ELECTROPHYSIOLOGY CATHETER

K012708 · Alliance Medical Corp. · NLH · Aug 13, 2002 · Cardiovascular

Device Facts

• Record ID: K012708
• Device Name: ELECTROPHYSIOLOGY CATHETER
• Applicant: Alliance Medical Corp.
• Product Code: NLH · Cardiovascular
• Decision Date: Aug 13, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1220
• Device Class: Class 2

Intended Use

Reprocessed diagnostic EP catheters are indicated for temporary intracardiac sensing, recording, stimulation, and electrophysiological mapping of cardiac structures.

Device Story

Diagnostic EP catheters are electrode-tipped devices used for intracardiac sensing, recording, stimulation, and mapping. The device consists of a connector, handpiece, flexible polymeric shaft, and a distal tip with two or more electrodes. Steerable models allow distal tip deflection via handpiece manipulation; fixed-curve models maintain a set shape. Used in clinical electrophysiology settings by physicians to navigate cardiac structures, the electrodes transmit electrical impulses to and from the heart. The device provides electrophysiological data to the clinician, aiding in the diagnosis and management of cardiac arrhythmias. Alliance Medical Corporation reprocesses these single-use devices, restoring them to their original functional specifications.

Clinical Evidence

No clinical data provided; substantial equivalence is based on the demonstration that reprocessing does not significantly change the device's technological parameters compared to the original predicate devices.

Technological Characteristics

Device consists of a connector, handpiece, flexible polymeric shaft, and distal tip with two or more electrodes. Available in fixed or steerable (deflectable) configurations. Operates via electrical conduction for sensing and stimulation. No specific materials or energy sources beyond standard electrical signal transmission are detailed.

Indications for Use

Indicated for patients requiring temporary intracardiac sensing, recording, stimulation, and electrophysiological 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

• Bard (K891908, K904080, K912213, K921872, K971265)
• Cordis Webster (K892265, K953663, K953678, K955817, K991531, K992965, K002333)
• Daig (K914278, K942379, K002976)
• EP Technologies (K913375, K924108, K924109, K924163, K940167, K940168, K003452)
• Medtronic (K931794, K951347, K953185, K964272, K981642)

Reference Devices

• Celsius/CelsiusII diagnostic catheters (PMA P950005)
• Livewire diagnostic catheter (PMA P960016)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three abstract human profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. The logo is presented in black and white.

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

NOV 1 2004

Re: K012708 - Supplemental Validation Submission Trade Name: See Enclosed List Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter Regulatory Class: Class II (two) Product Code: NLH Dated: August 14, 2001 Received: August 14, 2001

Dear Ms. Barton:

The above-referenced premarket notification (510(k)) was cleared by the Office of Device Evaluation (ODE) on August 13, 2002. 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.

{1}------------------------------------------------

### Page 2 - K012708

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,

Bhimmer for

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

Enclosures

{2}------------------------------------------------

# Page 3 - K012708

:

:

.

