(203 days)
The LIFEPAK 500 AED is intended for use on patients in cardiac arrest. It is intended for use in hospital and in out-of-hospital environments.
The LIFEPAK 500 AED is intended for use by personnel who are authorized by a medical director and have, at a minimum, the following skills and training:
- CPR training
- AED training equivalent to that recommended by the American Heart Association
- Training in the use of the LIFEPAK 500 AED
The LIFEPAK 500 AED is to be used only on patients in cardiopulmonary arrest. The patient must be unconscious, not breathing normally, and showing no signs of circulation (for example, no pulse, and/or no coughing, no movement) before the device is used to analyze the patient's ECG rhythm. With Infant/Child Reduced Energy Defibrillation Electrodes, the specially configured biphasic LIFEPAK 500 AED may be used on children up to 8 years old or 25kg (55 lb).
The LIFEPAK 500 automated external defibrillator is a small, portable, battery operated device intended for treatment of cardiac arrest. The device uses a patented software algorithm to analyze the patient's electrocardiogram (ECG) to determine if a shockable rhythm is present. The LIFEPAK 500 AED will inform the operator if it detects a shockable rhythm and the operator can press the shock button to deliver energy. The energy is delivered via disposable defibrillation electrodes applied to the chest.
The provided 510(k) summary for the Medtronic biphasic LIFEPAK 500 Automated External Defibrillator (AED) focuses on establishing substantial equivalence to previously cleared devices rather than presenting a detailed study proving the device meets specific acceptance criteria in the traditional sense of a performance study with numerical endpoints.
The submission states: "The features and functions of the modified biphasic LIFEPAK 500 AED are the readies and railer [likely a typo, suggesting 'the same as and similar'] to the previously cleared Medtronic LIFEPAK 500 AED, Substantially Squarants K955854 (11/4/96), K983393 (05/05/99), K012428 (09/28/01), 310(k) hambers 119690); and the Philips Medical Systems Heartstream Heartstart FR2+ AED, 510(k) number K013425 (01/14/2002)." It also mentions, "Defibrillation technology and functionality are unchanged from the previously Declorination technology and Imerely and 500 software has been modified to allow the medical director or physician greater control over CPR settings."
Therefore, the "acceptance criteria" here are implicitly tied to the performance characteristics of the predicate devices, and the "study" is a demonstration of substantial equivalence through design control activities and comparison to those predicates. The document does not provide quantitative performance metrics, sample sizes for a test set, ground truth experts, or details of a standalone or MRMC study.
However, based on the information provided, we can infer some aspects and highlight what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from Predicate Equivalence) | Reported Device Performance (as stated in 510(k)) |
|---|---|
| Safe and effective cardiac arrest treatment | Intended for treatment of cardiac arrest |
| Accurate ECG rhythm analysis for shockable rhythms | Uses software algorithm to analyze ECG and determine if a shockable rhythm is present |
| Delivers appropriate energy for defibrillation | Informs operator of shockable rhythm and allows energy delivery via disposable defibrillation electrodes |
| Equivalent defibrillation technology and functionality as predicate devices | "Defibrillation technology and functionality are unchanged from the previously [cleared] Medtronic LIFEPAK 500" |
| Compliance with design controls | Includes a summary of design control activities and a declaration of conformity to design controls |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. The submission relies on substantial equivalence to predicate devices, which would have undergone their own testing. There is no new, independent clinical or performance test set described for this modified device.
- Data Provenance: Not specified for new testing. The reference devices K955854, K983393, K012428, and K013425 would have generated their own clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable as no independent test set or ground truth establishment process is described for this specific 510(k). The regulatory review of the predicate devices would have involved expert review.
4. Adjudication method for the test set
- Not applicable as no independent test set or adjudication process is described for this specific 510(k).
5. 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 MRMC study is mentioned. This device is an AED that uses an algorithm to determine shockable rhythms, not an AI-assisted diagnostic tool for human readers in the context of MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The device inherently operates as a "standalone" algorithm in its primary function of ECG analysis. The human operator presses the shock button after the device informs them a shockable rhythm is detected. However, the document does not describe a formal "standalone performance study" with specific metrics (e.g., sensitivity, specificity for rhythm analysis) for this specific modified device. It relies on the performance of the predicate devices. The algorithm's performance for rhythm analysis would have been established for the original LIFEPAK 500.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not specified for this 510(k). For AEDs, ground truth for rhythm analysis typically involves expert review of ECGs, often verified against clinical outcomes where appropriate.
8. The sample size for the training set
- Not specified. The software algorithm is "patented" and "modified to allow the medical director or physician greater control over CPR settings," suggesting the core rhythm detection algorithm was developed and validated previously with an unspecified training set.
9. How the ground truth for the training set was established
- Not specified. This would have been established during the development of the original LIFEPAK 500 algorithm. Typically, this involves a large dataset of ECGs with rhythm classifications established by expert cardiologists or electrophysiologists.
Summary of the "Study" provided in the 510(k):
The "study" for this 510(k) is a demonstration of substantial equivalence rather than a traditional performance study with new raw data. The core of the argument is that:
- The device's intended use and indications for use are the same as predicate devices.
- The fundamental defibrillation technology and functionality remain unchanged from previously cleared versions of the LIFEPAK 500.
- The software modification is related to CPR settings, not the core rhythm analysis or energy delivery, implying no impact on primary safety or effectiveness.
- The submission includes "a summary of design control activities and a declaration of conformity to design controls," which is the regulatory mechanism used to demonstrate that the modified device's changes do not introduce new safety or effectiveness concerns compared to the predicates.
Therefore, the acceptance criteria are met by virtue of the modified device being substantially equivalent to legally marketed predicate devices which have already met their respective acceptance criteria for safety and effectiveness.
§ 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.