(126 days)
No
The summary does not mention AI, ML, or related terms, and the description focuses on standard defibrillator functionality and circuitry.
Yes
The device is described as providing "treatment for, ventricular tachyarrhythmias" and "therapy to patients at risk for Sudden Cardiac Arrest," including defibrillation and pacing, which are therapeutic interventions.
Yes
The device is intended to "acquire the ECG rhythm for the detection of... ventricular tachyarrhythmias," which is a diagnostic function.
No
The device description explicitly states it is a "compact, lightweight, automatic external cardioverter defibrillator" and incorporates "essential circuitry and software," indicating it is a hardware device with embedded software, not a software-only medical device.
Based on the provided information, 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 Cardiac Rhythm Module (CRM) is an external device that acquires ECG rhythm (electrical signals from the heart) and provides therapy (defibrillation and pacing) directly to the patient's body. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's for acquiring ECG rhythm and providing treatment for ventricular tachyarrhythmias in patients. This is a direct interaction with the patient's physiology, not an analysis of a biological sample.
Therefore, the Powerheart CRM falls under the category of a medical device that interacts directly with the patient, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Powerheart Cardiac Rhythm Module (CRM) is intended to acquire the ECG rhythm for the detection of, and to provide treatment for, ventricular tachyarrhythmias of patients who are at risk of sudden cardiac arrest. The device is intended to be used in medically supervised environments by trained personnel, in which patients are under the direct care of physicians and/or medical persons authorized by the state, province or country regulations in which they practice. The Powerheart CRM can be used in three modes: fully automatic mode, advisory mode or manual mode and includes a pacer which allows an operator to deliver external stimuli for temporary transcutaneous cardiac pacing. The Powerheart has previously undergone clinical testing on adults which support the safety and effectiveness of using the device on patients at risk of sudden cardiac arrest who are at least 8 years of age. The device is not classified as a wearable external defibrillator and is not intended for use in the home environment.
Product codes
MKJ, LDD, DRO
Device Description
The Powerheart Cardiac Rhythm Module (CRM) is a compact, lightweight, automatic external cardioverter defibrillator. It incorporates essential circuitry and software to provide a detection/analysis/defibrillation/pacing system, in a single device, for monitoring and providing therapy to patients at risk for Sudden Cardiac Arrest.
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
patients at least 8 years of age.
Intended User / Care Setting
medically supervised environments by trained personnel, in which patients are under the direct care of physicians and/or medical persons authorized by the state, province or country regulations in which they practice.
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 performance tests conducted on the Powerheart Cardiac Rhythm Module will follow the applicable portions of the ANSIAAMI DF2 and DF39 requirements for cardiac defibrillator devices and automatic external defibrillators to demonstrate the safety and efficacy of the CRM device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Powerheart® AECD®, K993533
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
510(k) SUMMARY
Submitter's Name and Address 10.1
NOV 1 6 2001
CARDIAC SCIENCE, INC. 16931 Millikan Avenue Irvine, CA. 92606
Contact person:
Sew-Wah Tay, PhD Vice President Cardiac Science, Inc. 5420 Feltl Road Minneapolis, MN 55343 Tel: 952-939-2942 Fax: 952-939-4191 Email: stay@cardiacscience.com
10.2 Date Summary was Prepared
October 21, 2001
10.3 Device Name
Proprietary: Powerheart® Cardiac Rhythm Module™ (CRMTM)
Common: Automatic External Cardioverter Defibrillator
10.4 Classification
-
- 870.5300 DC-defibrillator
-
- 870.5550 External Transcutaneous Cardiac Pacemaker (Noninvasive)
-
- Class III 74 MJK
10.5 Predicate Device
Powerheart® AECD®, K993533
10.6 Description of Device
The Powerheart Cardiac Rhythm Module (CRM) is a compact, lightweight, automatic external cardioverter defibrillator. It incorporates essential circuitry and software to provide a detection/analysis/defibrillation/pacing system, in a single device, for monitoring and providing therapy to patients at risk for Sudden Cardiac Arrest.
1
10.7 Intended Use of Device
Indication for Use:
The Powerheart Cardiac Rhythm Module (CRM) is intended to acquire the ECG rhythm for the detection of, and to provide treatment for, ventricular tachyarrhythmias of patients who are at risk of sudden cardiac arrest. The device is intended to be used in medically supervised environments by trained personnel, in which patients are under the direct care of physicians and/or medical persons authorized by the state, province or country regulations in which they practice. The Powerheart CRM can be used in three modes: fully automatic mode, advisory mode or manual mode and includes a pacer which allows an operator to deliver external stimuli for temporary transcutaneous cardiac pacing. The Powerheart has previously undergone clinical testing on adults which support the safety and effectiveness of using the device on patients at risk of sudden cardiac arrest who are at least 8 years of age. The device is not classified as a wearable external defibrillator and is not in the home environment.
