(131 days)
No
The description mentions "patented RHYTHMx® software which provides ECG rhythm analysis" and "STAR® Biphasic waveform delivers impedance-compensated energy". While these involve algorithms and signal processing, there is no explicit mention of AI, ML, or related concepts like neural networks, deep learning, or training/test sets, which are typically associated with AI/ML in regulatory submissions. The rhythm analysis and impedance compensation are more likely based on traditional signal processing and rule-based algorithms.
Yes
The device delivers various therapies, including defibrillation, cardioversion, and external pacing, which are direct medical interventions used to treat specific conditions.
Yes
The device performs diagnostic functions such as analysis of the patient's ECG rhythm, identification or interpretation of cardiac rhythms or dysrhythmias, calculation of heart rate, and continuous external monitoring of arterial oxygen saturation and pulse rate.
No
The device description clearly states it is a defibrillator/monitor/pacemaker, which are hardware components. It also mentions a display, power supply, battery, paddles, spoons, pads, printer, and internal storage, all of which are hardware. While it mentions software (RHYTHMx®), the device itself is a physical medical device with integrated software, not a software-only 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. They are used to examine specimens outside of the body.
- Device Function: The Powerheart ECD is a defibrillator/monitor/pacemaker. Its primary functions involve:
- Defibrillation/Cardioversion: Delivering electrical shocks to the body to correct heart rhythms.
- ECG Monitoring: Measuring electrical activity of the heart from the body.
- Pacing: Delivering electrical pulses to the heart through the body.
- Pulse Oximetry: Measuring oxygen saturation and pulse rate from the body.
- Lack of Specimen Analysis: The device does not analyze samples taken from the body. It interacts directly with the patient's body to monitor and treat cardiac conditions.
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
at least 8 years of age (for semi-automatic advisory mode)
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)
Representative samples of the device components underwent system, safety and bench testing on both hardware and software to demonstrate appropriate functional and performance characteristics.
Based on the results of the testing described above, it is concluded that the Powerheart ECD does not raise any different questions regarding the safety or effectiveness as compared with the predicate device. The Cardiac Science, Inc. Powerheart ECD is substantially equivalent to the Medtronic Physio- Control LIFEPAK 20 in terms of indications for use, features and functions.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Medtronic Physio-Control LIFEPAK® 20 Defibrillator (K012274)
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
JAN 3 2006
SECTION 2. SUMMARY AND CERTIFICATION
| 2.1. 510(k) Summary | |
|---|---|
| Submitter: | Cardiac Science, Inc. |
| 5474 Feltl Road | |
| Minnetonka, MN 55343 | |
| Contact Person: | Kenneth Olson |
| Phone: (952) 939-2912 | |
| Fax: (952) 939-4191 | |
| Date Prepared: | August 22, 2005 |
| 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 Medtronic Physio-Control | |
| LIFEPAK® 20 Defibrillator (K012274). | |
| 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 Powerheart ECD does not raise any different
questions regarding the safety or effectiveness as compared
with the predicate device. The Cardiac Science, Inc. Powerheart
ECD is substantially equivalent to the Medtronic Physio-
Control LIFEPAK 20 in terms of indications for use, features
and functions. |
2.1 510(k) Summarv
510(k) Premarket Submission Cardiac Science, Inc.
1
:
12
2
2.2. 510(k) Checklist
Traditional 510(k) Premarket Notification Checklist for Class III Device
| No. | Item | Included | Location |
|---|---|---|---|
| 1 | Cover letter clearly identifying submission as | ||
| "Traditional 510(k)" | Yes | Cover Letter | |
| 2 | Table of Contents | Yes | TOC |
| 3 | Indication for Use | Yes | IFU page |
| 4 | Manufacturer name and address | Yes | Section I |
| 5 | Contact person, phone number, fax number | Yes | Section 1 |
| 6 | Device common name and trade name | Yes | Section 1 |
| 7 | Establishment registration number | Yes | Section 1 |
| 8 | Device classification and product code | Yes | Section 1 |
| 9 | 510(k) Summary | Yes | Section 2.1 |
| 10 | Identification of predicate device | Yes | Section 2.1 |
| 11 | Truthful and Accurate Statement | Yes | Section 2.4 |
| 12 | Class III Certification and Summary | Yes | Section 2.5 |
| 13 | Proposed labeling | Yes | Section 3 |
| 14 | Description of the device | Yes | Section 4 |
| 15 | Substantial equivalence comparison | Yes | Section 5 |
| 16 | Performance testing | Yes | Section 6 |
| 17 | System Hazard Analysis | Yes | Section 6.1 |
| 18 | Clinical evaluation | Yes | Section 6.6 |
| 19 | Biocompatibility data | Yes | Section 7 |
| 20 | Sterilization information | Yes | Section 8 |
| 21 | Software documentation | Yes | Section 9 |
| 22 | Compliance with performance standards | Yes | Section 10 |
3
2.3. Premarket Notification Statement
:
. '
:
In lieu of a Pre Market Notification Statement, a 510(k) Summary is provided in Section 2.1. of this 510(k) Premarket Notification.
:
4
DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 3 2006
Cardiac Science, Inc. c/o Mr. Kenneth F. Olson Chief Technical Officer 5474 Feltl Road Minnetonka, MN 55343-7982
Re: K052316 Trade Name: Powerheart ECD Regulation Number: 21 CFR 870.5310 Regulation Name: Automated External Defibrillator Regulatory Class: Class III Product Code: MKJ Dated: December 20, 2005 Received: December 21, 2005
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.
5
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 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), 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours,
Bheminar for
Bram D. Zuckerman, M.D. Director Division of Cardiovacsular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Powerheart ECD TM
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.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page I of l
Blammymer
(Division Sign-Off
Division of Cardiovascular Devices
510(k) Number K052316
510(k) Premarket Submission Cardiac Science, Inc.
Powerheart ECD CONFIDENTIAL
August 23, 2005
9