(133 days)
The Powerheart® AED G3A 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 G3A 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.
The Powerheart® AED G3A is a portable, battery-operated, fully-automatic, low power DC defibrillator. The device is designed to diagnose and monitor the patient's cardiac rhythm and deliver the shock energy as required. The Powerheart® AED device in this submission is equivalent to the current Powerheart® AED and accessories in commercial distribution that was cleared under premarket 510(k) notifications K022929, K011901, K 982710 and K031987. The reason for this premarket notification is to introduce a fully -automation version of the device.
This product is an Automated External Defibrillator. The provided 510(k) summary (K040438) primarily focuses on establishing substantial equivalence to previously cleared AEDs, rather than presenting detailed new clinical study data with specific acceptance criteria and detailed performance metrics of the device as an AI-powered diagnostic tool. This is a common approach for device modifications or new versions of established devices when the underlying technology (e.g., software algorithm) remains the same or only minimally altered without impacting safety or effectiveness.
Here's an analysis based on the provided text, addressing your points where possible:
1. Table of acceptance criteria and the reported device performance
Based on the provided K040438 summary:
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Device modifications (to convert from semi-automatic to fully-automatic) should not affect the safety or effectiveness of the device. | "The results of the testing showed that the device modifications had no affect on the safety or effectiveness of the device." |
| All software tests must be passed. | "The Powerheart® AED G3A passed all software tests." |
| Device must perform as intended (i.e., function as a fully-automatic AED). | "and was found to perform as intended." |
| Substantial equivalence to predicate devices (Powerheart® AED and Physio-Control LIFEPAK CR PLUS AED) in indications for use, technological characteristics, materials, and software algorithm. | "Cardiac Science has demonstrated through its evaluation and testing of the Powerheart® AED G3A that the device is equivalent to the current Powerheart® AED and the Physio-Control LIFEPAK CR PLUS AED." |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not explicitly state a sample size for a "test set" in the context of diagnostic accuracy, nor does it detail data provenance. The testing mentioned refers to "performance software evaluations." This suggests testing of the software's functionality and adherence to specifications, rather than a clinical trial with a patient test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable. The submission does not describe a study involving expert-established ground truth for a test set of patient data. The evaluation appears to be internal software testing and comparison to predicate devices, not a diagnostic accuracy study using a panel of experts.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. The document does not describe a test set requiring adjudication by experts.
5. 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. The K040438 summary does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. AEDs like the Powerheart AED G3A are designed to automatically detect and advise on shockable rhythms, and in this fully-automatic version, they also deliver the therapy automatically. The role of "human readers" in the context of an MRMC study for an AED's primary function is not typically applicable in the same way as for image-based diagnostic AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, in essence, the "performance software evaluations" and the device's inherent design as a "fully-automatic" AED (meaning it diagnoses and delivers shock energy autonomously) can be considered a standalone performance assessment. The device's primary function is to operate independently of real-time human diagnostic input.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for the software evaluations would have been based on established engineering and cardiac rhythm analysis standards, likely involving:
- Simulated ECG waveforms: Known waveforms (shockable vs. non-shockable) would have been input to verify correct classification and action.
- Performance standards: Adherence to established standards for defibrillator performance (e.g., energy delivery, charge time, shock advisory accuracy).
- Predicate device's algorithm performance: The software algorithm is stated to be "identical... as the current commercially distributed Powerheart® AED," implying that the ground truth for its core functionality would have been established during the clearance of prior versions.
8. The sample size for the training set
The document does not specify a training set sample size. Given that the software algorithm is "identical... as the current commercially distributed Powerheart® AED," it implies the training (if any Machine Learning was involved, which is less common for traditional AED algorithms relying on rule-based detection) would have occurred for previous versions, and this submission is primarily about hardware/operational modifications (fully-automatic functionality) and demonstrating the continued validated performance of the existing algorithm.
9. How the ground truth for the training set was established
Not explicitly stated for this particular submission, as it focuses on equivalence. For the original development of an AED's rhythm analysis algorithm, the ground truth for a training set (if applicable) would typically be established by:
- Expert cardiologists/electrophysiologists: Annotation of ECG recordings to identify shockable rhythms (e.g., ventricular fibrillation, pulseless ventricular tachycardia) and non-shockable rhythms.
- Clinical outcomes data: Correlation of algorithm's outputs with actual patient outcomes (e.g., successful defibrillation, survival).
- Standardized databases: Use of well-characterized ECG databases (e.g., AHA/MIT-BIH) with expert-verified annotations.
