(222 days)
The LIFEPAK 500 AED is to be used only on patients in cardiopulmonary arrest. The patient must be unconscious, pulseless, and not breathing spontaneously before using the defibrillator to analyze the patient's ECG rhythm. It is not intended for use on children less than eight years of age, per Att A quidelines .
The Biphasic LIFEPAK 500 Automated External Defibrillator (AED) is a portable battery powered device which applies a brief, high energy pulse of electricity to the heart via defibrillation electrodes on the chest. A software algorithm analyzes the patients electrocardiogram (ECG) and informs the operator whether it detects a shockable rhythm. The operator can then press the shock button to deliver energy after confirming that the patient is unconscious, pulseless and apneic.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Medtronic Physio-Control Corporation Biphasic LIFEPAK® 500 Automated External Defibrillator:
Acceptance Criteria and Device Performance
The provided 510(k) summary does not explicitly list quantitative acceptance criteria in a table format, nor does it provide a direct table of reported device performance against such criteria. Instead, it states that the device is "substantially equivalent" to predicate devices and complies with relevant AAMI standards.
The primary performance metric mentioned is the "efficacy of the biphasic truncated exponential waveform."
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices | Claimed: "This defibrillator is substantially equivalent to the currently marketed Physio-Control LIFEPAK 500 automated external defibrillator, 510(k) no. K955854; the LIFEPAK® 100 AED, 510(k) no. K832833; the Heartstream Forerunner AED, 510(k) no. K955628; the Laerdal Heart-Start 3000 AED, 510(k) no. K896919; and the Mine Safety and CRC Heart Aid defibrillators, both Preamendment devices." |
| "Test information demonstrates that the safety and effectiveness of the biphasic LIFEPAK 500 are substantially equivalent to those of the predicate devices." | |
| Compliance with AAMI DF39-1993 | Claimed: "Information provided in the 510(k) demonstrates substantial compliance with applicable sections of AAMI DF39-1993, 'Automated External Defibrillators and Remote-Control Defibrillators.'" |
| Compliance with AAMI DF2-1989 | Claimed: "Information provided in the 510(k) demonstrates substantial compliance with applicable sections of AAMI DF2-1989, 'Cardiac Defibrillator Devices.'" |
| Efficacy of Biphasic Waveform (vs. Monophasic Predicate) | Claimed: "The efficacy of the biphasic truncated exponential waveform was demonstrated in a multisite clinical study. The results of this and other studies provided with the 510(k) demonstrate the substantial equivalence of the biphasic truncated exponential waveform." (Specific quantitative efficacy results are not provided in this summary, but the study "demonstrated" it). |
| Safe to use (Implied via regulatory approval and equivalence) | Claimed: Regulatory approval signifies that the FDA has determined the device to be safe and effective for its intended use, based on the provided data establishing substantial equivalence. The letter explicitly states, "We have determined the device is substantially equivalent... You may, therefore, market the device, subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act)." This implies all safety criteria for AEDs were met or demonstrated to be equivalent to safely marketed devices. |
Study Details from the Provided Text:
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Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated in the provided text. The text mentions a "multisite clinical study" but does not give the number of patients or events.
- Data Provenance: Not explicitly stated (e.g., country of origin). The study is described as "multisite clinical," suggesting it involved multiple locations, but specific geographic regions are not mentioned. It is implied to be prospective since it's a clinical study to demonstrate efficacy for a new waveform.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the given text.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not provided in the given text. The description focuses on the device's waveform efficacy rather than a diagnostic algorithm requiring expert adjudication of outputs.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No background for MRMC study: The device is an Automated External Defibrillator (AED), which relies on an algorithm to analyze the patient's ECG and inform the operator. It's not a diagnostic imaging device where human readers interpret results aided by AI. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not applicable in this context and was not done according to the provided information.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in essence. The core of the device is its "software algorithm [that] analyzes the patients electrocardiogram (ECG) and informs the operator whether it detects a shockable rhythm." The "efficacy of the biphasic truncated exponential waveform" was demonstrated in a clinical study. This efficacy relates to the device's ability to successfully defibrillate, which is a direct outcome of its core function (waveform delivery) after the algorithm identifies the rhythm. While a human delivers the shock, the critical step of rhythm analysis and energy delivery (waveform) is automated; therefore, the clinical study essentially evaluates the standalone performance of the device's ability to treat shockable rhythms.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for evaluating AEDs typically involves clinical outcomes data (e.g., successful termination of ventricular fibrillation/tachycardia, return of spontaneous circulation, survival to discharge) as observed in a clinical setting. The statement "The efficacy of the biphasic truncated exponential waveform was demonstrated in a multisite clinical study" strongly implies the use of such outcomes data as ground truth. The algorithm's accuracy in identifying shockable rhythms would also be a critical part of the ground truth, likely established by comparison to physician-interpreted ECGs or established rhythm classifications.
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The sample size for the training set:
- This information is not provided in the given text. The summary focuses on the substantial equivalence and clinical validation of the new waveform, not the internal development or training of the ECG analysis algorithm.
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How the ground truth for the training set was established:
- This information is not provided in the given text. Similarly to the training set sample size, details about the algorithm's development or training ground truth are outside the scope of this 510(k) summary.
§ 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.