(77 days)
K02338 T-Wave Alternans (TWA) Algorithm Option
Not Found
No
The description focuses on a deterministic algorithm for measuring T-wave alternans based on averaging and visual confirmation, with no mention of learning, training data, or AI/ML terminology.
No
The device is described as an algorithm that runs on electrocardiographic equipment to provide measurements and assist in risk stratification, but it does not directly treat or provide therapy to a patient.
Yes
The device is described as "predictive of arrhythmic death and can be used for the purposes of risk stratification," indicating its role in providing objective information for diagnosis or risk assessment.
Yes
The device description explicitly states that the T-Wave Alternans (TWA) Algorithm Option is a "software algorithm that runs on GE Medical Systems Information Technologies' electrocardiographic equipment." This indicates it is a software component intended to be integrated into existing hardware, not a standalone hardware 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.
- Device Function: The T-Wave Alternans (TWA) Algorithm Option analyzes electrocardiographic (ECG) signals, which are electrical signals measured directly from the patient's body surface. It does not process samples taken from the body.
- Intended Use: The intended use describes the analysis of ST-T wave morphology fluctuations from patients undergoing cardiovascular disease testing. This is a form of in vivo (within the living body) measurement and analysis.
Therefore, because the device analyzes signals directly from the patient's body rather than samples taken from the body, it falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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 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.
Product codes (comma separated list FDA assigned to the subject device)
DQK
Device Description
T-Wave Alternans (TWA) Algorithm Option is a software algorithm that runs on GE Medical Systems Information Technologies' electrocardiographic equipment.
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
Not Found
Intended User / Care Setting
competent healthcare professionals for recording ST-T wave morphology fluctuations for patients who are undergoing cardiovascular disease testing.
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
Tests results are identical. It is the same software as predicate device. Additional test results are provided via an independent, published study.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K02338 T-Wave Alternans (TWA) Algorithm Option
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
OCT 3 0 2003
·
510(k) Summary of Safety and Effectiveness
| Date: | August 12, 2003 |
|---|---|
| Submitter: | GE Medical Systems Information Technologies |
| 8200 West Tower Avenue | |
| Milwaukee, WI 53223 USA | |
| Contact Person: | David Wahlig |
| Sr. Regulatory Affairs Specialist | |
| GE Medical Systems Information Technologies | |
| Phone: (262) 293-1705 | |
| Fax: (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 diagnostic |
| computer | |
| Predicate Devices: | Classification Number: 74 DQK |
| K02338 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. |
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032513
. Z
1
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.
2
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
3
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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
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)