(97 days)
Not Found
No
The description focuses on traditional signal processing and programmed parameters for arrhythmia detection and treatment, with no mention of AI or ML techniques.
Yes
The device is intended to provide specific treatment (cardioversion and/or defibrillation energy) to restore normal cardiac rhythm for patients at risk of Sudden Cardiac Arrest.
Yes
The device acquires electrocardiograph rhythm for detection and determines the presence of shockable arrhythmias, which are diagnostic functions.
No
The device description explicitly mentions hardware components such as patient cables, ECG electrodes, defibrillation electrodes, and the delivery of electrical countershocks, indicating it is a hardware device with embedded software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Powerheart AECD directly interacts with the patient's body by acquiring ECG rhythm through electrodes and delivering electrical therapy (cardioversion/defibrillation) through defibrillation electrodes. It does not analyze samples taken from the body.
- Intended Use: The intended use is to acquire ECG rhythm and provide treatment for ventricular tachyarrhythmias in in-hospital patients. This is a direct patient intervention and therapy, not an in vitro diagnostic test.
The device is a therapeutic device that also has a diagnostic function (acquiring and analyzing ECG rhythm), but this diagnostic function is performed in vivo (within the living body) and is directly linked to the delivery of therapy.
N/A
Intended Use / Indications for Use
The Powerheart AECD is intended to acquire the electrocardiograph rhythm for the detection of, and to provide treatment for, ventricular tachyarrhythmias of in-hospital patients who are at risk of Sudden Cardiac Arrest.
Product codes
MKJ, LDD
Device Description
The Powerheart monitors a patient's cardiac electrical activity and detects and treats ventricular tachyarrhythmias. The patient is connected to the device by a patient cable which is attached to both a set of ECG electrodes and a set of defibrillation electrodes. The defibrillation electrodes can be positioned on the patient sternum- apex or anterior-posteriorly. The operator can program the device during set up to use either the ECG electrodes or the defibrillator electrodes to sense ECG. The Powerheart uses a combination of rate and, if programmed by the physician, morphology to determine the presence of shockable arrhythmias. When a shockable arrhythmia is detected, the system delivers cardioversion and/or defibrillation energy through defibrillator electrodes to restore normal cardiac rhythm. Should the arrhythmia continue, the Powerheart will deliver additional electrical countershocks after each subsequent evaluation and programmed delay. Depending upon the programmed parameters as prescribed by the physician, the Powerheart may deliver a maximum of nine pulse sequences. In the event that nine pulse sequences have been delivered, the Powerheart will not automatically deliver any further therapy until: 1) a new shockable rhythm is detected after 60 consecutive seconds of non-shockable rhythm is presented, or 2) the device is reset manually. The energy levels for each individual countershock are also programmed into the device per the physician's prescription.
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
Not Found
Intended User / Care Setting
in-hospital patients
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
Non-clinical Tests: Based on the non-clinical performance testing, the device was concluded is as safe Based on the non-chilical performance tosting, and the predicate device.
Summary of Performance Testing:
- System Validation .
- Observation of Requirements . Implementation
- Analysis Tests .
- Battery System Tests .
- Defibrillation Related Performance .
- . Alarm System Tests
- Environmental Testing .
- Electrical Safety Testing .
- Functional Safety Testing ●
- Electromagnetic Compatibility . Testing (EMC)
- ECG Channel/Defibrillator Pad ID .
- . Quality and Reliability
- Human Factors .
- System Software Validation and . Verification
- Arrhythmia Detection Software . Verification and Validation
Key Metrics
Not Found
Predicate Device(s)
Powerheart® AECD® (K970741).
