MESI mTABLET ECG is intended to measure heart activity by ten (10) electrodes placed on the patient's body which measure miniscule electrical activity generated by the heart muscle depolarizations.

The MESI mTABLET ECG is solely used in professional clinical environment by trained healthcare personnel. The MESI mTABLET ECG provides information regarding the patient's cardiac function. The physician has the responsibility of making proper judgments based on this information.

Prescription Use: Federal law restricts the use of this device to sale by or on the order of a physician.

Device Description

The MESI mTABLET ECG portable 12 lead resting ECG system is intended to screen cardiac abnormalities. The MESI mTABLET ECG System acquires, permits viewing and storing signals from adult and pediatric patients. The MESI mTABLET ECG is one of several variations of the company's MESI mTABLET system portfolio.

MESI mTABLET ECG is intended to measure heart activity by ten electrodes placed on the patient body which measure miniscule electrical activity generated by heart muscle depolarizations. This activity is captured and displayed on the MESI mTABLET UNIT. The MESI mTABLET ECG supports acquisition of 10 seconds signal or manual mode with acquisition up to 5 minutes.

The MESI mTABLET ECG provides analytical statements when configured with the appropriate options. It also comes with Glasgow algorithm for automatic interpretation which offers dagnostic opinion is not intended to constitute professional advice, diagnosis or treatment, or be a substitute for professional judgment.

AI/ML Overview

The request asks for specific details about the acceptance criteria and study that proves the device meets them. However, the provided document is a 510(k) summary for an FDA clearance, which focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed acceptance criteria and a performance study for a new algorithm.

Here's a breakdown of why the requested information cannot be fully extracted and what can be inferred:

The document does not contain:

A table of explicit "acceptance criteria" for an algorithm's performance (e.g., sensitivity, specificity thresholds at a certain operating point).
Details of a standalone study proving a new algorithm's performance against specific acceptance criteria. The Glasgow algorithm is a commercially available, previously developed and validated algorithm, not a new algorithm developed by MESI D.O.O. for this specific device.
Sample sizes, data provenance, number of experts, adjudication methods for ground truth, or MRMC study results related to a new algorithm's diagnostic performance.
Training set information for a new algorithm.

What can be extracted or inferred from the document:

1. A table of (implied) acceptance criteria and the reported device performance:

Since this is a substantial equivalence submission, the "acceptance criteria" are implicitly met by demonstrating that the device performs "as well as or better than" the predicate device and conforms to recognized standards for electrocardiographs.

Feature / Standard	Acceptance Criteria (Implied)	Reported Device Performance (MESI mTABLET ECG)
Indications for Use	Equivalent to predicate (CARDIOLINE HD+ & touchECG) for evaluating and diagnosing cardiac function in adult/pediatric patients.	Indicated for use on adult or pediatric patients, to evaluate and diagnose patient cardiac function. Measures heart activity via 10 electrodes. Similar to predicate.
Interpretation Algorithm	Utilizes a clinically accepted algorithm for ECG interpretation.	Employs the Glasgow Algorithm for interpretation (same as "touchECG" predicate).
Safety & Performance	Conformance to relevant medical device standards.	Compliant with: EN 60601-1, EN 60601-1-2, EN 60601-1-6, EN 60601-2-25, EN 303 446-1, EN 62304, EN 62366, EN ISO 15223-1, EN ISO 10993-1, EN ISO 14971, IEEE/ANSI C63.27, ANSI/AAMI EC53.
Wireless Technology	Bluetooth 2.1 + EDR	Bluetooth 2.1 + EDR (identical to CARDIOLINE HD+).
Data Resolution	Sufficient for clinical interpretation.	19 bit, 2.5 µV (slightly lower than CARDIOLINE HD+ 20 bit, < 1uV/LSB, but deemed "does not affect signal interpretation").
Defibrillator Protection	AAMI/IEC Standards	AAMI/IEC Standards (identical to CARDIOLINE HD+).
Pacemaker Detection	Hardware detection with digital filtering	Hardware detection coupled with convolution digital filtering (+/- 2 mV, 0.1 ms) (identical to CARDIOLINE HD+).
IP Degree	Adequate for intended use environment.	IP 44 (higher than both predicate devices, IP 40/42 for CARDIOLINE HD+, IP 42 for MESI mTABLET ABI).

