It is suitable for use in wound care assessment, for assessing symptomatic PAD, and as a screening device for PAD. It may also be used on patients with venous or arterial ulcers prior to application of compression therapy.

MESI mTABLET ABI can be used on patients with unilateral lower limb amputation. The MESI mTABLET ABI is intended to be used to spot-check patients.

The MESI mTABLET ABI provides information regarding patient risk.

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

MESI mTABLET ABI is a medical device comprised out of three parts. Diagnostic modules with a tubeless cuff (ABISYS) that is attached to a patient upper arms and ankles, a medical grade tablet used to display the measurement (MTABSYSW) and a charging station (CS4SYS). It is used in a professional clinical environment by trained medical experts for diaqnostic and screening purposes.

MESI mTABLET ABI is a device used for screening of Peripheral Arterial Disease (PAD). The measurement is performed non-invasively by measuring blood pressure in the brachial artery and pressures in the foot arteries (dorsalis pedis and the posterior tibial artery). After the blood pressures have been measured the MESI mTABLET ABI calculates the ration between higher of the two arm values and both ankles.

AI/ML Overview

The provided text is a 510(k) summary for the MESI mTABLET ABI, an automated ankle-brachial pressure index measuring device. This document focuses on demonstrating substantial equivalence to a predicate device (ABPI MD) and includes information about the device's design, intended use, and general testing compliance, rather than detailed performance study results that would typically include specific acceptance criteria and their outcome.

Therefore, I cannot provide a table of acceptance criteria and reported device performance directly from this document. The document states that the new device has "same performances and effectiveness" as the predicate device and that the "ABI results: Coefficient of correlation r with the standard Doppler probe method" for both the predicate and the new device is "r= 0.88". This is the closest the document comes to a performance metric, but it is presented as a characteristic shared with the predicate rather than an acceptance criterion for the new device's performance study.

Based on the provided text, here's what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance (from Predicate Device comparison)
ABI results: Coefficient of correlation 'r' with the standard Doppler probe method	r = 0.88
Limit values of measurement errors (for ABPI)	Within ± 0.1

Note: These are presented as characteristics shared with the predicate device, implying they are met by the new device. The document does not detail specific performance study acceptance criteria for the MESI mTABLET ABI itself beyond asserting "same performances and effectiveness" as the predicate.

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

Sample Size: Not specified in the provided text for any performance studies.
Data Provenance: Not specified. The document describes a comparison to a predicate device and general testing (biocompatibility, software, electrical, EMC, usability), but not a specific clinical test set for performance evaluation.

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

Not specified. The document states the device provides "information regarding patient risk" and "The physician has the responsibility of making proper judgments based on this information." This implies human expert involvement in diagnosis and judgment, but not their role in establishing ground truth for a test set for the device's performance validation.

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

Not specified.

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 specified. The device is for automated measurement of ABI and plethysmography, not an AI-assisted diagnostic imaging tool that would typically involve human readers.

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

The device is described as an "Automated ankle-brachial pressure index measuring device." This inherently suggests standalone algorithm performance for the measurement aspect. However, no specific standalone performance study details (metrics, results, methodology) are provided beyond the stated correlation and error limits.

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

The document mentions "Coefficient of correlation r with the standard Doppler probe method." This strongly suggests the Doppler probe method is considered the "ground truth" or reference standard against which the device's measurements are compared.

8. The sample size for the training set:

Not specified. This document is a 510(k) summary for a measurement device, not an AI/Machine Learning model that would typically have a "training set."

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

Not applicable as this is not an AI/ML device in the context of a training set. If considering "ground truth" for the device's development and calibration, it would likely be established through comparison to established, accurate methods like the Doppler probe.

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".

December 11, 2020

Mesi D.O.O. Elaine Duncan President Paladin Medical, Inc. P.O. Box 560 Stillwater, Minnesota 55082

Re: K201046

Trade/Device Name: Automated ankle brachial pressure index measuring device, MESI mTABLET system Regulation Number: 21 CFR 870.2780 Regulation Name: Hydraulic, Pneumatic, Or Photoelectric Plethysmographs Regulatory Class: Class II Product Code: JOM Dated: April 20, 2020 Received: April 21, 2020

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,

LT Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics, and Monitoring 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)

K201046

Device Name

MESI mTABLET ABI, Automated Wireless ABI system

Indications for Use (Describe)

The MESI mTABLET ABI is indicated for use on adult subjects at risk of having or developing peripheral arterial disease (PAD).

MESI mTABLET ABI is intended for the rapid measurement of ankle-brachial pressure index (AB) and pulse volume plethysmography in adults.

