CARDIOBLATE SURGICAL ABLATION GENERATOR, MODEL 68000; CARDIOBLATE BP2 SURGICAL ABLATION DEVICE, MODEL 60831; CARDIOBLAT

K060400 · Medtronic, Inc. · GEI · Feb 28, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K060400
• Device Name: CARDIOBLATE SURGICAL ABLATION GENERATOR, MODEL 68000; CARDIOBLATE BP2 SURGICAL ABLATION DEVICE, MODEL 60831; CARDIOBLAT
• Applicant: Medtronic, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Feb 28, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

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

Device Story

Cardioblate 68000 Generator is a reusable, non-sterile radiofrequency (RF) generator used in surgical settings. It delivers up to 50 Watts of RF energy to compatible bipolar or monopolar surgical ablation devices. The system is operated by surgeons to ablate soft tissue. The generator features a touchscreen interface and an updated microprocessor. It functions by providing controlled energy to the hand-held ablation device, which the surgeon applies directly to the target tissue. This process creates lesions for surgical ablation, potentially benefiting patients by facilitating tissue destruction during general surgical procedures.

Clinical Evidence

Bench testing only. Evidence includes software validation, hardware qualification, electromagnetic compatibility (EMC) testing, safety testing, and in vitro lesion equivalence and transmurality equivalence tests on tissue.

Technological Characteristics

Radiofrequency generator; 50W output; bipolar and monopolar modes; touchscreen interface; microprocessor-controlled; reusable, non-sterile unit; ergonomic molded case.

Indications for Use

Indicated for soft tissue ablation during general surgery. Contraindicated for patients with 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

• Cardioblate® Bipolar Radiofrequency Ablation System (K031247)

Submission Summary (Full Text)

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## FEB 2 8 2006 KD60400

Page 1 of 2

# 510(k) SUMMARY of Safety and Effectiveness

(In accordance with SMDA of 1990 and pursuant with 21 CFR 807.92)

#### I. Applicant Information:

| Date Prepared:<br>Submitter: | February 3, 2006<br>Medtronic, Inc. |
|-----------------------------------|-----------------------------------------------------------------------|
| Address: | 710 Medtronic Parkway, NE<br>Minneapolis, MN 55432-5604 |
| Establishment<br>Registration No. | 2135394 |
| Contact Person: | David D. Cox, Ph.D.<br>Senior Principal Regulatory Affairs Specialist |
| Telephone Number: | [phone] |
| Fax Number: | [phone] |

### II. Device Information:

| Trade Name: | Cardioblate® 68000 Generator |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Cardioblate® Surgical Ablation System, which consists of:<br>• Cardioblate® 68000 Generator |
| | Which can be used with:<br>• Cardioblate® BP2 Surgical Ablation Device, model 60831<br>• Cardioblate® LP Surgical Ablation Device, model 60841<br>• Cardioblate® Monopolar Pens (K013392) |
| Classification Name: | Electrosurgical, Cutting & Coagulation & Accessories |
| Classification: | Class II, 21 CFR 878.4400 |
| Product Code: | GEI |
| Predicate Device: | Cardioblate® Bipolar Radiofrequency Ablation System<br>510(k) No. K031247, Reg. No. 878.4400; Product Code: GEI |
| | Predicate Device Intended Use: The Medtronic Cardioblate<br>System is intended to ablate soft tissue during general surgery<br>using radiofrequency energy. |

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K060 400

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- The Medtronic Cardioblate® 68000 Generator is a reusable, non-Device Description: sterile radiofrequency generator. In bipolar mode, the generator is attached to a bipolar Surgical Ablation Device (e.g. Model 60831 or 60841), which is the hand-held, sterile, single-use device that applies radiofrequency energy to the selected tissue.
The Cardioblate® 68000 Generator is capable of delivering a controlled amount of radiofrequency energy for both Monopolar and Bipolar surgical ablation techniques. The generator delivers up to 50 Watts energy in either the bipolar or monopolar mode.

- The Cardioblate® Surgical Ablation System is intended to ablate Intended Use: soft tissue during general surgery using radiofrequency energy.
- The Cardioblate® Surgical Ablation System is contraindicated for Contraindications: patients that have active endocarditis at the time of surgery.
- The Cardioblate® Surgical Ablation System with the model 68000 Predicate Device: Generator is substantially equivalent to the Cardioblate" Surgical Ablation System with the Model 60890 Generator cleared by K031247. The Generator uses the same energy source to deliver the same amount of radiofrequency energy to ablate tissues, and uses the same surgical ablation devices. Although both generators use the same algorithms to operate, the Model 68000 Generator is updated to include a touchscreen interface, an updated microprocessor and a molded, ergonomic case.
- Verification and validation testing confirms that the functional Test Data: characteristics of the Cardioblate Surgical Ablation System with the Cardioblate® 68000 Generator are substantially equivalent to the predicate devices cited. This included software validation, hardware qualification, electromagnetic compatibility and safety testing on the generator, and lesion equivalence and transmurality equivalence tests on tissue with the entire system.
- Based on the technical information, intended use, laboratory Summary: verification tests and in vitro performance information provided, the system which includes the Cardioblate® 68000 in substantially equivalent to the currently marketed predicate device.

Comparison to

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 8 2006

Medtronic, Inc. c/o Ms. Silvia Ankova Senior Project Engineer Underwriters Laboratories, Inc. 333 Pfingsten Road Northbrook, Illinois 60062

Re: K060400

Trade/Device Name: Medtronic Cardioblate® 68000 Generator Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: February 10, 2006 Received: February 15, 2006

Dear Ms. Ankova:

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 - Ms. Ankova

This letter will allow you to begin marketing your device as described in your Section 510(k) This icticle will anow you to begin manieting of substantial equivalence of your device to a legally premarket nonifeddom "Te 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 If you desire specific at no 10-10-10-115. Also, please note the regulation entitled, Comation of Ornec of Compilance and Ert notification" (21 CFR Part 807.97). You may obtain Whisoranding of Torerence to promesponsibilities under the Act from the Division of Small other general mionnational and Consumer Assistance at its toll-free number [phone] or Mandracturers, International and ddress http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

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

Enclosure

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## Statement of Indications for Use

510(k) Number:

K 060400

Device Name: Medtronic Cardioblate® 68000 Generator

Indications for use:

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

Prescription Use X (Part 21 CFR 801 Subpart D) OR Over-The-Counter-Use (Part 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Q.MDL

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

长060400 510(k) Number_

Medtronic Cardioblate® 68000 Generator 510(k) Premarket Notification

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