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.

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.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for the Mediblu ECG System Models ME3, ME6P, ME12P, ME15P. This type of submission aims to demonstrate substantial equivalence to a predicate device, rather than proving the safety and effectiveness of a device from scratch through clinical studies with specific acceptance criteria and performance metrics.

Therefore, the document does not contain the information requested regarding acceptance criteria, a study proving the device meets those criteria, sample sizes for test/training sets, data provenance, expert qualifications, ground truth establishment, or multi-reader multi-case studies.

Instead, the submission focuses on comparing the subject devices to existing predicate devices to demonstrate that their indications for use, technological characteristics, and performance are substantially equivalent, implying that they are as safe and effective as the legally marketed predicate devices.

The document states:

"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..." (Page 0)
"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." (Page 15)
"There are no differences between the subject devices and the predicate devices." (Page 15)

The acceptance criteria here is "substantial equivalence" to a predicate device, which is demonstrated by presenting a side-by-side comparison of technical specifications and intended use. The "study" proving this largely involves non-clinical testing to ensure the device meets specified technical performance (e.g., input impedance, frequency response, noise level) and safety standards (e.g., IEC60601-1), and then detailing how these align with the predicate device.

Here's a summary of what is provided, framed in relation to your request, and why it doesn't fit the typical "acceptance criteria and study" for a de novo or PMA submission:

Mediblu ECG System Models (ME3, ME6P, ME12P, ME15P) 510(k) Premarket Notification

This submission is to demonstrate substantial equivalence to existing, legally marketed predicate devices, not to prove de novo safety and effectiveness through clinical trials against specific performance acceptance criteria. The "acceptance criteria" for a 510(k) is that the device is as safe and effective as a predicate device.

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (for 510(k)): Substantial equivalence to predicate devices, meaning the intended use and technological characteristics are the same, or if different, the differences do not raise new questions of safety or effectiveness.
Reported Device Performance: Instead of a single "performance" score against an acceptance criterion, the document provides detailed technical specifications for each Mediblu model (ME3, ME6P, ME12P, ME15P) and directly compares them to their respective predicate devices. The "performance" is implicitly demonstrated by showing that all key technical specifications and features are "Same" as the predicate.

Example Table (Extracted from document for ME3 comparison):

Characteristic	Mediblu ECG System Model ME3 (Subject Device)	Biocare Digital Electrocardiograph iE300 (Predicate Device K160092)	Comparison
Indications for Use	[Full definition, same as predicate]	[Full definition, same as subject]	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
Acquisition Mode	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
Filters	AC Filter, Baseline Wander Filter, EMG Filter	AC Filter, Baseline Wander Filter, EMG Filter	Same
Input CIR Current	<0.1 μA	<0.1 μA	Same
Input Impedance	≥30 MΩ (10Hz)	≥30 MΩ (10Hz)	Same
Time Constant	≥3.2 s	≥3.2 s	Same
Frequency Response	0.01 Hz~250 Hz	0.01 Hz~250 Hz	Same
Noise Level	≤12.5 μVp-v	≤12.5 μVp-v	Same
Sensitivity Threshold	20 μVp-v	20 μVp-v	Same
Sampling rate	8000Hz	8000Hz	Same
Safety Classification	IEC60601-1, Class I, TypeCF	IEC60601-1, Class I, Type CF	Same
AC Power Supply	100 V-240V, 50 Hz /60 Hz, 80 VA	100 V-240V, 50 Hz /60 Hz, 80 VA	Same
DC Power Supply	Rechargeable lithium battery, 11.1 V/2600mAh	Rechargeable lithium battery, 11.1 V/2600mAh	Same
and many more technical specs...

Similar tables showing "Same" for all key characteristics are provided for ME6P (vs. iE6), ME12P (vs. iE12), and ME15P (vs. iE15).

2. Sample sizes used for the test set and the data provenance

Not Applicable in this context. This 510(k) relies on non-clinical test data to demonstrate that the device meets safety and performance standards equivalent to the predicate, and that there are "no significant differences." It doesn't involve a separate "test set" of patient data for algorithm performance as would be required for an AI/ML device with a specific diagnostic claim. The comparison is based on the device's inherent physical and electrical properties, and its functional specifications.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. As there is no "test set" of patient data requiring expert ground truth, experts for this purpose are not mentioned.

