(57 days)
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No
The summary explicitly states the device provides "uninterpreted 12-lead ECG data" and does not mention any analysis or interpretation capabilities that would typically involve AI/ML.
No
Explanation: The device is intended to acquire and display diagnostic ECGs for clinical use, not to provide therapy or treatment. Its function is diagnostic, providing data for clinicians, and it explicitly states it "is not to be a sole means of diagnosis" and "is not for use as a vital signs physiological monitor."
Yes
The device is described as acquiring a "diagnostic 12-lead ECG" and clinicians use it to "acquire, store, and print diagnostic 12lead ECGs." Although it provides "uninterpreted 12-lead ECG data and is not to be a sole means of diagnosis," its primary function is clearly for diagnostic purposes.
No
The description explicitly states the system is intended to "acquire a resting, diagnostic 12-lead ECG". This acquisition process requires hardware (electrodes, leads, and a device to capture the electrical signals), which is not solely software. The software component is for display, storage, and upload, but the overall system includes hardware for data acquisition.
Based on the provided information, the EKGenius Smart System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information about a physiological state, health, or disease.
- The EKGenius Smart System acquires a resting, diagnostic 12-lead ECG. An ECG measures the electrical activity of the heart directly from the body's surface, not from a specimen taken from the body.
Therefore, the EKGenius Smart System falls under the category of a medical device that performs a physiological measurement, but it is not an IVD.
N/A
Intended Use / Indications for Use
The EKGenius Smart System is intended to acquire a resting, diagnostic 12-lead ECG for display and subsequent upload to EKGenius Smart System software, which is installed on an iPad or iPhone. This enables clinicians, or trained care personnel who are acting on the orders of a licensed physician, to acquire, store, and print diagnostic 12lead ECGs.
The EKGenius Smart System is for use on adult and pediations, diseased or non-diseased and is not intended for use on neonatal (birth to 28 days) or infants (29 days up to 2 years). The device is not for use as a vital signs physiological monitor.
The EKGenius Smart System is intended to be used for clinical use rather than home used in a professional healthcare facility, or a clinical environment such as clinics. It cannot be used in transport environment, such as ambulance.
The EKGenius Smart System provides uninterpreted 12-lead ECG data and is not to be a sole means of diagnosis.
Product codes
DPS
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
adult and pediations, diseased or non-diseased and is not intended for use on neonatal (birth to 28 days) or infants (29 days up to 2 years).
Intended User / Care Setting
clinicians, or trained care personnel who are acting on the orders of a licensed physician, to acquire, store, and print diagnostic 12lead ECGs.
The EKGenius Smart System is intended to be used for clinical use rather than home used in a professional healthcare facility, or a clinical environment such as clinics. It cannot be used in transport environment, such as ambulance.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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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)
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§ 870.2340 Electrocardiograph.
(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 17, 2023
EKGenius LLC % Raymond Kelly Consultant, Licensale Inc 3422 Leonardo Lane New Smyrna Beach, Florida 32168
Re: K232974
Trade/Device Name: EKGenius Smart System Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS Dated: September 13, 2023 Received: September 21, 2023
Dear Raymond Kelly:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Jennifer W. Shih -S
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
2
Indications for Use
510(k) Number (if known) K232974
Device Name EKGenius Smart System
Indications for Use (Describe)
The EKGenius Smart System is intended to acquire a resting, diagnostic 12-lead ECG for display and subsequent upload to EKGenius Smart System software, which is installed on an iPad or iPhone. This enables clinicians, or trained care personnel who are acting on the orders of a licensed physician, to acquire, store, and print diagnostic 12lead ECGs.
The EKGenius Smart System is for use on adult and pediations, diseased or non-diseased and is not intended for use on neonatal (birth to 28 days) or infants (29 days up to 2 years). The device is not for use as a vital signs physiological monitor.
The EKGenius Smart System is intended to be used for clinical use rather than home used in a professional healthcare facility, or a clinical environment such as clinics. It cannot be used in transport environment, such as ambulance.
The EKGenius Smart System provides uninterpreted 12-lead ECG data and is not to be a sole means of diagnosis.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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