LIVESIRE ELECTROPHYSIOLOGY CATHETER

K022380 · St Jude Medical · DRF · Oct 1, 2002 · Cardiovascular

Device Facts

• Record ID: K022380
• Device Name: LIVESIRE ELECTROPHYSIOLOGY CATHETER
• Applicant: St Jude Medical
• Product Code: DRF · Cardiovascular
• Decision Date: Oct 1, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1220
• Device Class: Class 2

Intended Use

The electrophysiology catheters are manufactured in various fixed and deflectable curve profiles and electrode spacings for electrophysiological mapping for the evaluation of a variety of cardiac arrhythmias from endocardial and intravacular sites.

Device Story

Livewire Electrophysiology Catheter is a diagnostic device used to map cardiac electrical activity. It features fixed or deflectable curve profiles and various electrode spacings. The catheter is inserted into the heart via endocardial or intravascular sites to record electrical signals. These signals are used by clinicians to evaluate cardiac arrhythmias. The device is intended for use by trained medical professionals in a clinical setting. It provides diagnostic information that assists in the identification and localization of arrhythmia sources, facilitating clinical decision-making regarding patient treatment.

Clinical Evidence

No clinical data provided. Safety and effectiveness were supported by cited published literature referenced in K002976.

Technological Characteristics

Diagnostic electrophysiology catheter with fixed or deflectable curve profiles and multiple electrode spacings. Materials, design, and sterilization methods are identical to the predicate device.

Indications for Use

Indicated for the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.

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)

Reference Devices

• K002976

Submission Summary (Full Text)

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K022380
page 1 of 2

# OCT 01 2002

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

#### Submitter Information A.

| Submitter's Name: | St. Jude Medical, DAIG Division |
|---------------------------|-----------------------------------------------------------------------------|
| Address: | 14900 Minnetonka Industrial Blvd<br>Minnetonka, Minnesota 55345-2126 U.S.A. |
| Telephone Number: | [phone] |
| Contact Person: | Jim M. Taufen |
| Date Submission Prepared: | 19-July-2002 |

#### B. Device Information

| Common or usual Name: | Diagnostic Electrophysiology Catheter |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification Name: | Catheter, Electrode Recording |
| Predicate Device: | Electrophysiology Catheter<br>DAIG Corporation |
| Device Description/Intended Use: | The electrophysiology catheters are manufactured in various<br>fixed and deflectable curve profiles and electrode spacings<br>for electrophysiological mapping for the evaluation of a<br>variety of cardiac arrhythmias from endocardial and<br>intravacular sites. |
| Indications for Use: | SJM-Daig Electrophysiology Catheters can be used in the<br>evaluation of a variety of cardiac arrhythmias from<br>endocardial and intravascular sites. |

#### C. Comparison of Required Technological Characteristics

All technological characteristics of the SJM-Daig Livewire Electrophysiology Catheters are substantially equivalent to the predicate SJM-Daig Electrophysiology Catheter including product design, materials, packaging, and sterilization.

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#### D. Performance Data

Related published literature was cited in K002976 to show Safety and Effectiveness of the use of electrophysiology diagnostic catheters to evaluate cardiac arrhythmias from endocardial and intravascular sites.

#### E. Conclusion

In accordance with the FDA guidance document entitled, "Deciding When to Submit a 510(k) for a Change to an Existing Device,' issued January 10, 1997; the new labeling is being submitted to FDA as part of a new 510(k) Change Being Effected. SJM-Daig intends to continue to market the Livewire device with the amended labeling.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure, with three distinct lines forming the body and wings. The bird is positioned within a circular frame, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 01 2002

St. Jude Medical c/o Mr. Jim M. Taufen Sr. Regulatory Affairs Specialist Daig Division 14901 DeVeau Place Minnetonka, MN 55345

Re: K022380

Trade Name: Livewire™ Electrophysiology Catheter Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter Regulatory Class: Class II (two) Product Code: DRF Dated: July 19, 2002 Received: July 22, 2002

Dear Mr. Taufen:

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 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, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Jim M. Taufen

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 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 Jetter 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 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 21 CFR Part 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

Kala Teth

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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Page

| 510(k) Number (if known): | K022380 |
|---------------------------|---------|
|---------------------------|---------|

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

### Indications for Use:

SJM-Daig electrophysiology catheters can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Cardiovascular & Respiratory Devices
510(k) Number K022380

Prescription Use (Per 21 CFR 801.109)

OR

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