1000

Enclosure – List of Devices

| Orig models found to be | SE |
|-------------------------------|----|
| Bard (55) | |
| 006245 | |
| 008567 | |
| 200060 | |
| 200066 | |
| 200067 | |
| 200069 | |
| 200151 | |
| 200202 | |
| 200203 | |
| 200472 | |
| 200473 | |
| 200573 | |
| 200574 | |
| 200578 | |
| 200580 | |
| 200581 | |
| 200583 | |
| 200584 | |
| 200591 | |
| 200594 | |
| 200596 | |
| 200597 | |
| 200624 | |
| 200719 | |
| 200792 | |
| 400001 | |
| 400004 | |
| 400005 | |
| 400006 | |
| 400007 | |
| 400008 | |
| 400011 | |
| 400012 | |
| 400014 | |
| 400016 | |
| 400017 | |
| 400023 | |
| Orig models found to be | SE |
| 400044 | |
| 400045 | |
| 400046 | |
| 400047 | |
| 400048 | |
| 400071 | |
| 400099 | |
| 400100 | |
| 500202 | |
| 500203 | |
| 006245P | |
| 200060E | |
| 200588E | |
| 5FVS00010 | |
| 6FMC00098 | |
| 6FMC00518 | |
| 6FMC00687 | |
| Cordis Webster (68) | |
| D5-08D-P10-FS | |
| D5S-06AL-252-MS | |
| D5S-06AL-252-RT | |
| D5S-AL-252-PS | |
| D6-06DR-002-FS | |
| D6-06DR-002-RT | |
| D6-06DR-005-FS | |
| D6-08DR-002-FS | |
| D6-08DR-002-RT | |
| D6-10DR-P10-FS | |
| D6-10DR-P10-RT | |
| D6-10FR-005-FS | |
| D6-AG-252-PS | |
| D6-AL-252-PS | |
| D6-BL-252-PS | |
| D6-DG-252-PS | |
| D6-DL-252-PS | |
| D6-DR-005-PS | |
| D6-DR-010-PS | |
| D6-DR-252-PS | |
| D6S-08DR-PRY-FS | |
| D6S-270L-252-PS | |
| D7-06DL-002-FS | |
| Orig models found to be | |
| SE | |
| D7-06DL-002-TS | |
| D7-06DR-002-TS | |
| D7-08DL-002-FS | |
| D7-08DL-002-RT | |
| D7-08DR-002-FS | |
| D7-08DR-002-RT | |
| D7-08DR-005-FS | |
| D7-08R-HIS-FS | |
| D7-10DR-P10-FS | |
| D7-10DR-P10-RT | |
| D7-10FR-010-FS | |
| D7-270L-252-PS | |
| D7-270RL-252-PS | |
| D7-A20-131-FS | |
| D7-AG-252-PS | |
| D7-AL-252-PS | |
| D7-BG-252-PS | |
| D7-BL-252-PS | |
| D7-CG-252-PS | |
| D7-CL-252-PS | |
| D7-DG-252-PS | |
| D7-DL-005-PS | |
| D7-DL-252-PS | |
| D7-DR-005-PS | |
| D7-DR-010-PS | |
| D7-DR-252-PS | |
| D7-EG-252-PS | |
| D7-EL-252-PS | |
| D7-FG-252-PS | |
| D7-FL-252-PS | |
| D7-PSL-252-PS | |
| D7R-20-P14-FS | |
| D7-T20-282-FS | |
| D7-T20-P15-FS | |
| D8BR-BG-252-PS | |
| D8BR-BL-252-PS | |
| D8BR-DG-252-PS | |
| D8BR-DL-252-PS | |
| D8BR-FL-252-PS | |
| D8-CG-252-PS | |
| D8-DG-252-PS | |
| Orig models found to be | |
| SE | |
| D8-DL-252-PS | |
| D8-FG-252-PS | |
| OD7-3X4D-010-FS | |
| OD7-8X2D-005-FS | |
| Daig (29) | |
| 401430 | |
| 401434 | |
| 401435 | |
| 401436 | |
| 401440 | |
| 401441 | |
| 401442 | |
| 401443 | |
| 401444 | |
| 401445 | |
| 401449 | |
| 401450 | |
| 401451 | |
| 401453 | |
| 401466 | |
| 401474 | |
| 401475 | |
| 401528 | |
| 401860 | |
| 401863 | |
| 401864 | |
| 401872 | |
| 401873 | |
| 401876 | |
| 401878 | |
| 401890 | |
| 401891 | |
| 401894 | |
| 401904 | |
| EPT (23) | |
| 5291 | |
| 5291S | |
| 5292 | |
| 5292S | |
| 5294 | |
| 5294S | |
| Orig models found to be<br>SE | |
| 5298S | |
| 5404S | |
| 5414S | |
| 5418 | |
| 5420 | |
| 5429 | |
| 5433 | |
| 5434 | |
| 5457 | |
| 5458 | |
| 5470 | |
| 5472 | |
| 5481 | |
| 5482 | |
| 5491 | |
| 5563 | |
| 5920 | |
| Medtronic (9) | |
| 041002JM | |
| 041002UM | |
| 041005DM | |
| 041005JM | |
| 041005UM | |
| 04122JM | |
| 04125JM | |
| 04125UM | |
| 044216J | |

