The Movement and Compressions System is intended to be a portable system, prescribed by healtheare professionals, to treat the following conditions by stimulating blood flow in the legs:

· Aid in the prevention of DVT (deep vein thrombosis) by enhancing blood circulation; and,
· As a prophylaxis for DVT by persons expecting to be stationary for long periods of time.

During use, the system also monitors patient orientation and movement. It allows healthcare providers and users to implement individualized patient management plans for DVT prophylaxis and patient mobility protocols by utilizing data accumulated by the patient on the previous day as a benchmark. The data displayed on the device allows providers to monitor the patient's orientation and activity, which can be used to identify risk factors for hospital-acquired events linked to immobility such as: deep vein thrombosis, pressure ulcers, pneumonia, atrophic muscles, and delirium.

The device can be used in the home or clinical setting. The device is intended for use in an adult patient population.

Device Description

The Movement and Compressions System (The MACTM System) is a prescriptive, portable, rechargeable-battery powered, intermittent compression device designed to stimulate blood flow in the lower limb. The MAC System consists of the MAC Strap, MAC Charging Hub, and MAC Controller. The MAC Strap is a disposable single patient use strap that is wrapped around the patient's calf muscle. The MAC Controller houses a rechargeable battery, DC motor, gyroscope sensor, and microprocessor that is attached to the strap during use. The battery is removed from the controller for charging in the supplied MAC Charging Hub when not in use.

Compression is applied to the calf, immediately below the knee, by intermittent application of mechanical force by the device strap. When the strap is contracted, compression is applied to the patient's calf muscle. When the strap is retracted, compression force is released from the patient's calf muscle. Since mechanical force is used to provide intermittent compression, the system does not require a powered air supply, so the risk of aerosolization of potential contaminants or germs is mitigated as there is no blowing air. There are no air connections or pneumatic pumps to clean between patients.

The MAC system also monitors and displays patient orientation and movement information. This data is stored in a RFID tag in the MAC Strap. When the MAC Controller is connected to the MAC Strap, and functioning, all DVT prophylaxis compliance data, orientation and movement data is synced between the controller and the strap using Radio Frequency Identification (RFID) communication and stored between them.

AI/ML Overview

The provided document, a 510(k) Premarket Notification for the "Movement and Compressions System (the MAC System)," primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance. While it outlines various performance tests, it does not contain the level of detail typically required to fully describe acceptance criteria for specific device performance metrics (beyond safety and electrical compliance) and a rigorous study proving the device meets these criteria in the context of clinical efficacy or deep learning model validation.

Specifically, for the "data accumulated by the patient on the previous day as a benchmark" and "monitor the patient's orientation and activity" functionalities, the document mentions "Performance testing also evaluated accuracy of mobility data and strap slippage." However, it does not provide quantitative acceptance criteria or detailed results for this "accuracy of mobility data" evaluation. It also does not elaborate on a study that would demonstrate how this data is "utilized" or its "effect size" regarding "how much human readers improve with AI vs without AI assistance" as it is related to a patient monitoring feature, not an AI-assisted diagnostic or interpretive system for human readers.

Therefore, many of the requested items related to deep learning model validation (such as sample size for test/training sets, data provenance, expert adjudication, MRMC studies, standalone performance, and ground truth establishment) are not present in this regulatory submission document as it pertains to a mechanical medical device with a monitoring feature, not an AI/ML-driven diagnostic or prognostic device requiring such extensive validation.

Below is an attempt to address the request based only on the information available in the provided text. Many fields will be marked as "Not provided/Not applicable" due to the nature of the device and the document.

Device Description and Functionality Summary:

The Movement and Compressions System (The MAC System) is a portable, rechargeable, intermittent compression device aimed at stimulating blood flow in the lower limb to aid in DVT prevention and prophylaxis. A key feature is its ability to monitor patient orientation and movement using a 6-axis gyroscope sensor and microprocessor, with data stored in an RFID tag in the MAC Strap. This mobility data is intended to help healthcare providers implement individualized patient management plans and identify risk factors for immobility-linked hospital-acquired events.

Acceptance Criteria and Reported Device Performance

The document primarily focuses on demonstrating substantial equivalence through safety, electrical, biocompatibility, and software testing, and general functionality. Specific quantitative acceptance criteria and performance data for the accuracy of mobility data are not detailed in a table format in the provided text. The document states that "Performance testing also evaluated accuracy of mobility data and strap slippage" and that the "device met all performance requirements," suggesting these evaluations were conducted and passed internal criteria, but the specific metrics and results are omitted from this public summary.

