The ManaFlow system, part numbers MFLOW51 and MFLOW52, is comprised of a gradient compression sleeve and a portable intermittent pump to provide graduated compression in both sustained and intermittent settings for use in both the hospital and outpatient setting. ManaFlow 51 is pre-set to the default setting of 50 mmHg and cannot be adjusted, whereas the ManaFlow 52 can be adjusted by the physician to a pressure within the specified range. It is intended for use in:

· Treatment of lymphedema
· Treatment of chronic venous insufficiency
· Treatment and promotion of healing of stasis dermatitis and venous stasis ulcers
· Reducing venous leg ulcer healing time
· Reducing edema due to venous stasis
Enhancing venous return
The device is intended for home, and hospital use.

Device Description

The ManaFlow system, part numbers MFLOW51 and MFLOW52, is a portable and rechargeable prescriptive device. It is intended to be used in the home or clinical/hospital setting by or under the direction of a medical professional to apply pressure to treat lymphedema and other edematous conditions and to prevent Deep Vein Thrombosis (DVT).
The ManaFlow, supplied clean and non-sterile, utilizes the pneumatically controlled cuff actuated by an electronically controlled air pump unit. All pump, battery and control components are protectively housed in a plastic case of the control unit that is attached to an inflatable cuff/sleeve. An ON/OFF button, a SET button, and a display provide for user interface. There is also a port for connecting the battery charger/AC adapter plug. The cuff component consists of multiple (four or so) air chambers/bladders encased inside a soft medical fabric or equivalent medical for increased patient comfort and biocompatibility compliance.
In operation, the user simply turns the power on via the ON/OFF button. A cuff containing air chambers/bladders is connected to the control unit. And the control unit then inflates the cuff to the default pre-determined pressure (50 mmHg), which could be adjusted/calibrated via the SET button. The cuff pressure is monitored by an internal pressure switch and system software. Once the cuff pressure of the multiple air chambers/bladders reaches the pre-determined or adjusted level, the pump is turned OFF for a rest period, and the cuff deflates to ambient pressure through a valve inside the plastic case. After the rest period, the cycle of inflation and deflation repeats until the device is turned off.

AI/ML Overview

The provided text is a 510(k) summary for the ManaFlow device, a compressible limb sleeve system. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific performance acceptance criteria through clinical studies. Therefore, much of the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of clinical performance (e.g., sample size for test set, number of experts for ground truth, MRMC studies, effect size, standalone performance, type of ground truth) is not present in this document.

The document describes non-clinical tests performed to validate the design and assure conformance with voluntary design standards related to electrical safety and electromagnetic compatibility, as well as bench tests for physical, electrical, and performance requirements, and software verification. However, it does not provide specific performance metrics or acceptance criteria for those tests.

Here's what can be extracted based on the provided text, and where information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present specific acceptance criteria for clinical performance or detailed quantitative results from those tests. Instead, it relies on demonstrating substantial equivalence to predicate devices based on intended use, indications for use, functions, design, and adherence to electrical safety and EMC standards.

The closest to a "table of performance" is the comparison table (Table 1) which highlights identical or similar characteristics between the ManaFlow device and its predicates. This table, however, is for comparison of features and design principles, not for reporting quantitative performance against defined acceptance criteria.

Feature / Characteristic	Acceptance Criteria (Implied by Substantial Equivalence to Predicates)	Reported ManaFlow Performance / Characteristic
Intended Use	Identical to Predicate Devices (ACTitouch™, PlasmaFlow, medi pcs-brio, SC-3004FC-DL)	Identical. For treatment of lymphedema, chronic venous insufficiency, stasis dermatitis, venous stasis ulcers, reducing ulcer healing time, reducing edema, enhancing venous return.
Functions and Design	Aids venous return by cyclic, intermittent, pneumatic pressure application (inflation followed by deflation) to compress extremities.	Identical. Aids venous return by using cyclic, intermittent, pneumatic pressure application (inflation followed by deflation) to compress the extremities.
Contraindications	Similar to Predicate Devices (specific conditions listed in Table 1)	Identical or similar to various predicates. Must NOT be used in active DVT, ischemic vascular disease, severe arteriosclerosis, pulmonary edema, severe CHF, thrombophlebitis, active infection, or where cuffs interfere with vein ligation, gangrene, dermatitis, open wounds, recent skin graft, massive edema, or extreme leg deformity.
Target Population	Patients who need venous return and lymphedema treatment.	Identical. Patients who need venous return and lymphedema treatment.
Where Used	Home, Hospital, Surgery Center, Altitude travel, areas of limited mobility.	Identical. Home, Hospital, Surgery Center, Altitude travel, areas of limited mobility.
Application	Non-invasive / external.	Identical. Non-invasive / external.
Portability	Portable, ambulant.	Identical. Portable, ambulant.
Pressure Source	Micro pump controlled by microprocessor.	Identical. Micro pump controlled by microprocessor.
Operating Modes	Preset and adjustable modes.	Identical. Preset and adjustable modes. (ManaFlow 51: 50 mmHg fixed; ManaFlow 52: adjustable 20-80 mmHg)
Working Pressure	Adjustable range similar to predicates (e.g., ACTitouch 20-50 mmHg, medi pcs-brio 20-80 mmHg, SC-3004FC-DL 30-120 mmHg).	Preset at 50 mmHg and adjustable from 20-80 mmHg. (Identical or similar to predicates)
Cycle Time	Cyclic inflation/deflation sequences, similar to predicates.	Identical or similar descriptions to predicates. Specifics detailed for 50mmHg mode and adjustable modes (sequential inflation, then deflation of all chambers).
System Diagnostics	Audible and visual alarms for system faults.	Identical. Audible and visual alarms prompt recognition of system faults.
Air Delivery	Via flexible plastic tube(s) connected directly to air bladder.	Identical. Via flexible plastic tube(s) connected directly to the air bladder.
Sterility	Clean / non-sterile.	Identical. Clean / non-sterile.
Leg cuff usage	Single Patient Use.	Identical. Single Patient Use.
Biocompatibility	Biocompatible materials.	Identical. Biocompatible. Materials are identical to those of legally marketed devices K160318 and K142640.
Software	Moderate level of concern.	Identical. Moderate.
Electrical Safety	Conformance to ANSI AAMI ES60601-1 and IEC 60601-1-2.	Conforms. Non-clinical tests were performed.
EMC	Conformance to IEC 60601-1-2.	Conforms. Non-clinical tests were performed.
Physical Requirements	Demonstrated conformance through bench tests.	Bench tests performed.
Electrical Requirements	Demonstrated conformance through bench tests.	Bench tests performed.
Performance Requirements	Demonstrated conformance through bench tests.	Bench tests performed.
Software Verification	Performed according to FDA Guidance.	Verification performed.

Regarding Clinical Study Details (information missing from this 510(k) summary):

Sample sizes used for the test set and the data provenance: This document does not describe any clinical test set using patient data. The tests mentioned are non-clinical (bench tests, electrical safety, EMC).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical test set using expert opinion for ground truth is described.
Adjudication method for the test set: Not applicable, as no clinical test set requiring adjudication is described.
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: Not applicable. This device is a physical medical device (compressible limb sleeve and pump), not an AI/imaging diagnostic device that would typically undergo MRMC studies.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-only device.
The type of ground truth used: For the non-clinical tests and substantial equivalence determination, the "ground truth" is largely defined by established engineering and safety standards (e.g., ANSI AAMI ES60601-1, IEC 60601-1-2) and the performance characteristics of predicate devices. There is no mention of clinical ground truth (e.g., pathology, outcomes data).
The sample size for the training set: Not applicable, as this is not a machine learning device requiring a training set in the AI sense.
How the ground truth for the training set was established: Not applicable.

Summary of available information related to "proof":

The document demonstrates that the ManaFlow device meets the requirements for 510(k) clearance by proving substantial equivalence to legally marketed predicate devices. This is achieved by:

Showing identical intended use and indications for use.
Comparing design features and specifications: Table 1 meticulously compares ManaFlow's characteristics (e.g., operating principles, contraindications, target population, portability, pressure source, operating modes, working pressure, cycle time, alarms, sterility, materials) to its four predicate devices, highlighting they are identical or similar, and arguing that any differences do not raise new safety or effectiveness concerns.
Conducting non-clinical tests:
- Electrical Safety: Conformance to ANSI AAMI ES60601-1 standards.
- Electromagnetic Compatibility (EMC): Conformance to IEC 60601-1-2 standards.
- Bench Tests: Performed for physical requirements, electrical requirements, and performance requirements. (Specific results or acceptance criteria for these bench tests are not detailed in this summary).
- Software Verification: Carried out according to FDA guidance for software in medical devices.
Biocompatibility: Stated that skin contact components are identical to those of previously cleared devices (K160318 and K142640), thus confirming biocompatibility without new concerns.

