CARDIOBLATE SURGICAL ABLATION PEN, MODEL 60811C; CARDIOBLATE SURGICAL ABLATION GENERATOR, MODEL 60880

K013392 · Medtronic Vascular · OCL · Jan 25, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K013392
• Device Name: CARDIOBLATE SURGICAL ABLATION PEN, MODEL 60811C; CARDIOBLATE SURGICAL ABLATION GENERATOR, MODEL 60880
• Applicant: Medtronic Vascular
• Product Code: OCL · General, Plastic Surgery
• Decision Date: Jan 25, 2002
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Medtronic® Cardioblate™ Radiofrequency Ablation System is intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy.

Device Story

Cardioblate System comprises hand-held unipolar radiofrequency (RF) ablation pen and RF generator; used during open-heart surgery by surgeons. Generator delivers controlled RF energy (up to 50 Watts, 20-500 Ohm range) to pen; energy applied to cardiac tissue to create linear lesions. Device enables surgical ablation; assists in cardiac rhythm management procedures. Surgeon operates pen manually; monitors generator output to ensure appropriate energy delivery. Clinical benefit includes creation of lesions for cardiac tissue ablation.

Clinical Evidence

Bench testing only. Performance characteristics compared to predicate devices via bench testing and non-bench analyses.

Technological Characteristics

Unipolar RF ablation system; includes hand-held pen and generator. Energy source: Radiofrequency. Output: Up to 50 Watts, 20-500 Ohm range. Intended for open-heart surgical use.

Indications for Use

Indicated for cardiac tissue ablation during cardiac surgery. Contraindicated in patients with active systemic infection or active endocarditis.

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.

Predicate Devices

• TissueLink™ Floating Ball (K010662)
• Boston Scientific Cobra RF System (K010956)
• EndoCare Cryocare Cardiac Surgical System (K011040)
• AFx Microwave Flex Ablation Wand System (K003978)
• ValleyLab Force 2 Electrosurgical Generator (K921884)

Submission Summary (Full Text)

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510(k) Premarket Submission - Medtronic, Inc. - Cardioblate™ System

# KO13392

### 510(k) Summary of Safety and Effectiveness

## JAN 2 5 2002

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92

#### Application Information:

...

| Date Prepared:<br>Submitter: | January 8, 2002<br>Medtronic, Inc. |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 710 Medtronic Parkway, NE<br>Minneapolis, MN 55432-5604 |
| Establishment<br>Registration No. | 2135394 |
| Contact Person: | Scott Cundy<br>Sr. Regulatory and Quality Manager |
| Telephone Number:<br>Fax Number: | [phone]<br>[phone] |
| Device Information: | |
| Trade Name: | Medtronic® Cardioblate™ Radiofrequency Ablation System |
| Common Names: | Cardioblate™ System, which is made up of Cardioblate™ Surgical<br>Ablation Pen & Cardioblate™ Surgical Ablation Generator |
| Classification Name:<br>Classification: | Electrosurgical Cutting, and Coagulation Device and Accessories<br>Class II, 21 CFR 878.4400 |
| Predicate Devices: | TissueLink™ Floating Ball (K010662), Boston Scientific Cobra<br>RF System (K010956), EndoCare Cryocare Cardiac Surgical<br>System (K011040), AFx Microwave Flex Ablation Wand System<br>(K003978), and ValleyLab Force 2 Electrosurgical Generator<br>(K921884). |
| Device Description: | The Medtronic Cardioblate System is comprised of a<br>radiofrequency ablation pen, radiofrequency generator, and<br>accessories for the application of radiofrequency energy to tissue.<br>The Cardioblate Pen is a hand-held, unipolar, radiofrequency<br>surgical ablation pen for use during open-heart surgery.<br>The Cardioblate Generator is capable of delivering the controlled<br>radiofrequency energy that is required for the creation of linear |

radiofrequency energy that is required for the creation of linear lesions during open-heart surgery. The Cardioblate Generator

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14.1 1

delivers up to 50 Watts to the delivery device with a 20 - 500 Ohm range.

The Medtronic Cardioblate System is intended to ablate cardiac Intended Uses: tissue during cardiac surgery using radiofrequency energy.

The Medtronic Cardioblate System is contraindicated for patients Contraindications: with active systemic infection or patients that have active endocarditis at time of surgery.

- The performance characteristics of the Medtronic Cardioblate Nonclinical System were tested and compared to the performance Performance: specifications of the listed predicate devices through both bench testing and non-bench analyses.
For the intended use listed above, the Medtronic Cardioblate Substantial System is considered substantially equivalent to the listed Equivanlence predicate devices. The differences that do exist are believed to be Conclusion: minor and not raise any concern regarding the overall safety and effectiveness.

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Public Health Service

Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.

MAR 1 1 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medtronic, Inc. c/o Mr. Scott Cundy Senior Product Regulation Manager Medtronic Cardiac Surgery Technologies 7601 Northland Drive Minneapolis, MN 55428

Re: K013392

Trade/Device Name: Medtronic ® Cardioblate™ Radiofrequency Ablation System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II (two) Product Code: OCL Dated: January 8, 2002 Received: January 10, 2002

Dear Mr. Cundy:

This letter corrects our substantially equivalent letter of January 25, 2002.

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 (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.

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Page 2 - Mr. Scott Cundy

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.

This letter will allow you to continue 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.

Q.mall.

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Device Name: Cardioblate Radiofrequency Ablation System 510(k) Number (if known): K013392

### Indications for Use:

The Medtronic® Cardioblate™ Radiofrequency Ablation System is intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy.

(Please do not Write below this line - continue on another page if needed)

CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)

Over the Counter Use: or Prescription Use: ✔ (Per 21 CFR 801.109)

Mark n-Millersen

eral, Rest Lative Division ological Device

K013392

510(k) Number

(optional format 1-2-96)