LOGIC LAPAROSCOPIC INSTRUMENT SYSTEM

K111986 · Surgical Innovations Plc · GEI · Jan 26, 2012 · General, Plastic Surgery

Device Facts

• Record ID: K111986
• Device Name: LOGIC LAPAROSCOPIC INSTRUMENT SYSTEM
• Applicant: Surgical Innovations Plc
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Jan 26, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Logic Laparoscopic Instrument System, Electrosurgical, Cutting & Coagulation & Accessories is designed to dissect, grasp, manipulate and/or cauterise various tissues during manual operations in minimally invasive surgery and general endoscopic/laparoscopic procedures.

Device Story

Logic Laparoscopic Instrument System is a manual surgical instrument set for minimally invasive surgery. Device functions include tissue dissection, grasping, manipulation, and cauterization. Operated by surgeons in clinical/OR settings. System provides mechanical tissue interaction and electrosurgical coagulation capabilities. Benefits include facilitating surgical access and tissue management during endoscopic procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Electrosurgical cutting and coagulation device. Class II, Product Code GEI. Manual laparoscopic instrument system.

Indications for Use

Indicated for use in patients undergoing minimally invasive surgery and general endoscopic/laparoscopic procedures requiring tissue dissection, grasping, manipulation, and cauterization.

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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## Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Surgical Innovations PLC % Mr. Paul Birtles Clayton Wood House 6 Clayton Wood Bank Leeds. West Yorkshire United Kingdom LS16 6ZQ

JAN 2 6 2012

Re: K111986

Trade/Device Name: Logic Laparoscopic Instrument System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories

Regulatory Class: Class II Product Code: GEI Dated: January 6, 2012 Received: January 10, 2012

Dear Mr. Birtles:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

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

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## Page 2 – Mr. Paul Birtles

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); 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 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/MedicalDevices/Safety/ReportaProblem/default.htm 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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson

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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## Attachment 2

## Indications for Use Statement K11986 510(k) Number Logic Laparoscopic Instrument System, Electrosurgical, Cutting & Device Name Coagulation & Accessories Indications for Use The Logic Laparoscopic Instrument System, Electrosurgical, Cutting & Coagulation & Accessories is designed to dissect, grasp, manipulate and/or cauterise various tissues during manual operations in minimally invasive surgery and general endoscopic/laparoscopic procedures.

Prescription Use _X (Per 21 CFR 801.109) OR

Over-The-Counter Use_

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of DFRH, Office of Device Evaluation (ODE)

signature

(Division ign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K111986