REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS

K092158 · Sterilmed, Inc. · NLH · Jan 14, 2010 · Cardiovascular

Device Facts

• Record ID: K092158
• Device Name: REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS
• Applicant: Sterilmed, Inc.
• Product Code: NLH · Cardiovascular
• Decision Date: Jan 14, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1220
• Device Class: Class 2

Intended Use

The reprocessed EP diagnostic catheters are intended for temporary use during electrophysiology studies for intracardiac sensing, recording, cardiac stimulation, and for the electrophysiological mapping and evaluation of cardiac structures and arrhythmias.

Device Story

Reprocessed steerable electrophysiology (EP) diagnostic catheters; used for intracardiac sensing, recording, and cardiac stimulation. Device consists of shaft, handle, and 2-20 platinum radiopaque tip electrodes. Distal tip steerable; cables interface with external stimulator/electrophysiological recorder. Used in clinical electrophysiology studies to map and evaluate cardiac structures and arrhythmias. Operates by transmitting electrical signals between heart tissue and external recording/stimulation equipment. Benefits patient by enabling diagnostic evaluation of cardiac arrhythmias. Subject device is a reprocessed version of original equipment manufacturer (OEM) catheters.

Clinical Evidence

Bench testing only. Includes process validation for cleaning and sterilization, device packaging validation, and 100% visual and functional testing of all produced units.

Technological Characteristics

Steerable diagnostic catheter; 6F or 7F diameter; 99cm or 105cm length; 2-20 platinum radiopaque electrodes. Materials and construction identical to predicate. Manual operation via handle. No software or electronic processing components integral to the catheter itself.

Indications for Use

Indicated for temporary use during electrophysiology studies for intracardiac sensing, cardiac stimulation, and electrophysiological mapping and evaluation of cardiac structures and arrhythmias.

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

• St. Jude Medical Reflexion™ catheters

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for SterilMed INC. The text "SterilMed INC." is in a bold, sans-serif font. Below the logo, in a smaller font, is the text "Medical Device Reprocessing" and "Small Equipment & Instrument Repair."

## II. SUMMARY AND CERTIFICATION

K092158

- A. 510(k) Summary
JAN 1 4 2010

| Submitter: | SterilMed, Inc. |
|-----------------|-------------------------|
| Contact Person: | Dennis Toussaint |
| | 11400 73rd Avenue North |
| | Maple Grove, MN 55369 |
| | Ph: 763-488-3410 |
| | Fax: [phone] |

| Date Prepared: | July 14, 2009 |
|------------------------|-----------------------------------------------------------|
| Trade Name: | Reprocessed Electrophysiology Diagnostic Catheters |
| Classification Name: | Electrode Recording Catheter or Electrode Recording Probe |
| Classification Number: | Class II, 21 CFR 870.1220 |
| Product Code: | NLH |

| Predicate<br>Devices: | The reprocessed EP diagnostic catheters are substantially equivalent to St. Jude Medical<br>Reflexion™ catheters. |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>Description: | SterilMed Reprocessed Reflexion EP diagnostic catheters consist of a shaft with a handle at the<br>proximal end, and are considered to be steerable. These catheters have an outer diameter of<br>either 6 or 7F and are either 99 or 105cm in length, with 2 - 20 platinum, radiopaque tip<br>electrodes and a variety of inter-electrode spacing's and curve styles at the distal tip. The distal<br>tip is steerable and cables connect to the handle and interface between the catheter and an<br>external stimulator and/or an electrophysiological recorder. |
| | Note: Only the catheter is the subject of this submission, the external stimulator and/or<br>electrophysiological recorder and any other related equipment are not included in the scope of<br>this submission. |
| Intended Use: | The reprocessed EP diagnostic catheters are intended for temporary use during<br>electrophysiology studies for intracardiac sensing, recording, cardiac stimulation, and for the<br>electrophysiological mapping and evaluation of cardiac structures and arrhythmias. |
| Functional and<br>Safety Testing: | Representative samples of reprocessed EP diagnostic catheters were tested to demonstrate<br>appropriate functional characteristics. Process validation testing was performed to validate the<br>cleaning and sterilization procedures as well as device packaging. In addition, the<br>manufacturing process includes visual and validated functional testing of all products produced. |
| Conclusion: | The reprocessed EP diagnostic catheters are substantially equivalent to the St. Jude Medical<br>Reflexion™ electrophysiology diagnostic catheters. |
| | This conclusion is based upon the devices' similarities in functional design (principle of<br>operation), materials, indications for use and methods of construction. |

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CONFIDENTIAL CEROPRIETARY INFORMATION OF STEBILMED, INC.

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

SterilMed, Inc c/o Mr. Garrett Ahlborg Regulatory Affairs Manager, 1400 73td Avenue North, Suite 100 Maple Grove, MN 55369

## JAN 1 4 2010

Re: K092158

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: December 22, 2009 Received: December 23, 2009

Dear Mr. Ahlborg:

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 - Mr. Garrett Ahlborg

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 vours.

Dina R. Vahuner

A 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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Image /page/3/Picture/0 description: The image shows the logo for SterilMed, INC. The logo is in black and white and features the company name in a bold, sans-serif font. Below the company name, there is smaller text that reads "Medical Device Reprocessing" and "Small Equipment & Instrument Repair". The logo is simple and professional, and it conveys the company's focus on medical device reprocessing and repair.

## Indications for Use

K092/58.

510(k) Number (if known):

Device Name: Reprocessed Electrophysiology Diagnostic Catheters

Indications for Use:

The reprocessed electrophysiology diagnostic catheters are indicated for temporary use during electrophysiology studies for intracardiac sensing, cardiac stimulation, and for the electrophysiological mapping and evaluation of cardiac structures and arrhythmias.

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

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off)

Division of Cardiovascular Devices

510(k) Number_ko-92158

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CONFIDENTIAL & PROPRIETARY INFORMATION OF STERILMED, INC.