MESI mTABLET ABI can be used on patients with unilateral lower limb amputation. The MESI mTABLET ABI is intended to be used to spot-check patients.

The MESI mTABLET ABI provides information regarding patient risk.

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.

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

K201046

SUBMITTER on behalf of	MESI D.O.O
Address:	Leskoskova cesta 11A1000 LjubijanaSlovenia, Europe
Telephone:	+386 1 620 34 87
Fax:	+386 8 2015 31 95
by:	Paladin Medical, Inc.PO Box 560Stillwater, MN 55082
Telephone:	715-549-6035
CONTACT PERSON:	Elaine Duncan, M.S.M.E., RAC, FAIMBE
DATE PREPARED:	December 12, 2020
TRADE NAME:	MESI mTABLET ABI
COMMON NAME:	Automated ankle-brachial pressure indexmeasuring device
CLASSIFICATION NAME:	Hydraulic, Pneumatic, or PhotoelectricPlethysmographs
Regulation	870.2780
CLASSIFICATION	Class II
PRO CODE:	JOM

SUMMARY of SUBSTANTIALLY EQUIVALENCE TO: ABPI MD, K172655 The MESI mTABLET ABI has the same indication for use and intended use as the ABPI MD predicate device, also manufactured by MESI D.O.O. Analysis of similarities and differences has shown that differences between the two products, primarily as a result of the use of the mTABLET and transmission of data to the tablet from the ABI cuffs, do not introduce new risks.

DESCRIPTION of the DEVICE: MESI mTABLET ABI is a medical device comprised out of three parts. Diagnostic modules with a tubeless cuff (ABISYS) that is attached to a patient upper arms and ankles, a medical grade tablet used to display the measurement (MTABSYSW) and a charging station (CS4SYS). It is used in a professional clinical environment by trained medical experts for diaqnostic and screening purposes.

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INDICATIONS FOR USE:

The MESI mTABLET ABI is indicated for use on adult subjects at risk of having or developing peripheral arterial disease (PAD). MESI mTABLET ABI is intended for the rapid measurement of ankle-brachial pressure index (ABI) and pulse volume plethysmography in adults. It is suitable for use in wound care assessment, for assessing symptomatic PAD, and as a screening device for PAD. It may also be used on patients with venous or arterial ulcers prior to application of compression therapy. MESI mTABLET ABI can be used on patients with unilateral lower limb amputation.

The MESI mTABLET ABI is intended to be used to spot-check patients.

The MESI mTABLET ABI provides information regarding patient risk.

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

BASIS OF SUBSTANTIAL EQUIVALENCE

The predicate a legally marketed device: ABPI MD has same indication for use, intended use, same technology (oscillometric method), and same performances and effectiveness as the MESI mTABLET ABI (device under submission).

Differences

The only differences between the two devices is use of the mTABLET and transmission of data to the tablet from the ABI cuffs. There are now 4 ABI tubeless cuffs with different fabric covering.

