(139 days)
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 AI/ML specific terms or training/test data sets typically associated with such technologies. The performance testing references a standard for cardiac rhythm and ST-segment measurement algorithms, which are often based on traditional signal processing techniques.
No.
The device's description and intended use solely focus on analyzing previously acquired ECG data for rhythm and measurements to create reports for medical professionals, without any mention of providing therapy or direct treatment.
Yes
The EK12 analyzes previously acquired ECGs to create reports for review and assessment by a Qualified Medical Professional for rhythm and measurements, which are diagnostic purposes. The device's intended use in an IDTF or professional medical facility further supports its diagnostic nature.
Yes
The device description explicitly states "The EK12 algorithm is a software only algorithm". While it processes data from physiological ECG signal recording devices, the device itself, as described, is solely the software algorithm.
Based on the provided information, the EK12 device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The definition of an IVD involves examining specimens such as blood, urine, tissue, etc., in vitro (outside the body).
- EK12 analyzes previously acquired physiological signals. The device description clearly states it analyzes a previously acquired electrocardiogram (ECG). An ECG is a recording of electrical activity from the body, not a sample taken from the body for analysis.
- The intended use is for rhythm and measurement analysis of an ECG. This is a form of signal processing and analysis, not the analysis of a biological sample.
Therefore, while EK12 is a medical device that analyzes physiological data, it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
EK12 analyzes ten or more seconds of a previously acquired electrocardiogram (ECG) from physiological ECG signal recording devices for rhythm and measurements.
EK12 is used to create reports intended for use by a Qualified Medical Professional, including a trained ECG Technician operating within Independent Diagnosic Testing Facility (IDTF) requirements and performance standards for the review and assessment of an ECG.
EK12 is indicated for use on adults and pediatric patients older than 2 years. The device is intended for use in an IDTF or a professional medical facility, such as a hospital, clinic, or doctor's office.
Product codes
MHX
Device Description
The EK12 algorithm 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
adults and pediatric patients older than 2 years.
Intended User / Care Setting
Qualified Medical Professional, including a trained ECG Technician operating within Independent Diagnosic Testing Facility (IDTF) requirements and performance standards for the review and assessment of an ECG.
The device is intended for use in an IDTF or a professional medical facility, such as a hospital, clinic, or doctor's office.
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 EK12 Algorithm program was designed and tested for compliance with applicable clauses of the following voluntary standard: AAMI/ANSI EC57: 2012 – Testing And Reporting Performance Results Of Cardiac Rhythm and St-Segment Measurement Algorithms. (Cardiovascular)
The following quality assurance measures were applied to the development of the system:
I Risk Analysis
I Requirements Reviews
Code Inspections
Software Verification Testing
Performance testing
The subject of this premarket submission, EK12 Algorithm, did not require clinical studies to support substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 6, 2017
GE Medical Systems Information Technologies, Inc. Amy Yang Regulatory Affairs Program Manager 9900 West Innovation Drive Wauwatosa, Wisconsin 53226
Re: K170155
Trade/Device Name: EK12 Algorithm 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: April 25, 2017 Received: April 27, 2017
Dear Amy Yang:
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 with all the Act's requirements, including, but not limited to: registration and listing (21 CFR
1
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,
M.A. Hillemann
for Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K170155
Device Name EK12 Algorithm
Indications for Use (Describe)
EK12 analyzes ten or more seconds of a previously acquired electrocardiogram (ECG) from physiological ECG signal recording devices for rhythm and measurements.
EK12 is used to create reports intended for use by a Qualified Medical Professional, including a trained ECG Technician operating within Independent Diagnosic Testing Facility (IDTF) requirements and performance standards for the review and assessment of an ECG.
EK12 is indicated for use on adults and pediatric patients older than 2 years. The device is intended for use in an IDTF or a professional medical facility, such as a hospital, clinic, or doctor's office.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
| In accordance with 21 CFR 807.92 the following summary of information is provided: | |
|---|---|
| Date: January 16, 2017 | |
| Submitter: | GE Medical Systems Information Technologies, Inc. |
| 9900 Innovation Drive | |
| Wauwatosa, WI 53226 | |
| Primary Contact Person: | Amy Yang |
| Regulatory Affairs Program Manager | |
| GE Medical Systems Information Technologies, Inc. | |
| Phone: (414)721-3807 | |
| Fax: (414) 721-3863 | |
| Secondary Contact Person: | Doug Kentz |
| Regulatory Affairs Director | |
| GE Medical Systems Information Technologies, Inc. | |
| Phone: (414)581-8987 | |
| Fax: (414)362-2585 | |
| Device Trade Name: | EK12 Algorithm |
| Common/Usual Name: | Arrhythmia Detection Algorithm |
| Classification Names: | Monitor, Physiological, Patient (With Arrhythmia Detection or |
| Alarms) | |
| Product Code: | MHX 21 CFR 870.1025 |
| Predicate Device(s): | EK-Pro Arrhythmia Detection Algorithm – K031320 |
| 12SL ECG Analysis Program – K141963 | |
| Device Description: | The EK12 algorithm is a software only algorithm |
| Intended Use: | EK12 analyzes ten or more seconds of a previously acquired |
| electrocardiogram (ECG) from physiological ECG signal recording | |
| devices for rhythm and measurements. | |
| EK12 is used to create reports intended for use by a Qualified | |
| Medical Professional, including a trained ECG Technician operating | |
| within Independent Diagnostic Testing Facility (IDTF) requirements | |
| and performance standards for the review and assessment of an | |
| ECG |
4
| Technology: | EK12 is indicated for use on adults and pediatric patients older than
2 years.
The device is intended for use in an IDTF or a professional medical
facility, such as a hospital, clinic, or doctor's office.
The EK12 Algorithm employs the same fundamental scientific |
|----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | technology as its predicate device. |
| Determination of
Substantial Equivalence: | Summary of Non-Clinical Tests: |
| | The EK12 Algorithm program was designed and tested for
compliance with applicable clauses of the following voluntary
standard: |
| | AAMI/ANSI EC57: 2012 – Testing And Reporting Performance
Results Of Cardiac Rhythm and St-Segment Measurement
Algorithms. (Cardiovascular) |
| | The following quality assurance measures were applied to the
development of the system: |
| | I
Risk Analysis |
| | I
Requirements Reviews |
| | ■
Code Inspections |
| | ■
Software Verification Testing |
| | ■
Performance testing |
| | Summary of Clinical Tests: |
| | The subject of this premarket submission, EK12 Algorithm, did not
require clinical studies to support substantial equivalence. |
| Conclusion: | GE Healthcare considers the EK12 Algorithm to be as safe, as
effective, and performance is substantially equivalent to the
predicate device. |
| | |