(173 days)
EK12 V2 analyzes 10 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.
EK 12 V2 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 physician's office.
EK12 V2 algorithm is a software only product that provides computerized measurements from the ECG parameter data acquired by the host device. EK12 V2 analyzes ECG recordings for rhythm and measurements that is deployed as part of a host system used to generate ECG reports
Here's a breakdown of the acceptance criteria and study information for the EK12 V2 Algorithm, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding performance metrics from a study. Instead, it states that "The EK12 V2 Algorithm complies with the voluntary consensus standard AAMI/ANSI EC57: 2012 – Testing And Reporting Performance Results Of Cardiac Rhythm and St-Segment Measurement Algorithms."
This implies that the acceptance criteria are the performance requirements outlined in the AAMI/ANSI EC57: 2012 standard for cardiac rhythm and ST-segment measurement algorithms. The document then asserts that the device meets these criteria by stating its compliance. However, specific numerical performance results against these criteria are not provided within the given text.
Therefore, a direct table cannot be constructed with numerical performance. The closest interpretation based on the provided text would be:
| Acceptance Criterion (Standard) | Reported Device Performance |
|---|---|
| AAMI/ANSI EC57: 2012 Standard | Complies |
| Cardiac Rhythm Measurement Performance | (Specific metrics not provided, but implies compliance with standard) |
| ST-Segment Measurement Algorithm Performance | (Specific metrics not provided, but implies compliance with standard) |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "The EK12 V2 Algorithm program was designed 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."
However, the provided text does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature) of the data used for the "Performance testing" mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not provide information on the number of experts used to establish ground truth or their qualifications for the test set.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not mention or describe a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, nor does it provide an effect size for human readers with and without AI assistance.
6. Standalone Performance Study
The document implies that standalone performance testing was conducted. It states, "Performance testing" was a quality assurance measure applied to the development of the system and that "The EK12 V2 Algorithm program was designed... 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." This suggests that the algorithm itself was tested against the standard.
However, specific results of this standalone performance are not detailed beyond the statement of compliance.
7. Type of Ground Truth Used
While the standard AAMI/ANSI EC57: 2012 typically involves a precise "ground truth" derived from expert review or more invasive methods for rhythm and ST-segment identification, the document does not explicitly state the type of ground truth used (e.g., expert consensus, pathology, outcomes data) for the testing of EK12 V2.
8. Sample Size for the Training Set
The document does not specify the sample size for the training set.
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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December 20, 2022
GE Medical Systems Information Technologies, Inc. Shlomi Deler Regulatory Affairs Director 9900 Innovation Drive Wauwatosa, Wisconsin 53226
Re: K221904
Trade/Device Name: EK12 V2 Algorithm Regulation Number: 21 CFR 870.1025 Regulation Name: Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) Regulatory Class: Class II Product Code: MHX Dated: November 21, 2022 Received: November 22, 2022
Dear Shlomi Deler:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Shruti N. Mistry -S
for
Jennifer Shih Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K221904
Device Name EK12 V2 Algorithm
Indications for Use (Describe)
EK12 V2 analyzes 10 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.
EK 12 V2 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 physician's office.