4. Adjudication method for the test set

Not Applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable. This is not an AI/ML-driven diagnostic device being evaluated for its interpretive or assistive capabilities. It's a standard electrocardiograph device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. The device does have an "analysis feature" and "interpretive statements," but these are explicitly stated to be "offered to clinician on an advisory basis only" (Page 2). The 510(k) substantiation focuses on the device's functional equivalence for acquiring ECG signals, not on the performance of its interpretive algorithms. The substantial equivalence relies on comparison of physical and electrical characteristics, and the fact that its advisory features are similar to the predicate.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not Applicable. The "ground truth" for this submission are the established technical specifications and safety standards (e.g., AAMI EC11, IEC 60601-1) and the documented specifications of the predicate devices.

8. The sample size for the training set

Not Applicable. No training set for an AI/ML algorithm is discussed.

9. How the ground truth for the training set was established

Not Applicable.

In conclusion, the document serves as a 510(k) Preamarket Notification, which fulfills regulatory requirements by establishing substantial equivalence to previously cleared devices. It does not contain the detailed study information typically associated with proving the performance of a novel diagnostic algorithm or AI-driven device against specific quantitative acceptance criteria on a patient dataset.

Summary

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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).

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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

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Indications for Use

510(k) Number (if known) K233266

Device Name Mediblu ECG System Models ME3. ME6P, ME12P, ME15P

Indications for Use (Describe)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Submitter Information

Submitter	Mediblu Medical LLC3016 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

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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

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Device Description

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.

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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 DeviceME3/K233266Mediblu	Predicate DeviceE300/K160092Biocare	Comparison
Indications forUse	The Digital Electrocardiograph ME3 isintended to acquire ECG signals fromadult and pediatric patients throughbody surface ECG electrodes. Theelectrocardiograph is only intended tobe used in hospitals or healthcarefacilities by doctors and trainedhealthcare professionals. Thecardiogram recorded by theelectrocardiograph can help users toanalyze and diagnose heart disease. Theproposed device has analysis feature,however the ECG with measurementsand interpretive statements is offered toclinician on an advisory basis only.	The Digital Electrocardiograph iE300 isintended to acquire ECG signals fromadult and pediatric patients throughbody surface ECG electrodes. Theelectrocardiograph is only intended tobe used in hospitals or healthcarefacilities by doctors and trainedhealthcare professionals. Thecardiogram recorded by theelectrocardiograph can help users toanalyze and diagnose heart disease.The proposed device has analysisfeature, however the ECG withmeasurements and interpretivestatements is offered to clinician on anadvisory 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	30~300s waveforms acquisition for rhythmanalysis	30~300s waveforms acquisition forrhythmanalysis	Same
MeasurementParameters	Ventricular Rate, PR Interval, QRS TimeLimit, QT/QTC Interval, P/QRS/TAxis,RV5/SV1 Amplitude and RV5+SV1Amplitude	Ventricular Rate, PR Interval, QRS TimeLimit, QT/QTC Interval, P/QRS/TAxis,RV5/SV1 Amplitude and Same RV5+SV1Amplitude	Same
Filters	AC FilterBaseline Wander FilterEMG Filter	AC FilterBaseline Wander FilterEMG Filter	Same
Input CIR Current	<0.1 μ A	<0.1 μ Α	Same

