(520 days)
Not Found
No
The document describes standard AED functionality based on ECG monitoring and does not mention AI/ML terms or capabilities.
Yes.
The device is an Automated External Defibrillator (AED) used for the emergency treatment of sudden cardiac arrest, which involves delivering a defibrillation shock to restore normal heart rhythm, thus providing therapeutic intervention.
Yes
The device description states it is used "to diagnose and treat life threatening ventricular arrhythmias." Additionally, it monitors "the patient's ECG" and detects ECG rhythm for shockable ventricular tachyarrhythmias.
No
The device description explicitly states it is a "portable, battery operated, self-testing defibrillator" and mentions "performance hardware and software evaluations," indicating it is a physical device with integrated software, not software only.
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 that the GS Automated External Defibrillator (AED) is used to diagnose and treat life-threatening ventricular arrhythmias by monitoring the patient's ECG and delivering a defibrillation shock. This is a direct interaction with the patient's body and a therapeutic intervention, not a test performed on a sample outside the body.
- Intended Use: The intended use is for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest. This is a clinical intervention, not a diagnostic test on a sample.
The device is a therapeutic medical device used for emergency cardiac care.
N/A
Intended Use / Indications for Use
The Powerheart® G5 Automated External Defibrillator (AED) is intended to be used by persons who have been trained in its operation. The user should be trained in basic life support or other physician-authorized emergency medical response.
An AED is indicated for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing or not breathing normally. Postresuscitation, if the patient 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 a shock, or for an automatic AED, automatically deliver a shock if needed.
When a patient is a child up to 8 years of age, or up to 25kg (55 lbs), the AED should be used with the Pediatric Defibrillation Pads. The therapy should not be delayed to determine the patient's exact age or weight.
Product codes (comma separated list FDA assigned to the subject device)
MKJ
Device Description
The Powerheart® G5 AED is a portable, battery operated, self-testing defibrillator used to diagnose and treat life threatening ventricular arrhythmias in patients who are unresponsive and not breathing or not breathing normally. This is accomplished by monitoring the patient's ECG and delivering a defibrillation shock if necessary.
The AED is intended to be used by a person designated within a community, locale or building who is the first responder to a medical emergency. This typically includes ambulance, police or fire fighting personnel, emergency response team members, security personnel, and lay persons who have been trained in CPR and in the use of the AED.
The Powerheart® G5 AED guides the user through a rescue using voice or text prompts. Defibrillation pads are used to monitor and defibrillate patients. Adult pads, meant for patients older than 8 years or heavier than 55 lb, are preconnected to the Powerheart G5 AED and placed in two locations on the patient during a resoue. Pediatric pads are connected to the AED when a pediatric patient is involved and meant for use on those patients 8 years or younger, or 55 lb or lighter.
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
Adult: older than 8 years or heavier than 55 lb. Pediatric: up to 8 years of age, or up to 25kg (55 lbs).
Intended User / Care Setting
persons who have been trained in its operation. The user should be trained in basic life support or other physician-authorized emergency medical response.
a person designated within a community, locale or building who is the first responder to a medical emergency. This typically includes ambulance, police or fire fighting personnel, emergency response team members, security personnel, and lay persons who have been trained in CPR and in the use of the AED.
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)
The Powerheart® G5 AED was subjected to performance hardware and software evaluations in accordance with industry standards. The G5 passed all software and hardware tests and was found to perform as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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510(k) Summary
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A. Submitter's name, address, telephone number, contact person, and data summary was prepared
Cardiac Science Corporation Submitter N7 W22025 Johnson Drive Waukesha, WI 53186-1856 Contact Person Kathleen Roberts Regulatory Affairs Manager Phone: (949) 797-3844 Fax: (949) 797-3801 Date Summary Prepared September 7, 2012
B. Name of device, including trade name and classification name
| Trade/Proprietary Name | Powerheart® G5 AED |
|---|---|
| Classification Name | Automated External Defibrillator |
| Classification Number | Class III, 21CFR 870.5310 |
| Product Code | MKJ |
C. Identification of the predicate device or legally marketed devices to which substantial equivalence is being claimed
| Company | Cardiac Science Corporation |
|---|---|
| Device | Powerheart® AED G3 |
| Model number | 9300A/E, 9390A/E |
| 510(k) number | K102496 |
| Date cleared | June 9, 2011 |
| Device | Defibrillation Electrodes |
| Model number | 9131 |
| 510(k) number | K082090 |
| Clearance date | December 12, 2008 |
| Device | Pediatric Attenuated Defibrillation Electrodes |
| Model number | 9730 |
| 510(k) number | K022929 |
| Clearance date | September 11, 2002 |
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D. Description of the device
The Powerheart® G5 AED is a portable, battery operated, self-testing defibrillator used to diagnose and treat life threatening ventricular arrhythmias in patients who are unresponsive and not breathing or not breathing normally. This is accomplished by monitoring the patient's ECG and delivering a defibrillation shock if necessary.
