MINI LAP ELECTROCAUTERY INSTRUMENTS

K083754 · Mini Lap Technologies, Inc. · GEI · Nov 20, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K083754
• Device Name: MINI LAP ELECTROCAUTERY INSTRUMENTS
• Applicant: Mini Lap Technologies, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Nov 20, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The devices are used to cut and cauterize soft tissue.

Device Story

Mini Lap Electrocautery Instruments are surgical tools designed for cutting and cauterizing soft tissue. Operated by surgeons in clinical or OR settings, these instruments function as electrosurgical accessories. They deliver electrical energy to tissue to achieve hemostasis or perform incisions. The device is used in conjunction with standard electrosurgical generators. By providing precise tissue management, the instruments assist in surgical procedures, potentially reducing trauma and improving procedural efficiency for the patient.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Electrosurgical cutting and coagulation instrument. Operates via electrical energy delivered from an external electrosurgical generator. Form factor designed for minimally invasive surgical access. Class II device under 21 CFR 878.4400.

Indications for Use

Indicated for cutting and cauterizing soft tissue in patients requiring electrosurgical intervention.

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 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Mini-Lap Technologies, Inc. % Orchard Design Mr. Joseph M. Azary 80 Shelton Technology Center Shelton, Connecticut 06484

NOV 2 0 2009

Re: K083754

Trade/Device Name: Mini Lap Electrocautery Instruments Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: November 6, 2009 Received: November 13, 2009

Dear Mr. Azary:

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 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

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Page 2 - Mr. Joseph Azary

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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,

Mark N. Millman

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

Enclosure

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## Indications for Use

KO 83754 510(k) Number (if known):

Device Name: MINI LAP Instruments

Indications For Use:

The devices are used to cut and cauterize soft tissue.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (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) (Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

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Orchid Design

-510(k)-Number k083754

A Division of Orchid Orthopedic Solutions www.orchid-orthopedics.com

80 Shelton Technology Center Shelton, Connecticut 06484 USA

Phone: [phone] [phone] Fax: