The PlasmaFlow, model PF0001, is intended to be an easy to use portable system, prescribed by a physician, for use in the home or clinical setting to help prevent the onset of DVT in patients by stimulating blood flow in the extremities (simulating muscle contractions). This device can be used to:

· Aid in the prevention of DVT;
· Enhance blood circulation;
· Diminish post-operative pain and swelling;
· Reduce wound healing time;
Aid in the treatment and healing of: stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs.
The unit can also be used as an aid in the prophylaxis for DVT by persons expecting to be stationary for long periods of time.

Device Description

The PlasmaFlow is an ambulatory, portable, light weight, prescriptive intermittent pneumatic compression system intended to provide sequential compression therapy to a patient's lower limbs. All pump control unit components are protectively enclosed in a plastic casing which is fixated to a single chamber cuff. The unit is supplied with a nonserviceable, rechargeable battery, to allow user portability, and a power supply transformer for main connection.

The PlasmaFlow is an ambulatory, portable, light weight, prescriptive device intermittent pneumatic compression system intended to provide sequential compression therapy to a patient's lower limbs. The housing on the garment is a lightweight, rechargeable battery-powered, electromechanical control unit intended to provide and digitally monitor through two LED screens the inflation cycle for enhanced circulation therapy. The controller on the sleeve allows the unit to inflate distal to proximal. It is intended to be used in the home, travel situations where altitude or lack of mobility occurs, or clinical setting by or under the direction of a medical professional to help stimulate blood flow as an aid in the prevention of deep vein thrombosis (DVT).

All pump control unit components are protectively enclosed in a plastic casing which is fixated to a single chamber cuff. The unit is supplied with a non-serviceable, rechargeable battery, to allow user portability, and a power supply transformer for main connection. The pump has two LED screens. The screen allows the prescriber and or patient to verify the pressure, the mode, and total run time.

The Patient Sleeve is a single Polyvinyl Chloride (PVC) air bladder intended to be attached directly to the patient's lower limb. It is intended to provide compression action to the tissue surrounding the venous vasculature in the calf of a patient. A compression unit with two LED screens is connected to sleeve for a completely ambulatory system. The compression unit has the ability to produce different compression modalities.

Default modality will be the same as the predicated devices, which is, a slow inflation up to 55 mmHg of air through the bladder cells. Once pressure is reached, the unit will deflate for approximately 50 seconds. Then the cycle repeats.

Another compression modality will be the step up technology that inflates the air cells at an increase of 10 mmHg pausing at increments of ten to 50 mmHg, with a final increase of 5 mmHg to 55mmHg. Once 55 mmHg is reached, the unit will decrease to 50 mmHg and then decrease in increments of 10 mmHg.

A single touch control switch located on the top of the unit powers on the unit and switches the mode.

Above the power button, a dual color LED light allows the user to verify for power on, low battery, charging and charge completed indication, and an audible alarm (for indicating a leak or low pressure alarm) provides for user interface. There is also a port for connecting the battery charger/AC adapter plug/USB chord.

The leg wrap (cuff) component consists of a Polyvinyl Chloride (PVC) air bladder encased inside a soft, non-woven medical fabric made from a Polyester blended medical fabric or equal, which is adhered to the PVC air bladder. The units are supplied clean, non-sterile, packaged in pairs.

In operation, the user simply runs the power ON via the multi-purpose control button. A single user "cuff containing air bladders is connected to the unit. The control unit then fills the cuff to a pressure of 55 mmHg. Cuff pressure is visually monitored by user pressure LED screen, internal pressure switch, and system software. Once the pressure reaches the proper level, the pump is deflated for an approximately 50 second deflate period. The device software ensures the cycle time is a minimum of 60 seconds (the cycle time is the length of time for one complete cycle on one cuff including fill time, exhaust, and relaxation time). The cycle repeats until the unit is turned off.

AI/ML Overview

This document is a 510(k) Premarket Notification for the PlasmaFlow device, which is an intermittent pneumatic compression system intended for preventing Deep Vein Thrombosis (DVT) and improving blood circulation. The submission argues for substantial equivalence to a predicate device, the Innovamed Health Venapro (K133274).