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
4 2000
Attachment F
510 (k) Summary
| Date | October 15, 1999 | |
|---|---|---|
| Submitter and Contact Person | Cardiac Science, Inc. | |
| 1176 Main Street, Building "C" | ||
| Irvine, CA 92614 | Contact: Stan Tillman, Dir. RA/QA | |
| Phone: 949/587-0357, ext. 238 |
| Device Name | Trade Name | Common/Classification Name |
|---|---|---|
| Powerheart® AECD® | Defibrillator, Automatic, External |
| Predicate Device | Powerheart® AECD® (K970741). |
|---|---|
| ------------------ | ------------------------------ |
| Device Description | The Powerheart monitors a patient's cardiac electrical activity and detects and treats ventricular tachyarrhythmias. The patient is connected to the device by a patient cable which is attached to both a set of ECG electrodes and a set of defibrillation electrodes. The defibrillation electrodes can be positioned on the patient sternum- apex or anterior-posteriorly. The operator can program the device during set up to use either the ECG electrodes or the defibrillator electrodes to sense ECG. The Powerheart uses a combination of rate and, if programmed by the physician, morphology to determine the presence of shockable arrhythmias. When a shockable arrhythmia is detected, the system delivers cardioversion and/or defibrillation energy through defibrillator electrodes to restore normal cardiac rhythm. Should the arrhythmia continue, the Powerheart will deliver additional electrical countershocks after each subsequent evaluation and programmed delay. Depending upon the programmed parameters as prescribed by the physician, the Powerheart may deliver a maximum of nine pulse sequences. In the event that nine pulse sequences have been delivered, the Powerheart will not automatically deliver any further therapy until: 1) a new shockable rhythm is detected after 60 consecutive seconds of non-shockable rhythm is presented, or 2) the device is reset manually. The energy levels for each individual countershock are also programmed into the device per the physician's prescription. |
|---|---|
| -------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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1
Intended Use The Powerheart AECD is intended to acquire the electrocardiograph rhythm for the detection of, and to provide treatment for, ventricular tachyarrhythmias of in-hospital patients who are at risk of Sudden Cardiac Arrest.
The modified Powerhear® has the same technological characteristics as the
unmodified device which previously received 510(k) clearance as shown in the table Comparison Table below:
| Feature | Predicate Device | Candidate Device |
|---|---|---|
| Primary | ||
| Component | Powerheart proprietary AECD® | |
| Arrhythmia Detection Software | ||
| (cleared under K970741 and | ||
| also cleared separately under | ||
| K982710) | Same | |
| Major | ||
| Components | 11. defibrillator |
- defibrillation electrodes
- ECG electrodes (off-the-
shelf) - patient cable
- computer system
- control panel
- display monitor
- chart recorder (printer)
- event recorder
- ECG out cable | Same |
| Input Data | Electrocardiogram (ECG) | Same |
| Output | Delivery of shock | Same |
| Maximum
Energy | 360 Joules | Same |
| Defibrillation
Waveform
and Charging
Time | Per AAMI DF2-1996 | Same |
| ECG Signal
Input | Defibrillation electrodes or
bipolar ECG electrodes | Same |
| Operating
Modes | 5. Automatic, - Advisory,
- Manual and
- Program | Same |
| Physician
Programmable
Parameters | 4. Patient ID number - Detection criteria, and
- Therapy criteria | Same |
Continued on next page
2
Non-clinical Tests
Based on the non-clinical performance testing, the device was concluded is as safe Based on the non-chilical performance tosting, and the predicate device.
Summary of Performance Testing
- System Validation .
- Observation of Requirements . Implementation
- Analysis Tests .
- Battery System Tests .
- Defibrillation Related Performance .
- . Alarm System Tests
- Environmental Testing .
- Electrical Safety Testing .
- Functional Safety Testing ●
- Electromagnetic Compatibility . Testing (EMC)
- ECG Channel/Defibrillator Pad ID .
- . Quality and Reliability
- Human Factors .
- System Software Validation and . Verification
- Arrhythmia Detection Software . Verification and Validation
END
3
Image /page/3/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings forming a protective shape. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" are arranged in a circular pattern around the eagle.
MAR 2 4 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Cardiac Science, Inc. c/o Mr. Stan E. Tillman 16931 Millikan Avenue Irvine, CA 92606
Re: K993533
Trade/Device Name: Powerheart External Cardioverter Defibrillator with RHYTHMx ECD Software Regulation Number: 21 CFR 870.5310 Regulation Name: Automated External Defibrillator Regulatory Class: Class III (Three) Product Code: MKJ, LDD Dated: January 13, 2000 Received: January 14, 2000
Dear Mr. Tillman:
This letter corrects our substantially equivalent letter of January 24, 2000.
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.
4
Page 2 - Mr. Stan E. Tillman
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
5
Indications for Use Statement
| 510(k)
Number
| (if known) | K993533 |
|---|---|
| Device Name | Powerheart® AECD® |
| Indications for | |
| Use | The Powerheart AECD is intended to acquire the electrocardiograph |
| rhythm for the detection of, and to provide treatment for, ventricular | |
| tachyarrhythmias of in-hospital patients who are at risk of Sudden Cardiac | |
| Arrest. |
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED
| Clearance of CDRH, Office of Device Evaluation (ODE) | ||
|---|---|---|
| (Division Sign-Off) | ||
| Division of Cardiovascular, Respiratory, | ||
| and Neurological Devices | ||
| 510(k) Number | ||
| Prescription Use | OR | Over-The-Counter Use |
| (Per 21 CFR 801.109) |
122