REPROCESSED EP TECHNOLOGIES ELECTROPHYSIOLOGY CATHETERS

K043393 · Alliance Medical Corp. · NLH · Mar 23, 2005 · Cardiovascular

Device Facts

• Record ID: K043393
• Device Name: REPROCESSED EP TECHNOLOGIES ELECTROPHYSIOLOGY CATHETERS
• Applicant: Alliance Medical Corp.
• Product Code: NLH · Cardiovascular
• Decision Date: Mar 23, 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 electrophysiology 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 hand piece, flexible shaft, and distal tip with diagnostic electrodes; deflectable models allow tip curvature via hand piece manipulation. Reprocessing involves removal of adherent visible soil, decontamination, and functional testing of components prior to packaging/labeling. Used by clinicians in clinical settings. Device transmits electrical impulses to/from cardiac tissue; output used by physicians to diagnose cardiac electrical activity. Benefits include providing diagnostic data for cardiac mapping and stimulation.

Clinical Evidence

Bench testing only. Evidence includes validation of reprocessing, sterilization validation, biocompatibility testing, and functional testing of device components to ensure performance equivalent to original devices.

Technological Characteristics

Diagnostic electrode catheter; hand piece, flexible shaft, distal tip with electrodes. Deflectable tip mechanism. Materials and mechanical design identical to original predicate devices. Reprocessed via cleaning and decontamination. Sterilization validation performed.

Indications for Use

Indicated for temporary intracardiac sensing, recording, stimulation, and electrophysiology 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

• Steerocath Dx (K924109)
• Polaris LE (K924163)
• Polaris X (K003452)
• Electrode Recording Catheter (K954651)
• Reprocessed Electrophysiology Catheters (K012708)

Submission Summary (Full Text)

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K043393
1 of 2

# SECTION B: 510(k) SUMMARY

10232 South 5 Ist Street Phoenix, Arizona 85044

TEL [phone] FAX 480,763,5310 Toll Free 888.888.3433 www.alliance-medical.com

| Submitter: | Alliance Medical Corporation<br>10232 South 51st Street<br>Phoenix, Arizona 85044 |
|------------|-----------------------------------------------------------------------------------|
| Contact: | Jenn Selvey |

Research and Development Specialist [phone] (o) [phone] (f) [e-mail]

November 16, 2004 Date of preparation:

Trade/Proprietary Name: Reprocessed EP Technologies Name of device: Electrophysiology Catheters Common or Usual Name: Electrophysiology Catheter or Electrode Recording Catheter Classification Name: Electrode Recording Catheter

MAR 2 3 2005

## Predicate device:

| K924109 | Steerocath Dx |
|---------|-----------------------------------------|
| K924163 | Polaris LE |
| K003452 | Polaris X |
| K954651 | Electrode Recording 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 hand piece, a flexible shaft and a distal tip section containing diagnostic electrodes. The distal tip of deflectable catheters can be deflected into a curve by manipulating the hand piece.

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

The design, materials, and intended use of Reprocessed Technological Electrophysiology Catheters are identical to the predicate characteristics: devices. The mechanism of action of Reprocessed

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

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Electrophysiology Catheters is identical to the predicate devices in that the same standard mechanical design, marerials 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 EP Technologies 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.

Bench and laboratory testing was conducted to demonstrate Performance data: performance (safety and effectiveness) of the Reprocessed Electrophysiology (EP) Catheters.

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

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

Alliance Medical Corporation concludes that the modified device Conclusion: (the Reprocessed Electrophysiology Catheter) is safe, effective and substantially equivalent to the predicate devices as described herein.

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Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol is a stylized representation of an eagle with three lines forming its body and wings, conveying a sense of motion and progress.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 3 2005

Alliance Medical Corporation c/o Ms. Jenn Selvey Research and Development Specialist 10232 South 51st Street Phoenix, AZ 85044

Re: K043393

K043393
Trade Name: Reprocessed EP Technologies Electrophysiology Catheters (See Enclosed List)
Trade Name: Reprocessed EP Technologies Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: NLH Dated: January 19, 2005 Received: January 21, 2005

Dear Ms. Selvey:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Section 910(x) press.) presidentially equivalent (for the indications for use stated in the enclosure) the aveced predicate devices marketed in interstate for use stated in the encrosure) to regally manative in commerce prior to May 20, 1770, the enascance with the provisions of the Federal Food, Drug, devices that have bech recalismed in asserval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval applicati and Cosment Act (Act) that do not require subject to the general controls provisions of the Act. The Act. The You may, therefore, market the act include requirements for annual registration, listing of general controls provisions of the fiel labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), it If your device is classified (500 abs. 19) ins. Existing major regulations affecting your device can hiay be subject to such additional controller. Entroller of the 21, Parts 800 to 898. In addition, FDA may the found in the Gods acements concerning your device in the Federal Register.

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Page 2 - Ms. Jenn Selvey

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualled of a budenice complies with other requirements of the Act that I DA has made a determination administered by other Federal agencies. You must of ally reachardes and regularents aincluding, but not limited to: registration and listing (21 Comply with an the Hot 810 CFR Part 801); good manufacturing practice requirements as set CTN Fart 807), rabeing (21 OFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control pro horoms (seting your device as described in your Section 510(k) This icher wifi anow you to oegin maining of substantial equivalence of your device to a legally premarket notification: "The PDA mailing of basification 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 If you desire specific acrisoliation of [phone] Also, please note the regulation entitled, Connect the Office of Comparket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general 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,

B. Limmer 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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## Page 3 – Ms. Jenn Selvey

Г

..

| Orig models found to be SE |
|--------------------------------|
| EPT-Dx (5) |
| 1101 |
| 1102 |
| 1103 |
| 1300 |
| 1301 |
| Valve Mapper SteeroCath-Dx (7) |
| 2200 |
| 2250 |
| 2270 |
| 2250K2 |
| 2270K2 |
| 2270L |
| 2270N4 |
| Polaris-Dx (15) |
| 5571 |
| 5572 |
| 5574 |
| 5570S |
| 5571S |
| 5572S |
| 5573S |
| 5574S |
| 5577 |
| 5579 |
| 5427S |
| 9663S |
| 5575 |
| 5576 |
| 5578 |
| Polaris LE Mapping (2) |
| 5593 |
| 5595 |

.

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### Indications for Use Statement 2.

**510(k) Number (if known):**

510(k) Number (if known):

Device Name: Alliance Medical Corporation Reprocessed EP Technologies Electrophysiology (EP) Catheters

Indications for Use: Reprocessed diagnostic EP catheters are indicated for Indications for ooking, recording, stimulation, and electrophysiology 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. Hummer

Division Sign-Of Division of Cardlovascular Devices 510(k) Number