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Input Impedance	≥30 MΩ (10Hz)	≥30 MΩ (10Hz)	Same
Time Constant	≥3.2 s	≥3.2 s	Same
FrequencyResponse	0.01 Hz~250 Hz	0.01 Hz~250 Hz	Same
Noise Level	≤12.5 μ Vp-v	≤12.5 μ Vp-v	Same
SensitivityThreshold	20 μ Vp-v	20 μ Vp-v	Same
Sensitivity	Auto, 0.625 mm/mV, 1.25mm/mV, 2.5 mm/mV, 5 mm/mV, 10/5mm/mV, 10mm/mV, 20/10mm/mV, 20mm/mV, and 40 mm/mV	Auto, 0.625 mm/mV, 1.25 mm/mV,2.5 mm/mV, 5 mm/mV, 10/5mm/mV, 10mm/mV, 20/10mm/mV, 20 mm/mV,and40 mm/mV	Same
Sensitivity	10 mm/mV ± 2%	10 mm/mV ± 2%	Same
CalibrationVoltage	1 mV±3 %	1 mV±3 %	Same
Accuracy of inputsignalreproduction	Using the method described in4.2.7.1 of AAMI EC11 to test the overallsystem error, which is within±5%;Using method A and D described in4.2.7.1 of AAMI EC11 to test frequencyresponse. Because of samplingcharacteristics and the asynchronismECG machine, digital systems may producea noticeable modulating effect from onecycle to the next, particularly in pediatricphysiologic, shall be clearly described in the be clearly describedoperator's and service manuals.	Using the method described in4.2.7.1 of AAMI EC11 to test the overallsystem error, which is within±5%;Using method A and D described in4.2.7.1 of AAMI EC11 to test frequencyresponse. Because of sampling characteristicsand the asynchronism between sample ratebetween sample rate and signal rate of the and signal rate of the ECG machine, digitalsystems may produce a noticeablemodulating effect from one cycle to the next,particularly in pediatric recordings. Thisrecordings. This phenomenon, which is not phenomenon, which is not physiologic, shallin the operator's and servicemanuals.	Same
CMRR	>115 dB	>115 dB	Same
Patient LeakCurrent	< 10 μA	<10 μA	Same
Sampling rate	8000Hz	8000Hz	Same
Display on LCD	5-inch TFT LCD screen	5-inch TFT LCD screen	Same
SafetyClassification	IEC60601-1, Class I, TypeCF	IEC60601-1, Class I, Type CF	Same
AC Power Supply	100 V-240V, 50 Hz /60 Hz, 80 VA	100 V-240V, 50 Hz /60 Hz, 80 VA	Same
DC Power Supply	Rechargeable lithium battery, 11.1 V/2600mAh.In environment temperature25 °C± 5 °C and with the machineturning off, the charging time is notmore than 2 hours to charge the batteryto 90%. In environment temperature 25°C± 5 °C, the continuous working timeis not less than 3 hours while the ECGdeviceiscontinuously printing.	Rechargeable lithium battery, 11.1 V/2600mAh. In environment temperature 25°C± 5 °C and with the machine turningoff, the chargingtime is not more than 2hours to charge the battery to 90%. Inenvironment temperature 25 °C± 5°C, thecontinuous working time is not less than 3hours while the ECGdevice is continuouslyprinting.	Same