Type of Use (Select one or both, as applicable)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: | 20-June-2022 |
| Submitter: | GE Medical Systems Information Technologies, Inc. |
| 9900 Innovation Drive | |
| Wauwatosa, WI 53226 | |
| Primary Contact Person: | Shlomi Deler |
| Regulatory Affairs Director | |
| GE Medical Systems Information Technologies, Inc. | |
| Phone: +(972) 544301056 | |
| Secondary Contact Person: | Michael Petrini |
| Regulatory Affairs Executive | |
| GE Medical Systems Information Technologies, Inc. | |
| Phone: +1(414)581-8987 | |
| Device Trade Name: | EK12 V2 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): | Ek12 Algorithm (K170155) |
| Reference Device: | 12SL ECG Analysis Program (K141963) |
| Device Description: | EK12 V2 algorithm is a software only product that providescomputerized measurements from the ECG parameter dataacquired by the host device. EK12 V2 analyzes ECG recordings forrhythm and measurements that is deployed as part of a hostsystem used to generate ECG reports |
| Intended Use: | EK12 v2 analyzes 10 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.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 physician's office. |
| Technology: | The EK12 V2 Algorithm employs the same fundamental scientifictechnology as its predicate and the reference devices. |
| Determination of SubstantialEquivalence: | The EK12 V2 Algorithm is substantially equivalent to the predicateEk12 Algorithm (K170155) and the reference device 12SL ECGAnalysis Program (K141963) as described in the table below: |
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| Feature /Function | Proposed DeviceEK12v2 | Predicate DeviceEK12v1 (K170155) | Change Explanation /Notes |
|---|---|---|---|
| Intended Use | EK12 analyzes 10 or more seconds of apreviously acquired electrocardiogram (ECG)from physiological ECG signal recordingdevices for rhythm and measurements.EK12 is used to create reports intended foruse by a Qualified Medical Professional,including a trained ECG Technician operatingwithin Independent Diagnostic Testing Facility(IDTF) requirements and performancestandards for the review and assessment ofan ECG.EK12 is indicated for use on adults andpediatric patients older than 2 years.The device is intended for use in an IDTF or aprofessional medical facility, such as ahospital, clinic, or physician's office. | EK12 analyzes ten or more seconds of apreviously acquired electrocardiogram (ECG)from physiological ECG signal recordingdevices for rhythm and measurements.EK12 is used to create reports intended foruse by a Qualified Medical Professional,including a trained ECG Technician operatingwithin Independent Diagnostic Testing Facility(IDTF) requirements and performancestandards for the review and assessment ofan ECG.EK12 is indicated for use on adults andpediatric patients older than 2 years.The device is intended for use in an IDTF or aprofessional medical facility, such as ahospital, clinic, or doctor's office. | Identical |
| Indications forUse | EK12 is software algorithm that analyzes ECGsfor rhythm and measurements that isdeployed as part of a system used to generateECG reports / findings. | EK12 is software algorithm that analyzes ECGsfor rhythm and measurements that isdeployed as part of a system used to generateECG reports / findings. | Identical |
| Contraindications | EK12 cannot be used for active patientmonitoring since it can only analyzeprerecorded ECG signals that are at least 10seconds long. It does not provide any time-sensitive information, continuous display ofinformation, alarms, or alerts intended toalert a caregiver to take an immediate clinicalaction. | EK12 cannot be used for active patientmonitoring since it can only analyzeprerecorded ECG signals that are at least 10seconds long. It does not provide any time-sensitive information, continuous display ofinformation, alarms, or alerts intended toalert a caregiver to take an immediate clinicalaction. | Identical |
| PatientPopulation | EK12 is indicated for use on adults andpediatric patients older than 2 years. | EK12 is indicated for use on adults andpediatric patients older than 2 years. | Identical |
| Use Environment | The device is intended for use in an IDTF or aprofessional medical facility, such as ahospital, clinic, or physician's office. | The device is intended for use in an IDTF or aprofessional medical facility, such as ahospital, clinic, or doctor's office. | Identical |
| Result | An output text file containing the pass/failstatus (result) of the analysis | An output text file containing the pass/failresult of the analysis | Identical |
| Final report | An output text file containing the finalevaluation results for rhythms,measurements, and other information. | An output text file containing the finalevaluation results for rhythms,measurements, and other information. | Identical |
| Event logdetectedarrhythmias,noise) | A column-oriented tab-delimited output textfile annotating the beginning and end of alldetected rhythm and noise events. | A column-oriented tab-delimited output textfile annotating the beginning and end of alldetected rhythm and noise events. | Identical |
