REPROCESSED ELECTROPHYSIOLOGY CATHETERS

K090323 · Ascent Healthcare Solutions · NLH · Apr 1, 2009 · Cardiovascular

Device Facts

• Record ID: K090323
• Device Name: REPROCESSED ELECTROPHYSIOLOGY CATHETERS
• Applicant: Ascent Healthcare Solutions
• Product Code: NLH · Cardiovascular
• Decision Date: Apr 1, 2009
• 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. In addition, the Lasso® 2515 Variable Circular Mapping Catheter and the Reflexion SpiralTM Variable Radius Catheter are designed for electrophysiological mapping of the atria of the heart.

Device Story

Diagnostic EP catheters consist of hand piece, flexible shaft, and distal tip with electrodes. Device transmits electrical impulses for endocardial recording or stimulation. Deflectable models allow tip curvature via hand piece manipulation. Used by physicians in clinical settings for cardiac electrophysiology procedures. Reprocessing involves removal of adherent soil, decontamination, and functional testing of components prior to repackaging. Output is electrical signal data used by clinicians to map cardiac structures and guide clinical decision-making during EP studies.

Clinical Evidence

Bench testing only. Included biocompatibility, validation of reprocessing, sterilization validation, and functional testing to demonstrate safety and effectiveness.

Technological Characteristics

Diagnostic EP catheters with hand piece, flexible shaft, and distal tip electrodes. Mechanical design, materials, and sizes identical to predicate devices. No software or electronic processing components integral to the catheter itself.

Indications for Use

Indicated for patients requiring temporary intracardiac sensing, recording, stimulation, and electrophysiological mapping of cardiac structures, including atrial mapping.

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

• Reflexion SpiralTM Variable Radius Catheter (K072012)
• Reflexion SpiralTM Variable Radius Catheter (K062251)

Submission Summary (Full Text)

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# K090323

## SECTION 5: 510(k) SUMMARY

| Submitter: | Ascent Healthcare Solutions<br>10232 South 51st Street<br>Phoenix, Arizona 85044 | APR - 1 2005 |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|
| Contact: | Katie Bray<br>Regulatory Affairs Manager<br>[phone] (o)<br>[phone] (f)<br>[e-mail] | |
| Date of preparation: | February 6, 2009 | |
| Name of device: | Trade/Proprietary Name: Reprocessed Electrophysiology<br>Catheters<br>Classification Name: Electrode recording catheter or electrode<br>recording probe | |
| Predicate Device<br>K072012 | 510(k) Title<br>Reflexion SpiralTM Variable Radius<br>Catheter | Manufacturer<br>St. Jude Medical |
| K062251 | Reflexion SpiralTM Variable Radius<br>Catheter | St. Jude Medical |
| 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. | |
| Indications for Use: | Reprocessed diagnostic EP catheters are indicated for<br>temporary intracardiac sensing, recording, stimulation and<br>electrophysiological mapping of cardiac structures. In addition,<br>the Lasso® 2515 Variable Circular Mapping Catheter and the<br>Reflexion SpiralTM Variable Radius Catheter are designed for<br>electrophysiological mapping of the atria of the heart. | |
| Technological<br>characteristics: | The design, materials, and intended use of Reprocessed<br>Electrophysiology Catheters are identical to the predicate<br>devices. The mechanism of action of Reprocessed<br>Electrophysiology Catheters is identical to the predicate devices<br>in that the same standard mechanical design, materials, and<br>sizes are utilized. There are no changes to the claims, intended<br>use, clinical applications, patient population, performance<br>specifications, or method of operation. In addition, Ascent | |

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K090323

Healthcare Solutions' 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 Reprocessed Electrophysiology Catheters. This included the following tests:

- Biocompatibility .
- Validation of reprocessing .
- Sterilization Validation .
- . Function test(s)
- Packaging Validation .

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

#### Conclusion:

Ascent Healthcare Solutions concludes that the modified devices (Reprocessed Electrophysiology Catheters) are safe, effective, and substantially equivalent to the predicate devices as described herein.

Ascent Healthcare Solutions Reprocessed Electrophysiology Catheters Traditional 510(k)

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, along with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The logo is black and white.

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## APR - 1 2009

Ascent Healthcare Solutions c/o Ms. Katie Bray Regulatory Affairs Manager, 10232 South 51st Street Phoenix, AZ 85044

Re: K090323

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 (two) Product Code: NLH Dated: February 6, 2009 Received: February 9, 2009

Dear Ms. Bray:

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. Katie Bray

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/industry/support/index.html.

Sincerely, yours,

signature

& 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. Katie Bray

## List of Models Found SE:

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、

| Item<br>No. | Description | Electrodes | French<br>Size | Electrode<br>Spacing | Lasso<br>Diameter | Insertion<br>Length | Curve Type |
|-------------|----------------------------------------------------------|------------|----------------|----------------------|-------------------|---------------------|------------------------------------------|
| 402800 | Daig Reflexion™<br>Steerable EP<br>Catheter | 10 | 6Fr | 2-5-2 mm | N/A | 105 cm | Bi-Directional<br>Med Curl |
| 402804 | Daig Reflexion<br>Spiral™ Variable<br>Radius EP Catheter | 20 | 7Fr | 1-4-1 mm | 25-15 mm | 99 cm | Bi-Directional<br>90°/180°<br>Asymmetric |
| 402865 | Daig Reflexion<br>Spiral™ Variable<br>Radius EP Catheter | 10 | 7Fr | 6.30 mm | 25-15 mm | 99 cm | Bidirectional<br>180° |
| 401661 | Daig Reflexion™<br>Diagnostic EP<br>Connecting Cable | N/A | N/A | N/A | N/A | 150 cm | N/A |

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## SECTION 4: INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

K090323

Device Name: Reprocessed Electrophysiology Catheters

#### Indications For Use:

Reprocessed diagnostic EP catheters are indicated for temporary intracardiac sensing, recording, stimulation and electrophysiological mapping of cardiac structures. In addition, the LASSO® 2515 Variable Circular Mapping Catheter and the Reflexion Spiral 140 Variable Radius Catheter are designed for electrophysiological mapping of the atria of the heart.

Prescription Use AND/OR (Part 21 CFR 801 Subpart D)

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)

Atul Bhattar for B Zuckerman

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number K090323

Ascent Healthcare Solutions Reprocessed Electrophysiology Catheters Traditional 510(k)