Automated ankle brachial pressure index measuring device, MESI mTABLET system

{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). 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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) | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(K) SUMMARY # K201046 | SUBMITTER on behalf of | MESI D.O.O | |------------------------|-------------------------------------------------------------| | Address: | Leskoskova cesta 11A<br>1000 Ljubijana<br>Slovenia, Europe | | Telephone: | +386 1 620 34 87 | | Fax: | +386 8 2015 31 95 | | by: | Paladin Medical, Inc.<br>PO Box 560<br>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<br>measuring device | | CLASSIFICATION NAME: | Hydraulic, Pneumatic, or Photoelectric<br>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<br>Use / Intended<br>use | ABPI MD system is indicated for use on adult<br>subjects at risk of having or developing<br>peripheral arterial disease (PAD).<br>ABPI MD system is intended for the rapid<br>measurement of ankle-brachial pressure index<br>(ABPI) or ankle-brachial index (ABI), and pulse<br>volume recording (PVR) / volume<br>plethysmography in adults.<br>It is suitable for use in wound care assessment,<br>for assessing symptomatic PAD, and as a<br>screening device for PAD. It may also be used on<br>patients with venous or arterial ulcers prior to<br>application of compression therapy. ABPI MD<br>can be used on patients with unilateral lower<br>limb amputation.<br>The ABPI MD system is intended to be used to<br>spot-check patients.<br>The ABPI MD system provides information<br>regarding patient risk.<br>The physician has the responsibility of making<br>proper judgments based on this information.<br>Prescription Use: Federal law restricts the use of<br>this device to sale by or on the order of a<br>physician. | The MESI mTABLET ABI is indicated<br>for use on adult subjects at risk of<br>having or developing peripheral<br>arterial disease (PAD).<br>MESI mTABLET ABI is intended for the<br>rapid measurement of ankle-brachial<br>pressure index (ABI) and pulse volume<br>plethysmography in adults.<br>It is suitable for use in wound care<br>assessment, for assessing<br>symptomatic PAD, and as a screening<br>device for PAD. It may also be used on<br>patients with venous or arterial ulcers<br>prior to application of compression<br>therapy.<br>MESI mTABLET ABI can be used on<br>patients with unilateral lower limb<br>amputation.<br>The MESI mTABLET ABI is intended to<br>be used to spot-check patients.<br>The MESI MTABLET ABI provides<br>information regarding patient risk.<br>The physician has the responsibility of<br>making proper judgments based on<br>this information.<br>Prescription Use: Federal law restricts<br>the use of this device to sale by or on<br>the order of a physician. | Identical | | | Substantial Equivalence Determination Table | | | | Feature | ABPI MD | MESI mTABLET ABI | Analysis | | Dimensions /<br>weight | Width: 250 mm, Height: 730 mm, Depth: 200<br>mm, Weight: 0.60 kg | mTABLET UNIT<br>Width: 199 mm (7,83 inches), Depth:<br>278mm (10,95 inches), Height: 53mm<br>(2,08 inches), Weight:757grams<br><br>mTABLET WI-FI DOCKING UNIT<br>Width: 176 mm (6,93 inches), Depth:<br>126 mm (4,96 inches), Height: 40 mm | NOTE 1 | | | | (1,57inches), Weight: 717grams<br><br>TUBELESS CUFF UNIT (4x):<br>Width: 40 mm (1.57 inches)<br>Depth: 40 mm (1.57 inches)<br>Height: 150 mm (5.91 inches) Weight:<br>286 g<br><br>LARGE CHARGING PLATE UNIT:<br>Width: 400 mm (15.75 inches), Depth:<br>200 mm (7.87 inches), Height: 38 mm<br>(1.49 inches), Weight: 675 grams | | | Power Supply | Output: 5V DC/3.0A. Battery type: rechargeable<br>lithium polymer<br>AC/DC converter 5V.