In summary, this 510(k) submission for the Powerheart® AED G3A is primarily a declaration of substantial equivalence to previously cleared AEDs, particularly a fully-automatic version from another manufacturer, and a semi-automatic version of their own device. The performance testing described focuses on software functionality and ensuring that the conversion to fully-automatic operation did not negatively impact safety or effectiveness, rather than a de novo clinical study establishing diagnostic accuracy with a new AI algorithm.
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JUL - 1 2004
SUMMARY OF SAFETY AND EFFECTIVENESS SECTION 16:
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92.
16.1: ADMINSTRATIVE INFORMATION
| Name and AddressSubmitted by: | Cardiac Science Incorporated5474 Feltl RoadMinnetonka, MN 55343 |
|---|---|
| Contact Person: | Kenneth F. Olson |
| Telephone No.: | 952-939-4181 |
| Facsimile No.: | 952-939-4191 |
| Email: | kolson@cardiacscience.com |
February 16, 2004 Date Prepared:
DEVICE INFORMATION 16.2:
Automatic External Defibrillator Common or Usual Name:
Trade Name:
Powerheart® Automatic External Defibrillator G3A
DEVICE CLASSIFICATION 16.3:
| Automated | |
|---|---|
| l | 1 |
Classification Name:
Automated External Defibrillator 21 CFR 870.5310 MK1 Device Class: III
16.4: DEVICE DESCRIPTION
The Powerheart® AED G3A is a portable, battery-operated, fully-automatic, low power DC defibrillator. The device is designed to diagnose and monitor the patient's cardiac rhythm and deliver the shock energy as required. The Powerheart® AED device in this submission is equivalent to the current Powerheart® AED and accessories in commercial distribution that was cleared under premarket 510(k) notifications K022929, K011901, K 982710 and K031987. The reason for this premarket notification is to introduce a fully -automation version of the device.
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16.5: INDICATION FOR USE
The Powerheart® AED G3A 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 G3A 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.
16.6: IDENTIFICATION OF PREDICATE DEVICE
| Company | Device | 510(k) No. | Date Cleared |
|---|---|---|---|
| Cardiac Science | Powerheart AED | K031987 | 07/30/2003 |
| Survivalink | FirstSave Biphasic AED | K022929 | 01/27/2003 |
| Corporation(Cardiac Science) | (renamed Powerheart AED) | K011901 | 02/01/2002 |
| K982264 | 01/25/1999 | ||
| Medtronic Physio-Control Corp. | LIFEPAK CR PLUS AED | K011144 | 12/03/2001 |
16.7: SUBSTANTIAL EQUIVALENCE
The Powerheart® AED G3A 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 equivalent to the current Powerheart® AED in commercial distribution with the exception of being a fullyautomatic AED. The Powerheart AED G3A is substantially equivalent to the Medtronic Physio-Control LIFEPAK CR PLUS fully-automatic AED.
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PERFORMANCE TESTING 16.8
The Powerheart® AED G3A was subjected to performance 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 G3A passed all software tests and was found to perform as intended.
CONCLUSIONS 16.9
Cardiac Science has demonstrated through its evaluation and testing of the Powerheart® AED G3A that the device is equivalent to the current Powerheart® AED and the Physio-Control LIFEPAK CR PLUS AED. The proposed Powerheart® AED G3A is identical with respect to indications for use, technological characteristics, materials, 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.
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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 1 2004
Cardiac Science, Inc. c/o Mr. Kenneth Olson Chief Technical Officer 5474 Feltl Road Minnetonka, MN 55343
Re: K040438
Trade Name: Powerheart® Automatic External Defibrillator Regulation Number: 21 CFR 870.5310 Regulation Name: Automatic External Defibrillator Regulatory Class: III (three) Product Code: MKJ Dated: May 21, 2004 Received: May 24, 2004
Dear Mr. Olson:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave rorrowed your your your see device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use sured in the encreat. 976, the enactment date of the Medical Device Amendments, or to conniner of the to THB) 2011-07-11 and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Oosmeter For (110) market the device, subject to the general controls provisions of the Act. The r ou may, ater severy withe 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 (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 - Mr. Kenneth Olson
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act 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) 594-4648. 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 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
Enclosure
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INDICATIONS FOR USE
510(k) Number:
Powerheart® Automatic External Defibrillator G3A Device Name: Indications for Use: The Powerheart® AED G3A 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,
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.
the device will charge automatically and advise the operator to
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
deliver therapy.
| Prescription Use | OR | Over-The-Counter Use ______ | |
|---|---|---|---|
| (Per 21 CFR 801.109) |
| (Division Sign-Off) | <img src="data:image/png;base64,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 of Cardiovascular Devices |
|---|---|
| 510(k) Number | K040438 |
PROPRIETARY - Do Not Duplicate or Distribute
§ 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.