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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.

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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 setup options in automated external defibrillation (AED) mode to give medical directors or physicians flexibility in establishing their AED protocols including consistency with the recently updated 2005 AHA Guidelines for CPR and ECC.

The provided document describes a 510(k) premarket notification for a modification to the Medtronic LIFEPAK® 20 Defibrillator/Monitor. While it outlines the device's features and intended use, it does not contain specific acceptance criteria or details of a study that proves the device meets those criteria for its modified features.

The modification described is related to "new setup options in automated external defibrillation (AED) mode to give medical directors or physicians flexibility in establishing their AED protocols including consistency with the recently updated 2005 AHA Guidelines for CPR and ECC."

The document states: "The new cprMAX setup options only affect operation in automated external defibrillation mode. Features of the modified LIFEPAK 20 defibrillator/monitor such as the ECG analysis system, defibrillation waveform, pacing, and pulse oximetry are the same as those of the predicate device. Defibrillation technology and functionality of the LIFEPAK 20 defibrillator/monitor has not changed from the previously cleared device."

This implies that for the new setup options, the company is asserting substantial equivalence based on consistency with guidelines rather than presenting a new study with acceptance criteria. For the core functionalities (ECG analysis, defibrillation waveform, pacing, pulse oximetry), they rely on the previous clearances (K033275, K012274) of the predicate device, as those features have not changed.

Therefore, I cannot extract the requested information (1-9) as it pertains to a new study proving performance against acceptance criteria for the modified device, because such information is not present in the provided text. The document focuses on regulatory compliance through substantial equivalence, not on new performance study data for the specific modification.

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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.

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.

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