2. Sample size used for the test set and the data provenance:

The document states, "No clinical data is required to determine substantial equivalence." This implies that no primary clinical test set was used by MESI D.O.O. to validate the diagnostic performance of its device's interpretation against specific acceptance criteria. The performance of the Glasgow algorithm itself would have been established historically by its developers.

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

Not applicable for this submission, as no new clinical test data was presented for algorithm performance. The Glasgow algorithm's validation would have involved expert review at the time of its original development.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable for this submission, as no new clinical test data was presented for algorithm performance.

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:

No MRMC study was reported in this document. The device offers "analytical statements when configured with the appropriate options" and uses the "Glasgow algorithm for automatic interpretation," but explicitly states this "diagnostic opinion is not intended to constitute professional advice, diagnosis or treatment, or be a substitute for professional judgment." This indicates it's an aid, but its effectiveness in improving human reader performance was not quantified in this submission.

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

A standalone performance assessment of the Glasgow algorithm would have been conducted by its original developers. This submission did not report a new standalone performance study for the MESI mTABLET ECG's interpretation capabilities. It leverages an existing, commercially available algorithm.

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

Not applicable for this submission regarding new algorithm validation. The underlying Glasgow algorithm would have been validated using clinically established ground truth, likely expert interpretation of ECGs.

8. The sample size for the training set:

Not applicable. The Glasgow algorithm is a pre-existing, commercially available algorithm. MESI D.O.O. integrated this algorithm; they did not train a new algorithm.

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

Not applicable, as MESI D.O.O. did not train a new algorithm. The ground truth for the Glasgow algorithm's training would have been established by its developers.

In summary: The provided document is an FDA 510(k) submission focused on demonstrating substantial equivalence, mainly through technical comparisons and adherence to standards, rather than proving the diagnostic performance of a novel AI algorithm with specific acceptance criteria and a dedicated study. The device integrates a well-known, pre-existing algorithm (Glasgow algorithm), whose performance validation would have occurred prior to its integration into this device.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

July 28, 2023

MESI, Development of Medical Devices, Ltd; MESI, D.O.O. % Elaine Duncan President Paladin Medical, Inc. P.O. Box 560 Stillwater, Minnesota 55082

Re: K223670

Trade/Device Name: MESI mTablet ECG Diagnostic System, MESI mTablet ECG Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS Dated: June 23, 2023 Received: June 27, 2023

Dear Elaine Duncan:

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

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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 803) for devices or postmarketing safety reporting (21 CFR 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 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 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

Enclosure

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Indications for Use

510(k) Number (if known) K223670

Device Name MESI mTABLET ECG

Indications for Use (Describe)

The MESI mTABLET ECG is indicated for use on adult or pediatric patients, to evaluate and diagnose patient cardiac function.

MESI mTABLET ECG is intended to measure heart activity by ten (10) electrodes placed on the patient's body which measure miniscule electrical activity generated by the heart muscle depolarizations.

Prescription Use: Federal law restricts the use of this device to sale by or on the order of a physician.

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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510(k) Summary

Submitted on behalf of:	MESI D.O.O
Date Prepared:	July 28, 2023
Address:	Lesloskova cesta11A, 1000 LjubijanaSlovenia, Europe
Telephone:	+386 1 620 34 87+ 386 8 2015 32 95
Submitted by:	Paladin Medical, Inc.PO Box 560Stillwater, MN 55082
Telephone:	715-549-6035
CONTACT PERSON:	Elaine Duncan, MSME, RAC, FAIMBEPresident, Paladin Medical, Inc.
Trade name	MESI mTABLET ECG
Common name	12-lead resting wireless ECG system
Classification name	Cardiac Electrophysiology, Diagnostics, and Monitoring Devices
Device classification	Class II
Product classification	870.2340
Product code	DPS
Classification panel	Cardiovascular

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DEVICE DESCRIPTION

INDICATIONS FOR USE:

The MESI mTABLET ECG is indicated for use on adult or pediatic patients, to evaluate and diagnose patient cardiac function. MESI mTABLET ECG is intended to measure heart activity by ten (10) electrodes placed on the patient's body which measure mimiscule electrical activity generated by the heart muscle depolarizations. The MESI mTABLET ECG is solely used in professional clinical environment by trained healthcare persomel. The MESI mTABLET ECG provides information the patient's cardiac function. The physician has the responsibility of making proper judgments based on this information. Prescription Use: Federal law restricts the use of this device to sale by or on the order of a physician.

PREDICATE DEVICE and EQUIVALENCE:

The MESI mTABLET ECG has a similar indication for use and intended use as the CARDIOLINE HD+ predicate device (K150289), manufactured by Cardioline S.p.A. In addition, the MESI mTABLET ECG is equivalent to the reference device "touchECG" (K160746) that is intended to be used in conjunction with CARDIOLINE HD+ device (K150289) that acquires the ECG signal and transmits it. The

"touchECG is a software medical device provided on a CD support. The touch ECG employs the Glasgow Algorithm for interpretation. The MESI mTABLET ECG is intended for spot-checking use.

Additionally, the MESI mTABLET ABI (K201046), manufactured by MESI D.O.O serves as a reference device to the basic technology of the tablet communication and several similar components, such as charging unit. Indeed, the MESI mTABLET ECG uses the same tablet device and charging plate as MESI mTABLET ABI, cleared under 510(k) number K201046.