The AED is intended to be used by a person designated within a community, locale or building who is the first responder to a medical emergency. This typically includes ambulance, police or fire fighting personnel, emergency response team members, security personnel, and lay persons who have been trained in CPR and in the use of the AED.
The Powerheart® G5 AED guides the user through a rescue using voice or text prompts. Defibrillation pads are used to monitor and defibrillate patients. Adult pads, meant for patients older than 8 years or heavier than 55 lb, are preconnected to the Powerheart G5 AED and placed in two locations on the patient during a resoue. Pediatric pads are connected to the AED when a pediatric patient is involved and meant for use on those patients 8 years or younger, or 55 lb or lighter.
E. Intended use of the device
The Powerheart® Automated External Defibrillator (AED) is intended to be used by persons who have been trained in its operation. The user should be trained in basic life support or other physician-authorized emergency medical response.
An AED is indicated for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing or not breathing normally. Post-resuscitation, if the patient 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 a shock, or for an automatic AED, automatically deliver a shock if needed.
When a patient is a child up to 8 years of age, or up to 25kg (55 lbs), the AED should be used with the Pediatric Defibrillation Pads. The therapy should not be delayed to determine the patient's exact age or weight.
F. Functional Tests
The Powerheart® G5 AED was subjected to performance hardware and software evaluations in accordance with industry standards. The G5 passed all software and hardware tests and was found to perform as intended.
G. Conclusion
Cardiac Science has demonstrated through evaluation and testing of the Powerheart® G5 AED that the device is equivalent to the Powerheart® AED G3. The proposed device is equivalent with respect to indications for use, technological characteristics. materials, and software algorithm. Based on the results of testing, it is concluded that the Powerheart® G5 AED with Adult Electrodes and Pediatric Electrodes does not raise any new questions regarding the safety or effectiveness as compared with the predicate devices.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 12, 2014
Cardiac Science Corporation c/o Ms. Kathleen Roberts Regulatory Affairs Manager N7 W22025 Johnson Drive Waukesha, Wisconsin 53186-1856
Re: K122758
Trade/Device Name: Powerheart G5 AED Regulation Number: 21 CFR 870.5310 Regulation Name: Automated External Defibrillator Regulatory Class: III Product Code: MKJ Dated: November 15, 2013 Received: November 18, 2013
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. Isting 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.
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
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Page 2 - Ms. Kathleen Roberts
forth in the quality systems (OS) 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 yours,
Owen-Pi Faris -S
for
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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Image /page/4/Picture/1 description: The image shows the logo for Cardiac Science. The logo consists of a stylized shield shape on the left and the words "CARDIAC SCIENCE" on the right. The word "CARDIAC" is on the top line and "SCIENCE" is on the bottom line.
Indications for Use
510(k) Number: K122758:
Device Name: Powerheart® G5 AED Powerheart® G5 Adult Defibrillation Pads Powerheart® G5 Pediatric Defibrillation Pads
Indications for Use:
The GS Automated External Defibrillator (AED) is intended to be used by persons who have been trained in its operation. The user should be trained in basic life support or other physician-authorized emergency medical response.
An AED is indicated for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing or not breathing normally. Postresuscitation, if the patient 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 a shock, or for an automatic AED, automatically deliver a shock if needed.
When a patient is a child up to 8 years of age, or up to 25kg (55 lbs), the AED should be used with the Pediatric Defibrillation Pads. The therapy should not be delayed to determine the patient's exact age or weight.
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
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)
Digitally signed by
Owen P. Faris -S
Date: 2014.02.12
08:34:30-05'00'
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