ST. JUDE MEDICAL EPICARDIAL CATHETER SYSTEM

K081803 · St Jude Medical · DRF · May 13, 2009 · Cardiovascular

Device Facts

• Record ID: K081803
• Device Name: ST. JUDE MEDICAL EPICARDIAL CATHETER SYSTEM
• Applicant: St Jude Medical
• Product Code: DRF · Cardiovascular
• Decision Date: May 13, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1220
• Device Class: Class 2

Intended Use

The St. Jude Medical Epicardial Catheter System is intended for electrophysiology studies involving the epicardial surface of the heart.

Device Story

The St. Jude Medical Epicardial Catheter System comprises a Response 6 French quadripolar electrophysiology catheter and an Agilis NxT 40 cm steerable guiding introducer (including dilator, guidewire, and steerable sheath). The system provides pericardial access for the catheter to perform electrophysiology studies on the epicardial surface of the heart. Used in clinical settings by physicians; the steerable introducer facilitates precise catheter placement. The system enables mapping or recording of electrical signals from the heart's epicardium, assisting clinicians in diagnosing cardiac electrophysiological conditions.

Clinical Evidence

Bench testing only.

Technological Characteristics

System includes a 6 French quadripolar electrophysiology catheter and a steerable guiding introducer (sheath, dilator, guidewire). Materials, packaging, biocompatibility, and sterilization methods are consistent with predicate devices. No software or electronic processing algorithms are described.

Indications for Use

Indicated for patients undergoing electrophysiology studies of the epicardial surface of the heart.

Regulatory Classification

Identification

An electrode recording catheter or an electrode recording probe is a device used to detect an intracardiac electrocardiogram, or to detect cardiac output or left-to-right heart shunts. The device may be unipolar or multipolar for electrocardiogram detection, or may be a platinum-tipped catheter which senses the presence of a special indicator for cardiac output or left-to-right heart shunt determinations.

Predicate Devices

• Response Electrophysiology Catheter
• Agilis NxT Steerable Introducer

Submission Summary (Full Text)

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KO81803

MAY 1 3 2009

## Section 5 – 510(k) Summary

| Submitter: | St. Jude Medical - Atrial Fibrillation Division<br>14901 DeVeau Place<br>Minnetonka, MN 55345<br>Establishment Registration Number: 2182269 |
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| Contact Person: | Joshua Clarin<br>Regulatory Affairs Specialist<br>Phone [phone]<br>Fax [phone] |
| Date Prepared: | June 25, 2008 |
| Trade Name: | St. Jude Medical Epicardial Catheter System |
| Classification: | Class 11 - 21 CFR 870.1220<br>Electrode recording catheter or electrode recording probe<br>Class II - 21 CFR 870.1340<br>Catheter Introducer |
| Product Code: | DRF<br>DYB |
| Predicate Device(s): | The subject device is equivalent to the following St. Jude Medical<br>devices:<br>◦ ResponseTM Electrophysiology Catheter<br>◦ AgilisTM NxT Steerable Introducer |
| Device Description: | The St. Jude Medical Epicardial Catheter System consists of the<br>ResponseTM 6 French quadripolar electrophysiology catheter and the<br>AgilisTM NxT 40 cm steerable guiding introducer (which includes a<br>dilator, guidewire and steerable sheath). The Agilis NxT Steerable<br>Introducer provides pericardial access for the Response catheter to<br>perform electrophysiology studies of the epicardial surface of the heart. |
| Intended Use: | The St. Jude Medical Epicardial Catheter System is intended for<br>electrophysiology studies involving the epicardial surface of the heart. |
| Comparison to<br>Predicate Devices | The St. Jude Medical Epicardial Catheter System has a similar intended<br>use and the same fundamental scientific technology as the predicate<br>devices. All technological characteristics of the of the Epicardial Catheter<br>System are substantially equivalent to the predicate devices including<br>packaging, biocompatibility, sterilization, and labeling. Where<br>differences exist between the proposed devices and the predicate devices,<br>performance testing demonstrated that these differences do not adversely<br>affect the safety and effectiveness of the proposed devices. |
| Conclusion: | St. Jude Medical considers the Epicardial Catheter System to be<br>equivalent to the predicate devices listed above. This conclusion is based<br>upon the devices' similarities in design, technological characteristics,<br>principles of operation, materials, and indications for use. |

PreMarket Notification for the St. Jude Medical Epicardial Catheter System

Page 14 of 68

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Image /page/1/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized symbol resembling an abstract human figure or bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the symbol.

MAY 1 3 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

St. Jude Medical c/o Mr. Joshua Clarin Regulatory Affair Specialist One St. Jude Medical Drive St. Paul, MN 55117

Re: K081803

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Trade/Device Name: Epicardial Catheter System Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter Regulatory Class: Class II (two) Product Code: DRF Dated: April 17, 2009 Received: April 20, 2009

Dear Mr. Clarin:

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 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.

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Page 2 - Mr. Joshua Clarin

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); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.

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 the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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,

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 | |
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| 510(k) Number (if known): | K081803 | | |
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| Device Name: | St Jude Medical Epicardial Catheter System | | |
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| Indications for Use: | | | |
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| The St. Jude Medical Epicardial Catheter System is intended for electrophysiology studies involving the epicardial surface of the heart. | | | |
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| | AND/OR | Over-The-Counter | |
| Prescription Use | X | | |
| (Part 21 CFR 801 Subpart D | (21 CFR 801 Subpart | | |
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| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) | | | |
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| | Concurrence of CDRH, Office of Device Evaluation (ODE) | | |
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| | (Division/Sign-Off) | | |
| | | Division of Cardiovascular Devices | |
| | 510(k) Number | K081803 | |
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ACT 2000 Company Company

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