	Substantial Equivalence Determination Table
Feature	ABPI MD	MESI mTABLET ABI	Analysis
510(k) Number	K172655	K201046
Manufacturer	MESI D.O.O.	MESI D.O.O.	same
Indications forUse / Intendeduse	ABPI MD system is indicated for use on adultsubjects at risk of having or developingperipheral arterial disease (PAD).ABPI MD system is intended for the rapidmeasurement of ankle-brachial pressure index(ABPI) or ankle-brachial index (ABI), and pulsevolume recording (PVR) / volumeplethysmography in adults.It is suitable for use in wound care assessment,for assessing symptomatic PAD, and as ascreening device for PAD. It may also be used onpatients with venous or arterial ulcers prior toapplication of compression therapy. ABPI MDcan be used on patients with unilateral lowerlimb amputation.The ABPI MD system is intended to be used tospot-check patients.The ABPI MD system provides informationregarding patient risk.The physician has the responsibility of makingproper judgments based on this information.Prescription Use: Federal law restricts the use ofthis device to sale by or on the order of aphysician.	The MESI mTABLET ABI is indicatedfor use on adult subjects at risk ofhaving or developing peripheralarterial disease (PAD).MESI mTABLET ABI is intended for therapid measurement of ankle-brachialpressure index (ABI) and pulse volumeplethysmography in adults.It is suitable for use in wound careassessment, for assessingsymptomatic PAD, and as a screeningdevice for PAD. It may also be used onpatients with venous or arterial ulcersprior to application of compressiontherapy.MESI mTABLET ABI can be used onpatients with unilateral lower limbamputation.The MESI mTABLET ABI is intended tobe used to spot-check patients.The MESI MTABLET ABI providesinformation regarding patient risk.The physician has the responsibility ofmaking proper judgments based onthis information.Prescription Use: Federal law restrictsthe use of this device to sale by or onthe order of a physician.	Identical
	Substantial Equivalence Determination Table
Feature	ABPI MD	MESI mTABLET ABI	Analysis
Dimensions /weight	Width: 250 mm, Height: 730 mm, Depth: 200mm, Weight: 0.60 kg	mTABLET UNITWidth: 199 mm (7,83 inches), Depth:278mm (10,95 inches), Height: 53mm(2,08 inches), Weight:757gramsmTABLET WI-FI DOCKING UNITWidth: 176 mm (6,93 inches), Depth:126 mm (4,96 inches), Height: 40 mm	NOTE 1
		(1,57inches), Weight: 717gramsTUBELESS CUFF UNIT (4x):Width: 40 mm (1.57 inches)Depth: 40 mm (1.57 inches)Height: 150 mm (5.91 inches) Weight:286 gLARGE CHARGING PLATE UNIT:Width: 400 mm (15.75 inches), Depth:200 mm (7.87 inches), Height: 38 mm(1.49 inches), Weight: 675 grams
Power Supply	Output: 5V DC/3.0A. Battery type: rechargeablelithium polymerAC/DC converter 5V.Capacity: 2,300mAh, number of measurementsper charge: 30	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, Batteryoperation: more than 8 hoursWIRELESS CUFF UNITBattery type: Rechargeable Lithium-Polymer battery, Capacity: 1240 mAhExaminations per battery charge: >200Charge time for depleted battery (foreach unit): approximately 1.5 hours(minimum charge time for 1 ABImeasurement, with all units on thecharging station : 10 minutes)LARGE CHARGING PLATE UNITAC/DC adaptor: FW8030M/05 (FRIWOFOX30-XM)Input: 100-240 V~; 50-60 HzOutput: 5 Vdc / 5000 mA	NOTE 2
Display	4,3" color LCD screen with 16-bit color depthresolution: 480 x 272 pixels	10,1" color IPS screen with 1280x800resolution	NOTE 3
Applied parts incontact with thepatient	3 cuffs, tubes and bladders	4x tubeless cuffs	NOTE 4
	Substantial Equivalence Determination Table
Feature	ABPI MD	MESI mTABLET ABI	Analysis
Materials incontact with thepatient	Silicon (Tubes),PU bladder, Nylon-Cotton protecting layer(Pressure cuffs)	TPU coated PU leather - outside layerNylex based PU leather - inside layerTPU bladder	NOTE 5
Testing bench	Type of protection against electric shock:Class II. BFCompliant with standards:60601-1,60601-1-280601-2-30.	See list below	equivalent
Measurementtypes	Right and left Ankle brachial pressure index :Left ABI =Left ankle pressureArm pressureRight ABI =Right ankle pressureArm pressure	Right and left Ankle brachial pressureindex :Left ABI =Left ankle pressureArm pressureRight ABI =Right ankle pressureArm pressure	Identical
Limit values ofmeasurementerrors	ABPI: Within ± 0.1	ABPI: Within ± 0.1	Identical
Cuffs inflationanddeflation	Automatic inflation using an air pump anddeflation using an electromagnetic valve.	Automatic inflation using an air pumpand deflation using anelectromagnetic valve.	Identical
Pulse Volume /Plethysmography	Pneumo-plethysmography method using thecuffs measuring the blood pressure values :Plethysmography displayed at the inflammationand deflation pressure	Pneumo-plethysmography methodusing the cuffs measuring the bloodpressure values: Plethysmographydisplayed at the inflammation anddeflation pressure.	Identical
Temperatureandhumidity range	Working environment: 10 to 40°C,30 to 85% relative air humidity,IPX0 protection,transport and storage: 0 to 60°C, up to 85%relative air humidity.	Working environment:10° to 40°C,relative air humidity: 25 to 85%IP42 protectionTransport and storage environment:-15° to 50°C (<1 month) / -15° to 40°C(<3 month) / -15° to 25°C (<12month) Relative humidity: 25 to 85%(no condensation)IP42 protection	NOTE 6
Targetpopulation	Adult	Adult	Identical
Where used	Clinical environment	Clinical environment	Identical
PC Datatransmission	USB	Cloud	NOTE 7
ABI results:Coefficient ofcorrelation r withthe standardDoppler probemethod	r= 0.88	r= 0.88	Identical

For purpose of this submission, MESI mTABLET ABI was compared to ABPI MD (predicate device), in the Table of Substantial Equivalence Determination.