Acceptance Criteria Category	Specific Acceptance Criteria (Not explicitly detailed in source for performance, only for safety/compliance)	Reported Device Performance (Summary from text)
Biocompatibility	Adherence to ISO 10993-1 for cytotoxicity, sensitization, and irritation.	Non-cytotoxic, non-sensitizer, and produces no dermal irritation.
Electrical Safety & EMC	Compliance with IEC 60601-1-2:2014, IEC 60601-1:2005 (3rd Ed), IEC 60601-1-11:2015, IEC 60601-1-6:2013	Testing successfully performed according to all applicable portions of the listed standards.
Software Verification & Validation	As recommended by FDA's Guidance for Software, for "minor" level of concern.	Verification and validation conducted; documentation provided. Software considered "minor" level of concern.
Mechanical Performance	Not explicitly detailed (e.g., specific thresholds for elasticity, shear strength).	Verification of strap elasticity and shear strength successful.
Electrical Components Performance	Not explicitly detailed (e.g., specific thresholds for controller/charging hub, battery).	MAC Controller and Charging Hub electrical verification successful. Verification of battery pack safety and performance successful according to applicable standards.
Radiofrequency & Radiated Emissions	Compliance with established requirements.	Compliance with established requirements applicable to radiofrequency and radiated emissions testing successful.
Overall Functionality & Reliability	Not explicitly detailed.	Functionality and reliability testing successful.
Blood Flow Increase (Compression)	Not explicitly detailed (e.g., specific percentage increase over baseline).	Performance testing of the subject device and predicate device to evaluate blood flow increase over baseline was conducted and successful, demonstrating "similar performance characteristics as the predicate devices."
Accuracy of Mobility Data	Not explicitly detailed (e.g., specific accuracy/precision metrics for orientation or steps).	Performance testing also evaluated accuracy of mobility data. The document states "device met all performance requirements," implying accuracy criteria were met, but quantitative results are not provided. This feature is compared to the DynaSense System, which also monitors orientation and activity (K130752).
Strap Slippage	Not explicitly detailed.	Performance testing also evaluated strap slippage. The document states "device met all performance requirements," implying criteria were met.
Usability Testing	Not explicitly detailed.	Usability testing successful.

Study Details for Performance Evaluation (Specifically for Mobility Data/Other Performance)

Sample size used for the test set and the data provenance:
- Test set sample size: Not provided. The document states "Performance testing" was done, but does not specify the number of subjects or data points used for evaluating mobility data accuracy or other performance aspects.
- Data provenance: Not provided (e.g., country of origin, retrospective or prospective nature).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is a sensor-based measurement device, not an AI/ML system requiring expert interpretation for ground truth. It's likely that a physical standard or reference measurement was used for "accuracy of mobility data."
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. Ground truth for sensor data accuracy would be established by comparison to a calibrated reference system or direct physical measurement, not human adjudication.
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:
- No MRMC study was done, and it is not applicable for this device. The device's mobility monitoring feature is for providing data to healthcare providers, not for assisting human readers in interpreting complex medical images or data from an AI-driven component where performance enhancement would be measured.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- A standalone performance evaluation of the "accuracy of mobility data" was indicated as part of "Performance Testing." However, specific quantitative results or methodologies are not provided beyond the statement that it was "evaluated" and the device "met all performance requirements." This would have involved comparing the device's sensor output to a known, true value of orientation and movement (e.g., from a more precise measurement system). The "algorithm" here refers to the device's internal processing of sensor data.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For "accuracy of mobility data," the ground truth would likely be based on a physical reference standard or a highly accurate, calibrated measurement system for orientation and movement tracking, not expert consensus or pathology.
The sample size for the training set:
- Not applicable. This document describes a traditional medical device with embedded sensor capabilities, not a deep learning model that requires a "training set" in the machine learning sense.
How the ground truth for the training set was established:
- Not applicable, as there is no "training set" for a deep learning model. The device's internal algorithms for processing sensor data would typically be developed and validated against engineering specifications and reference measurements.

Summary

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Image /page/0/Picture/0 description: The image contains 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 is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 21, 2021

Recovery Force, LLC % Deborah Grayeski Sr. Project Manager M Squared Associates 127 West 30th Street. 9th Floor New York, New York 10001

Re: K203052

Trade/Device Name: Movement and Compressions System (the MAC System) Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: February 16, 2021 Received: February 17, 2021

Dear Deborah Grayeski:

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.