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Substantial Equivalence Determination Table
Device	CARDIOLINE HD+	touchECG	MESI mTABLET ABI	MESI mTABLETECG	Equivalence offeatures &characteristics
510(k)Number	K150289	K160746	K201046	K223670
Manufacturer	Cardioline S.p.A.Predicate	Cardioline S.p.AReference	MESI D.O.O.Reference	MESI D.O.O.Subject Device
Indicationsfor Use /Intended use	HD+ is a physiologicalECG acquisition module.HD+ transmits wireless,via Bluetooth to a PC orTablet, the data acquired,without making anyanalysis or filtering onthe data acquired.HD+ acquires 12-leadECG waveforms meetingthe standards for clinicaland diagnosticapplications (AAMI,ANSI, AHA, ACC) andoffers full ECGacquisition.HD+ is designed toacquire and transmit ahigh quality ECG dataallowing the patient to befree to moving (withoutcable connected to theprocessing unit).The HD+ transmits theacquired physiologicalsignals in real-time to acomputer/device where acompatible application isinstalled.All data acquired are sentvia Bluetooth to areceiver that it can be aPC, tablet or devicecapable of receiving BT	touchECG is designed tocheck and diagnosecardiac function.However, a physicianmust validate the resultsof the analysis run by theECG. touchECG isintended for use inhospitals, clinics andoutpatient departments ofany size. It is suited foruse by health professionalin emergencies(ambulances). touchECGis intended to be used inconjunction withCARDIOLINE HD+device.The device analyzes,displays and prints outelectrocardiograms. TheECG's are acquired fromCARDIOLINE HD+device.The device interprets thedata for review by aphysician.The device must be usedby a physician or byhealth professionals onbehalf of an authorizeddoctor in clinicalfacilities. It is notintended as the onlymeans for determining thediagnosis.The device's	The MESI MTABLET ABIisindicated for use on adultsubjects at risk of havingor developing peripheralarterial disease (PAD).MESI MTABLET ABI isintended for the rapidmeasurement of ankle-brachial pressure index(ABI) and pulse volumeplethysmography in adults.It is suitable for use inwound care assessment,for assessing symptomaticPAD, and as a screeningdevice for PAD. It mayalso be used on patientswith venous or arterialulcers prior to applicationof compression therapy.MESI MTABLET ABI canbe used on patients withunilateral lower limbamputation.The MESI MTABLET ABIisintended to be used to spot-check patients.The MESI MTABLET ABIprovides information	The MESI MTABLETECG isindicated for use onadult or pediatricpatients, to evaluateand diagnose patientcardiac function.MESI MTABLETECG isintended to measurehearth activity by ten(10) electrodes placedon the patient's bodywhich measureminiscule electricalactivity generated bythe heart muscledepolarizations.The MESI MTABLETECG issolely used inprofessional clinicalenvironment by trainedhealthcare personnelfor spot- checking.The MESI MTABLETECGprovides informationregarding the patient's	EQUIVALENT;MESI MTABLET ECGhassame indication for useas the Cardioline and isalso tablet andbluetooth based. Bothcan use 12 lead ECGelectrodes Both areindicated for adult andpediatric patients.MESI MTABLETECG uses the sametechnological platformas the MESImTABLET ABI.
	The ECG is transmittedverbatim to the receivingsystem, without LSB orsampling adjustment. It isup to the receivingsystem/application toperform the necessaryprocessing such as (butnot limited to) LSBscaling, signal filtering,Resting ECG analysisetc.The device HD+ isintended to be used onadult and on all pediatricpatients.The device is intendedfor use by qualified,trained nurses andphysicians operating inhospitals, clinics andmedicalpractices.	analysis is onlysignificant if usedtogether with anadditional analysis by thephysician and by anassessment of all thepatient's important data.The device can be used onadults patients.The device must not beused as a physiologicalmonitoring of vital signs.touchECGis intended tobe used in conjunctionwith CARDIOLINEHD+ device (K150289that acquires the ECGsignal and transmits it.touchECG is a softwaremedical device providedon a CD support	The physician has theresponsibility of makingproper judgments based onthis information.Prescription Use: Federallaw restricts the use of thisdevice to sale by or on theorder of a physician.	physician has theresponsibility ofmaking properjudgments based onthis information.Prescription Use:Federal law restrictsthe use of this deviceto sale by or on theorder of a physician.
