The ABPI MD system is indicated for use on adult subjects at risk of having or developing peripheral arterial disease (PAD). The ABPI MD system is intended for the rapid measurement of ankle-brachial pressure index (ABPI), or ankle-brachial index (ABI) and pulse volume recording (PVR)/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. ABPI MD system can be used on patients with unilateral lower limb amputation.

The ABPI MD system is intended to be used to spot-check patients. The ABPI MD system 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

The ABPI MD system, is an automated ankle brachial pressure index measuring device, the system includes the following components:

-ABPI measuring unit
-Arm cuff size M
-Left ankle cuff size M
-Right ankle cuff size M
-AC/DC power supply
Tubes -
-USB cable
-Instructions for use, Installation and User guide, Certificate of Calibration, Certificate of Conformity and Warranty
Software installed on a computer -

It is intended to measure a patient's Ankle Brachial Pressure Index (ABPI) and Ankle Brachial Index (ABI) and provides Pulse Volume Recording (PVR) / volume plethysmography. This is done through an automated process. The operator places the three color coded cuffs on the right or left arm, and on each ankle as described in the instructions for use, and connects to the device. When connected, the operator clicks start button to begin measurement. The device will then automatically control the inflation of the cuffs and monitor variations in individual pressures to determine values to be used for the calculation of the ABI values for the both left and right of the patient.

AI/ML Overview

The provided text describes the MESI ABPI MD device, an automated ankle-brachial index measuring device, and its substantial equivalence to a predicate device, the TM-ABI System. However, the document does not contain an independent clinical study that directly proves the ABPI MD device meets specific acceptance criteria in terms of accuracy or performance metrics beyond those stated for the predicate device.

Instead, the submission relies on the assertion of identicality to the predicate device, TM-ABI, for which the original testing results are then applied. The core argument for the ABPI MD meeting acceptance criteria is that it is essentially the same device (manufactured by the same OEM) as the already cleared TM-ABI.

Here's the information extracted and organized based on your request, with the caveat that the "study that proves the device meets the acceptance criteria" refers to the predicate device's performance, as the ABPI MD itself did not undergo separate performance studies for this 510(k) submission.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (from Predicate Device)	Reported Device Performance (ABPI MD claims identicality to Predicate)
Ankle brachial pressure index: ± 0.1	Ankle brachial pressure index: ± 0.1
Diastolic pressure range: 40 to 180 mmHg	Diastolic pressure range: 40 to 180 mmHg
Systolic pressure range: 39 to 242 mmHg	Systolic pressure range: 39 to 242 mmHg
ABI results: Coefficient of correlation (r) with the standard Doppler probe method = 0.88	ABI results: Coefficient of correlation (r) with the standard Doppler probe method = 0.88
Electrical safety (IEC 60601-1, 60601-1-2, 80601-2-30)	Compliant with standards: 60601-1, 60601-1-2, 80601-2-30
Biocompatibility (ISO 10993-1)	Biocompatibility testing performed in accordance to ISO 10993-1
Software verification and validation	Software verification and validation testing conducted and documentation provided

2. Sample Size Used for the Test Set and Data Provenance

The document states, "The same testing and validation performed to qualify the TM-ABI is the testing for the ABPI MD." Therefore, information regarding the specific sample size, country of origin, and retrospective/prospective nature of the data for these performance metrics would come from the original 510(k) submission for the TM-ABI System (K143152). This information is not provided in the current document (K172655).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not provided in the current document (K172655). It would be found in the original 510(k) submission for the predicate device (TM-ABI System).

4. Adjudication Method for the Test Set

This information is not provided in the current document (K172655). It would be found in the original 510(k) submission for the predicate device (TM-ABI System).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

An MRMC study is typically for evaluating devices involving human interpretation of medical images or data. The ABPI MD (and its predicate) is an automated measuring device that produces numerical values (ABI, pressures). Therefore, an MRMC comparative effectiveness study in the traditional sense, comparing human readers with and without AI assistance, is not applicable to this type of device. The comparison is between the automated device and a gold standard measurement method (like a standard Doppler probe method, as indicated by the correlation coefficient).

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the device (ABPI MD, and by extension, its predicate TM-ABI) is described as an "automated ankle brachial pressure index measuring device." This strongly implies that its performance metrics (like the ABI results and correlation with Doppler) are based on the standalone performance of the algorithm/device itself in comparison to a reference standard, without human-in-the-loop assistance influencing the measurement outcome.

7. The Type of Ground Truth Used

The ground truth for evaluating the accuracy of the ABI measurement is indicated by the "Coefficient of correlation r with the standard Doppler probe method." This suggests that the standard Doppler probe method was used as the reference or "ground truth" to which the automated device's measurements were compared.

8. The Sample Size for the Training Set

The document states that the ABPI MD is "identical to the predicate device" and that the "same test results apply to both devices" because MESI, d.o.o. is the OEM for both. This implies that the ABPI MD did not undergo a separate training process or study. Information regarding any training set used for the predicate device's development is not provided in the current document (K172655).

