REPROCESSED CS BI-DIECTIONAL DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER

K100254 · Ascent Healthcare Solutions · NLH · May 28, 2010 · Cardiovascular

Device Facts

• Record ID: K100254
• Device Name: REPROCESSED CS BI-DIECTIONAL DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER
• Applicant: Ascent Healthcare Solutions
• Product Code: NLH · Cardiovascular
• Decision Date: May 28, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1220
• Device Class: Class 2

Intended Use

The Reprocessed CS Bi-Directional Diagnostic EP Catheter is indicated for electrophysiological mapping of cardiac structures; i.e., stimulation and recording only. The catheter is designed for use in the coronary sinus.

Device Story

Reprocessed steerable, multi-electrode diagnostic electrophysiology (EP) catheter; 7FR diameter; 115 cm length. Features high-torque shaft with braided bi-directional deflectable tip containing platinum electrodes. Rocker lever on handpiece controls tip deflection; friction control knob locks tip curve and rocker lever. Used by physicians in clinical settings for cardiac electrophysiological mapping via stimulation and recording in the coronary sinus. Device is a reprocessed version of original equipment; undergoes cleaning, decontamination, and functional testing to ensure performance equivalent to original device.

Clinical Evidence

Bench testing only. Testing included biocompatibility, validation of reprocessing, sterilization validation, function tests, and packaging validation to demonstrate that reprocessed catheters perform as originally intended.

Technological Characteristics

7FR, 115 cm steerable catheter; platinum electrodes; high-torque shaft; bi-directional deflectable tip (D and J curve types). Mechanical operation via rocker lever and friction control knob. Reprocessed device; no changes to original materials or design.

Indications for Use

Indicated for electrophysiological mapping of cardiac structures (stimulation and recording) within the coronary sinus.

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

• Coronary Sinus Deflectable Mapping Catheter (K050877)

Submission Summary (Full Text)

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K100254/

# SECTION 5: 510(k) SUMMARY

| Submitter: | Ascent Healthcare Solutions<br>10232 South 51st Street<br>Phoenix, Arizona 85044 | | MAY 2 8 2010 |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|--------------|
| Contact: | Amanda Babcock<br>Senior Regulatory Affairs Specialist<br>[phone] (o)<br>[phone] (f)<br>[e-mail] | | |
| Date of preparation: | January 27, 2010 | | |
| Name of device: | Trade/Proprietary Name: Reprocessed CS Bi-Directional<br>Diagnostic Electrophysiology Catheter<br>Classification Name: Electrode recording catheter or electrode<br>recording probe | | |
| Predicate Device<br>K050877 | 510(k) Title<br>Coronary Sinus Deflectable Mapping<br>Catheter | Manufacturer<br>Biosense Webster, Inc. | |
| Device description: | The reprocessed Biosense Webster® Coronary Sinus (CS) EZ<br>STEER™ Diagnostic Electrophysiology (EP) Catheter<br>(hereinafter CS Bi-Directional Diagnostic EP Catheter) is a<br>steerable, multi-electrode catheter with a deflectable tip<br>designed to facilitate electrophysiological mapping of the heart.<br>The device is a 7FR catheter with a usable length of 115 cm.<br>The catheter has a high-torque shaft with a braided bi-<br>directional deflectable tip section containing platinum electrodes<br>that can be used for recording and stimulation. Two asymmetric<br>curve types, DF and FJ, are available providing two 180°<br>opposed, single plane curves.<br>The rocker lever located on the handpiece is used to deflect the<br>tip section. A Friction Control Knob is located on the opposite<br>side of the rocker lever and can be rotated clockwise to lock<br>both the tip curve and rocker lever in place. The high torque<br>shaft allows the plane of the curved tip to rotate, enabling<br>accurate positioning of the catheter tip at the preferred site. | | |
| Indications for Use: | The Reprocessed CS Bi-Directional Diagnostic EP Catheter is<br>indicated for electrophysiological mapping of cardiac structures;<br>i.e., stimulation and recording only. The catheter is designed for<br>use in the coronary sinus. | | |
| Technological<br>characteristics: | The design, materials, and intended use of Reprocessed CS Bi-<br>Directional Diagnostic EP Catheters are identical to the | | |

Ascent Healthcare Solutions Reprocessed Coronary Sinus Bi-Directional Diagnostic Electrophysiology Catheter
Traditional 510(k)

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predicate devices. The mechanism of action of Reprocessed CS Bi-Directional Diagnostic 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. In addition, Ascent Healthcare Solutions' reprocessing of CS Bi-Directional Diagnostic EP Catheters includes removal of adherent visible soil and decontamination. Each individual CS Bi-Directional Diagnostic EP 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.

Ascent Healthcare Solutions concludes that the modified devices (Reprocessed CS Bi-Directional Diagnostic EP Catheter) are safe, effective, and substantially equivalent to the predicate devices as described herein.

### Conclusion:

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name arranged in a circular pattern around a central emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with a distinctive design of intertwined snakes and a staff.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Ascent Healthcare Solutions c/o Ms. Amanda Babcock Senior Regulatory Affairs Specialist, 10232 South 51st Street Phoenix, AZ 85044

MAY 2 8 2010

Re: K100254

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: May 19, 2010 Received: May 21, 2010

Dear: Ms. Babcock;

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. Amanda Babcock

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,
W. Wood.

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. Amanda Babcock

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# List of Models Found SE:

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| Item No. | Description | French<br>Size | Insertion<br>Length | Curve Type |
|---------------|--------------------------------------------------------------------|----------------|---------------------|---------------------------------------------------------------------------|
| BD710FJ282RTS | Biosense Webster<br>CS Bi-Directional<br>Diagnostic EP<br>Catheter | 7Fr | 115 cm | B-directional;<br>J curve with a<br>10.2 cm<br>deflectable<br>span length |
| BD710DF282RTS | Biosense Webster<br>CS Bi-Directional<br>Diagnostic EP<br>Catheter | 7Fr | 115 cm | Bi-directional;<br>D curve with<br>6.4 cm<br>deflectable<br>span length |

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## SECTION 4: INDICATIONS FOR USE STATEMENT

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

Device Name: Reprocessed Coronary Sinus Bi-Directional Diagnostic Electrophysiology Catheter

#### Indications For Use:

The Reprocessed CS Bi-Directional Diagnostic EP Catheter is indicated for electrophysiological mapping of cardiac structures; i.e., stimulation and recording only. The catheter is designed for use in the coronary sinus.

Prescription Use _ × (Part 21 CFR 801 Subpart D)

AND/OR

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)

W.M.D.

ision Sign-Off) sion of Cardiovascular Devices

510(k) Numbe

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