DISPOSABLE LAPAROSCOPIC INSTRUMENT

K070812 · Modern Medical Equipment Mfg., Ltd. · GEI · Sep 14, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K070812
• Device Name: DISPOSABLE LAPAROSCOPIC INSTRUMENT
• Applicant: Modern Medical Equipment Mfg., Ltd.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Sep 14, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The instrument is used to cut and coagulate the selected tissue for Laparoscopic procedure.

Device Story

Laparoscopic instrument and electrode tips used for tissue cutting and coagulation during laparoscopic surgery. Device functions as an electrosurgical accessory; delivers electrical energy to target tissue to achieve hemostasis or incision. Operated by surgeons in clinical/OR settings. Output is thermal effect on tissue; assists in surgical dissection and bleeding control. Benefits include minimally invasive access and precise tissue management.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Electrosurgical cutting and coagulation device; accessory to electrosurgical units. Class II device (21 CFR 878.4400, Product Code GEI).

Indications for Use

Indicated for cutting and coagulating tissue during laparoscopic surgical procedures.

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

Modern Medical Equipment Manufacturing Ltd. % E & M Engineering, Inc. Mr. Robert Stillman 1705 Dabney Road Richmond, Virginia 23230

SEP 1 4 2007

Re: K070812

Trade/Device Name: Laparoscopic Instrument and Electrode Tips Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: August 7, 2007 Received: August 15, 2007

Dear Mr. Stillman:

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. Robert Stillman

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, permitte 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 only) pro "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 vours 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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## Indication for Use Statement

| Applicant: | Modern Medical Equipment Manufacturing Ltd. |
|---------------|---------------------------------------------|
| 510(k) Number | K070812 |
| Device Name: | Laparoscopic Instrument and Electrode Tips |

Indications For Use:

The instrument is used to cut and coagulate the selected tissue for Laparoscopic procedure.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number L070812

Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use

(Optional Format 1-2-96)