Dimensions /weight	Dimensions: 115 x 65 x15 mmWeight: < 90 grams(including batteries)	The device installs on anyPC, tablet or notebookwith the minimumrequisites shown below:Operating System -Windows 7, Windows8.1, Windows 10Processor - Intel I5 orhigher RAM - 4GB ormoreFree space on Hard Disk -3GB or more. Monitor -640 x 480 pixel or moreBluetooth - Bluetooth 2.1+EDR Printer - Laser(colour/BW) Printingpaper: A4, LetterInterpretation Algorithm:Glasgow algorithmAdditional applications -Email application whichsupports the EML format(only required for theemail File	MESI mTABLET UNITWidth: 199 mm (7,83inches), Depth: 278mm(10,95 inches), Height:53mm (2,08 inches),Weight: 757gramsMESI mTABLET WI-FIDOCKING UNITWidth: 176 mm (6,93inches),Depth: 126 mm (4,96inches), Height: 40 mm(1,57inches), Weight:717gramsMESI TUBELESS CUFFUNIT (4x):Width: 40 mm (1.57inches)Depth: 40 mm (1.57 inches)Height: 150 mm (5.91inches)Weight: 286 g	MESI mTABLETUNITWidth: 199 mm (7,83inches), Depth:278mm (10.95 inches),Height: 53mm (2,08inches), Weight:757gramsMESI mTABLET WI-FI DOCKING UNITWidth: 176 mm (6,93inches),Depth: 126 mm (4,96inches), Height: 40mm (1,57inches),Weight: 717gramsMESI ECG UNIT:Width: 40 mm (1.57inches)Depth: 40 mm (1.57inches)Height: 125 mm (5.31	MESI mTABLETdimensionsIDENTICAL TO THEMESI mTABLET ABIDimensionaldifferences betweenMESI TUBELESSCUFF UNIT and MESIECGUNIT due to internalhardware differencesare insignificant
		Upload feature)It prints out in thefollowing formats:standard or Cabrera 3,3+1,3+3, 6 or 12 channel inautomatic mode,and 3, 6 or 12 printoutchannels of the rhythmstrip.	MESI LARGECHARGING PLATEUNIT:Width: 400 mm (15.75inches),Depth: 200 mm (7.87inches),Height: 38 mm (1.49inches),Weight: 675 grams	inches)Weight: 220 gMESI LARGECHARGING PLATEUNIT:Width: 400 mm (15.75inches),Depth: 200 mm (7.87inches),Height: 38 mm (1.49inches),Weight: 675 grams
Power Supply	2x AAA standard 1,5 Vbatteries	Intrinsic to add on system	MESI mTABLET UNITAC/DC adaptor:FW8030M/05(FRIWO)Input: 100-240 V~; 50-60 HzOutput: 5 Vdc; 5000 mABattery type:RechargeableLithium-Polymer battery(LP6058110)Capacity: 8800 mAh,Battery operation: more than 8 hoursMESI TUBELESS CUFF UNITBattery type: Rechargeable Lithium-Polymer battery,Capacity: 1240 mAhExaminations per battery charge: >Power Supply2x AAA standard 1,5 V batteriesIntrinsic to add on systemMESI mTABLET UNIT	MESI mTABLET UNITAC/DC adaptor:FW8030M/05(FRIWO)Input: 100-240 V~; 50-60 HzOutput: 5 Vdc; 5000 mA Battery type:RechargeableLithium-Polymer battery(LP6058110)Capacity: 8800 mAh,Battery operation: more than 8 hoursMESI ECG UNITBattery type:RechargeableLithium-Polymerbattery, Capacity:1240 mAhExaminations perbattery charge: > 2000Charge time fordepleted battery:approximately 2 hours(minimum charge timefor 1 automatic modeECG: 10 minutes)MESI LARGECHARGING PLATEUNITAC/DC adaptor:FW8030M/05	IDENTICAL TO THEMESI mTABLET ABI
Display	LCD color touch screen	various	AC/DC adaptor:FW8030M/05(FRIWO) Input:100-240 V~; 50-60 HzOutput: 5 Vdc; 5000 mABattery type:RechargeableLithium- Polymerbattery(LP6058110) Capacity:8800 mAh, Battery operation:more than 8 hoursMESI TUBELESS CUFFUNITBattery type: RechargeableLithium-Polymer battery,Capacity: 1240 mAhExaminations per batterycharge: > MESI mTABLETUNITAC/DC adaptor:FW8030M/05(FRIWO) Input:100-240 V~; 50-60 HzOutput: 5 Vdc; 5000 mABattery type:RechargeableLithium-Polymerbattery(LP6058110)Capacity: 8800 mAh, Batteryoperation: more than 8 hoursMESI ECG UNITBattery type: RechargeableLithium-Polymer battery,Capacity: 1240 mAhIDENTICAL TO THE MESImTABLET ABI	(FRIWO FOX30-XM)Input: 100-240 V~; 50-60 HzOutput: 5 Vdc / 5000mA	IDENTICAL TO THEMESI mTABLET ABI
			10,1" color IPS screen with1280x800 resolution	10,1" color IPS screenwith 1280x800resolution
Applied partsin contactwith thepatient	Disposable electrodes,clamps	NONE	2x tubeless arm cuffs 2xankle cuffs	Disposable electrodes	The user supplies thedisposable electrodes