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510 (k) Summary

ME6 Comparison

Name / 510K #Owner	Subject DeviceME6 / K233266Mediblu	Predicate DeviceiE6 / K132758Biocare	Comparison
Indications forUse	The ME6 is intended to acquire ECGsignals from adult and pediatric patientsthrough body surface ECG electrodes.The obtained ECG records can help usersto analyze and diagnose heart disease.Digital Electrocardiographs shall be usedin healthcare facilities by doctors and/ortrained healthcare professionals.	The intended use of the iE6electrocardiograph is to acquire ECGsignals from adult and pediatric patientsthrough body surface ECG electrodes.The obtained ECG records can help usersto analyze and diagnose heart disease.Digital Electrocardiographs shall be usedin healthcare facilities by doctors and/ortrained healthcare professionals.	Same
Dimensions	257 mm × 291 mm × 106 mm	257 mm × 291 mm × 106 mm	Same
Net Weight	2.5 kg	2.5 kg	Same
Leads	Standard 12-lead	Standard 12-lead	Same
AcquisitionMode	Simultaneous 12-leadAcquisition	Simultaneous 12-leadAcquisition	Same
Record Format	1 × 12, 1 × 12+1R, 3 × 4, 3 ×4+1R (3-channel)3 × 4,3 × 4+1R,3 × 4+3R,6 × 2,6× 2+1R (6-channel, Standard leads) 6 × 1,3×2	1 × 12, 1 × 12+1R, 3 × 4, 3 ×4+1R (3-channel)3 × 4,3 × 4+1R,3 × 4+3R,6 × 2,6× 2+1R (6-channel, Standardleads) 6 × 1,3×2	Same
Record Mode	Auto, Manual, Upload (3-channel)Auto, Manual, Upload, Cycle,Trigger(6-channel)	Auto, Manual, Upload (3-channel)Auto, Manual, Upload, Cycle,Trigger(6-channel)	Same
Lead Format	Standard leads: 3 × 4, 3 × 4+1R,6 × 2,6×2+1R, 12×16-channel, Nehb lead: 6 × 1, 3 ×2	Standard leads: 3 × 4, 3 × 4+1R,6 × 2,6×2+1R, 12×16-channel, Nehb lead: 6 × 1, 3 × 2	Same
Rhythm Time	30~300s waveforms acquisitionforrhythm analysis	30~300s waveforms acquisitionforrhythm analysis	Same
MeasurementParameters	Standard leads:HR, PR Interval, QRSduration, QT/QTC Interval, P/QRS/TAxis, RV5/SV1 voltage and RV5+SV1voltageNehb lead: HR, PR interval, Pduration, T duration, QRS duration,QT/QTC interval,P/QRS/T axis, P amplitude	Standard leads:HR, PR Interval, QRSduration, QT/QTC Interval, P/QRS/T Axis,RV5/SV1 voltageand RV5+SV1 voltageNehb lead: HR, PR interval, Pduration, Tduration, QRS duration, QT/QTC interval,P/QRS/T axis, P amplitude	Same
Filters	AC FilterBaseline Wander FilterEMGFilter	AC FilterBaseline Wander FilterEMGFilter	Same
Input CIRCurrent	≤0.1 μ A	≤0.1 μ A	Same
Input Impedance	≥2.5 M $\Omega$	≥2.5 M $\Omega$	Same
Time Constant	≥3.2 s	≥3.2 s	Same
FrequencyResponse	0.05 Hz~250 Hz	0.05 Hz~250 Hz	Same
Noise Level	≤15 μ Vp-v	≤15 μ Vp-v	Same
SensitivityThreshold	20 μ Vp-v	20 μ Vp-v	Same
Sensitivity	Auto, 1.25 mm/mV, 2.5 mm/mV,5 mm/mV, 10 mm/mV, 20mm/mV, 40 mm/mV,10/5 mm/mV, 20/10 mm/mV	Auto, 1.25 mm/mV, 2.5 mm/mV,5 mm/mV, 10 mm/mV, 20mm/mV, 40 mm/mV,10/5 mm/mV, 20/10 mm/mV	Same
StandardSensitivity	10 mm/mV ± 2%	10 mm/mV ± 2%	Same
CalibrationVoltage	1 mV±5 %	1 mV±5 %	Same
Accuracy of inputsignal reproduction	Using the method described in4.2.7.1 of AAMI EC11 to test theoverallsystem error, which is within ±5%;Using method A and D described in4.2.7.1 of AAMI EC11 to test frequencyresponse.Because of sampling characteristics andthe asynchronism between samplerate and signal rate of the ECG machine,digital systems may produce anoticeable modulating effect from onecycle to the next, particularly in pediatricrecordings. This phenomenon, which isnot physiologic, shall be clearly describedin the operator's and service manuals.	Using the method described in4.2.7.1 of AAMI EC11 to test the overallsystem error, which is within ±5%;Using method A and D described in 4.2.7.1of AAMI EC11 to test frequency response.Because of sampling characteristics and theasynchronism between samplerate and signal rate of the ECG machine,digital systems may produce anoticeable modulating effect from onecycle to the next, particularly in pediatricrecordings. This phenomenon, which isnot physiologic, shall be clearlydescribed in the operator's and servicemanuals.	Same
CMRR	>89 dB	>89 dB	Same
Patient LeakCurrent	<10 μ A	<10 μ A	Same
Sampling rate	8000 Hz	8000 Hz	Same
Display on LCD	8-inch TFT LCD screen (6-channel)	8-inch TFT LCD screen (6-channel)	Same
Safety Class	IEC60601-1, Class I, Type CF	IEC60601-1, Class I, Type CF	Same
AC PowerSupply	100 V~240 V, 50 Hz/60 Hz,80VA(6-channel)	100 V~240 V, 50 Hz/60 Hz,80VA(6-channel)	Same
DC PowerSupply	Rechargeable lithium battery,14.8 V/ 2200mAh.In environment temperature rangingfrom 20 °C to 30 °C and with themachine turning off, the charging timeis not more than 2 hours to charge the	Rechargeable lithium battery,14.8 V/ 2200mAh.In environment temperature ranging from20 °C to 30 °C and with the machineturning off, thecharging time is not morethan 2hours to charge the battery to 90%.	Same

