REFLEXION SPIRAL VARIABLE RADIUS CATHETER, MODEL 402804

K062251 · St Jude Medical · DRF · Oct 20, 2006 · Cardiovascular

Device Facts

• Record ID: K062251
• Device Name: REFLEXION SPIRAL VARIABLE RADIUS CATHETER, MODEL 402804
• Applicant: St Jude Medical
• Product Code: DRF · Cardiovascular
• Decision Date: Oct 20, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1220
• Device Class: Class 2

Intended Use

The Reflexion Spiral catheter can be used for recording intracardiac signals and for cardiac stimulation during electrophysiology studies. The Reflexion Spiral catheter is to be used to map the atrial regions of the heart.

Device Story

Reflexion Spiral Variable Radius Catheter is a flexible, asymmetric, bi-directional, radiopaque loop electrophysiology catheter. Device features a polymer shaft with platinum electrodes and a ComfortGrip proximal handle. Handle contains a shaft actuator for varying sweep (90°) and curl (180°) of the distal shaft, and a loop actuator for adjusting loop diameter (15mm to 25mm). Used by physicians in clinical electrophysiology settings to record intracardiac signals and provide cardiac stimulation for mapping atrial heart regions. Output consists of electrical signals transmitted via a proximal connector to external recording/stimulation equipment. Device enables precise positioning and mapping of atrial tissue to assist in diagnosing or treating cardiac arrhythmias.

Clinical Evidence

Bench testing conducted per FDA 'Electrode Recording Catheter Preliminary Guidance' (1995) and ISO 10555-1. Results demonstrate conformance to standards and reliable performance. No clinical human data provided.

Technological Characteristics

Polymer shaft with platinum electrodes; bi-directional, variable radius loop design. Proximal handle with mechanical actuators for sweep, curl, and loop diameter control. Radiopaque. Sterile, single-use. No software or electronic processing components.

Indications for Use

Indicated for patients undergoing electrophysiology studies requiring intracardiac signal recording and cardiac stimulation, specifically for mapping atrial regions 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

• Irvine Biomedical, Inc., (IBI) Inquiry™ Optima™ Steerable Electrophysiology Catheter (K042775)

Submission Summary (Full Text)

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# 510(k) Summary

As required by 21 CFR 807.92(c)

KO62251 510(k) Number: _

OCT 2 0 2006

#### Date Prepared:

August 2, 2006

#### 1. Submitter Information:

| Submitter's Name/<br>Address: | St. Jude Medical<br>14901 DeVeau Place<br>Minnetonka, MN 55345-2126 |
|-------------------------------|---------------------------------------------------------------------|
| Contact Person: | Glenn Jacques<br>Regulatory Affairs Manager |

#### 2. Device Information:

| Trade Name: | Reflexion Spiral™ Variable Radius Catheter |
|----------------------|-------------------------------------------------------------|
| Common Name: | Catheter, electrode recording |
| Classification Name: | Catheter, electrode recording or probe, electrode recording |
| Class: | Class II, 21 CFR 870.1220, Product Code DRF |

Tel: [phone] Fax: [phone] [e-mail]

#### 3. Predicate Device:

Irvine Biomedical, Inc., (IBI) Inquiry™ Optima™ Steerable Electrophysiology Catheter (K042775)

## 4. Device Description:

The St. Jude Medical (SJM) Reflexion Spiral™ Variable Radius Catheter (Reflexion Spiral catheter) is a flexible, asymmetric, bi-directional, radiopaque variable radius loop electrophysiology catheter constructed of a polymer shaft that incorporates platinum electrodes.

The Reflexion Spiral catheter has a proximal handle (ComfortGrip™) that contains: 1) A shaft actuator mechanism for varying the asymmetrical sweep (90° sweep) and curl (180° curl) of the distal portion of the shaft. 2) A loop actuator mechanism for varying the loop diameter from approximately 25mm to approximately 15mm. 3) An electrical connector fitted into the proximal end of the handle.

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## 5. Indications for Use:

The Reflexion Spiral catheter can be used for recording intracardiac signals and for cardiac stimulation during electrophysiology studies. The Reflexion Spiral catheter is to be used to map the atrial regions of the heart.

## 6. Statement of how the technological characteristics of the device compare to those of the predicate or legally marketed device:

The Reflexion Spiral catheter and the predicate IBI Inquiry™ Optima™ catheter are both intended for electrogram recording and stimulation during electrophysiological studies. The different proximal handles show equivalent performance of the loop radius control and sweep/curl positioning control and does not affect the intended use or the scientific technology of the device.

## 7. Brief summary of non-clinical tests and results:

The test plan for the Reflexion Spiral catheter was based on FDA Guidance "Electrode Recording Catheter Preliminary Guidance, Draft Version," March 1995 and ISO 10555-1, Sterile Single-Use Intravascular Catheters Part 1: General Requirements. The test results indicate conformance to the standards and reliable performance when used in conformance with the device Instructions for Use. The Reflexion Spiral catheter does not raise any new issues of safety, effectiveness or performance of the device.

#### 8. Statement of Equivalence:

Through the comparison data, the equivalence evaluation, and supporting bench and animal data, SJM considers the Reflexion Spiral™ Variable Radius Catheter to be substantially equivalent to the Irvine Biomedical, Inc. Inquiry™ Optima™ Steerable Electrophysiology Catheter.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## OCT 2 0 2006

St. Jude Medical Atrial Fibrillation Division c/o Mr. Glenn Jacques Regulatory Affairs Manager 14901 DeVeau Place Minnetonka MN 55345

Re: K062251

Trade/Device Name: Reflexion Spiral Variable Radius Catheter, Model 402804 Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter or Electrode Recording Probe Regulatory Class: II Product Code: DRF Dated: August 2, 2006 Received: August 4, 2006

Dear Mr. Jacques:

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 market to in intristate 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, Dr ug 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, istin gof 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, IDA max 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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

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Page 2 - Mr. Glenn Jacques

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 varied to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,

Bhimmar for
Dr. D. Zochowski, M.D.

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

510(K) Number (if known): _K 06225 | _________________________________________________________________________________________________________________________________________

Device Name: Reflexion Spiral™ Variable Radius Catheter

Indications for Use:

The Reflexion Spiral™ catheter can be used for recording intracardiac signals and for cardiac stimulation during electrophysiology studies. The Reflexion Spiral™ catheter is to be used to map the atrial regions of the heart.

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)

Bhimnima

(Division Sign-Off) Division of Cardiovascular Devices 510(k) Nu

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