(282 days)
Not Found
No
The document describes standard AED functionality including ECG analysis and self-testing, with a software modification focused on enhancing the self-test feature. There is no mention of AI or ML algorithms being used for diagnosis, treatment decisions, or any other function beyond basic signal processing and device self-checks.
Yes
The device is an Automated External Defibrillator (AED) indicated for emergency treatment of sudden cardiac arrest, which delivers therapy (electrical shock) to restore normal heart rhythm.
No
The Powerheart® AED G3Pro, when used with the ECG Patient Cable, provides a "non-diagnostic display for attended patient monitoring," explicitly stating that this function is not for diagnosis. The primary function of the AED is emergency treatment (defibrillation) and analysis of ECG for shock advisement, not diagnosis of conditions.
No
The device description explicitly states that the Powerheart® AED G3 family of devices are "portable, battery operated, automatic or semi-automatic, automated external defibrillators (AED)". This indicates a physical hardware device, not software only. The submission focuses on a software modification to an existing hardware device.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The description of the Powerheart® AED G3 family of devices clearly states that it analyzes the patient's electrocardiogram (ECG) by applying electrodes to the patient's bare chest. This is a direct measurement from the patient, not an analysis of a specimen taken from the patient.
- The intended use is for emergency treatment of sudden cardiac arrest. This is a therapeutic intervention based on real-time physiological data, not a diagnostic test performed on a sample.
- The device description focuses on analyzing the patient's ECG and delivering electrical therapy. This aligns with the function of a defibrillator, not an IVD.
- The mention of the ECG Patient Cable for the G3Pro is for "non-diagnostic display for attended patient monitoring." This explicitly states that this function is not for diagnostic purposes.
Therefore, the Powerheart® AED G3 family of devices, as described, falls under the category of a therapeutic medical device, specifically an automated external defibrillator (AED), rather than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Powerheart® AED G3 family of devices 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 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.
Additional information exclusive to the Powerheart® AED G3 Pro, Model 9300P:
At the discretion of emergency care personnel, the G3Pro with ECG display enabled can also be used with Model 5111 ECG Patient Cable to display the rhythm of a responsive or breathing patient, regardless of age. The G3Pro and ECG Patient Cable system provides a non-diagnostic display for attended patient monitoring. While connected the G3Pro ECG Patient Cable, the G3Pro evaluates the patient's ECG and disables its shock capability.
Product codes
MKJ
Device Description
The Powerheart® AED G3 family of devices (Model numbers 9300A/E, model numbers 9390A/E, and model number 9300P) are portable, battery operated, automatic or semi-automatic, automated external defibrillators (AED). After applying the AED electrodes (pads) to the patient's bare chest, the AED automatically analyzes the patient's electrocardiogram (EGG) 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. For the Powerheart® AED G3 Semi-automatic, the AED uses one button and advises the operator to press the button and deliver a shock if needed.
The Powerheart® AED G3 family of devices includes a periodic automatic self-test feature. The focus of this submission is a software modification to enhance the detection capability of the device self-test feature.
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
Patient age up to 8 years of age for children or infant. Regardless of age for the G3Pro with ECG display.
Intended User / Care Setting
Personnel who have been trained in its operation, qualified by training in basic life support or other physician-authorized emergency medical response. Emergency care personnel.
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)
Software verification and validation testing has been successfully completed for all models of the modified Powerheart® AED G3 family of devices to demonstrate appropriate functional and performance characteristics.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K031987, K040438, K040637, K052161
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
JUN - 9 2011
510(k) Summary
- Submitter's name, address, telephone number, contact person, and data A. summary was prepared
Submitter
Contact Person
Cardiac Science Corporation 3303 Monte Villa Parkway Bothell, WA 98021-8969
Kathleen Roberts Regulatory Affairs Manager Phone: (949) 797-3844 Fax: (949) 797-3801
Date Summary Prepared
March 24, 2011
B. Name of device, including trade name and classification name
Trade/Proprietary Name
Powerheart® AED G3 Semi-Automatic (Model 9300E)
Powerheart® AED G3 Automatic (Model 9300A)
Powerheart® AED G3 Pro (Model 9300P)
Powerheart® AED G3 Plus (Models 9390A and 9390E)
Automated External Defibrillator
Class III, 21CFR 870.5310
Classification Name
Classification Number
Product Code
MKJ
- C. Identification of the predicate device or legally marketed devices to which substantial equivalence is being claimed.
