(139 days)
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.
The EK12 algorithm is a software only algorithm
The provided text is a 510(k) summary for the GE Medical Systems Information Technologies, Inc.'s EK12 Algorithm. While it discusses non-clinical tests and standards, it explicitly states that clinical studies were not required to support substantial equivalence, and thus, does not provide detailed information about a study proving the device meets acceptance criteria derived from clinical performance.
However, it does reference compliance with a voluntary standard, AAMI/ANSI EC57: 2012 – Testing And Reporting Performance Results Of Cardiac Rhythm and ST-Segment Measurement Algorithms. This standard likely defines acceptance criteria for rhythm and ST-segment measurement algorithms. Without the full standard, I can only infer the type of criteria.
Based on the information provided, here's what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states: "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."
Since no specific acceptance criteria or reported performance values are explicitly stated in this 510(k) summary, I cannot populate a table with the exact metrics. However, conceptually, the table would look like this if the data were available:
| Feature / Metric (as per AAMI/ANSI EC57) | Acceptance Criteria (from AAMI/ANSI EC57) | Reported Device Performance (EK12 Algorithm) | Result (Met/Not Met) |
|---|---|---|---|
| Rhythm Detection Accuracy | X% Sensitivity, Y% Specificity | N/A (data not provided) | N/A |
| ST-segment Measurement Accuracy (e.g., bias, precision) | Within +/- Z μV (or other unit) | N/A (data not provided) | N/A |
| Heart Rate Accuracy | Within +/- W bpm | N/A (data not provided) | N/A |
| Arrhythmia Classification Accuracy | Appropriate metrics for each arrhythmia | N/A (data not provided) | N/A |
| ... (other relevant metrics from AAMI/ANSI EC57) | ... | N/A (data not provided) | N/A |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample size for a "test set" or its data provenance. It refers to "Software Verification Testing" and "Performance testing" but does not detail the datasets used for these. Given it's a non-clinical evaluation, it's possible simulated data or pre-existing standard datasets (e.g., MIT-BIH Arrhythmia Database, European ST-T Database) might have been used, but this is not mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided. As per the document: "The subject of this premarket submission, EK12 Algorithm, did not require clinical studies to support substantial equivalence." Therefore, there's no mention of expert-adjudicated ground truth for a clinical test set. If the non-clinical performance testing involved expert annotation, it is not detailed here.
4. Adjudication Method for the Test Set:
Not applicable, as no clinical test set or expert ground truth establishment is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No, an MRMC comparative effectiveness study was not conducted or reported in this document. The device did not require clinical studies/data.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, the testing described appears to be for the standalone algorithm, as it refers to "Software Verification Testing" and "Performance testing" of the "EK12 Algorithm program" for compliance with a cardiac rhythm and ST-segment measurement standard. The intended use states that EK12 "is used to create reports intended for use by a Qualified Medical Professional" who performs review and assessment, indicating it's a decision support tool, but the testing itself would be for the algorithm's output.
7. The Type of Ground Truth Used:
The document does not specify the type of ground truth. Given compliance with AAMI/ANSI EC57, the standard typically defines methods for establishing ground truth, often relying on a combination of expert review (e.g., highly experienced cardiologists or electrophysiologists) of ECGs, sometimes corroborated with clinical outcomes or other diagnostic tests, for standardized databases. However, the specific method used for the EK12's performance testing is not detailed here.
8. The Sample Size for the Training Set:
The document does not provide the sample size for the training set. It only mentions the "EK12 Algorithm" as a software-only algorithm and its testing for compliance.
9. How the Ground Truth for the Training Set was Established:
The document does not provide information on how the ground truth for the training set was established.
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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
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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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Image /page/3/Picture/1 description: The image shows the alphanumeric string "K170155" in a simple, sans-serif font. The text is horizontally oriented and appears to be a code or identifier. The characters are uniformly sized and spaced, with a clear distinction between the letters and numbers.
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 orAlarms) |
| Product Code: | MHX 21 CFR 870.1025 |
| Predicate Device(s): | EK-Pro Arrhythmia Detection Algorithm – K03132012SL 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 acquiredelectrocardiogram (ECG) from physiological ECG signal recordingdevices for rhythm and measurements.EK12 is used to create reports intended for use by a QualifiedMedical Professional, including a trained ECG Technician operatingwithin Independent Diagnostic Testing Facility (IDTF) requirementsand performance standards for the review and assessment of anECG |
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| Technology: | EK12 is indicated for use on adults and pediatric patients older than2 years.The device is intended for use in an IDTF or a professional medicalfacility, such as a hospital, clinic, or doctor's office.The EK12 Algorithm employs the same fundamental scientific |
|---|---|
| technology as its predicate device. | |
| Determination ofSubstantial Equivalence: | Summary of Non-Clinical Tests: |
| The EK12 Algorithm program was designed and tested forcompliance with applicable clauses of the following voluntarystandard: | |
| AAMI/ANSI EC57: 2012 – Testing And Reporting PerformanceResults Of Cardiac Rhythm and St-Segment MeasurementAlgorithms. (Cardiovascular) | |
| The following quality assurance measures were applied to thedevelopment of the system: | |
| IRisk Analysis | |
| IRequirements Reviews | |
| ■Code Inspections | |
| ■Software Verification Testing | |
| ■Performance testing | |
| Summary of Clinical Tests: | |
| The subject of this premarket submission, EK12 Algorithm, did notrequire clinical studies to support substantial equivalence. | |
| Conclusion: | GE Healthcare considers the EK12 Algorithm to be as safe, aseffective, and performance is substantially equivalent to thepredicate device. |
§ 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.