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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) 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 (OS) 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.

for Fernando Aguel Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: 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)

K203052

Device Name

Movement and Compressions System (The MACTM System)

Indications for Use (Describe)

The Movement and Compressions System is intended to be a portable system, prescribed by healtheare professionals, to treat the following conditions by stimulating blood flow in the legs:

· Aid in the prevention of DVT (deep vein thrombosis) by enhancing blood circulation; and,
· As a prophylaxis for DVT by persons expecting to be stationary for long periods of time.

The device can be used in the home or clinical setting. The device is intended for use in an adult patient population.

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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510(K) SUMMARY

SUBMITTER:	Recovery Force LLC
	10022 Lantern Rd., Suite 100
	Fishers, IN 46037

CONTACT: Deborah Lavoie Grayeski M Squared Associates, Inc. 127 West 30th Street, 9th Floor New York NY 10001 Ph. 347-307-6951/202-550-7395 Fax. 703-562-9797 Email. dgrayeski@msquaredassociates.com

DATE PREPARED:

DEVICE:

Proprietary Name:	Movement and Compressions System (The MAC™ System)
Common Name:	Compressible Limb Sleeve
Classification Name:	Compressible Limb Sleeve, 21 CFR 870.5800
Regulatory Class:	Class II
Product Code:	JOW

March 17, 2021

PREDICATE AND REFERENCE DEVICE:

Primary Predicate: Medical Compression Systems (DBN) Ltd's ActiveCare DVT
System. K140755

Reference Devices: Recovery Force RF1400 Active Compression Wrap, K162481 Centauri Medical, Inc., DynaSense System, K130752
Neither the predicate nor reference devices has been subject to a recall.

DEVICE DESCRIPTION:

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patient use strap that is wrapped around the patient's calf muscle. The MAC Controller houses a rechargeable battery, DC motor, gyroscope sensor, and microprocessor that is attached to the strap during use. The battery is removed from the controller for charging in the supplied MAC Charging Hub when not in use.

INDICATIONS FOR USE:

The Movement and Compressions System is intended to be a portable and wearable system, prescribed by healthcare professionals, to treat the following conditions by stimulating blood flow in the legs:

Aid in the prevention of DVT (deep vein thrombosis) by enhancing blood . circulation: and,
As a prophylaxis for DVT by persons expecting to be stationary for long periods . of time.

The device can be used in the home or clinical setting. The device is intended for use in an adult patient population.

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COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE:

A comparison of the technological characteristics between The MAC System to the predicate and reference devices is presented in Table 1.

