(59 days)
Not Found
No
The description mentions a "patented software algorithm" for ECG analysis, which is typical for traditional signal processing in AEDs and does not explicitly indicate AI/ML. There are no mentions of AI, ML, DNN, or training/test sets.
Yes
The device is an Automated External Defibrillator (AED), which applies a pulse of electricity to the heart to address cardiopulmonary arrest, directly treating a medical condition.
Yes.
The device analyzes the patient's electrocardiogram (ECG) to detect a shockable rhythm, which is a form of diagnosis.
No
The device description explicitly states it is a "portable battery powered, low energy defibrillator" that applies electricity via "disposable defibrillation electrodes," indicating it is a hardware device with embedded software.
Based on the provided information, the LIFEPAK 500 AED is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- LIFEPAK 500 Function: The LIFEPAK 500 AED analyzes the patient's electrocardiogram (ECG), which is an electrical signal from the heart, and delivers an electrical shock directly to the patient's chest. It does not analyze any specimens taken from the body.
Therefore, the LIFEPAK 500 AED falls under the category of a therapeutic device that interacts directly with the patient's body, rather than an in vitro diagnostic device that analyzes samples outside the body.
N/A
Intended Use / Indications for Use
The LIFEPAK 500 AED may be used in the hospital or pre-hospital setting by emergency responders to terminate certain potentially fatal cardiac arrhythmias. It is not intended for use on pediatric patients less than eight vears of age.
The LIFEPAK 500 AED is to be used only on patients in cardiopulmonary arrest. The The In Life In First 500 rassious, not breathing normally and showing no signs of circulation (for example, no pulse, no coughing, no movement) before the device is used to analyze the patient's ECG rhythm. This device is not intended for use on children less than eight years of age, per AHA/ILCOR Guidelines.
Product codes
MKJ
Device Description
The LIFEPAK 500 Automated External Defibrillator (AED) is a portable battery powered, low energy defibrillator that applies a pulse of electricity to the heart via disposable defibrillation electrodes on the chest. A patented software algorithm analyzes the patient's electrocardiogram (ECG) and informs the operator if it detects a shockable rhythm. The operator can then press the shock button to deliver energy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Heart
Indicated Patient Age Range
Not intended for use on pediatric patients less than eight years of age; Not intended for use on children less than eight years of age.
Intended User / Care Setting
Used in the hospital or pre-hospital setting by emergency responders.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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
SECTION E - 510(k) SUMMARY
Submitter's Name and Address:
Medtronic Physio-Control Corp. 11811 Willows Road Northeast P.O. Box 97006 Redmond, WA 98073
Contact Person:
Sherri L. Pocock, Esq. (425) 867-4332
Date Summary Prepared:
August 29, 2001
Device:
Medtronic Physio-Control LIFEPAK® 500 Automated External Defibrillator (biphasic and monophasic versions)
Classification:
Low-Energy DC - Defibrillator (360 Joules maximum): Class II (See 21 CFR 870.5300)
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) nos. K983393 (Biphasic, cleared 6/6/99) and K955854 (Monophasic, cleared 11/4/96).
Description and Reason for 510(k):
The LIFEPAK 500 Automated External Defibrillator (AED) is a portable battery powered, low energy defibrillator that applies a pulse of electricity to the heart via disposable defibrillation electrodes on the chest. A patented software algorithm analyzes the patient's electrocardiogram (ECG) and informs the operator if it detects a shockable rhythm. The operator can then press the shock button to deliver energy.
1
With the LIFEPAK 500 AED, shocks are not limited to a single energy setting; the device can be programmed to deliver subsequent shocks at higher energies if the first one is not successful.
The subject of this 510(k) is a change to the operating instructions and voice rno oubjob. of the oulse checks by lay users. There will be two levels of prompts that can be selected in the setup mode: the original voice roompt, "check for pulse - if no pulse start CPR" or the new prompt "check patient - if not moving and not breathing normally, start CPR.
Operating instructions now advise the user to "check for signs of circulation, e.g., no pulse, no coughing, no movement."
Intended Use:
The LIFEPAK 500 AED may be used in the hospital or pre-hospital setting by emergency responders to terminate certain potentially fatal cardiac arrhythmias. It is not intended for use on pediatric patients less than eight vears of age.
Technological characteristics of new and predicate devices:
The features and functions of the new LIFEPAK 500 AED are the same as those of the currently marketed LIFEPAK 500 AED.
Summary of Design Controls:
The 510(k) includes a summary of design control activities and a declaration of conformity to design controls.
Conclusion:
The LIFEPAK 500 AED has identical technological characteristics as the predicate version. The shock advisory algorithm, defibrillation waveforms, etc. are all the same. The intended user and intended patient populations are the same. The changes made are pursuant to recent recommendations in the American Heart Association Guidelines 2000 for CPR and ECC. The rationale for those recommendations are presented in detail in that document and summarized in this 510(k). Because this is a Special 510(k), a summary of design control activities and a declaration of conformity to design controls are included.
The information in this 510(k) notification demonstrates that the modified LIFEPAK 500 AED is substantially equivalent to the predicate devices with respect to safety, effectiveness, and performance.
2
Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of a bird.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 8 2001
Ms. Sherri L. Pocock Medtronic Physio-Control Corp. 11811 Willows Road NE P.O. Box 97006 Redmond. WA 98073-9706
Re: K012428
LIFEPAK 500 Automated External Defibrillator Regulation Number: 870.1025 Regulation Name: Arrythmia Detector and Alarm Regulatory Class: III (three) Product Code: MKJ Dated: September 5, 2001 Received: September 7, 2001
Dear Ms. Pocock:
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, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, 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, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish
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Page 2 - Ms. Sherri L. Pocock
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 sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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) 594-4646. 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance (DSMICA) 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,
N. Dale Tull
James E. Dillard II Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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SECTION D: STATEMENT OF INDICATIONS FOR USE
Verl 3 - 4/24/96
Applicant: Medtronic Physio-Control
510(k) Number (if known): Not yet assigned
KO17428
Device Name: LIFEPAK 500 Automated External Defibrillator
Indications For Use:
The LIFEPAK 500 AED is to be used only on patients in cardiopulmonary arrest. The The In Life In First 500 rassious, not breathing normally and showing no signs of circulation (for example, no pulse, no coughing, no movement) before the device is used to analyze the patient's ECG rhythm. This device is not intended for use on children less than eight years of age, per AHA/ILCOR Guidelines.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
Division of Cardiovascular & Respiratory Devices
510(k) Number K012428
Prescription Use
(Per 21 CFR 801.109)