(202 days)
K#092369
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and describes the device as a "software only algorithm" without mentioning any characteristics typically associated with AI/ML, such as training data or complex model architectures.
No.
The device assists in measuring and interpreting ECGs, providing diagnostic information, but it does not directly treat or provide therapy to patients.
Yes
The device assists physicians in measuring and interpreting resting 12-lead ECGs and provides an automated interpretation, which directly supports the diagnosis of cardiac conditions.
Yes
The device description explicitly states "The 12SL ECG Analysis Program is a software only algorithm".
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 12SL ECG Analysis Program analyzes electrocardiogram (ECG) data, which is a recording of the electrical activity of the heart. This data is obtained through electrodes placed on the body, not from a sample taken from the body.
- Intended Use: The intended use clearly states it assists in measuring and interpreting resting 12-lead ECGs. This is a non-invasive procedure that does not involve analyzing biological samples.
Therefore, the 12SL ECG Analysis Program falls under the category of a medical device that analyzes physiological signals, not an in vitro diagnostic device.
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. The interpretation by the analysis program may then be 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.
The ACS Tool option is intended for adult patient populations who are suspected clinically to have acute coronary syndrome.
Product codes
MHX
Device Description
The 12SL ECG Analysis Program is a software only algorithm
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. The ACS Tool option is intended for adult patient populations.
Intended User / Care Setting
The physician. Intended for use in 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
The subject of this premarket submission, 12SL ECG Analysis Program, did not require clinical studies to support substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
12SL ECG Analysis Program K#092369
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 5, 2015
GE Medical Systems Information Technologies, Inc. Kristin Pabst Regulatory Affairs Manager 9900 West Innovation Drive Wauwatosa, Wisconsin 53226
Re: K141963
Trade/Device Name: 12SL ECG Analysis Program Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector And Alarm (Including ST-Segment Measurement And Alarm) Regulatory Class: Class II Product Code: MHX
Dated: January 29, 2015 Received: February 2, 2015
Dear Kristin 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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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
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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 of medical devicerelated 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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,
Melissa A. Torres -S
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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GE Healthcare
510(k) Premarket Notification Submission
510(k) Number:
Device Name: 12SL ECG Analysis Program
Indications for Use:
The 12SL ECG Analysis Program assists the physician in measuring and interpreting resting 12lead ECGs for rhythm and contour information by providing an initial automated interpretation. The interpretation by the analysis program may then be 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.
The ACS Tool option is intended for adult patient populations who are suspected clinically to have acute coronary syndrome.
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)
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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: | July 17, 2014 |
| Submitter: | GE Medical Systems Information Technologies |
| 9900 Innovation Drive | |
| Wauwatosa, WI 53226 | |
| Primary Contact Person: | Kristin Pabst |
| Regulatory Affairs Manager | |
| GE Medical Systems Information Technologies | |
| Phone: (414) 721-3104 | |
| Fax: (414) 721-3863 | |
| Secondary Contact Person: | Doug Kentz |
| Regulatory Affairs | |
| GE Medical Systems Information Technologies | |
| Phone (414) 362-2038 | |
| FAX: (414) 362-2585 | |
| Device: Trade Name: | 12SL ECG Analysis Program |
| Common/Usual Name: | ECG Analysis Program |
| Classification Names: | Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms) |
| Product Code: | MHX 21CFR 870.1025 |
| Predicate Device(s): | 12SL ECG Analysis Program K#092369 |
| Device Description: | The 12SL ECG Analysis Program is a software only algorithm |
| Intended 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. The | |
| interpretation by the analysis program may then be 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. | |
| The ACS Tool option is intended for adult patient populations who are | |
| suspected clinically to have acute coronary syndrome. | |
| Technology: | The 12SL ECG Analysis Program employs the same functional |
| scientific technology as its predicate device. 12SL ECG Analysis | |
| Program (K092369). | |
| Determination of Substantial | |
| Equivalence: | Summary of Non-Clinical Tests: |
| The 12SL ECG Analysis program was designed and tested for | |
| compliance with applicable clauses of the following voluntary standard: |
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GE Healthcare
510(k) Premarket Notification Submission
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. IEC 60601-2-25:2011Medical electrical equipment – Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs - Edition 2.0
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
-
o Risk Analysis
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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.
- GE Healthcare considers the 12SL ECG Analysis Program to be as Conclusion: safe, as effective, and performance is substantially equivalent to the predicate device.