PlasmaFlow

K160318 · Manamed, Inc. · JOW · Apr 1, 2016 · Cardiovascular

Device Facts

• Record ID: K160318
• Device Name: PlasmaFlow
• Applicant: Manamed, Inc.
• Product Code: JOW · Cardiovascular
• Decision Date: Apr 1, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5800
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

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 Story

PlasmaFlow is a portable, battery-powered, intermittent pneumatic compression system for lower limbs. It consists of a control unit in a plastic casing attached to a single-chamber PVC air bladder cuff. Operated by a physician or patient in home/clinical settings, it stimulates blood flow by simulating muscle contractions. The device inflates the cuff to 55 mmHg, followed by a 50-second deflation period, repeating in a 60-second cycle. It features two LED screens for monitoring pressure, mode, and run time, and includes audible/visual alarms for leaks or low pressure. The device offers two compression modalities: a standard mode and a 'step-up' mode that increases pressure in 10 mmHg increments. It is powered by a rechargeable Li-ion battery or AC adapter. By enhancing venous return, it aids in DVT prophylaxis, pain/swelling reduction, and wound healing. The system is non-sterile and intended for single-patient use.

Clinical Evidence

No clinical testing was performed. Substantial equivalence is supported by non-clinical bench testing, including electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), usability (IEC 62366), biocompatibility (ISO 10993), and mechanical performance (pressure delivery, leak/burst testing).

Technological Characteristics

System: Microprocessor-controlled intermittent pneumatic compression. Materials: PVC air bladder, Polyester-blend non-woven fabric cuff. Energy: 7.4V Li-ion rechargeable battery or AC power (100-240V). Dimensions: 58cm x 26cm x 4cm. Connectivity: Standalone, LED status/pressure display. Sterilization: Non-sterile. Software: Moderate level of concern, embedded firmware.

Indications for Use

Indicated for patients requiring venous return stimulation to prevent DVT, enhance circulation, reduce post-op pain/swelling, improve wound healing, or treat venous/arterial/diabetic ulcers, chronic venous insufficiency, and lower limb edema. Contraindicated for patients with suspected/active DVT, ischemic vascular disease, severe arteriosclerosis, pulmonary edema, severe congestive heart failure, thrombophlebitis, active infection, neuropathy, insensitive extremities, or conditions where increased venous/lymphatic return is undesirable (e.g., vein ligation, gangrene, dermatitis, open wounds, recent skin grafts, massive edema, extreme deformity).

Regulatory Classification

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.

Predicate Devices

• Innovamed Health, VENAPRO (K133274)

Reference Devices

• Cothera, VPULSE (K122640)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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)

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.

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: [phone] Fax: [phone]

### Contact Person:

Trevor Theriot President 287 Cabrillo St. Unit C Costa Mesa, CA 92627 U.S.A. Phone: [phone] Fax: [phone]

### Date Prepared:

March 29, 2016

### DEVICE INFORMATION:

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.

#### 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:

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.

## 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).

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

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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.

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.

