REPROCESSED ELECTROPHYSIOLOGY CATHETERS

K043392 · Alliance Medical Corp. · NLH · Mar 25, 2005 · Cardiovascular

Device Facts

• Record ID: K043392
• Device Name: REPROCESSED ELECTROPHYSIOLOGY CATHETERS
• Applicant: Alliance Medical Corp.
• Product Code: NLH · Cardiovascular
• Decision Date: Mar 25, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1220
• Device Class: Class 2

Intended Use

Reprocessed Electrophysiology (EP) Catheters are indicated 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 electrodes; deflectable models allow curve manipulation via handpiece; fixed curve models have established shape. Reprocessing involves removal of adherent visible soil and decontamination of previously used catheters. Each unit undergoes functional testing prior to packaging and labeling. Used by clinicians in clinical settings for cardiac electrophysiology procedures. Benefits include providing diagnostic data for cardiac rhythm management and mapping.

Clinical Evidence

Bench testing only. Evidence includes biocompatibility testing, validation of the reprocessing procedure, sterilization validation, functional testing of components, and packaging validation to ensure safety and effectiveness.

Technological Characteristics

Catheter with handpiece, flexible shaft, and distal electrode tip. Available in deflectable and fixed-curve configurations. Reprocessing includes cleaning and decontamination. Sterilization validation performed. Design and materials identical to original predicate devices.

Indications for Use

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

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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K04239?

Image /page/0/Picture/1 description: The image shows a logo for Alliance Medical Corporation. The logo consists of three curved lines above the word "ALLIANCE" in a sans-serif font. Below the word "ALLIANCE" is the phrase "MEDICAL CORPORATION" in a smaller font.

MEDICAL CORPORATION

10232 South 51st Street Phoenix, Arizona 85044

TEL [phone] FAX [phone] oll Free 888.888.3433 iance-medical.com

| MAR 25 2003 |
|-------------|
|-------------|

## SECTION B: 510(k) SUMMARY

| | 10232 South 51st Street<br>Phoenix, Arizona 85044 | |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Contact: | Moira Barton<br>Regulatory Affairs Manager<br>[phone] (o)<br>[phone] (f)<br>[e-mail] | |
| Date of preparation: | December 6, 2004 | |
| 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 | |

Alliance Medical Corporation

## Predicate device:

Submitter:

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

Diagnostic electrophysiology (EP) catheters are specially Device description: 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. Reprocessed Electrophysiology Catheters are intended for Intended use: temporary intracardiac sensing, recording, stimulation, and electrophysiological mapping of cardiac structures. Reprocessed diagnostic EP catheters are indicated for Indications

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| 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. |

:

the predicate devices as described herein.

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Image /page/2/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.

MAR 2 5 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Alliance Medical Corporation c/o Ms. Moira Barton Regulatory Affairs Manager 10232 South 51st Street Phoenix, AZ 85044

## Re: K043392

K043392
Trade Name: Reprocessed Electrophysiology Catheters (See Enclosed List)
Trade Name: Reprocessed Electrophysiology Catheters (See Enclosed List) Regulation Number: 21 CFR 870.1220 Regulation Number: 21 CFN 870.1220
Regulation Name: Electrode Recording Catheter or Electrode Recording Probe
Seconding Name: Electrode Recording Catheter or Electrode Rec Regulatory Class: Class II Product Code: NLH Dated: January 19, 2005 Reccived: January 21, 2005

Dear Ms. Barton:

We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 910(x) premained in substantially equivalent (for the indications
referenced above and have determined the device is substantial in interstate referenced above and nave decemblic the arrest received ate devices marketed in interstate for use stated in the encrosule) to regally manced promotion Device Americans, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food. Drug commerce prior to May 28, 1970, the chance with the provisions of the Federal Food. Drug, devices that have been reciassified in accordance while toper of a provide approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a provisions of and Cosmetic Act (Act) that do not require approval of the general controls provisions of the Act. The You may, therefore, market the device, successfor for annual registration, listing of
general controls provisions of the Act include requirements michaeading and general controls provisions of the rict merides requests of the summer misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), in If your device is classified (sec above) mis exist case regulations affecting your device can
may be subject to such additional controls. Existing major regulations EDA may may be subject to such additional controlls. Existing major segment of addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898 may be found in the Code of Peachar Regaring your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA 3 issumted on a bacevice complies with other requirements of the Act
that FDA has made a determination that your device complies with other require that FDA has made a decemmanon that your are received by other Federal agencies. You must

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Page 2 – Ms. Moira Barton

comply with all the Act's requirements, including, but not limited to: registration and listing (21 l comply with all the Act s requirements, nieras manufacturing practice requirements as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements CFR Part 807); labeling (21 CFR Part 800); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR 100); and if applicable, the electronic forth in the quality systems (Sections (Sections 531-542 of the Act); 21 CFR 100-1050.
product radiation control provisions (Sections 531-542 of the Action Section 2 product radiation control provisions (occuolis 95 = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = This letter will allow you to begin marketing your antial equivalence of your device to a legally premarket notification. The PDA mailing of subscribed on 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
s and the many of the many of any 1100 - All and case the regulation entitl If you desire specific advice for your ac no no no the more the regulation entitled, and the regulation entitled, a contact the Office of Complance at (210) 270 - 17 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 " Misbranding by reletence to premarket issuffication - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - other general information on your responsionnes and its toll-free number [phone] or
Manufacturers, International and Consumer Assistent (demonsin html Manufacturers, International and Consulter Piessenser Piessens of Carb/dsmamain.html

Sincerely yours,

B Sommer for

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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| St. Jude Daig LiveWire TM Steerable Diagnostic Catheter - 33- | | | | |
|---------------------------------------------------------------------------|--------|--------|--------|--------|
| Models | | | | |
| 401939 | 401933 | 401578 | 401580 | 401932 |
| 401940 | 401934 | 401586 | 401581 | - |
| 401938 | 401575 | 401587 | 401582 | - |
| 401941 | 401915 | 401588 | 401904 | - |
| 401600 | 401923 | 401583 | 401905 | - |
| 401603 | 401926 | 401584 | 401914 | - |
| 401572 | 401576 | 401585 | 401908 | - |
| 401606 | 401577 | 401579 | 401918 | - |

1000 Children

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## Indications for Use Statement 2.

510(k) Number (if known)

510(k) Number (if known): /K043392

Device Name: Alliance Medical Corporation 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
(per 21 CFR 801.109)

or

Over-the-Counter Use _ . .__

Concurrence of CDRH, Office of Device Evaluation (ODE)

B. Simmon

Division Sign-Off ular Devices Division of Cardlov 510(k) Number

> Alliance Medical Corporation Reprocessed EP Catheters Traditional 510(k)