(40 days)
No
The description mentions "patented RHYTHMx® software which provides ECG rhythm analysis" and "STAR® Biphasic waveform delivers impedance-compensated energy". While these involve sophisticated algorithms for signal processing and therapy delivery, the summary does not explicitly mention or imply the use of AI or ML techniques for these functions. The focus is on established signal analysis and waveform technology.
Yes
The device delivers various therapies, including defibrillation, cardioversion, and external pacing, which are direct medical interventions aimed at treating specific conditions.
Yes
The device is described as allowing for "identification or interpretation of cardiac rhythms or dysrhythmias" through 3-lead and 5-lead ECG monitoring, and it performs "ECG rhythm analysis" using RHYTHMx® software. These functions indicate its role in diagnosing medical conditions.
No
The device description clearly states it is a defibrillator/monitor/pacemaker and details hardware components like a display, power supply, paddles, and a thermal printer. While it mentions software (RHYTHMx®), it is an integral part of a physical 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 ECD is a medical device that provides therapies (defibrillation, cardioversion, pacing) and monitoring (ECG, pulse oximetry). It directly interacts with the patient's body to deliver treatment or gather physiological data.
- Lack of Sample Analysis: The description does not mention the analysis of any biological samples taken from the patient. The monitoring functions (ECG, SpO2) are performed externally on the patient.
Therefore, the Powerheart ECD 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 ECD defibrillator system is intended to be used by personnel who have been trained in its operation.
The Powerheart ECD is indicated for the termination of certain fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. Delivery of energy in the synchronized mode is a method for treating atrial fibrillation, atrial flutter, paroxysmal supraventricular tachycardia, and in relatively stable patients, ventricular tachycardia.
The semi-automatic advisory mode is for use in cardiac arrest in patients of at least 8 years of age. The patient must be unconscious, pulseless, and not breathing spontaneously before using the defibrillator to analyze the patient's ECG rhythm.
The Powerheart ECD 3-lead and 5-lead ECG monitoring allows for identification or interpretation of cardiac rhythms or dysrhythmias and calculation of heart rate.
The Powerheart ECD noninvasive pacing as a therapy is indicated for patients with symptomatic bradycardia or asystole.
The Powerheart ECD pulse oximetry is intended for the continuous external monitoring of arterial oxygen saturation and pulse rate and is indicated for use in any patient who is at risk of developing hypoxemia.
Product codes
MKJ
Device Description
The Powerheart® ECD is a defibrillator/monitor/pacemaker intended for use by personnel trained in its operation. The device is lightweight, portable, easy to use and reliable. It incorporates a 320 x 240 transmissive TFT color display for wide viewing angles in all light conditions. The device operates using either an AC power supply or internal rechargeable Li-Ion battery. The device provides continuous ECG monitoring and three types of therapies: defibrillation, cardioversion and external pacing. Defibrillation can be applied manually or semi-automatically. Pacing therapy can be either fixed or demand. The device employs patented RHYTHMx® software which provides ECG rhythm analysis. STAR® Biphasic waveform delivers impedance-compensated energy ranging from 2-270 Joules. Features and options include external paddles, spoons, disposable pads, 3- and 5-lead ECG, pulse oximetry (SpO2), built-in 60 mm thermal printer, internal storage of event history and remote synchronization to bedside monitor.
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 semi-automatic advisory mode is for use in cardiac arrest in patients of at least 8 years of age.
Intended User / Care Setting
personnel who have been trained in its operation.
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)
Functional and Safety Testing: Representative samples of the device components underwent system, safety and bench testing on both hardware and software to demonstrate appropriate functional and performance characteristics.