Company Device
Cardiac Science Corporation Powerheart® AED G3
Confidential Cardiac Science Corporation March 24, 2011
1
| Device
Identification | Model
Number | 510(k)
Number | Date Cleared |
|---------------------------------------|-----------------|------------------|--------------|
| Powerheart® AED G3 Semi-
Automatic | 9300E | K031987 | 7/30/2003 |
| Powerheart® AED G3 Automatic | 9300A | K040438 | 7/1/2004 |
| Powerheart® AED G3 Pro | 9300P | K040637 | 8/6/2004 |
| Powerheart® AED G3 Plus | 9390A/E | K052161 | 10/21/2005 |
D. Description of the device
The Powerheart® AED G3 family of devices (Model numbers 9300A/E, model numbers 9390A/E, and model number 9300P) are portable, battery operated, automatic or semi-automatic, automated external defibrillators (AED). After applying the AED electrodes (pads) to the patient's bare chest, the AED automatically analyzes the patient's electrocardiogram (EGG) 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. For the Powerheart® AED G3 Semi-automatic, the AED uses one button and advises the operator to press the button and deliver a shock if needed.
The Powerheart® AED G3 family of devices includes a periodic automatic self-test feature. The focus of this submission is a software modification to enhance the detection capability of the device self-test feature.
E. Intended use of the device
The Powerheart® AED G3 family of devices 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 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.
2
Additional information exclusive to the Powerheart® AED G3 Pro, Model 9300P :
At the discretion of emergency care personnel, the G3Pro with ECG display enabled can also be used with Model 5111 ECG Patient Cable to display the rhythm of a responsive or breathing patient, regardless of age. The G3Pro and ECG Patient Cable system provides a non-diagnostic display for attended patient monitoring. While connected the G3Pro ECG Patient Cable, the G3Pro evaluates the patient's ECG and disables its shock capability.
F. Functional Tests
Software verification and validation testing has been successfully completed for all models of the modified Powerheart® AED G3 family of devices to demonstrate appropriate functional and performance characteristics.
G. Conclusion
Based on the results of the testing, 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 Corporation Powerheart® AED G3 family of devices described in this submission is substantially equivalent to the previously cleared Powerheart® AED G3 products in terms of indications for use, features and functions.
There are no technological differences between the predicate devices and the modified devices.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in capital letters.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUN - 9 2011
Cardiac Science Corporation c/o Ms. Kathleen Roberts Regulatory Affairs Manager 3303 Monte Villa Parkway Bothell, WA 98021
Re: K102496
Trade/Device Name: Powerheart AED G3 Models 9300A/E, 9390 A/E, and 9300P Regulation Number: 21 CFR 870.5310 Regulation Name: Automated External Defibrillator Regulatory Class: Class III (three) Product Code: MKJ Dated: May 10, 2011 Received: May 11, 2011
Dear Ms. Roberts:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you however, that device labeling must be truthful and not misleading.
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.
4
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/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K1024960
Device Name: Powerheart® AED G3 Model 9300A/E Powerheart® AED G3 Model 9390A/E Powerheart® AED G3 Model 9300P
Indications for Use:
The Powerheart® AED G3 family of devices 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 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.
Additional information exclusive to the Powerheart® AED G3 Pro, Model 9300P:
At the discretion of emergency care personnel, the G3Pro with ECG display enabled can also be used with Model 5111 ECG Patient Cable to display the rhythm of a responsive or breathing patient, regardless of age. The G3Pro and ECG Patient Cable system provides a non-diagnostic display for attended patient monitoring. While connected the G3Pro ECG Patient Cable, the G3Pro evaluates the patient's ECG and disables its shock capability.
Prescription Use X _ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovascular Devices
| Confidential
Cardiac Science Corporation | 510(k) NumberK102496August 27, 2010 | 510(k) Number | K102496 | | August 27, 2010 | Page 1 of 1
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Special 510(k) |
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| 510(k) Number | K102496 | | | | | |
| | August 27, 2010 | | | | | |