K Number
K022929
Device Name
PEDIATRIC ATTENUATED DEFIBRILLATION ELECTRODES, MODEL 9730, POWEDERHEART AED, MODEL 9200/9210
Date Cleared
2003-01-27

(145 days)

Product Code
Regulation Number
870.5310
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Powerheart AED is intended for use 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 tachyarrythmia recurs, the device will charge automatically and advise the operator to deliver therapy. When the patient is a child or infant is up to 8 years of age, or up to 55 lbs (25kg), the Powerheart AED 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.
Device Description
The Powerheart AED is a portable, battery-operated, semi-automatic, low power DC defibrillator. It will diagnose the patient's cardiac rhythm and advise the operator if and when to deliver the shock energy. The Model 9730 Pediatric Attenuated Defibrillation Electrodes are specially designed electrodes for operation with only the Powerheart AED biphasic waveform. The Model 9730 pediatric electrode has been designed to reduce the energy delivered to the patient from a standard biphasic defibrillation waveforms generated by the Powerheart AED to levels applicable for use on children and infants up to 8 yrs of age or weighing less than 55 lbs (25 kg). This is performed though the use of an attenuating circuit that absorbs the excess energy during defibrillation without adversely affecting the electrode's performance during ECG monitoring. The Model 9730 pediatric electrode is designed as a single use device and is intended for use to defibrillate and monitor of children.
More Information

No
The description focuses on standard ECG analysis and energy attenuation, with no mention of AI or ML terms or concepts.

Yes
The device is intended for the "emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing" and advises the operator to "deliver therapy," indicating a direct therapeutic function.

Yes

The device description states, "It will diagnose the patient's cardiac rhythm and advise the operator if and when to deliver the shock energy," which indicates it performs a diagnostic function. The Intended Use also mentions "acquisition and detection of the ECG rhythm."

No

The device description explicitly states it is a "portable, battery-operated, semi-automatic, low power DC defibrillator" and mentions "defibrillation electrodes," indicating it is a hardware device with software components, not a software-only 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 Powerheart AED is a defibrillator. Its function is to deliver an electrical shock to the heart to restore a normal rhythm in cases of sudden cardiac arrest. This is a therapeutic intervention performed on the patient's body, not a diagnostic test performed on a sample from the body.
  • Intended Use: The intended use clearly states it's for the "emergency treatment of victims exhibiting symptoms of sudden cardiac arrest." This is a treatment, not a diagnostic process.
  • Device Description: The description details its function as a "low power DC defibrillator" that "diagnose the patient's cardiac rhythm and advise the operator if and when to deliver the shock energy." While it analyzes the ECG rhythm, this analysis is done in vivo (on the living patient) to guide the delivery of therapy, not in vitro on a sample.

Therefore, the Powerheart AED falls under the category of a therapeutic medical device, not an in vitro diagnostic device.

N/A

Intended Use / Indications for Use

The Powerheart AED is intended for use 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 tachyarrythmia recurs, the device will charge automatically and advise the operator to deliver therapy.

When the patient is a child or infant is up to 8 years of age, or up to 55 lbs (25kg), the Powerheart AED 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 (comma separated list FDA assigned to the subject device)

MKJ, MLN

Device Description

The Powerheart AED is a portable, battery-operated, semi-automatic, low power DC defibrillator. It will diagnose the patient's cardiac rhythm and advise the operator if and when to deliver the shock energy.

The Model 9730 Pediatric Attenuated Defibrillation Electrodes are specially designed electrodes for operation with only the Powerheart AED biphasic waveform.

The Model 9730 pediatric electrode has been designed to reduce the energy delivered to the patient from a standard biphasic defibrillation waveforms generated by the Powerheart AED to levels applicable for use on children and infants up to 8 yrs of age or weighing less than 55 lbs (25 kg). This is performed though the use of an attenuating circuit that absorbs the excess energy during defibrillation without adversely affecting the electrode's performance during ECG monitoring.

The Model 9730 pediatric electrode is designed as a single use device and is intended for use to defibrillate and monitor of children.

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

Children or infants 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

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)

Performance testing was conducted to verify that the Powerheart AED with the Model 9730 Pediatric Attenuated Defibrillation Electrodes has been designed in accordance with industry standards ANSI AAMI DF-39. In addition, biocompatibility assessments were conducted on the components that come into contact with the patient's skin. The Powerheart AED with the Model 9730 electrodes were 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.

K003819

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.