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510 (k) Summary

	battery to 90%.
		Optional Wireless Networks Specifications			Same
ApplicableStandard	IEEE802.11b/g/n(2.4G)	IEEE802.11a/n(5G)	IEEE802.11b/g/n(2.4G)	IEEE802.11a/n(5G)	Same
FrequencyRange	2.412 GHz~2.472 GHz	4.9 GHz~5.975 GHz	2.412 GHz~2.472 GHz	4.9 GHz~5.975 GHz	Same
Band Width	20~40MHz	20~40MHz	20~40MHz	20~40MHz	Same
Radiated Power	+18dBm	+13.5dBm	+18dBm	+13.5dBm	Same
Signal Path	1-13 (China)		1-13 (China)		Same
Type and FrequencyCharacteristicsof theModulation	CCK/DSSS/OFDM/MCS7/MCS0		CCK/DSSS/OFDM/MCS7/MCS0		Same

ME12P Comparison

Name / 510K #Owner	Subject DeviceME12PMediblu	Predicate DeviceiE 12 / K123816Biocare	Comparison
Indications forUse	Digital Electrocardiographs ME12P isintended to acquire ECG signals from adultand pediatric patients through bodysurface ECG electrodes. The obtained ECGrecords can help users to analyze anddiagnose heart disease. DigitalElectrocardiographs shall be used inhealthcare facilities by doctors and/ortrained healthcare professionals.	Digital Electrocardiograph iEI12A isintended to acquire ECG signals from adultand pediatric patients through bodysurface ECG electrodes. The obtained ECGrecords can help users to analyze anddiagnose heart disease. DigitalElectrocardiographs shall be used inhealthcare facilities by doctors and/ortrained healthcare professionals.	Same
Dimensions	345mm x 260mm x 86.7mm	345mm x 260mm x 86.7mm	Same
Net Weight	4 kg	4 kg	Same
Lead	Standard 12-lead	Standard 12-lead	Same
AcquisitionMode	Simultaneous 12-lead	Simultaneous 12-lead	Same
Record Format	Standard leads: 3×4, 3×4+1R, 3×4+3R,6×2, 6×2+1R, 6×2+3R,12×1 Nehb lead: 6×1, 3×2VCG: 6×1+3, 3×2+3, 3×2+3+1R,3×2+3+3R, Frank	Standard leads: 3×4, 3×4+1R, 3×4+3R, 6×2,6×2+1R, 6×2+3R,12×1 Nehb lead: 6×1, 3×2VCG: 6×1+3, 3×2+3, 3×2+3+1R, 3×2+3+3R,Frank	Same
Record Mode	Economic, Auto, Manual,Upload, Cycle, Trigger	Economic, Auto, Manual,Upload. Cycle. Trigger	Same