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" in the format of specific thresholds for device performance metrics. Instead, it argues for substantial equivalence by comparing the PlasmaFlow (subject device) with the Venapro (predicate device) across various characteristics and showing that they are either identical or that any differences do not raise new questions of safety or effectiveness.

However, based on the non-clinical testing performed, we can infer some performance aspects:

Acceptance Criteria (Inferred from Predicate Equivalence)	PlasmaFlow Reported Performance
Device Classification	Compressible Limb Sleeve, 21 CFR 870.5800
FDA Product Code	JOW
Function	Aids venous return by using cyclic, intermittent, pneumatic pressure application (inflation followed by deflation) to compress the lower limb(s).
Working Pressure	Mode one and Mode two are preset at 55 mmHg. (Predicate: 50 mmHg)
Cycle Time	60 seconds
System Diagnostics	Audible and visual alarms prompt recognition of system faults.
Battery Specifications	7.4 volt Li-ion battery pack rechargeable (made of 2 x 3.7 volt cells).
Sterility	Clean / non-sterile
Leg Cuff Usage	Single Patient Use
Biocompatibility	Must pass Cytotoxicity, Sensitization, and Irritation tests according to ISO 10993-1, -5, -10, -12, and USP 35.
Electrical Safety & EMC	Must conform to IEC 60601-1, AAMI ES 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-1-6, IEC 62366.
Software	Software verification and validation conducted; considered "moderate" level of concern.
Risk Management	Must conform to ISO14971, IEC 60812, ISO 13485.
Performance (Bench Testing)	Equivalent pressure delivery, cuff (bladder) fill time, cycle time and overall system performance as the predicate devices listed.
Leak Burst Pressure	Results of outside testing of pressure, leak, and burst should be similar to predicates.

2. Sample Size Used for the Test Set and Data Provenance

The submission explicitly states: "No clinical testing was performed on the PlasmaFlow to support the decision of substantial equivalence."

Therefore, there is no specific sample size or test set derived from clinical data for the PlasmaFlow device itself mentioned in this document. The data provenance related to "clinical studies" refers to results from predicate devices and not studies conducted on the PlasmaFlow. The non-clinical testing was in-house bench testing and outside laboratory testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

As no clinical testing was performed on the PlasmaFlow and no specific test set data is presented for human interpretation, this information is not applicable to the PlasmaFlow device within this 510(k) submission.

4. Adjudication Method for the Test Set

Again, since no clinical test set for human interpretation was used for the PlasmaFlow device, this information is not applicable.

5. 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

The PlasmaFlow is an intermittent pneumatic compression device, not an AI-powered diagnostic or interpretive device. Therefore, an MRMC comparative effectiveness study is not applicable as there are no "human readers" interpreting images or data with or without AI assistance in this context.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

The PlasmaFlow is a mechanical compression device, not an algorithm. Therefore, standalone algorithm performance is not applicable. The non-clinical testing (bench testing, electrical safety, EMC, etc.) can be considered "standalone" in the sense that it evaluates the device's technical performance independently.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the PlasmaFlow device based on non-clinical testing:

Bench Testing: The ground truth for performance metrics like pressure delivery, cuff fill time, and cycle time was established through objective measurements against defined specifications (e.g., 55 mmHg pressure, 60-second cycle time). These are quantifiable engineering parameters.
Biocompatibility: Ground truth was established through laboratory testing protocols (e.g., ISO 10993 series) to detect cytotoxicity, sensitization, and irritation.
Electrical Safety & EMC: Ground truth was established by conformance to international safety standards (e.g., IEC 60601 series), involving specific test procedures and measurements.
Risk Management: Conformance to quality management system standards (e.g., ISO 14971, ISO 13485).

For the clinical effectiveness for similar devices (predicates): The document refers to published clinical studies evaluating intermittent pneumatic compression devices, which would typically rely on clinical outcomes data (e.g., DVT incidence, blood flow measurements, reduction in pain/swelling). However, these studies were not specific to PlasmaFlow.

