(128 days)
Not Found
No
The summary describes an automated system for measuring ABPI and PVR using cuffs and pressure variations. There is no mention of AI, ML, or any related technologies in the device description, intended use, or performance studies. The software mentioned appears to be for controlling the automated process and calculating standard physiological indices, not for complex pattern recognition or learning.
No.
The device is intended for diagnosis and screening of PAD by measuring ABPI/ABI and PVR, not for direct treatment of a disease or condition.
Yes
The device 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 used for "wound care assessment, for assessing symptomatic PAD, and as a screening device for PAD," all of which are diagnostic purposes. The statement "The ABPI MD system provides information regarding patient risk" further supports its role in diagnostics.
No
The device description explicitly lists multiple hardware components including a measuring unit, cuffs, power supply, tubes, and a USB cable, in addition to software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The ABPI MD system measures physiological parameters (blood pressure and pulse volume) directly from the patient's body using cuffs. It does not analyze samples taken from the body.
- Intended Use: The intended use describes the measurement of ABPI/ABI and PVR/volume plethysmography, which are physical measurements, not laboratory tests on biological samples.
- Device Description: The description details the components and process of applying cuffs and measuring pressure and volume, which aligns with a non-IVD medical device.
Therefore, the ABPI MD system is a medical device used for physiological measurements, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
JOM
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
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ankle, brachial
Indicated Patient Age Range
adult subjects
Intended User / Care Setting
Physician / Clinical environment
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key results: ABI results: Coefficient of correlation r with the standard Doppler probe method r= 0.88.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
ABI results: Coefficient of correlation r with the standard Doppler probe method r= 0.88.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image shows 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, and then the word "ADMINISTRATION" in a smaller font size below that.
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);
1
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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
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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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
3
510(K) SUMMARY - K172655
SUBMITTER:
Submitted on behalf of:
| Company Name:
Address: | MESI, development of medical devices, Ltd.
Letaliska cesta 3C
1000 Ljubljana
Slovenia, Europe |
|----------------------------------------------------|--------------------------------------------------------------------------------------------------------|
| Telephone:
Fax: | +386 1 620 34 87
+386 8 2015 31 95 |
| by: | Elaine Duncan, M.S.M.E., RAC
President, Paladin Medical, Inc.
PO Box 560
Stillwater, MN 55082 |
| Telephone:
Fax: | 715-549-6035
715-549-5380 |
| CONTACT PERSON: | Elaine Duncan |
| DATE PREPARED: | September 1, 2017 |
| TRADE NAME: | ABPI MD |
| COMMON NAME: | Automated ankle-brachial pressure index
measuring device |
| CLASSIFICATION NAME: | 21 CFR 870.2780
Hydraulic, Pneumatic, or Photoelectric
Plethysmographs |
| 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
4
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 -
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.
INDICATIONS FOR USE:
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.
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 (predicate | ||||
| device) | ABPI MD (Device under | ||||
| submission) | Equivalence of | ||||
| features & | |||||
| characteristics | |||||
| 510(k) Number | K143152 | TBD | |||
| Indications for | |||||
| Use / Intended | |||||
| use | TM-ABI system is indicated for | ||||
| use on adult subjects at risk of | |||||
| having or developing peripheral | |||||
| arterial disease (PAD). | |||||
| TM-ABI system is intended for | |||||
| the rapid measurement of | |||||
| ankle-brachial pressure index | |||||
| (ABPI) or ankle-brachial index | ABPI MD system is indicated for | ||||
| use on adult subjects at risk of | |||||
| having or developing peripheral | |||||
| arterial disease (PAD). | |||||
| ABPI MD system is intended for | |||||
| the rapid measurement of | |||||
| ankle-brachial pressure index | |||||
| (ABPI) or ankle-brachial index | Identical |
5
