(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.
§ 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.