REPROCESSED DAIG LIVEWIRE ELECTROPHYSIOLOGY CATHETERS

K052603 · Alliance Medical Corp. · NLH · Nov 16, 2005 · Cardiovascular

Device Facts

• Record ID: K052603
• Device Name: REPROCESSED DAIG LIVEWIRE ELECTROPHYSIOLOGY CATHETERS
• Applicant: Alliance Medical Corp.
• Product Code: NLH · Cardiovascular
• Decision Date: Nov 16, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1220
• Device Class: Class 2

Intended Use

Reprocessed Electrophysiology Catheters are intended for temporary intracardiac sensing, recording, stimulation, and electrophysiological mapping of cardiac structures.

Device Story

Reprocessed diagnostic electrophysiology (EP) catheters; used for temporary intracardiac sensing, recording, stimulation, and mapping of cardiac structures. Device consists of handpiece, flexible shaft, and distal tip with diagnostic electrodes; deflectable models allow curve manipulation via handpiece; fixed curve models have established shape. Used by clinicians in clinical settings. Reprocessing involves removal of adherent visible soil and decontamination of previously used catheters; each unit undergoes functional testing prior to packaging and labeling. Output is electrical signal transmission for cardiac mapping; assists physicians in diagnosing cardiac arrhythmias and guiding clinical decision-making.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included biocompatibility, reprocessing validation, sterilization validation, packaging validation, and functional testing to confirm performance equivalent to original devices.

Technological Characteristics

Electrode recording catheter; consists of handpiece, flexible shaft, and distal tip electrodes. Mechanical design, materials, and sizes identical to predicate devices. Manual operation for deflection or fixed-curve positioning. Non-powered (passive sensing/stimulation). Sterilization process validated as part of reprocessing.

Indications for Use

Indicated for temporary intracardiac sensing, recording, stimulation, and electrophysiological mapping of cardiac structures in patients requiring electrophysiological evaluation.

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

• Daig Electrophysiology Catheter (K894500)
• Daig Diagnostic Electrophysiology Catheter (K942379)
• Reprocessed Electrophysiology Catheters (K012708)

Submission Summary (Full Text)

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KD52603

NOV 1 6 2005

# SECTION B: 510(k) SUMMARY

| Submitter: | Alliance Medical Corporation<br>10232 South 51st Street<br>Phoenix, Arizona 85044 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Elizabeth Renken<br>Regulatory Affairs Specialist<br>[phone] (o)<br>[phone] (f)<br>[e-mail] |
| Date of preparation: | September 9, 2005 |
| Name of device: | Trade/Proprietary Name: Reprocessed Electrophysiology<br>Catheters<br>Common or Usual Name: Electrophysiology Catheter or<br>Electrode Recording Catheter<br>Classification Name: Electrode Recording Catheter |

Predicate device:

| K Number | Device Description |
|----------|--------------------------------------------|
| K894500 | Daig Electrophysiology Catheter |
| K942379 | Daig Diagnostic Electrophysiology Catheter |
| K012708 | Reprocessed Electrophysiology Catheters |

Device description: Diagnostic electrophysiology (EP) catheters are specially designed electrode catheters that transmit electrical impulses and can be positioned for endocardial recording or stimulation. Diagnostic EP catheters incorporate a handpiece, a flexible shaft and a distal tip section containing diagnostic electrodes. The distal tips of deflectable catheters can be deflected into a curve by manipulating the handpiece; fixed curve catheters have an established distal tip shape.

- Intended use: Reprocessed Electrophysiology Catheters are intended for temporary intracardiac sensing, recording, stimulation, and electrophysiological mapping of cardiac structures.
- Indications Reprocessed diagnostic EP catheters are indicated for statement: temporary intracardiac sensing, recording, stimulation and electrophysiological mapping of cardiac structures.

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Image /page/1/Picture/0 description: The image shows a handwritten number, which appears to be "2052603". The numbers are written in a simple, slightly irregular style. The digits are spaced closely together, and the overall impression is that of a quickly written or informal number.

| Technological characteristics: | The design, materials, and intended use of Reprocessed Electrophysiology (EP) Catheters are identical to the predicate devices. The mechanism of action of Reprocessed Electrophysiology (EP) Catheters is identical to the predicate devices in that the same standard mechanical design, materials and sizes are utilized. There are no changes to the claims, intended use, clinical applications, patient population, performance specifications, or method of operation. |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Alliance Medical Corporation's reprocessing of electrophysiology catheters includes removal of adherent visible soil and decontamination. Each individual electrophysiology catheter is tested for appropriate function of its components prior to packaging and labeling operations. |
| | Alliance Medical Corporation's reprocessing of EP Catheters includes removal of adherent visible soil and decontamination. Each individual EP Catheter is tested for appropriate function of its components prior to packaging and labeling operations. |
| Performance data: | Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of the Reprocessed EP Catheter. |
| | <ul><li>Biocompatibility</li><li>Validation of reprocessing</li><li>Sterilization Validation</li><li>Function test(s)</li><li>Packaging Validation</li></ul> |
| | Performance testing demonstrates that Reprocessed EP Catheters perform as originally intended. |
| Conclusion: | In accordance with the Federal Food, Drug and Cosmetic Act 21 CFR Part 807 and based on the information provided in this premarket notification, Alliance Medical Corporation concludes that the modified device (the Reprocessed Electrophysiology (EP) Catheter) is safe, effective and substantially equivalent to the predicate devices as described herein. |

:

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 6 2005

Alliance Medical Corporation c/o Ms. Elizabeth Renken Regulatory Affairs Specialist 10232 South 51st Street Phoenix, AZ 85044

Re: K052603

Trade Name: Reprocessed Electrophysiology Catheters (See Enclosed List) Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter or Electrode Recording Probe Regulatory Class: Class II Product Code: NLH Dated: September 13, 2005 Received: September 21, 2005

Dear Ms. Renken:

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 - Ms. Elizabeth Renken

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 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 your device 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,

B.Jiminmarfor

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 3 – Ms. Elizabeth Renken

### List of Models:

| St. Jude Live Wire™ Steerable<br>Diagnostic Catheters |
|-------------------------------------------------------|
| 401575 |
| 401576 |
| 401577 |
| 401578 |
| 401579 |
| 401580 |
| 401581 |
| 401582 |
| 401586 |
| 401587 |
| 401588 |
| 401600 |
| 401603 |
| 401606 |
| 401652 |
| 401653 |
| 401654 |
| 401904 |
| 401905 |
| 401914 |
| 401915 |
| 401918 |
| 401923 |
| 401926 |
| 401932 |
| 401933 |
| 401934 |
| 401572 |
| 401908 |
| 401917 |
| 401938 |
| 401939 |
| 401940 |
| 401941 |
| 401949 |
| 401990 |
| 401991 |

-

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## Indications for Use

510(k) Number (if known): K052603

Device Name: Reprocessed Electrophysiology Catheters

Indications For Use: Reprocessed Electrophysiology (EP) Catheters are indicated for temporary intracardiac sensing, recording, stimulation and electrophysiological mapping of cardiac structures.

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

B. Bhumima
Sign-Off

ardlovascular Devices

iance Medical Corporation Reprocessed EP C: Traditional 510/k

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