The core of the "proof" is that the ManaFlow device functions fundamentally the same way, has the same intended use, and has passed the necessary engineering and safety tests as similar devices already on the market, thereby establishing it as "substantially equivalent" rather than requiring a de novo clinical trial to prove a new performance claim.

Summary

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August 6, 2020

ManaMed, Inc Bill Dai Consultant 14271 Jeffrey Rd. #246 Irvine, California 92620

Re: K200353

Trade/Device Name: ManaFlow Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: July 3, 2020 Received: July 7, 2020

Dear Bill Dai:

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 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

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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,

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) K200353

Device Name ManaFlow

Indications for Use (Describe)

· Treatment of lymphedema
· Treatment of chronic venous insufficiency
· Treatment and promotion of healing of stasis dermatitis and venous stasis ulcers
· Reducing venous leg ulcer healing time
· Reducing edema due to venous stasis
Enhancing venous return

The device is intended for home, and hospital use.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

1. Submitter's Information

Submitter: ManaMed. Inc. Address: 5240 W. Charleston Blvd. Las Vegas, NV 89146 Contact Person: Trevor Theriot Tel : 702-781-1117 Date of Preparation: 12/20/2019

2. Subject Device

Trade/Device Name: ManaFlow Common Name: Compressible Limb Sleeve Regulation Medical Specialty: Cardiovascular Review Panel: Cardiovascular Product Code: JOW Regulation Number: 21 CFR 870.5800 Device Class: II Use: Prescription

3. Predicate device

Primary Predicate Device: ACTitouch™ Adaptive Compression Therapy system 510(k) Number: K131193 Clearance Date: June 18, 2013 Submitter: Tactile Systems Technology, Inc.

Predicate Device: PlasmaFlow 510(k) Number: K160318 Clearance Date: April 1, 2016 Submitter: ManaMed. Inc.

Predicate Device: medi pneumatic compression system (pcs) - brio (Model 651) 510(k) Number: K183631 Clearance Date: January 25, 2019 Submitter: Medi USA, LP

Predicate Device: SC-3004FC-DL Sequential Circulator 510(k) Number: K142640 Clearance Date: November 6, 2014 Submitter: Bio Compression Systems, Inc.

4. Description of Subject Device

The ManaFlow, supplied clean and non-sterile, utilizes the pneumatically controlled cuff actuated by an electronically controlled air pump unit. All pump, battery and control components are protectively

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housed in a plastic case of the control unit that is attached to an inflatable cuff/sleeve. An ON/OFF button, a SET button, and a display provide for user interface. There is also a port for connecting the battery charger/AC adapter plug. The cuff component consists of multiple (four or so) air chambers/bladders encased inside a soft medical fabric or equivalent medical for increased patient comfort and biocompatibility compliance.

In operation, the user simply turns the power on via the ON/OFF button. A cuff containing air chambers/bladders is connected to the control unit. And the control unit then inflates the cuff to the default pre-determined pressure (50 mmHg), which could be adjusted/calibrated via the SET button. The cuff pressure is monitored by an internal pressure switch and system software. Once the cuff pressure of the multiple air chambers/bladders reaches the pre-determined or adjusted level, the pump is turned OFF for a rest period, and the cuff deflates to ambient pressure through a valve inside the plastic case. After the rest period, the cycle of inflation and deflation repeats until the device is turned off.

5. Indications for Use

Prescription Use:

Treatment of lymphedema
Treatment of chronic venous insufficiency
Treatment and promotion of healing of stasis dermatitis and venous stasis ulcers
Reducing venous leg ulcer healing time
Reducing edema due to venous stasis
Enhancing venous return

The device is intended for home, and hospital use.

6. Summary of Substantial Equivalence

The following comparison Table 1 summarizes the comparison between the subject device and the predicate device, indicating the intended use and technical characteristics of the subject device are substantially equivalent to those of the predicate device.

