(73 days)
Powerheart® AED G3,Powerheart® AED G3 Automatic
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No
The document describes a standard automated external defibrillator (AED) with enhanced voice prompts. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The modifications are limited to voice prompts.
Yes
The device is described as an automated external defibrillator (AED) intended for the emergency treatment of sudden cardiac arrest, which involves delivering therapy (electrical shocks) to a patient. This direct application of energy to treat a medical condition qualifies it as a therapeutic device.
No
The device is an automated external defibrillator (AED) used for emergency treatment of sudden cardiac arrest by delivering electrical therapy. While it does detect the ECG rhythm to determine if a shockable rhythm is present, its primary function is therapeutic (delivering a shock) rather than solely diagnostic. It assesses the rhythm to guide therapy, not to provide a comprehensive diagnosis of a medical condition.
No
The device description explicitly states it is a portable, battery-operated, automated external defibrillator (AED), which is a hardware device. The modification mentioned is to provide enhanced voice prompts, which is a software change to an existing hardware 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 description clearly states the device is an "automated external defibrillator (AED)" used for "emergency treatment of victims exhibiting symptoms of sudden cardiac arrest." It analyzes the heart's electrical rhythm and delivers an electrical shock if necessary.
- Lack of Sample Analysis: The device does not analyze any biological samples taken from the patient. It directly interacts with the patient's body through electrodes to detect and treat a medical condition.
Therefore, the Powerheart® AED G3 and G3 Automatic devices fall under the category of therapeutic medical devices, not in vitro diagnostics.
N/A
Intended Use / 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 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 (G3) or automatically deliver the charge (G3 Automatic).
When a 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.
Product codes
MKJ
Device Description
The Powerheart® AED G3 and G3 Automatic devices are portable, battery-operated, automated external defibrillators (AED) indicated for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing. The devices were modified to provide enhanced voice prompts.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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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
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Validation testing relevant to the enhanced voice prompts further supports a substantial equivalence claim.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Powerheart® AED G3 and Powerheart® AED G3 Automatic
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
OCT 2 1 2005
Premarket Notification (510(k)) Summary
| 510(k) Number: | K052161 |
|---|---|
| Product Name: | Powerheart® AED G3 (Model 9390E) |
| Powerheart® AED G3 Automatic (Model 9390A) | |
| Common Name: | Automated External Defibrillator |
| Class: | III |
| Submitter's Name: | Official Contact: Kenneth F. Olson |
| Chief Technical Officer | |
| Phone: 952-939-2912 | |
| Fax: 952-939-4191 | |
| Cardiac Science, Inc. | |
| 5474 Feltl Road | |
| Minnetonka, MN 55343-7982 |
Summary Preparation Date:
October 19, 2005
This summary is provided in compliance with section 513(I)(3)(A) of the Act and summarizes the safety and effectiveness information contained in this premarket notification submission for a modification to the Powerheart® AED G3 and Powerheart® AED G3 Automatic devices.
The Powerheart® AED G3 and G3 Automatic devices are portable, battery-operated, automated external defibrillators (AED) indicated for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing. The devices were modified to provide enhanced voice prompts.
The modified device is substantially equivalent to the previously cleared Powerheart® AED G3 and Powerheart® AED G3 Automatic devices in intended use, materials, technological characteristics and performance. Validation testing relevant to the enhanced voice prompts further supports a substantial equivalence claim. The collective evidence provides assurance that the modified Powerheart® AED G3 and Powerheart® AED G3 Automatic devices meets the requirements that are considered acceptable for the intended use.
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
1
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 (G3) or automatically deliver the charge (G3 Automatic).
When a 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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Public Health Service
OCT 2 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Cardiac Science, Inc. c/o Mr. Kenneth F. Olson Chief Technical Officer 5474 Feltl Road Minnetonka, MN 55343-7982
Re: K052161 Trade Name: Powerheart AED G3 Regulation Number: 21 CFR 870.53 10 Regulation Name: Automated External Defibrillator Regulatory Class: Class III (three) Product Code: MKJ Dated: September 20, 2005 Received: September 22, 2005
Dear Mr. Olson:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becaon 310(t) premier is substantially equivalent (for the indications felerenced above and nave determined by marketed predicate devices marketed in interstate for use stated in the enclosury to regars) manager and the Medical Device American of the debecal commerce prior to May 20, 1978, the enaomance with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA). alle Costietic Act (11ct) that to not requent to the general controls provisions of the Act. The T ou may, merciole, market the do received on the new registration, listing of general controls provisions of the rise 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 If your device is classified (500 abor of the Existing major regulations affecting your device can may be subject to subli additional controller in the 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 F. Olson
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that IDA's issualice of a succession with other requirements of the Act
that FDA has made a determination that your device complies with other mat that FDA has made a decemination that Jour Coronal agencies. You must or any Federal statutes and regulations daminities but not limited to: registration and listing (21 comply with an the Act s requirements, mortalians and acturing practice requirements as set CFR Part 807), labeling (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (QD) rogulations (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000 product radiation control provisions (Dections of a described in your Section 510(k) I his letter will anow you to begin manceing your antial equivalence of your device to a legally prematket notification. The PDA miding of backand 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 If you desire specific advice for your ac not and and and and the regulation entitled, Contact the Office of Compunation at (216) 276 Part 807.97). You may obtain "Misbranding by relerence to premarkst notheader the Act from the Division of Small
other general information on your responsibilities under the Act from the 1900 C28.00 other general information on your responsion.com at its toll-free number (800) 638-2041 or and Consumer of Supply of the Manufacturers, internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
C. Megle Ney
Bram D. Zuckerman, MD
Luckerman Bram Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): _ Ko 5 21 la l
Device Name: Powerheart® AED G3, Powerheart® AED G3 Automatic
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 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 (G3) or automatically deliver the charge (G3 Automatic).
When a 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 X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Metzger
(Digital Sign on)
(Division Sign-On)
Division of Cardiovascular Devices
510(k) Number.
Page 1 of 1
Confidential
Cardiac Science, Inc.