| Substantial Equivalence Determination Table | |||
|---|---|---|---|
| Device | TM-ABI system (predicate | ||
| device) | ABPI MD (Device under | ||
| submission) | Equivalence of | ||
| features & | |||
| characteristics | |||
| (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. TM-ABI | |||
| system can be used on | |||
| patients with unilateral lower | |||
| limb amputation. | |||
| The TM-ABI system is intended | |||
| to be used to spot-check | |||
| patients. | |||
| The TM-ABI 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. | (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 | |||
| 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. | |||
| Dimensions / | |||
| weight | Width: 250 mm, Height: 730 | ||
| mm, Depth: 200 mm, Weight: | |||
| 0.60 kg | Width: 250 mm, Height: 730 | ||
| mm, Depth: 200 mm, Weight: | |||
| 0.60 kg | Identical | ||
| Power Supply | Output: 5V DC/3.0A. Battery | ||
| type: rechargeable lithium | |||
| polymer | |||
| AC/DC converter 5V. | |||
| Capacity: 2,300mAh, number | |||
| of measurements per charge: | |||
| 30 | Output: 5V DC/3.0A. Battery | ||
| type: rechargeable lithium | |||
| polymer | |||
| AC/DC converter 5V . | |||
| Capacity: 2,300mAh, number of | |||
| measurements per charge: 30 | Identical | ||
| Display | 4,3" color LCD screen with 16- | ||
| bit color depth resolution: 480 x | |||
| 272 pixels | 4,3" color LCD screen with 16- | ||
| bit color depth resolution: 480 x | |||
| 272 pixels | Identical | ||
| Applied parts in | |||
| contact with the | |||
| patient | 3 cuffs, tubes and bladders | 3 cuffs, tubes and bladders | Identical |
| Materials | ABS plastic (Device Housing), | ||
| Silicon (Tubes), | |||
| PU bladder, Nylon-Cotton | |||
| protecting layer (Pressure | |||
| cuffs) | ABS plastic (Device Housing), | ||
| Silicon (Tubes), | |||
| PU bladder, Nylon-Cotton | |||
| protecting layer (Pressure | |||
| cuffs) | Identical |
6
| Substantial Equivalence Determination Table | |||||
|---|---|---|---|---|---|
| Device | TM-ABI system (predicate | ||||
| device) | ABPI MD (Device under | ||||
| submission) | Equivalence of | ||||
| features & | |||||
| characteristics | |||||
| Testing Bench | Type of protection aqainst | ||||
| electric shock: | |||||
| Class II. BF | |||||
| Compliant with standards: | |||||
| 60601-1, | |||||
| 60601-1-2 | |||||
| 80601-2-30. | Type of protection against | ||||
| electric shock: | |||||
| Class II. BF | |||||
| Compliant with standards: | |||||
| 60601-1, | |||||
| 60601-1-2 | |||||
| 80601-2-30. | Identical | ||||
| Measurement | |||||
| types | Right and left Ankle brachial | ||||
| pressure index : | |||||
| Left ABI = Left ankle pressure | |||||
| Arm pressure | |||||
| Right ABI = Right ankle | |||||
| pressure | |||||
| Arm pressure | Right and left Ankle brachial | ||||
| pressure index : | |||||
| Left ABI = Left ankle pressure | |||||
| Arm pressure | |||||
| Right ABI = Right ankle | |||||
| pressure | |||||
| Arm pressure | Identical | ||||
| Measurement | |||||
| ranges | Pressures range : | ||||
| Diastolic 40 to 180mmHg | |||||
| Systolic 39 to 242 mmHg | Pressures range : | ||||
| Diastolic 40 to 180mmHg | |||||
| Systolic 39 to 242 mmHg | Identical | ||||
| Limit values of | |||||
| measurement | |||||
| errors | Ankle brachial pressure index: | ||||
| ± 0.1 | Ankle brachial pressure index: ± | ||||
| 0.1 | Identical | ||||
| Cuffs inflation | |||||
| and | |||||
| deflation | Automatic inflation using an air | ||||
| pump and deflation using an | |||||
| electromagnetic valve. | Automatic inflation using an air | ||||
| pump and deflation using an | |||||
| electromagnetic valve. | Identical | ||||
| Pulse Volume / | |||||
| Plethysmography | Pneumo-plethysmography | ||||
| method using the cuffs | |||||
| measuring the blood pressure | |||||
| values : Plethysmography | |||||
| displayed at the inflammation | |||||
| and deflation pressure | Pneumo-plethysmography | ||||
| method using the cuffs | |||||
| measuring the blood pressure | |||||
| values : Plethysmography | |||||
| displayed at the inflammation | |||||
| and deflation pressure | Identical | ||||
| Temperature and | |||||
| humidity 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, 30 to 85% relative air | |||||
| humidity, IPX0 protection, | |||||
| transport and storage: 0 to | |||||
| 60°C, up to 85% relative air | |||||
| humidity. | Identical | ||||
| Target | |||||
| population | Adult | Adult | Identical | ||
| Where used | Clinical environment | Clinical environment | Identical | ||
| PC Data | |||||
| transmission | USB | USB | Identical | ||
| ABI results: | |||||
| Coefficient of | |||||
| correlation r with | |||||
| the | |||||
| standard Doppler | |||||
| probe method | r= 0.88 | r= 0.88 | Identical |
7
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.