	Subject Device	PrimaryPredicate Device	Predicate Device	Predicate Device	Predicate Device	Equivalence	Prescription orOTC	numbersMFLOW51 andMFLOW52, iscomprised of agradientcompression sleeveand a portableintermittent pump toprovide graduatedcompression in bothsustained andintermittent settingsfor use in both thehospital andoutpatient setting.ManaFlow 51 ispre-set to the defaultsetting of 50 mmHgand cannot beadjusted, whereasthe ManaFlow 52can be adjusted bythe physician to apressure within thespecified range. It isintended for use in:	CompressionTherapy systemprovides graduatedcompression inboth sustained andintermittentsettings for use in:	intended to be aneasy to use portablesystem, prescribedby a physician, foruse in the home orclinical setting tohelp prevent theonsetof DVT in patientsby stimulating bloodflow in theextremities(simulating musclecontractions). Thisdevice can be usedto:	(pcs)-brio is acompression devicebased on sequentialpneumaticcompressiontechnique which isintended for thetreatment of thefollowingconditions:-Lymphedema-Venous stasisulcers-Venousinsufficiency-Peripheral edemaThe device isintended for home,and hospital use.	Systems' SC-3008-DL, SC-3004-DL,SC-3004FC-DL andSC-2008-DL pumpsand associatedgarments aresequential,pneumaticcompressiondevices intended forthe primary oradjunctive treatmentof primary orsecondarylymphedema. Thesedevices are alsointended for theadditional oralternate treatmentof venousinsufficiency andchronic venousstasis ulcersassociated withvenousinsufficiency, aswell as generaltreatment forswelling of theextremities. Thedevices are intendedfor home or hospitaluse.	Identical							raise any newissue of the safetyor effectiveness.
510(k) Number	K200353	K131193	K160318	K183631	K142640	N/A	Prescription	Treatmentof lymphedemaTreatmentof chronic venousinsufficiencyTreatmentand promotion ofhealing of stasisdermatitis andvenous stasis ulcersReducingvenous leg ulcerhealing timeReducingedema due tovenous stasisEnhancingvenous returnThe device isintended for home,and hospital use.	Enhancing venous returnReducing venous leg ulcerhealing timeTreatment and promotionof healing of stasisdermatitis andvenous stasisulcersTreatment of chronicvenousinsufficiencyReducing edema due tovenous stasisTreatment of lymphedema	Aid in theprevention of DVT;Enhanceblood circulation;Diminishpost-operative painand swelling;Reducewound healing time;Aid in thetreatment andhealing of: stasisdermatitis, venousstasis ulcers, arterialand diabetic legulcers, chronicvenousinsufficiency andreduction of edemain the lower limbs.The unit can also beused as an aid in theprophylaxis forDVT by personsexpecting to bestationary for longperiods of time.	Prescription	Prescription	Identical	Power Supply	Input: 100 - 240Vac, 50 - 60 Hz,Output: 5 Vdc @ 2Amp)	Input: 100 - 240Vac, 50 - 60 Hz,Output: 7.5 Vdc @0.9 Amp)	Input: 100 - 240Vac, 50 - 60 Hz,Output: 5 Vdc @ 1Amp)	115V AC, 50-60Hz	115V AC, 50-60Hz	Identical orSimilar. Thevoltage differenceof power supplyused does notchange theproductperformance orparameters,which will notraise any newissue of the safetyor effectiveness.
Submitter	ManaMed, Inc.	Tactile SystemsTechnology, Inc.	ManaMed, Inc.	Medi USA, LP	Bio CompressionSystems, Inc.	N/A	Power Source(s)	5V DC powersupply (100-240VAC input) and3.7V rechargeablebattery	5V DC powersupply (100-240VAC input) and3.7V rechargeablebattery	5V DC powersupply (100-240VAC input) and3.7V rechargeablebattery	115V AC, 50-60Hz	115V AC, 50-60Hz	Identical orsimilar	Internalrechargeablebatteries	Yes	Yes	Yes	N/A	No	Identical
DeviceName/Model	ManaFlow	ACTitouchTMAdaptiveCompressionTherapy system	PlasmaFlow	medi pneumaticcompression system(pcs) - brio (Model651)	SC-3004FC-DLSequentialCirculator	N/A	Battery Charge	Takesapproximately 4hours (fromdepleted state).	Takesapproximately 4hours (fromdepleted state).	Takesapproximately 2.5hours (fromdepleted state).	N/A	N/A	Identical orsimilar. Thedifference ofcharging timedoes not changethe productperformance orparameters,which will not	Compliancewith VoluntaryStandards?	Yes	Yes	Yes	Yes	Yes	Identical
Intended Use	The ManaFlowsystem, part	The ACTitouchTMAdaptive	The PlasmaFlow,model PF0001, is	The medi pneumaticcompression system	The BioCompression	Identical	Electrical SafetyMechanicalSafety ChemicalSafety ThermalSafety RadiationSafety?	Yes	Yes	Yes	Yes	Yes	Identical
Functions anddesign	Aids venous returnby using cyclic,intermittent,pneumatic pressureapplication(inflation followedby deflation) tocompress theextremities.	Aids venous returnby using cyclic,intermittent,pneumatic pressureapplication(inflation followedby deflation) tocompress theextremities.	Aids venous returnby using cyclic,intermittent,pneumatic pressureapplication(inflation followedby deflation) tocompress theextremities.	Aids venous returnby using cyclic,intermittent,pneumatic pressureapplication(inflation followedby deflation) tocompress theextremities.	Aids venous returnby using cyclic,intermittent,pneumatic pressureapplication(inflation followedby deflation) tocompress theextremities.	Identical
Contraindication(s)	MUST NOT beused to treat thefollowingconditions: Personswith suspected,active or untreated:deep veinthrombosis,ischemic vasculardisease, severearteriosclerosis,pulmonary edema,severe congestiveheart failure,thrombophlebitis, oran active infection.On the legs wherecuffs wouldinterfere with thefollowingconditions: veinligation, gangrene,dermatitis, openwounds, a recentskin graft, massiveedema or extremedeformity of the leg.	The ACTitouchSystem iscontraindicated ifthe patient has:• An AnkleBrachial PressureIndex of less than0.8;• Diagnosed orsuspected acuteDeep VeinThrombosis (DVT)or pulmonaryembolism;• Pulmonaryedema;• Leg gangrene;• Acutethrombophlebitis;• Decompensated/CongestiveCardiac Failure;• Severearteriosclerosis orother ischemicvascular disease;• Diabetes in	MUST NOT beused to treat thefollowingconditions: Personswith suspected,active or untreated:deep veinthrombosis,ischemic vasculardisease, severearteriosclerosis,pulmonary edema,severe congestiveheart failure,thrombophlebitis, oran active infection.On the legs wherecuffs wouldinterfere with thefollowingconditions: veinligation, gangrene,dermatitis, openwounds, a recentskin graft, massiveedema or extremedeformity of the leg.	Contraindicated forpatients with acuteDeep VeinThrombosis.	Compression ISNOT recommendedin the followingconditions:• Infections in thelimb, includingcellulitis withoutappropriateantibioticcoverage• The presence oflymphangiosarcoma• Deep veinthrombosis (DVT)• Inflammatoryphlebitis or episodesof pulmonaryembolism• Congestive heartfailure (CHF)	Identical orsimilar

