(257 days)
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No
The document describes standard digital electrocardiograph functionality and does not mention AI, ML, or related concepts. The analysis feature is described as advisory, which is typical for traditional ECG interpretation algorithms.
No
The device is described as an electrocardiograph intended to acquire, display, and record ECG signals to help analyze and diagnose heart disease, not to treat it.
Yes
The text explicitly states that "The obtained ECG records can help users to analyze and diagnose heart disease." This directly indicates a diagnostic purpose.
No
The device description explicitly mentions acquiring, displaying, and recording ECG signals through body surface electrodes, displaying waveforms on an LCD, and recording on paper via a thermal printer, all of which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the device acquires ECG signals from the body surface using electrodes. This is a non-invasive measurement of electrical activity within the body, not a test performed on a sample taken from the body.
- Intended Use: The intended use is to acquire ECG signals to help users analyze and diagnose heart disease. While this is a diagnostic purpose, it's based on a physiological measurement from the body, not an analysis of a biological sample.
Therefore, the Digital Electrocardiograph ME3, ME6, ME12P, and ME15P are considered medical devices but not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
The Digital Electrocardiograph ME3 is intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The electrocardiograph is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by the electrocardiograph can help users to analyze and diagnose heart disease. The proposed device has analysis feature, however the ECG with measurements and interpretive statements is offered to clinician on an advisory basis only.
The ME6 is intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The obtained ECG records can help users to analyze and disease. Digital Electrocardiographs shall be used in healthcare facilities by doctors and/or trained healthcare professionals.
Digital Electrocardiographs ME12P is intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The obtained ECG records can help users to analyze and diagnose heart disease. Digital Electrocardiographs shall be used in healthcare facilities by doctors and/or trained healthcare professionals.
Digital Electrocardiograph ME15P is intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The obtained ECG records can help users to analyze and diagnose heart disease. Digital Electrocardiographs shall he used in healtheare facilities by doctors and/or trained healthcare professionals.
Product codes (comma separated list FDA assigned to the subject device)
DPS
Device Description
The Mediblu ME3 Digital Electrocardiograph is intended to acquire, display and record ECG signals from adult and pediatric patients through body surface ECG electrodes. ECG data result and patient information could be stored in the memory of the device. The obtained ECG records can help users to analyze and diagnose heart disease.
The Mediblu ME6P Digital Electrocardiograph is intended to acquire, display and record ECG signals from adult and pediatric patients through body surface ECG electrodes. ECG data result and patient information could be stored in the memory of the device. The obtained ECG records can help users to analyze and diagnose heart disease.
The Mediblu ME12P Digital Electrocardiograph is designed to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. After been amplified and filtered, the ECG signal waveforms are displayed in the LCD and recorded in the paper through thermal printer. ECG data result and patient information could be stored in the memory of the device.
The Mediblu ME15P Digital Electrocardiograph is designed to acquire, display and record ECG signals from adult and pediatric patients through body surface ECG electrodes. After been amplified and filtered, the ECG signal waveforms are displayed in the LCD and recorded in the paper through thermal printer. ECG data result and patient information could be stored in the memory of the device.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult and pediatric patients
Intended User / Care Setting
hospitals or healthcare facilities by doctors and trained healthcare professionals.
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)
The non-clinical test data demonstrates that the Mediblu ECG system models are substantially equivalent to digital electrocardiograph systems cleared for marketing in the US.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
K160092, K132758, K123816, K122712
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.
Not Found
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
§ 870.2340 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 in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
June 12, 2024
Mediblu Medical LLC % Jorge Millan Biomedical Director Sigma Biomedical 490 Sawgrass Corporate Parkway Suite 130 Sunrise, Florida 33325
Re: K233266
Trade/Device Name: Mediblu ECG System Models ME3, ME6P, ME12P, ME15P Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS Dated: Mav 8, 2024 Received: May 13, 2024
Dear Jorge Millan:
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 OS 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 medical devices and radiation-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) K233266
Device Name Mediblu ECG System Models ME3. ME6P, ME12P, ME15P
Indications for Use (Describe)
The Digital Electrocardiograph ME3 is intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The electrocardiograph is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The carded by the electrocardiograph can help users to analyze and diagnose heart disease. The proposed device has analysis feature, however the ECG with measurements and interpretive statements is offered to clinician on an advisory basis only.
