MEDI-TRACE 1610C COMBINATION DEFIBRILLATION, MONITORING AND PACING ELECTRODE

{0}------------------------------------------------ 5 1998 NOV K98328 ## 510(k) SUMMARY المشاركة المستوى المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المن | | Date: | Graphic Controls<br>September 16, 1998 | |--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Manufacturing Facility: | Graphic Controls Corporation<br>189 Van Rensselaer Street<br>P.O. Box 1271<br>Buffalo, NY 14240<br>Registration Number 1317188 | | | Telephone: | (716) 853-7500 | | | Contact Person: | Kathleen Selover<br>Regulatory Affairs Specialist<br>(716) 853-7500, extension 7630<br>Fax: (716) 847-7531 | | | Device Trade Name: | Medi-Trace® 1610C Combination Defibrillation,<br>Monitoring and Pacing Electrode | | | Device Common Name: | Self Adhesive Defibrillation and Monitoring<br>Electrode | | | Classification Name: | Electrode, Electrocardiograph, Multifunction | | | Regulatory Reference: | 74MLN | | | Predicate Device: | Cardiotronics Systems, Inc., a division of Ballard<br>Medical Products,.R2® Pads™ Pacing/Defibrillation<br>and ECG Electrode | | | Description: | A pre-gelled conductive electrode consisting of a<br>pre-attached leadwire, and insulating layer of a vinyl<br>substrate, a secondary vinyl piece covering the<br>crimped wire connector, a layer of metal foil, a<br>conductive adhesive hydrogel, a pressure sensitive<br>adhesive (PSA) ring and a release liner. Device is<br>packaged in pairs in a heat sealed pouch; 10 pouches<br>are packaged into one shelf box shipper. | | Intended/Indications for Use: | Intended for use in defibrillation procedures,<br>cardioversion and pacing. This device is intended for<br>use on adults. | | | Physical/Technical Comparison: | Medi-Trace® 1610C Electrode is replaceable with<br>the Cardiotronics, Inc, a division of Ballard Medical<br>Products, R2® Pads™ Pacing/Defibrillation/ECG<br>Electrodes. Physical and technical characteristics,<br>including materials used in construction, size,<br>intended use and conductive gel type of these<br>electrodes are comparable. Since the formulation of<br>conductive gel of the predicate is considered to be<br>proprietary, exact chemical comparison could not be<br>made. | | | Performance Summary: | The device and the predicate were subject to AAMI<br>electrical tests as described in DF-39, 3.3.19 and<br>energy through put testing. Test results for both the<br>device and the predicate meet the specifications as<br>established in DF-39 for self adhesive electrodes for<br>monitoring and defibrillation and pacing. | | | | In addition, the device was subjected to simulated use<br>testing consisting of multiple defibrillation shocks,<br>maximum current pacing and ECG monitoring. Test<br>results for the device met the specifications as<br>established in DF-39 for self adhesive electrodes for<br>monitoring, defibrillation and pacing. | | | Biocompatibility Testing: | The device was subjected to biocompatibility testing<br>as recommended in ISO-10993, Biological<br>Evaluation of Medical Devices Part I: Evaluation<br>and Testing." The device was found to be<br>non-irritating, non-cytotoxic and non-sensitizing. | | | Shelf Life: | Data obtained in accelerated shelf life studies were<br>reviewed and found to substantiate our claimed shelf<br>life. | | {1}------------------------------------------------ 510(k) Summary Page 2 {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle faces right and appears to be in flight. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 NOV 5 1998 Susan A. Krasny, Ph.D. Graphic Controls Corporation 189 Van Rensselaer Street P.O. Box 1271 Buffalo, NY 14240-1271 K983287 Re: Medi-Trace® 1610C Combination Defibrillation, Monitoring and Pacing Electrode Requlatory Class: III (Three) Product Code: 74 MLN Dated: September 16, 1998 Received: September 18, 1998 Dear Dr. Krasny: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 reqistration, 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. {3}------------------------------------------------ Page 2 - Susan A. Krasny, Ph.D. This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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, sincerely yours, Thomas J. Callahon Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ Page _ 1 _ of ________________________________________________________________________________________________________________________________________________________________ 510(k) Number, if known: _____________________________________________________________________________________________________________________________________________________ K983287 ______________________________________________________________________________________________________________________________________________________________________________ Medi-Trace® 1610C Combination Defibrillation, Device Name: Monitoring and Pacing Electrode Indications for Use: The Medi-Trace® 1610C Combination Defibrillation, Monitoring and Pacing Electrode is intended for use in defibrillation procedures, cardioversion, pacing and ECG monitoring on adults. ## (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) ______________________________________________________________________________________________________________________________________________________________________________ ______________________________________________________________________________________________________________________________________________________________________________ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Concurrence of CDRH, Office of Device Evaluation (ODE) Mark Kramer | Prescription Use | OR | Over-the-Counter Use (Per 21 CFR 801.109) | |------------------|----|-------------------------------------------| |------------------|----|-------------------------------------------| (Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices | 510(k) Number | | |---------------|--| |---------------|--|