Lead Format	Standard leads: 3×4, 3×4+1R,6×2,6×2+1R, 12×1Nehb lead: 6×1, 3×2VCG: 3×2+3, 6×1+3, Frank	Standard leads: 3×4, 3×4+1R,6×2,6×2+1R, 12×1Nehb lead: 6×1, 3×2VCG: 3×2+3, 6×1+3, Frank	Same
Long-termRecording	Record for a long term (30 s~300 s)and rhythm analysis	Record for a long term (30 s ~ 300 s)and rhythm analysis	Same
MeasurementParameters	Standard leads: HR, PR interval,QRSduration, QT/QTC interval,P/QRS/Taxis, RV5/SV1 voltage andRV5+SV1 voltageNehb lead: HR, PR interval, Pduration, Tduration, QRS duration, QT/QTC interval,P/QRS/T axis, P amplitude	Standard leads: HR, PR interval,QRSduration, QT/QTC interval,P/QRS/Taxis, RV5/SV1 voltage andRV5+SV1voltageNehb lead: HR, PR interval, Pduration, Tduration, QRS duration, QT/QTC interval,P/QRS/T axis, P amplitude	Same
Filters	AC, low-pass and high-passfilters	AC, low-pass and high-passfilters	Same
CMRR	>89 dB>100 dB (with AC interferencefilter)	>89 dB>100 dB (with AC interferencefilter)	Same
Input CIRCurrent	≤0.1 μΑ	≤0.1 μΑ	Same
Patient LeakCurrent	<10 μΑ	<10 μΑ	Same
Time Constant	≥3.2 s	≥3.2 s	Same
FrequencyResponse	0.05 Hz~250 Hz	0.05 Hz~250 Hz	Same
Noise LevelSensitivityThreshold	≤15 μVp-v20 μVp-v	≤15 μVp-v20 μVp-v	Same
Signal Gain	1.25 mm/mV, 2.5 mm/mV, 5mm/mV, 10mm/mV, 20 mm/mV, 40 mm/mV,10/5 mm/mV, 20/10 mm/mV, AutoGain (Auto Gain is just forthe Automaticmode)	1.25 mm/mV, 2.5 mm/mV, 5mm/mV, 10 mm/mV, 20 mm/mV,40 mm/mV,10/5 mm/mV, 20/10 mm/mV, Auto Gain(Auto Gain is just forthe Automaticmode)	Same
CalibrationVoltage	1 mV±5 %	1 mV±5 %	Same
Accuracy of InputSignal Reproduction	Using the method described in4.2.7.1 of AAMI EC11 to test theoverallsystem error, which is within ±5%;Using method A and D describedin 4.2.7.1of AAMI EC11 to test frequency response.Because of sampling characteristics and theasynchronism between samplerate andsignal rate of the ECGmachine, digitalsystems may produce a noticeable	Using the method described in4.2.7.1 of AAMI EC11 to test the overallsystem error, which is within ±5%;Using method A and D described in 4.2.7.1of AAMI EC11 to test frequency response.Because of sampling characteristics and theasynchronism between sample rate andsignal rate of the ECG machine, digitalsystems may produce a noticeable	Same
Input Circuit	Floating circuit input	Floating circuit input	Same
Input Impedance	$≥2.5ΜΩ$ (full-band)	$≥2.5ΜΩ$ (full-band)	Same
Sampling Rateof Signals	8000 Hz	8000 Hz	Same
Display on LCD	1280×800, 9-inch LCD touch screen, the whole instrumentwork status, time, heart rate, and with the backlight	1280×800, 9-inch LCD touch screen, the whole instrumentwork status, time, heart rate, and with the backlight	Same
SafetyClassification	IEC60601-1 Class I Type CF	IEC60601-1 Class I Type CF	Same
AC PowerSupply	100 V~240 V, 50 Hz /60 Hz, 110VA	100 V~240 V, 50 Hz /60 Hz, 110VA	Same
DC PowerSupply	Rechargeable lithium battery, 14.8 V/ 4400mAh. In environment temperature ranging from 20 °C to 30 °C andwith the machine turning off, the charging time is not more than 4 hours to charge the battery to 90%.	Rechargeable lithium battery, 14.8 V/ 4400mAh. In environment temperature ranging from 20 °C to 30 °C and with the machine turning off, the charging time is not more than 4hours to charge the battery to 90%.	Same
Optional Wireless Networks Specifications
ApplicableStandard	IEEE802.11b/g/n(2.4G)	IEEE802.11a/n(5G)	Same
FrequencyRange	2.412 GHz~2.472 GHz	4.9 GHz~5.975 GHz	Same
Band Width	20~40MHz	20~40MHz	Same
Radiated Power	+18dBm	+13.5dBm	Same
Signal Path	1-13 (China)	1-13 (China)	Same
Type and FrequencyCharacteristicsof theModulation	CCK/DSSS/OFDM/MCS7/MCS0	CCK/DSSS/OFDM/MCS7/MCS0	Same

