(116 days)
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.
The Heart Rate Turbulence Analysis Program is a software algorithm that runs in GE Medical Systems Information Technologies electrocardiographic equipment.
The provided text does not contain detailed acceptance criteria or a comprehensive study report with the requested metrics. The document is a 510(k) premarket notification summary and an FDA clearance letter, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study for novel performance claims.
However, based on the limited information available in the "Test Summary" and "Conclusion" sections, here's what can be extracted and inferred, along with what is explicitly not available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional Equivalence to Predicate Device: The device should perform as well as the predicate device (MARS Unity Workstation with Heart Rate Variability Option) in calculating variations of heart rate (RR) intervals, with an enhancement for reporting time domain measurements related to PVCs. | "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)." "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." |
| Compliance with Voluntary Standards: Adherence to voluntary standards detailed in Section 9 (not provided in this excerpt). | "The Heart Rate Turbulence Analysis Program and its host electrocardiograph comply with the voluntary standards as detailed in Section 9 of this submission." |
| Quality Assurance Measures Applied: Demonstrable application of development processes. | Risk Analysis, Requirements Specification Review, Code Inspections, Software Verification and Validation Testing. |
| Clinical Performance (Inferred): Implicitly, the device's measurements for heart rate turbulence should be reliable for risk stratification and prediction of sudden cardiac death, similar to how the predicate device's heart rate variability measurements are used. (No specific quantitative clinical acceptance criteria or performance metrics are provided in this excerpt.) | "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." (This is a high-level statement, not specific performance metrics.) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified in the provided text. The term "measurements" is used, implying some testing, but the number of patient records or cases is not mentioned.
- Data Provenance: Not specified. It's unclear if the data was retrospective or prospective, or its country of origin.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not specified. The document does not describe the establishment of a ground truth or the involvement of experts for this purpose in the context of the device's performance validation. The device "only provides measurements, not interpretations," suggesting the ground truth would relate to the accuracy of these measurements rather than diagnostic outcomes.
4. Adjudication Method for the Test Set
- Not specified. Without information on experts or ground truth establishment for the test set, an adjudication method cannot be determined.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- No, an MRMC comparative effectiveness study was not done according to the provided text. The submission focuses on demonstrating substantial equivalence to a predicate device based on functional technology and internal quality assurance measures, not on comparing human reader performance with and without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Yes, implicitly. The "Test Summary" and "Conclusion" indicate that the algorithm's performance was evaluated in isolation ("The Heart Rate Turbulence Analysis Program... complies with the voluntary standards," "The results of these measurements demonstrated that the Heart Rate Turbulence Analysis Program is... effective..."), separate from human interpretation. The statement "The Heart Rate Turbulence Analysis Program only provides measurements, not interpretations" directly supports this, as its function is to provide raw data for a human to interpret.
7. The Type of Ground Truth Used
- Not explicitly stated, but inferred to be based on physical signal processing accuracy. Given the device's function is to "analyze ECG signals" and "provide measurements of Heart Rate Turbulence," the ground truth likely relates to the accurate calculation of these measurements from the raw ECG signals, possibly against established mathematical models or manually derived gold standard measurements from a subset of data. It is not based on "expert consensus, pathology, or outcomes data" in the conventional sense for diagnostic devices, as the device does not make a diagnosis.
8. The Sample Size for the Training Set
- Not specified. The document does not mention a training set or the process of machine learning model development.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as no training set or machine learning model development is described. The technology is described as employing "the same functional technology as the predicate device for calculating variations of heart rate (RR) intervals," suggesting a rule-based or algorithmic approach rather than a data-driven machine learning model requiring a large labeled training set.
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DEC - 3 2004
Section 2 Summary of Safety and Effectiveness
| Date: | August 6, 2004 |
|---|---|
| Submitter: | GE Medical Systems Information Technologies8200 West Tower AvenueMilwaukee, WI 53223 USA |
| Contact Person: | Lisa M. BaumhardtRegulatory Affairs SpecialistGE Medical Systems Information TechnologiesPhone: 262-293-1699Fax: 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
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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.
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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
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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
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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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§ 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).