(234 days)
Not Found
No
The provided text does not mention AI, ML, or any related terms or concepts in the device description or intended use.
No.
The device is used for diagnostic and screening purposes (specifically for Peripheral Arterial Disease) and provides information regarding patient risk, rather than actively treating a condition.
Yes
The "Intended Use/Indications for Use" section states it is "indicated for use on adult subjects at risk of having or developing peripheral arterial disease (PAD)." It also says it is for "rapid measurement of ankle-brachial pressure index (AB) and pulse volume plethysmography in adults," and is "suitable for use in wound care assessment, for assessing symptomatic PAD, and as a screening device for PAD." The "Device Description" also explicitly states it is used "for diagnostic and screening purposes" and "for screening of Peripheral Arterial Disease (PAD)." These uses clearly indicate a diagnostic purpose.
No
The device description explicitly states it is comprised of three parts: diagnostic modules with a tubeless cuff, a medical grade tablet, and a charging station. These are hardware components, not just software.
Based on the provided information, the MESI mTABLET ABI 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.
- MESI mTABLET ABI Function: The MESI mTABLET ABI measures blood pressure in the brachial artery and foot arteries using non-invasive cuffs. It then calculates the ankle-brachial pressure index (ABI). This process does not involve analyzing samples taken from the body.
- Device Description: The description clearly states it's a medical device comprised of diagnostic modules with tubeless cuffs, a tablet, and a charging station. It measures blood pressure non-invasively.
Therefore, the MESI mTABLET ABI is a non-invasive medical device used for physiological measurements and calculations, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
JOM
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.
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
Intended User / Care Setting
professional clinical environment by trained medical experts
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 device underwent biocompatibility testing, software documentation review, and standardized testing according to various IEC and EN standards for electrical safety, electromagnetic compatibility, usability, and automated non-invasive sphygmomanometers. Wireless coexistence testing was performed per Tier 2 specifications of the ANSI/IEEE C63.27:2017.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
ABI results: Coefficient of correlation r with the standard Doppler probe method: r= 0.88
Limit values of measurement errors: ABPI: Within ± 0.1
Predicate Device(s)
ABPI MD, K172655
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). 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
1
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
2
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.
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.
| 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 11A |
| 1000 Ljubijana | |
| Slovenia, Europe | |
| Telephone: | +386 1 620 34 87 |
| Fax: | +386 8 2015 31 95 |
| by: | Paladin Medical, Inc. |
| PO Box 560 | |
| Stillwater, 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 index |
| measuring device | |
| CLASSIFICATION NAME: | Hydraulic, Pneumatic, or Photoelectric |
| Plethysmographs | |
| 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.
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.
4
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 for | |||
| Use / Intended | |||
| use | 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 (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. | 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. | Identical | ||
| Substantial Equivalence Determination Table | |||
| Feature | ABPI MD | MESI mTABLET ABI | Analysis |
| Dimensions / | |||
| weight | Width: 250 mm, Height: 730 mm, Depth: 200 | ||
| mm, Weight: 0.60 kg | mTABLET UNIT | ||
| Width: 199 mm (7,83 inches), Depth: | |||
| 278mm (10,95 inches), Height: 53mm | |||
| (2,08 inches), Weight:757grams |
mTABLET WI-FI DOCKING UNIT
Width: 176 mm (6,93 inches), Depth:
126 mm (4,96 inches), Height: 40 mm | NOTE 1 |
| | | (1,57inches), Weight: 717grams
TUBELESS CUFF UNIT (4x):
Width: 40 mm (1.57 inches)
Depth: 40 mm (1.57 inches)
Height: 150 mm (5.91 inches) Weight:
286 g
LARGE 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: rechargeable
lithium polymer
AC/DC converter 5V.
Capacity: 2,300mAh, number of measurements
per charge: 30 | mTABLET UNIT
AC/DC adaptor:
FW8030M/05(FRIWO)
Input: 100-240 V~; 50-60 Hz
Output: 5 Vdc; 5000 mA
Battery type: RechargeableLithium-
Polymer battery(LP6058110)
Capacity: 8800 mAh, Battery
operation: more than 8 hours
WIRELESS CUFF UNIT
Battery type: Rechargeable Lithium-
Polymer battery, Capacity: 1240 mAh
Examinations per battery charge: >
200
Charge time for depleted battery (for
each unit): approximately 1.5 hours
(minimum charge time for 1 ABI
measurement, with all units on the
charging station : 10 minutes)
LARGE CHARGING PLATE UNIT
AC/DC adaptor: FW8030M/05 (FRIWO
FOX30-XM)
Input: 100-240 V~; 50-60 Hz
Output: 5 Vdc / 5000 mA | NOTE 2 |
| Display | 4,3" color LCD screen with 16-bit color depth
resolution: 480 x 272 pixels | 10,1" color IPS screen with 1280x800
resolution | NOTE 3 |
| Applied parts in
contact with the
patient | 3 cuffs, tubes and bladders | 4x tubeless cuffs | NOTE 4 |
| | Substantial Equivalence Determination Table | | |
| Feature | ABPI MD | MESI mTABLET ABI | Analysis |
| Materials in
contact with the
patient | Silicon (Tubes),
PU bladder, Nylon-Cotton protecting layer
(Pressure cuffs) | TPU coated PU leather - outside layer
Nylex based PU leather - inside layer
TPU bladder | NOTE 5 |
| Testing bench | Type of protection against electric shock:
Class II. BF
Compliant with standards:
60601-1,
60601-1-2
80601-2-30. | See list below | equivalent |
| 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 |
| Limit values of
measurement
errors | ABPI: Within ± 0.1 | ABPI: Within ± 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,
relative air humidity: 25 to 85%
IP42 protection
Transport and storage environment:
-15° to 50°C (