ATRICURE DISSECTOR

K041681 · AtriCure, Inc. · FTD · Jul 1, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K041681
• Device Name: ATRICURE DISSECTOR
• Applicant: AtriCure, Inc.
• Product Code: FTD · General, Plastic Surgery
• Decision Date: Jul 1, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4580
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The AtriCure dissector™ is intended to dissect soft tissue during general, ENT, thoracic, urological and gynecological surgical procedures. The Dissector's battery-powered light source is used to navigate soft tissue for identification of anatomic structures.

Device Story

AtriCure dissector is a handheld, single-use, articulated surgical instrument. Device features an integrated battery-powered light source. Used by surgeons in general, ENT, thoracic, urological, and gynecological procedures to dissect soft tissue and illuminate anatomical structures for identification. Device provides mechanical dissection capability combined with localized illumination to assist the surgeon in navigating tissue planes during surgery.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Handheld, single-use, articulated surgical dissector. Includes integrated battery-powered light source. Materials are biocompatible per ISO 10993-1. Device is non-powered for dissection; light source is battery-powered.

Indications for Use

Indicated for soft tissue dissection during general, ENT, thoracic, urological, and gynecological surgical procedures; includes use of integrated battery-powered light source for anatomical structure identification.

Regulatory Classification

Identification

A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient.

Special Controls

*Classification.* Class II (special controls). The device, when it is an operating room lamp, a surgical instrument light, a surgical floor standing light, an endoscopic surgical light, a surgical light connector, a ceiling mounted surgical light, a surgical light carrier, surgical light accessories, a surgical lamp, a remote illuminator, or an incandescent surgical lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.

Predicate Devices

• Stryker Knifelight Lighted Knife (K961122)

Submission Summary (Full Text)

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K041681

### 510(k) Summary

General Information JUL 0 1 2004 Classification Class I/Ii Trade Name AtriCure dissector™ Manufacturer AtriCure, Inc. 6033 Schumacher Park Drive West Chester, OH 45069 Contact Elsa Abruzzo Vice President, Regulatory and Clinical Affairs

#### Intended Use

·

The AtriCure dissector™ is intended to dissect soft tissue during general, ENT, thoracic, urological and gynecological surgical procedures. The Dissector's battery-powered light source is used to navigate soft tissue for identification of anatomic structures.

#### Predicate Devices

The predicate device for the AtriCure dissector™ is the Stryker Knifelight Lighted Knife (K961122). The Stryker Knifelight Lighted Knife is classified as a Dissector, Surgical, General and Plastic Surgery, per 21CFR878.4800 and a Lamp, Surgical, per 21CFR 878.4580.

#### Device Description

The AtriCure dissector™ is a hand held, single use, surgical articulated dissector with integral light source.

#### Materials

All materials used in the manufacture of the AtriCure dissector™ are suitable for this use and have been used in numerous previously cleared products. Testing was conducted in Accordance with ISO 10993-1 to ensure appropriate biocompatibility of all materials.

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K041681 page 2/2

## Testing

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

## Summary of Substantial Equivalence

The AtriCure dissector™ is equivalent to the predicate products. The indications for use, basic overall function, and materials used are substantially equivalent.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

JUL 01 2004

Re: K041681

Trade/Device Name: AtriCure Dissector™ Regulation Number: 21 CFR 878.4580 Regulation Name: Surgical lamp Regulatory Class: II Product Code: FTD Dated: June 17, 2004 Received: June 21, 2004

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.

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Page 2 - Mr. Mark Job

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 yours,

Miriam C. Provost

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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# Indications for Use

510(k) Number (if known):

Device Name: AtriCure dissector™

Indications For Use:

The AtriCure dissector™ is intended to dissect soft tissue during general, ENT, thoracic, urological and gynecological surgical procedures. The Dissector's battery-powered light source is used to navigate soft tissue for identification of anatomic structures.

___ Prescription Use _________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

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**510(k) Number** K041681

000150