K011901

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

IC022929

SECTION 17. 510K SUMMARY OF SAFETY AND EFFECTIVENESS

JAN 2 7 2003

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
Submitted by: | Cardiac Science Incorporated
16931 Millikan Ave
Irvine, CA 92606 |
|---------------------------------------------------------------|----------------------------------------------------------------------------|
| Contact Person:
Telephone No.:
Facsimile No.:
Email: | Kenneth Olson
952-939-4181
952-939-4191
kolson@cardiacscience.com |
| Date Prepared: | January 15, 2003 |

Device Information 17.2

Common or Usual Name:Automated External Defibrillator
Trade Name:Powerheart® AED Model 9200/9210
Use with Models 9730 Pediatric Attenuated
Defibrillation Electrode.

Device Classification 17.3

Automatic External Defibrillator Classification Name: 21 CFR 870.1025 MKJ Device Class: III

Multifunctional Electrocardiograph Electrode 21 CFR 870.2360 MLN Device Class: III

17.4 Device Description

The Powerheart AED is a portable, battery-operated, semi-automatic, low power DC defibrillator. It will diagnose the patient's cardiac rhythm and advise the operator if and

1

when to deliver the shock energy.

The Model 9730 Pediatric Attenuated Defibrillation Electrodes are specially designed electrodes for operation with only the Powerheart AED biphasic waveform.

The Model 9730 pediatric electrode has been designed to reduce the energy delivered to the patient from a standard biphasic defibrillation waveforms generated by the Powerheart AED to levels applicable for use on children and infants up to 8 yrs of age or weighing less than 55 lbs (25 kg). This is performed though the use of an attenuating circuit that absorbs the excess energy during defibrillation without adversely affecting the electrode's performance during ECG monitoring.

The Model 9730 pediatric electrode is designed as a single use device and is intended for use to defibrillate and monitor of children.

17.5 Indication for use

The Powerheart AED is intended for 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 tachyarrythmia recurs, the device will charge automatically and advise the operator to deliver therapy.

When the patient is a child or infant up to 8 years of age, or up to 55 lbs (25kg), the Powerheart AED 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

17.6 Identification of Predicate Device

CompanyDevice510(k) #Date Cleared
Agilent Technologies
(Philips Medical
System)FR2 AED with Model M3870A Pediatric
Attenuated Defibrillation Electrodes.K003819May 2, 2001
Survivalink
(Wholly Owned
Subsidiary of Cardiac
Science)Powerheart AEDK011901Feb 1, 2002

Substantial Equivalence 17.7

The Powerheart AED with the Model 9730 Pediatric Attenuated Defibrillation Electrodes covered by this submission is substantially equivalent to other legally marketed AED and pediatric attenuated defibrillation electrodes. Specifically, the Powerheart AED with the Model 9730 electrode is substantially equivalent to Agilent Technologies (acquired by Philips Medical System) FR2 AED with model M3870A pediatric attenuated defibrillation cleared under premarket 510(k) notification, K0038198 on May 2, 2002.

17.8 Performance Data

Performance testing was conducted to verify that the Powerheart AED with the Model 9730 Pediatric Attenuated Defibrillation Electrodes has been designed in accordance with industry standards ANSI AAMI DF-39. In addition, biocompatibility assessments were conducted on the components that come into contact with the patient's skin. The Powerheart AED with the Model 9730 electrodes were found to perform as intended.

17.9 Conclusions

Cardiac Science has demonstrated through its evaluation and testing of the Powerheart AED with the model 9730 Pediatric Attenuated Defibrillation Electrodes that the device is equivalent to the predicate device with respect to intended use, technological characteristics, materials, function and safety and effectiveness.

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.

3

Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in all capital letters and is evenly spaced around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 7 2003

Cardiac Science Incorporated Mr. Kenneth Olson Chief technology Officer 16931 Millikan Avenue Irvine, CA 92606

Re: K022929

Trade/Device Name: Powerheart AED Model 9200/9210 with Model 9730 Pediatric Attenuated Defibrillation Electrodes Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia detector and alarm. Regulatory Class: Class III Product Code: MKJ, MLN Dated: December 13, 2002 Received: December 16, 2002

Dear Mr. Olson:

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 such 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

4

Page 2 -- Mr. Kenneth Olson

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 begin 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4586. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely vours.

K.G. Tell

Bram D. uckerman. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

5

INDICATIONS FOR USE

K022929 510(k) Number:

Device Name:

Powerheart AED Model 9200/9210 Us Ha Model 9730 Pediating Cetternated Efectrodes

Indications for Use:

The Powerheart AED is intended for use 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 tachyarrythmia recurs, the device will charge automatically and advise the operator to deliver therapy.

When the patient is a child or infant is up to 8 years of age, or up to 55 lbs (25kg), the Powerheart AED 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.

(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
510(k) NumberK022929
------------------------
Prescription UseOROver-The-Counter Use
(Per 21 CFR 801.109)