STERILMED REPROCESSED DEFLECTABLE ELECTROPHYSIOLOGY DIAGNOSTIC CATHETER

K043513 · Sterilmed, Inc. · NLH · Mar 1, 2005 · Cardiovascular

Device Facts

• Record ID: K043513
• Device Name: STERILMED REPROCESSED DEFLECTABLE ELECTROPHYSIOLOGY DIAGNOSTIC CATHETER
• Applicant: Sterilmed, Inc.
• Product Code: NLH · Cardiovascular
• Decision Date: Mar 1, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1220
• Device Class: Class 2

Intended Use

The SterilMed Reprocessed Electrophysiology 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 deflectable electrophysiology diagnostic catheter; high-torque shaft with proximal handle; steerable tip. Outer diameter 5F-7F; length 80-115 cm; 4-10 platinum radiopaque electrodes. Connects to external stimulator/electrophysiologic recorder via manufacturer-recommended cables. Used by physicians in clinical settings for intracardiac sensing, recording, stimulation, and mapping of cardiac structures during electrophysiology studies. Enables temporary pacing for arrhythmia evaluation. Device provides diagnostic data to clinicians to guide cardiac rhythm management decisions.

Clinical Evidence

Bench testing only. Includes functional design testing, biocompatibility testing, and process validation for cleaning, sterilization, and packaging. Manufacturing process includes visual and functional testing of all units.

Technological Characteristics

Platinum electrodes; high-torque shaft; steerable tip. Dimensions: 5F-7F diameter, 80-115 cm length. Connectivity: interface cables to external stimulators/recorders. Sterilization: validated reprocessing cycle.

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)

Submission Summary (Full Text)

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MAR 1 - 2005

043513
Page 1 of 2

# SECTION 2. SUMMARY AND CERTIFICATION

#### 2.A. 510(K) SUMMARY

| Submitter: | SterilMed, Inc. |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Dr. Bruce R. Lester<br>SterilMed, Inc.<br>11400 73rd Avenue North<br>Minneapolis, MN 55369<br>Ph: 763-488-3400<br>Fax: [phone] |
| Date Prepared: | December 17, 2004 |
| Trade Name: | SterilMed Reprocessed Deflectable Electrophysiology<br>Diagnostic Catheter |
| Classification Name:<br>and Number: | Electrode Recording Catheter<br>Class II, 21 CFR 870.1220 |
| Product Code: | NLH |
| Predicate Device(s): | The SterilMed reprocessed deflectable 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), manufactured by C.R. Bard Inc.; and their<br>counterparts from the original manufacturers. |
| Device Description: | The device consists of a reprocessed catheter that has a high-<br>torque shaft with a handle at the proximal end, and is steerable.<br>These catheters have an outer diameter of 5F to 7F, a length<br>ranging from 80 to 115 cm, with 4-10 platinum, radiopaque<br>electrodes along the tip shaft and a variety of inter-electrode<br>spacings and curve styles at the tip. The tip is deflectable.<br>Specific cables, as recommended by the original manufacturer,<br>connect to the handle and interface between the catheter and an<br>external stimulator and/or an electrophysiologic recorder. It<br>should be noted that this submission pertains to the catheter<br>only. It does not include any other components in a system<br>such as connector cables, external stimulators, or<br>electrophysiologic recorders. |

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page 2 of 2

| Intended Use: | The SterilMed Reprocessed Electrophysiology 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. |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Functional and<br>Safety Testing: | Representative samples of reprocessed deflectable electrophysiology diagnostic catheters underwent design testing to demonstrate appropriate functional characteristics, and biocompatibility testing to demonstrate compatibility of the device materials. 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. |
| Conclusion: | The deflectable electrophysiology diagnostic catheters reprocessed by SterilMed are substantially equivalent to the A20 (K953768) manufactured by Biosense Webster (formerly known as Cordis Webster) and the Bard Dynamic Tip Catheter (K912213) manufactured by C.R. Bard Inc., and their counterparts from the original manufacturers. This conclusion is based upon the fact that these devices are identical to the predicate devices in terms of their design, materials, indications for use, and construction. |

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Public Health Service

Image /page/2/Picture/2 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 a stylized image of an eagle or bird with three wing-like shapes.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 - 2005

SterilMed, Inc. Bruce Lester, Ph.D. Vice President Research and Development 11400 73rd Avenue North Minneapolis, MN 55369

Re: K043513

R043313
Trade Name: Sterilmed Reprocessed Deflectable Electrophysiology Diagnostic Catheters (See Enclosed List) Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: NLH Dated: December 17, 2004 Received: December 20, 2004

Dear Dr. Lester:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becaren b r (x) pe device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass stated in the encreased of 76, the enactment date of the Medical Device Amendments, or to commerce proct to may 20, 1773, in accordance with the provisions of the Federal Food, Drug, de nec.s mat have been room do require approval of a premarket approval application (PMA). and Costietle Act (110.) that the device, subject to the general controls provisions of the Act. The r ou may, mererore, mains 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 may oc subject to back as a sateral 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 -- Bruce Lester, Ph.D.

