(56 days)
No
The document describes a simple electromechanical device with basic digital monitoring and control based on pressure and time, with no mention of AI or ML.
Yes
The device is intended to aid in the prevention and treatment of various medical conditions, including DVT, post-operative pain and swelling, wound healing, stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency, and edema.
No
The device is intended for therapeutic purposes like preventing DVT, enhancing circulation, and reducing pain/swelling, not for diagnosing conditions.
No
The device description clearly outlines hardware components including a plastic casing, rechargeable battery, power supply transformer, LED screens, a single touch control switch, a dual color LED light, a port for connecting the battery charger/AC adapter plug/USB chord, and a PVC air bladder encased in medical fabric. While software is mentioned for monitoring and controlling the inflation cycle, it is integral to the function of the physical device.
Based on the provided information, the PlasmaFlow, model PF0001, is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- PlasmaFlow's Function: The PlasmaFlow is a mechanical device that applies external pressure to the lower limbs to stimulate blood flow. It does not analyze any biological samples from the patient.
- Intended Use: The intended use clearly states its purpose is to prevent DVT by stimulating blood flow and aiding in the treatment of various circulatory conditions through mechanical compression.
- Device Description: The description details a pneumatic compression system with cuffs and a control unit, not equipment for analyzing biological specimens.
Therefore, the PlasmaFlow is a therapeutic medical device, specifically an intermittent pneumatic compression system, and does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
JOW
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Lower limb(s) (Calf)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Home, Hospital, Surgery Center, or under the direction of a medical professional.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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
1
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
2
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(K) Summary
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:
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)
4
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
5
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.
6
| Compression Sleeve Device | |||
|---|---|---|---|
| Characteristics / | |||
| Features | PlasmaFlow | ||
| Subject Device | Venapro | ||
| Predicate (K133274) | Comments | ||
| COMPARISON OF GENERAL INFORMATION / USES AND INDICATIONS | |||
| Photograph | Image: PlasmaFlow Subject Device | Image: Venapro Predicate (K133274) | For Information |
| Purposes only | |||
| FDA Device | |||
| Description | Compressible Limb | ||
| Sleeve, 21 CFR | |||
| 870.5800 | Compressible Limb | ||
| Sleeve, 21 CFR | |||
| 870.5800 | Identical; | ||
| therefore | |||
| substantially | |||
| equivalent. | |||
| FDA Product Code | JOW | JOW | Identical; |
| therefore | |||
| substantially | |||
| equivalent. | |||
| Function | 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). | |||
| Indications for 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 | •The Vena Pro Vascular | ||
| Therapy System, model | |||
| VP-31 II, 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 | Identical except
for branding
issues; therefore
substantially
equivalent. |
| | | | Compression Sleeve Device |
| | 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. | 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. | |
| Contraindication(s) | 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. | The VenaPro 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 the legs 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 any
neuropathy. On
extremities that are
insensitive to pain.
Where increased venous
or lymphatic return is
undesirable. | Identical;
therefore
substantially
equivalent. |
| Target Population /
Intended Users | Patients who need
venous return. | Patients who need
venous return. | Identical;
therefore
substantially
equivalent. |
| Where Used | Home, Hospital,
Surgery Center, | Home, Hospital,
Surgery Center, | Identical;
therefore
substantially
equivalent. |
| Application | Altitude travel, areas of limited mobility | Altitude travel, areas of limited mobility | Compression Sleeve Device |
| | Non-invasive / external | Non-invasive / external | substantially
equivalent.
Identical;
therefore
substantially
equivalent. |
| Portability | Portable, ambulant | Portable, ambulant | Identical;
therefore
substantially
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;
therefore
substantially
equivalent. |
| Anatomical Site /
Location of treatment
application | Lower limb(s) (Calf) | Lower limb(s) (Calf) | Identical;
therefore
substantially
equivalent. |
| System
management | Electronic, microprocessor controlled | Electronic, microprocessor controlled | Identical; except
for different
microprocessor
design; therefore
substantially
equivalent. |
| Pressure Source | Micro pump
controlled by
electronic processor | Micro pump
controlled by
electronic processor | Identical; except
for different pump
design; therefore
substantially
equivalent. |
| Operating Modes | Mode 1
Mode 2 | Default mode one | Identical; except for
multiple modes;
therefore
substantially
equivalent.
