CARDIOBLATE GEMINI SURGICAL ABLATION DEVICE, MODELS 49260 AND 49261 by MEDTRONIC VASCULAR

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 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.

AI/ML Overview

The Medtronic Cardioblate® Gemini™ Surgical Ablation Device (K070311) is a medical device for ablating soft tissue. Its acceptance criteria and performance are established through substantial equivalence testing, rather than a study with specific performance metrics against an acceptance criteria table.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

This 510(k) summary does not present a table of specific acceptance criteria with corresponding device performance values (e.g., accuracy, sensitivity, specificity, or specific ablation lesion dimensions). Instead, the device's performance and safety are substantiated by demonstrating adherence to recognized consensus standards.

2. Sample Size Used for the Test Set and Data Provenance

No test set sample size or data provenance is mentioned in the provided text. The submission relies on compliance with established standards rather than data from a clinical test set.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Since no clinical test set data is provided, there is no mention of experts used to establish ground truth.

4. Adjudication Method for the Test Set

As there is no clinical test set presented, no adjudication method is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No MRMC comparative effectiveness study is mentioned in the provided document. The submission focuses on device safety and efficacy through compliance with engineering standards.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This device is a surgical ablation tool, not an AI algorithm. Therefore, the concept of "standalone (algorithm only)" performance, as typically understood in AI/ML, is not applicable. Its performance is inherent in its physical and functional design.

7. The Type of Ground Truth Used

The "ground truth" for this device's acceptance is its compliance with recognized consensus standards for electrosurgical devices. These standards (AAMI/ANSI HF18:2001, IEC 60601-1, and IEC 60601-2-2) define safety and performance requirements that the device must meet. This is a form of engineering and regulatory "ground truth."

8. The Sample Size for the Training Set

As this is a physical medical device and not an AI/ML algorithm, there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study proving the device meets acceptance criteria is detailed in Section III. SUBSTANTIAL EQUIVALENCE TESTING SUMMARY.

Acceptance Criteria Approach: The device demonstratessubstantial equivalence to predicate devices (Cardioblate® LP Model 60841 and BP2 Model 60831 Surgical Ablation Device, K060400; and Guidant FLEX 10 Probe Accessory, K013946) based on indications for use, basic overall function, and performance characteristics.
Performance Proof: The device's safety and effectiveness are proven by its compliance with the following recognized consensus standards:
- AAMI/ANSI HF18:2001, Electrosurgical Devices: This standard likely covers general requirements for electrosurgical equipment.
- IEC 60601-1: This is the general standard for basic safety and essential performance of medical electrical equipment.
- IEC 60601-2-2: This is the particular standard for the basic safety and essential performance of high-frequency surgical equipment and high-frequency surgical accessories.

This approach signifies that the device has undergone testing and evaluation to ensure it meets the established engineering and safety benchmarks outlined in these standards, thereby proving its suitability for its intended use.

Summary

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K070311

Page 1 of 2

510(k) SUMMARY of Safety and Effectiveness

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: (763) 391-9251 Fax Number: (763) 391-9279 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:

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 (240) 276-0115. 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 (800) 638-2041 or (240) 276-3150 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:

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

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

Section 4 - Page 1

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
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.(b)
Classification. Class II.