ELECTROPHYSIOLOGY CATHETER

K030109 · Alliance Medical Corp. · NLH · Aug 8, 2003 · Cardiovascular

Device Facts

• Record ID: K030109
• Device Name: ELECTROPHYSIOLOGY CATHETER
• Applicant: Alliance Medical Corp.
• Product Code: NLH · Cardiovascular
• Decision Date: Aug 8, 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

Diagnostic EP catheters; transmit electrical impulses; used for endocardial recording or stimulation. Device comprises handpiece, flexible shaft, distal tip with diagnostic electrodes. Deflectable models allow curve adjustment via handpiece; fixed curve models have established shape. Used in clinical electrophysiology studies; operated by physicians. Reprocessing involves removal of adherent soil, decontamination, and functional testing of components. Output consists of electrical signals from cardiac tissue; used by clinicians to map cardiac structures and guide clinical decision-making regarding cardiac arrhythmias.

Clinical Evidence

No clinical data. Bench testing only. Evidence includes biocompatibility, validation of reprocessing, sterilization validation, and functional testing to demonstrate safety and effectiveness.

Technological Characteristics

Standard mechanical design; materials identical to OEM predicate devices. Sensing/actuation via distal electrodes for electrical signal transmission. Form factor includes handpiece, flexible shaft, and distal tip (fixed or deflectable). Sterilization validation performed. No software or electronic algorithms.

Indications for Use

Indicated for temporary intracardiac sensing, recording, stimulation, and electrophysiological mapping of cardiac structures in patients undergoing electrophysiology studies. Catheter cables are indicated for use with appropriate electrode catheters during these 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

• Cordis Webster Fixed Curve Catheters, Models D-11 (K992965)

Submission Summary (Full Text)

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#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

1 2004 NOV

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

Re: K030109 - Supplemental Validation Submission Trade Name: See Enclosed List Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter and Patient Transducer and Electrode Cable (including connector) Regulatory Class: Class II (two) Product Code: NLH & DSA Dated: January 9, 2003 Received: January 13, 2003

Dear Ms. Barton:

The above-referenced premarket notification (510(k)) was cleared by the Office of Device Evaluation (ODE) on August 8, 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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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 http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

B. Zimmer, M.D.

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 3 – K030109

1000 - 1000

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### Enclosure – List of Devices

| K030109 |
|-------------------------------|
| Models [OEM, (n)]<br>(n = 38) |
| Cordis Webster (38) |
| 1086-182-RT |
| 1086-223-RT |
| 1086-259-S |
| 1086-463-S |
| 1086-508-S |
| 1086-515-RT |
| 1086-577-S |
| F5-QA-005-PS |
| F5-QA-252-PS |
| F5-QD-005-PS |
| F5-QF-005-PS |
| F5-QF-005-TS |
| F5-QF-010-PS |
| F5-QL-005-PS |
| F6-20T-282-FS |
| F65-QA-005-PS |
| F6-DF-252-FS |
| F6-HA-002-FS |
| F6-HA-002-RT |
| F6-HF-002-TS |
| F6-HF-005-FS |
| F6-HF-010-TS |
| F6-OA-002-TS |
| F6-OF-002-FS |
| F6-QA-002-PS |
| F6-QA-005-PS |
| F6-QA-005-RT |
| F6-QA-010-PS |
| F6-QA-252-PS |
| F6-QD-002-PS |
| F6-QD-005-PS |
| F6-QD-010-PS |
| F6-QF-002-PS |
| F6-QF-005-PS |
| F6-QF-010-PS |
| F6-QF-010-TS |

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Image /page/3/Picture/1 description: The image shows a label with the text "K030109" at the top, followed by "Models [OEM (n))". Below this, the text "(#=38)" is visible. The label also contains two lines of text: "F6-QF-252-PS" and "F6-QL-005-PS". The text appears to be machine-printed on a label, which is likely affixed to a product or component.

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Carlos Concession

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#### Indications for Use Statement II.

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 (EP) Catheter Cables are indicated for use with the appropriate electrode catheter during electrophysiology studies.

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|------------------------------------|---------|
| Division of Cardiovascular Devices | |
| 510(k) Number | K030109 |

| Prescription Use | <div style="text-align:center;">X</div> | or | Over-the-Counter Use ______ |
|----------------------|-----------------------------------------|----|-----------------------------|
| (per 21 CFR 801.109) | | | |

Alliance Medical Corporation Reprocessed Electrophysiology Catheters Traditional 510(k)

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AUG - 8 2003

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A L L I A N C E
MEDICAL CORPORATION

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# PART B: 510(k) SUMMARY

| | 10232 South 51st Street<br>Phoenix, Arizona 85044 | |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|
| Submitter: | Alliance Medical Corporation<br>10232 South 51st Street<br>Phoenix, Arizona 85044 | TEL [phone]<br>FAX [phone]<br>Toll Free 888.888.3433<br>www.alliance-medical.com |
| 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): | K992965 Cordis Webster Fixed Curve Catheters, Models D-11 | |
| 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 statement: | Reprocessed diagnostic EP catheters are indicated for<br>temporary intracardiac sensing, recording, stimulation and<br>electrophysiological mapping of cardiac structures. | |
| | Reprocessed electrophysiology catheter cables are indicated for<br>use with the appropriate electrode catheter during<br>electrophysiology studies. | |
| Technological 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 | |

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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.

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

- Biocompatibilitv ●
- 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.