Reference device
VPULSE
(K122640) has
multiple modes of
compression and
supports multiple
modes used in |
| | | | Compression Sleeve Device |
| Working Pressure | Mode one and Mode
two are preset at 55
mmHg | Default mode is preset
at 50 mmHg | Identical to the
predicate except
that PlasmaFlow
reaches max
pressure of
55mmHg.
Reference device
VPULSE
(K122640) supports
higher pressure and
claims 60 mmHg of
pressure. Therefore
Substantially
Equivalent |
| Cycle Time | 60 seconds | 60 seconds | Identical to the
predicate. Therefore
Substantially
Equivalent |
| System diagnostics | Audible and visual
alarms prompt
recognition of system
faults | Audible and visual
alarms prompt
recognition of system
faults | Identical to the
predicate. Therefore
Substantially
Equivalent |
| Modes | 2 different modes | 1 Modality | Identical; except for
multiple modes;
therefore substantially
equivalent. |
| Battery
Specifications | 7.4 volt Li-ion battery
pack rechargeable | 7.4 volt Li-ion battery
pack rechargeable | Identical; therefore
substantially
equivalent. |
| Internal
rechargeable
batteries | Yes | Yes | Identical; therefore
substantially
equivalent. |
| Air delivery from
pump to cuff bladder | Via flexible plastic
(PVC) tube(s)
connected directly to
the air bladder. | Via flexible plastic
(PVC) tube(s)
connected directly to the
air bladder. | Identical; therefore
substantially
equivalent. |
| Sterility | Clean / non-sterile | Clean / non-sterile | Identical; therefore
substantially
equivalent. |
| Leg cuff usage | Single Patient Use | Single Patient Use | Identical; therefore
substantially
equivalent. |
| Material Used | 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 | 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 | Identical; except
for fabric
thickness, color,
and feel is different;
does not pose a risk
in safety or
effectiveness as it
passed current |
| | | | Model Name: PlasmaFlow
Compression Sleeve Device |
| | biocompatibility
compliance. Grey
colored, stitched, and
thick. Material does
not raise any question
of safety or
effectiveness. | biocompatibility
compliance. White
colored, glued, and
thin. | testing standards;
therefore
substantially
equivalent. |
| | Comparison of Applicable Standards | | |
| Biocompatibility | Equivalent to predicate
confirming with
outside testing results. | Passed or N/A | Identical; except
for testing results
and facilities not
available for
predicate but
standards for
device are similar
and it is
determined
predicate had
same testing
standards;
therefore
substantially
equivalent. |
| Software | Moderate | N/A | Identical; except
for testing results
and facilities not
available for
predicate but
standards for
device are similar
and it is
determined
predicate had
same testing
standards;
therefore
substantially
equivalent. |
| Standards Met | Equivalent to predicate
confirming with
outside testing results. | Passed or N/A | Identical; except
for testing results
and facilities not
available for
predicate but
standards for
device are similar
and it is |
| Model Name: PlasmaFlow
Compression Sleeve Device | | | |
| Electrical Safety
Mechanical Safety
Chemical Safety
Thermal Safety
Radiation Safety | Equivalent to predicate
confirming with
outside testing results.
Safety also confirmed
in our risk assessment
and usability
document. | Passed or N/A | determined
predicate had
same testing
standards;
therefore
substantially
equivalent.
