(267 days)
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.
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.
The provided text, a 510(k) Premarket Notification Submission for the GE Healthcare QT Guard Plus Analysis System, states that no clinical studies were required to support substantial equivalence, and therefore, no specific acceptance criteria or study demonstrating device performance against such criteria are explicitly detailed in this document.
The submission focuses on establishing substantial equivalence to predicate devices (K981024; QT Dispersion and T Wave Analysis Program (QT-Guard Analysis System) and K072502 MUSE Cardiology Information System) based on fundamental scientific technology and non-clinical tests.
However, I can extract the information provided about the development and testing that was performed:
1. Table of Acceptance Criteria and Reported Device Performance:
Since no clinical studies or specific quantitative acceptance criteria are presented in this document, a table correlating acceptance criteria with reported device performance cannot be generated based on the provided text. The document states:
"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."
And later, under "Summary of Clinical Tests":
"The subject of this premarket submission, QT Guard Plus did not require clinical studies to support substantial equivalence."
2. Sample Size Used for the Test Set and Data Provenance:
Not applicable. No clinical test set data is provided or referenced in this document. The submission explicitly states that clinical studies were not required.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. No clinical test set and thus no ground truth established by experts is mentioned.
4. Adjudication Method for the Test Set:
Not applicable. No clinical test set is mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. No clinical efficacy study comparing human readers with and without AI assistance is mentioned.
6. Standalone (Algorithm Only) Performance Study:
A standalone performance study of the algorithm (QT Guard Plus) was conducted, but it was non-clinical. The "Summary of Non-Clinical Tests" states that "Performance testing" was applied to the development of the system. However, specific results, metrics, or the dataset used for this performance testing are not detailed in this 510(k) summary.
7. Type of Ground Truth Used:
For the non-clinical "Performance testing," the type of ground truth used is not specified. Given the nature of an ECG analysis program, it's highly probable that the ground truth for this internal performance testing would be derived from precisely measured intervals by expert cardiologists or a gold standard reference method applied to a dataset of ECGs. However, this is not explicitly stated.
8. Sample Size for the Training Set:
Not applicable. The document does not provide information on a training set as it refers to a software component that performs measurements rather than a machine learning model that would typically require a training set. The device is described as "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." This suggests an algorithmic approach rather than a data-driven machine learning approach that requires a distinct training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as no training set is mentioned for this device.
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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 oralarms)Programmable Diagnostic Computer |
| Product Code: | MHX 21CFR 870.1025DQK 21CFR 870.1425 |
| Predicate Device(s): | K981024; QT Dispersion and T Wave Analysis Program (QT-GuardAnalysis System)K072502 MUSE Cardiology Information System |
| Device Description: | QT Guard Plus is a software program that runs on a Microsoft WindowsPC-based platform and utilizes 12 lead data from GE's 12SL ECGAnalysis Program (K092369) to measure QT and T Wavemeasurements for clinical or scientific investigation. The programanalyzes simultaneously acquired digital 12 lead ECGs that have beenpreviously acquired by other ECG acquisition and storage devices. QTGuard Plus does not directly acquire data from a patient. The programhas a user interface that displays the ECG along with themeasurements generated by the program. These measurements canbe 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 ofsimultaneously acquired 12-lead ECGs for obtaining the measurement |
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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
15
§ 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).