<br>Capacity: 2,300mAh, number of measurements<br>per charge: 30 | mTABLET UNIT<br>AC/DC adaptor:<br>FW8030M/05(FRIWO)<br>Input: 100-240 V~; 50-60 Hz<br>Output: 5 Vdc; 5000 mA<br>Battery type: RechargeableLithium-<br>Polymer battery(LP6058110)<br>Capacity: 8800 mAh, Battery<br>operation: more than 8 hours<br><br>WIRELESS CUFF UNIT<br>Battery type: Rechargeable Lithium-<br>Polymer battery, Capacity: 1240 mAh<br>Examinations per battery charge: ><br>200<br>Charge time for depleted battery (for<br>each unit): approximately 1.5 hours<br>(minimum charge time for 1 ABI<br>measurement, with all units on the<br>charging station : 10 minutes)<br><br>LARGE CHARGING PLATE UNIT<br>AC/DC adaptor: FW8030M/05 (FRIWO<br>FOX30-XM)<br>Input: 100-240 V~; 50-60 Hz<br>Output: 5 Vdc / 5000 mA | NOTE 2 | | Display | 4,3" color LCD screen with 16-bit color depth<br>resolution: 480 x 272 pixels | 10,1" color IPS screen with 1280x800<br>resolution | NOTE 3 | | Applied parts in<br>contact with the<br>patient | 3 cuffs, tubes and bladders | 4x tubeless cuffs | NOTE 4 | | | Substantial Equivalence Determination Table | | | | Feature | ABPI MD | MESI mTABLET ABI | Analysis | | Materials in<br>contact with the<br>patient | Silicon (Tubes),<br>PU bladder, Nylon-Cotton protecting layer<br>(Pressure cuffs) | TPU coated PU leather - outside layer<br>Nylex based PU leather - inside layer<br>TPU bladder | NOTE 5 | | Testing bench | Type of protection against electric shock:<br>Class II. BF<br>Compliant with standards:<br>60601-1,<br>60601-1-2<br>80601-2-30. | See list below | equivalent | | Measurement<br>types | Right and left Ankle brachial pressure index :<br>Left ABI =<br>Left ankle pressure<br>Arm pressure<br>Right ABI =<br>Right ankle pressure<br>Arm pressure | Right and left Ankle brachial pressure<br>index :<br>Left ABI =<br>Left ankle pressure<br>Arm pressure<br>Right ABI =<br>Right ankle pressure<br>Arm pressure | Identical | | Limit values of<br>measurement<br>errors | ABPI: Within ± 0.1 | ABPI: Within ± 0.1 | Identical | | Cuffs inflation<br>and<br>deflation | Automatic inflation using an air pump and<br>deflation using an electromagnetic valve. | Automatic inflation using an air pump<br>and deflation using an<br>electromagnetic valve. | Identical | | Pulse Volume /<br>Plethysmography | Pneumo-plethysmography method using the<br>cuffs measuring the blood pressure values :<br>Plethysmography displayed at the inflammation<br>and deflation pressure | Pneumo-plethysmography method<br>using the cuffs measuring the blood<br>pressure values: Plethysmography<br>displayed at the inflammation and<br>deflation pressure. | Identical | | Temperature<br>and<br>humidity range | Working environment: 10 to 40°C,<br>30 to 85% relative air humidity,<br>IPX0 protection,<br>transport and storage: 0 to 60°C, up to 85%<br>relative air humidity. | Working environment:<br>10° to 40°C,<br>relative air humidity: 25 to 85%<br>IP42 protection<br>Transport and storage environment:<br>-15° to 50°C (<1 month) / -15° to 40°C<br>(<3 month) / -15° to 25°C (<12<br>month) Relative humidity: 25 to 85%<br>(no condensation)<br>IP42 protection | NOTE 6 | | Target<br>population | Adult | Adult | Identical | | Where used | Clinical environment | Clinical environment | Identical | | PC Data<br>transmission | USB | Cloud | NOTE 7 | | ABI results:<br>Coefficient of<br>correlation r with<br>the standard<br>Doppler probe<br>method | 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. {5}------------------------------------------------ {6}------------------------------------------------ # 510(k) Summary-Continued {7}------------------------------------------------ #### 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. {8}------------------------------------------------ ### 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.