RESPONSE ELECTROPHYSIOLOGY CATHETER, SUPREME ELECTROPHYSIOLOGY CATHETER, MODEL 401XXX AND 401XXX

K002976 · St Jude Medical · DRF · Dec 22, 2000 · Cardiovascular

Device Facts

• Record ID: K002976
• Device Name: RESPONSE ELECTROPHYSIOLOGY CATHETER, SUPREME ELECTROPHYSIOLOGY CATHETER, MODEL 401XXX AND 401XXX
• Applicant: St Jude Medical
• Product Code: DRF · Cardiovascular
• Decision Date: Dec 22, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1220
• Device Class: Class 2

Intended Use

Daig Electrophysiology Catheters can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.

Device Story

Diagnostic electrophysiology catheters (Response™ and Supreme™ models) used for mapping cardiac arrhythmias. Catheters feature various fixed curves and electrode spacings to facilitate signal acquisition from endocardial and intravascular sites. Operated by physicians in clinical settings to record electrical activity within the heart; output used to evaluate cardiac arrhythmias and guide clinical decision-making. Device design, materials, and sterilization are consistent with established predicate technology.

Clinical Evidence

No clinical data provided. Safety and effectiveness supported by cited published literature regarding the use of electrophysiology diagnostic catheters for evaluating cardiac arrhythmias.

Technological Characteristics

Diagnostic electrophysiology catheter with fixed curves and varying electrode spacings. Materials, design, and sterilization methods are equivalent to the predicate device. No electronic or software components described.

Indications for Use

Indicated for the evaluation of cardiac arrhythmias from endocardial and intravascular sites in patients requiring electrophysiological mapping.

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

• Electrophysiology Catheter (DAIG Corporation)

Submission Summary (Full Text)

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|K002976

DEC 22 2000

510(k) Summary (as required by 21 CFR 807.92)

## A. Submitter Information

Submitter’s Name: St. Jude Medical, DAIG Division

Address: 14901 DeVeau Place
Minnetonka, Minnesota 55345-2126 U.S.A.

Telephone Number: [phone]

Contact Person: Dean Bruhn-Ding

Date Submission Prepared: September 22, 2000

## B. Device Information

Common or usual Name: Diagnostic Electrophysiology Catheter

Classification Name: Catheter, Electrode Recording

Predicate Device: Electrophysiology Catheter
DAIG Corporation

Device Description/Intended Use: The electrophysiology catheters are manufactured in various fixed curves and electrode spacings for electrophysiological mapping for the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.

Indications for Use: DAIG Electrophysiology Catheters can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.

## C. Comparison of Required Technological Characteristics

All technological characteristics of the DAIG Response™ and Supreme™ Electrophysiology Catheters are substantially equivalent to the predicate DAIG Electrophysiology Catheter including product design, materials, packaging, and sterilization.

Electrophysiology Catheters
St. Jude Medical, DAIG Division, September 2000

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## D. Performance Data

Related published literature was cited to show Safety and Effectiveness of the use of electrophysiology diagnostic catheters to evaluate cardiac arrhythmias from endocardial and intravascular sites.

## E. Conclusion

St. Jude Medical, Daig Division considers the subject devices to be substantially equivalent to the same predicate device: the DAIG Electrophysiology Catheter, a legally marketed device.

Electrophysiology Catheters
St. Jude Medical, DAIG Division, September 2000

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration
2098 Gaither Road
Rockville MD 20850

# DEC 22 2000

Mr. Dean Bruhn-Ding
St. Jude Medical
Daig Division
14901 Deveau Place
Minnetonka, MN 55345

Re: K002976
Trade Name: Daig EP Mapping Catheters
Regulatory Class: II (two)
Product Code: DRF
Dated: September 22, 2000
Received: September 25, 2000

Dear Mr. Bruhn-Ding

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 (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

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Page 2 - Mr. Dean Bruhn-Ding

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,


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

Enclosure

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Page 1 of 1

510(K) Number (if known): K002976

Device Name: **Daig Electrophysiology Catheter – Response™ and Supreme™**

Indications for Use:

Daig Electrophysiology Catheters can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (per 21 CFR 801.109)

OR

Over-The-Counter Use (Optional Format 1-2-96)