REPROCESSED ELECTROPHYSIOLOGY CATHETERS

K061045 · Alliance Medical Corp. · NLH · Aug 31, 2006 · Cardiovascular

Device Facts

• Record ID: K061045
• Device Name: REPROCESSED ELECTROPHYSIOLOGY CATHETERS
• Applicant: Alliance Medical Corp.
• Product Code: NLH · Cardiovascular
• Decision Date: Aug 31, 2006
• 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 electrophysiology mapping of cardiac structures.

Device Story

Diagnostic EP catheters; hand piece, flexible shaft, distal tip with electrodes; deflectable tip models available. Device used for temporary intracardiac sensing, recording, stimulation, and mapping of cardiac structures. Physician operates device to position electrodes endocardially. Reprocessing involves removal of adherent visible soil, decontamination, and functional testing of components. Device provides electrical signal transmission for diagnostic purposes; aids clinical decision-making regarding cardiac electrophysiology.

Clinical Evidence

Bench testing only. Testing included biocompatibility, reprocessing validation, sterilization validation, function tests, and packaging validation to demonstrate safety and effectiveness.

Technological Characteristics

Electrode recording catheter; hand piece, flexible shaft, distal tip electrodes. Deflectable tip mechanism. Reprocessed device utilizes same materials and mechanical design as predicate. Sterilization validation performed.

Indications for Use

Indicated for temporary intracardiac sensing, recording, stimulation, and electrophysiological mapping of cardiac structures.

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

• CardioRhythm's Torqr Catheters (K915563)

Submission Summary (Full Text)

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K061045
p 1/2

AUG 3 1 2006

# PART 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: | April 5, 2006 |
| Name of device: | Trade/Proprietary Name: Reprocessed Electrophysiology<br>Catheters<br>Classification Name: Reprocessed Electrode Recording<br>Catheter |

| Predicate Device | 510(k) Title | Manufacturer |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| K915563 | CardioRhythm's Torqr Catheters | CardioRhythm/Medtronic |
| Device description: | Diagnostic Electrophysiology (EP) Catheters are specially<br>designed electrode catheters that transmit electrical impulses<br>and can be positioned for endocardial recording or stimulation.<br>Diagnostic EP catheters incorporate a hand piece, a flexible<br>shaft and a distal tip section containing diagnostic electrodes.<br>The distal tip of deflectable catheters can be deflected into a<br>curve by manipulating the hand piece. | |
| Intended use: | Reprocessed Electrophysiology Catheters are intended for<br>temporary intracardiac sensing, recording, stimulation, and<br>electrophysiology mapping of cardiac structures. | |
| Indications<br>statement: | Reprocessed Electrophysiology Catheters are indicated for<br>temporary intracardiac sensing, recording, stimulation and<br>electrophysiological mapping of cardiac structures. | |
| Technological<br>characteristics: | The design, materials, and intended use of Reprocessed<br>Electrophysiology Catheters are identical to the predicate<br>devices. The mechanism of action of Reprocessed<br>Electrophysiology Catheters is identical to the predicate devices<br>in that the same standard mechanical design, materials, and<br>sizes are utilized. There are no changes to the claims, intended<br>use, clinical applications, patient population, performance<br>specifications, or method of operation. In addition, Alliance<br>Medical Corporation's reprocessing of Endoscopic<br>Electrophysiology Catheters includes removal of adherent<br>visible soil and decontamination. Each individual<br>Electrophysiology Catheters is tested for appropriate function of | |

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its components prior to packaging and labeling operations.

#### Performance data: Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of Reprocessed Electrophysiology Catheters. This included the following tests:

- . Biocompatibility
- Validation of reprocessing .
- . Sterilization Validation
- . Function test(s)
- . Packaging Validation

Performance testing demonstrates that Reprocessed Electrophysiology Catheters perform as originally intended.

Conclusion: Alliance Medical Corporation concludes that the modified devices (Reprocessed Electrophysiology Catheters) are 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 logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## AUG 3 1 2006

Ascent Healthcare Solutions c/o Ms. Elizabeth Renken Regulatory Affairs Specialist 10232 South 51st Street Phoenix, Arizona 85044

Re: K061045

Trade Name: Reprocessed Electrophysiology Catheters (See Attached List) Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter or Electrode Recording Probe Regulatory Class: II (two) Product Code: NLH Dated: August 4, 2006 Received: August 8, 2006

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 for and in 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,

Brimmerfor

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosures (2)

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Page 3 - Ms. Elizabeth Renken ,

:

## Device Models Found SE:

- - -:

| Medtronic ==================================================================================================================================================================== |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Torqr® CS Fixed Curve |
| Decapolar Coronary Sinus |
| Catheter |
| 041265CS |
| 041290CS |
| 041565CS |
| 041865CS |
| 041590CS |
| 041890CS |

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#### 2. Indications for Use Statement

510(k) Number (if known):

K061045

Device Name: Reprocessed Electrophysiology Catheters

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

Prescription Use × AND/OR (Part 21 CFR 801 Subpart D)

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)

Bikmuma

(Divisish Sign-Off) Division of Cardlovascular Deyloes 510(k) Number Knli/045

Alliance Medical Corporation Reprocessed Electrophysiology Catheters Traditional 510(k)