Fully Automatic Mode
In this mode, the device continuously monitors the patient's ECG rhythm, detects shockable ventricular tachyarrhythmias and automatically provides defibrillation therapy for the treatment of sudden cardiac arrest.
Advisory (AED) Mode
In this mode, the device continuously monitors the patient's ECG rhythm, detects shockable ventricular tachyarrhythmias and advises the operator to press the shock button to deliver defibrillation therapy for the treatment of sudden cardiac arrest.
Manual Mode
In this mode, as is the case with all standard manual defibrillators, the operator manually selects the energy setting, manually selects the charge button, determines if the patient has a shockable ventricular tachyarrhythmia and decides when to manually deliver defibrillation therapy.
Pacing
The device includes a non-invasive external pacer that allows a physician and/or trained medical person to provide temporary external cardiac pacing for patients with symptomatic bradycardia or asystole.
10.8 Summary of Technological Characteristics
The Powerheart CRM utilizes an FDA-cleared and patented arrhythmia detection software that continuously monitors, detects and delivers therapy, according to physician-prescribed parameters, to patients experiencing ventricular tachyarrhythmias. The delivery output is an FDA-cleared, biphasic truncated exponential waveform, which the Powerheart CRM can transmit in one of three modes: Automatic, Advisory and Manual. The Powerheart CRM also provides non-invasive temporary cardiac pacing.
10.9 Summary of Performance Data
The performance tests conducted on the Powerheart Cardiac Rhythm Module will follow the applicable portions of the ANSIAAMI DF2 and DF39 requirements for cardiac defibrillator devices and automatic external defibrillators to demonstrate the safety and efficacy of the CRM device.
2
10.10 Conclusion
The performance tests conducted on the Powerheart CRM will be subjected to pre-determined pass criteria that will support claims of substantial equivalence.
3
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 6 2001
Sew-Wah Tay, Ph.D. Vice President Cardiac Science, Inc. 5420 Feltl Road Minneapolis, MN 55343
Re: K012197
Trade Name: Powerheart® Cardiac Rhythm Module Regulation Number: 21 CFR 870.5300 Regulation Name: Defibrillator, Automatic, External Regulatory Class: Class III (three) Product Code: MKJ, LDD, DRO Dated: October 29, 2001 Received: October 30, 2001
Dear Ms. Tay:
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.
4
Page 2 - Sew-Wah Tay, Ph.D.
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 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) 594-4646. 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 yours,
signature
James H. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/5/Picture/2 description: The image shows a heavily edited or obscured piece of text. Due to the extensive alterations, it is impossible to discern the original content or meaning of the text. The image appears to be a close-up of the text, with the modifications applied directly to the characters.
510(k) Number: K012197
NOV 1 6 2001
Device Name: Powerheart® Cardiac Rhythm Module
Indication for Use:
The Powerheart Cardiac Rhythm Module (CRM) is intended to acquire the ECG rhythm for the detection of, and to provide treatment for, ventricular tachyarrhythmias of patients who are at risk of sudden cardiac arrest. The device is intended to be used in medically supervised environments by trained personnel, in which patients are under the direct care of physicians and/or medical persons authorized by the state, province or country regulations in which they practice. The Powerheart CRM can be used in three modes: fully automatic mode, advisory mode or manual mode and includes a pacer which allows an operator to deliver external stimuli for temporary transcutaneous cardiac pacing. The Powerheart has previously undergone clinical testing on adults which support the safety and effectiveness of using the device on patients at risk of sudden cardiac arrest who are at least 8 years of age. The device is not classified as a wearable external defibrillator and is not intended for use in the home environment.
Fully Automatic Mode
In this mode, the device continuously monitors the patient's ECG rhythm, detects shockable ventricular tachyarthythmias and automatically provides defibrillation therapy for the treatment of sudden cardiac arrest.
Advisory (AED) Mode
In this mode, the device continuously monitors the patient's ECG rhythm, detects shockable ventricular tachyarrhythmias and advises the operator to press the shock button to deliver defibrillation therapy for the treatment of sudden cardiac arrest.
Manual Mode
In this mode, as is the case with all standard manual defibrillators, the operator manually selects the energy setting, manually selects the charge button, determines if the patient has a shockable ventricular tachyarrhythmia and decides when to manually deliver defibrillation therapy.
Pacing
The device includes a non-invasive external pacer that allows a physician and/or trained medical person to provide temporary external cardiac pacing for patients with symptomatic bradycardia or asystole.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||
|---|---|---|
| Division of Cardiovascular & Respiratory Devices | ||
| K012/197 | ||
| Prescription Use | OR | Over-The Counter Use |
| (Per 21 CFR 801.109) |