Table 1. Comparison between the subject device and the predicate device

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	On extremities thatare insensitive topain.Where increasedvenous or lymphaticreturn isundesirable.	peripheral arterialdisease;• Acute infectionsof the skin such ascellulitis;• Any lower limbmalignancy.	On extremities thatare insensitive topain.Where increasedvenous or lymphaticreturn isundesirable.			Identical
TargetPopulation /Intended Users	Patients who needvenous return andlymphedematreatment	Patients who needvenous return andlymphedematreatment	Patients who needvenous return	Patients who needvenous return andlymphedematreatment	Patients who needvenous return andlymphedematreatment	Identical
Where Used	Home, Hospital,Surgery Center,Altitude travel,areas of limitedmobility	Home, Hospital,Surgery Center,Altitude travel,areas of limitedmobility	Home, Hospital,Surgery Center,Altitude travel,areas of limitedmobility	Home, Hospital,Surgery Center,Altitude travel,areas of limitedmobility	Home, Hospital,Surgery Center,Altitude travel,areas of limitedmobility	Identical
Application	Non-invasive /external	Non-invasive /external	Non-invasive /external	Non-invasive /external	Non-invasive /external	Identical
Portability	Portable, ambulant	Portable, ambulant	Portable, ambulant	Portable, ambulant	Portable, ambulant	Identical
Basis ofoperation	Aids venous returnby using cyclic,intermittent,pneumatic pressureapplication(inflation followedby deflation) tocompress theextremities	Aids venous returnby using cyclic,intermittent,pneumatic pressureapplication(inflation followedby deflation) tocompress theextremities	Aids venous returnby using cyclic,intermittent,pneumatic pressureapplication(inflation followedby deflation) tocompress theextremities	Aids venous returnby using cyclic,intermittent,pneumatic pressureapplication(inflation followedby deflation) tocompress theextremities	Aids venous returnby using cyclic,intermittent,pneumatic pressureapplication(inflation followedby deflation) tocompress theextremities	Identical
Anatomical Site/ Location oftreatmentapplication	Leg	Leg	Lower limb(s)(Calf)	Leg, Arm	Leg, Arm, Vest	Identical
Systemmanagement	Microprocessor	Microprocessor	Microprocessor	Microprocessor	Microprocessor	Identical
Pressure Source	Micro pumpcontrolled bymicroprocessor	Micro pumpcontrolled bymicroprocessor	Micro pumpcontrolled bymicroprocessor	Micro pumpcontrolled bymicroprocessor	Micro pumpcontrolled bymicroprocessor	Identical
OperatingModes	Preset andadjustable modes	Two preset modes	Two preset modes	Adjustable modes	Preset andadjustable modes	Identical
WorkingPressure	Preset at 50 mmHgand adjustable from20 - 80 mmHg	Preset at 20 - 50mmHg	Preset atapproximately 55mmHg	Adjustable at 20 -80 mmHg	Preset at 60 mmHgand adjustable from30 – 120 mmHg	Identical orsimilar
Cycle Time	In the preset50mmHg mode,each chamber willinflate in sequence,starting at the footand working uptoward the kneeuntil all of thechambers reach theintended pressurelevels. All fourchambers will thendeflate to the lowpressure level. Thiscycle of inflationand deflation willcontinue until thedevice is turn off.In the adjustable 20	When it is firstswitched on in theSustainedCompressionMode, the devicegradually inflates,starting at the footand working uptoward the knee.Each chamber willstop inflating whenthe correctpressures areachieved and willhold thesepressures until thedevice is turnedoff.When inIntermittent	The PlasmaFlowutilizesmicroprocessorcontrolled pumps todeliverapproximately 55mmHg ofpressurized air tobladders that areattached to thepatient's lowerlimbs, using a cycletime ofapproximately 60seconds / leg. Eachcycle consists ofinflation of abladder, followedby a rest periodduring which the	Stays on in apulsing manner andthen release untilthe user turns it offor can be set up toturn off in a rangeof 10 to 180 minutes	In the preset60mmHg mode,each chamber willinflate in sequence,starting at the footand working uptoward the kneeuntil all of thechambers reach theintended pressurelevels. All fourchambers will thendeflate to the lowpressure level. Thiscycle of inflationand deflation willcontinue until thedevice is turn off.In the adjustable 30	Identical orsimilar