### 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 /<br>Features | PlasmaFlow<br>Subject Device | Venapro<br>Predicate (K133274) | Comments |
| COMPARISON OF GENERAL INFORMATION / USES AND INDICATIONS | | | |
| Photograph | Image: PlasmaFlow Subject Device | Image: Venapro Predicate (K133274) | For Information<br>Purposes only |
| FDA Device<br>Description | Compressible Limb<br>Sleeve, 21 CFR<br>870.5800 | Compressible Limb<br>Sleeve, 21 CFR<br>870.5800 | Identical;<br>therefore<br>substantially<br>equivalent. |
| FDA Product Code | JOW | JOW | Identical;<br>therefore<br>substantially<br>equivalent. |
| Function | Aids venous return<br>by using cyclic,<br>intermittent,<br>pneumatic pressure<br>application (inflation<br>followed by<br>deflation) to<br>compress the lower<br>limb(s). | Aids venous return by<br>using cyclic,<br>intermittent,<br>pneumatic pressure<br>application (inflation<br>followed by deflation)<br>to compress the lower<br>limb(s). | |
| Indications for use | The PlasmaFlow, model<br>PF0001, is intended to be<br>an easy to use portable<br>system, prescribed by a<br>physician, for use in the<br>home or clinical setting to<br>help prevent the onset of<br>DVT in patients by<br>stimulating blood flow in<br>the extremities<br>(simulating muscle<br>contractions). This device<br>can be used to:<br>• Aid in the prevention of<br>DVT;<br>• Enhance blood<br>circulation;<br>• Diminish post-operative<br>pain and swelling;<br>• Reduce wound healing<br>time;<br>• Aid in the treatment and<br>healing of: stasis | •The Vena Pro Vascular<br>Therapy System, model<br>VP-31 II, is intended to be<br>an easy to use portable<br>system, prescribed by a<br>physician, for use in the<br>home or clinical setting to<br>help prevent the onset of<br>DVT in patients by<br>stimulating blood flow in<br>the extremities (simulating<br>muscle contractions). This<br>device can be used to:<br>* Aid in the prevention of<br>DVT;<br>* Enhance blood<br>circulation:<br>* Diminish post-operative<br>pain and swelling;<br>* Reduce wound healing<br>time;<br>* Aid in the treatment and<br>healing of: stasis | Identical except<br>for branding<br>issues; therefore<br>substantially<br>equivalent. |
| | | | Compression Sleeve Device |
| | ulcers, arterial and<br>diabetic leg ulcers,<br>chronic venous<br>insufficiency and<br>reduction of edema in the<br>lower limbs.<br>The unit can also be used<br>as an aid in the<br>prophylaxis for DVT by<br>persons expecting to be<br>stationary for long periods<br>of time. | ulcers, arterial and diabetic<br>leg ulcers, chronic venous<br>insufficiency and<br>reduction of edema in the<br>lower limbs.<br>The unit can also be used<br>as an aid in the<br>prophylaxis for DVT by<br>persons expecting to be<br>stationary for long periods<br>of time. | |
| Contraindication(s) | The PlasmaFlow must<br>not be used to treat the<br>following conditions:<br>Persons with suspected,<br>active or untreated:<br>deep vein thrombosis,<br>ischemic vascular<br>disease, severe<br>arteriosclerosis,<br>pulmonary edema,<br>severe congestive heart<br>failure,<br>thrombophlebitis or an<br>active infection;<br>On a leg where cuffs<br>would interfere with the<br>following conditions:<br>vein ligation, gangrene,<br>dermatitis, open<br>wounds, a recent skin<br>graft, massive edema or<br>extreme deformity of<br>the leg; On patients<br>with neuropathy; On<br>extremities that are<br>insensitive to pain;<br>Where increased<br>venous or lymphatic<br>return is undesirable. | The VenaPro MUST<br>NOT be used to treat the<br>following conditions:<br>Persons with suspected,<br>active or untreated: deep<br>vein thrombosis,<br>ischemic vascular<br>disease, severe<br>arteriosclerosis,<br>pulmonary edema,<br>severe congestive heart<br>failure,<br>thrombophlebitis, or an<br>active infection.<br>On the legs where cuffs<br>would interfere with the<br>following conditions:<br>vein ligation, gangrene,<br>dermatitis, open<br>wounds, a recent skin<br>graft, massive edema or<br>extreme deformity of<br>the leg. On any<br>neuropathy. On<br>extremities that are<br>insensitive to pain.<br>Where increased venous<br>or lymphatic return is<br>undesirable. | Identical;<br>therefore<br>substantially<br>equivalent. |
| Target Population /<br>Intended Users | Patients who need<br>venous return. | Patients who need<br>venous return. | Identical;<br>therefore<br>substantially<br>equivalent. |
| Where Used | Home, Hospital,<br>Surgery Center, | Home, Hospital,<br>Surgery Center, | Identical;<br>therefore<br>substantially<br>equivalent. |
| Application | Altitude travel, areas of limited mobility | Altitude travel, areas of limited mobility | Compression Sleeve Device |
| | Non-invasive / external | Non-invasive / external | substantially<br>equivalent.<br>Identical;<br>therefore<br>substantially<br>equivalent. |
| Portability | Portable, ambulant | Portable, ambulant | Identical;<br>therefore<br>substantially<br>equivalent. |
| 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;<br>therefore<br>substantially<br>equivalent. |
| Anatomical Site /<br>Location of treatment<br>application | Lower limb(s) (Calf) | Lower limb(s) (Calf) | Identical;<br>therefore<br>substantially<br>equivalent. |
| System<br>management | Electronic, microprocessor controlled | Electronic, microprocessor controlled | Identical; except<br>for different<br>microprocessor<br>design; therefore<br>substantially<br>equivalent. |
| Pressure Source | Micro pump<br>controlled by<br>electronic processor | Micro pump<br>controlled by<br>electronic processor | Identical; except<br>for different pump<br>design; therefore<br>substantially<br>equivalent. |
| Operating Modes | Mode 1<br>Mode 2 | Default mode one | Identical; except for<br>multiple modes;<br>therefore<br>substantially<br>equivalent.<br>Reference device<br>VPULSE<br>(K122640) has<br>multiple modes of<br>compression and<br>supports multiple<br>modes used in |
| | | | Compression Sleeve Device |
| Working Pressure | Mode one and Mode<br>two are preset at 55<br>mmHg | Default mode is preset<br>at 50 mmHg | Identical to the<br>predicate except<br>that PlasmaFlow<br>reaches max<br>pressure of<br>55mmHg.<br>Reference device<br><i>VPULSE</i><br>(K122640) supports<br>higher pressure and<br>claims 60 mmHg of<br>pressure. Therefore<br>Substantially<br>Equivalent |
| Cycle Time | 60 seconds | 60 seconds | Identical to the<br>predicate. Therefore<br>Substantially<br>Equivalent |
| System diagnostics | Audible and visual<br>alarms prompt<br>recognition of system<br>faults | Audible and visual<br>alarms prompt<br>recognition of system<br>faults | Identical to the<br>predicate. Therefore<br>Substantially<br>Equivalent |
| Modes | 2 different modes | 1 Modality | Identical; except for<br>multiple modes;<br>therefore substantially<br>equivalent. |
| Battery<br>Specifications | 7.4 volt Li-ion battery<br>pack rechargeable | 7.4 volt Li-ion battery<br>pack rechargeable | Identical; therefore<br>substantially<br>equivalent. |
| Internal<br>rechargeable<br>batteries | Yes | Yes | Identical; therefore<br>substantially<br>equivalent. |
| Air delivery from<br>pump to cuff bladder | Via flexible plastic<br>(PVC) tube(s)<br>connected directly to<br>the air bladder. | Via flexible plastic<br>(PVC) tube(s)<br>connected directly to the<br>air bladder. | Identical; therefore<br>substantially<br>equivalent. |
| Sterility | Clean / non-sterile…