| QRS detections | Two output files:1. A column-oriented tab-delimited outputtext file listing annotations of QRS detectiontimes and beat classification. | Two output files:1. A column-oriented tab-delimited outputtext file listing annotations of QRS detectiontimes and beat classification. | Identical |
| Feature / Function | Proposed DeviceEK12v2 | Predicate DeviceEK12v1 (K170155) | Change Explanation / Notes |
| 2. A binary file in the WFDB annotation fileformat containing QRS detection times andbeat classification. | 2. A binary file in the WFDB-formatannotation file format containing QRSdetection times and beat classification. |
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GE Healthcare 510(k) Premarket Notification Submission
Substantial Equivalence to the reference device, 12SL ECG Analysis Program (K141963):
| Feature /Function | Proposed:EK12v2 | Reference device: 12SL ECG AnalysisProgram (K141963) | Discussion of Differences |
|---|---|---|---|
| Patient age andgender | Optional inputs. If present, theyare contained within the WFDBinput record. When present,they are validated and passeddirectly to the 12SL analysis. Ifnot present, the value forunknown age and/or gender areprovided to the 12SL analysis | Required inputs which are used in the ECGinterpretation.Age is provided to the program in years,an encoded value for age less than oneyear, or an encoded value for ageunknown.Gender is provided to the program asone of male, female, or unknown. | Substantial equivalentThe proposed EK12 V2 adds support for theoptional input of patient age and/or gender. |
| Identification ofECG leads | Lead names are an optionalcomponent of the input WFDBinput record and are an optionalinput of EK12 V2. Any inputsignals containing a lead namefrom the set {I, II, V1, V2, V3, V4,V5, V6} will be treated as thatlead in the internal 12SL analysis | Assumes the first 8 channels are ECGleads I, II, V1, V2, V3, V4, V5, V6.Measurements are provided for leadsafter the first 8 channels but areotherwise not used in any interpretationstatements with the exception of leadV4r, which if present, will be examined forright ventricular involvement (STelevation) if an acute inferior infarct isdetected | Substantial equivalentThe proposed EK12 V2 adds support for theoptional identification of ECG leads. |
| 12SL rhythmstatementtrends | A column-oriented tab-delimitedtext file that provides the 12SLinterpretation statement codesfor rhythm statements from each10-second 12SL analysis atintervals of every 5 seconds. Thatis, each consecutive analysis has5 seconds of overlappingwaveform.The 12SL interpretationstatement codes are censored toremove all statement codes notrelated to rhythm interpretation. | All output is contained in an in-memorydata structure; the host product isresponsible for creation of the outputrecord and/or report. There is no conceptof "trends" in a single execution of the12SL analysis.The method of creating the 12SLstatements are identical to the referencedevice for the "12SL interpretationstatement codes" as described above | Substantial equivalentInterpretation statement codes forming theoverall ECG interpretation is identical to thereference 12SL ECG Analysis Program(K141963).The proposed EK12 v2 adds the export ofthe rhythm statement codes to an outputfile. |
| Mediancomplexwaveformtrends | A column-oriented tab-delimitedtext file that provides the mediancomplexes for each supplied leadfrom each 10-second 12SLanalysis at intervals of every 5seconds. That is, eachconsecutive analysis has 5seconds of overlappingwaveform | All output is contained in an in-memorydata structure; the host product isresponsible for creation of the outputrecord and/or report. There is no conceptof "trends" in a single execution of the12SL analysis.The method of creating the 12SL mediancomplexes are identical to the referencedevice for the "12SL median complexes"as described above | Substantial equivalentMedian complexes were formed as part ofthe internal 12SL analysis and were the basisfor the per-lead measurements provided inthe predicate EK12 v1 (K170155). Themethod for median waveform formation isidentical to the reference device 12SL ECGAnalysis Program (K141963).The proposed EK12 v2 adds the export ofthe median complexes to an output file. |
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| Performance standards: | The EK12 V2 Algorithm complies with thevoluntary consensus standard AAMI/ANSI EC57: 2012 –Testing And Reporting Performance Results Of CardiacRhythm and St-Segment Measurement Algorithms. |
|---|---|
| Determination ofSubstantial Equivalence:tested | Summary of Non-Clinical TestsThe EK12 V2 Algorithm program was designed andfor compliance with applicable clauses of the followingvoluntary standard:AAMI/ANSI EC57: 2012 – Testing And ReportingPerformance Results Of Cardiac Rhythm and St-SegmentMeasurement Algorithms. (Cardiovascular)The following quality assurance measures were applied tothe development of the system:- Risk Analysis- Requirements Reviews- Code Inspections- Software Verification Testing- Performance testing |
| Summary of Clinical Tests: | The subject of this premarket submission, EK12 V2Algorithm, did not require clinical studies to supportsubstantial equivalence. |
| Conclusion: | GE Healthcare considers the EK12 V2 Algorithm to be assafe, as effective, and performance is substantiallyequivalent to the predicate 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.