	the pressure of eachchamber could beadjusted first, andeach chamber willinflate in sequence,starting at the footand working uptoward the kneeuntil all of thechambers reach theintended pressurelevels. All fourchambers will thendeflate to the lowpressure level. Thiscycle of inflationand deflation willcontinue until thedevice is turn off.	PneumaticCompressionMode, the devicewillperform cyclicinflation/deflationsequencesto preset gradientpressures. Oncethe startingpressure isreached, eachchamber willinflate in sequence,starting at the footand working uptoward the kneeuntil all of thechambers reach theintended pressurelevels. All four (4)chambers will thendeflate to the lowpressure level.This cycle ofinflation anddeflation willcontinue until thedevice is eitherunplugged fromthe PowerAdapter/Chargeror aftertwo (2) hours ofuse.	bladder deflates andthe limb relaxeswithout anycompression.		the pressure of eachchamber could beadjusted first, andeach chamber willinflate in sequence,starting at the footand working uptoward the kneeuntil all of thechambers reach theintended pressurelevels. All fourchambers will thendeflate to the lowpressure level. Thiscycle of inflationand deflation willcontinue until thedevice is turn off.
Systemdiagnostics	Audible and visualalarms promptrecognition ofsystem faults	Audible and visualalarms promptrecognition ofsystem faults	Audible and visualalarms promptrecognition ofsystem faults	Audible and visualalarms promptrecognition ofsystem faults	Audible and/orvisual alarmsprompt recognitionof system faults	Identical
Air deliveryfrom pump tocuff bladder	Via flexible plastictube(s) connecteddirectly to the airbladder	Via flexible plastictube(s) connecteddirectly to the airbladder	Via flexible plastictube(s) connecteddirectly to the airbladder	Via flexible plastictube(s) connecteddirectly to the airbladder	Via flexible plastictube(s) connecteddirectly to the airbladder	Identical
Sterility	Clean / non-sterile	Clean / non-sterile	Clean / non-sterile	Clean / non-sterile	Clean / non-sterile	Identical
Leg cuff usage	Single Patient Use	Single Patient Use	Single Patient Use	Single Patient Use	Single Patient Use	Identical
Material Used	Air bladderchambers encased ina covering of softand nonlatexmedical fabric orequivalent medicalmaterial forincreased patientcomfort andbiocompatibilitycompliance.	Air bladderchambers encasedin a covering ofsoft and nonlatexmedical fabric orequivalent medicalmaterial forincreased patientcomfort andbiocompatibilitycompliance.	Air bladderchambers encased ina covering of softand nonlatexmedical fabric orequivalent medicalmaterial forincreased patientcomfort andbiocompatibilitycompliance.	Air bladderchambers encased ina covering of softand nonlatexmedical fabric orequivalent medicalmaterial forincreased patientcomfort andbiocompatibilitycompliance.	Air bladderchambers encased ina covering of softand nonlatexmedical fabric orequivalent medicalmaterial forincreased patientcomfort andbiocompatibilitycompliance.	Identical orsimilar
Fasteningbetween theplastic case andthe fabric wrap	Snap and screw	Snap and screw	Snap and screw	Snap and tube	Snap and tube	Identical orsimilar

