CARDIOBLATE GEMINI SURGICAL ABLATION DEVICE, MODELS 49260 AND 49261

K070311 · Medtronic Vascular · GEI · Apr 24, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K070311
• Device Name: CARDIOBLATE GEMINI SURGICAL ABLATION DEVICE, MODELS 49260 AND 49261
• Applicant: Medtronic Vascular
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Apr 24, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The Cardioblate Gemini Surgical Ablation Device is intended to ablate soft tissue during general surgery using radiofrequency energy. The system is indicated for use, under direct or endoscopic visualization, in surgical procedures, including minimally invasive surgical procedures.

Device Story

Hand-held, bipolar radiofrequency (RF) ablation device; features saline irrigation system to cool tissue at contact point between tissue and electrode during energy delivery. Available in two jaw curvatures: standard (Model 49260) and extra (Model 49261). Used in general surgery, including minimally invasive cardiac procedures, under direct or endoscopic visualization by surgeons. Device creates thermal necrosis in targeted tissue to ablate soft tissue. Sterile, single-use, disposable. Intermittent operation.

Clinical Evidence

Bench testing only. Device tested for safety and effectiveness per recognized consensus standards AAMI/ANSI HF18:2001, IEC 60601-1, and IEC 60601-2-2.

Technological Characteristics

Bipolar radiofrequency ablation device; saline irrigation system for electrode cooling. Two jaw curvatures (standard/extra). Sterile, single-use, disposable. Complies with AAMI/ANSI HF18:2001, IEC 60601-1, and IEC 60601-2-2.

Indications for Use

Indicated for surgical ablation of soft tissue during general surgery, including minimally invasive procedures, under direct or endoscopic visualization. Contraindicated in 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 LP Surgical Ablation Device, Model 60841 (K060400)
• Cardioblate BP2 Surgical Ablation Device, Model 60831 (K060400)
• Guidant FLEX 10 Probe Accessory (K013946)

Submission Summary (Full Text)

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K070311

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## 510(k) SUMMARY of Safety and Effectiveness

I.

APR 2 4 2007 (In accordance with SMDA of 1990 and pursuant with 21 CFR 807.92)

## Applicant Information: Date Prepared: April 6, 2007 Submitter: Medtronic, Inc. Address: 710 Medtronic Parkway, NE Minneapolis, MN 55432-5604 Establishment Registration No. 2135394 Contact Person: Debbie Kidder. Senior Regulatory Affairs Specialist Telephone Number: [phone] Fax Number: [phone] II. Device Information: Cardioblate® Gemini™ Surgical Ablation Device, Model 49260 Trade Name: and Model 49261 Cardioblate® Surgical Ablation System, which consists of: Common Name: Cardioblate® 68000 Generator (K060400) and the following devices: Cardioblate® BP2 Surgical Ablation Device, Model 60831 ■ (K060400) Cardioblate® LP Surgical Ablation Device, Model 60841 ■ (K060400) Cardioblate® Monopolar Pen, Model 60813 and Model ■ 60814 (K013392) Classification Name: Electrosurgical, Cutting & Coagulation & Accessories Classification: Class II, 21 CFR 878.4400 Product Code: GEI Cardioblate® LP Model 60841 and BP2 Predicate Device: Model 60831 Surgical Ablation Device, (K060400), Reg. No. 878.4400; Product Code: GEI The Medtronic Cardioblate® Predicate Device Intended Use: System is intended to ablate soft tissue during general surgery using radiofrequency energy.

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Guidant FLEX 10 Probe Accessory, Predicate Device: (K013946), Reg. No. 878.4400; Product Code: NYE

Predicate Device Intended Use: The FLEX 10 Accessory is indicated for surgical ablation of soft tissue, in addition to striated, cardiac and smooth muscle by induction of thermal necrosis in the targeted tissue. The system is a device indicated for use under direct visualization, in surgical procedures, including minimally invasive cardiac surgery procedures. The probes ablate the target tissue by creating an inflammatory response, or thermal necrosis.

Device Description:

The Medtronic Cardioblate Gemini™ Surgical Ablation Device is a hand held, bipolar radiofrequency ablation device intended to ablate soft tissue during general surgery. It has a saline irrigation system to deliver fluid at the contact point between the tissue and electrode to cool the tissue during radiofrequency energy delivery. Two unique jaw curvatures are provided: a standard curve (Model 49260) and extra curve (Model 49261). This device is intended for intermittent operation. Sterile, Nonpyrogenic, Disposable, Single use only.

Intended Use: The Cardioblate Gemini Surgical Ablation Device is intended to ablate soft tissue during general surgery using radiofrequency energy. The system is indicated for use under direct or endoscopic visualization, in surgical procedures, including minimally invasive surgical procedures.

The Cardioblate® Surgical Ablation System is contraindicated for Contraindications: patients that have active endocarditis at the time of surgery.

> Ablation in a pool of blood (eg, through a purse string suture on a beating heart). Effects of this type of ablation have not been studied.

## III.SUBSTANTIAL EQUIVALENCE TESTING SUMMARY

The Cardioblate Gemini™ Surgical Ablation Device has demonstrated substantial equivalence to the predicate devices based on the indications for use, basic overall function and performance characteristics. The Cardioblate® Gemini™ Surgical Ablation Device has been tested and is considered safe and effective per the following recognized consensus standard AAMI/ANSI HF18:2001, Electrosurgical Devices, IEC 60601-1, and IEC 60601-2-2.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains an image of an eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medtronic, Inc. % Regulatory Technology Services. LLC Mr. Mark Job 1394 25th Street, Northwest Buffalo, Minnesota 55313

APR 2 4 2007

Re: K070311

Trade/Device Name: Medtronic Cardioblate® Gemini™Surgical Ablation Device Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: April 9, 2007 Received: April 10, 2007

Dear Mr. Job:

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 - Mr. Mark Job

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/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson

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

K070311 510(k) Number:

Device Name: Medtronic Cardioblate® Gemini™ Surgical Ablation Device

Indications for use:

The Cardioblate Gemini Surgical Ablation Device is intended to ablate soft tissue during general surgery using radiofrequency energy. The system is indicated for use, under direct or endoscopic visualization, in surgical procedures, including minimally invasive surgical procedures.

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) | |
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| (Division Sign-Off) | |
| Division of General, Restorative, and Neurological Devices | |
| 510(k) Number | L070311 |

Medtronic Cardioblate® Gemini™ Surgical Ablation Device 510(k) Premarket Notification

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