REPROCESSED ELECTROPHYSIOLOGY CATHETER

K030026 · Alliance Medical Corp. · NLH · May 2, 2003 · Cardiovascular

Device Facts

• Record ID: K030026
• Device Name: REPROCESSED ELECTROPHYSIOLOGY CATHETER
• Applicant: Alliance Medical Corp.
• Product Code: NLH · Cardiovascular
• Decision Date: May 2, 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 EP catheters; transmit electrical impulses; used for endocardial recording or stimulation. Device components: handpiece, flexible shaft, distal tip with diagnostic electrodes. Deflectable models allow curve manipulation via handpiece; fixed curve models have established shapes. Used in clinical electrophysiology studies by physicians. Reprocessing involves removal of adherent visible soil, decontamination, and functional testing of components prior to packaging. Output consists of electrical signals for cardiac mapping/stimulation; aids clinical decision-making regarding cardiac rhythm management.

Clinical Evidence

Bench testing only. Evidence includes biocompatibility testing, validation of the reprocessing procedure, sterilization validation, and functional testing of device components to ensure performance remains consistent with original specifications.

Technological Characteristics

Diagnostic electrode catheter; handpiece-actuated distal tip deflection or fixed-curve geometry. Materials and design identical to OEM predicates. Reprocessing includes decontamination and functional verification. Sterilization validation performed. No software or electronic processing components.

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

• Daig Electrophysiology Catheter (K894500)
• Response™ Steerable Catheter (K913940)
• Daig Diagnostic Electrophysiology Catheter (K942379)
• Daig Electrophysiology Catheter - Response™ and Supreme™ (K002976)
• Reprocessed Electrophysiology Catheters (K012708)

Submission Summary (Full Text)

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

Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" written around it.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 0 6 2004

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

Re: K030026

Trade Name: Reprocessed Electrophysiology (EP) Catheters & Cables 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: April 7, 2003

Dear Ms. Barton:

Received: April 7, 2003

This letter corrects our substantially equivalent letter of May 02, 2003 regarding one of the product codes for your devices. The code was erroneously written as NHL when it should have been NLH.

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.

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

Page 2 - Ms. Moira Barton

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 (QS) 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/dsma/dsmamain.html

Sincerely yours,

Blyumman for

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

Enclosure

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

#### II. Indications for Use Statement

K030026 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)


(Division Sign-Off)
Division of Cardiovascular Devices

| 510(k) Number | K050026 |
|---------------|---------|
|---------------|---------|

| Prescription Use (per 21 CFR 801.109) | <img alt="Prescription Use" src="prescription_use.png"/> | or | Over-the-Counter Use | __________ |
|---------------------------------------|----------------------------------------------------------|----|----------------------|------------|
|---------------------------------------|----------------------------------------------------------|----|----------------------|------------|

CONFIDENTIAL
Alliance Medical Corporation
Reprocessed Electrophysiology Catheters
Traditional 510(k)
13

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

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol featuring three horizontal lines that curve and converge, resembling a human figure in profile.

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: K030026 - 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 2, 2003 Received: January 3, 2003

Dear Ms. Barton:

The above-referenced premarket notification (510(k)) was cleared by the Office of Device Evaluation (ODE) on May 2, 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.

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

#### Page 2 - K030026

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

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

## Page 3 – K030026

.

## Enclosure – List of Devices

and the comments of the comments of the comments of the contribution of the contribution of the contribution of the contribution of the contribution of the contribution of th

| K030026 |
|-----------------|
| Models OEM (n)) |
| (total=37) |
| Daig (37) |
| 401206 |
| 401210 |
| 401211 |
| 401222 |
| 401223 |
| 401225 |
| 401226 |
| 401227 |
| 401228 |
| 401260 |
| 401261 |
| 401262 |
| 401275 |
| 401276 |
| 401281 |
| 401287 |
| 401305 |
| 401306 |
| 401309 |
| 401311 |
| 401328 |
| 401353 |
| 401356 |
| 401357 |
| 401362 |
| 401379 |
| 401380 |
| 401381 |
| 401382 |
| 401383 |
| 401386 |
| 401389 |
| 401392 |
| 401393 |
| 401399 |
| 401400 |

.

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

## Page 4 - K030026

1

Image /page/6/Figure/1 description: The image shows a label with the text "K030026" at the top, followed by "M.4.1.1.5 [OEM](n)1" in the middle, and "L-370" below that. At the bottom of the label, there is a box with the number "401401" inside. The text is in black and the background is a light gray color.

100 Career States

: 上一篇:

1. Participant

: 2017-02-20 1

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

AY - 2 2003

Image /page/7/Picture/1 description: The image shows the text "K030026" on the top line and "Q1/2" on the bottom line. The text is written in a handwritten style, with thick, dark strokes. The numbers and letters are clearly legible, although the handwriting is not perfectly neat.

Image /page/7/Picture/2 description: The image shows the word "ALLIANCE" in a serif font, with a stylized graphic above it. The graphic consists of three curved lines that are thick and black. The lines are arranged in a parallel fashion, with the top line being the shortest and the bottom line being the longest, creating a sense of depth and movement.

RATION

# PART B: 510(k) SUMMARY

| TEL | 480.763.5300 |
|-----------|--------------------------|
| 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 | TEL [phone]<br>FAX [phone]<br>Toll Free 888.888.34<br>www.alliance-medical. |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| Contact: | Moira Barton<br>Senior Regulatory Affairs Specialist<br>[phone] (o)<br>[phone] (f) | |
| Date of preparation: | 12/30/2002 | |
| Name of device: | <i>Trade/Proprietary Name:</i> Reprocessed Electrophysiology<br>Catheter<br><i>Common or Usual Name:</i> Electrophysiology Catheter or<br>Electrode Recording Catheter<br><i>Classification Name:</i> Electrode Recording Catheter | |
| Predicate device(s): | Daig Response™ legally marketed Electrophysiology Catheter<br>devices under various 510(k) premarket notifications. | |
| | K894500 Daig Electrophysiology Catheter<br>K913940 Response™ Steerable Catheter<br>K942379 Daig Diagnostic Electrophysiology Catheter<br>K002976 Daig Electrophysiology Catheter - Response™ and Supreme™<br>K012708 Reprocessed 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 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.<br><br>Reprocessed electrophysiology catheter cables are indicated for<br>use with the appropriate electrode catheter during<br>electrophysiology studies. | |

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

K030026
p.2/2

| Technological characteristics: | The design, materials, and intended use of Reprocessed Electrophysiology (EP) Catheters and Electrophysiology Catheter Cables are identical to the predicate devices. The mechanism of action 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. |
| Performance data: | Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of the Reprocessed Electrophysiology (EP) Catheters. |
| | <ul><li>Biocompatibility</li><li>Validation of reprocessing</li><li>Sterilization Validation</li><li>Function test(s)</li></ul> |
| | 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. |

.