(86 days)
The BIO-DETEK Modified Adult Multi-Function Electrode with Connector is indicated for use with Medtronic Physio-Control Defibrillator Models: LIFEPAK 9, LIFEPAK 10C, LIFEPAK 11, LIFEPAK 500, LIFEPAK 12, and LIFEPAK 20, all fitted with QUIK-COMBO Therapy Cables, for defibrillation, cardioversion, non-invasive pacing, and electrocardingraph monitoring.
The BIO-DETEK Modified Adult Multi-Function Electrodes with Connector is indicated for use with Medtronic Physio-Control Defibrillator Models: LIFEPAK 9, LIFEPAK 10C, LIFEPAK 11, LIFEPAK 12, and LIFEPAK 20, all fitted with QUIK-COMBO Therapy Cable, for defibrillation, cardioversion, non-invasive pacing, and electrocardiograph monitoring.
The provided document does not contain information about specific acceptance criteria, device performance, a study conducted to demonstrate the device meets acceptance criteria, sample sizes, ground truth establishment, or human expert involvement.
Instead, this document is a 510(k) Premarket Notification Submission for the BIO-DETEK Modified Adult Multi-Function Electrodes with Connector. It focuses on demonstrating substantial equivalence to a previously marketed predicate device (BIO-DETEK Adult Multi-Function Electrodes, K931801).
The core of this submission is to show that the new device has "operation and technological characteristics" that are sufficiently similar to the predicate device, not necessarily to present a study proving the new device meets specific, quantifiable performance acceptance criteria.
The information provided includes:
- Device Name: BIO-DETEK Modified Adult Multi-Function Electrodes with Connector
- Intended Use: For use with specific Medtronic Physio-Control Defibrillator Models (LIFEPAK 9, 10C, 11, 12, 20) with QUIK-COMBO Therapy Cables for defibrillation, cardioversion, non-invasive pacing, and electrocardiograph monitoring.
- Predicate Device: BIO-DETEK Adult Multi-Function Electrodes (K931801)
- Compliance with Standards: The device is designed to comply with applicable portions of IEC 60601-2-4, ANSI/AAMI/ISO DF39-1993, ANSI/AAMI EC53:1995, and 21 CFR Part 898. These standards would contain performance requirements that the device should meet, but the document does not explicitly state the acceptance criteria derived from these standards or present test results against them.
- FDA Decision: The FDA letter confirms that the device is "substantially equivalent" to legally marketed predicate devices, allowing it to be marketed.
Therefore, based on the provided text, I cannot complete the requested tables and information regarding acceptance criteria and performance study details. The document is a regulatory submission for substantial equivalence, not a detailed technical report of a performance study.
§ 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.