BIO-DETEK ELECTRODE ADAPTER, MODEL R2001-90

{0}------------------------------------------------ # BIO-DETEK Electrode Adaptor 510(k) Premarket-Notification Submission #### 8.0 BIO-DETEK Electrode Adaptor 510(k) Summary | Company: | BIO-DETEK<br>525 Narragansett Park Drive<br>Pawtucket, RI 02861-4323 | |-------------------|----------------------------------------------------------------------| | Contact: | Robert Morse<br>QA/QC Manager | | Date Prepared: | January 12, 2004 | | Name of Device: | BIO-DETEK Electrode Adaptor | | Predicate Device: | Heartstream Electrode Adaptor K#984286 | # Device Description and Intended Use: The BIO-DETEK Electrode Adaptor is indicated for use with ZOLL CPR-D, Stat*padz, and Stat*padz II Electrodes for connection with Medtronic Physio-Control Defibrillator Models: LIFEPAK 9, LIFEPAK 10C, LIFEPAK 11, LIFEPAK 12, and LIFEPAK 20, all fitted with QUIK-COMBO™ Therapy Cable. The BIO-DETEK Electrode Adaptor is made of rigid thermoplastic and conductive material. The adaptor will be provided as a reusable stand-alone accessory to be used in conjunction with ZOLL CPR-D, Stat*padz, and Stat*padz II Electrodes. # Technological Characteristics The BIO-DETEK Electrode Adaptor is designed to comply with the applicable portions of the following standards: - 9 IEC 60601-2-4 Medical Electrical Equipment - 트 ANSI/AAMI/ISO DF39-1993 - 지 ANSI/AAMI EC53:1995 - 21 CFR Par 898 Performance Standards for Electrode Lead Wires and Patient Cables {1}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the department's name around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure. APR = 9 2004 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Bio-Detek, Inc. c/o Mr. Robert Morse QA/QC Manager 525 Narragansett Park Drive Pawtucket, RI 02861-4323 Re: K040056 Trade Name: BIO-DETEK Electrode Adaptor Regulation Number: 21 CFR 870.2360 Regulation Name: Electrocardiograph Electrode Regulatory Class: III (three) Product Codc: MLN Dated: January 12, 2004 Received: January 13, 2004 Dear Mr. Morse: 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 prodicate 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 aporoval 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 adultcration. 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. {2}------------------------------------------------ Page 2 - Mr. Robert Morse Please be advised that FDA's issuance of a substantial equivalence determination does not mean r that FDA has made a determination that your device complies with other requirements of the Act that I Dr Has intact and regulations administered by other Federal agencies. You must or uny vith 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. product taxialled on and begin marketing your device as described in your Section 510(k) I mis letter will and my and one of substantial equivalence of your device to a legally premarket netilicated 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 if you desire specific as not as (301) 594-4648. 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, Dina R. Vahner Image /page/2/Picture/5 description: The image shows a signature. The signature is composed of a few curved lines and a straight line. The signature is in black ink and is on a white background. Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ # Indications for Use 510(k) Number: K040056 Device Name: BIO-DETEK Electrode Adapter Intended Use: The BIO-DETEK Electrode Adapter is indicated for use with ZOLL CPR-D, stat-padz™ and statepadz II™ Electrodes for connection with Medtronic Physio-Control Defibrillator and dala: LIFEPAK 9, LIFEPAK 10C, LIFEPAK 11, LIFEPAK 12, and LIFEPAK 20, all fitted with QUIK-COMBO Therapy Cable .. Prescription Use ﺮ (Part 21 CFR 801 Subpart D) Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ AND/OR (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Dana R. Vachner (Division Sign-off) Division of Cardiovascular Devices E NUMBER K040056