(267 days)
No
The summary describes a software program that performs measurements of QT interval dispersion and T wave complexity from existing ECG data. It does not mention any AI/ML techniques, training data, or performance metrics typically associated with such technologies. The analysis is based on pre-existing ECG data and provides measurements, not interpretations or diagnoses.
No
The device is described as a software program that analyzes existing ECG data to provide measurements of QT interval dispersion and T wave complexity, but it is explicitly stated that it is "not intended to produce any interpretation of those measurement or diagnosis" and "does not directly acquire data from a patient." Its output is intended to be used by qualified personnel in conjunction with other clinical information, suggesting it is a diagnostic or assessment tool rather than a therapeutic one.
No
The device is explicitly stated as "not intended to produce any interpretation of those measurement or diagnosis." It provides measurements (QT interval dispersion and T wave complexity) that are intended to be used in conjunction with other clinical information and professional judgment, rather than providing a diagnosis itself.
Yes
The device description explicitly states that "QT Guard Plus is a software program that runs on a Microsoft Windows PC-based platform" and "does not directly acquire data from a patient," indicating it is solely a software application processing data from other devices.
Based on the provided information, the QT Guard Plus Analysis System is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The device description explicitly states that "QT Guard Plus does not directly acquire data from a patient." It analyzes previously acquired digital 12-lead ECGs.
- The analysis is performed on electrical signals (ECG data), not biological samples. IVDs typically analyze things like blood, urine, tissue, etc.
The QT Guard Plus Analysis System is a software program that analyzes existing ECG data to provide measurements. It falls under the category of medical devices that process physiological signals, but not IVDs.
N/A
Intended Use / Indications for Use
QT Guard Plus Analysis System is intended to be used in a hospital, clinic or research environment by competent health professionals. QT Guard Plus Analysis System is intended to perform the analysis of simultaneously acquired 12-lead ECGs for obtaining the measurement of QT interval dispersion and T wave complexity. QT Guard Plus Analysis System is intended to provide only the measurements of the QT dispersion and T wave complexity and is not intended to produce any interpretation of those measurement or diagnosis. The QT dispersion and T wave complexity measurements produced by QT Guard Plus Analysis System are intended to be used by qualified personnel in evaluating ECG data and the patient in conjunction with patient's clinical history, symptoms other diagnostic tests, as well as the professional's clinical judgment. QT Guard Plus Analysis System is intended for adult patient populations.
Product codes (comma separated list FDA assigned to the subject device)
MHX 21CFR 870.1025, DQK 21CFR 870.1425, DPS, MLC
Device Description
QT Guard Plus is a software program that runs on a Microsoft Windows PC-based platform and utilizes 12 lead data from GE's 12SL ECG Analysis Program (K092369) to measure QT and T Wave measurements for clinical or scientific investigation. The program analyzes simultaneously acquired digital 12 lead ECGs that have been previously acquired by other ECG acquisition and storage devices. QT Guard Plus does not directly acquire data from a patient. The program has a user interface that displays the ECG along with the measurements generated by the program. These measurements can be modified via the user interface.
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
adult patient populations
Intended User / Care Setting
hospital, clinic or research environment by competent health 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Summary of Non-Clinical Tests: There are no recognized consensus standards applicable to QT Guard Plus Analysis System. QT Guard Plus and its applications comply with the Guidances and/or Special Controls as detailed in Section 9 of this premarket submission. The following quality assurance measures were applied to the development of the system: . Requirements Reviews - Risk Analysis . . Software Verification and Validation - Performance testing Summary of Clinical Tests: The subject of this premarket submission, QT Guard Plus did not require clinical studies to support substantial equivalence.
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.
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.
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
§ 870.2340 Electrocardiograph.
(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).
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DEC 0 6 2012
Image /page/0/Picture/2 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The letters and the interior of the circle are filled with a dark color, while the border is white.