8. The Sample Size for the Training Set

As the PlasmaFlow is a mechanical medical device and not an AI/algorithm-based system requiring a "training set" of data, this concept is not applicable.

9. How the Ground Truth for the Training Set Was Established

Since a "training set" is not applicable, this information is not relevant.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract human profiles facing to the right, with flowing lines extending from their heads.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 1, 2016

ManaMed, Inc % Dave Yungvirt CEO Third Party Review Group, LLC The Old Station House 24 Lackawanna Place Millburn, NJ 07041

Re: K160318

Trade/Device Name: PlasmaFlow Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: March 17, 2016 Received: March 21, 2016

Dear Dave Yungvirt:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Fernando Aguel -
Fernando Aguel

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K160318

Device Name PlasmaFlow

Indications for Use (Describe)

· Aid in the prevention of DVT;
· Enhance blood circulation;
· Diminish post-operative pain and swelling;
· Reduce wound healing time;

· Aid in the treatment and healing of: stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs.

The unit can also be used as an aid in the prophylaxis for DVT by persons expecting to be stationary for long periods of time.

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

GENERAL INFORMATION

Applicant:

510(k) Notification: ManaMed, Inc. 287 Cabrillo St. Unit C Costa Mesa, CA 92627 U.S.A. Phone: 949-632-0355 Fax: 949-258-9900

Contact Person:

Trevor Theriot President 287 Cabrillo St. Unit C Costa Mesa, CA 92627 U.S.A. Phone: 949-632-0355 Fax: 949-258-9900

Date Prepared:

March 29, 2016

DEVICE INFORMATION:

Trade Name / Model:

PlasmaFlow / PF0001 Generic/Common Name: Compressible Limb Sleeve Device Classification: Compressible Limb Sleeve, 21 CFR 870.5800 Class: II Product Code: JOW

PREDICATE DEVICE Innovamed Health, VENAPRO

(K133274)

Reference Device Information: Cothera, VPULSE (K122640)

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Intended Use and Indications for Use of the subject device:

· Aid in the prevention of DVT;
· Enhance blood circulation;
· Diminish post-operative pain and swelling:
· Reduce wound healing time;

• Aid in the treatment and healing of: stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs.

The unit can also be used as an aid in the prophylaxis for DVT by persons expecting to be stationary for long periods of time.

Contraindications:

The PlasmaFlow must not be used to treat the following conditions:

Persons with suspected, active or untreated: deep vein thrombosis, ischemic vascular disease, severe arteriosclerosis, pulmonary edema, severe congestive heart failure, thrombophlebitis or an active infection;

On a leg where cuffs would interfere with the following conditions: vein ligation, gangrene. dermatitis, open wounds, a recent skin graft, massive edema or extreme deformity of the leg: On patients with neuropathy: On extremities that are insensitive to pain: Where increased venous or lymphatic return is undesirable.

PRODUCT DESCRIPTION:

The PlasmaFlow is an ambulatory, portable, light weight, prescriptive device intermittent pneumatic compression system intended to provide sequential compression therapy to a patient's lower limbs. The housing on the garment is a lightweight, rechargeable batterypowered, electromechanical control unit intended to provide and digitally monitor through two LED screens the inflation cycle for enhanced circulation therapy. The controller on the sleeve allows the unit to inflate distal to proximal. It is intended to be used in the home, travel situations where altitude or lack of mobility occurs, or clinical setting by or under the direction of a medical professional to help stimulate blood flow as an aid in the prevention of deep vein thrombosis (DVT).

The Patient Sleeve is a single Polyvinyl Chloride (PVC) air bladder intended to be

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attached directly to the patient's lower limb. It is intended to provide compression action to the tissue surrounding the venous vasculature in the calf of a patient. A compression unit with two LED screens is connected to sleeve for a completely ambulatory system. The compression unit has the ability to produce different compression modalities.

A single touch control switch located on the top of the unit powers on the unit and switches the mode.

