(201 days)
Defibrillation is indicated for the termination of 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.
The biphasic waveform has only been clinically studied on adults; it has not been studied on pediatric patients.
The AED mode 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.
In AED mode, the LIFEPAK 20 defibrillator/monitor is not intended for use on pediatric patients less than eight years old.
Noninvasive pacing as a therapy is indicated for patients with symptomatic bradycardia or asystole.
Pulse Oximetry is indicated for use in any patient who is at risk of developing hypoxemia.
The LIFEPAK 20 device is a defibrillator/monitor primarily intended for the hospital and clinic setting. It is easy to use, portable, easy to maintain, and fits comfortably on a gurney during transport. It has a built in AC power supply and backup NiMH battery. It uses a biphasic waveform with an energy range from 2 - 360 Joules.
Features and options include: external noninvasive pacemaker; pulse oximeter; 3-, 6-, and 7-lead ECG; defibrillation paddles; ability to use all disposable electrodes or paddles currently used with the LIFEPAK 12 defibrillator/monitor/pacemaker; internal paddles capability; 50 mm printer; automated external defibrillator mode; built in AC power with NiMH battery backup; digital remote synchronization to bedside monitor; and an infrared and serial ports for data download.
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Medtronic Physio-Control LIFEPAK 20 Defibrillator/Monitor:
Overall Assessment:
The provided document (510(k) Premarket Notification) for the LIFEPAK 20 primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices (LIFEPAK 9P and LIFEPAK 12). This means that instead of conducting new, extensive clinical studies to prove effectiveness and safety from scratch, the manufacturer argues that the new device is as safe and effective as existing, legally marketed devices.
Therefore, the document does not describe specific acceptance criteria and detailed study results in the manner one might expect for a de novo device submission where new performance metrics are established and then proven through dedicated trials. Instead, it relies on compliance with recognized standards and the inherent equivalence to predicate devices that have already met regulatory requirements.
1. Table of Acceptance Criteria and Reported Device Performance:
Given the nature of this 510(k) submission, a direct table of "acceptance criteria" against "reported device performance" (in the sense of specific clinical endpoints with numerical targets) is not explicitly provided. The acceptance criteria are implicitly tied to:
- Compliance with recognized standards: AAMI, IEC, and ISO standards for defibrillators, monitors, and pulse oximeters.
- Substantial equivalence to the predicate devices in terms of safety, effectiveness, and performance.
The document states that these criteria are met, but does not provide specific performance data points in a table format.
| Acceptance Criterion (Implicit) | Reported Device Performance (Implicit/Stated) |
|---|---|
| Compliance with AAMI, IEC, and ISO defibrillator standards | "The 510(k) includes documentation related to the compliance of the LIFEPAK 20 device with AAMI, IEC, and ISO defibrillator, monitor, and pulse oximeter standards." (SECTION E - Summary of Performance Information) |
| Compliance with AAMI, IEC, and ISO monitor standards | "The 510(k) includes documentation related to the compliance of the LIFEPAK 20 device with AAMI, IEC, and ISO defibrillator, monitor, and pulse oximeter standards." |
| Compliance with AAMI, IEC, and ISO pulse oximeter standards | "The 510(k) includes documentation related to the compliance of the LIFEPAK 20 device with AAMI, IEC, and ISO defibrillator, monitor, and pulse oximeter standards." |
| Substantial equivalence to predicate devices (LIFEPAK 9P, 12) | "The features and functions of the LIFEPAK 20 defibrillator/monitor are substantially equivalent to those of the Medtronic Physio-Control LIFEPAK 9P defibrillator/monitor... and the LIFEPAK 12 defibrillator/monitor..." |
| "The information in this 510(k) demonstrates that the LIFEPAK 20 defibrillator/monitor is substantially equivalent to the predicate devices with respect to safety, effectiveness, and performance." (SECTION E - Substantial Equivalence and Summary of Performance Information) | |
| Biphasic waveform effectiveness (adults) | "The biphasic waveform has only been clinically studied on adults" (Implying effectiveness for adults based on previous studies, not necessarily a new study for this specific device). |
| AED mode for patients in cardiopulmonary arrest (>= 8 years old) | "The Automated External Defibrillation mode is for use on patients in cardiopulmonary arrest. It is not intended for use on patients less than 8 years old." (Indication for Use) |
| Noninvasive pacing for symptomatic bradycardia/asystole | "Noninvasive pacing is used as a means of treating symptomatic bradycardia and asystole." (Indication for Use) |
| Pulse Oximetry for hypoxemia risk | "Pulse Oximetry is used to check the saturation of oxygen in arterial blood (SpQs). It is indicated for use in any patient who is at risk of developing hypoxemia." (Indication for Use) |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not describe a specific "test set" or a new clinical study with a defined sample size for the LIFEPAK 20 itself. Instead, it relies on the established performance of its predicate devices and compliance with international standards.
