REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS

K012523 · Sterilmed, Inc. · NLH · Aug 14, 2002 · Cardiovascular

Device Facts

• Record ID: K012523
• Device Name: REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS
• Applicant: Sterilmed, Inc.
• Product Code: NLH · Cardiovascular
• Decision Date: Aug 14, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1220
• Device Class: Class 2

Intended Use

These cardiac diagnostic catheters are intended for temporary use during electrophysiology studies for intracardiac sensing, recording, and stimulation. They also provide temporary pacing for the evaluation of cardiac arrhythmias, and are used for electrophysiology mapping of cardiac structures during these evaluations.

Device Story

Reprocessed electrophysiology diagnostic catheter; high-torque shaft; proximal handle; steerable or non-steerable; 4F-8F diameter; 60-160 cm length; 2-20 platinum radiopaque electrodes. Used in clinical electrophysiology labs by physicians. Catheter connects to external stimulator/electrophysiologic recorder via manufacturer-recommended cables. Device provides intracardiac signals for recording/mapping and delivers pacing stimuli. Output used by clinicians to evaluate cardiac arrhythmias and map cardiac structures. Reprocessing restores device to original functional specifications.

Clinical Evidence

Bench testing only. Includes design testing for functional characteristics and process validation for cleaning, sterilization, and packaging. Manufacturing process includes 100% visual and functional testing.

Technological Characteristics

High-torque shaft; 4F-8F diameter; 60-160 cm length; 2-20 platinum radiopaque electrodes; deflectable tip. Connectivity via external cables to stimulators/recorders. Sterilization validated for reprocessed units.

Indications for Use

Indicated for patients undergoing electrophysiology studies requiring intracardiac sensing, recording, stimulation, temporary pacing for arrhythmia evaluation, and 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

• A20 (K953768)
• Bard Dynamic Tip Catheter (K912213)
• Bard Intracardiac Electrode Catheter
• Stablemapr EP Diagnostic Catheter (K981642)

Submission Summary (Full Text)

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K012523

# SECTION 2. SUMMARY AND CERTIFICATION

#### 510(K) SUMMARY A.

| Submitter: | SterilMed, Inc. |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Patrick Fleischhacker<br>11400 73rd Avenue North<br>Minneapolis MN, 55369<br>Ph: 888-856-4870<br>Fax: [phone] |
| Date Prepared: | August 3, 2001 |
| Trade Name: | SterilMed Reprocessed Electrophysiology Diagnostic<br>Catheters |
| Classification Name:<br>and Number: | Class II, 21 CFR 870.1220 |
| Product Code: | DRF |
| Predicate Device(s): | The SterilMed reprocessed electrophysiology diagnostic<br>catheter is substantially equivalent to: the A20 (K953768),<br>manufactured by Biosense Webster (formerly known as<br>Cordis Webster), the Bard Dynamic Tip Catheter<br>(K912213), and the Bard Intracardiac Electrode Catheter<br>manufactured by C.R. Bard Inc., the Stablemapr EP<br>Diagnostic Catheter (K981642), manufactured by<br>Medtronic Inc., and the original manufacturers' devices. |
| Device Description: | The device consists of a reprocessed catheter that has a<br>high-torque shaft with a handle at the proximal end, and<br>may or may not be steerable. These catheters have an outer<br>diameter of 4F to 8F, a length ranging from 60 to 160 cm,<br>with 2-20 platinum, radiopaque electrodes along the tip<br>shaft and a variety of inter-electrode spacings and curve<br>styles at the tip. The tip generally is deflectable. Specific<br>cables, as recommended by the original manufacturer,<br>connect to the handle and interface between the catheter<br>and an external stimulator and/or an electrophysiologic<br>recorder. It should be noted that this submission pertains to<br>the catheter only. It does not include any other components<br>in a system such as, connector cables, external stimulators,<br>or electrophysiologic recorders. |
| Intended Use: | These cardiac diagnostic catheters are intended for<br>temporary use during electrophysiology studies for<br>intracardiac sensing, recording, and stimulation. They also<br>provide temporary pacing for the evaluation of cardiac<br>arrhythmias, and are used for electrophysiology mapping of<br>cardiac structures during these evaluations. |
| Functional and<br>Safety Testing: | Representative samples of reprocessed electrophysiology<br>diagnostic catheters underwent design testing to<br>demonstrate appropriate functional characteristics. Process<br>validation testing was done to validate the cleaning and<br>sterilization procedures as well as the device's packaging.<br>In addition, the manufacturing process includes visual and<br>functional testing of all products produced. |
| Conclusion: | The electrophysiology diagnostic catheters reprocessed by<br>SterilMed are substantially equivalent to the A20<br>(K953768), manufactured by Biosense Webster (formerly<br>known as Cordis Webster), the Bard Dynamic Tip Catheter<br>(K912213), and the Bard Intracardiac Electrode Catheter<br>manufactured by C.R. Bard Inc., the Stablemapr EP<br>Diagnostic Catheter (K981642), manufactured by<br>Medtronic Inc., and the reprocessed devices' counterparts<br>from the original manufacturers. This conclusion is based<br>upon the fact that these devices' are essentially identical to<br>the predicate devices in terms of functional design.<br>materials, indications for use, and construction. |

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Image /page/2/Picture/0 description: The image is a black and white circular logo. The logo features the symbol of the Department of Health and Human Services (HHS) in the center. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 4 2002

SterilMed. Inc. c/o Mr. Patrick Fleischhacker Vice President of Regulatory and Quality 11400 730 Avenue North Minneapolis, MN 55369

Rc: K012523

Trade Name: Reprocessed Electrophysiology Diagnostic Catheters Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter Regulatory Class: Class II (two) Product Code: DRF Dated: May 20, 2002 Received: May 21, 2002

Dear Mr. Fleischhacker:

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. Iisting 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. Patrick Fleischhacker

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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

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

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Enclosure

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# Indications for Use Page

Device Name: Reprocessed Electrophysiology Diagnostic Catheters

Indications for Use:

The Reprocessed Electrophysiology Diagnostic Catheters are intended for temporary use during electrophysiology studies for intracardiac sensing, recording, stimulation and temporary pacing during the evaluation of cardiac arrhythmias; and for electrophysiologic mapping of cardiac structures during these evaluations.

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign Off)
Division of Cardiovascular
and Respiratory Devices
8/14/02
510(k) Number K012523

**Prescription Use**
(Per 21 CFR 801.109)