(33 days)
No
The document describes a standard AED with rhythm analysis and shock advisory functions, which are typical for such devices and do not inherently indicate the use of AI/ML. There are no mentions of AI, ML, or related concepts like deep learning or neural networks. The software upgrade mentioned is likely related to general device functionality rather than AI/ML capabilities.
Yes
The device is indicated for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest and delivers therapeutic shock energy.
Yes
The "Device Description" section states that the device is "designed to diagnose and monitor the patient's cardiac rhythm."
No
The device description explicitly states it is a "portable, battery-operated, semi-automatic, low power DC defibrillator" and mentions "performance hardware and software evaluations," indicating it is a physical device with integrated software, not a software-only medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Powerheart® AED G3 is a defibrillator. Its function is to analyze the electrical activity of the heart (ECG rhythm) and deliver an electrical shock to treat sudden cardiac arrest. It does not perform tests on bodily fluids or tissues.
- Intended Use: The intended use clearly states it's for the emergency treatment of victims exhibiting symptoms of sudden cardiac arrest. This is a therapeutic intervention, not a diagnostic test performed on a sample.
The device analyzes the patient's cardiac rhythm, which is a physiological signal, not a sample taken from the body for in vitro analysis.
N/A
Intended Use / Indications for Use
The Powerheart® AED G3 is intended to be used by personnel who have been trained in its operation. The user should be qualified by training in basic life support or other physician-authorized emergency medical response.
The device is indicated for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing. Post-resuscitation, if the victim is breathing, the AED should be left attached to allow for acquisition and detection of the ECG rhythm. If a shockable ventricular tachyarrhythmia recurs, the device will charge automatically and advise the operator to deliver therapy.
When the patient is a child or infant up to 8 years of age, or up to 55 lbs (25kg), the Powerheart® AED G3 should be used with the Model 9730 Pediatric Attenuated Defibrillation Electrodes. The therapy should not be delayed to determine the patient's exact age or weight.
Product codes
MKJ
Device Description
The Powerheart® AED G3 is a portable, battery-operated, semi-automatic, low power DC defibrillator. The device is designed to diagnose and monitor the patient's cardiac rhythm and advise the operator if and when to deliver the shock energy. The Powerheart® AED device in this submission is identical to the current Powerheart® AED and accessories in commercial distribution that was cleared under premarket 510(k) notifications K022929, K011901 and K982710. The reason for this premarket notification is to introduce minor modifications to the device and upgrade software.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
child or infant up to 8 years of age
Intended User / Care Setting
personnel who have been trained in its operation. The user should be qualified by training in basic life support or other physician-authorized emergency medical response.
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
The Powerheart® AED G3 was subjected to performance hardware and software evaluations in accordance with FDA guidelines and industry standards. The results of the testing showed that the device modifications had no affect on the safety or effectiveness of the device. The Powerheart® AED G3 passed all software and hardware tests and was found to perform as intended.
Key Metrics
Not Found
Predicate Device(s)
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
K 03/987
Cardiac Science Powerheart® AED G3 Special Premarket 510(k) Notification
JUL 3 0 2003
SECTION 17: SUMMARY OF SAFETY AND EFFECTIVENESS
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92.
17.1: ADMINSTRATIVE INFORMATION
| Name and Address | |
|---|---|
| Submitted by: | Cardiac Science Incorporated |
| 5474 Feltl Road | |
| Minnetonka, MN 55343 | |
| Contact Person: | Kenneth F. Olson |
| Telephone No.: | 952-939-4181 |
| Facsimile No.: | 952-939-4191 |
| Email: | kolson@cardiacscience.com |
Date Prepared: June 25, 2003
17.2: DEVICE INFORMATION
| Common or Usual Name: | Automatic External Defibrillator |
|---|---|
| Trade Name: | Powerheart® Automatic External Defibrillator G3 |
| Model 9300 |
17.3: DEVICE CLASSIFICATION
| Classification Name: | Automatic External Defibrillator | |
|---|---|---|
| 21 CFR 870.1025 MKJ | ||
| Device Class: | III |
17.4: DEVICE DESCRIPTION
The Powerheart® AED G3 is a portable, battery-operated, semi-automatic, low power DC defibrillator. The device is designed to diagnose and monitor the patient's cardiac rhythm and advise the operator if and when to deliver the shock energy. The Powerheart® AED device in this submission is identical to the current Powerheart® AED and accessories in commercial distribution that was cleared under premarket 510(k) notifications K022929, K011901 and K982710. The reason for this premarket notification is to introduce minor modifications to the device and upgrade software.
