(87 days)
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 data: 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, Statpadz, and Statpadz II Electrodes.
The provided text describes the BIO-DETEK Electrode Adaptor and its 510(k) premarket notification. However, it does not contain information about specific acceptance criteria, device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case studies.
The document primarily focuses on:
- Device description and intended use.
- Technological characteristics and compliance with standards.
- The FDA's decision regarding substantial equivalence to a predicate device.
- Indications for Use.
Therefore, I cannot provide the requested information from the given text.
To answer your request, a study report or clinical data section would be needed, which is not present in this 510(k) summary and FDA letter.
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BIO-DETEK Electrode Adaptor 510(k) Premarket-Notification Submission
8.0 BIO-DETEK Electrode Adaptor 510(k) Summary
| Company: | BIO-DETEK525 Narragansett Park DrivePawtucket, RI 02861-4323 |
|---|---|
| Contact: | Robert MorseQA/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, Statpadz, and Statpadz 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, Statpadz, and Statpadz 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
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
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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.
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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
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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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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
§ 870.5310 Automated external defibrillator system.
(a)
Identification. An automated external defibrillator (AED) system consists of an AED and those accessories necessary for the AED to detect and interpret an electrocardiogram and deliver an electrical shock (e.g., battery, pad electrode, adapter, and hardware key for pediatric use). An AED system analyzes the patient's electrocardiogram, interprets the cardiac rhythm, and automatically delivers an electrical shock (fully automated AED), or advises the user to deliver the shock (semi-automated or shock advisory AED) to treat ventricular fibrillation or pulseless ventricular tachycardia.(b)
Classification. Class III (premarket approval)(c)
Date PMA or notice of completion of PDP is required. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED that was in commercial distribution before May 28, 1976. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976. Any other AED and AED accessory described in paragraph (a), shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.