REPROCESSED ELECTROPHYSIOLOGY CATHETER

K052414 · Alliance Medical Corp. · NLH · Nov 16, 2005 · Cardiovascular

Device Facts

• Record ID: K052414
• Device Name: REPROCESSED ELECTROPHYSIOLOGY CATHETER
• 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 electrophysiology mapping of cardiac structures.

Device Story

Diagnostic EP catheters; hand piece, flexible shaft, distal tip with electrodes; used for intracardiac sensing, recording, stimulation, and mapping. Physician-operated in clinical settings. Device transmits electrical impulses; deflectable tip controlled via hand piece. Reprocessing by Alliance Medical Corporation involves cleaning, decontamination, and functional testing of original EP Technologies catheters. Output is electrical signal data used by clinicians for cardiac mapping and diagnosis. Benefits include clinical utility of diagnostic catheters through a reprocessed, validated device.

Clinical Evidence

Bench testing only. Validation included biocompatibility, reprocessing validation, sterilization validation, functional testing, and packaging validation to demonstrate performance equivalent to original devices.

Technological Characteristics

Electrode recording catheter; flexible shaft with deflectable distal tip; hand piece control. Materials and design identical to original predicate devices. Sterilization and reprocessing protocols validated.

Indications for Use

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

• Steerocath Dx (K924109)
• Polaris LE (K924163)
• Polaris X (K003452)
• Electrode Recording Catheter (K954651)
• Reprocessed Electrophysiology Catheters (K012708)
• Reprocessed EP Technologies Electrophysiology Catheters (K043393)

Submission Summary (Full Text)

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# Kosa414

·

# 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: | August 26, 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: | |
| K924109<br>K924163<br>K003452<br>K954651<br>K012708<br>K043393 | Steerocath Dx<br>Polaris LE<br>Polaris X<br>Electrode Recording Catheter<br>Reprocessed Electrophysiology Catheters<br>Reprocessed EP Technologies Electrophysiology Catheters |
| 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 Diagnostic Electrophysiology Catheters are<br>indicated for temporary intracardiac sensing, recording,<br>stimulation, and electrophysiology mapping of cardiac<br>structures. |
| Technological<br>characteristics: | The design, materials, and intended use of Reprocessed<br>Electrophysiology Catheters are identical to the predicate |

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devices. The mechanism of action of Reprocessed Electrophysiology 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 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.

Performance data: Bench and laboratory testing was conducted to demonstrate 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.

#### Conclusion:

Alliance Medical Corporation concludes that the modified device (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/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted with three lines forming the wings and a snake-like form at the bottom. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular fashion around the caduceus.

Public Health Service

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: K052414

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: August 26, 2005 Received: September 2, 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 (OS) 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 vours,

B.Jimmumfor

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:

...

| EPT-Dx (5)<br>1101<br>1102<br>1103<br>1300<br>1301<br>Valve Mapper SteeroCath-Dx (7)<br>2200<br>2250<br>2270<br>2250K2<br>2270K2<br>2270L<br>2270N4<br>Polaris-Dx (15)<br>5571<br>5572<br>5574<br>55708<br>55718<br>55728<br>55738<br>5574S<br>5577<br>5579<br>54278<br>તેરણે તે જણાવતા વ્યવસાય ખેતી ખેતી કરવામાં આવેલું એક ગામના લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામના લોકોનો મુખ્યત્વે આ ગામના લોકોનો મુખ્ય વ્યવસાય ખેતી,<br>ર્રતત્<br>5576<br>5578<br>Polaris LE Mapping (2)<br>ર રેતે 3<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>ર રતેર<br>SteeroCath-Dx (2)<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>2027BL<br>and the same of the same of the same of the same of the same of the same of the states of the seat the states of the states of the states of the states of the states of the s<br>2028BL<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | EP Technologies, Inc., Mo |
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| ______________________________________________________________________________________________________________________________________________________________________________<br>and the same of the same of the same of the same of the same of the same of the states of the states of the states of the states of the states of the states of the states of<br>and the state of the state of the state of the states of the states of the states of the states of the states of the states of the states of the states of the states of the s | |
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# Indications for Use

510(k) Number (if known): K052414

Device Name: Reprocessed Electrophysiology Catheters

Indications For Use: Reprocessed Diagnostic Electrophysiology Catheters are indicated for temporary intracardiac sensing, recording, stimulation, and electrophysiology mapping of cardiac structures.

Prescription Use X (Part 21 CFR 801 Subpart D)

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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)

Blythman
Division Sign-Off

(Division Sign-Off) Division of Cardlovascular Deyloss 510(k) Number 4/5 。

> Alliance Medical Corporation Reprocessed Electrophysiology Catheter Traditional 510(k)

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