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Table 1. Comparison of the technological characteristics between The MAC System to the predicate and reference devices.
Company	Recovery Force	Medical Compression Systems	Recovery Force	Centauri Medical, Inc.
Device	The MAC System(Subject Device)	ActiveCare DVT System(Primary Predicate)	Recovery Force RF1400 ActiveCompression Wrap(Reference Device)	DynaSense System(Reference Device)
510(k) Number	TBD	K140755	K162481	K130752
ClassificationRegulationProduct Code	Class II, (21 CFR 870.5800)Compressible Limb SleeveJOW	Class II, (21 CFR 870.5800)Compressible Limb SleeveJOW	Class II, (21 CFR 870.5800)Compressible Limb SleeveJOW	Class I, (21 CFR 880.2400)Bed-patient monitorKMI
	Subsequent code: KMI
DeviceDescription	The Movement and CompressionsSystem (The MAC™ System) is aprescriptive, portable, rechargeable-battery powered, intermittentcompression device designed tostimulate blood flow in the lowerlimb. The MAC System consists ofthe MAC Strap, MAC ChargingHub, and MAC Controller. TheMAC Strap is a disposable single-patient use strap that is wrappedaround the patient's calf muscle.The MAC Controller houses arechargeable battery, a small DCmotor, a 6-axis gyroscope sensor,and microprocessor that is attachedto the strap during use. The batteryis removed from the controller forcharging in the supplied MACCharging Hub when not in use.Compression is applied to the calf,immediately below the knee, byintermittent application ofmechanical force by the devicestrap. When the strap is contracted,compression is applied to the	The ActiveCare+DTx,ActiveCare+SFT and ActiveCare DVTSystems are prescriptive, pneumaticcompression Systems designed toapply sequential compression to thelower limb. The control units of theSystems provide the user with severaltreatment options: compression of thefoot - single or double, compression ofthe calf - single or double,compression of the thigh - single ordouble, and combined compression ofany combination of two sleeves. Thefoot compression program is anintermittent pressure pulse applicationto a single celled foot sleeve. The calfand thigh compression program is asequential intermittent application of apressure to a three-celled cuff sleeve.	The RF1400 Active CompressionWrap is a lightweight, portable,rechargeable battery powered,prescriptive device that helpsstimulate blood flow in the lower limbthrough the use of intermittentsequential compression. The wrapcontains nickel titanium, martensite toaustenite phase change wires, using abattery-powered microprocessor to"excite" and "relax" the wiresresulting in compression. The batteryand microprocessor components areprotectively housed in a plasticcontroller case that is permanentlyattached to the wrap. A single, touchcontrol button interface and a RGBLED light indicator provide the userinterface, and there is a port forconnecting the battery charger plug.The wrap is available in a wide rangeof sizes XS, S, M, and L, toaccommodate varying anatomy sizes.The wrap is divided into three discretezones which are externally applied tothe limb. After one zone is fully	DynaSense is a patient monitoringsystem that has been designed foruse in hospitals, nursing homes, orother patient care facilities to aidstandard care procedures forpatients who are susceptible topressure ulcers. The systemmonitors and reports patientactivity and orientation as well asalerts the user (i.e., healthcareprovider) when activity levelsdeviate from parameters set byhealthcare providers. DynaSense iscomprised of Patient Sensors, RelayAntennas, a USB RE Transceiver,Mesh Network Server Software,and User Interface software. EachPatient Sensor is associated with asingle patient, such that the patient'sorientation and activity can bemonitored. Data collected by thePatient Sensor is automaticallycommunicated wirelessly to anearby Relay Antenna, whichsubsequently relays these data to bedisplayed on the User Interface andmaintained in a database. The

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patient's calf muscle. When the	activated for a period of time and turns	system's Relay Antennas that are
strap is retracted, compression force	off, then the next zone is activated.	plugged into electrical outlets on
is released from the patient's calf	This cycle continues until all three	the walls of the facility and the
muscle.	zones have activated and turned off.	USB RIF Transceiver that is
	Then the sequence is repeated after a	plugged into the computer, on
Since mechanical force is used to	short delay. This cycle repeats until	which the Mesh Network Server
provide intermittent compression,	the unit is turned off. The wrap may	Software is installed or accessed,
the system does not require a	be used on one or both legs. When	form a wireless network that allows
powered air supply, so the risk of	used on both legs, the wraps operate	data to be transmitted for display.
aerosolization of potential	separately. The wrap is supplied with	The Mesh Network Server
contaminants or germs is mitigated	a rechargeable battery, which can be	Software manages this network of
as there is no blowing air. There	charged when not in use.	Relay Antennas and USB REF
are no air connections or pneumatic		Transceiver and collects the data
pumps to clean between patients.		from the Patient Sensors to allow
		monitoring of multiple patients on a
The strap is available in two sizes:		single screen within the User
Standard and XL. The system may		Interface.
be used on one or both legs. When
used on both legs, the wraps operate
separately.

The MAC System also monitors
and displays patient orientation and
movement information (see
DynaSense reference device,
K130752). This data is stored in a
RFID tag in the MAC Strap. When
the MAC Controller is connected to
the MAC Strap, and functioning, all
DVT prophylaxis compliance data,
orientation and movement data is
synced between the strap and
controller using Radio Frequency
Identification (RFID)
communication and stored between
them.