9. How the Ground Truth for the Training Set Was Established

Similar to point 8, this information is not provided in the current document (K172655). It would pertain to the development of the predicate device (TM-ABI System).

Summary

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January 11, 2018

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

Re: K172655

Trade/Device Name: ABPI MD Regulation Number: 21 CFR 870.2780 Regulation Name: Hydraulic, Pneumatic, Or Photoelectric Plethysmographs Regulatory Class: Class II Product Code: JOM Dated: December 6, 2017 Received: December 6, 2017

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. 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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Page 2 - Elaine Duncan

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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

M. A. Hillemann

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K172655

Device Name

ABPI MD, Automated ankle-brachial index measuring device

Indications for Use (Describe)

The ABPI MD system is indicated for use on adult subjects at risk of having or developing peripheral arterial disease (PAD).

The ABPI MD system is intended for the rapid measurement of ankle-brachial pressure index (ABP), or ankle-brachial index (ABI) and pulse volume recording (PVR)/volume plethysmography in adults.

It is suitable for use in wound care 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,

The ABPI MD system can be used on patients with unilateral lower limb amputation.

The ABPI MD system is intended to be used to spot-check patients.

The ABPI MD system provides information regarding patient risk.

The physician has the responsibility of making proper judgements based on this information.

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

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) SUMMARY - K172655

SUBMITTER:

Submitted on behalf of:

Company Name:Address:	MESI, development of medical devices, Ltd.Letaliska cesta 3C1000 LjubljanaSlovenia, Europe
Telephone:Fax:	+386 1 620 34 87+386 8 2015 31 95
by:	Elaine Duncan, M.S.M.E., RACPresident, Paladin Medical, Inc.PO Box 560Stillwater, MN 55082
Telephone:Fax:	715-549-6035715-549-5380
CONTACT PERSON:	Elaine Duncan
DATE PREPARED:	September 1, 2017
TRADE NAME:	ABPI MD
COMMON NAME:	Automated ankle-brachial pressure indexmeasuring device
CLASSIFICATION NAME:	21 CFR 870.2780Hydraulic, Pneumatic, or PhotoelectricPlethysmographs
PRO CODE:	JOM
SUBSTANTIALLY EQUIVALENT TO: K143152 TM-ABI System

ﺍﻹﻟﻜﺎ C Cleared July 22, 2015

DESCRIPTION of the DEVICE:

The ABPI MD system, is an automated ankle brachial pressure index measuring device, the system includes the following components:

-ABPI measuring unit
-Arm cuff size M
-Left ankle cuff size M
-Right ankle cuff size M
-AC/DC power supply
Tubes -
-USB cable

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510(k) Summary-Continued K172655

-Instructions for use, Installation and User guide, Certificate of Calibration, Certificate of Conformity and Warranty
Software installed on a computer -

INDICATIONS FOR USE:

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: TM-ABI System has same indication for use, intended use, same technology (oscillometric method), and same performances and effectiveness as the ABPI MD System (device under submission).

Differences

The only difference between the two devices is labeling (trade name, manufacturer's name and logo).

For purpose of this submission. ABPI MD was compared to TM-ABI (predicate device). A detailed comparison is given in the Table of Substantial Equivalence Determination for ABPI MD and TM ABI predicate device below.

Substantial Equivalence Determination Table
Device	TM-ABI system (predicatedevice)	ABPI MD (Device undersubmission)	Equivalence offeatures &characteristics
510(k) Number	K143152	TBD
Indications forUse / Intendeduse	TM-ABI system is indicated foruse on adult subjects at risk ofhaving or developing peripheralarterial disease (PAD).TM-ABI system is intended forthe rapid measurement ofankle-brachial pressure index(ABPI) or ankle-brachial index	ABPI MD system is indicated foruse on adult subjects at risk ofhaving or developing peripheralarterial disease (PAD).ABPI MD system is intended forthe rapid measurement ofankle-brachial pressure index(ABPI) or ankle-brachial index	Identical