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510 (k) Summary

ME15P Comparison

Common Name	Candidate DeviceME15PMediblu	Predicate Device (K123816)iE 15Biocare	Comparison
OwnerIndications forUse	Digital Electrocardiograph ME15P isintended to acquire ECG signals from adultand pediatric patients through bodysurface ECG electrodes. The obtained ECGrecords can help users to analyze anddiagnose heart disease. DigitalElectrocardiographs shall he used inhealthcare facilities by doctors and/ortrained healthcare professionals.	Digital Electrocardiograph iE 15S isintended to acquire ECG signals fromadult and pediatric patients through bodysurface ECG electrodes. The obtained ECGrecords can help users to analyze anddiagnose heart disease. DigitalElectrocardiographs shall he used inhealthcare facilities by doctors and/ortrained healthcare professionals.	Same
Dimensions	460mm x 370mm x 250mm	460mm x 370mm x 250mm	Same
Net Weight	8.8 kg	8.8 kg	Same
Lead	Standard 15-lead	Standard 15-lead	Same
AcquisitionMode	Simultaneous 15-leadAcquisition	Simultaneous 15-leadAcquisition	Same
Record Format	12-lead: 3×4, 3×4+1R, 3×4+3R,6×2, 6×2+1R, 6×2+3R,12×115-lead: 3×5, 3×5+1, 3×5+3R,6×2+3, 6×2+3+1R, 6+9, 15×1,Extra 3VCG: 3×4+3, 3×4+3+1R,3×4+3+3R, 6×2+3, 6×2+3+1R,15×1, Frank	12-lead: 3×4, 3×4+1R, 3×4+3R,6×2, 6×2+1R, 6×2+3R,12×115-lead: 3×5, 3×5+1, 3×5+3R,6×2+3, 6×2+3+1R, 6+9, 15×1,Extra 3VCG: 3×4+3, 3×4+3+1R,3×4+3+3R, 6×2+3, 6×2+3+1R,15×1, Frank	Same
Record Mode	Economic, Auto, Manual,Upload,Cycle, Trigger	Economic, Auto, Manual,Upload,Cycle, Trigger	Same
Lead Format	12-lead: 3×4, 3×4+1R, 6×2,6×2+1R, 12×115-lead: 3×5, 3×5+1R, 6×2+3,6×2+3+1R, 6+9, 6+9+1R, Extra 3VCG: 3×4+3, 6×2+3, Frank	12-lead: 3×4, 3×4+1R, 6×2,6×2+1R, 12×115-lead: 3×5, 3×5+1R, 6×2+3,6×2+3+1R, 6+9, 6+9+1R, Extra 3VCG: 3×4+3, 6×2+3, Frank	Same
Rhythm Time:	30~300s waveforms acquisitionforrhythm analysis	30~300s waveforms acquisitionforrhythm analysis	Same
MeasurementParameters	Ventricular Rate, PR Interval, QRS TimeLimit, QT/QTC Interval,P/QRS/T Axis,RV5/SV1 Amplitude andRV5+SV1Amplitude	Ventricular Rate, PR Interval, QRS TimeLimit, QT/QTC Interval,P/QRS/T Axis,RV5/SV1 Amplitude andRV5+SV1Amplitude	Same
Filters	AC FilterBaseline Wander FilterEMGFilter	AC FilterBaseline Wander FilterEMGFilter	Same
CMRR	>89 dB	>89 dB	Same
Input CIR	≤0.1 μΑ	≤0.1 μΑ	Same
Current
Patient LeakCurrent	<10 μA	<10 μA	Same
Time Constant	≥3.2 s	≥3.2 s	Same
FrequencyResponse	0.05 Hz~250 Hz	0.05 Hz~250 Hz	Same
Noise Level	≤15 μVp-v	≤15 μVp-v	Same
SensitivityThreshold	20 μVp-v	20 μVp-v	Same
StandardSensitivity	10 mm/mV ± 2%	10 mm/mV ± 2%	Same
CalibrationVoltage	1 mV±5 %	1 mV±5 %	Same
Accuracy of InputSignal Reproduction	Using the method described in4.2.7.1 of AAMI EC11 to test theoverallsystem error, which is within ±5%;Using method A and D describedin 4.2.7.1of AAMI EC11 to test frequency response.Because of sampling characteristics and theasynchronism between samplerate andsignal rate of the ECG machine,digitalsystems may produce a noticeablemodulating effect from one cycle to thenext	Using the method described in4.2.7.1 of AAMI EC11 to test theoverallsystem error, which is within ±5%;Using method A and D describedin 4.2.7.1 ofAAMI EC11 to test frequency response.Because of sampling characteristics and theasynchronism between samplerate andsignal rate of the ECG machine,digitalsystems may produce a noticeablemodulating effect from one cycle to the next	Same
	particularly in pediatric recordings. Thisphenomenon, which is not physiologic,shall beclearly described in theoperator's and service manuals	particularly in pediatric recordings. Thisphenomenon, which is not physiologic,shall beclearly described in theoperator's and service manuals	Same
Input Impedance	≥2.5 MΩ	≥2.5 MΩ	Same
Sampling Rateof Signals	8000 Hz	8000 Hz	Same
Display on LCD	12.1-inch TFT LCD screen	12.1-inch TFT LCD screen	Same
SafetyClassification	IEC60601-1, Class I, Type CF	IEC60601-1, Class I, Type CF	Same
AC PowerSupply	100 V~240 V, 50 Hz/60 Hz,90VA	100 V~240 V, 50 Hz/60 Hz,90VA	Same
DC PowerSupply	Rechargeable lithium battery,14.8 V/ 4400mAh.In environment temperature rangingfrom 20 °C to 30 °C andwith the machineturningoff, the charging time is not more than 4hours to charge thebattery to 90%.	Rechargeable lithium battery,14.8 V/ 4400mAh.In environment temperature rangingfrom 20 °C to 30 °C andwith the machineturningoff, the charging time is not more than 4hours to charge thebattery to 90%.	Same
Optional Wireless Networks Specifications
ApplicableStandard	IEEE802.11b/g/n(2.4G)	IEEE802.11a/n(5G)	Same
FrequencyRange	2.412 GHz~2.472 GHz	4.9 GHz~5.975 GHz	Same