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Intended Use	Lower limb compression	Lower limb compression	Lower limb compression	Monitor orientation and activity.
Indications forUse	The Movement and CompressionsSystem is intended to be a portableand wearable system, prescribed byhealthcare professionals, to treat thefollowing conditions by stimulatingblood flow in the legs:• Aid in the prevention of DVT(deep vein thrombosis) byenhancing blood circulation;and,• As a prophylaxis for DVT bypersons expecting to bestationary for long periods oftime.During use, the system alsomonitors patient orientation andmovement. It allows healthcareproviders and users to implementindividualized patient managementplans for DVT prophylaxis andpatient mobility protocols byutilizing data accumulated by thepatient on the previous day as abenchmark. The data displayed onthe device allows providers tomonitor the patient's orientationand activity, which can be used toidentify risk factors for hospital-acquired events linked toimmobility such as: deep veinthrombosis, pressure ulcers,pneumonia, atrophic muscles, anddelirium.	The ActiveCare DVT, ActiveCare+SFTand ActiveCare+DTx Systems areprescriptive devices that induceContinuous Enhanced CirculationTherapy of the lower limbs. TheSystems are intended for use in:• Preventing Deep Vein Thrombosis(DVT).• Enhancing blood circulation.• Diminishing post-operative pain andswelling.• Reducing wound-healing time.• Treatment and assistance in healing:stasis dermatitis; venous stasisulcers; arterial and diabetic legulcers.• Treatment of chronic venousinsufficiency.• Reducing edema.	Intended to be a portable and wearablesystem, prescribed by healthcareprofessionals, to treat the followingconditions by stimulating blood flowin the lower limbs:• Aid in the prevention of DVT;• Enhance blood circulation;• Diminish post-operative pain andswelling;• Reduce wound healing time;• Aid in the treatment and healing of:stasis dermatitis, venous stasisulcers, arterial and diabetic legulcers, chronic venousinsufficiency, chronic lymphedema,and reduction of edema in the lowerlimbs;• As a prophylaxis for DVT bypersons expecting to be stationaryfor long periods of time.• Reduction of edema associated withsoft tissue injuries, such as burns,postoperative or post-immobilization edema, or ligamentsprains.The device can be used in the home orclinical setting. The device isintended for use in an adult patientpopulation.	DynaSense monitors orientationand activity of patients susceptibleto pressure ulcers. It allowshealthcare providers to implementindividualized turn managementplans and continuously monitoreach patient. DynaSense providesalerts when patient orientation oractivity deviates from parametersset by healthcare providers. Thedevice is intended for use inmedical, nursing and long-term carefacilities including independentliving, assisted living andrehabilitation facilities.
TargetPopulation/Where used	The device can be used in the homeor clinical setting. The device isintended for use in an adult patientpopulation.	Home or clinical setting.	Home or clinical setting.	Medical, nursing and long-termcare facilities includingindependent living, assisted living
	Home or clinical setting.	Home or clinical setting.	Home or clinical setting.
Anatomical Site	Lower leg	Lower leg	Lower leg	Sensor attaches to patient'ssternum.
Principle ofOperation	Intermittent compression via DCmotor strap tightening.Patient orientation and movementmonitored using a 6-axis gyroscopesensor/step counter.	Sequential, intermittent, pneumaticcompression	Nickel titanium, martensite toaustenite phase change wires, resultingin compression.	Patient orientation and activitymonitored using a patient sensor.
Weight	11 oz	1.65 lb	1.00 lb	Unknown
Dimension	6 H (at largest part) x 22.25 L(Standard size), 0.3 thick(Excluding Controller) inches.	5.3 x 5.3 x 2.4 inches	9 H x 20 L (Small size), 0.3 thick(excluding controller) inches	Sensor 1.8" x 2.0"
Cycle Time	60 seconds consisting of thefollowing sequence:• Compression for ≤1 second• Hold for 1 second• Compression release for ≤ 2seconds• No compressions for ~ 56seconds	30 seconds consisting of thefollowing sequence:• Bottom Zone inflation for 2-3seconds• Middle Zone inflation for 2-3seconds• Top Zone inflation for 2-3secondsCuff deflates to a total cycle time of 30seconds, then cycle restarts.	30 seconds consisting of thefollowing sequence:• Bottom Zone compression for2 seconds• Middle Zone compression for2 seconds• Top Zone compression for 2seconds• No compressions for 24seconds	N/A, this device is solelyreferenced for its use inmonitoring patient orientationand activity.
Biocompatibility	Biocompatible	Biocompatible	Biocompatible	Biocompatible
Bilateraltreatmentoption	Yes	Yes	Yes	N/A, this device is solelyreferenced for its use in monitoringpatient orientation and activity.