- Sample Size for Test Set: Not applicable or not specified for a new, dedicated study. The evidence is based on the general acceptance of the predicate devices and standard compliance.
- Data Provenance: Not applicable in the sense of a new clinical trial. The "data" stems from the validation/clearance of the predicate devices and the technical verification processes (likely in-house testing) to ensure compliance with standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This information is not provided. Since no new clinical "test set" (in the sense of patient data requiring expert ground truth) is described for the LIFEPAK 20's performance validation, there's no mention of experts or their qualifications for establishing ground truth for a novel dataset.
4. Adjudication Method for the Test Set:
Not applicable, as no new clinical "test set" requiring expert adjudication is described in this 510(k) summary.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
No, an MRMC comparative effectiveness study is not mentioned or described in the provided text.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
The LIFEPAK 20 is a medical device that includes various functions (defibrillation, monitoring, pacing, oximetry). While it has an "automated external defibrillator mode," the document does not describe a separate "standalone algorithm" performance study in the context of AI or advanced diagnostic algorithms. Its "automated" function would have been validated as part of its overall design and compliance with AED standards.
7. The Type of Ground Truth Used:
For the LIFEPAK 20 itself, the "ground truth" for its performance is implicitly derived from:
- Compliance with established performance standards (AAMI, IEC, ISO): These standards define performance requirements that are met through engineering validation and testing.
- Performance of predicate devices: The predicate devices (LIFEPAK 9P, LIFEPAK 12) have already undergone their own regulatory clearance, which would have involved demonstrating effectiveness and safety, potentially using clinical data, expert consensus, or other forms of ground truth suitable for those devices at their time of submission.
There's no mention of pathology, explicit expert consensus on a novel dataset for the LIFEPAK 20, or outcomes data specific to the LIFEPAK 20's primary 510(k) submission.
8. The Sample Size for the Training Set:
Not applicable. This is a medical device, not an AI/machine learning algorithm that requires a "training set" in the conventional sense. Its design and functionality are based on engineering principles and established medical science, not on a machine learning model trained on a dataset.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no "training set" for this type of device.
§ 870.5300 DC-defibrillator (including paddles).
(a)
Low-energy DC-defibrillator —(1)Identification. A low-energy DC-defibrillator is a device that delivers into a 50 ohm test load an electrical shock of a maximum of 360 joules of energy used for defibrillating (restoring normal heart rhythm) the atria or ventricles of the heart or to terminate other cardiac arrhythmias. This generic type of device includes low energy defibrillators with a maximum electrical output of less than 360 joules of energy that are used in pediatric defibrillation or in cardiac surgery. The device may either synchronize the shock with the proper phase of the electrocardiogram or may operate asynchronously. The device delivers the electrical shock through paddles placed either directly across the heart or on the surface of the body.(2)
Classification. Class II (performance standards).(b)
High-energy DC-defibrillator —(1)Identification. A high-energy DC-defibrillator is a device that delivers into a 50 ohm test load an electrical shock of greater than 360 joules of energy used for defibrillating the atria or ventricles of the heart or to terminate other cardiac arrhythmias. The device may either synchronize the shock with the proper phase of the electrocardiogram or may operate asynchronously. The device delivers the electrical shock through paddles placed either directly across the heart or on the surface of the body.(2)
Classification. Class III (premarket approval).(c)
Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any DC-defibrillator (including paddles) described in paragraph (b)(1) of this section that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a DC-defibrillator (including paddles) described in paragraph (b)(1) of this section that was in commercial distribution before May 28, 1976. Any other DC-defibrillator (including paddles) described in paragraph (b)(1) of this section shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.