(116 days)
Not Found
No
The summary describes a software algorithm for analyzing ECG signals and providing measurements, but there is no mention of AI, ML, or related concepts. The performance studies focus on compliance with standards and software verification/validation, not on training or testing of AI/ML models.
No
The device analyzes ECG signals and provides measurements for risk stratification and prediction, but it does not directly treat or alleviate a medical condition. It is a diagnostic tool used in conjunction with other clinical information.
Yes
The device analyzes ECG signals to provide measurements for risk stratification and prediction of sudden cardiac death, which are diagnostic purposes when used in conjunction with other clinical information.
Yes
The device description explicitly states it is a "software algorithm" that runs on existing electrocardiographic equipment, indicating it is a software-only component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is performed outside of the body (in vitro).
- Device Function: The Heart Rate Turbulence Analysis Program analyzes ECG signals. ECG signals are electrical signals measured directly from the body's surface, not from a specimen taken from the body.
- Intended Use: The intended use is to analyze ECG signals for risk stratification and prediction of sudden cardiac death. This analysis is based on physiological measurements from the patient, not on testing of a biological sample.
Therefore, because the device analyzes signals directly from the patient's body rather than a specimen taken from the body, it falls outside the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Heart Rate Turbulence Analysis Program is intended for use in a hospital, doctor's office, or clinic environment under the direct supervision of a licensed healthcare practitioner. The intended use of the Heart Rate Turbulence Analysis Program is to analyze ECG signals, provide measurements of Heart Rate Turbulence in patients undergoing cardiovascular disease testing for interpretation by qualified healthcare practitioner for the purposes of risk stratification and prediction of sudden cardiac death. The Heart Rate Turbulence Analysis Program only provides measurements, not interpretations. The Heart Rate Turbulence Analysis Program is to be used in conjunction with the patient's clinical history, symptoms, and other diagnostic tests for final clinical judgment.
Product codes
DQK
Device Description
The Heart Rate Turbulence Analysis Program is a software algorithm that runs in GE Medical Systems Information Technologies electrocardiographic equipment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ECG signals
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospital, doctor's office, or clinic environment under the direct supervision of a licensed healthcare practitioner.
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
The Heart Rate Turbulence Analysis Program and its host electrocardiograph comply with the voluntary standards as detailed in Section 9 of this submission. The following quality assurance measures were applied to the development of the Heart Rate Turbulence algorithm:
- Risk Analysis
- Requirements Specification Review
- Code Inspections
- Software Verification and Validation Testing
Key Metrics
Not Found
Predicate Device(s)
K991786 MARS Unity Workstation with Heart Rate Variability Option
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).
0
DEC - 3 2004
Section 2 Summary of Safety and Effectiveness
| Date: | August 6, 2004 |
|---|---|
| Submitter: | GE Medical Systems Information Technologies |
| 8200 West Tower Avenue | |
| Milwaukee, WI 53223 USA | |
| Contact Person: | Lisa M. Baumhardt |
| Regulatory Affairs Specialist | |
| GE Medical Systems Information Technologies | |
| Phone: 262-293-1699 | |
| Fax: 262-293-1460 | |
| Device: | |
| Trade Name: | Heart Rate Turbulence Analysis Program |
| Common/Usual Name: | ECG Analysis Algorithm |
| Classification Names: | 21 CFR 870.1425 Programmable Diagnostic Computer |
| Predicate Device: | K991786 MARS Unity Workstation with Heart Rate Variability Option |
| Device Description: | The Heart Rate Turbulence Analysis Program is a software algorithm that runs in GE Medical Systems Information Technologies electrocardiographic equipment. |
| Intended Use: | The Heart Rate Turbulence Analysis Program is intended for use in a hospital, doctor's office, or clinic environment under the direct supervision of a licensed healthcare practitioner. The intended use of the Heart Rate Turbulence Analysis Program is to analyze ECG signals, provide measurements of Heart Rate Turbulence in patients undergoing cardiovascular disease testing for interpretation by qualified healthcare practitioner for the purposes of risk stratification and prediction of sudden cardiac death. The Heart Rate Turbulence Analysis Program only provides measurements, not interpretations. The Heart Rate Turbulence Analysis Program is to be used in conjunction with the patient's clinical history, symptoms, and other diagnostic tests for final clinical judgment. |
| Technology: | The Heart Rate Turbulence Analysis Program employs the same functional technology as the predicate device for calculating variations of heart rate (RR) intervals. An enhancement was made to the reporting of the time domain measurements to include the variation in RR intervals associated with a single premature ventricular contraction (PVC). |
| Test Summary: | The Heart Rate Turbulence Analysis Program and its host electrocardiograph comply with the voluntary standards as detailed in Section 9 of this submission. The following quality assurance measures were applied to the development of the Heart Rate Turbulence algorithm: |
| Risk AnalysisRequirements Specification ReviewCode InspectionsSoftware Verification and Validation Testing | |
| Conclusion: | The results of these measurements demonstrated that the Heart Rate Turbulence Analysis Program is as safe, as effective, and performs as well as the predicate device. |
GE Medical Systems Information Technologies Confidential
1
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 3 2004
GE Medical Systems Information Technologies c/o Lisa M. Baumhardt, M.T. (A.S.C.P.) Regulatory Affairs Specialist 8200 West Tower Ave. Milwaukee, WI 53223
Re: K042148
Trade Name: Heart Rate Turbulence Analysis Program Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computers Regulatory Class: II (two) Product Code: DQK Dated: November 29, 2004 Received: November 30, 2004
Dear Ms. Baumhardt:
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.
2
Page 2 - Ms. Lisa Baumhardt, M.T. (A.S.C.P.)
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r rease of acresed 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 or any I vith 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 (21 CFR Part 820); and if applicable, the electronic for and and ation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation of 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 promanted 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 other general 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,
Duna R. bechner
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known): K 04-2 ) 48
Device Name: Heart Rate Turbulence Algorithm
Indications For Use:
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Prescription Use_X (Per 21 CFR 801.109 Subpart D) OR
Over-The-Counter Use_ (21 CFR 801 Subpart C)
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Dunes R. Vachner
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പ്രീ Cardiovascular Devices
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