GEMINI SURGICAL CONTROL & DISPLAY SYSTEM

K051831 · Applied Surgical, LLC · GEI · Sep 7, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K051831
• Device Name: GEMINI SURGICAL CONTROL & DISPLAY SYSTEM
• Applicant: Applied Surgical, LLC
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Sep 7, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2

Intended Use

The Gemini Surgical Control & Display System is indicated for use in any surgical procedure where single or multiple electrosurgical (unipolar, harmonic scalpel, etc.) devices that with a foot control are used. The Gemini Surgical Control & Display System integrates the electrosurgical devices into a central system that uses a single Master Foot Control to activate the devices. The SurgiClear smoke evacuation activation unit is indicated for use during laparoscopic cases to automatically remove the smoke/steam/debris resulting from the use of electrosurgical instruments. The system is intended for use in hospitals or outpatient clinics.

Device Story

Gemini Surgical Control & Display System integrates multiple electrosurgical devices into a centralized control unit; utilizes single Master Foot Control for activation; replaces individual foot pedals for each device. Includes SurgiClear smoke evacuation activation unit for laparoscopic procedures; automatically triggers evacuation upon electrosurgical instrument use. Used in hospitals and outpatient clinics by surgical staff. System simplifies OR environment by consolidating device controls; reduces clutter; improves workflow efficiency during surgery.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Centralized control and display system for electrosurgical devices. Integrates unipolar and harmonic scalpel inputs. Features Master Foot Control interface. Includes automated smoke evacuation activation unit for laparoscopic applications. Class II device under 21 CFR 878.4400.

Indications for Use

Indicated for use in surgical procedures requiring electrosurgical devices (unipolar, harmonic scalpel, etc.) utilizing foot controls. SurgiClear unit indicated for laparoscopic smoke/steam/debris removal. Intended for hospital or outpatient clinic settings.

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

SEP - 7 2005

Mr. David A. Alexander President/CTO Applied Surgical, LLC 300 Riverchase Parkway East Birmingham, Alabama 35244

Re: K051831

Trade/Device Name: Gemini Surgical Control & Display System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: August 18, 2005 Received: August 22, 2005

Dear Mr. Alexander:

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. David A. Alexander

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/dsma/dsmamain.html

Sincerely vours.

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

Enclosure

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| Indications For Use | |
|---------------------|---------|
| 510(k) Number: | K051831 |

Device Name: Gemini Surgical Control & Display System

Indications For Use:

The Gemini Surgical Control & Display System is indicated for use in any surgical procedure where single or multiple electrosurgical (unipolar, harmonic scalpel, etc.) devices that with a foot control are used. The Gemini Surgical Control & Display System integrates the electrosurgical devices into a central system that uses a single Master Foot Control to activate the devices.

The SurgiClear smoke evacuation activation unit is indicated for use during laparoscopic cases to automatically remove the smoke/steam/debris resulting from the use of electrosurgical instruments.

The system is intended for use in hospitals or outpatient clinics.

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

Over-The-Counter Use __ NO (Part 21 CFR 801 Subpart C)

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> currence of CDRH. Office of Device Evaluation (ODE) meeting for the Kerson Division Sign-Off) Division of General, Restorative,

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**510(k) Number** K051831

and Neurological Devices