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510(k) Summary-Continued

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NOTES to DIFFERENCES in COMPARATIVE ANALYSIS:

NOTE 1:

Predicate ABPI MD is all in one device system, with charging adaptor and cuffs connected to the main display unit. MESI mTABLET ABI is a system that uses a wireless connection between display unit (mTABLET UNIT) and TUBELESS CUFF UNITS (CUFFMD). The only dimension difference that would have a potential impact on the patient is the weight and size of the CUFFs. Since the patient is laying supine during testing, differences in cuff weights do not have an impact on patient comfort or usability.

NOTE 2:

MESI ABPIMD performs the ABI measurement only on battery power. The mTABLET UNIT uses a battery with bigger capacity (compared to predicate ABPI MD) which requires a different, more powerful power supply. WIRELESS CUFF UNITS are charged with a charging station with 4 charging ports (LARGE CHARGING PLATE UNIT). WIRELESS CUFF UNITS are charged all at once and require a more powerful power supply. The differences in power supply do not introduce new risks because the recharging of the batteries is not conducted while attached to the patient.

NOTE 3:

MESI mTABLET ABI system uses mTABLET UNIT as a display device whereas the predicate device display was incorporated into the main unit. mTABLET UNIT has a 10,1" touch-screen IPS screen which provides a better user experience and shows more details about measurements. The testing of the mTABLET has shown that this device is safe.

NOTE 4:

MESI mTABLET ABI has 4 cuffs instead of 3 cuffs as with the MESI ABPI. The one additional cuff provides users with the option to put all 4 cuffs on both legs and both arms at the same time. The MESI mTABLET ABI will perform simultaneous blood pressure measurement on both arms. The arm with the higher blood pressure is identified and used for the 3 cuff ABI measurement. The MESI ABPI MD has 3 cuffs which causes the users need to identify the arm with the higher blood pressure before performing the ABI measurement, or to perform the ABI measurement twice (once with each arm). Therefore, the system now provides 4 cuffs as a convenience to the user.

NOTE 5:

MESI mTABLET ABI system uses slightly different tubeless cuffs material compared to predicate ABPI MD. Biocompatibility testing shows there are no new risks from the different cuff material.

NOTE 6:

MESI mTABLET ABI is assembled of different components compared to predicate ABPI MD. This is the main reason why mTABLET ABI device has slightly different operating condition tolerances. The differences do not affect any risks.

NOTE 7:

Predicate device ABPI MD uses a USB connection to transfer measurement data to PC. MESI mTABLET ABI uses a Bluetooth connection to transfer measurement data from the WIRELESS CUFF UNIT to the mTABLET UNIT. Validation of performance has shown that this does not introduce new risks.

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SUMMARY of TESTING and QUALIFICATION:

All applied parts or parts of CUFFSYS that come in direct contact with the patient have passed biocompatibility testing according to EN ISO 10993-1 2009/AC:2010 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.

EN ISO 15223-1:2016- Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied

Software documentation and review has complied with the US FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices; and Content of Premarket Submissions for Management of Cybersecurity in Medical Devices Guidance for Industry and Food and Drug Administration Staff; in addition to

EN IEC 62366 2008 Medical device software - Software life cycle ISO 14971 2012 Medical devices - Application of risk management to medical devices IEC 62304 2006/A1:2015 Medical device software - Software life cycle Processes

The following standardized testing has been performed:

IEC 60601-1 v1 2006/A1:2013 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance

IEC 60601-1-2 v1-2 2015 Medical electrical equipment - Part 1 - 2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and test

IEC 60601-1-6 2010/A1:2015 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability

IEC 80601-2-30 2-30 2010 form basic safety and essential performance of automated non-invasive sphygmomanometers

EN 303 446-1 2017 ElectroMagnetic Compatibility (EMC) standard for combined and/or integrated radio and non-radio equipment

Wireless coexistence testing was performed per Tier 2 specifications of the ANSI/IEEE C63.27:2017 American National Standard for Evaluation of Wireless Coexistence.

Regulation Number and Section

§ 870.2780 Hydraulic, pneumatic, or photoelectric plethysmographs.

(a)
Identification. A hydraulic, pneumatic, or photoelectric plethysmograph is a device used to estimate blood flow in a region of the body using hydraulic, pneumatic, or photoelectric measurement techniques.(b)
Classification. Class II (performance standards).