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Substantial Equivalence Determination Table
Device	TM-ABI system (predicatedevice)	ABPI MD (Device undersubmission)	Equivalence offeatures &characteristics
	(ABI), and pulse volumerecording (PVR) / volumeplethysmography in adults.It is suitable for use in woundcare assessment, forassessing symptomatic PAD,and as a screening device forPADIt may also be used on patientswith venous or arterial ulcersprior to application ofcompression therapy. TM-ABIsystem can be used onpatients with unilateral lowerlimb amputation.The TM-ABI system is intendedto be used to spot-checkpatients.The TM-ABI system providesinformation regarding patientrisk.The physician has theresponsibility of making properjudgments based on thisinformation.Prescription Use: Federal lawrestricts the use of this deviceto sale by or on the order of aphysician.	(ABI), and pulse volumerecording (PVR) / volumeplethysmography in adults.It is suitable for use in woundcare assessment, for assessingsymptomatic PAD, and as ascreening device for PAD.It may also be used on patientswith venous or arterial ulcersprior to application ofcompression therapy. ABPI MDcan be used on patients withunilateral lower limb amputation.The ABPI MD system isintended to be used to spot-check patients.The ABPI MD system providesinformation regarding patientrisk.The physician has theresponsibility of making properjudgments based on thisinformation.Prescription Use: Federal lawrestricts the use of this device tosale by or on the order of aphysician.
Dimensions /weight	Width: 250 mm, Height: 730mm, Depth: 200 mm, Weight:0.60 kg	Width: 250 mm, Height: 730mm, Depth: 200 mm, Weight:0.60 kg	Identical
Power Supply	Output: 5V DC/3.0A. Batterytype: rechargeable lithiumpolymerAC/DC converter 5V.Capacity: 2,300mAh, numberof measurements per charge:30	Output: 5V DC/3.0A. Batterytype: rechargeable lithiumpolymerAC/DC converter 5V .Capacity: 2,300mAh, number ofmeasurements per charge: 30	Identical
Display	4,3" color LCD screen with 16-bit color depth resolution: 480 x272 pixels	4,3" color LCD screen with 16-bit color depth resolution: 480 x272 pixels	Identical
Applied parts incontact with thepatient	3 cuffs, tubes and bladders	3 cuffs, tubes and bladders	Identical
Materials	ABS plastic (Device Housing),Silicon (Tubes),PU bladder, Nylon-Cottonprotecting layer (Pressurecuffs)	ABS plastic (Device Housing),Silicon (Tubes),PU bladder, Nylon-Cottonprotecting layer (Pressurecuffs)	Identical

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Substantial Equivalence Determination Table
Device	TM-ABI system (predicatedevice)	ABPI MD (Device undersubmission)	Equivalence offeatures &characteristics
Testing Bench	Type of protection aqainstelectric shock:Class II. BFCompliant with standards:60601-1,60601-1-280601-2-30.	Type of protection againstelectric shock:Class II. BFCompliant with standards:60601-1,60601-1-280601-2-30.	Identical
Measurementtypes	Right and left Ankle brachialpressure index :Left ABI = Left ankle pressureArm pressureRight ABI = Right anklepressureArm pressure	Right and left Ankle brachialpressure index :Left ABI = Left ankle pressureArm pressureRight ABI = Right anklepressureArm pressure	Identical
Measurementranges	Pressures range :Diastolic 40 to 180mmHgSystolic 39 to 242 mmHg	Pressures range :Diastolic 40 to 180mmHgSystolic 39 to 242 mmHg	Identical
Limit values ofmeasurementerrors	Ankle brachial pressure index:± 0.1	Ankle brachial pressure index: ±0.1	Identical
Cuffs inflationanddeflation	Automatic inflation using an airpump and deflation using anelectromagnetic valve.	Automatic inflation using an airpump and deflation using anelectromagnetic valve.	Identical
Pulse Volume /Plethysmography	Pneumo-plethysmographymethod using the cuffsmeasuring the blood pressurevalues : Plethysmographydisplayed at the inflammationand deflation pressure	Pneumo-plethysmographymethod using the cuffsmeasuring the blood pressurevalues : Plethysmographydisplayed at the inflammationand deflation pressure	Identical
Temperature andhumidity range	Working environment: 10 to40°C, 30 to 85% relative airhumidity, IPX0 protection,transport and storage: 0 to60°C, up to 85% relative airhumidity.	Working environment: 10 to40°C, 30 to 85% relative airhumidity, IPX0 protection,transport and storage: 0 to60°C, up to 85% relative airhumidity.	Identical
Targetpopulation	Adult	Adult	Identical
Where used	Clinical environment	Clinical environment	Identical
PC Datatransmission	USB	USB	Identical
ABI results:Coefficient ofcorrelation r withthestandard Dopplerprobe method	r= 0.88	r= 0.88	Identical

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SUMMARY of TESTING:

The same testing and validation performed to qualify the TM-ABI is the testing for the ABPI MD, which includes:

Biocompatibility testing was performed in accordance to ISO 10993-1 "Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing.'

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."

Electrical Standard tests were performed to evaluate its electromagnetic compatibility (EMC). Device was tested according to standards IEC 60601-1-2:2007 Medical Electrical Equipment - Part 1: General Requirements for Safety: Electromagnetic Compatibility -Requirements and Test.

CONCLUSION:

The ABPI MD by MESI, Ltd. is identical to the predicate device. The ABPI MD device has the same indication for use, intended use as the TM-ABI predicate device, the same materials and technology as the predicate device, and utilizes the same manufacturing processes as the predicate device. The same test results apply to both devices, because MESI, d.o.o. is Original Equipment Manufacturer (OEM) of the predicate device (TM-ABI system) and manufacturer of the ABPI MD. The only difference between the TM-ABI predicate device and ABPI MD device is labeling of the device and distributor's name and logo.

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).