EPICOR ABLATION CONTROL SYSTEM, MODEL ACS-US-2, ACS-EUR-2

K082279 · St Jude Medical · OCL · Sep 16, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K082279
• Device Name: EPICOR ABLATION CONTROL SYSTEM, MODEL ACS-US-2, ACS-EUR-2
• Applicant: St Jude Medical
• Product Code: OCL · General, Plastic Surgery
• Decision Date: Sep 16, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Epicor Medical Ablation Control System is intended for the ablation of cardiac tissue during cardiac surgery

Device Story

Epicor Ablation System delivers ultrasound energy to cardiac tissue to create ablation lesions during cardiac surgery. System components include Ablation Control System instrument, reusable connecting cable, and sterile, disposable ablation devices. Operated by surgeons in clinical/surgical settings. Device transforms electrical energy into ultrasound energy for tissue ablation. Benefits include precise cardiac tissue ablation during surgical procedures.

Clinical Evidence

Bench testing only. Device validation testing was conducted in accordance with in-house procedures.

Technological Characteristics

Ultrasound ablation system; consists of control instrument, reusable cable, and sterile disposable ablation devices. Operates via delivery of ultrasound energy to tissue. Class II device (21 CFR 878.4400).

Indications for Use

Indicated for the ablation of cardiac tissue during cardiac surgery.

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

• Epicor Ablation System (K080292)

Submission Summary (Full Text)

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| 510(k) Summary for Public Disclosure | | SEP 1 6 2008 |
|--------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|
| Submitter: | St. Jude Medical<br>240 Santa Ana Court<br>Sunnyvale, CA 94085-4512 USA<br>Phone: [phone] ext. 2024<br>Fax: [phone] | |
| | Contact:<br>Donna R. Lunak<br>Regulatory Specialist II | |
| Date Prepared: | August 6, 2008 | |
| Trade Name: | The Epicor™ Ablation System | |
| Common Name: | Ultrasonic Surgical Instrument | |
| Classification Name: | System, Ablation, Ultrasound and Accessories<br>(21 CFR 878.4400) | |
| Predicate Device: | | |
| | Product | 510(k) Number |
| | Epicor Ablation System | K080292 |
| Device Description: | The Epicor Ablation System is designed to deliver ultrasound<br>energy to tissue in order to create an ablation lesion.<br>Specifically, the system is intended for the ablation of cardiac<br>tissue during cardiac surgery. The Ablation System consists of<br>the Ablation Control System instrument, a reusable connecting<br>cable, a family of sterile, disposable ablation devices, and<br>accessories. | |
| Epicor Ablation<br>System<br>Intended use: | The Epicor Medical Ablation Control System is intended for the<br>ablation of cardiac tissue during cardiac surgery | |
| Technological<br>Characteristics: | The new device has the same technological characteristics as the<br>legally marketed predicate device. | |
| Non-clinical<br>Performance Data: | The changes made to the Epicor Ablation System underwent a<br>battery of bench and user tests. Device validation testing was<br>conducted in accordance with in-house procedures. | |
| Conclusion: | An evaluation of the device changes indicates that the devices<br>are as safe and effective as the previously marketed device to<br>which they are being compared and do not raise any new issues<br>of safety and effectiveness. | |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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SEP 1 6 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

St. Jude Medical c/o Ms. Donna R. Lunak Regulatory Specialist II 1350 Energy Lane, Suite 110 St. Paul, MN 55108

Re: K082279

Trade/Device Name: Epicor™ Ablation System Regulation Number: 21 CFR 878.4400 Regulation Names: Ultrasound Ablation System and Accessories Regulatory Class: Class II Product Code: OCL Dated: August 8, 2008 Received: August 11, 2008

Dear Ms. Lunak:

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

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Page 2 - Ms. Donna R. Lunak

comply with all the Act's requirements, including, but not limited to: registration and lisung (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 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,

[signature]

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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## Indications for Use 9.0

510(k) Number (if known): N/A

Device Name: The Epicor™ Ablation System

## Indications for Use:

The Epicor Ablation System is intended for the ablation of cardiac tissue during cardiac surgery.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) B Zuckerman
9/16/08

vision of Cardiovascular Device

St. Jude Medical

510(k) Number_ K082279