(222 days)
Not Found
No
The description mentions a "software algorithm" for ECG analysis, which is a standard component of AEDs and does not necessarily imply AI/ML. There are no mentions of AI, DNN, or ML, nor descriptions of training or test sets typically associated with AI/ML development.
Yes
The device applies a brief, high-energy pulse of electricity to the heart, which directly treats cardiopulmonary arrest.
Yes
The device analyzes the patient's ECG rhythm to determine if a shockable rhythm is detected, which is a diagnostic function.
No
The device description clearly states it is a "portable battery powered device which applies a brief, high energy pulse of electricity to the heart via defibrillation electrodes on the chest." This indicates it is a hardware device with integrated software, not a software-only medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- LIFEPAK 500 Function: The LIFEPAK 500 AED is a device that analyzes the electrical activity of the heart (ECG) directly from the patient's chest via electrodes and delivers an electrical shock to the patient's body. It does not analyze specimens taken from the body.
The description clearly indicates that the device interacts directly with the patient's body for diagnosis (ECG analysis) and treatment (defibrillation). This is the opposite of an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
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.
Product codes
74 MKJ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Heart / Chest
Indicated Patient Age Range
Patients in cardiopulmonary arrest. Not intended for use on children less than eight years of age.
Intended User / Care Setting
The Biphasic LIFEPAK 500 Automated External Defibrillator may be used in the hospital or pre-hospital setting by emergency responders.
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.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K955854, K832833, K955628, K896919
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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:
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.
1
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.
2
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 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 .
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