REPROCESSED ELECTROPHYSIOLOGY CATHETER

K030187 · Alliance Medical, Inc. · NLH · Sep 24, 2003 · Cardiovascular

Device Facts

• Record ID: K030187
• Device Name: REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Applicant: Alliance Medical, Inc.
• Product Code: NLH · Cardiovascular
• Decision Date: Sep 24, 2003
• 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 adjustment via handpiece; fixed-curve models maintain established shape. Operated by physicians in clinical settings during electrophysiology studies. Device transmits electrical impulses to/from cardiac tissue. Output viewed by clinicians on external monitoring/recording equipment to guide clinical decision-making regarding cardiac arrhythmias. Reprocessing involves removal of adherent soil, decontamination, and functional testing of components.

Clinical Evidence

Bench testing only. Evidence includes biocompatibility testing, validation of reprocessing procedures, sterilization validation, and functional testing of device components. No clinical data presented.

Technological Characteristics

Catheter with handpiece, flexible shaft, and distal electrode tip. Materials and mechanical design identical to predicate devices. Energy source: electrical (for sensing/stimulation). Connectivity: connects to external recording/stimulation equipment. Sterilization: validated reprocessing method.

Indications for Use

Indicated for temporary intracardiac sensing, recording, stimulation, and electrophysiological mapping of cardiac structures in patients undergoing electrophysiology studies.

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

• Bard Tip Deflecting Electrode Catheter (K891908)
• Bard Octapolar Electrode Catheter (K874208)
• Electrophysiology Electrode Catheter with Silver/Silver (K881966)
• Orbiter ST Diagnostic Electrode Catheter (K992373)

Submission Summary (Full Text)

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Image /page/0/Picture/10 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 2004

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

Re: K030187 - Supplemental Validation Submission Trade Name: See Enclosed List Regulation Number: 21 CFR 870.1220 & 870.2900 Regulation Name: Electrode Recording Catheter and Patient Transducer and Electrode Cable (including connector) Regulatory Class: Class II (two) Product Code: NLH & DSA Dated: January 17, 2003 Received: January 21, 2003

Dear Ms. Barton:

The above-referenced premarket notification (510(k)) was cleared by the Office of Device Evaluation (ODE) on September 24, 2003. We have received your supplemental validation data as required for reprocessed single-use devices by the Medical Device User Fee and Modernization Act of 2002. After reviewing your supplemental validation data, we have determined the devices listed in the enclosure accompanying this letter are 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 these devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (PMA) they 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 devices in the Federal Register.

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## Page 2 - K030187

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your devices comply 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 applicable 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.

The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in classification for your devices and thus, permits you to legally market the devices. This letter will allow you to continue marketing the devices listed in the enclosure accompanying this letter.

If you desire specific advice for your devices 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 littp://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Bfimmuman for

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

Enclosures

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# Page 4 – K030187

## Enclosure – List of Devices

:

| Bard (24) |
|-----------|
| 200131 |
| 200344 |
| 200526 |
| 200740 |
| 200769 |
| 200770 |
| 200794 |
| 200795 |
| 200796 |
| 200797 |
| 200798 |
| 201101 |
| 201102 |
| 201103 |
| 201104 |
| 201105 |
| 201106 |
| 201107 |
| 201109 |
| 201114 |
| 320001 |
| 320002 |
| 7FAM00004 |
| 7FAM00007 |

:

: 上一篇:

.

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#### Indications for Use Statement ll.

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

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

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

Indications for Use: Reprocessed Electrophysiology Catheter Cables are indicated for use with the appropriate electrode catheter during electrophysiology studies.

Concurrence of CDRH, Office of Device Evaluation (ODE)

N. Q. Cetter

diovascular Devices

510(k) Number K030187

Prescription Use
(per 21 CFR 801.109)

ОГ

Over-the-Counter Use

Alliance Medical Corporation Reprocessed Electrophysiology Catheters Traditional 510(k)

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K030187

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A L L I A N C E
MEDICAL CORPORATION

# PART B: 510(k) SUMMARY

SEP 2 4 2003

8.5100
8.5310
8.12.2018 12.00 10.000
2.1.2018
1.000 1.000 1.000 1.000 1.000 1.000 1.000 1.000 1.000 1.000 1.000 1.000 1.000 1.000 1.000 1.000 1.000 1.000 1.000 1.000 1.000 1.

| Submitter: | Alliance Medical Corporation<br>10232 South 51st Street<br>Phoenix, Arizona 85044 | TEL 480.763<br>FAX 480.763<br>Toll Free 888.888<br>www.alliance-medic |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|
| Contact: | Moira Barton<br>Senior Regulatory Affairs Specialist<br>[phone] (o)<br>[phone] (f) | |
| Date of preparation: | 6/13/2002 | |
| Name of device: | Trade/Proprietary Name: Reprocessed Electrophysiology<br>Catheter<br>Common or Usual Name: Electrophysiology Catheter or<br>Electrode Recording Catheter<br>Classification Name: Electrode Recording Catheter | |
| Predicate device(s): | | |
| | K891908 Bard Tip Deflecting Electrode Catheter<br>K874208 Bard Octapolar Electrode Catheter<br>K881966 Electrophysiology Electrode Catheter with Silver/Silver<br>K992373 Orbiter ST Diagnostic Electrode Catheter | |
| 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 handpiece, a flexible<br>shaft and a distal tip section containing diagnostic electrodes.<br>The distal tips of deflectable catheters can be deflected into a<br>curve by manipulating the handpiece; fixed curve catheters have<br>an established distal tip shape. | |
| Intended use: | Reprocessed Electrophysiology Catheters are intended for<br>temporary intracardiac sensing, recording, stimulation, and<br>electrophysiological mapping of cardiac structures. | |
| Indications<br>statement: | Reprocessed diagnostic EP 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 (EP) Catheters are identical to the predicate<br>devices. The mechanism of action of Reprocessed<br>Electrophysiology (EP) Catheters is identical to the predicate | |

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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.

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)

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

Conclusion: 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.