CARDIOBLATE BIPOLAR RADIOFREQUENCY SURGICAL ABLATION SYSTEM

K031247 · Medtronic Vascular · GEI · Jul 17, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K031247
• Device Name: CARDIOBLATE BIPOLAR RADIOFREQUENCY SURGICAL ABLATION SYSTEM
• Applicant: Medtronic Vascular
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Jul 17, 2003
• Decision: SESE
• Submission Type: Traditional
• 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

The Medtronic Cardioblate Bipolar Radiofrequency Ablation System consists of a hand-held bipolar surgical ablation device (models 60821, 60822) and a surgical ablation generator (model 60890). The system delivers controlled radiofrequency (RF) energy to soft tissue to achieve ablation. The generator operates in bipolar mode (up to 40 Watts, 20-350 Ohm range) or monopolar mode (up to 50 Watts, 20-500 Ohm range). Used by surgeons in a clinical/surgical setting to ablate soft tissue. The device provides the energy necessary for surgical coagulation and cutting, aiding in tissue management during general surgical procedures.

Clinical Evidence

No clinical data. Performance characteristics were evaluated through bench testing and non-bench analyses comparing the system to predicate device specifications.

Technological Characteristics

System comprises a hand-held bipolar ablation device and an RF generator. Energy source: Radiofrequency. Bipolar mode: up to 40W (20-350 Ohm). Monopolar mode: up to 50W (20-500 Ohm).

Indications for Use

Indicated for soft tissue ablation during general surgery. Contraindicated in patients with active endocarditis or for ablation in a pool of blood (e.g., through a purse string suture on a beating heart).

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

• Medtronic Cardioblate Radiofrequency Ablation System (K013392)
• AtriCure Bipolar System (K020919)

Submission Summary (Full Text)

{0}------------------------------------------------

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

JUL 17 2003

## 510(k) Summary of Safety and Effectiveness

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:

| 510(k) No.: | K031247 |
|-----------------------------------|---------------------------------------------------------|
| Date Prepared:<br>Submitter: | April 17, 2003<br>Medtronic, Inc. |
| Address: | 710 Medtronic Parkway, NE<br>Minneapolis, MN 55432-5604 |
| Establishment<br>Registration No. | 2135394 |
| Contact Person: | Scott Cundy<br>Director Regulatory, Clinical & Quality |
| Telephone Number:<br>Fax Number: | [phone]<br>[phone] |

## Device Information:

| Trade Name: | Medtronic® Cardioblate® Bipolar Radiofrequency Ablation System | | | | | |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|
| Common Names: | Medtronic® Cardioblate® Bipolar Surgical Ablation System, which consists of:<br>• Medtronic® Cardioblate® (Bipolar & Monopolar) Surgical Ablation Generator, model 60890<br>• Medtronic® Cardioblate® Bipolar Surgical Ablation Device, models 60821 & 60822 | | | | | |
| Classification Name: | Electrosurgical Cutting, and Coagulation Device and Accessories | | | | | |
| Classification: | Class II, 21 CFR 878.4400 | | | | | |
| Predicate Devices: | Medtronic® Cardioblate® Radiofrequency Ablation System K013392<br>AtriCure Bipolar System K020919 | | | | | |

a marka mana mana mana mana mana mana mana mana mana mana mara mara mara mara mara mara mara ma

:

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

{1}------------------------------------------------

- Device Description: The Medtronic® Cardioblate® Bipolar Radiofrequecy Ablation System is made of bipolar Surgical Ablation Device (Model 60821 & 60822) and a Cardioblate® (Bipolar & Monopolar) Surgical Ablation Generator & accessories (Model 60890) for the application of radiofrequency energy to tissue.
The Medtronic® Cardioblate® BP (Bipolar) Surgical Ablation Device, (Model 60821 & 60822) is a hand-held, bipolar, radiofrequency surgical ablation device.

The Medtronic® Cardioblate® (Bipolar & Monopolar) Surgical Ablation Generator, (Model 60890) is capable of delivering the controlled radiofrequency energy for Bipolar or Monopolar surgical ablation. The Generator delivers in Bipolar mode up to 40 Watts, with a 20 - 350 Ohm range, and a Monopolar mode up to 50 Watts to the delivery device with a 20-500 Ohm range.

- Intended Uses: The Medtronic Cardioblate System is intended to ablate soft tissue during general surgery using radiofrequency energy.
- Contraindications: The Cardioblate® BP Surgical Ablation Device should not be used for patients that have:

Active endocarditis at time of surgery.

Ablation in a pool of blood (e.g., through a purse string suture on a beating heart). Effects of this type of ablation are unknown.

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

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, representing the department's mission to protect the health of all Americans.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 17 2003

Mr. Scott Cundy Director Regulatory, Clinical & Quality Medtronic, Inc. 710 Medtronic Parkway, NE Minneapolis, Minnesota 55432-5604

Re: K031247

Trade/Device Name: Medtronic® Cardioblate® Bipolar Radiofrequency Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: April 17, 2003 Received: April 23, 2003

Dear Mr. Cundy:

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. Iisting 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.

{3}------------------------------------------------

Page 2 - Mr. Scott Cundy

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]. Additionally, for questions on the promotion and advertising of your device, 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 may be obtained 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.

Miriam C. Provost

(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

{4}------------------------------------------------

Device Name: Cardioblate® Bipolar Radiofrequency Ablation System 510(k) Number (if known): KO31247

Indications for Use:

The Medtronic® Cardioblate® Bipolar Radiofrequency Ablation System is intended to ablate soft tissue during general 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) | |

(optional format 1-2-96)

Miriam C. Provost

Division of General, Restorative and Neurological Devi

510(k) Number K031247