(173 days)
Ek12 Algorithm (K170155)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and describes the algorithm as providing "computerized measurements" based on ECG parameter data, which is typical of traditional signal processing rather than AI/ML.
No
The device analyzes ECG recordings to create reports for medical professionals, but it does not directly treat or alleviate a disease or condition.
Yes
The "Intended Use / Indications for Use" section states that EK12 V2 "analyzes ... electrocardiogram (ECG) ... for rhythm and measurements" and is "used to create reports intended for use by a Qualified Medical Professional, including a trained ECG Technician... for the review and assessment of an ECG." This clearly indicates its role in analyzing patient data for medical assessment, which is a diagnostic function.
Yes
The device description explicitly states that "EK12 V2 algorithm is a software only product". While it analyzes data from a "host device" (which is a physiological ECG signal recording device), the EK12 V2 itself is presented as solely the software component for analysis and reporting.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The description clearly states that EK12 V2 analyzes a previously acquired electrocardiogram (ECG) from physiological ECG signal recording devices. An ECG is a recording of electrical activity of the heart, not a sample taken from the body (like blood, urine, or tissue).
- The intended use is for analyzing electrical signals, not biological samples. The device processes electrical data from an ECG to provide rhythm and measurements. This is distinct from the analysis of biological or chemical components found in bodily fluids or tissues, which is the domain of IVDs.
Therefore, based on the definition and typical scope of In Vitro Diagnostics, the EK12 V2 algorithm does not fit the criteria. It is a software device that analyzes physiological signals.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
MHX
Device Description
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
electrocardiogram (ECG) from physiological ECG signal recording devices
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.
IDTF or a professional medical facility, such as a hospital, clinic, or physician'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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The EK12 V2 Algorithm program was designed and 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:
- Risk Analysis
- Requirements Reviews
- Code Inspections
- Software Verification Testing
- Performance testing
The subject of this premarket submission, EK12 V2 Algorithm, did not require clinical studies to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Ek12 Algorithm (K170155)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
12SL ECG Analysis Program (K141963)
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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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.
1
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
2
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 or |
| Alarms) | |
| 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 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 | |
| Intended Use: | 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 Diagnostic 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 physician's office. | |
| Technology: | The EK12 V2 Algorithm employs the same fundamental scientific |
| technology as its predicate and the reference devices. | |
| Determination of Substantial | |
| Equivalence: | The EK12 V2 Algorithm is substantially equivalent to the predicate |
| Ek12 Algorithm (K170155) and the reference device 12SL ECG | |
| Analysis Program (K141963) as described in the table below: |
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| Feature /
Function | Proposed Device
EK12v2 | Predicate Device
EK12v1 (K170155) | Change Explanation /
Notes |
|-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|
| Intended Use | EK12 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 Diagnostic 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 physician's office. | 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.
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. | Identical |
| Indications for
Use | EK12 is software algorithm that analyzes ECGs
for rhythm and measurements that is
deployed as part of a system used to generate
ECG reports / findings. | EK12 is software algorithm that analyzes ECGs
for rhythm and measurements that is
deployed as part of a system used to generate
ECG reports / findings. | Identical |
| Contraindications | EK12 cannot be used for active patient
monitoring since it can only analyze
prerecorded ECG signals that are at least 10
seconds long. It does not provide any time-
sensitive information, continuous display of
information, alarms, or alerts intended to
alert a caregiver to take an immediate clinical
action. | EK12 cannot be used for active patient
monitoring since it can only analyze
prerecorded ECG signals that are at least 10
seconds long. It does not provide any time-
sensitive information, continuous display of
information, alarms, or alerts intended to
alert a caregiver to take an immediate clinical
action. | Identical |
| Patient
Population | EK12 is indicated for use on adults and
pediatric patients older than 2 years. | EK12 is indicated for use on adults and
pediatric patients older than 2 years. | Identical |
| Use Environment | The device is intended for use in an IDTF or a
professional medical facility, such as a
hospital, clinic, or physician's office. | The device is intended for use in an IDTF or a
professional medical facility, such as a
hospital, clinic, or doctor's office. | Identical |
| Result | An output text file containing the pass/fail
status (result) of the analysis | An output text file containing the pass/fail
result of the analysis | Identical |
| Final report | An output text file containing the final
evaluation results for rhythms,
measurements, and other information. | An output text file containing the final
evaluation results for rhythms,
measurements, and other information. | Identical |
| Event log
detected
arrhythmias,
noise) | A column-oriented tab-delimited output text
file annotating the beginning and end of all
detected rhythm and noise events. | A column-oriented tab-delimited output text
file annotating the beginning and end of all
detected rhythm and noise events. | Identical |
| QRS detections | Two output files:
- A column-oriented tab-delimited output
text file listing annotations of QRS detection
times and beat classification. | Two output files: - A column-oriented tab-delimited output
text file listing annotations of QRS detection
times and beat classification. | Identical |
| Feature / Function | Proposed Device
EK12v2 | Predicate Device
EK12v1 (K170155) | Change Explanation / Notes |
| | 2. A binary file in the WFDB annotation file
format containing QRS detection times and
beat classification. | 2. A binary file in the WFDB-format
annotation file format containing QRS
detection 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 Analysis
Program (K141963) | Discussion of Differences |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Patient age and
gender | Optional inputs. If present, they
are contained within the WFDB
input record. When present,
they are validated and passed
directly to the 12SL analysis. If
not present, the value for
unknown age and/or gender are
provided to the 12SL analysis | Required inputs which are used in the ECG
interpretation.