Materials incontact withthe patient	Not specified	NONE	ARM CUFFS:TPU coated PU leather –outside layerNylex based PU leather -inside layerTPU bladder	Requires user tosupply disposableelectrodes: Adhesive:Medical gradepressure sensitiveadhesive Foam:	MESI mTABLET ECGusesdisposable electrodes,which meet ISO10993-1. Not suppliedby MESI.
				cell; Connector:stainless steel
BenchTesting	Applied parts: CFRF emissions: Group 2,Class BCompliant withstandards: EC 60601-1IEC 60601-1-2IEC 60601-2-25ETSI EN 300 328ETSI EN 301 489 -1ETSI EN 301 489 -17ETSI EN 300 440 -2FCC CFR47 Part 15 (US)	Defibrillation ProtectionOverload ToleranceRequirements formplitude measurementsInterval MeasurementsRequirements for intervalmeasurements onbiological ECGsIndication of InoperableECG LeadsMinimum LeadConfiguration WilsonLeadsInput ImpedanceRequired GainsCommon Mode RejectionLine Filter ResponseNoise LevelChannel CrosstalkHigh FrequencyResponse LowFrequency ResponseLinearity and DynamicRange Sampling andAmplitude QuantizationRecord IdentificationPatient IdentificationRecording SpeedTime and AmplitudeRuling Use with CardiacPacemakers	Type of protection againstelectric shock: Class IIApplied parts: BFSoftWare classification:Class B RF emissions:Group 1, Class BCompliant with standards:EN 60601-1:2006/A1:2013EN 60601-1-2:2015EN 60601-1-6:2010/A1:2015 EN80601-2-30:2010EN ISO 15223-1:2016EN 303 446-1:2017EN 62366:2008EN 62304:2006/A1:2015EN ISO 10993-1:2009/AC:2010 EN ISO14971:2012 IEEE/ANSIC63.27-2017	Type of protectionagainst electric shock:Class II Applied parts:CFSoftWareclassification: Class BRF emissions: Group 1,Class BCompliant withstandards: EN 60601-1:2006/A1:2013 EN60601-1-6:2010/A1:2015 EN60601-2-25:2015EN62304:2006/A1:2015EN 62366:2008EN 60601-1-2:2015EN ISO 15223-1:2016EN1064:2005/A1:2007EN 303 446-1:2017EN ISO 14971:2012EN ISO 10993-1:2009/AC:2010IEEE/ANSI C63.27-2017	MESI mTABLET ECGmeets more ECGstandards and betterRF emissoncompliance thanCardioline HD+.EMC and safety testreports are available inthe Section 17 - BenchTesting. Test reports:T223-0126-20 60601-1T251-0146-20 60601-1-2T223-0127-20_60601-1-6T223-0122-20 60601-2- 25F2P27871A-03E
Temperatureand humidityrange	Working environment:Temperature between+10 and+40 °C inclusive,Relative humiditybetween 25 and 95% inclusive (withoutcondensation),Atmospheric pressurebetween 700 and 1060mbarTransport and storageenvironment:		Working environment:10° to 40°C,relative air humidity: 25 to85%Transport and storageenvironment:	Working environment:10° to 40°C,relative air humidity:25 to 85%Transport and storageenvironment:-15° to 50°C (<1month) /	IDENTICAL TO THEMESI mTABLET ABI
	Temperature between -10e +40°C inclusiveRelative humiditybetween 25 and 95% inclusive (withoutcondensation)Atmospheric pressurebetween 500 and 1060mbar inclusive	Adults	-15° to 40°C (<3 month) /-15° to 25°C (<12 month)Relativehumidity: 25 to 85% (nocondensation)IP42 protection	-15° to 40°C (<3month) /-15° to 25°C (<12month)Relative humidity: 25to 85% (nocondensation)IP44 protection	IDENTICAL TO THECARDIOLINE HD+
Targetpopulation	Adults and pediatricpatients	Adult	Adult	Adults and pediatricpatients	IDENTICAL TO THECARDIOLINE HD+
Where used	Clinical environment	Clinical environment	Clinical environment	Clinical environment	IDENTICAL
Leadsconnector	Single connector	Not applicable	/	Single connector	IDENTICAL TO THECARDIOLINE HD+
A/Dconversion	24 bit	/	/	24 bit	IDENTICAL TO THECARDIOLINE HD+
Dataresolution	20 bit, < 1uV/LSB	/	/	19 bit, 2,5 uV	MESI data resolution isslightly lower thanCardioline HD+ butboth devices are highresolution ECGs andthe MESI differencedoes not affect signalinterpretaion.
Defibrilatorprotection	AAMI/IEC Standards	/	/	AAMI/IEC Standards	IDENTICAL TO THECARDIOLINE HD+
Pacemakerdetection	Hardware detectioncoupled withconvolution digitalfiltering	/	/	Hardware detectioncoupled withconvolution digitalfiltering (+/- 2 mV, 0,1ms)	IDENTICAL TO THECARDIOLINE HD+
Wirelesssystem	Bluetooth 2.1 + EDR	/	Bluetooth 2.1 + EDR	Bluetooth 2.1 + EDR	IDENTICAL
Patient cable	10 wire single connector	/	/	10 wire singleconnector	IDENTICAL TO THECARDIOLINE HD+
IP degree	IP 40 / IP 42 with siliconcover	/	IP 42	IP 44	MESI MTABLET ECGhashigher IP degree thanboth predicate devices
ECGInterpretation	/	Glasgow Algorithm	/	Glasgow Algorithm	Same as theCARDIOLINETOUCHECG