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Single PatientUse	Yes (Controller and Charging Hubthat only have transient contact withthe patient are reusable)	Yes	Yes	Yes (sensor that adheres to thepatient is single use, while othercomponents for transmitting anddisplaying the information arereusable)
Sterility	Non-Sterile	Non-Sterile	Non-Sterile	Non-Sterile
PowerRequirements(Battery Spec's)	3.6V; 2.9Ah; 10.44Wh Li-Ion18650 single cell rechargeablebattery pack	7.2 V; 1.8Ah; 12.96Wh Ni-MH battery6 cell rechargeable battery pack	14.4V; 2.0Ah; 28.8Wh Li-Ion 18650four-cell rechargeable battery pack	Unknown

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The differences between the MAC System and the predicate device does not affect the intended use and does not raise new questions of safety and effectiveness. The MAC System is equivalent to the listed predicate device in that they both use a microprocessor to provide intermittent compression to simulate muscle contractions in the lower limbs aiding the return of venous flow. Intermittent compression is the technological principle for both the subject and predicate/reference devices. Both devices have a user interface, which in addition to controlling the system, provides battery and system information (including error notification). All compression systems are encased in soft, non-latex fabrics for patient comfort and biocompatibility. All systems are prescription only and provided non-sterile. The MAC System is supplied with a rechargeable battery, which can be charged when not in use, whereas the predicate devices use a rechargeable battery or utilize a power source that must be plugged into a wall outlet. Both devices are lightweight, portable and wrap around the lower limb. Like the reference device, the MAC System can be used on one or both legs. When used on both legs, the wraps operate separately.

In addition to compression, the MAC System also monitors and reports patient orientation and movement. While the primary predicate does not provide this functionality, there are other devices that include similar functionality. Table 2 provides a comparison of the characteristics between the MAC System and the DynaSense System.

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	Recovery ForceThe MAC System	Centauri Medical, Inc.DynaSense System(Reference Device)K130752, Class I device	Remarks
Clinical Application	Sensor is located in theMAC Controller that isattached to the disposableMAC Strap which iswrapped around thepatient's lower leg.	Non-invasive adherence topatient's skin	Similar to ReferenceDevice: bothsensors are placednon-invasively, nearthe surface of thepatient's skin.
Principle ofOperation	A gyroscope monitorspatient orientation(horizontal versusvertical) and movement(steps).	Patient sensor that monitorspatient orientation andmovements (based uponpublicly availableinformation).	Similar to ReferenceDevice: bothdevices monitorpatient orientationand movement.
Device Output	Monitors and reportsbody orientation andmovement. Thisinformation is displayedon a User Interface.	Monitors and reports bodyorientation and movement.This information iscommunicated wirelesslythrough an antenna, savedon a server and displayed ona User Interface.	Similar to referencedevice: bothdevices display theinformation on auser interface.

Table 2. Technological comparison to bed-patient monitor reference device.

PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility testing

The biocompatibility evaluation for the MAC Strap was conducted in accordance with ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The battery of testing included the following tests:

Cytotoxicity testing ●
Closed Patch Sensitization testing ●
Primary Skin Irritation testing ●

Based upon this testing, The MAC Strap is considered non-cytotoxic, a non-sensitizer, and produces no dermal irritation.

Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the MAC System and Charging Hub. Testing was successfully performed according to all applicable portions of:

. IEC 60601-1-2:2014/Edition 4.0 - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral

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Standard: Electromagnetic disturbances - Requirements and tests

IEC 60601-1:2005 (3rd Edition), Corr. 1:2006, Corr. 2:2007, A1:2012 (IEC . 60601-1: 2012 reprint) - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-11 Medical electrical equipment Part 1-11, Edition 2.0 2015-01: ● General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
IEC 60601-1-6 Medical electrical equipment Part 1-6, Edition 3.1 2013-10: ● General requirements for basic safety and essential performance - Collateral standard: Usability

Software Verification and Validation 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." The software for this device was considered as a "minor" level of concern since failures, malfunction or latent design flaws are unlikely to cause any injury to the patient or operator.

Performance Testing

Nonclinical verification and validation of performance was also performed to establish substantial equivalence to the listed predicate device. Testing was successfully performed as follows:

Verification of strap elasticity and shear strength
MAC Controller and Charging Hub electrical verification
Verification of battery pack safety and performance according to applicable standards
Compliance with established requirements applicable to radiofrequency and radiated emissions testing
Functionality and reliability testing
Performance testing of the subject device and predicate device to evaluate blood ● flow increase over baseline. Performance testing also evaluated accuracy of mobility data and strap slippage.
Usability testing

CONCLUSION

The MAC System has the same intended use and similar performance characteristics as the predicate devices. The results of non-clinical and usability testing demonstrates that

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the device met all performance requirements and that the subject device is substantially equivalent to the predicate device.

Regulation Number and Section

§ 870.5800 Compressible limb sleeve.

(a)
Identification. A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb.(b)
Classification. Class II (performance standards).