6F EVALUATOR ELECTROPHYSIOLOGY CATHETER, CRD # 402720,402722; 6F EAVUATOR ELECTROPHYSISOLOGY CATHETER, JSN #402721, 4027

K011766 · St Jude Medical · DRF · Jul 3, 2001 · Cardiovascular

Device Facts

• Record ID: K011766
• Device Name: 6F EVALUATOR ELECTROPHYSIOLOGY CATHETER, CRD # 402720,402722; 6F EAVUATOR ELECTROPHYSISOLOGY CATHETER, JSN #402721, 4027
• Applicant: St Jude Medical
• Product Code: DRF · Cardiovascular
• Decision Date: Jul 3, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1220
• Device Class: Class 2

Intended Use

The St. Jude Medical electrophysiology catheters can be used in the evaluation of a variety of cardiac arrhythmias.

Device Story

Evaluator™ Electrophysiology Catheter is a fixed-curve, electrode recording catheter. Device features ring electrodes electrically coupled to conductor wires. Used by physicians in clinical settings to pace the heart and sense/record bipolar intracardiac electrograms. Output allows clinicians to evaluate cardiac arrhythmias, facilitating diagnostic decision-making.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and design similarities to the predicate device.

Technological Characteristics

Fixed-curve, electrode recording catheter with ring electrodes and conductor wires. Materials, sterilization, and design are equivalent to the predicate device.

Indications for Use

Indicated for the evaluation of cardiac arrhythmias in patients requiring electrophysiological assessment.

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 (St. Jude Medical, Daig Division)

Submission Summary (Full Text)

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| | JUL - 3 2001 | 510(k) Summary<br>(As required by 21 CFR 807.92) |
|----|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| A. | Submitter Information | |
| | Submitter's Name: | St. Jude Medical, Daig Division |
| | Address: | 14901 DeVeau Place<br>Minnetonka, Minnesota 55345-2126 U.S.A. |
| | Telephone Number: | [phone] |
| | Contact Person: | Angela Byland |
| | Date Submission Prepared: | June 6, 2001 |
| B. | Device Information | |
| | Common or Usual Name: | Evaluator™ Electrophysiology Catheter |
| | Classification Name: | Electrode Recording Catheter |
| | Predicate Device: | Response™ Electrophysiology Catheter<br>St. Jude Medical, Daig Division |
| | Device Description: | The Evaluator™ Electrophysiology Catheter is a fixed-<br>curve, electrode recording catheter with ring electrodes<br>that are electrically coupled to conductor wires to pace<br>the heart and sense and record bipolar intracardiac<br>electrograms. |
| | Intended Use: | The St. Jude Medical electrophysiology catheters can be<br>used in the evaluation of a variety of cardiac<br>arrhythmias. |

## C. Comparison of Required Technological Characteristics

All technological characteristics of the Evaluator™ Electrophysiology Catheters are substantially equivalent to the predicate device including product design, sterilization, and labeling.

## Support of the Substantial Equivalence D.

St. Jude Medical, Daig Division considers the Evaluator™ Electrophysiology Catheters to be substantially equivalent to the predicate device, Response™ Electrophysiology Catheters.

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Image /page/1/Picture/11 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 3 2001

Ms. Angela Byland Senior Regulatory Affairs Manager St. Jude Medical, Daig Division 14901 DeVeau Place Minnetonka, MN 55345

Re: K011766

Trade Name: Evaluator™ Electrophysiology Catheter Regulation Number: 870.1220 Regulatory Class: II (two) Product Code: 74 DRF Dated: June 6, 2001 Received: June 7, 2001

Dear Ms. Byland:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish

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## Page 2 - Ms. Angela Byland

further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Dak Telle

James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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______________________________________________________________________________________________________________________________________________________________________________ Page _________________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

St. Jude Medical, Daig Division™ Electrophysiology Catheter (Evaluator™) Device Name:

Indications for Use:

The St. Jude Medical electrophysiology catheters can be used in the evaluation of a variety of cardiac arrhythmias.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)


Division of Cardiovascular & Respiratory Devices

| 510(k) Number | R011766 |
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| Prescription Use<br>(Per 21 CFR 801.109) | <img alt="check" src="check"/> | OR | Over-The-Counter Use<br>(Optional Format 1-2-96) |
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