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1
17.5: INDICATION FOR USE
The Powerheart® AED G3 is intended to be used by personnel who have been trained in its operation. The user should be qualified by training in basic life support or other physician-authorized emergency medical response.
The device is indicated for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing. Post-resuscitation, if the victim is breathing, the AED should be left attached to allow for acquisition and detection of the ECG rhythm. If a shockable ventricular tachyarrhythmia recurs, the device will charge automatically and advise the operator to deliver therapy.
When the patient is a child or infant up to 8 years of age, or up to 55 lbs (25kg), the Powerheart® AED G3 should be used with the Model 9730 Pediatric Attenuated Defibrillation Electrodes. The therapy should not be delayed to determine the patient's exact age or weight.
17.6: IDENTIFICATION OF PREDICATE DEVICE
| Company | Device | 510(k) No. | Date Cleared |
|---|---|---|---|
| Cardiac Science | Powerheart AED | K022929 | 01/27/2003 |
| Survivalink | FirstSave Biphasic AED | K011901 | 02/01/2002 |
| Corporation | |||
| (Cardiac Science) | (renamed Powerheart AED) | K982264 | 01/25/1999 |
17.7: SUBSTANTIAL EQUIVALENCE
The Powerheart® AED G3, Model 9300 covered by this submission is substantially equivalent to other legally marketed automatic external defibrillators. Specifically, the Powerheart® AED G3 that is the subject of this premarket notification is identical to current Powerheart® AED in commercial distribution with the exception of minor device modifications to the hardware and software. The device modifications do not raise any new issues of safety or effectiveness.
2
Cardiac Science Powerheart® AED G3 Special Premarket 510(k) Notification
PERFORMANCE TESTING 17.8
The Powerheart® AED G3 was subjected to performance hardware and software evaluations in accordance with FDA guidelines and industry standards. The results of the testing showed that the device modifications had no affect on the safety or effectiveness of the device. The Powerheart® AED G3 passed all software and hardware tests and was found to perform as intended.
CONCLUSIONS 17.9
. '
Cardiac Science has demonstrated through its evaluation and testing of the Powerheart® AED G3, Model 9300, that the device with minor modifications is equivalent to the current Powerheart® AED. The proposed Powerheart® AED G3 is identical with respect to indications for use, technological characteristics, materials, function and software algorithm as the current commercially distributed Powerheart® AED. This notification contains all information required by 21 CFR 807.87. A completed copy of the Premarket Notification 510(k) Reviewer's Checklist is provided in this submission.
i
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Public Health Service
Image /page/3/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with its wings spread, surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The eagle is composed of three curved lines, giving it a modern and abstract appearance. The overall design is simple and recognizable, representing the department's role in public health and human services.
Food and Druq Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 3 0 2003
Cardiac Science, Inc. Minneapolis Operations c/o Mr. Kenneth Olson Chief Technical Officer 5474 Feltl Rd. Minneapolis, MN 55343
K031987 Re: PowerHeart AED G3, Model 9300 Regulation Number: 870.1025 Regulation Name: Arrhythmia Defector and Alarm Regulatory Class: Class III Product Code: MKJ Dated: July 18, 2003 Received: July 21, 2003
Dear Mr. Olson:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Iisting 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Kenneth Olson
or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), 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 Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
5
Cardiac Science Powerheart® AED G3 Special Premarket 510(k) Notification
INDICATIONS FOR USE
510(k) Number:
:
| Device Name: | Powerheart® Automatic External Defibrillator G3
Model 9300 |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use: | The Powerheart® AED G3 is intended to be used by personnel who have been trained in its operation. The user should be qualified by training in basic life support or other physician-authorized emergency medical response. |
| | The device is indicated for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing. Post-resuscitation, if the victim is breathing, the AED should be left attached to allow for acquisition and detection of the ECG rhythm. If a shockable ventricular tachyarrhythmia recurs, the device will charge automatically and advise the operator to deliver therapy. |
| | When a patient is a child or infant up to 8 years of age, or up to 55 lbs (25kg), the Powerheart AED G3 should be used with the Model 9730 Pediatric Attentuated Defibrillation Electrodes. The therapy should not be delayed to determine the patient's exact age or weight. |
| | (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) |
| | Concurrence of CDRH, Office of Device Evaluation (ODE) |
| Prescription Use
(Per 21 CFR 801.109) | OR |
| | Over-The-Counter Use |
| | |
| | (Division Sign-Off) |
| | Division of Cardiovascular Devices |
| 510(k) Number | K031987 |
510(k) Number_
.