The ME6 is intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The obtained ECG records can help users to analyze and disease. Digital Electrocardiographs shall be used in healthcare facilities by doctors and/or trained healthcare professionals.
Digital Electrocardiographs ME12P is intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The obtained ECG records can help users to analyze and diagnose heart disease. Digital Electrocardiographs shall be used in healthcare facilities by doctors and/or trained healthcare professionals.
Digital Electrocardiograph ME15P is intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The obtained ECG records can help users to analyze and diagnose heart disease. Digital Electrocardiographs shall he used in healtheare facilities by doctors and/or trained healthcare professionals.
| 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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3
Submitter Information
| Submitter | Mediblu Medical LLC
3016 NW 82 Ave Doral, FL-USA- 33122 |
|------------------|------------------------------------------------------------|
| Contact: | Jorge Millan, PhD |
| Telephone number | (786) 416-5587 |
| E-mail | jmillan@sigmabiomedical.com |
| Date prepared: | June 11, 2024 |
Subject Device Name
| Trade/Proprietary Name: | Mediblu ECG System Models ME3, ME6P, ME12P, ME15P |
|---|---|
| Regulation Number: | 870.2340 |
| Regulation Name: | Electrocardiograph |
| Product Code: | DPS |
| Class | II |
| Panel | Cardiovascular |
Predicate Devices
| Predicate Device: | iE 15 |
|---|---|
| Sponsor | Biocare Bio-medical Equipment Co., Ltd. |
| 510(K) | K123816 |
| Regulation Number: | 870.2340 |
| Regulation Name: | Electrocardiograph |
| Product Code: | DPS |
| Class | II |
| Panel | Cardiovascular |
4
| Predicate Device: | iE 3, iE 6 |
|---|---|
| Sponsor | Biocare Bio-medical Equipment Co., Ltd. |
| 510(K) | K132758 |
| Regulation Number: | 870.2340 |
| Regulation Name: | Electrocardiograph |
| Product Code: | DPS |
| Class | II |
| Panel | Cardiovascular |
| Predicate Device: | Digital Electrocardiograph, iE300 |
|---|---|
| Sponsor | Biocare Bio-medical Equipment Co., Ltd. |
| 510(K) | K160092 |
| Regulation Number: | 870.2340 |
| Regulation Name: | Electrocardiograph |
| Product Code: | DPS |
| Class | II |
| Panel | Cardiovascular |
| Predicate Device: | iE 12 |
| Sponsor | Shenzhen Biocare Electronics Co., Ltd. |
| 510(K) | K122712 |
| Regulation Number: | 870.2340 |
| Regulation Name: | Electrocardiograph |
| Product Code: | DPS |
| Class | II |
| Panel | Cardiovascular |
5
Device Description
The Mediblu ME3 Digital Electrocardiograph is intended to acquire, display and record ECG signals from adult and pediatric patients through body surface ECG electrodes. ECG data result and patient information could be stored in the memory of the device. The obtained ECG records can help users to analyze and diagnose heart disease.
The Mediblu ME6P Digital Electrocardiograph is intended to acquire, display and record ECG signals from adult and pediatric patients through body surface ECG electrodes. ECG data result and patient information could be stored in the memory of the device. The obtained ECG records can help users to analyze and diagnose heart disease.
The Mediblu ME12P Digital Electrocardiograph is designed to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. After been amplified and filtered, the ECG signal waveforms are displayed in the LCD and recorded in the paper through thermal printer. ECG data result and patient information could be stored in the memory of the device.
The Mediblu ME15P Digital Electrocardiograph is designed to acquire, display and record ECG signals from adult and pediatric patients through body surface ECG electrodes. After been amplified and filtered, the ECG signal waveforms are displayed in the LCD and recorded in the paper through thermal printer. ECG data result and patient information could be stored in the memory of the device.
