(203 days)
Not Found
No
The document describes a software algorithm for ECG analysis but does not mention AI, ML, or related concepts like training/test sets, which are typical indicators of such technologies in medical devices. The performance studies section also focuses on non-clinical testing and compliance with guidances rather than performance metrics commonly associated with AI/ML models.
No
The device is a software algorithm that assists physicians in measuring and interpreting ECGs by providing an initial automated interpretation. It is a diagnostic tool, not a therapeutic one.
Yes
The 'Intended Use' section states that the program assists in "measuring and interpreting resting 12-lead ECGs for rhythm and contour information by providing an initial automated interpretation" to help "the physician". It is also intended for use in patients with "cardiac and/or non-cardiac abnormalities" and "suspected clinically to have acute coronary syndrome," all of which indicate the device is used to diagnose medical conditions.
Yes
The device description explicitly states "The 12SL ECG Analysis Program is a software algorithm only."
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is performed outside of the body.
- Device Description and Intended Use: The 12SL ECG Analysis Program analyzes resting 12-lead ECGs. ECGs are recordings of the electrical activity of the heart, obtained through electrodes placed on the skin. This is a measurement of a physiological signal from the body, not the analysis of a specimen taken from the body.
- No Mention of Specimens: The description and intended use do not mention the analysis of any biological specimens.
Therefore, while it's a medical device used for diagnosis, it falls under the category of devices that analyze physiological signals rather than in vitro diagnostics.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
74MHX
Device Description
The 12SL ECG Analysis Program is a software algorithm only.
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
general population ranging from healthy subjects to patients with cardiac and/or non-cardiac abnormalities.
ACS Tool option is intended for adult patient population
Intended User / Care Setting
physician; hospitals, outpatient clinics, emergency departments, and out-of hospital sites such as ambulances and patients' homes.
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 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 Reviews
- Risk Analysis
- Software Verification and Validation
- Performance testing
Summary of Clinical Tests:
The subject of this premarket submission, 12SL ECG Analysis Program, 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.
K060833; 12SL EGG Analysis Program with Right Ventricular Analysis
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
§ 870.1025 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.
0
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
1
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.
. .
2
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
3
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
4
Image /page/4/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized, cursive font. The letters are enclosed within a circular border. The logo is in black and white.
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