Identical; except
for testing results
and facilities not
available for
predicate but
standards for
device are similar
and it is
determined
predicate had
same testing
standards;
therefore
substantially
equivalent. |
| Labeling,
Packaging, and
sterilization
Standards | Substantial Equivalent | Substantial Equivalent | Identical; except
for design of
documents and
word choice; does
not pose a danger
to device safety or
effectiveness;
therefore
substantially
equivalent. |
| Technical Data | | | |
| Dimensions | 23" x 10.25" x 1.5"
(58cm x 26cm x 4cm) | N/A | Identical to the
predicate except
that PlasmaFlow
measurements
pertain to the unit
and the sleeve;
whereas, Venapro
measured only the
main unit.
Therefore
Substantially
Equivalent |
| Weight: Approx. | 1.43 lb (.65 kg) | 0.5 lb (0.227 kg) | Identical to the |
| | | | Compression Sleeve Device |
| | | | predicate except
that PlasmaFlow
weight pertains to
both units and the
sleeves; whereas,
Venapro weighed
only the main
unit, weights are
similar. Therefore
Substantially
Equivalent |
| Source of Power | DC 8.4V or Inner
Battery (7.4 volt Li-ion
battery
pack—made up of 2 x
3.7 volt cells) | 7.4 volt Li-ion battery
pack (made up of 2 -
3.7 volt cells) | Identical to the
predicate.
Therefore
Substantially
Equivalent |
| Power Supply | Class II, input: 100 -
240 Vac, 50 - 60 Hz,
output: 8.4V @ 1
Amp) | Class II, input: 100 -
240 Vac, 50 - 60 Hz,
output: 10 Vdc @ 1.1
Amp) | Identical to the
predicate.
Therefore
Substantially
Equivalent |
| Temperature | +10°C (50°F) to +40°C
(104°F) | +10 Degrees C (50
Degrees F) to +40
degrees C (104 degrees
F) | Identical to the
predicate.
Therefore
Substantially
Equivalent |
| Humidity | 30%-75%. Keep dry. | 30%-75% | Identical to the
predicate.
Therefore
Substantially
Equivalent |
| Tolerances | 5% | Pressure 5% | Identical to the
predicate.
Therefore
Substantially
Equivalent |
| Battery Charge | Approximately
4-5
hours | Takes approximately 6
hours (from
depleted state). | Identical to the
predicate except
that PlasmaFlow
claims full charge
battery between 4-
5 hours.
Therefore
Substantially
Equivalent |
| Cleaning and Disinfecting | | | |
| Cleaning and
Disinfecting | | | Compression Sleeve Device |
| | • Clean the outer
surface of the pump
unit using a soft
cloth, moistened with
soapy water or 70%
isopropyl alcohol. Air
dry only.
Clean the exterior of
the cuffs using a soft
cloth, moistened with
soapy water or 70%
isopropyl alcohol. Air
dry.
Unit must be
completely dry prior
to use. To ensure that,
leave the device in
the OFF position and
disconnected from
the wall outlet for at
least 30 minutes (and
as long as necessary
for the unit to dry
completely) after
cleaning or
disinfecting.
Do not remove the
pump unit from the
cuff..
Do not place cuffs in
dryer or microwave.
Do not use hair dryer
to accelerate drying.
Do not place the
device on top or in
front of portable
stationary radiators to
accelerate drying.
Do not use abrasive
cleaners. | • Clean the outer
surface of the pump
unit using a soft cloth,
moistened with soapy
water or 70%
isopropyl alcohol.
• Do not use abrasive
or volatile cleaners.
• Do not place cuffs in
dryer.
• NEVER remove the
unit from the cuff.
• Hand wash the
exterior of the cuffs
using a soft cloth,
moistened with soapy
water or 70%
isopropyl alcohol and
let air dry.
• To ensure the unit IS
completely dry prior
to use, leave unit in
the OFF
condition and
disconnected from the
wall outlet for 30
minutes after cleaning
or disinfecting. | Identical to the
predicate except
word choice and
order; therefore
Substantially
Equivalent |
| Disposal | This unit is an
electromechanical
device that includes
printed circuit boards
and rechargeable | This unit is an
electromechanical
device that includes
printed circuit boards
and rechargeable | Identical to the
predicate.
