PLASMASEAL OPEN FORCEPS, MODELS 2103PK AND 91701PK

K061975 · Acmi Corporation · GEI · Aug 10, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K061975
• Device Name: PLASMASEAL OPEN FORCEPS, MODELS 2103PK AND 91701PK
• Applicant: Acmi Corporation
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Aug 10, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Gyrus Medical Inc. Open Forceps are intended for electrosurgical coagulation, mechanical grasping and dissection of tissue, and sealing of vessels up to 7mm, during the performance of open general surgical procedures.

Device Story

Gyrus Medical Open Forceps are electrosurgical instruments designed for use in open general surgery. The device functions by providing mechanical grasping and dissection of tissue, combined with electrosurgical energy for coagulation and vessel sealing (up to 7mm). Operated by surgeons in an OR setting, the device facilitates hemostasis and tissue manipulation. The output is the physical effect of the electrosurgical current on the targeted tissue, enabling the surgeon to control bleeding and perform surgical dissection. The device benefits patients by providing a dual-purpose tool for grasping and sealing, potentially reducing operative time and blood loss.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Electrosurgical instrument for cutting and coagulation. Class II device (21 CFR 878.4400). Mechanical grasping and dissection capability with integrated electrosurgical energy delivery for vessel sealing up to 7mm.

Indications for Use

Indicated for use in open general surgical procedures for electrosurgical coagulation, mechanical grasping, tissue dissection, and vessel sealing up to 7mm.

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

• Gyrus Medical Open Forceps (K024286)

Submission Summary (Full Text)

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Gyrus Medical Inc. Open Forceps ACMI Corporation 136 Turnpike Road Southborough, MA 01772

Special 510(k) Notification Summary of Safety and Effectiveness August 4, 2006

AUG 1 0 2006 510(k) Summary of Safety and Effectiveness ACMI Corporation Gyrus Medical Inc. Open Forceps

K061975

General Information

Manufacturer:

Gyrus Medical Inc. 6655 Wedgwood Rd. Maple Grove, MN 55311-3602

Establishment Registration Number:

510(k) Submitter:

MMMM

2183680

ACMI Corporation 136 Turnpike Rd. Southborough, MA 01772-2104

. .

Establishment Registration Number:

Contact Person:

Date Prepared:

Device Description

Classification Name:

3003790304

Terrence E. Sullivan Director, Regulatory Affairs

Gyrus Medical Open Forceps

Electrosurgical Instruments

August 4, 2006

Electrosurgical cutting and coagulation device and accessories (21 CFR 878.4400), Class II General and Plastic Surgery Panel

Generic/Common Name:

Predicate Device

Trade Name:

Gyrus Medical Open Forceps

K024286

Intended Uses

The Gyrus Medical Inc. Open Forceps are intended for electrosurgical coagalation, mechanical grasping and dissection of tissue, and sealing of vessels up to 7mm, during the performance of open general surgical procedures.

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Image /page/1/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 enclosed within a circle, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## AUG 1 0 2006

ACMI Corporation % Mr. Terrence E. Sullivan Director, Regulatory Affairs 136 Turnpike Road Southborough, Massachusetts 01772-2104

Re: K061975

Trade/Device Name: Gyrus Medical Inc. Open Forceps Regulatory Number: 21 CFR 878.4400 Regulatory Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: July 28, 2006 Received: August 1, 2006

Dear Mr. Sullivan:

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. Terrence E. Sullivan

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,

Hubert Remer
Mark N. Melkerson

Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Gyrus Medical Inc. Open Forceps ACMI Corporation 136 Turnpike Road Southborough, MA 01772

Special 510(k) Notification -Statement of Intended Use August 4, 2006

Device Name: Gyrus Medical Inc. Open Forceps

510(k) Number:

061975

Indications for use:

The Gyrus Medical Inc. Open Forceps are intended for electrosurgical coagulation, mechanical grasping and dissection of tissue, and sealing of vessels up to 7mm, during the performance of open general surgical procedures.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use: __ X __

OR Over-the-Counter Use: _

(Per 21 CFR 801.109)

Hulbert Leeman

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

**510(k) Number** k061975