SUBSTANTIAL EQUIVALENCE:

The intended for use for the PlasmaFlow are substantially equivalent to the proposed indications for use for the predicate device. Any differences in the technological characteristics between the devices do not raise any new issues of safety or effectiveness. Thus, the PlasmaFlow is substantially equivalent to the predicate device. A comparison of the main characteristics and features of these devices is provided as a table formant and detailed discussion.

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Compression Sleeve Device
Characteristics /Features	PlasmaFlowSubject Device	VenaproPredicate (K133274)	Comments
COMPARISON OF GENERAL INFORMATION / USES AND INDICATIONS
Photograph	Image: PlasmaFlow Subject Device	Image: Venapro Predicate (K133274)	For InformationPurposes only
FDA DeviceDescription	Compressible LimbSleeve, 21 CFR870.5800	Compressible LimbSleeve, 21 CFR870.5800	Identical;thereforesubstantiallyequivalent.
FDA Product Code	JOW	JOW	Identical;thereforesubstantiallyequivalent.
Function	Aids venous returnby using cyclic,intermittent,pneumatic pressureapplication (inflationfollowed bydeflation) tocompress the lowerlimb(s).	Aids venous return byusing cyclic,intermittent,pneumatic pressureapplication (inflationfollowed by deflation)to compress the lowerlimb(s).
Indications for use	The PlasmaFlow, modelPF0001, is intended to bean easy to use portablesystem, prescribed by aphysician, for use in thehome or clinical setting tohelp prevent the onset ofDVT in patients bystimulating blood flow inthe extremities(simulating musclecontractions). This devicecan be used to:• Aid in the prevention ofDVT;• Enhance bloodcirculation;• Diminish post-operativepain and swelling;• Reduce wound healingtime;• Aid in the treatment andhealing of: stasis	•The Vena Pro VascularTherapy System, modelVP-31 II, is intended to bean easy to use portablesystem, prescribed by aphysician, for use in thehome or clinical setting tohelp prevent the onset ofDVT in patients bystimulating blood flow inthe extremities (simulatingmuscle contractions). Thisdevice can be used to:* Aid in the prevention ofDVT;* Enhance bloodcirculation:* Diminish post-operativepain and swelling;* Reduce wound healingtime;* Aid in the treatment andhealing of: stasis	Identical exceptfor brandingissues; thereforesubstantiallyequivalent.
			Compression Sleeve Device
	ulcers, arterial anddiabetic leg ulcers,chronic venousinsufficiency andreduction of edema in thelower limbs.The unit can also be usedas an aid in theprophylaxis for DVT bypersons expecting to bestationary for long periodsof time.	ulcers, arterial and diabeticleg ulcers, chronic venousinsufficiency andreduction of edema in thelower limbs.The unit can also be usedas an aid in theprophylaxis for DVT bypersons expecting to bestationary for long periodsof time.
Contraindication(s)	The PlasmaFlow mustnot be used to treat thefollowing conditions:Persons with suspected,active or untreated:deep vein thrombosis,ischemic vasculardisease, severearteriosclerosis,pulmonary edema,severe congestive heartfailure,thrombophlebitis or anactive infection;On a leg where cuffswould interfere with thefollowing conditions:vein ligation, gangrene,dermatitis, openwounds, a recent skingraft, massive edema orextreme deformity ofthe leg; On patientswith neuropathy; Onextremities that areinsensitive to pain;Where increasedvenous or lymphaticreturn is undesirable.	The VenaPro MUSTNOT be used to treat thefollowing conditions:Persons with suspected,active or untreated: deepvein thrombosis,ischemic vasculardisease, severearteriosclerosis,pulmonary edema,severe congestive heartfailure,thrombophlebitis, or anactive infection.On the legs where cuffswould interfere with thefollowing conditions:vein ligation, gangrene,dermatitis, openwounds, a recent skingraft, massive edema orextreme deformity ofthe leg. On anyneuropathy. Onextremities that areinsensitive to pain.Where increased venousor lymphatic return isundesirable.	Identical;thereforesubstantiallyequivalent.
Target Population /Intended Users	Patients who needvenous return.	Patients who needvenous return.	Identical;thereforesubstantiallyequivalent.
Where Used	Home, Hospital,Surgery Center,	Home, Hospital,Surgery Center,	Identical;thereforesubstantiallyequivalent.
