CORDIS WEBSTER FIXED CURVE CATHETERS, MODELS D-1124, D-1085

K992965 · Cordis Webster, Inc. · DRF · Nov 26, 1999 · Cardiovascular

Device Facts

• Record ID: K992965
• Device Name: CORDIS WEBSTER FIXED CURVE CATHETERS, MODELS D-1124, D-1085
• Applicant: Cordis Webster, Inc.
• Product Code: DRF · Cardiovascular
• Decision Date: Nov 26, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1220
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The intended use of the Fixed Curve Catheter is to map cardiac structures using stimulation and recording techniques.

Device Story

Fixed Curve Catheter used for electrophysiology mapping of cardiac structures. Device inputs include electrical signals from cardiac tissue; device facilitates stimulation and recording of cardiac electrical activity. Used in clinical settings by physicians. Output consists of electrophysiological data used by clinicians to map cardiac structures and guide clinical decision-making. Benefits include diagnostic mapping capabilities in both adult and pediatric (4+ years) populations.

Clinical Evidence

No clinical trials performed. Evidence consists of bench testing (pull strength) and physician testimonials regarding clinical experience with smaller French size catheters in pediatric patients.

Technological Characteristics

Fixed curve catheter design. Technological characteristics unchanged from predicate. No specific materials or software algorithms described.

Indications for Use

Indicated for electrophysiology mapping of cardiac structures in adults and children 4 years of age and older; limited to stimulation and recording only.

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.

Submission Summary (Full Text)

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## Appendix A: 510(k) Summary of Safety and Effectiveness, Continued

| Intended use | The intended use of the Fixed Curve Catheter is to map cardiac structures<br>using stimulation and recording techniques. |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications<br>statement | The Cordis Webster Fixed Curve Catheter is indicated for electrophysiology<br>mapping of cardiac structures in adults and children 4 years of age and older;<br>i.e. stimulation and recording only. |
| Technological<br>characteristics | The technological characteristics of the Subject device have not changed due<br>to the addition of the pediatric indication. |
| Performance<br>data | Capability testing was performed to ensure adequate pull strength. All<br>samples passed the acceptance criteria. Performance data was provided as the<br>number of complaints versus the number of units sold. Further, three letters<br>from physicians were included as they discuss their clinical experience with<br>the absence of adverse events by using smaller French size catheters in<br>pediatric patients. |
| Conclusion | Based on the 510(k) summaries and the 510(k) statements (21 CFR §807) and<br>the information provided herein, we conclude that the Subject device is<br>substantially equivalent to the same Predicate Device under the Federal Food,<br>Drug and Cosmetic Act. |
| Contact | Mary Adams<br>Regulatory Affairs Manager<br>Cordis Webster, Inc.<br>4750 Littlejohn Street<br>Baldwin Park, CA 91706 |
| Date | September 1, 1999<br>*CORDIS WEBSTER, INC. - STRICTLY CONFIDENTIAL*<br>30 |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 26 1999

Ms. Nanette Canepa Requlatory Affairs Associate Cordis Webster, Inc. 3333 Diamond Canyon Road Diamond Bar, CA 91765

Re : K992965 Cordis Webster Fixed Curve Catheters Requlatory Class: II (two) Product Code: DRF September 1, 1999 Dated: Received: September 2, 1999

Dear Ms. Canepa:

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 leqally 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, Druq, 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 (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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 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.

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## Page 2 - Ms. Nanette Canepa

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial in your 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 Also, please note the regulation entitled, [phone]. "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,

Celia M. Witten, Ph.D.

lia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Appendix B: Indications for Use Statement

Statement

Indications for Use Statement:

510(k) Number: K 992965

Device Name: Fixed Curve Catheter

Indications for Use: The Cordis Webster Fixed Curve Catheter is indicated for electrophysiology mapping of cardiac structures in adults and children 4 years of age and older; i.e. stimulation and recording only.

N. Dale Tiller

(Divis Division of Ca and Neurologica 510k) Num

**Prescription Use**
(Per 21 CFR 801.109)