(271 days)
The LIFEPAK 20e defibrillator/monitor is intended for use in the hospital, physician's office, and clinic setting by personnel who are authorized by a physician/medical director. It is intended for use on a "crash cart" as well as for portable emergency response throughout a hospital.
Manual Defibrillation:
Indications: Defibrillation is a recognized means of terminating certain 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.
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.
The LIFEPAK 20 defibrillator/monitor was created especially for hospitals and clinics for use on "crash carts" as well as for portable emergency response throughout a hospital. The LIFEPAK 20 defibrillator/monitor is equipped with AC power and a backup internal battery. Features of the LIFEPAK 20 defibrillator/monitor include manual and automated external defibrillation, noninvasive pacing, ECG monitoring (3-wire or 5-wire), pulse oximetry, and synchronized cardioversion.
The LIFEPAK 20 defibrillator/monitor has been modified with new battery technology. This modification includes a change in the chemistry of the internal battery from nickel-metal hydride to lithium ion, and the addition of a battery status indicator on the device display indicating the approximate amount of operating time available while using battery power.
The model name of devices with this new battery technology is the LIFEPAK 20e defibrillator/monitor.
The provided text describes a 510(k) premarket notification for the Physio-Control Inc. LIFEPAK 20e defibrillator/monitor. This submission focuses on modifications to an existing device, the LIFEPAK 20, specifically changing the internal battery chemistry and adding a battery status indicator.
Based on the provided information, a traditional "study" proving device performance against acceptance criteria, as one might expect for a novel AI device or a device with new clinical functionality, is not described. The submission leverages the substantial equivalence pathway, asserting that the new device's core functionalities (ECG analysis, defibrillation waveform, noninvasive pacing) are identical to the already cleared predicate device (LIFEPAK 20). The focus of this 510(k) is the battery change and its associated indicator.
Therefore, the acceptance criteria and supporting study are framed around demonstrating that the new battery technology does not adversely affect the device's existing, cleared performance and that the new battery indicator functions as intended.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with reported numerical performance for the LIFEPAK 20e. Instead, it states that the technological characteristics of the new device's core functions (ECG analysis system, defibrillation waveform, and noninvasive pacing) are the same as those of the predicate device. This implies that the acceptance criteria for these functionalities are met by virtue of being identical to the cleared predicate.
The main change is the battery, and the acceptance criterion implicitly relates to the battery's ability to power the device and its status indicator.
| Feature/Functionality | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Defibrillation waveform | Same as predicate LIFEPAK 20 | Same as predicate LIFEPAK 20 |
| ECG analysis system | Same as predicate LIFEPAK 20 | Same as predicate LIFEPAK 20 |
| Noninvasive pacing | Same as predicate LIFEPAK 20 | Same as predicate LIFEPAK 20 |
| Internal Battery | Functionally equivalent to predicate's battery (NiMH) in powering the device; safe and reliable operation. | Changed from Nickel-metal hydride to Lithium-ion; deemed substantially equivalent through design controls. |
| Battery status indicator | Provides accurate indication of available operating time. | Added to the device display and indicates approximate operating time. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a sample size for a test set in the context of clinical or performance data for the battery or the overall device performance. Given that the core functionalities are asserted to be identical to the predicate, it's highly probable that performance testing for the battery would involve bench testing and electrical safety assessments rather than a clinical "test set" with patient data.
The data provenance is not explicitly mentioned but would be from Physio-Control Inc.'s internal testing and design control activities, as implied by "Summary of Design Controls" and "declaration of conformity to design controls."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Given the nature of the submission (a battery change in an existing, cleared device), there is no mention of "experts" being used to establish ground truth in the way one would for a diagnostic AI algorithm. The performance of the underlying defibrillation, ECG, and pacing technologies is assumed to be established by the predicate device's clearance. For the battery component, electrical engineers and quality assurance experts within Physio-Control would have verified its performance against internal specifications.
4. Adjudication Method for the Test Set
No adjudication method is described, as there isn't a traditional clinical "test set" requiring expert review/adjudication in this 510(k) summary.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No MRMC study was done. This type of study is irrelevant for a device modification focused on a battery change, where the core clinical algorithms (defibrillation, ECG, pacing) remain unchanged from a predicate device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The device is not an "algorithm-only" device. It is a medical device, and its algorithms (ECG analysis, etc.) are integrated into the hardware. Its standalone performance for defibrillation, pacing, and ECG monitoring was part of the original predicate device's clearance. This 510(k) does not describe new standalone performance studies.
7. The Type of Ground Truth Used
For the core functionalities (defibrillation waveform, ECG analysis, pacing), the "ground truth" was established during the clearance of the predicate LIFEPAK 20. This would have involved a combination of:
- Engineering validation: Verifying the waveform output, energy delivery, etc.
- Physiological models: For testing rhythm analysis and pacing capabilities.
- Possibly clinical studies: For the original predicate device to demonstrate safety and effectiveness for its intended uses.
For the new battery technology, the "ground truth" would be engineering specifications and safety standards for lithium-ion batteries in medical devices, along with performance targets for operating time.
8. The Sample Size for the Training Set
There is no mention of a "training set" in the context of machine learning. The device is not described as an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set, the establishment of its ground truth is not applicable to this submission.
§ 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.