Application	Altitude travel, areas of limited mobility	Altitude travel, areas of limited mobility	Compression Sleeve Device
	Non-invasive / external	Non-invasive / external	substantiallyequivalent.Identical;thereforesubstantiallyequivalent.
Portability	Portable, ambulant	Portable, ambulant	Identical;thereforesubstantiallyequivalent.
Basis of operation	Aids venous return by using cyclic, intermittent, pneumatic pressure application (inflation followed by deflation) to compress the lower limb(s).	Aids venous return by using cyclic, intermittent, pneumatic pressure application (inflation followed by deflation) to compress the lower limb(s).	Identical;thereforesubstantiallyequivalent.
Anatomical Site /Location of treatmentapplication	Lower limb(s) (Calf)	Lower limb(s) (Calf)	Identical;thereforesubstantiallyequivalent.
Systemmanagement	Electronic, microprocessor controlled	Electronic, microprocessor controlled	Identical; exceptfor differentmicroprocessordesign; thereforesubstantiallyequivalent.
Pressure Source	Micro pumpcontrolled byelectronic processor	Micro pumpcontrolled byelectronic processor	Identical; exceptfor different pumpdesign; thereforesubstantiallyequivalent.
Operating Modes	Mode 1Mode 2	Default mode one	Identical; except formultiple modes;thereforesubstantiallyequivalent.Reference deviceVPULSE(K122640) hasmultiple modes ofcompression andsupports multiplemodes used in
			Compression Sleeve Device
Working Pressure	Mode one and Modetwo are preset at 55mmHg	Default mode is presetat 50 mmHg	Identical to thepredicate exceptthat PlasmaFlowreaches maxpressure of55mmHg.Reference deviceVPULSE(K122640) supportshigher pressure andclaims 60 mmHg ofpressure. ThereforeSubstantiallyEquivalent
Cycle Time	60 seconds	60 seconds	Identical to thepredicate. ThereforeSubstantiallyEquivalent
System diagnostics	Audible and visualalarms promptrecognition of systemfaults	Audible and visualalarms promptrecognition of systemfaults	Identical to thepredicate. ThereforeSubstantiallyEquivalent
Modes	2 different modes	1 Modality	Identical; except formultiple modes;therefore substantiallyequivalent.
BatterySpecifications	7.4 volt Li-ion batterypack rechargeable	7.4 volt Li-ion batterypack rechargeable	Identical; thereforesubstantiallyequivalent.
Internalrechargeablebatteries	Yes	Yes	Identical; thereforesubstantiallyequivalent.
Air delivery frompump to cuff bladder	Via flexible plastic(PVC) tube(s)connected directly tothe air bladder.	Via flexible plastic(PVC) tube(s)connected directly to theair bladder.	Identical; thereforesubstantiallyequivalent.
Sterility	Clean / non-sterile	Clean / non-sterile	Identical; thereforesubstantiallyequivalent.
Leg cuff usage	Single Patient Use	Single Patient Use	Identical; thereforesubstantiallyequivalent.
Material Used	Single bladder PVCchambers encased in acovering of soft, non-latex, non-woven medicalfabric (a Polyester blend)or equivalent medicalmaterial for increasedpatient comfort and	Single bladder PVCchambers encased in acovering of soft, non-latex, non-woven medicalfabric (a Polyester blend)or equivalent medicalmaterial for increasedpatient comfort and	Identical; exceptfor fabricthickness, color,and feel is different;does not pose a riskin safety oreffectiveness as itpassed current
			Model Name: PlasmaFlowCompression Sleeve Device
	biocompatibilitycompliance. Greycolored, stitched, andthick. Material doesnot raise any questionof safety oreffectiveness.	biocompatibilitycompliance. Whitecolored, glued, andthin.	testing standards;thereforesubstantiallyequivalent.
	Comparison of Applicable Standards
Biocompatibility	Equivalent to predicateconfirming withoutside testing results.	Passed or N/A	Identical; exceptfor testing resultsand facilities notavailable forpredicate butstandards fordevice are similarand it isdeterminedpredicate hadsame testingstandards;thereforesubstantiallyequivalent.
Software	Moderate	N/A	Identical; exceptfor testing resultsand facilities notavailable forpredicate butstandards fordevice are similarand it isdeterminedpredicate hadsame testingstandards;thereforesubstantiallyequivalent.
Standards Met	Equivalent to predicateconfirming withoutside testing results.	Passed or N/A	Identical; exceptfor testing resultsand facilities notavailable forpredicate butstandards fordevice are similarand it is
Model Name: PlasmaFlowCompression Sleeve Device
