EK12 Algorithm

K170155 · Ge Medical Systems Information Technologies, Inc. · MHX · Jun 6, 2017 · Cardiovascular

Device Facts

• Record ID: K170155
• Device Name: EK12 Algorithm
• Applicant: Ge Medical Systems Information Technologies, Inc.
• Product Code: MHX · Cardiovascular
• Decision Date: Jun 6, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Software as a Medical Device, Pediatric

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 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.

Device Story

EK12 is a software-only algorithm; processes 10+ seconds of previously acquired ECG data from physiological recording devices. Operates in IDTFs, hospitals, clinics, or doctor's offices; used by qualified medical professionals or trained ECG technicians. Transforms raw ECG signals into rhythm and measurement reports; assists clinicians in ECG review and assessment. Facilitates clinical decision-making by providing automated analysis of cardiac rhythm and measurements. Benefits patients through standardized, efficient diagnostic reporting.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing and compliance with AAMI/ANSI EC57:2012 (Testing and Reporting Performance Results of Cardiac Rhythm and ST-Segment Measurement Algorithms).

Technological Characteristics

Software-only algorithm. Designed for rhythm and ST-segment measurement. Complies with AAMI/ANSI EC57:2012. Development includes risk analysis, requirements reviews, code inspections, and software verification/performance testing.

Indications for Use

Indicated for adults and pediatric patients older than 2 years for rhythm and measurement analysis of previously acquired ECG signals.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• EK-Pro Arrhythmia Detection Algorithm (K031320)
• 12SL ECG Analysis Program (K141963)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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: [phone] |
| | Fax: [phone] |
| Secondary Contact Person: | Doug Kentz |
| | Regulatory Affairs Director |
| | GE Medical Systems Information Technologies, Inc. |
| | Phone: [phone] |
| | Fax: [phone] |
| Device Trade Name: | EK12 Algorithm |
| Common/Usual Name: | Arrhythmia Detection Algorithm |
| Classification Names: | Monitor, Physiological, Patient (With Arrhythmia Detection or<br>Alarms) |
| Product Code: | MHX 21 CFR 870.1025 |
| Predicate Device(s): | EK-Pro Arrhythmia Detection Algorithm – K031320<br>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<br>electrocardiogram (ECG) from physiological ECG signal recording<br>devices for rhythm and measurements.<br>EK12 is used to create reports intended for use by a Qualified<br>Medical Professional, including a trained ECG Technician operating<br>within Independent Diagnostic Testing Facility (IDTF) requirements<br>and performance standards for the review and assessment of an<br>ECG |

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| Technology: | EK12 is indicated for use on adults and pediatric patients older than<br>2 years.<br>The device is intended for use in an IDTF or a professional medical<br>facility, such as a hospital, clinic, or doctor's office.<br>The EK12 Algorithm employs the same fundamental scientific |
|----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | technology as its predicate device. |
| Determination of<br>Substantial Equivalence: | Summary of Non-Clinical Tests: |
| | The EK12 Algorithm program was designed and tested for<br>compliance with applicable clauses of the following voluntary<br>standard: |
| | AAMI/ANSI EC57: 2012 – Testing And Reporting Performance<br>Results Of Cardiac Rhythm and St-Segment Measurement<br>Algorithms. (Cardiovascular) |
| | The following quality assurance measures were applied to the<br>development of the system: |
| | I<br>Risk Analysis |
| | I<br>Requirements Reviews |
| | ■<br>Code Inspections |
| | ■<br>Software Verification Testing |
| | ■<br>Performance testing |
| | Summary of Clinical Tests: |
| | The subject of this premarket submission, EK12 Algorithm, did not<br>require clinical studies to support substantial equivalence. |
| Conclusion: | GE Healthcare considers the EK12 Algorithm to be as safe, as<br>effective, and performance is substantially equivalent to the<br>predicate device. |
| | |