The LIFEPAK 500 AED 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. It is not intended for use on children less than eight years of age, per Att A quidelines .

Device Description

The Biphasic LIFEPAK 500 Automated External Defibrillator (AED) is a portable battery powered device which applies a brief, high energy pulse of electricity to the heart via defibrillation electrodes on the chest. A software algorithm analyzes the patients electrocardiogram (ECG) and informs the operator whether it detects a shockable rhythm. The operator can then press the shock button to deliver energy after confirming that the patient is unconscious, pulseless and apneic.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Medtronic Physio-Control Corporation Biphasic LIFEPAK® 500 Automated External Defibrillator:

Acceptance Criteria and Device Performance

The provided 510(k) summary does not explicitly list quantitative acceptance criteria in a table format, nor does it provide a direct table of reported device performance against such criteria. Instead, it states that the device is "substantially equivalent" to predicate devices and complies with relevant AAMI standards.

The primary performance metric mentioned is the "efficacy of the biphasic truncated exponential waveform."

Acceptance Criteria (Inferred)	Reported Device Performance
Substantial Equivalence to Predicate Devices	Claimed: "This defibrillator is substantially equivalent to the currently marketed Physio-Control LIFEPAK 500 automated external defibrillator, 510(k) no. K955854; the LIFEPAK® 100 AED, 510(k) no. K832833; the Heartstream Forerunner AED, 510(k) no. K955628; the Laerdal Heart-Start 3000 AED, 510(k) no. K896919; and the Mine Safety and CRC Heart Aid defibrillators, both Preamendment devices." "Test information demonstrates that the safety and effectiveness of the biphasic LIFEPAK 500 are substantially equivalent to those of the predicate devices."
Compliance with AAMI DF39-1993	Claimed: "Information provided in the 510(k) demonstrates substantial compliance with applicable sections of AAMI DF39-1993, 'Automated External Defibrillators and Remote-Control Defibrillators.'"
Compliance with AAMI DF2-1989	Claimed: "Information provided in the 510(k) demonstrates substantial compliance with applicable sections of AAMI DF2-1989, 'Cardiac Defibrillator Devices.'"
Efficacy of Biphasic Waveform (vs. Monophasic Predicate)	Claimed: "The efficacy of the biphasic truncated exponential waveform was demonstrated in a multisite clinical study. The results of this and other studies provided with the 510(k) demonstrate the substantial equivalence of the biphasic truncated exponential waveform." (Specific quantitative efficacy results are not provided in this summary, but the study "demonstrated" it).
Safe to use (Implied via regulatory approval and equivalence)	Claimed: Regulatory approval signifies that the FDA has determined the device to be safe and effective for its intended use, based on the provided data establishing substantial equivalence. The letter explicitly states, "We have determined the device is substantially equivalent... You may, therefore, market the device, subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act)." This implies all safety criteria for AEDs were met or demonstrated to be equivalent to safely marketed devices.

Study Details from the Provided Text:

Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated in the provided text. The text mentions a "multisite clinical study" but does not give the number of patients or events.
- Data Provenance: Not explicitly stated (e.g., country of origin). The study is described as "multisite clinical," suggesting it involved multiple locations, but specific geographic regions are not mentioned. It is implied to be prospective since it's a clinical study to demonstrate efficacy for a new waveform.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the given text.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not provided in the given text. The description focuses on the device's waveform efficacy rather than a diagnostic algorithm requiring expert adjudication of outputs.
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 background for MRMC study: The device is an Automated External Defibrillator (AED), which relies on an algorithm to analyze the patient's ECG and inform the operator. It's not a diagnostic imaging device where human readers interpret results aided by AI. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not applicable in this context and was not done according to the provided information.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in essence. The core of the device is its "software algorithm [that] analyzes the patients electrocardiogram (ECG) and informs the operator whether it detects a shockable rhythm." The "efficacy of the biphasic truncated exponential waveform" was demonstrated in a clinical study. This efficacy relates to the device's ability to successfully defibrillate, which is a direct outcome of its core function (waveform delivery) after the algorithm identifies the rhythm. While a human delivers the shock, the critical step of rhythm analysis and energy delivery (waveform) is automated; therefore, the clinical study essentially evaluates the standalone performance of the device's ability to treat shockable rhythms.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for evaluating AEDs typically involves clinical outcomes data (e.g., successful termination of ventricular fibrillation/tachycardia, return of spontaneous circulation, survival to discharge) as observed in a clinical setting. The statement "The efficacy of the biphasic truncated exponential waveform was demonstrated in a multisite clinical study" strongly implies the use of such outcomes data as ground truth. The algorithm's accuracy in identifying shockable rhythms would also be a critical part of the ground truth, likely established by comparison to physician-interpreted ECGs or established rhythm classifications.
The sample size for the training set:
- This information is not provided in the given text. The summary focuses on the substantial equivalence and clinical validation of the new waveform, not the internal development or training of the ECG analysis algorithm.
How the ground truth for the training set was established:
- This information is not provided in the given text. Similarly to the training set sample size, details about the algorithm's development or training ground truth are outside the scope of this 510(k) summary.

