(56 days)
No
The summary describes a software algorithm for measuring ST-T wave fluctuations and does not mention AI, ML, or related concepts.
No.
This device is an analytical tool for cardiovascular disease testing, providing measurements of ST-T wave fluctuations without generating interpretations or directly treating a condition.
Yes
The device provides "measurements of the fluctuations of the ST-T-waves" for patients undergoing "Cardiovascular disease testing." These measurements are intended to be used by qualified personnel "in evaluating the patient in conjunction with the patients clinical history, symptoms, other diagnostic tests, as well as the professional's clinical judgment," indicating its role in diagnosis despite stating "No interpretation is generated."
No
The device is described as a "software algorithm that runs on GE Medical Systems Information Technologies' electrocardiographs," indicating it is a software component of a larger hardware system (the electrocardiograph).
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 electrocardiograph (ECG) data, which is a measurement of electrical activity of the heart. This data is acquired directly from the patient's body, not from a sample taken from the body.
- Intended Use: The intended use describes the analysis of ST-T wave morphology fluctuations for patients undergoing cardiovascular disease testing. This is a direct physiological measurement, not a test on a biological sample.
Therefore, the T-Wave Alternans (TWA) Algorithm Option falls under the category of a medical device that performs physiological measurements, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The T-Wave Alternans (TWA) Algorithm Option is to be used in a hospital, doctor's office, or clinic environment by competent health care professionals for recording ST-T wave morphology fluctuations for patients who are undergoing Cardiovascular disease testing.
The T-Wave alternans analysis is intended to provide only the measurements of the fluctuations of the ST-T-waves. The T-Wave alternans measurements produced by the T-Wave Alternans analysis are intended to be used by qualified personnel in evaluating the patient in conjunction with the patients clinical history, symptoms, other diagnostic tests, as well as the professional's clinical judgment. No interpretation is generated.
Product codes
DQK
Device Description
T-Wave Alternans (TWA) Algorithm Option is a software algorithm that runs on GE Medical Systems Information Technologies' electrocardiographs.
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
hospital, doctor's office, or clinic environment by competent health care professionals
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 T-Wave Alternans (TWA) Algorithm Option 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 T-Wave Alternans (TWA) Algorithm Option:
- Risk Analysis
- Requirements Reviews
- Design Reviews
- Code inspections
- Verification and Validation
Key Metrics
Not Found
Predicate Device(s)
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 0 3 2002
K023380 page 1 of 1
510(k) Summary of Safety and Effectiveness
| Date: | October 4, 2002 |
|---|---|
| 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 |
| Classification Number: 74 DQK | |
| Predicate Devices: | K991014 CASE 8000 Exercise Testing System |
| Device Description: | T-Wave Alternans (TWA) Algorithm Option is a software algorithm that runs on GE Medical Systems Information Technologies' electrocardiographs. |
| Intended Use: | The T-Wave Alternans (TWA) Algorithm Option is to be used in a hospital, doctor's office, or clinic environment by competent health care professionals for recording ST-T wave morphology fluctuations for patients who are undergoing Cardiovascular disease testing. |
The T-Wave alternans analysis is intended to provide only the measurements of the fluctuations of the ST-T-waves. The T-Wave alternans measurements produced by the T-Wave Alternans analysis are intended to be used by qualified personnel in evaluating the patient in conjunction with the patients 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 the same functional technology as the predicate device. |
| Test Summary: | The T-Wave Alternans (TWA) Algorithm Option 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 T-Wave Alternans (TWA) Algorithm Option:
- Risk Analysis
- Requirements Reviews
- Design Reviews
- Code inspections
- Verification and Validation |
| Conclusion: | The results of these measures demonstrate T-Wave Alternans (TWA) Algorithm Option is as safe, as effective, and performs as well as the predicate software option offered with device, CASE 8000 Exercise Testing System. |
1
0 Cornorate Boulev ockville MD 20850
GE Medical Systems Information Technologies c/o Mr. David Wahlig Sr. Regulatory Affairs Specialist 8200 West Tower Avenue Milwaukee, WI 53223
Re: K023380
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: DOK Dated: October 4, 2002 Received: October 8, 2002
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. Iisting 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 – 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 (OS) 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. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Karthik
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page 1 of 1
510(k) Number (if known):
510(k) filed on October 4, 2002
Device Name: T-Wave Alternans (TWA) Algorithm Option
Indications For Use:
The T-Wave Alternans (TWA) Algorithm Option is to be used in a hospital, doctor's office, or clinic environment by competent health care professionals for recording ST-T wave morphology fluctuations for patients who are undergoing Cardiovascular disease testing.
The T-Wave alternans analysis is intended to provide only the measurements of the fluctuations of the ST-T-waves. The T-Wave alternans measurements produced by the T-Wave Alternans analysis are intended to be used by qualified personnel in evaluating the patient in conjunction with the patients 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)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
CATTUR
KOSSO