(77 days)
The T-Wave Alternans (TWA) Algorithm Option is intended for use in a hospital, doctor's office or clinic environment by competent healthcare professionals for recording ST-T wave morphology fluctuations for patients who are undergoing cardiovascular disease testing.
T-Wave Alternans (TWA) Algorithm Option is a software algorithm that runs on GE Medical Systems Information Technologies' electrocardiographic equipment.
Here's an analysis of the provided text regarding the acceptance criteria and study for the T-Wave Alternans (TWA) Algorithm Option:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific quantitative acceptance criteria for the T-Wave Alternans (TWA) Algorithm Option. Instead, it relies on substantial equivalence to a predicate device and a general statement of performance.
| Acceptance Criteria (Quantitative) | Reported Device Performance |
|---|---|
| Not explicitly defined in the document. The primary criterion is "as safe, as effective, and performs as well as the predicate software option." | "Tests results are identical. It is the same software as predicate device." |
| Implicit: Accuracy and resolution of 1-microvolt for measuring T-wave alternans. | "The algorithm performs the measurement of this variation at an accuracy and resolution of 1-microvolt." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified.
- Data Provenance: Not specified. The document mentions an "independent, published study" but does not provide details about its specific test set or data provenance. The primary justification is that the device is "the same software as predicate device."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
- How Ground Truth was Established: Not specified for the predicate device's original testing, which this submission relies upon. The current device "provides only the measurements of the ST-T-waves" and states "No interpretation is generated," implying that the ground truth for TWA measurements would likely be based on comparison to an established gold standard for TWA detection (e.g., highly accurate spectral analysis or expert visual assessment using specific criteria) rather than expert interpretation of a TWA diagnosis itself.
4. Adjudication Method for the Test Set
Not specified.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not reported in this document. The submission relies on equivalence to a predicate device and an "independent, published study" without detailing its methodology.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, indirectly. The TWA Algorithm Option is described as a "software algorithm" that performs "measurements of the fluctuations of the ST-T-waves." It explicitly states that "No interpretation is generated" by the algorithm. This indicates that its performance is assessed as a standalone measurement tool, providing data for healthcare professionals to interpret. The stated performance is related to its measurement capability (1-microvolt accuracy and resolution).
7. The Type of Ground Truth Used
The document does not explicitly state the type of ground truth used for the original predicate device's validation. Given that the algorithm performs "measurements of this variation at an accuracy and resolution of 1-microvolt," the ground truth likely involved a highly precise method for determining actual T-wave alternans magnitude, possibly through:
- Expert Consensus: Experts meticulously reviewing ECGs for TWA patterns and their characteristics using established criteria.
- Validated Reference Method: Another, more established and precise method for quantifying TWA (e.g., a highly accurate
spectral analysis-based system or specialized signal processing techniques). - The "independent, published study" mentioned might contain further details on this, but it is not provided in this submission.
8. The Sample Size for the Training Set
Not specified. The document states that the new device "employs identical technology as the predicate device" and that "Tests results are identical. It is the same software as predicate device." This suggests that the training was done for the predicate device, but no details are provided here.
9. How the Ground Truth for the Training Set Was Established
Not specified. As with the test set, this information would pertain to the predicate device's development and is not detailed in this 510(k) summary.
