablate soft tissues during i General, ENT, Thoracic, Gynecology, and Urology surgical procedures.

Device Story

The AtriCure Transpolar System is a handheld, single-use, bipolar radiofrequency (RF) surgical instrument (Transpolar Clamp) used for soft tissue ablation. The system includes a Glidepath Tape guide and an integral cable connecting to the AtriCure reusable Ablation and Sensing Unit (ASU). Operated by trained surgeons in surgical settings, the device delivers RF energy to target tissues. The ASU provides the energy source and sensing capabilities. The system is designed to facilitate surgical ablation, aiding in tissue coagulation and cutting during various surgical procedures.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Bipolar radiofrequency (RF) surgical instrument. Includes handheld clamp, Glidepath Tape, and integral cable for connection to reusable Ablation and Sensing Unit (ASU). Materials are biocompatible and consistent with previously cleared products.

Indications for Use

Indicated for ablation of soft tissues during general, ENT, thoracic, gynecological, and urological surgical procedures. For use by trained surgeons only.

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

• AtriCure Bipolar System (K020919)

Submission Summary (Full Text)

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131 2 5 2005

K 052893

### 510(k) Summary

General Information

| Classification | Class II |
|----------------|------------------------------------------------------------------------|
| Trade Name | AtriCure Transpolar™ System |
| Manufacturer | AtriCure, Inc.<br>6033 Schumacher Park Drive<br>West Chester, OH 45069 |
| Contact | Elsa Abruzzo<br>Vice President, Clinical and Regulatory Affairs |

### Intended Use

The AtriCure Transpolar System is intended to ablate soft tissues during i General, ENT, Thoracic, Gynecology, and Urology surgical procedures.

#### Predicate Devices

The predicate device for the AtriCure Transpolar System is the AtriCure Bipolar System (K020919).

# Device Description

The AtriCure Transpolar System includes a hand held, single use, bipolar radiofrequency (RF) surgical instrument (AtriCure Transpolar Clamp) intended for the ablation of soft tissues (for use by trained surgeons only) innonou for the and the and guide (Glidepath™ Tape). The Transpolar and an accessory of an integral cable to the AtriCure re-useable Ablation and Sensing Unit (ASU).

### Materials

all materials used in the manufacture of the AtriCure Transpolar Clamp and / Ill matchale are suitable for this use and have been use and have been used Ondepath Tapo inously cleared products. Testing was conducted in in numbrous provise in to ensure appropriate biocompatibility of all materials.

#### Testing

Appropriate product testing was conducted to evaluate conformance to Approphate product and substantial equivalence to predicate devices.

# Summary of Substantial Equivalence

The Atricure Transpolar System is equivalent to the predicate products. The indications for use, basic overall function, and materials used are substantially equivalent.

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Public Health Service

OCT 2 5 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AtriCure, Inc. c/o Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, Minnesota 55313

Re: K052893

Trade/Device Name: Atricure Transpolar System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: October 11, 2005 Received: October 14, 2005

Dear Mr. Job:

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.