Please be advised that FDA's issuance of a substantial equivalence determination and mean Please be advised that FDA s issuance of a cevice complies with other requirements of the Act
that FDA has made a determination that your device complies with other may that FDA has made a decemmanen and Jointistered by other Federal agencies. You must or any Federal Statules and regulations adminities. by registration and listing (21 comply with an the Act 31equirements, newally, good manufacturing practice requirements as set CFK Part 807), labeling (21 CFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (becares over device as described in your Section 510(k) I mis letter will anow you to begin manteang your antial equivalence of your device to a legally premarket notification. The PDA mixing of basification 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 If you desire specific at not its you [phone] Also, please note the regulation entitled, Comact the Office of Complance at (210) = 10 = 10 = 10 = 10 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = = = Misoranuing by telefono to promazion ibilities under the Act from the Division of Small other general information on your response Assistance at its toll-free number [phone] or Manufacturers, micriational and Soless http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours,

Blairimmar for

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 – K043513

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# List of Model numbers

| No. | BiosenseWebster (47 Models) | Bard (18 Models) |
|-----|-----------------------------|------------------|
| 1 | D5-08D-P10-FS | 200131 |
| 2 | D5-08D-P10-RT | 200344 |
| 3 | D5-DL-005-PS | 200345 |
| 4 | D5S-06AL-252-FS | 200443 |
| 5 | D5S-270L-B02-PS | 201101 |
| 6 | D5S-AL-252-PS | 201102 |
| 7 | D6-06DR-002-FS | 201103 |
| 8 | D6-08DR-002-FS | 201104 |
| 9 | D6-08DR-002-RT | 201105 |
| 10 | D6-08DR-252-RT | 201106 |
| 11 | D6-10DR-282-RT | 201107 |
| 12 | D6-10DR-P10-FS | 201108 |
| 13 | D6-10DR-P10-RS | 201109 |
| 14 | D6-10DR-P10-RT | 201110 |
| 15 | D6-DR-005-PS | 201112 |
| 16 | D6-DR-010-PS | 201113 |
| 17 | D6-DR-231-PS | 201114 |
| 18 | D6-DR-252-PS | 201115 |
| 19 | D6-QA-005-PS | - |
| 20 | D6-QD-010-PS | - |
| 21 | D6-QF-005-PS | - |
| 22 | D6S-08DR-PRY-FS | - |
| 23 | D6S-270L-252-PS | - |
| 24 | D7-06DL-002-FS | - |
| 25 | D7-08DL-002-FS | - |
| 26 | D7-08DR-002-FS | - |
| 27 | D7-08DR-002-RT | - |
| 28 | D7-08DR-005-FS | - |
| 29 | D7-08DR-252-RT | - |
| 30 | D7-08R-HIS-FS | - |
| 31 | D7-08R-HIS-RT | - |
| 32 | D7-10DR-282-RT | - |
| 33 | D7-10DR-P10-FS | - |
| 34 | D7-10DR-P10-RS | - |
| 35 | D7-10DR-P10-RT | - |
| 36 | D7-10FR-252-RT | - |
| 37 | D7-270RG-252-PS | - |
| 38 | D7-270RL-252-PS | - |
| 39 | D7-DL-005-PS | - |
| 40 | D7-DL-010-PS | - |
| 41 | D7-DL-252-RT | - |
| 42 | D7-DR-005-PS | - |
| 43 | D7-DR-010-PS | - |
| 44 | D7-DR-252-PS | - |
| 45 | D7-PSL-252-PS | - |
| 46 | OD7-3X4D-010-FS | - |
| 47 | OD7-8X2D-005-FS | - |

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### Indications for Use

510(k) Number (if known): K043513

Reprocessed Deflectable Electrophysiology Diagnostic Catheters Device Name:

Indications For Use:

The SterilMed Reprocessed Electrophysiological Diagnostic Catheters are intended for The Dierminou resproosescophysiology studies for intracardiac sensing, recording, and stimulation. They also provide temporary pacing for the evaluation of cardiac armulation. - They are used for electrophysiology mapping of cardiac structures during these evaluations.

Prescription Use X

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AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(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)

Blumme
(Division Sign-Off)

Division of Cardiovascular Devices 510(k) Number

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