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510 (k) Summary

Band Width	20~40MHz	20~40MHz	20~40MHz	20~40MHz	Same
Radiated Power	+18dBm	+13.5dBm	+18dBm	+13.5dBm	Same
Signal Path	1-13 (China)		1-13 (China)		Same
Type and FrequencyCharacteristicsof theModulation	CCK/DSSS/OFDM/MCS7/MCS0		CCK/DSSS/OFDM/MCS7/MCS0		Same

Characteristics Comparison:

The basic and main technical features of the subject device are the predicate devices. The intended use, design, materials, and fabrication technologies are the same. The Mediblu Digital Electrograph models ME3, ME6P, ME12P, and ME15P have passed all non-clinical testing. All Mediblu digital electrocardiograph models in this 510(k) submission have shown to be equivalent to their predicate devices and show no significant differences. There are no differences between the subject devices and the predicate devices.

Conclusion

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. The Mediblu model ME3 is equivalent to the iE300 Digital Electrocardiograph manufactured by Shenzhen Biocare Bio-medical Equipment Co., Ltd (K160092). The Mediblu model ME6P is equivalent to the iE6 Digital Electrocardiograph manufactured by Shenzhen Biocare Bio-medical Equipment Co., Ltd (K132758). The Mediblu model ME12P is equivalent to the iE12 Digital Electrocardiograph manufactured by Shenzhen Biocare Bio-medical Equipment Co., Ltd (K122712). The Mediblu model ME15P is equivalent to the iE15 Digital Electrocardiograph manufactured by Shenzhen Biocare Bio-medical Equipment Co., Ltd (K123816).

Regulation Number and Section

§ 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).