(203 days)
The 12SL ECG Analysis Program assists the physician in measuring and interpreting resting 12-lead ECGs for rhythm and contour information by providing an initial automated interpretation. Interpretation by the product is then confirmed, edited, or deleted by the physician. The analysis program is intended for use in the general population ranging from healthy subjects to patients with cardiac and/or non-cardiac abnormalities. The analysis program is intended for use in hospitals, outpatient clinics, emergency departments, and out-of hospital sites such as ambulances and patients' homes.
ACS Tool option is intended for adult patient population who are suspected clinically to have acute coronary syndrome.
The 12SL ECG Analysis Program is a software algorithm only.
The provided document is a 510(k) Premarket Notification Summary for the GE Healthcare 12SL ECG Analysis Program. It explicitly states that no clinical studies were required or performed to support substantial equivalence (K092369, Page 1). Therefore, the device does not have acceptance criteria and a study to prove it meets them in the conventional sense of a clinical trial demonstrating performance against predefined metrics.
The FDA cleared this device based on substantial equivalence to a predicate device (K060833; 12SL EGG Analysis Program with Right Ventricular Analysis) and non-clinical tests.
However, I can still extract the information relevant to understanding why no clinical study was deemed necessary and the basis for its clearance:
1. Table of Acceptance Criteria and Reported Device Performance:
Since no clinical studies were performed, there are no specific performance-based acceptance criteria or reported device performance metrics in the format of sensitivity, specificity, accuracy, etc., in this submission. The device's "performance" for regulatory purposes was assessed through its technological similarity to the predicate.
2. Sample Size Used for the Test Set and Data Provenance:
Not applicable, as no clinical test set was used for performance evaluation in this submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable, as no clinical test set was used.
4. Adjudication Method for the Test Set:
Not applicable, as no clinical test set was used.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC study was performed or required. The submission explicitly states, "The subject of this premarket submission, 12SL ECG Analysis Program, did not require clinical studies to support substantial equivalence" (K092369, Page 1).
6. Standalone Performance Study:
No standalone (algorithm only without human-in-the-loop performance) study was described in this submission, as clinical studies were not deemed necessary for substantial equivalence.
7. Type of Ground Truth Used:
Not applicable, as no clinical ground truth was established for a new performance study. The device's substantial equivalence relies on its underlying technology being the same as the predicate, which presumably had its performance established previously. The intended use specifies that "Interpretation by the product is then confirmed, edited, or deleted by the physician." This highlights that the device is an assistive tool, not a standalone diagnostic.
8. Sample Size for the Training Set:
Not applicable. The document does not describe the development or training of a new algorithm requiring a training set for this submission. The device employs "the same functional scientific technology as its predicate device" (K092369, Page 1).
9. How the Ground Truth for the Training Set Was Established:
Not applicable. The document does not describe the development or training of a new algorithm for this submission.
Summary of Basis for Substantial Equivalence:
The 12SL ECG Analysis Program was deemed substantially equivalent based on:
- Technological Equivalence: It "employs the same functional scientific technology as its predicate device" (K092369, Page 1).
- Non-Clinical Tests: These included "Requirements Reviews, Risk Analysis, Software Verification and Validation, and Performance testing" (K092369, Page 1). These are internal quality assurance and engineering tests, not clinical performance studies.
- Predicate Device: The predicate device (K060833; 12SL EGG Analysis Program with Right Ventricular Analysis) was previously cleared, and this submission argues that the current device is equally safe and effective due to its similarity.
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K092369 1/2
FEB 2 4 2010
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 border are in black, creating a high-contrast design.
