REPROCESSED SEALED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS

K012678 · Sterilmed, Inc. · NLH · Aug 14, 2002 · Cardiovascular

Device Facts

• Record ID: K012678
• Device Name: REPROCESSED SEALED 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

The Reprocessed Sealed 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.

Device Story

Reprocessed single-use electrophysiology diagnostic catheters; high-torque shaft with proximal handle; steerable or non-steerable; 4F to 7F diameter; 65-120 cm length; 2-20 platinum radiopaque electrodes. Used in clinical electrophysiology labs by physicians. Catheter connects via cables to external stimulators and electrophysiologic recorders. Device facilitates intracardiac signal acquisition and electrical stimulation for arrhythmia evaluation and cardiac mapping. Reprocessing restores device to original manufacturer specifications; includes cleaning, sterilization, and functional testing. Benefits include clinical utility of diagnostic catheters for cardiac rhythm management.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including functional design testing, process validation for cleaning and sterilization, and packaging validation. Manufacturing process includes 100% visual and functional testing of all reprocessed units.

Technological Characteristics

High-torque shaft, handle, 2-20 platinum radiopaque electrodes. Diameter 4F-7F, length 65-120 cm. Deflectable tip. Connects to external stimulators/recorders via manufacturer-recommended cables. Sterilization and cleaning processes validated for reprocessing.

Indications for Use

Indicated for patients undergoing electrophysiology studies for the evaluation of cardiac arrhythmias, requiring intracardiac sensing, recording, stimulation, temporary pacing, or electrophysiologic 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 (unspecified)
• Stablemapr EP Diagnostic Catheter (K981642)

Submission Summary (Full Text)

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Image /page/0/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 an abstract symbol that resembles an eagle or a stylized human figure, composed of three overlapping profiles.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 2004

SterilMed, Inc. c/o Dr. Bruce Lester Vice President Research and Development 11400 7310 Avenue North Minneapolis, MN 55369

Re: K012678 - Supplemental Validation Submission Trade Name: See Enclosed List Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter Regulatory Class: Class II (two) Product Code: NLH Dated: August 13, 2001 Received: August 14, 2001

Dear Dr. Lester:

The above-referenced premarket notification (510(k)) was cleared by the Office of Device Evaluation (ODE) on August 14, 2002 . 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.

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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
Roy D. Zuckerman, M.D.

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

Enclosures

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# Enclosure – List of Devices

| Orig models found to be | SE |
|-------------------------|----|
| Daig (132) | |
| 401206 | |
| 401207 | |
| 401209 | |
| 401210 | |
| 401211 | |
| 401212 | |
| 401221 | |
| 401222 | |
| 401223 | |
| 401224 | |
| 401225 | |
| 401226 | |
| 401227 | |
| 401228 | |
| 401259 | |
| 401260 | |
| 401261 | |
| 401262 | |
| 401271 | |
| 401272 | |
| 401273 | |
| 401274 | |
| 401275 | |
| 401276 | |
| 401277 | |
| 401278 | |
| 401279 | |
| 401281 | |
| 401282 | |
| 401283 | |
| 401284 | |
| 401285 | |
| 401287 | |
| 401288 | |
| 401290 | |
| 401291 | |
| 401293 | |
| 401294 | |
| Orig models found to be | SE |
| 401296 | |
| 401297 | |
| 401298 | |
| 401299 | |
| 401300 | |
| 401301 | |
| 401305 | |
| 401306 | |
| 401307 | |
| 401308 | |
| 401309 | |
| 401310 | |
| 401311 | |
| 401312 | |
| 401313 | |
| 401317 | |
| 401318 | |
| 401325 | |
| 401328 | |
| 401329 | |
| 401353 | |
| 401354 | |
| 401355 | |
| 401356 | |
| 401357 | |
| 401359 | |
| 401360 | |
| 401362 | |
| 401366 | |
| 401374 | |
| 401375 | |
| 401376 | |
| 401379 | |
| 401380 | |
| 401381 | |
| 401382 | |
| 401383 | |
| 401384 | |
| 401385 | |
| 401386 | |
| 401387 | |
| Orig models found to be | SE |
| 401388 | |
| 401389 | |
| 401390 | |
| 401392 | |
| 401393 | |
| 401397 | |
| 401399 | |
| 401400 | |
| 401401 | |
| 401430 | |
| 401433 | |
| 401434 | |
| 401435 | |
| 401436 | |
| 401438 | |
| 401440 | |
| 401441 | |
| 401442 | |
| 401443 | |
| 401444 | |
| 401445 | |
| 401448 | |
| 401449 | |
| 401450 | |
| 401451 | |
| 401453 | |
| 401466 | |
| 401468 | |
| 401474 | |
| 401475 | |
| 401527 | |
| 401528 | |
| 401530 | |
| 401531 | |
| 401532 | |
| 401534 | |
| 401688 | |
| 401859 | |
| 401860 | |
| 401863 | |
| 401864 | |
| Orig models found to be | SE |
| 401865 | |
| 401871 | |
| 401872 | |
| 401873 | |
| 401874 | |
| 401876 | |
| 401877 | |
| 401878 | |
| 401890 | |
| 401891 | |
| 401893 | |
| 401894 | |

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# Indications for Use Page

Device Name: Reprocessed Sealed Electrophysiology Diagnostic Catheters

Indications for Use:

The Reprocessed Sealed 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)

Thos. A. for Bran Zucher
(Division Sign-Off)

Division of Cardiovascular
and Respiratory Devices

510(k) Number K012628

Prescription Use
(Per 21 CFR 801.109)

SterilMed, Inc. Reprocessed Sealed EP Diagnostic Catheters Confidential

Premarket Notification

Page I

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# AUG 1 4 2002

# 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 13, 2001 |
| Trade Name: | SterilMed Reprocessed Sealed Electrophysiology<br>Diagnostic Catheters |
| Classification Name:<br>and Number: | Class II, 21 CFR 870.1220 |
| Product Code: | DRF |
| Predicate Device(s): | The SterilMed reprocessed sealed electrophysiology<br>diagnostic catheter is 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 original manufacturer's 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 7F, a length ranging from 65 to 120 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. |

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The reprocessed sealed electrophysiology diagnostic Intended Use: 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. Functional and Representative samples of reprocessed sealed Safety Testing: electrophysiology diagnostic catheters underwent design testing to demonstrate appropriate functional characteristics. Process validation testing was done to validate the cleaning and sterilization procedures as well as the device's packaging. In addition, the manufacturing process includes visual and functional testing of all products produced. The electrophysiology diagnostic catheters sealed and Conclusion: reprocessed by SterilMed are substantially equivalent to the A20 (K953768), manufactured by Biosense Webster (formerly known as Cordis Webster), the Bard Dynamic Tip Catheter (K912213), and the Bard Intracardiac Electrode Catheter manufactured by C.R. Bard Inc., the Stablemapr EP Diagnostic Catheter (K981642), manufactured by Medtronic Inc., and the reprocessed devices' counterparts from the original manufacturer. This conclusion is based upon the fact that these devices' are essentially identical to the predicate devices in terms of functional design, materials, indications for use, and construction.