REPROCESSED DEFLECTABLE ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS

{0}------------------------------------------------ K051220 p.1/2 #### SECTION 3. 510(K) SUMMARY # JUN 1 4 2005 | Submitter: | SterilMed, Inc.<br>11400 73rd Avenue North<br>Minneapolis, MN 55369 | |------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Dr. Bruce Lester<br>VP Research and Development<br>Phone: (888) 856-4870<br>Fax: (763) 488-3350<br>blester@sterilmed.com | | Date Prepared: | May 11, 2005 | | Trade Name: | SterilMed Reprocessed Deflectable Electrophysiology<br>Diagnostic Catheters | | Classification Name<br>and Number: | Electrode Recording Catheter<br>Class II, 21 CFR 870.1220 | | Product Code: | NLH | | Predicate Device: | SterilMed Reprocessed Deflectable Electrophysiology<br>Diagnostic Catheters (K043513) | | Device Description: | The subject device consists of a reprocessed catheter that has a<br>high-torque shaft with a handle at the proximal end, and is<br>steerable. These catheters have an outer diameter of 5F to 7F, a<br>length ranging from 85 to 125 cm, with 4-20 platinum/iridium,<br>radiopaque electrodes along the tip shaft and a variety of inter-<br>electrode spacings and curve styles at the tip. The tip is<br>deflectable. Specific cables, as recommended by the original<br>manufacturer, connect to the handle and interface between the<br>catheter and an external stimulator and/or an electrophysiologic<br>recorder. It should be noted that this submission pertains to the<br>catheter only. It does not include any other components in a<br>system such as, connector cables, external stimulators, or<br>electrophysiologic recorders. | | Intended Use: | The SterilMed Reprocessed Electrophysiology Diagnostic<br>Catheters are intended for temporary use during<br>electrophysiology studies for intracardiac sensing, recording,<br>and stimulation. They also provide temporary pacing for the<br>evaluation of cardiac arrhythmias, and are used for<br>electrophysiology mapping of cardiac structures during these<br>evaluations. | | Functional and<br>Safety Testing: | Representative samples of reprocessed deflectable<br>electrophysiology diagnostic catheters underwent design testing<br>to demonstrate appropriate functional characteristics, and<br>biocompatibility testing to demonstrate compatibility of the<br>device materials. Process validation testing wa | | | | | addition, | the manufacturing process includes visual and functional testing of all products produced. | | Conclusion: | The new models of deflectable electrophysiology diagnostic catheters reprocessed by SterilMed are substantially equivalent to the models in the original 510(k). This conclusion is based upon the fact that the modified devices have the same fundamental scientific technology and intended use as the predicate device. | {1}------------------------------------------------ ## 长051220 p 2/2 1 {2}------------------------------------------------ Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human figure with outstretched arms. The symbol is composed of three curved lines that create a sense of movement and dynamism. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUN 1 4 2005 SterilMed, Inc. Bruce Lester, Ph.D. Vice President Research and Development 11400 73td Avenue North Minneapolis, MN 55369 Re: K051220 Trade Name: Sterilmed Reprocessed Deflectable Electrophysiology Diagnostic Catheters (See Enclosed List) Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter or Electrode Recording Probe Regulatory Class: Class II Product Code: NLH Dated: May 11, 2005 Received: May 12, 2005 Dear Dr. Lester: 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. {3}------------------------------------------------ Page 2 - Bruce Lester, Ph.D. 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 (240) 276-0120 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Bhimmon for Bran D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ## Page 3 – Bruce Lester, Ph.D. ## List of Model numbers | | Daig Livewire™ Electrophysiology Catheter | | | |--------|-------------------------------------------|--------|--------| | 401938 | 401606 | 401578 | 401581 | | 401939 | 401933 | 401579 | 401917 | | 401940 | 401934 | 401583 | 401582 | | 401941 | 401575 | 401584 | 401904 | | 401990 | 401915 | 401585 | 401905 | | 401991 | 401923 | 401586 | 401914 | | 401600 | 401926 | 401587 | 401908 | | 401603 | 401576 | 401588 | - | | 401572 | 401577 | 401580 | - | | EPT Polaris DX TM Steerable Diagnostic Catheter | EPT Polaris DX TM Steerable Diagnostic Catheter Shielded Connector | |-------------------------------------------------------|--------------------------------------------------------------------| | 5570 | 5570S | | 5571 | 5571S | | 5572 | 5572S | | 5573 | 5573S | | 5574 | 5574S | | 5575 | 5575S | | 5576 | 5576S | | 5577 | 5577S | | 5578 | 5578S | | 5579 | 5579S | | 9663 | 9663S | | 5427 | 5427S | | EPT Polaris XTTM Steerable Decapolar Mapping Catheter | | | 7000D | | | 7001D | | | 7003D | | | 7004D | | | 7005D | | | 7006D | | | EPT Polaris LETM Mapping Catheter | EPT Polaris LETM Mapping Catheter Shielded Connector | | 5590 | 5590S | | 5591 | 5591S | | 5592 | 5592S | | 5593 | 5593S | {5}------------------------------------------------ #### Page 4 – Bruce Lester, Ph.D. . --. : : : | 5501<br>ﻟﻢ ﺍﻟﺘﻲ ﺍﻟﻤﻬﺎﺟﺮ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘ | 55010<br>1 | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------| | 5505 | 55050 | | ن مور آهي له | ران ۾ ال ال | | 44.00 | 19 11 11 | and the comments of the comments of the comments of : ، : | Bard EP-XT Steerable Catheter | | |-------------------------------|--------| | 200769 | 200771 | | 200770 | 201009 | | 201116 | 200740 | | 200737 | 200738 | | 200735 | 200739 | | 200898 | 200736 | | 200525 | 200794 | | 200526 | 200795 | | 200527 | 200796 | | 200741 | 200797 | | 200772 | 200798 | {6}------------------------------------------------ #### INDICATIONS FOR USE SECTION 2: 510(k) Number (if known): Reprocessed Deflectable Electrophysiology Diagnostic Catheters Device Name: Indications For Use: The SterilMed Reprocessed Electrophysiological 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. Prescription Use X 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) Вватимиров vision Sian-Off Division of Cardiovascular Devices 510(k) Number Page 1 of 1