GE Healthcare 510(K) Premarket Notification Submission
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided: August 4, 2009 Date: GE Healthcare (GE Medical Systems Information Technologies) Submitter: 9900 Innovation Drive Wauwatosa, WI 53226 Primary Contact Person: Joe Lucas Regulatory Affairs - Diagnostic Cardiology 9900 Innovation Drive Wauwatosa, WI 53226 T: (414) 721-2593 F: (414) 721-3863 Kristin Pabst Secondary Contact Person: Regulatory Affairs - Diagnostic Cardiology 9900 Innovation Drive Wauwatosa, WI 53226 T: (414) 721-3104 F: (414) 721-3863 12SL ECG Analysis Program Device: Trade Name: ECG Analysis Program Common/Usual Name: Monitor, Physiological, Patient (With Arrhythmia Detection Or Classification Names: Alarms) 74MHX 21CFR 870.1025 Product Code: K060833; 12SL EGG Analysis Program with Right Ventricular Predicate Device(s): Analysis The 12SL ECG Analysis Program is a software algorithm only. Device Description: The 12SL ECG Analysis Program assists the physician in Intended Use: measuring and interpreting resting 12-lead ECGs for rhythm and contour information by providing an initial automated interpretation. Interpretation by the product is then confirmed, edited, or deleted by the physician. The analysis program is intended for use in the general population ranging from healthy subjects to patients with cardiac and/or non-cardiac abnormalities. The analysis program is intended for use in hospitals, outpatient clinics, emergency departments, and out-of hospital sites such as ambulances and patients' homes. ACS Tool option is intended for adult patient population who are suspected clinically to have acute coronary syndrome.
Page 3 of 4 GEMS-IT Confidential
Appendix A
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K0923672/2
Image /page/1/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined and enclosed within a circular shape. The letters are stylized and have a flowing, interconnected design. The logo is in black and white.
GE Healthcare 510(K) Premarket Notification Submission
| Technology: | The 12SL ECG Analysis Program employs the same functional scientific technology as its predicate device. |
|---|---|
| Determination of Substantial Equivalence: | Summary of Non-Clinical Tests: |
| There are no recognized consensus standards applicable to the 12SL ECG Analysis System algorithm. The 12SL ECG Analysis Program 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 ReviewsRisk AnalysisSoftware Verification and ValidationPerformance testing | |
| Summary of Clinical Tests: | |
| The subject of this premarket submission, 12SL ECG Analysis Program, did not require clinical studies to support substantial equivalence. |
- GE Healthcare considers the 12SL ECG Analysis Program to be Conclusion: as safe, as effective, and performance is substantially equivalent to the predicate device.
. .
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, on the right side. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus. The seal is simple and monochromatic.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
EEB 8 4 2010
GE Medical Systems Information Technologies c/o Joseph Lucas, Regulatory Leader 9900 Innovation Drive Wauwatosa, WI 53226
Re: K092369
Trade/Device Name: 12SL ECG Analysis Program Regulation Number: 21 CFR 870.1025 Regulation Name: Monitor, Physiological, Patient (With Arrhythmia Detection or Alarms) Regulatory Class: Class II (special controls) Product Code: MHX Dated: February 15, 2010 Received: February 18, 2010
Dear Mr. Lucas:
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 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 - Mr. Joseph Lucas
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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
CBram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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GE Healthcare 510(K) Premarket Notification Submission
510(k) Number: K092369
12SL ECG Analysis Program Device Name:
Indications for Use:
The 12SL ECG Analysis Program assists the physician in measuring and interpreting resting 12-lead ECGs for rhythm and contour information by providing an initial automated interpretation. Interpretation by the product is then confirmed, edited, or deleted by the physician. The analysis program is intended for use in the general population ranging from healthy subjects to patients with cardiac and/or non-cardiac abnormalities. The analysis program is intended for use in hospitals, outpatient clinics, emergency departments, and out-of hospital sites such as ambulances and patients' homes.
ACS Tool option is intended for adult patient population who are suspected clinically to have acute coronary syndrome.
Prescription Use_X_ 1 (Part 21 CFR 801 Subpart D) AND/OR
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) |
|---|
| Division of Cardiovascular Devices |
| 510(k) Number | K092369 |
|---|---|
| --------------- | --------- |
Page 2 of 4 Appendix AGEMS-IT Confidential
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.