STARION INSTRUMENTS THERMAL LITIGATING SHEARS

K062257 · Starion Instruments · GEI · Oct 10, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K062257
• Device Name: STARION INSTRUMENTS THERMAL LITIGATING SHEARS
• Applicant: Starion Instruments
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Oct 10, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For the simultaneous cutting and cauterization of soft tissue during surgery. Cutting of natural or synthetic, non-metallic, sutures during surgery.

Device Story

Single-use, handheld surgical instrument for simultaneous cutting and cauterization of soft tissue and cutting of non-metallic sutures. Surgeon positions distal jaws around target tissue; squeezing handle and depressing switch activates internal heating elements. Heat conducts to tissue to achieve cutting and cauterization. Used in surgical settings by physicians. Benefits include efficient tissue management and hemostasis during procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Handheld, single-use surgical instrument. Employs thermal energy via internal heating elements in the jaws for tissue cutting and cauterization. Class II device (21 CFR 878.4400).

Indications for Use

Indicated for simultaneous cutting and cauterization of soft tissue and cutting of natural or synthetic, non-metallic sutures during surgery.

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

• Starion Instruments Thermal Cautery Grasper/Dissector (K002547)

Submission Summary (Full Text)

{0}------------------------------------------------

OCT 1 0 2006

Summary - 510(k) Subject:

Starion Instruments Thermal Ligating Shears Product:

## Summary:

This summary of 510(k) safety and effectiveness data is being submitted in accordance with the requirements of 21 CFR 807.92.

The Starion Instruments Thermal Ligating Shears are a single use, handheld surgical instrument intended for simultaneous cutting and cauterization of soft tissue during surgery. The Food and Drug Administration has classified electrosurgical cutting and coagulating devices as Class II devices (21 CFR 878.4400).

The Starion Instruments Universal Thermal Ligating Shears are substantially equivalent in terms of intended use, target population, energy source, and principles of operation to the Starion Instruments Thermal Cautery Grasper/Dissector, a legally marketable predicate device which has been granted marketing clearance via K002547.

The Starion Instruments Thermal Ligating Shears allow the surgeon to position the distal jaws of the instrument around the region of tissue to be cut/cauterized. While squeezing the handle, the surgeon depresses a switch, which activates heating element(s) in the jaws. This heat is conducted to the tissue between the jaws to provide cutting/cauterization.

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## OCT 1 0 2006

Starion Instruments % Mr. Brian Grigsby 20665 4" Street Saratoga, California 95070

Re: K062257

Trade/Device Name: Starion Instruments Thermal Ligating Shears Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: September 18, 2006 Received: September 20, 2006

Dear Mr. Grisby:

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.

{2}------------------------------------------------

Page 2 - Mr. Brian Grigsby

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 vo

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

Enclosure

{3}------------------------------------------------

## Indications for Use

KO62257 510(k) Number (if known):

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

For the simultaneous cutting and cauterization of soft tissue during surgery.

Cutting of natural or synthetic, non-metallic, sutures during surgery.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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 Devies Evaluation (ODE)

R. R. R.

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

**510(k) Number** K062257 Page 1 of 1