Age is provided to the program in years,
an encoded value for age less than one
year, or an encoded value for age
unknown.
Gender is provided to the program as
one of male, female, or unknown. | Substantial equivalent
The proposed EK12 V2 adds support for the
optional input of patient age and/or gender. |
| Identification of
ECG leads | Lead names are an optional
component of the input WFDB
input record and are an optional
input of EK12 V2. Any input
signals containing a lead name
from the set {I, II, V1, V2, V3, V4,
V5, V6} will be treated as that
lead in the internal 12SL analysis | Assumes the first 8 channels are ECG
leads I, II, V1, V2, V3, V4, V5, V6.
Measurements are provided for leads
after the first 8 channels but are
otherwise not used in any interpretation
statements with the exception of lead
V4r, which if present, will be examined for
right ventricular involvement (ST
elevation) if an acute inferior infarct is
detected | Substantial equivalent
The proposed EK12 V2 adds support for the
optional identification of ECG leads. |
| 12SL rhythm
statement
trends | A column-oriented tab-delimited
text file that provides the 12SL
interpretation statement codes
for rhythm statements from each
10-second 12SL analysis at
intervals of every 5 seconds. That
is, each consecutive analysis has
5 seconds of overlapping
waveform.
The 12SL interpretation
statement codes are censored to
remove all statement codes not
related to rhythm interpretation. | All output is contained in an in-memory
data structure; the host product is
responsible for creation of the output
record and/or report. There is no concept
of "trends" in a single execution of the
12SL analysis.
The method of creating the 12SL
statements are identical to the reference
device for the "12SL interpretation
statement codes" as described above | Substantial equivalent
Interpretation statement codes forming the
overall ECG interpretation is identical to the
reference 12SL ECG Analysis Program
(K141963).
The proposed EK12 v2 adds the export of
the rhythm statement codes to an output
file. |
| Median
complex
waveform
trends | A column-oriented tab-delimited
text file that provides the median
complexes for each supplied lead
from each 10-second 12SL
analysis at intervals of every 5
seconds. That is, each
consecutive analysis has 5
seconds of overlapping
waveform | All output is contained in an in-memory
data structure; the host product is
responsible for creation of the output
record and/or report. There is no concept
of "trends" in a single execution of the
12SL analysis.
The method of creating the 12SL median
complexes are identical to the reference
device for the "12SL median complexes"
as described above | Substantial equivalent
Median complexes were formed as part of
the internal 12SL analysis and were the basis
for the per-lead measurements provided in
the predicate EK12 v1 (K170155). The
method for median waveform formation is
identical to the reference device 12SL ECG
Analysis Program (K141963).
The proposed EK12 v2 adds the export of
the median complexes to an output file. |
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| Performance standards: | 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. |
|--------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Determination of
Substantial Equivalence:
tested | Summary of Non-Clinical Tests
The EK12 V2 Algorithm program was designed and
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:
- Risk Analysis
- Requirements Reviews
- Code Inspections
- Software Verification Testing
- Performance testing |
| Summary of Clinical Tests: | The subject of this premarket submission, EK12 V2
Algorithm, did not require clinical studies to support
substantial equivalence. |
| Conclusion: | GE Healthcare considers the EK12 V2 Algorithm to be as
safe, as effective, and performance is substantially
equivalent to the predicate device. |