(6 days)
The AECD Arrhythmia Detection Software, when loaded into 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 Cardiac Science, Inc., AECD Arrhythmia Detection Software is simply the "arrhythmia detector" software program which is the primary component of the unmodified Powerheart AECD (K970741).
This is a computer software program which analyzes the patient's ECG waveform and determines whether the patient exhibits a non-shockable rhythm, based upon the physician programmed parameters for the patient.
This software is not a standalone medical software device. The AECD Arrhythmia Detection Software will be marketed as a component intended to enhance the performance of defibrillators and/or patient monitors by adding this functionality to those products.
This document describes the AECD® Arrhythmia Detection Software®, solely referring to the software component of a previously cleared device, the Powerheart® AECD®.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state quantitative acceptance criteria or a specific table for the performance of the AECD Arrhythmia Detection Software as a standalone submission. Instead, it refers to the performance of the Powerheart AECD (K970741), of which this software is a component.
Therefore, the table below reflects what can be inferred about the software's performance from the context of its predicate device, as directly stated performance metrics for the software alone are not provided in this specific submission.
| Acceptance Criteria (Inferred from Predicate Device) | Reported Device Performance (Inferred for Software) |
|---|---|
| Performance according to specifications (for arrhythmia detection) | Performs according to its specifications (as part of the Powerheart AECD) |
| Ability to acquire electrocardiograph rhythm | Acquires electrocardiograph rhythm |
| Detection of ventricular tachyarrhythmias | Detects ventricular tachyarrhythmias |
| Ability to determine non-shockable rhythms based on programmed parameters | Determines non-shockable rhythms based on physician programmed parameters |
2. Sample Size Used for the Test Set and Data Provenance:
The document refers to "bench testing using standard ECG databases" and "clinical data resulting from IDE Application G920078" from the predicate device (Powerheart AECD, K970741).
- Sample Size for Test Set: Not specified in this document. It mentions "standard ECG databases" for bench testing and "clinical data" from an IDE. To find the exact sample size, the predicate device's (K970741) submission would need to be reviewed.
- Data Provenance:
- Bench Testing: Standard ECG databases (specific origin not detailed in this document).
- Clinical Data: From IDE Application G920078 (no country of origin or retrospective/prospective nature specified in this document, but IDEs are typically prospective clinical trials).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not specified in this document. The document only mentions "standard ECG databases" and "clinical data," but provides no details on how ground truth was established for these datasets, nor the number or qualifications of experts involved.
4. Adjudication Method for the Test Set:
Not specified in this document.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study is not mentioned in this document. The device is a "computer software program which analyzes the patient's ECG waveform," implying an automated detection system, not one that assists human readers.
6. Standalone (Algorithm Only) Performance:
Yes, a standalone performance evaluation of the algorithm was done. The document explicitly states: "Bench testing was performed using standard ECG databases prior to the clinical trials. Testing demonstrated that the software performs according to its specifications." This refers to the algorithm's performance without human interaction.
7. Type of Ground Truth Used:
Based on the description of the device's function (detecting ventricular tachyarrhythmias and non-shockable rhythms) and the use of "standard ECG databases" and "clinical data," the ground truth likely involved:
- Expert Consensus/Diagnosis: For clinical data, this would involve diagnoses made by cardiologists or electrophysiologists.
- Reference Annotations: For standard ECG databases, these often contain expert-annotated rhythm labels, which serve as ground truth for algorithm training and testing.
8. Sample Size for the Training Set:
Not specified in this document. The document refers to "standard ECG databases" which are often used for both training and testing, but separates them as "bench testing prior to clinical trials." The size of any training set used for the software's development is not detailed.
9. How the Ground Truth for the Training Set Was Established:
Not specified in this document. As with the test set, it can be inferred that expert annotations or diagnoses, typical for ECG databases, would have been used.
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AUG | 0 |998
Attachment D
SUMMARY OF SAFETY AND EFFECTIVENESS
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92.
Submitter Information
| a. Company Name: | Cardiac Science, Inc. |
|---|---|
| b. Company Address: | 1176 Main Street, Suite C |
| c. Company Phone: | (949) 587-0357 |
| d. Company Facsimile: | (949) 951-7315 |
| e. Contact Person: | Stan Tillman, RAC, CQM, CQE, CQADirector of Regulatory Affairs and Quality Assurance |
| f. Date Prepared: | July 16, 1998 |
Device Identification
| a. Trade/Proprietary Name: | Automatic External Cardioverter Defibrillator (AECD)®Arrhythmia Detection Software® |
|---|---|
| b. Classification Name: | Defibrillators, Automatic, External |
Identification of Predicate Device
| Company | Unmodified Device | 510(k) No. | Date Cleared |
|---|---|---|---|
| Cardiac Science | Powerheart® AECD® | K970741 | Oct. 16, 1997 |
Device Description
The Cardiac Science, Inc., AECD Arrhythmia Detection Software is simply the "arrhythmia detector" software program which is the primary component of the unmodified Powerheart AECD (K970741).
This is a computer software program which analyzes the patient's ECG waveform and determines whether the patient exhibits a non-shockable rhythm, based upon the physician programmed parameters for the patient.
This software is not a standalone medical software device. The AECD Arrhythmia Detection Software will be marketed as a component intended to enhance the performance of defibrillators and/or patient monitors by adding this functionality to those products.
Substantial Equivalence.
The AECD Arrhythmia Detection Software is substantially equivalent to the unmodified Powerheart AECD cleared under 510(k) K970741 on October 16, 1997. The software which is the subject of this submission is virtually unchanged from the previously cleared version. The
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difference between this submission and the previously cleared device is that this submission is for the arrhythmia detection software only and does not include hardware.
Intended Use
The AECD Arthythmia Detection Software, when loaded into the Powerheart ABCD 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.
Performance Data
The AECD Arrhythmia Detection Software is the same proprietary arrhythmia detector 510(k) cleared in the Powerheart AECD submission (K970741). The detector was subjected to preclinical, clinical and software validation testing as the primary component of the 510(k) cleared Powerheart AECD submission (K970741). Bench testing was performed using standard ECG databases prior to the clinical trials. Testing demonstrated that the software performs according to its specifications. Documentation to support the performance evaluation, including clinical data resulting from IDE Application G920078, was provided in the Powerheart AECD submission (K970741).
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized human figure with three faces in profile, overlaid with three wing-like shapes above them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG / 0 1998
Mr. Stan Tillman Cardiac Science, Inc. 1176 Main Street Building "C" Irvine, CA 92614
Re: K982710 AECD® Arrhythmia Detection Software® Regulatory Class: III (three) Product Code: 74 MKJ Dated: August 3, 1998 Received: August 4, 1998
Dear Mr. Tillman:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Stan Tillman
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Thomas J. Callehan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Attachment C
Page 1 of 1
Indications for Use
510(k) Number (if known):
Device Name: ____________________________________________________________________________________ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
Indications for Use:
The AECD Arrhythmia Detection Software, when loaded into 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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Krame
Prescription Use ✓
(Optional Format 3-10-98)
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§ 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.