(505 days)
For emergency treatment of patients in cardiac arrest who are unconscious and lack pulse and spontaneous breath. The device may be used for automated ECG analysis or, alternatively as a standard cardiac monitor for manual BCG assessment.
The LIFEPAK 300 is a portable external cardiac defibrillator. It can operate in either the semi-automated mode or the manual mode. A lesser trained emergency responder such as an EMT can use the device in the semi automated mode; the device analyzes the cardiac rhythm and indicates "shock advised" if it detects a shockable rhythm. If the device is in the manual mode a person trained in cardiac rhythm interpretation, such as a paramedic, can deliver a defibrillation shock without relying on the automated analysis of the device.
This document describes the acceptance criteria and supporting study for the Physio-Control Corporation LIFEPAK 300 automated external defibrillator (modified) (K962359).
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly state quantitative acceptance criteria or detailed device performance metrics in a readily extractable format. It mentions "qualification testing and software/system validation testing" were provided. However, the key modification and implied performance relates to the device's ability to allow shock delivery in the presence of motion if a shockable rhythm is detected, which the unmodified version would not. Without explicit performance data provided in the summary, we cannot create a precise table.
Implied Performance Focus: The primary functional change is allowing shock delivery in the presence of motion when a shockable rhythm is detected, unlike the predicate device. The performance would be assessed on the accuracy of rhythm analysis under these specific conditions.
2. Sample Size and Data Provenance for Test Set
The provided 510(k) summary does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It generally refers to "qualification testing and software/system validation testing."
3. Number and Qualifications of Experts for Ground Truth (Test Set)
The 510(k) summary does not specify the number of experts used to establish ground truth for the test set or their qualifications.
4. Adjudication Method for Test Set
The 510(k) summary does not describe any adjudication method used for establishing ground truth on the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The provided text does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The device is an automated external defibrillator, and its performance evaluation typically focuses on the accuracy of its automated rhythm analysis, rather than human reader improvement with AI assistance.
6. Standalone Performance Study
Yes, a standalone study of the algorithm's performance was implied by the mention of "qualification testing and software/system validation testing." The device operates in a "semi-automated mode" where it "analyzes the cardiac rhythm and indicates 'shock advised' if it detects a shockable rhythm." This indicates that the algorithm's ability to accurately detect shockable rhythms is a core performance characteristic assessed in standalone mode. However, specific metrics of this standalone performance are not provided.
7. Type of Ground Truth Used
The type of ground truth used is not explicitly stated. However, given the nature of an automated external defibrillator, the ground truth for rhythm analysis in testing would typically be established by:
- Expert Consensus: Review of ECG waveforms by qualified cardiologists or electrophysiologists.
- Known Rhythm Libraries: Using pre-recorded ECGs with confirmed diagnoses of shockable (e.g., ventricular fibrillation, pulse-less ventricular tachycardia) and non-shockable rhythms.
- Experimental/Simulated Data: Where the cardiac rhythm can be precisely controlled and known.
8. Sample Size for Training Set
The 510(k) summary does not provide details on the sample size for any training set used for the device's software/algorithm. This information is typically not detailed in the public 510(k) summary for such devices unless it's a novel AI/ML device where this is a primary focus.
9. How Ground Truth for Training Set Was Established
The 510(k) summary does not provide details on how the ground truth for any training set was established. Similar to the test set, it would likely involve expert review of ECGs, known rhythm databases, or controlled experimental data.
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510(k) Summary (Summary of information contained in the 510(k) premarket notification)
Submitter's Name and Address: Physio-Control Corporation 11811 Willows Road Northeast P.O. Box 97006 Redmond, WA 98073
NOV - 6 1997
Sherri L. Pocock Contact Person: (206) 867-4332
Date Summary Prepared: June 18, 1996
Device:
Physio-Control Corporation LIFEPAK 300 automated external defibrillator (modified)
Classification:
a) Low Energy DC-Defibrillator (including paddles) 21 CFR 870.5300; Class II;
FDA has considered automated defibrillators to be class III devices
Substantial Equivalence:
The intended use and function of the LIFEPAK 300 defibrillator (modified) are substantially equivalent to those of the LIFEPAK 300 defibrillator 510(k) no. K925936.
The unmodified LIFEPAK 300 AED (510(k) no. K925936) will not allow the operator to deliver a shock if the device detects motion; the modified LIFEPAK 300 will allow the operator to deliver a shock in the presence of motion if a shockable rhythm is detected.
Description:
The LIFEPAK 300 is a portable external cardiac defibrillator. It can operate in either the semi-automated mode or the manual mode. A lesser trained emergency responder such as an EMT can use the device in the semi automated mode; the device analyzes the cardiac rhythm and indicates "shock advised" if it detects a shockable rhythm. If the device is
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in the manual mode a person trained in cardiac rhythm interpretation, such as a paramedic, can deliver a defibrillation shock without relying on the automated analysis of the device.
Intended Use:
Emergency treatment of patients in cardiac arrest.
Technological characteristics of new and predicate devices:
The technological characteristics are the same. Only software has been modified from the original LIFEPAK 300 AED.
Summary of Performance Information:
Performance testing provided with the 510(k) includes qualification testing and software/system validation testing.
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
NOV - 6 1997
Mr. Michael D. Willingham Vice President Quality & Requlatory Affairs Physio-Control Corporation 11811 Willows Road Northeast Post Office Box 97006 Redmond, Washington 98073-9706
Re : K962359 LIFEPAK® 300 Automated External Defibrillator (AED) Regulatory Class: III (three) Product Code: 74 MKJ Dated: August 21, 1997 Received: August 29, 1997
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 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, Drug, and Cosmetic Act (Act). The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and labeling, and prohibitions against 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 regulation 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 legally 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 regulation (21 CFR part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note 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/dsmamain.html".
Please be advised that, in the future, FDA may require postmarket surveillance of this device under the authorities granted under section 522 of the Federal Food, Drug and cosmetic Act. This issue is currently under consideration by FDA and you will be notified of our decision in writing.
Sincerely yours,
Thomas f. Cole
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
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510(k) Number (if known): K962359
LIFEPAK 300 Automatic Advisory Defibrillator Device Name: ___
Indication for Use:
For emergency treatment of patients in cardiac arrest who are unconscious and lack pulse and spontaneous breath. The device may be used for automated ECG analysis or, alternatively as a standard cardiac monitor for manual BCG assessment.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | |
|---|---|
| (Per 21 CFR 801.109) |
OR
| Over-The-Counter Use | |
|---|---|
| (Optional Format 1-2-96) |
§ 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.