(29 days)
Use the AED when a suspected cardiac arrest victim has an apparent LACK OF CIRCULATION as indicated by: Unconsciousness and Absence of normal breathing and Absence of a pulse or signs of circulation. When a victim is less than 8 years of age, or weighs less thank 55 lbs (25kg), the ZOLL AED Plus should be used with the ZOLL AED Plus Pediatric Electrodes. Therapy should not be delayed to determine the patient's exact age or weight.
The device is a lightweight, portable, battery-powered semi-automatic external defibrillator that uses voice prompts and visual icons to guide a user through a cardiac arrest rescue. The device utilized the ZOLL Rectilinear Bi-Phasic defibrillation waveform. The device is designed to be used by trained responders for the treatment of cardiac arrest. When connected with ZOLL AED Plus defibrillation electrodes to a patient, the device will analyze the electrocardiographic (ECG) rhythm of the patient and detect whether the rhythm is shockable or non-shockable. If the device detects a shockable rhythm, the device charges the capacitor, enables the treatment button and prompt the user to deliver the defibrillation energy to the patient. If the device detects a non-shockable rhythm, the device will prompt the user to begin CPR. The electrodes used with the device incorporates an accelerometer that mesures the depth of CPR compressions. This information is used by the device to provide feedback to the user and encourage the user to administer CPR in compliance with the American Heart Association (AHA) Guidelines. The device provides feedback in the form of a metronome (to encourage the proper CPR frequency of 100 compressions per minute) and a visual depth indicator on the display (to encourage the recommended compression depth).
Here's an analysis of the acceptance criteria and study information for the ZOLL AED Plus with the 2010 AHA Guidelines Software Update, based on the provided text.
Based on the provided text, the device in question is a software update for an existing Automatic External Defibrillator (AED), the ZOLL AED Plus. The update primarily changes the CPR compression depth feedback to align with the 2010 AHA Guidelines.
It is critical to understand that this submission is a 510(k) for a software update to an already cleared device, not a new device requiring extensive clinical trials for a de novo clearance. This means the performance testing primarily focuses on demonstrating that the updated software maintains the safety and effectiveness of the predicate device and meets the new CPR depth recommendations.
Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative "acceptance criteria" in a table format that would typically be seen for a new device's diagnostic performance (e.g., sensitivity, specificity for a diagnostic algorithm). Instead, the "acceptance criteria" implicitly relate to adhering to the new AHA guidelines and demonstrating substantial equivalence to the predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| CPR Compression Depth Feedback | |
| - Prompt user to "push harder" when compressions are |
§ 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.