Summary

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1983393

MAY 5 1599

510(k) Summary

Submitter's Name and Address: Medtronic Physio-Control Corp. 11811 Willows Road Northeast P.O. Box 97006 Redmond, WA 98073

Michael D. Willingham Contact Person: (425) 867-4329

Date Summary Prepared: September 23, 1998

Device:

Physio-Control Corporation Biphasic LIFEPAK® 500 Automated External Defibrillator

Classification:

Low-Energy DC - Defibrillators (including Paddles): Class II (21 CFR 870.5300) (Federal Register Vol. 45, No. 25; Tuesday, February 5, 1980)

Automatic External Defibrillators have been considered Class III devices by FDA.

Substantial Equivalence:

This defibrillator is substantially equivalent to the currently marketed Physio-Control LIFEPAK 500 automated external defibrillator, 510(k) no. K955854; the LIFEPAK® 100 AED, 510(k) no. K832833; the Heartstream Forerunner AED, 510(k) no. K955628; the Laerdal Heart-Start 3000 AED, 510(k) no. K896919; and the Mine Safety and CRC Heart Aid defibrillators, both Preamendment devices.

Description:

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Intended Use:

The Biphasic LIFEPAK 500 Automated External Defibrillator may be used in the hospital or pre-hospital setting by emergency responders to terminate certain potentially fatal cardiac arrhythmias.

Technological characteristics of new and predicate devices:

The features and functionality of the new LIFEPAK 500 AED are the same as those of the currently marketed LIFEPAK 500 AED with one exception: The currently marketed LIFEPAK 500 AED uses a monophasic damped sine waveform; the new LIFEPAK 500 AED uses a biphasic truncated exponential waveform.

Summary of Performance Information:

Test information demonstrates that the safety and effectiveness of the biphasic LIFEPAK 500 are substantially equivalent to those of the predicate devices:

Information on regression testing of the waveform circuit change has been provided in the 510(k).

Information provided in the 510(k) demonstrates substantial compliance with applicable sections of AAMI DF39-1993, " Automated External Defibrillators and Remote-Control Defibrillators," and AAMI DF2-1989, "Cardiac Defibrillator Devices."

The efficacy of the biphasic truncated exponential waveform was demonstrated in a multisite clinical study. The results of this and other studies provided with the 510(k) demonstrate the substantial equivalence of the biphasic truncated exponential waveform.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle or bird with three lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 5 1999

Mr. Michael D. Willingham Vice President, Quality & Regulatory Affairs Physio-Control Corporation 11811 Willows Road Northeast Post Office Box 97006 Redmond, WA 98073-9706

Re: K983393 LIFEPAK 500® Biphasic Automatic External Defibrillator Requlatory Class: III (three) Product Code: 74 MKJ Dated: January 29, 1999 Received: February 4, 1999

Dear Mr. Willingham:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments. You may, therefore, market the device, subject to the general controls provisions of the Federal Food, Druq, and Cosmetic Act (Act). The general controls provisions of the Act include requirements for annual reqistration, listing of devices, qood manufacturing practice, and labeling, and prohibitions aqainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under section 531 through 542 of the Act for

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Page 2 - Mr. Michael D. Willingham

devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.

On August 16, 1993 the Final Rule for Device Tracking was published in the Federal Register, pages 43442-43455 (copy enclosed). Be advised that under Section 519(e) of the Act as amended by the Safe Medical Devices Act of 1990, FDA has identified the above device as a device which requires tracking. Because the device is subject to tracking, you are required to adopt a method of tracking that follows the devices through the distribution chain and then identifies and follows the patients who receive them. The specific requirements of the requlation are found in 21 CFR 821 as described in the August 16, 1993 Federal Register beginning on page 43447.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a leqally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please not the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act, may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Arth. A. Ciarlowski.

Thomas J. Callahan, Ph.D. 6 ** Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosures

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LIFEPAK® 500 automatic external defibrillator - Indications for Use

The LIFEPAK 500 AED is intended for use by personnel who are authorized by a physician/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 ●

Federal law restricts this device to sale by or on the order of a physician.

Section of the country

At. A. CiarlawsL.

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number K983393

$\checkmark$ Prescription Use

OTC

Regulation Number and Section

§ 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.