Electrical SafetyMechanical SafetyChemical SafetyThermal SafetyRadiation Safety	Equivalent to predicateconfirming withoutside testing results.Safety also confirmedin our risk assessmentand usabilitydocument.	Passed or N/A	determinedpredicate hadsame testingstandards;thereforesubstantiallyequivalent.Identical; exceptfor testing resultsand facilities notavailable forpredicate butstandards fordevice are similarand it isdeterminedpredicate hadsame testingstandards;thereforesubstantiallyequivalent.
Labeling,Packaging, andsterilizationStandards	Substantial Equivalent	Substantial Equivalent	Identical; exceptfor design ofdocuments andword choice; doesnot pose a dangerto device safety oreffectiveness;thereforesubstantiallyequivalent.
Technical Data
Dimensions	23" x 10.25" x 1.5"(58cm x 26cm x 4cm)	N/A	Identical to thepredicate exceptthat PlasmaFlowmeasurementspertain to the unitand the sleeve;whereas, Venapromeasured only themain unit.ThereforeSubstantiallyEquivalent
Weight: Approx.	1.43 lb (.65 kg)	0.5 lb (0.227 kg)	Identical to the
			Compression Sleeve Device
			predicate exceptthat PlasmaFlowweight pertains toboth units and thesleeves; whereas,Venapro weighedonly the mainunit, weights aresimilar. ThereforeSubstantiallyEquivalent
Source of Power	DC 8.4V or InnerBattery (7.4 volt Li-ionbatterypack—made up of 2 x3.7 volt cells)	7.4 volt Li-ion batterypack (made up of 2 -3.7 volt cells)	Identical to thepredicate.ThereforeSubstantiallyEquivalent
Power Supply	Class II, input: 100 -240 Vac, 50 - 60 Hz,output: 8.4V @ 1Amp)	Class II, input: 100 -240 Vac, 50 - 60 Hz,output: 10 Vdc @ 1.1Amp)	Identical to thepredicate.ThereforeSubstantiallyEquivalent
Temperature	+10°C (50°F) to +40°C(104°F)	+10 Degrees C (50Degrees F) to +40degrees C (104 degreesF)	Identical to thepredicate.ThereforeSubstantiallyEquivalent
Humidity	30%-75%. Keep dry.	30%-75%	Identical to thepredicate.ThereforeSubstantiallyEquivalent
Tolerances	5%	Pressure 5%	Identical to thepredicate.ThereforeSubstantiallyEquivalent
Battery Charge	Approximately4-5hours	Takes approximately 6hours (fromdepleted state).	Identical to thepredicate exceptthat PlasmaFlowclaims full chargebattery between 4-5 hours.ThereforeSubstantiallyEquivalent
Cleaning and Disinfecting
Cleaning andDisinfecting			Compression Sleeve Device
	• Clean the outersurface of the pumpunit using a softcloth, moistened withsoapy water or 70%isopropyl alcohol. Airdry only.Clean the exterior ofthe cuffs using a softcloth, moistened withsoapy water or 70%isopropyl alcohol. Airdry.Unit must becompletely dry priorto use. To ensure that,leave the device inthe OFF position anddisconnected fromthe wall outlet for atleast 30 minutes (andas long as necessaryfor the unit to drycompletely) aftercleaning ordisinfecting.Do not remove thepump unit from thecuff..Do not place cuffs indryer or microwave.Do not use hair dryerto accelerate drying.Do not place thedevice on top or infront of portablestationary radiators toaccelerate drying.Do not use abrasivecleaners.	• Clean the outersurface of the pumpunit using a soft cloth,moistened with soapywater or 70%isopropyl alcohol.• Do not use abrasiveor volatile cleaners.• Do not place cuffs indryer.• NEVER remove theunit from the cuff.• Hand wash theexterior of the cuffsusing a soft cloth,moistened with soapywater or 70%isopropyl alcohol andlet air dry.• To ensure the unit IScompletely dry priorto use, leave unit inthe OFFcondition anddisconnected from thewall outlet for 30minutes after cleaningor disinfecting.	Identical to thepredicate exceptword choice andorder; thereforeSubstantiallyEquivalent
Disposal	This unit is anelectromechanicaldevice that includesprinted circuit boardsand rechargeable	This unit is anelectromechanicaldevice that includesprinted circuit boardsand rechargeable	Identical to thepredicate.ThereforeSubstantiallyEquivalent
batteries. Do not	batteries.
discard in landfill.Consult local countyrequirements for properdisposal instructions.Pump control unitscontain rechargeablebatteries. Do notdiscard the pump unitin regular waste.Bring the unit to yourlocal recycle center orcontact ManaMed.	Do not discard inlandfill. Consult localcounty requirements forproper disposalinstructions.Pump control unitscontain rechargeablebatteries. Do not discardthe pump unit in regularwaste. Bring the unit toyour local recyclecenter or contactInnovaMed Health.