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OCT 3 0 2003
·
510(k) Summary of Safety and Effectiveness
| Date: | August 12, 2003 |
|---|---|
| Submitter: | GE Medical Systems Information Technologies8200 West Tower AvenueMilwaukee, WI 53223 USA |
| Contact Person: | David WahligSr. Regulatory Affairs SpecialistGE Medical Systems Information TechnologiesPhone: (262) 293-1705Fax: (414) 918-8112 |
| Device: Trade Name: | T-Wave Alternans (TWA) Algorithm Option |
| Common/Usual Name: | ECG Analysis Algorithm |
| Classification Names: | Classification Name: 21 CFR 870.1425 Programmable diagnosticcomputer |
| Predicate Devices: | Classification Number: 74 DQKK02338 T-Wave Alternans (TWA) Algorithm Option |
| Device Description: | T-Wave Alternans (TWA) Algorithm Option is a software algorithm that runs on GE Medical Systems Information Technologies' electrocardiographic equipment. |
| Intended Use: | The T-Wave Alternans (TWA) Algorithm Option is intended for use in a hospital, doctor's office or clinic environment by competent healthcare professionals for recording ST-T wave morphology fluctuations for patients who are undergoing cardiovascular disease testing. |
| T-Wave Alternans (TWA) describes an electrocardiographic (ECG) pattern that exhibits different ST/T-wave morphologies on alternating beats. The algorithm performs the measurement of this variation at an accuracy and resolution of 1-microvolt. The TWA Algorithm Option permits visual confirmation of TWA by displaying the original ECG along with representative complexes made from a moving average of every other beat. | |
| The TWA Algorithm measurements have been found to be predictive of arrhythmic death and can be used for the purposes of risk stratification. The TWA Algorithm Option allows the user to specify the maximal heart rate for valid TWA measurements and the specific heart rate to be attained before TWA is measured. | |
| The TWA Algorithm Option is intended to provide only the measurements of the fluctuations of the ST-T-waves. TWA measurements are intended for qualified personnel in evaluating the patient in conjunction with the patient's clinical history, symptoms, other diagnostic tests, as well as the professional's clinical judgment. No interpretation is generated. | |
| Technology: | The T-Wave Alternans (TWA) Algorithm Option employs identical technology as the predicate device. |
·
032513
. Z
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Test Summary:
Tests results are identical. It is the same software as predicate device. Additional test results are provided via an independent, published study.
The T-Wave Atternans (TWA) Algorithm Option and its host electrocardiographic equipment comply with the voluntary standards as detailed in Section 9 of this submission.
The following quality assurance measures were applied to the development of T-Wave Alternans (TWA) Algorithm Option:
- l Risk Analysis
- u Requirements Reviews
- . Design Reviews
- . Code inspections
- . Verification and Validation
Conclusion:
The results of these measures demonstrate that the T-Wave Alternans (TWA) Algorithm Option is as safe, as effective, and performs as well as the predicate software option. Results form an independent, published study provides additional support for this conclusion.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle with three lines representing its wings.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
GE Medical Systems Information Technologies c/o Mr. David Wahlig Sr. Regulatory Affairs Specialist 8200 West Tower Avenue Milwaukee, WI 53223
Re: K032513
Trade Name: T-Wave Alternans (TWA) Algorithm Option Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II (two) Product Code: DQK Dated: August 12, 2003 Received: August 14, 2003
Dear Mr. Wahlig:
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.
OCT 3 0 2003
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Page 2 – Mr. David Wahlig
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 (301) 594-4646. 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/dsma/dsmamain.html
Sincerely yours,
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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Page 1 of 1
510(k) Number (if known):
510(k) filed on August 12, 2003
Device Name: T-Wave Alternans (TWA) Algorithm Option
Indications For Use:
The T-Wave Altemans (TWA) Algorithm Option is intended for use in a hospital, doctor's office or clinic environment by competent healthcare professionals for recording ST-T wave morphology fluctuations for patients who are undergoing cardiovascular disease testing.
T-Wave Alternans (TWA) describes an electrocardiographic (ECG) pattern that exhibits different STTTcave morphologies on alternating beats. The algorithm performs the measurement of this variation at an accuracy and resolution of 1-microvolt. The TWA Algorithm Option permits visual confirmation of TVA by displaying the original ECG along with representative complexes made from a moving average of every other beat.
The TWA Algorithm measurements have been found to be predictive of arrhythmic death and can be used for the purposes of risk stratification. The TWA Algorithm Option allows the user to specify the maximal heart rate for valid TWA measurements and the specific heart rate to be attained before TWA is measured.
The TWA Algorithm Option is intended to provide only the measurements of the ST-Twaves. TWA measurements are intended for qualified personnel in evaluating the patient in conjunction with the patient's clinical history, symptoms, other diagnostic tests, as well as the professional's clinical judgment. No interpretation is generated.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
510(k) Numbe
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use_
(Optional Format 1-2-96)
§ 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).