(72 days)
The Powerheart AED G3 and the Powerheart AED G3 Automatic devices are 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 physicianauthorized emergency medical response.
The device is indicated for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing. Postresuscitation, if the victim is breathing, the AED should be left attached to allow for acquisition and detection of ECG rhythm. If a shockable ventricular tachyarrhythmia recurs, the device will charge automatically and advise the operator to deliver therapy (G3) or automatically deliver the charge (G3 Automatic).
When the patient is a child or infant up to 8 years of age, or up to 55 lbs (25kg), the device 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 G3 and G3 Automatic are portable, battery operated, automated external defibrillators (AED). After applying the AED's electrodes (pads) to the patient's bare chest, the AED automatically analyzes the patient's electrocardiogram (ECG) and advises the operator to press the button and deliver a shock if needed. The AED uses one button and guides the operator through the rescue using a combination of voice prompts, audible alerts, and visible indicators. For the Powerheart AED G3 Automatic, the AED automatically delivers a shock if needed. The Cardiac Science G3 AEDs may be used in conjunction with an adaptor cable that allows the use of AAMI DF-80 compliant electrodes other than the Cardiac Science brand. This adaptor cable is provided as an accessory to the Cardiac Science AEDs.
1. Acceptance Criteria and Reported Device Performance
The provided document describes a Special 510(k) for modifications to the Powerheart AED G3 and G3 Automatic devices. The acceptance criteria and device performance are primarily evaluated through functional and safety testing to ensure equivalence with predicate devices.
| Acceptance Criteria | Reported Device Performance/Conclusion |
|---|---|
| Functional and Safety | Representative samples of the device and adapter cables were tested in accordance with the system, safety, functional, and performance specifications. All samples successfully passed. |
| Substantial Equivalence | Modifications to the Powerheart AED do not raise any new questions regarding safety or effectiveness as compared with the predicate device (Cardiac Science Powerheart AED G3, K052161, and FirstSave™ STAR Biphasic™ AED, K010214). The device is substantially equivalent in terms of indications for use, features, and functions. |
2. Sample Size and Data Provenance
The document states that "Representative samples of the device and adapter cables were tested." However, it does not specify the exact sample size used for the functional and safety testing. The data provenance is derived from internal testing conducted by Cardiac Science Corporation in Bothell, WA. The study is prospective in the sense that the new device and adapter cables were subjected to testing.
3. Number and Qualifications of Experts for Ground Truth
Based on the provided document, there is no mention of external experts or a panel used to establish ground truth for a test set. The evaluation relies on the device meeting pre-defined functional and safety specifications.
4. Adjudication Method
Since there is no mention of a test set requiring expert interpretation or a ground truth established by experts, there is no adjudication method described in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not conducted as described in the provided document. The focus of this 510(k) is on demonstrating substantial equivalence of a modified device and accessory through functional and safety testing rather than evaluating reader performance.
6. Standalone (Algorithm Only) Performance Study
The document describes testing of the device and adapter cables as a complete system, including its automatic analysis of ECG and delivery/advising of shock. Therefore, a standalone performance of the algorithm without human-in-the-loop is inherent to its functionality. However, it does not explicitly present a separate "algorithm only" performance study distinct from the overall system's functional testing. The device itself is an automated external defibrillator, meaning its core function is algorithmic analysis and action.
7. Type of Ground Truth Used for Test Set
The "ground truth" for the test set (functional and safety testing) is based on pre-established system, safety, functional, and performance specifications. The device's ability to operate according to these engineering and regulatory standards serves as the ground truth. This is not clinical ground truth (e.g., pathology, outcomes data, or expert consensus on clinical diagnoses).
8. Sample Size for the Training Set
The document does not mention a training set or any machine learning/AI model training in the context of this 510(k) submission. Therefore, no sample size for a training set is provided. The device likely uses established algorithms for ECG analysis that predate this specific submission.
9. How the Ground Truth for the Training Set was Established
Since a training set is not mentioned, the method for establishing its ground truth is not applicable based on the provided information.
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SEP 1: 0 2009
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K691943 Cardiac Science Corporation.