Comparison of Technological Characteristics with Predicate and Reference Device

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SUMMARY OF NON-CLINICAL TESTING:

In addition to conformance with requirements for software as recommended in the 2005 FDA guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, the following testing demonstrated conformity to appropriate safety and performance testing including cybersecurity.

IEC 60601-2-25- Medical electrical equipment – Particular requirements for the basicsafety and essential performance of electrocardiographs
IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basicsafety and essential performance
IEC 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for basicsafetyand essential performance – Collateral Standard: Electromagnetic disturbances –Requirements and tests
IEC 60601-1-6 Medical electrical equipment – Part 1-6: General requirements forbasic safety and essential performance – Collateral standard: Usability
EN 303 446-1 ElectroMagnetic Compatibility (EMC)standard for combined and/or integrated radio and non-radio equipment; Part 1:Requirements for equipment intended to be used in residential, commercial and lightindustry locations
Wireless Coexistence Risk Analysis
IEEE/ANSI C63.27-2017 American National Standard for Evaluation of WirelessCoexistence+ FDA Guidance documents
IEEE/ANSI C63.27-2017
ANSI/AAMI EC53:2013 ECG trunk cables and patient leadwires

No clinical data is required to determine substantial equivalence.

CONCLUSION:

The MESI mTABLET ECG has a similar indication for use and intended use as the predicate device Cardioline HD+ (K150289). Both devices use a Bluetooth communication to transfer the acquired cardiac data from the ECG unit to another device where the waveforms are displayed. The only difference is in a few non-significant technical details the Cardioline HD+ (K150289) uses another type of electrodes - clamps - MESI mTABLET ECG only uses disposable electrodes. In addition, the MESI mTABLET ECG is equivalent to the "touchECG" that is intended to be used in conjunction with CARDIOLINE HD+ device (K150289) that acquires the ECG signal and transmits it. The "touchECG is a software medical device provided on a CD support. The touch ECG employs the Glasgow Algorithm for interpretation. The MESI mTABLET ECG is intended for spot-checking use.

The MESI mTABLET ECG uses the same tablet device and charging plate as the predicate device MESI mTABLET ABI (K201046), also manufactured by MESI D.O.O. Consequently, the MESI mTABLET ECG uses the same hardware and software for Wireless connection and the same charging equipment. Analysis of similarities and differences has shown that differences between the products do not introduce new or significant risks.

21 CFR 807.92: The conclusions drawn from the nonclinical tests demonstrate that the subject device is substantially equivalent to the predicate devices, and performs as well as or better than the legally marketed device identified.

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).