ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES

K061829 · New Leaf Medical, Inc. · GEI · Nov 17, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K061829
• Device Name: ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES
• Applicant: New Leaf Medical, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Nov 17, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2

Intended Use

The BoVac Electrosurgery Suction Device removes smoke, odors, gases, particles, and fluids directly from the surgical site during electrosurgery procedures. The device is single-use and disposable.

Device Story

BoVac Electrosurgery Suction Device is a single-use, disposable accessory for electrosurgical procedures. Device functions by providing suction at the surgical site to evacuate smoke, odors, gases, particles, and fluids generated during electrosurgery. Operated by surgical staff in clinical settings; connects to standard suction systems. Benefits include improved visibility and air quality at the surgical site by removing hazardous surgical smoke and debris.

Clinical Evidence

Bench testing only.

Technological Characteristics

Single-use, disposable suction device. Designed for integration with electrosurgical units to facilitate smoke and fluid evacuation. Operates via connection to external vacuum/suction source. No electronic components or software.

Indications for Use

Indicated for removal of smoke, odors, gases, particles, and fluids from the surgical site during electrosurgical procedures. Intended for prescription use.

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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Richard T. Nock President New Leaf Medical, Incorporated 11476 Hawke Road, Suite #C Columbia Station, Ohio 44028

NUV 1 7 2006

Re: K061829

Trade/Device Name: BoVac Electrosurgery Suction Device Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: II Product Code: GEI Dated: October 31, 2006 Received: November 6, 2006

Dear Mr. Nock:

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.

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Page 2 - Mr. Nock

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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,

Gulate Y. Michieu DmD.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number: K061829

Device Name: BoVac Electrosurgery Suction Device

Indications For Use:

The BoVac Electrosurgery Suction Device removes smoke, odors, gases, particles, and fluids directly from the surgical site during electrosurgery procedures. The device is single-use and disposable.

× AND/OR Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Shule A. Murphy, MD

ion of Anesthesiology, General Hospital,
ion Control, Dental Devices

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