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Biocompatibility	Biocompatible	Biocompatible	Biocompatible	Biocompatible	Biocompatible	Identical
Software	Moderate	Moderate	Moderate	Moderate	Moderate	Identical
Dimensions	165x83x55mm	187x69x32mm	116x65x19mm	N/A	114x298x197mm	Similar
Weight Approx.	0.80kg	0.22kg	0.23kg	N/A	2.5kg	Similar
Temperature	+10 °C (50 °F) to+40 °C (104 °F)	+10 °C (50 °F) to+40 °C (104 °F)	+10 °C (50 °F) to+40 °C (104 °F)	+5 °C (41 °F) to +40°C (104 °F)	+10 °C (50 °F) to+37 °C (100 °F)	Identical orsimilar
Humidity	30%-75%	0%-75%	30%-75%	15%-93%	30%-75%	Identical orsimilar
Cleaning andDisinfecting	• Clean the outersurface of the pumpunit using a softcloth, moistenedwith soapy water or70% isopropylalcohol.• Do not useabrasive or volatilecleaners.• Do not place cuffsin dryer.• NEVER removethe unit from thecuff.• Hand wash theexterior of the cuffsusing a soft cloth,moistened withsoapy water or 70%isopropyl alcoholand let air dry.• To ensure the unitIS completely dryprior to use, leaveunit in the OFFcondition anddisconnected fromthewall outlet for 30minutes aftercleaning ordisinfecting.	Switch off anddisconnect thePower Adapter/Charger beforecleaning ordisinfecting.It is recommendedthat the ACTitouchUndersock bereplaced after amaximum of 60washes. Machinewash hot on agentle cycle. Airdry or tumble dryon a low-temperaturesetting.To clean theACTitouchCompressionSleeve, wipe downwith a soft clothdampened withmild soap andwater. Do notimmerse in fluids.Air drythoroughly.To disinfect theACTitouchCompressionSleeve betweenpatient use, or ifthere are visiblebiologicalcontaminants orvisible stains, thefollowing steps arerecommended:1. Clean anyvisible blood orbody fluids fromthe surface of thesleeve.2. Thoroughly wetsurface withDisCide ULTRADisinfecting Spray.3. Allow surfacesto remain wet forone minute and	• Clean the outersurface of the pumpunit using a softcloth, moistenedwith soapy water or70% isopropylalcohol.• Do not useabrasive or volatilecleaners.• Do not place cuffsin dryer.• NEVER removethe unit from thecuff.• Hand wash theexterior of the cuffsusing a soft cloth,moistened withsoapy water or 70%isopropyl alcoholand let air dry.• To ensure the unitIS completely dryprior to use, leaveunit in the OFFcondition anddisconnected fromthewall outlet for 30minutes aftercleaning ordisinfecting.	To clean the ControlUnit:• Wipe down thesystem with a damp,clean cloth.• Dry thoroughlywith a fresh, cleancloth.Cleaning the singleperson-useinflatable cuff:• Wipe down thecuff inside and outwith a damp, cleancloth. Drythoroughly with afresh, clean cloth.• Do not machinewash or dry!• Do not dry clean!	• Clean the exteriorcase and tubing witha damp (not wet)cloth using mildsoap and watersolution once permonth or as needed.• Open garment toexpose all sideseither by separatingVelcro type hookand loop or byunzipping(depending on typeof garment).• Cleaning solutionshould consist of1/3 cup of laundrydetergent per 1gallon of warm tapwater. Use either alarge sink or plastictub able to holdenough solution(depending on sizeand quantity ofgarments) tocompletelysubmerge thegarment leaving thelatch connector barsout of the water.• Garment should besoaked for 30minutes with mildagitation every 5 to10 minutes whilekeeping it belowwater surface.• Thoroughly rinsegarment with warmtap water and allowto air dry.• Harder to removesoil on surface ofgarment mayrequire additionalwashing by handwith a clean towelwhile submerged.Avoid using anyabrasive materials	Identical orsimilar
		then allow to airdry.To clean theACTitouchControl Unit, wipedown with a softcloth dampenedwith mild soap andwater. Do notimmerse in fluids.Air drythoroughly.To disinfect theACTitouchControl Unitbetween patientuse, or if there arevisible biologicalcontaminants orvisible stains, thefollowing steps arerecommended:1. Clean anyvisible blood orbody fluids fromthe surface of thecontroller.2. Thoroughly wetsurface withDisCide ULTRADisinfecting Spray.3. Allow surfacesto remain wet forone minute andthen allow to airdry.			such as scrubbingpads or chemicalsthat could causedamage to theexterior surface ofgarment.• Re-Submergegarment for 30minutes (withexception of tubingconnectors) in solu-tion consisting of 1cup of bleach per 1gallon of warm tapwater, againagitating garmentevery 5 to 10minutes whilekeeping garmentbelow watersurface. Rinsegarment thoroughlywith warm tap waterand allow to air dry.This completes thedisinfecting step.
Disposal	This unit is anelectromechanicaldevice that includesprinted circuitboards andrechargeablebatteries.Do not discard inlandfill. Consultlocal countyrequirements forproper disposalinstructions. Pumpcontrol units containrechargeablebatteries. Do notdiscard the pumpunit in regularwaste. Bring theunit to your localrecycle center orcontact ManaMed,Inc.	For disposal of anycomponents of theACTitouchSystem, pleasefollow local wasteregulations orconsult your localinstitutional waste-managementservice ormunicipal wasteauthority.	This unit is anelectromechanicaldevice that includesprinted circuitboards andrechargeablebatteries.Do not discard inlandfill. Consultlocal countyrequirements forproper disposalinstructions. Pumpcontrol units containrechargeablebatteries. Do notdiscard the pumpunit in regularwaste. Bring theunit to your localrecycle center orcontact ManaMed,Inc.	Dispose of thisproduct inaccordance withlocal regulations.	Medical equipmentand devices shouldbe disposed of inproper containersthat meetEnvironmentalProtection Agencystandards. Checkwith your local,regional andnational laws andregulations to seewhat is required.	Identical orsimilar