Indications for Use:
The Digital Electrocardiograph ME3 is intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The electrocardiograph is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by the electrocardiograph can help users to analyze and diagnose heart disease. The proposed device has analysis feature, however the ECG with measurements and interpretive statements is offered to clinician on an advisory basis only.
The ME6 is intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The obtained ECG records can help users to analyze and diagnose heart disease. Digital Electrocardiographs shall be used in healthcare facilities by doctors and/or trained healthcare professionals.
Digital Electrocardiographs ME12P is intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The obtained ECG records can help users to analyze and diagnose heart disease. Digital Electrocardiographs shall be used in healthcare facilities by doctors and/or trained healthcare professionals.
6
Digital Electrocardiograph ME15P is intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The obtained ECG records can help users to analyze and diagnose heart disease. Digital Electrocardiographs shall he used in healthcare facilities by doctors and/or trained healthcare professionals.
Predicate Device Comparison
ME3 Comparison
| Name/510K #
Owner | Subject Device
ME3/K233266
Mediblu | Predicate Device
E300/K160092
Biocare | Comparison |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Indications forUse | The Digital Electrocardiograph ME3 is
intended to acquire ECG signals from
adult and pediatric patients through
body surface ECG electrodes. The
electrocardiograph is only intended to
be used in hospitals or healthcare
facilities by doctors and trained
healthcare professionals. The
cardiogram recorded by the
electrocardiograph can help users to
analyze and diagnose heart disease. The
proposed device has analysis feature,
however the ECG with measurements
and interpretive statements is offered to
clinician on an advisory basis only. | The Digital Electrocardiograph iE300 is
intended to acquire ECG signals from
adult and pediatric patients through
body surface ECG electrodes. The
electrocardiograph is only intended to
be used in hospitals or healthcare
facilities by doctors and trained
healthcare professionals. The
cardiogram recorded by the
electrocardiograph can help users to
analyze and diagnose heart disease.
The proposed device has analysis
feature, however the ECG with
measurements and interpretive
statements is offered to clinician on an
advisory basis only. | Same |
| Dimensions | 281mm x 191mm x 59mm | 281mm x 191mm x 59mm | Same |
| Net Weight | 1.3 kg | 1.3 kg | Same |
| Lead | Standard 12-lead | Standard 12-lead | Same |
| AcquisitionMode | 1 × 12, 1 × 12+1R, 3 × 4, 3 ×
4+1R, 3/2 | 1 × 12, 1 × 12+1R, 3 × 4, 3 ×
4+1R, 3/2 | Same |
| Record Format | Auto, Manual, Upload | Auto, Manual, Upload | Same |
| Display Format | 3 × 4, 3 × 4+1R, 6 × 2, 6 × 2+1R, 12 ×
1 | 3 × 4, 3 × 4+1R, 6 × 2, 6 × 2+1R, 12 × 1 | Same |
| Rhythm Time | 30300s waveforms acquisition for rhythm300s waveforms acquisition forrhythm
analysis | 30
analysis | Same |
| Measurement
Parameters | Ventricular Rate, PR Interval, QRS Time
Limit, QT/QTC Interval, P/QRS/TAxis,
RV5/SV1 Amplitude and RV5+SV1
Amplitude | Ventricular Rate, PR Interval, QRS Time
Limit, QT/QTC Interval, P/QRS/TAxis,
RV5/SV1 Amplitude and Same RV5+SV1
Amplitude | Same |
| Filters | AC Filter
Baseline Wander FilterEMG Filter | AC Filter
Baseline Wander Filter
EMG Filter | Same |
| Input CIR Current | 115 dB | >115 dB | Same |
| Patient Leak
Current | 89 dB | >89 dB | Same |
| Patient LeakCurrent | 89 dB
100 dB (with AC interferencefilter) | >89 dB
100 dB (with AC interferencefilter) | Same |
| Input CIR
Current | ≤0.1 μΑ | ≤0.1 μΑ | Same |
| Patient Leak
Current | 89 dB | >89 dB | Same |
| Input CIR | ≤0.1 μΑ | ≤0.1 μΑ | Same |
| Current | | | |
| Patient Leak
Current |