Bothell, WA Special 510(k)
June 4, 2009
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���. 510(k) Summary
| Submitter: | Cardiac Science Corporation3303 Monte Villa ParkwayBothell, WA 98021-8969 |
|---|---|
| Contact Person: | Beverly MagranePhone: (425) 402-2365Fax: (425) 402-2017 |
| Date Prepared: | June 4, 2009 |
| Trade Name: | Powerheart® AED G3 (Model 9390E)Powerheart® AED G3 Automatic (Model 9390A) |
| ClassificationName and Number: | Automated External DefibrillatorClass III, 21CFR 870.5310 |
| Product Code: | MKJ |
| PredicateDevice(s): | The Powerheart® AED G3 manufactured by CardiacScience, Inc is substantially equivalent to the CardiacScience Powerheart AED G3, K052161 (10/21/2005) andto the FirstSaveTM STAR BiphasicTM AED, K010214,(2/22/2001), manufactured by Survivalink Corporation. |
| DeviceDescription: | The Powerheart® AED G3 and G3 Automatic areportable, battery operated, automated externaldefibrillators (AED). After applying the AED's electrodes(pads) to the patient's bare chest, the AED automaticallyanalyzes the patient's electrocardiogram (ECG) andadvises the operator to press the button and deliver ashock if needed. The AED uses one button and guidesthe operator through the rescue using a combination ofvoice prompts, audible alerts, and visible indicators. Forthe Powerheart AED G3 Automatic, the AEDautomatically delivers a shock if needed.The Cardiac Science G3 AEDs may be used inconjunction with an adaptor cable that allows the use ofAAMI DF-80 compliant electrodes other than the Cardiac |
:
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Cardiac Science Corporation. Bothell, WA Special 510(k) June 4, 2009
691943
Indications For Use:
Functional and Safety Testing:
Conclusion:
Science brand. This adaptor cable is provided as an accessory to the Cardiac Science AEDs.
The Powerheart AED G3 and the Powerheart AED G3 Automatic devices are 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 ECG rhythm. If a shockable ventricular tachyarrhythmia recurs, the device will change automatically and advise the operator to deliver therapy (G3) or automatically deliver the charge (G3 Automatic).
When the patient is a child or infant up to 8 years of age, or up to 55 lbs (25kg), the device 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.
Representative samples of the device and adapter cables were tested in accordance with the system, safety, functional and performance specifications. All samples successfully passed.
Based on the results of the testing described above, it is concluded that the modifications to the Powerheart AED do not raise any new questions regarding the safety or effectiveness as compared with the predicate device. The Cardiac Science, Inc. Powerheart AED is substantially equivalent to the Powerheart AED cleared in K052161 and FirstSave STAR Biphasic AED cleared in K010214 in terms of indications for use, features and functions.
Confidential
5
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure.
Public Health Service
SEP 1 0 2009
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Cardiac Science Corporation c/o Ms. Beverly Magrane Sr. Manager RA/RC 3303 Monte Villa Pkwy. Bothell, WA 98021
K091943 Re:
Trade/Device Name: 9055 Electrode Adapter Cable Regulation Number: 21 CFR 870.5310 Regulation Name: Automated external defibrillator Regulatory Class: Class III (three) Product Code: MKJ Dated: August 25, 2009 Received: August 27, 2009
Dear Ms. Magrane:
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, 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 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 - Ms. Beverly Magrane
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
W.M.P.
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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K0919443
Indications for Use Statement
510(k) Number:
Device Name: Powerheart® AED G3 (Model 9390E), Powerheart® AED G3 Automatic (Model 9390A)
Indications for Use:
The Powerheart AED G3 and the Powerheart AED G3 Automatic devices are 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 physicianauthorized emergency medical response.
The device is indicated for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing. Postresuscitation, if the victim is breathing, the AED should be left attached to allow for acquisition and detection of ECG rhythm. If a shockable ventricular tachyarrhythmia recurs, the device will charge automatically and advise the operator to deliver therapy (G3) or automatically deliver the charge (G3 Automatic).
When the patient is a child or infant up to 8 years of age, or up to 55 lbs (25kg), the device 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.
Prescription Use (Per 21 CFR 801.109) OR
Over-The Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) |
|---|
| Division of Cardiovascular Devices |
| 510(k) Number | K091943 |
|---|---|
| --------------- | --------- |
§ 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.