Therefore
Substantially
Equivalent |
| batteries. Do not | batteries. | | |
| discard in landfill.
Consult local county
requirements for proper
disposal instructions.
Pump control units
contain rechargeable
batteries. Do not
discard the pump unit
in regular waste.
Bring the unit to your
local recycle center or
contact ManaMed. | Do not discard in
landfill. Consult local
county requirements for
proper disposal
instructions.
Pump control units
contain rechargeable
batteries. Do not discard
the pump unit in regular
waste. Bring the unit to
your local recycle
center or contact
InnovaMed Health. | | |
7
8
9
10
11
12
13
ManaMed Inc.
14
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.
15
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 Regulations
Applied | Comments |
|------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| Biocompatibility | ISO 10993-1:2009/Cor.
1:2010(E) Biological
evaluation of medical devices
- Part 1: Evaluation and
testing with a risk
management process.
ISO 10993-5:2009 (E)
Biological evaluation of
medical devices - Part 5:
Tests for in vitro cytotoxicity.
ISO 10993-10:2010(E)
Biological evaluation of
medical devices - Part 10:
Tests for Tests for irritation
and skin sensitization.
ISO 10993-12: 2012
Biological Evaluation Of
Medical Devices -- Part 12:
Sample Preparation And
Reference Materials. | Biocompatibility tests
for PlasmaFlow
PF0001 were
performed.
PlasmaFlow passed
Cytotoxicity,
Sensitization, and
Irritation tests. |
| | ISO/IEC 17025:2005 General
Requirements for the
Competence of Testing and
Calibration Laboratories. | |
16
| | USP 35 Biological reactivity
tests, in vitro | Compression Sleeve Device |
|--------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Electromagnetic Compatibility
and Electrical Safety | IEC 60601-1: 2005-12, 3rd
Edition +A1:2012 – medical
electrical equipment – part 1:
General Requirements for
basic safety and essential
performance
AAMI ES 60601-1: 2005
+A1: 2012 – Medical
electrical equipment – Part 1:
General Requirements for
basic safety and essential
performance - Deviations
from
IEC 60601-1: 2005
IEC 60601-1-2 Edition
3:2007-03 Medical electrical
equipment - Part 1-2: General
requirements for basic safety
and essential performance -
Collateral standard:
Electromagnetic compatibility
-Requirements and tests.
(EN 60601-1-2)
IEC 60601-1-11: 2010 –
medical electrical equipment –
part 1-11: General
requirements for basic safety
and essential performance –
collateral standard:
requirements for medical
electrical equipment and | EMC tests were
conducted according
to the same standards
as the predicate. |
| | medical electrical systems
used in the home healthcare
environment (EN 60601-1-11:
2010)
IEC 60601-1-6 2010 3rd
edition Medical electrical
equipment Part 1-6: General
requirements for safety –
collateral standard: Usability
IEC 62366: 2007 +A1: 2014 -
Medical Devices –
Application of usability
engineering to medical
devices (EN 62366: 2008) | Compression Sleeve Device |
| Software | Software verification and
validation was conducted and
documentation is provided.
The software was considered
as a “moderate” level of
concern, since a failure or
latent flaw in the software
could directly result in serious
injury to the patient or
operator. | |
| Risk Management | ISO14971 Medical Devices -
Application Of Risk
Management To Medical
Devices. (General I (QS/RM))
IEC 60812 Analysis
Techniques for System
Reliability – Procedure for
Failure Mode and Effects
Analysis
ISO 13485: 2003 – Medical
Devices – Quality
management systems –
requirements for regulatory
purposes | Manufacturing was
consistent with the
required mechanisms
for change control,
identification, and
traceability. The risk
management document
exemplifies the
process of controls in
place. |
| Performance | Pressure delivery, cuff (bladder)
fill time, cycle time and overall
system performance as the
predicate devices listed | |
| Leak Burst Pressure Testing | Outside testing of pressure, leak, | |
| | and burst. Results included with
full validation and similar with
predicates. | |
17
18
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.