Conclusion: Based on the results of the testing described above, it is concluded that the modifications to the Powerheart ECD do not raise any new questions regarding the safety or effectiveness as compared with the predicate device. The Cardiac Science, Inc. Powerheart ECD is substantially equivalent to the Powerheart ECD cleared in K052316 in terms of indications for use, features and functions.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
Ko60934i|500
MIY 1 5 2005
IX. 510(k) Summary
| Submitter: | Cardiac Science Corporation
3303 Monte Villa Parkway
Bothell, WA 98021-8969 |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Cheryl Shea
Phone: (425) 402-2255
Fax: (425) 402-2017 |
| Date Prepared: | April 4, 2006 |
| Trade Name: | Powerheart ECD™ |
| Classification
Name and Number: | Automated External Defibrillator
Class III, 21CFR 870.5310 |
| Product Code: | MKJ |
| Predicate
Device(s): | The Powerheart ECD™ manufactured by Cardiac
Science, Inc is substantially equivalent to the Cardiac
Science Powerheart ECD - K052316 (1/3/2006) |
| Device
Description: | The Powerheart® ECD is a defibrillator/monitor/
pacemaker intended for use by personnel trained in its
operation. The device is lightweight, portable, easy to
use and reliable. It incorporates a 320 x 240 transmissive
TFT color display for wide viewing angles in all light
conditions. The device operates using either an AC power
supply or internal rechargeable Li-Ion battery. The device
provides continuous ECG monitoring and three types of
therapies: defibrillation, cardioversion and external
pacing. Defibrillation can be applied manually or semi-
automatically. Pacing therapy can be either fixed or
demand. The device employs patented RHYTHMx®
software which provides ECG rhythm analysis. STAR®
Biphasic waveform delivers impedance-compensated
energy ranging from 2-270 Joules. Features and options
include external paddles, spoons, disposable pads, 3-
and 5-lead ECG, pulse oximetry (SpO2), built-in 60 mm
thermal printer, internal storage of event history and
remote synchronization to bedside monitor. |
| Indications For Use: | The Powerheart ECD defibrillator system is intended to be used by personnel who have been trained in its operation. |
| | The Powerheart ECD is indicated for the termination of certain fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. Delivery of energy in the synchronized mode is a method for treating atrial fibrillation, atrial flutter, paroxysmal supraventricular tachycardia, and in relatively stable patients, ventricular tachycardia. |
| | The semi-automatic advisory mode is for use in cardiac arrest in patients of at least 8 years of age. The patient must be unconscious, pulseless, and not breathing spontaneously before using the defibrillator to analyze the patient's ECG rhythm. |
| | The Powerheart ECD 3-lead and 5-lead ECG monitoring allows for identification or interpretation of cardiac rhythms or dysrhythmias and calculation of heart rate. |
| | The Powerheart ECD noninvasive pacing as a therapy is indicated for patients with symptomatic bradycardia or asystole. |
| | The Powerheart ECD pulse oximetry is intended for the continuous external monitoring of arterial oxygen saturation and pulse rate and is indicated for use in any patient who is at risk of developing hypoxemia. |
| Functional and Safety Testing: | Representative samples of the device components underwent system, safety and bench testing on both hardware and software to demonstrate appropriate functional and performance characteristics. |
| Conclusion: | Based on the results of the testing described above, it is concluded that the modifications to the Powerheart ECD do not raise any new questions regarding the safety or effectiveness as compared with the predicate device. The Cardiac Science, Inc. Powerheart ECD is substantially equivalent to the Powerheart ECD cleared in K052316 in terms of indications for use, features and functions. |
Confidential
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized caduceus, which is a staff with two snakes entwined around it, representing medicine and health.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 15 2006
Cardiac Science Corporation C/O Ms. Cheryl L. Shea, RAC VP-RA/QA 3303 Monte Villa Parkway Bothell, WA 98021-8969
Re: K060934
Trade/Device Name: Powerheart ECD Regulation Number: 21 CFR 870.5310 Regulation Name: Automated External Defibrillator Regulatory Class: Class III Product Code: MKJ Dated: May 3, 2006 Received: May 5, 2006
Dear Ms. Shea:
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 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.
3
This letter will allow you to begin marketing your device as described in your Section 510(k) I mb letter natification. The FDA finding of substantial equivalence of your device to a legally premainer modicate 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-__. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Bymmuma for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number:
Device Name: Powerheart ECD™
Indications for Use:
The Powerheart ECD defibrillator system is intended to be used by personnel who have been trained in its operation.
The Powerheart ECD is indicated for the termination of certain fatal arrhythmias, The Townson LED illation and symptomatic ventricular tachycardia. Delivery of energy in the synchronized mode is a method for treating atrial fibrillation, atrial energy in the cyntillion tachycardia, and in relatively stable patients, ventricular tachycardia.
The semi-automatic advisory mode is for use in cardiac arrest in patients of at least 8 years of age. The patient must be unconscious, pulseless, and not breathing y on overy before using the defibrillator to analyze the patient's ECG rhythm.
The Powerheart ECD 3-lead and 5-lead ECG monitoring allows for identification or interpretation of cardiac rhythms or dysrhythmias and calculation of heart rate.
The Powerheart ECD noninvasive pacing as a therapy is indicated for patients with symptomatic bradycardia or asystole.
The Powerheart ECD pulse oximetry is intended for the continuous external monitoring of arterial oxygen saturation and pulse rate and is indicated for use in any patient who is at risk of developing hypoxemia.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation
Prescription Use (Per 21 CFR 801.109) OR
Over-The Counter Use
Alumuma
riston Sian-Division of Cardiovascular Devices 510(k) Number