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ManaMed Inc.

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The PlasmaFlow is substantially equivalent to the predicate devices listed in function and operating principals to achieve identical results. The predicate system (VENAPRO-K133274) utilize microprocessor controlled pumps to deliver approximately 50 mmHg of pressurized air to bladders that are attached to the patient's lower limbs, using a cycle time of approximately 60 seconds / leg. Each cycle consists of inflation of a bladder, followed by a rest period during which the bladder deflates and the limb relaxes without any compression.

Multiple audible and visual safety alarms are built into the system, similar to those built into the Venapro, including; Low pressure alarms, low battery alarm and system malfunction overpressure safety alarm.

Cycle and maximum fill times are available in 2 different modes. The default settings are similar to predicate devices in fill time, cycle time and pressure settings. The default pressure setting for the wraps are factory preset at approximately 55 mmHg and cannot be adjusted.

The PlasmaFlow uses similar means for pressure delivery to the cuffs as the predicate devices. Pressurized air is delivered by the pump to the cuffs using an air pump and circuit board that has up to 5 modalities. One unique modality to the PlasmaFlow is step up technology which is modality two. Modality two increases in increments of 10 and stops at 55. Then it decreases in increments of ten.

Unlike Venapro, the PlasmaFlow units visually verify the mmHz through the dual LED screen technology.

Like the VenaPro the PlasmaFlow cuffs are comprised of single bladder PVC chambers encased in a covering of soft, non-latex, non-woven medical fabric (a Polyester blend) or equivalent medical material for increased patient comfort and biocompatibility compliance.

As with the Venapro system, 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.

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The PlasmaFlow is designed for the same intended use as the predicated device such as the Venapro. The comparison of the specifications demonstrates the functional equivalence of the products. ManaMed Inc. concludes that the PlasmaFlow is substantially equivalent and performs in a manner that is substantially equivalent to predicated devices.

Non-Clinical Testing:

Non-clinical validation, including electrical safety, EMC, Usability, Risk Analysis, mechanical integrity, environmental and life cycle testing have shown that the PlasmaFlow has performance characteristics substantially equivalent to or surpassing those of the listed predicate devices. Inhouse bench testing has verified equivalent pressure delivery, cuff (bladder) fill time, cycle time and overall system performance as the predicate devices listed. The results from these nonclinical tests demonstrated that the proposed PlasmaFlow meets design, safety and performance requirements; and does not raise any new concerns of safety and effectiveness.