:

·

:

{3}------------------------------------------------

## Page 4 – K012708

"

·

{4}------------------------------------------------

## Page 5 – K012708

.

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

.

:

.

.

.

:

.

{5}------------------------------------------------

## Page 6 - K012708

.

.

.

..

.

:

.

.

.

.

.

:

.

:

:

,

{6}------------------------------------------------

## Page 7 – K012708

. . . . . .

.

:

{7}------------------------------------------------

Electrophysiology Catheters Alliance Medical Corporation Part D. Certifications

CONFIDENTIAL 08/14/01

510(k) Premarket Notification

Page 2 of 2

#### Indications for Use Statement 2.

## INDICATIONS FOR USE STATEMENT

Kol 2708

510(k) Number: (if known)

.

Device Name:

Electrophysiology (EP) Catheter

Sponsor Name:

Alliance Medical Corporation

### Indications for Use:

Reprocessed diagnostic EP catheters are indicated for temporary intracardiac sensing, recording, stimulation, and electrophysiological mapping of cardiac structures.

### Do Not Write Below This Line - Continue on Another Page if Needed

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Division of Cardiovascular & Respiratory Devices | |
|--------------------------------------------------|---------|
| 510(k) Number | K012708 |
| Emballus | |

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

{8}------------------------------------------------

## PART C. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

### Submitter 1.

Alliance Medical Corporation 10232 51st Street Phoenix, Arizona 85044

### 2. Contact Person

Don Selvey Vice President, Regulatory Affairs & Quality Assurance Alliance Medical Corporation [phone] – Telephone [phone] -- Facsimile [e-mail]

### 3. Device Name

### a. Trade or Proprietary Name

Electrophysiology Catheter

### b. Common Name, Usual or Classification Name

Electrode recording catheter

### 4. Predicate Devices

| Bard | Cordis<br>Webster* | Daig** | EP<br>Technologies | Medtronic |
|---------|--------------------|---------|--------------------|-----------|
| K891908 | K892265 | K914278 | K913375 | K931794 |
| K904080 | K953663 | K942379 | K924108 | K951347 |
| K912213 | K953678 | K002976 | K924109 | K953185 |
| K921872 | K955817 | | K924163 | K964272 |
| K971265 | K991531 | | K940167 | K981642 |
| | K992965 | | K940168 | |
| | K002333 | | K003452 | |

*The Celsius/CelsiusII diagnostic catheters were approved under PMA P950005. **The Livewire diagnostic catheter was approved under PMA P960016.

### 5. Description of the Device

Diagnostic Electrophysiology (EP) catheters are specially designed electrode catheters that transmit electrical impulses and can be positioned for endocardial recording or stimulation.

{9}------------------------------------------------

EP catheter designs all incorporate a connector, a handpiece, a flexible polymeric shaft, and a distal tip containing two or more electrodes. The distal tips of steerable catheters can be deflected into a curve by manipulating the handpiece; fixed curve catheters have an established distal tip shape.

### 6. Intended Use of the Device

Reprocessed diagnostic EP catheters are indicated for temporary intracardiac sensing, recording, stimulation, and electrophysiological mapping of cardiac structures.

### 7. Comparison of the Technological Features of the Reprocessed and Original Devices

Diagnostic catheters are available in various configurations. Key parameters include the size of the tip, number of electrodes, length, curve of the tip, and whether or not the tip is deflectable. Since reprocessing does not significantly change any of these parameters, the reprocessed catheters are the same as the original devices.