(149 days)
No
The summary describes standard AED functionality, including ECG analysis and shock delivery, without mentioning any AI or ML components. The device description focuses on traditional hardware and software evaluations.
Yes.
The device is indicated for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest, which directly treats a medical condition.
Yes
The "Intended Use / Indications for Use" states, "The G3Pro and ECG Patient Cable system provides a non-diagnostic display for attended patient monitoring." However, the "Device Description" states, "The device is designed to diagnose and monitor the patient's cardiac rhythm and deliver the shock energy as required." The primary function of an AED is to analyze (diagnose) heart rhythm to determine if a shock is needed. This diagnostic capability is what allows it to function as a defibrillator, even if a specific display mode is "non-diagnostic."
No
The device description explicitly states it is a "portable, battery-operated, semi-automatic, low power DC defibrillator" and mentions hardware evaluations, indicating it is a physical device with hardware components.
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 Powerheart® AED G3 Pro is a defibrillator. Its primary function is to analyze the electrical activity of the heart (ECG) and deliver an electrical shock to restore a normal rhythm in cases of sudden cardiac arrest.
- Lack of Sample Analysis: The device does not analyze samples taken from the body. It directly interacts with the patient's body surface via electrodes to acquire the ECG signal.
- Intended Use: The intended use clearly describes emergency treatment of victims of sudden cardiac arrest and monitoring of the ECG rhythm. This is a direct therapeutic and monitoring function, not an in vitro diagnostic test.
Therefore, the Powerheart® AED G3 Pro falls under the category of a therapeutic and monitoring medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Powerheart® AED G3 Pro, model 9300P, 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 a patient is a child or infant up to 8 years of age, or up to 55 Ibs (25kg), the Powerheart AED G3 Pro 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.
At the discretion of emergency care personnel, the G3Pro with ECG display enabled can also be used with the 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 (comma separated list FDA assigned to the subject device)
MKJ
Device Description
The Powerheart® AED G3Pro is a portable, battery-operated, semi-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 G3Pro also has an ECG display and manual override for advanced users.
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
The device is indicated for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest.
When a patient is a child or infant up to 8 years of age, or up to 55 Ibs (25kg), the Powerheart AED G3 Pro 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.
At the discretion of emergency care personnel, the G3Pro with ECG display enabled can also be used with the Model 5111 ECG Patient Cable to display the rhythm of a responsive or breathing patient, regardless 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
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)
The Powerheart® AED G3Pro is subjected to performance software and hardware 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 G3Pro was found to perform as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
K022929, K011901, K982710, K031987
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.
0
Cardiaς Science Powerheart® AED G3 Pro Original Premarket 510(k) Notification
KD40637
AUG = 6 2004
SUMMARY OF SAFETY AND EFFECTIVENESS SECTION 17:
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92.
17.1: ADMINSTRATIVE INFORMATION
| Name and Address | Cardiac Science Incorporated
5474 Feltl Road
Minnetonka, MN 55343 |
|------------------|-------------------------------------------------------------------------|
| Submitted by: | |
| Contact Person: | Kenneth F. Olson |
| Telephone No.: | 952-939-4181 |
| Facsimile No.: | 952-939-4191 |
| Email: | kolson@cardiacscience.com |
| Date Prepared: | March 5, 2004 |
17.2: DEVICE INFORMATION
| Common or Usual Name: | Automatic External Defibrillator |
|---|---|
| Trade Name: | Powerheart® Automatic External Defibrillator |
| G3Pro |
17.3: DEVICE CLASSETCATION
| Classification Name: | Automated External Defibrillator | ||
|---|---|---|---|
| 21 CFR 870.5310 | MKJ | ||
| Device Class: | III |
17.4: DEVICE DESCRIPTION
The Powerheart® AED G3Pro is a portable, battery-operated, semi-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 G3Pro also has an ECG display and manual override for advanced users. The device in this submission is equivalent to the current Powerheart® ABD and accessories in commercial distribution that was cleared under premarket 510(k) notifications K022929, K011901, K982710 and K031987. The reason for this premarket notification is to introduce the semi-sutomatic
252
1
Cardiac Science Powerheart® AED G3 Pro Original Premarket 510(k) Notification
17.6: IDENTIFICATION OF PREDICATE DEVICE
| Company | Device | 510(k) No. | Date Cleared |
|---|---|---|---|
| Cardiac Science | Powerheart AED | K031987 | 07/30/2003 |
| Philips Medical Systems | Heartstream FR2 | K014157 | 01/17/2002 |
| K013425 | 01/14/2002 |
17.7: SUBSTANTIAL EQUIVALENCE
The Powerheart® AED G3Pro covered by this submission is substantially equivalent to other legally marketed automatic external defibrillators. Specifically, the Powerheart® AED G3Pro that is the subject of this premarket notification is equivalent to the current Powerheart® AED G3 in commercial distribution with the exception of having the ECG display and manual override options. The Powerheart AED G3Pro is substantially equivalent to the ECG display and manual override features of the Philips Medical Systems Heartstream FR2 AED.
17.8 PERFORMANCE TESTING
The Powerheart® AED G3Pro is subjected to performance software and hardware 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 G3Pro was found to perform as intended.
17.9 CONCLUSIONS
Cardiac Science has demonstrated through its evaluation and testing of the Powerheart® AED G3Pro that the device is equivalent to the current Powerheart® AED and the Philips Medical Systems Heartstream FR2 AED. The proposed Powerheart® AED G3Pro is equivalent with respect to indications for use, technological characteristics, and software algorithm as the current commercially distributed Powerheart® AED and the Heartstream 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.
2
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
MAR 2 4 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Cardiac Science, Inc. c/o Mr. Kenneth F. Olson Chief Technology Officer 5474 Feltl Road Minnetonka, MN 55343
Re: K040637
Trade/Device Name: Powerheart Automatic External Defibrillator G3Pro Regulation Number: 21 CFR 870.5310 Regulation Name: Automated External Defibrillator Regulatory Class: Class III (Three) Product Code: MKJ Dated: June 22, 2004 Received: June 23, 2004
Dear Mr. Olson:
This letter corrects our substantially equivalent letter of August 6, 2004. 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 (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.
3
Page 2 - Mr. Kenneth F. 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 continue 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 (240) 276-0120. 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 (240) 276-3150 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
4
Indications for Use
K040637 510(k) Number:
Powerheart® Automatic External Defibrillator G3 Pro Device Name:
Indications For Use:
The Powerheart® AED G3 Pro, model 9300P, 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 a patient is a child or infant up to 8 years of age, or up to 55 Ibs (25kg), the Powerheart AED G3 Pro 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.
At the discretion of emergency care personnel, the G3Pro with ECG display enabled can also be used with the 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 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nilm N. Dahan
(Division Sign-Off) JV BDZ
Division of Cardiovascular De
510(k) Number K040637
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