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7. Substantial Equivalence

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As shown in the above table of comparison, the subject device in this submission has the identical performance and parameter to the predicate device. And the differences between the subject device and the predicate device do not raise any new issues of safety or effectiveness.

The subject device is substantially equivalent to the predicate devices listed in function and operating principals to achieve identical results. The predicate device utilizes microprocessor controlled pumps to deliver pressurized air to bladders that are attached to the patient's extremities. Each cycle consists of inflation of air bladders, followed by a rest period during which the bladders deflate and relax without any compression.

Identical to the predicate device, the subject device has multiple audible and visual safety alarms built into the system, including low pressure alarm and low battery alarm. In addition, the cuff is comprised of multiple air bladder chambers encased in a covering of soft and non-latex medical fabric or equivalent medical material for increased patient comfort and biocompatibility compliance. The microprocessor and pump units are powered by internal rechargeable batteries, and can be connected to the main AC power line (through the battery charger / AC adaptor) while in use, allowing uninterrupted prolonged service.

The skin contact components and materials of the subject device are identical to those of the legally marketed device in K160318 and K142640 in formulation, suppliers, processing, and geometry and no other chemicals have been added (e.g., plasticizers, fillers, cleaning agents, mold release agents, etc.). Therefore, there is no issue or concern of biocompatibility.

The subject device is designed for the same intended use as the predicated device. The comparison of the specifications demonstrates the functional equivalence of the products, concluding that the subject device is substantially equivalent to the predicate device.

8. Non-Clinical Tests Performed

Non-clinical tests were performed on the subject device in order to validate the design and to assure conformance with the following voluntary design standards in connection with medical device electrical safety, and electromagnetic compatibility.

(a) ANSI AAMI ES60601-1 "Medical Electrical Equipment Part 1: General requirements for basic safety and essential performance (IEC 60601-1)".
(b) IEC 60601-1-2 "Medical Electrical Equipment Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral standard: Electromagnetic Compatibility - Requirements and Tests".

In addition to the compliance of voluntary standards, bench tests have been performed on the physical requirements, electrical requirement, and performance requirement; the verification of software used in the subject device has been carried out according to the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.

9. Conclusion

The tests and comparison performed demonstrate the subject device is substantially equivalent to the predicate device. Therefore, the subject device is as safe and effective as the predicate device that has been legally marketed in the United States.

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).