(180 days)
The LIFEPAK 20 and LIFEPAK 20e defibrillator/monitors are intended for use in the hospital, physician's office, and clinic setting by personnel who are authorized by a physician/medical director. Thev are intended for use on a "crash cart" as well as for portable emergency response throughout a hospital.
Indications for Use (for both the LIFEPAK 20 and LIFEPAK 20e defibrillator/monitors):
Manual Defibrillation
Indications: Defibrillation is a recognized means of terminating certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. Delivery of this energy in the synchronized mode is a method for treating atrial fibrillation, atrial flutter, paroxysmal supraventricular tachycardia, and, in relatively stable patients, ventricular tachycardia.
Contraindications: Defibrillation is contraindicated in the treatment of Pulseless Electrical Activity (PEA) such as idioventricular escape rhythms, and in the treatment of asystole.
Automated External Defibrillation:
Indications: The AED mode is to be used only on patients in cardiopulmonary arrest. The patient must be unconscious, pulseless, and not breathing normally before using the defibrillator to analyze the patient's ECG rhythm. In AED mode, the LIFEPAK 20 (and LIFEPAK 20e) defibrillator/monitor is not intended for use on pediatric patients less than 8 years old.
Noninvasive Pacing
Indications: Noninvasive pacing is indicated for symptomatic bradycardia in patients with a pulse.
Contraindications: Noninvasive pacing is contraindicated for the treatment of ventricular fibrillation and asystole.
Pulse Oximetry
Indications: The pulse oximeter is indicated for use in any patient who is at risk of developing hypoxemia.
End-Tidal CO2 monitoring:
Indications: EtCO2 monitoring is used to detect the level of expired CO2. It is used for monitoring breathing efficacy and treatment effectiveness in acute cardiopulmonary care, for example, to determine if adequate compressions are being performed during CPR or to rapidly detect whether an endotracheal tube has been placed successfully.
The LIFEPAK 20 and LIFEPAK 20e defibrillator/monitors were designed especially for hospitals and clinics for use on "crash carts" as well as for portable emergency response throughout a hospital. Features of the LIFEPAK 20 and LIFEPAK 20e defibrillator/monitors include manual and automated external defibrillation, noninvasive pacing, ECG monitoring (3-wire or 5-wire), pulse oximetry, and synchronized cardioversion. The LIFEPAK 20 and LIFEPAK 20e defibrillator/monitors are powered by AC power and a backup internal battery. The LIFEPAK 20 defibrillator/monitor utilizes a nickel-metal hydride internal battery while the LIFEPAK 20e defibrillator/monitor utilizes a lithium-ion internal battery. The LIFEPAK 20e defibrillator/monitor also has a battery status indicator on the device screen.
In addition to the features described above, the proposed LIFEPAK 20 and LIFEPAK 20e defibrillator/monitors have a new CO2 monitoring feature, CPR metronome feature, wireless data transmission capability and a new optional accessory named the CodeManagement Module™.
This document describes the Physio-Control LIFEPAK® 20 defibrillator/monitor and LIFEPAK® 20e defibrillator/monitor. The notification focuses on a new CO2 monitoring feature and a CPR metronome feature added to these existing devices.
Here's an analysis of the provided information regarding acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that the new features in the proposed LIFEPAK 20 and LIFEPAK 20e defibrillator/monitors are similar to the CO2 monitoring and CPR metronome features in the predicate LIFEPAK 15 monitor/defibrillator.
The conclusion of testing states: "The information in this 510(k) notification demonstrates that the LIFEPAK 20 and LIFEPAK 20e defibrillator/monitors are substantially equivalent to the predicate LIFEPAK 20 defibrillator/monitor, LIFEPAK 20e defibrillator/monitor and the LIFEPAK 15 monitor/defibrillator with respect to safety, effectiveness, and performance."
Since the primary claim for the new features is substantial equivalence to existing predicate devices, the "acceptance criteria" are implicitly met by demonstrating that the new features function comparably to the predicate device, the LIFEPAK 15 monitor/defibrillator. The provided text does not explicitly list quantitative acceptance criteria for the CO2 monitoring or CPR metronome features, nor does it provide a table of "reported device performance" in terms of specific metrics like accuracy, sensitivity, or specificity for these new features. Instead, it relies on the established performance of the predicate device.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document states "Performance testing of the proposed devices consisted of bench testing."
- Data Provenance: Not specified, but generally, bench testing would involve laboratory-generated or simulated data. It does not mention real patient data or country of origin.
- Retrospective/Prospective: Not applicable as no clinical studies were performed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No experts or ground truth establishment relevant to algorithm performance (like image interpretation) using a test set is described. The evaluation was bench testing based on substantial equivalence.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No human adjudication for a test set is described.
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. The document explicitly states: "No clinical studies or non-clinical (i.e. animal) studies were submitted as part of this 510(k) notification." This means no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in a sense, as the performance testing described as "bench testing" would evaluate the device's CO2 monitoring and CPR metronome features independently, likely against known physiological parameters or simulated conditions. However, the exact methodology and metrics are not detailed beyond "bench testing."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For "bench testing," the ground truth would typically be established by known, controlled inputs (e.g., a gas mixture with a specific CO2 concentration, or a mechanical device simulating CPR compressions at a known rate). The document does not specify the exact nature of the ground truth for the bench testing, but it would not be expert consensus, pathology, or outcomes data.
8. The sample size for the training set:
- Not applicable. The document describes a 510(k) submission for device modifications (CO2 monitoring and CPR metronome) based on substantial equivalence to a predicate device. It is not an AI/ML algorithm requiring a training set in the conventional sense. The features are presented as being "similar to" those in the predicate, implying established engineering principles and likely internally validated existing algorithms from the predicate device.
9. How the ground truth for the training set was established:
- Not applicable, as there is no mention of a training set for an AI/ML algorithm.
§ 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.