GE Healthcare GE Healthcare
510(K) Premarket Notification Submission
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | March 9, 2012 |
|---|---|
| Submitter: | GE Healthcare (GE Medical Systems Information Technologies) |
| 9900 Innovation Drive | |
| Wauwatosa, WI 53226 | |
| Primary Contact Person: | Kristin Pabst |
| Regulatory Affairs - Diagnostic Cardiology | |
| 9900 Innovation Drive | |
| Wauwatosa, WI 53226 | |
| T: (414) 721-3104 | |
| F: (414) 721-3863 | |
| Secondary Contact Person: | Doug Kentz |
| Regulatory Affairs Director | |
| 9900 Innovation Drive | |
| Wauwatosa, WI 53226 | |
| T: (414) 362-2038 | |
| F: (414) 362-2585 | |
| Device: Trade Name: | QT Guard Plus Analysis System |
| Common/Usual Name: | ECG Analysis Program |
| Classification Names: | Monitor, Physiological, Patient (with arrhythmia detection or |
| alarms)Programmable Diagnostic Computer | |
| Product Code: | MHX 21CFR 870.1025 |
| DQK 21CFR 870.1425 | |
| Predicate Device(s): | K981024; QT Dispersion and T Wave Analysis Program (QT-Guard |
| Analysis System) | |
| K072502 MUSE Cardiology Information System | |
| Device Description: | QT Guard Plus is a software program that runs on a Microsoft Windows |
| PC-based platform and utilizes 12 lead data from GE's 12SL ECG | |
| Analysis Program (K092369) to measure QT and T Wave | |
| measurements for clinical or scientific investigation. The program | |
| analyzes simultaneously acquired digital 12 lead ECGs that have been | |
| previously acquired by other ECG acquisition and storage devices. QT | |
| Guard Plus does not directly acquire data from a patient. The program | |
| has a user interface that displays the ECG along with the | |
| measurements generated by the program. These measurements can | |
| be modified via the user interface. | |
| Intended Use: | QT Guard Plus Analysis System is intended to be used in a hospital, |
| clinic or research environment by competent health professionals. | |
| QT Guard Plus Analysis System is intended to perform the analysis of | |
| simultaneously acquired 12-lead ECGs for obtaining the measurement |
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Image /page/1/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined in a stylized, circular design. The logo is black and white.
GE Healthcare 510(K) Premarket Notification Submission
of QT interval dispersion and T wave complexity.
QT Guard Plus Analysis System is intended to provide only the measurements of the QT dispersion and T wave complexity and is not intended to produce any interpretation of those measurement or diagnosis.
The QT dispersion and T wave complexity measurements produced by QT Guard Plus Analysis System are intended to be used by qualified personnel in evaluating ECG data and the patient in conjunction with patient's clinical history, symptoms other diagnostic tests, as well as the professional's clinical judgment.
QT Guard Plus Analysis System is intended for adult patient populations.
Technology:
Determination of Substantial Equivalence: QT Guard Plus employs the same fundamental scientific technology as its predicate devices.
Summary of Non-Clinical Tests:
There are no recognized consensus standards applicable to QT Guard Plus Analysis System. QT Guard Plus and its applications comply with the Guidances and/or Special Controls as detailed in Section 9 of this premarket submission. The following quality assurance measures were applied to the development of the system:
- . Requirements Reviews
- Risk Analysis .
- . Software Verification and Validation
- . Performance testing
- Summary of Clinical Tests:
The subject of this premarket submission, QT Guard Plus did not require clinical studies to support substantial equivalence.
Conclusion:
GE Healthcare considers QT Guard Plus Analysis System to be as safe, as effective, and performance is substantially equivalent to the predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
DEC 0 6 2012
GE Healthcare Systems Information Technologies c/o Kristin Pabst 9900 Innovation Drive Wauwatosa, WI 53226
Re: K120770
Trade/Device Name: QT Guard Plus Analysis System Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph. Regulatory Class: Class II (two) Product Code: DPS, MLC Dated: November 14, 2012 Received: November 15, 2012
Dear Ms. Pabst:
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 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. 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); medical device reporting (reporting of medical
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Page 2 – Ms. Kristin Pabst
device-related adverse events) (21 CFR 803); 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mitchell J. Shein 2.12.12.06 11:44:40 -05'00' for
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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120770
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GE Healthcare 510(K) Premarket Notification Submission
510(k) Number (if known):
QT Guard Plus Analysis System Device Name: .
Indications for Use:
QT Guard Plus Analysis System is intended to be used in a hospital, clinic or research environment by competent health professionals.
QT Guard Plus Analysis System is intended to perform the analysis of simultaneously acquired 12-lead ECGs for obtaining the measurement of QT interval dispersion and T wave complexity.
QT Guard Plus Analysis System is intended to provide only the measurements of the QT dispersion and T wave complexity and is not intended to produce any interpretation of those measurement or diagnosis. The QT dispersion and T wave complexity measurements produced by QT Guard Plus Analysis System are intended to be used by qualified personnel in evaluating ECG data and the patient in conjunction with patient's clinical history, symptoms other diagnostic tests, as well as the professional's clinical judgment.
QT Guard Plus Analysis System is intended for adult patient populations.
Prescription Use_X_ AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH/Office of Device Evaluation (ODE)
(Division Sign-Off)
12/6/2012
Division of Cardiovascular Devices
) Number K120770
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