Testing Item	Standard and RegulationsApplied	Comments
Biocompatibility	ISO 10993-1:2009/Cor.1:2010(E) Biologicalevaluation of medical devices- Part 1: Evaluation andtesting with a riskmanagement process.ISO 10993-5:2009 (E)Biological evaluation ofmedical devices - Part 5:Tests for in vitro cytotoxicity.ISO 10993-10:2010(E)Biological evaluation ofmedical devices - Part 10:Tests for Tests for irritationand skin sensitization.ISO 10993-12: 2012Biological Evaluation OfMedical Devices -- Part 12:Sample Preparation AndReference Materials.	Biocompatibility testsfor PlasmaFlowPF0001 wereperformed.PlasmaFlow passedCytotoxicity,Sensitization, andIrritation tests.
	ISO/IEC 17025:2005 GeneralRequirements for theCompetence of Testing andCalibration Laboratories.

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	USP 35 Biological reactivitytests, in vitro	Compression Sleeve Device
Electromagnetic Compatibilityand Electrical Safety	IEC 60601-1: 2005-12, 3rdEdition +A1:2012 – medicalelectrical equipment – part 1:General Requirements forbasic safety and essentialperformanceAAMI ES 60601-1: 2005+A1: 2012 – Medicalelectrical equipment – Part 1:General Requirements forbasic safety and essentialperformance - DeviationsfromIEC 60601-1: 2005IEC 60601-1-2 Edition3:2007-03 Medical electricalequipment - Part 1-2: Generalrequirements for basic safetyand essential performance -Collateral standard:Electromagnetic compatibility-Requirements and tests.(EN 60601-1-2)IEC 60601-1-11: 2010 –medical electrical equipment –part 1-11: Generalrequirements for basic safetyand essential performance –collateral standard:requirements for medicalelectrical equipment and	EMC tests wereconducted accordingto the same standardsas the predicate.
	medical electrical systemsused in the home healthcareenvironment (EN 60601-1-11:2010)IEC 60601-1-6 2010 3rdedition Medical electricalequipment Part 1-6: Generalrequirements for safety –collateral standard: UsabilityIEC 62366: 2007 +A1: 2014 -Medical Devices –Application of usabilityengineering to medicaldevices (EN 62366: 2008)	Compression Sleeve Device
Software	Software verification andvalidation was conducted anddocumentation is provided.The software was consideredas a “moderate” level ofconcern, since a failure orlatent flaw in the softwarecould directly result in seriousinjury to the patient oroperator.
Risk Management	ISO14971 Medical Devices -Application Of RiskManagement To MedicalDevices. (General I (QS/RM))IEC 60812 AnalysisTechniques for SystemReliability – Procedure forFailure Mode and EffectsAnalysisISO 13485: 2003 – MedicalDevices – Qualitymanagement systems –requirements for regulatorypurposes	Manufacturing wasconsistent with therequired mechanismsfor change control,identification, andtraceability. The riskmanagement documentexemplifies theprocess of controls inplace.
Performance	Pressure delivery, cuff (bladder)fill time, cycle time and overallsystem performance as thepredicate devices listed
Leak Burst Pressure Testing	Outside testing of pressure, leak,
	and burst. Results included withfull validation and similar withpredicates.

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Clinical Testing:

No clinical testing was performed on the PlasmaFlow to support the decision of substantial equivalence; however, test results of some predicate devices have been compared in the following published clinical studies:

Evaluation of Intermittent Pneumatic Compression Devices (Orthopedics 24(3):257-261, 2001);

Venous hemodynamics after total knee arthroplasty: Evaluation of active dorsal to planar flexion and several mechanical compression devices (Journal of Bone and Joint Surgery, November 1998)

A Mobile Compression Device for Thrombosis Prevention in Hip and Knee Arthroplasty (Journal of Bone and Joint Surgery, 2014)

SUMMARY:

The PlasmaFlow is designed for the same intended use as the predicated device such as the VENAPRO. The comparison of the specifications demonstrates the functional equivalence of the products. ManaMed Inc. concludes that the PlasmaFlow is substantially equivalent and performs in a manner that is substantially equivalent to predicated devices.

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).