CARDIOBLATE DISPERSIVE ELECTRODE ADAPTER (ACCESSORY), MODEL 60884

K043291 · Medtronic Vascular · GEI · Dec 21, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K043291
• Device Name: CARDIOBLATE DISPERSIVE ELECTRODE ADAPTER (ACCESSORY), MODEL 60884
• Applicant: Medtronic Vascular
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Dec 21, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Medtronic Cardioblate System is intended to ablate soft tissue during general surgery using radiofrequency energy.

Device Story

Cardioblate Bipolar Radiofrequency Surgical Ablation System uses radiofrequency (RF) energy to ablate soft tissue. Device operates by delivering RF energy to target tissue during general surgical procedures. System intended for use by surgeons in clinical settings. Output consists of controlled thermal energy for tissue coagulation/ablation. Benefits include effective soft tissue management during surgery.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Bipolar radiofrequency electrosurgical ablation system. Class II device (21 CFR 878.4400). Product code GEI.

Indications for Use

Indicated for ablation of soft tissue during general surgery. Prescription use only.

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

DEC 2 1 2004

David D. Cox, Ph.D. Senior Principle Regulatory Affairs Specialist Medtronic, Inc. Medtronic Cardiac Surgery Technologies 7601 Northland Drive Minneapolis, Minnesota 55428

Re: K043291

R049271
Trade/Device Name: Cardioblate® Bipolar Radiofrequency Surgical Ablation System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: November 22, 2004 Received: December 1, 2004

Dear Dr. Cox:

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 carı 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 - David D. Cox, Ph.D.

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 yours,

Miriam C. Provost
65

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Attachment 2

## Indications for Use Statement

510(k) Number

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(if known)

Cardioblate® Bipolar Radiofrequency Surgical Ablation Device Name System

The Medtronic Cardioblate System is intended to ablate soft Indications tissue during general surgery using radiofrequency energy. for Use

Over-The-Counter Use OR Prescription Use_ V (Per 21 CFR 801. 109) PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER

PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

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

**510(k) Number** K043291