(175 days)
Not Found
No
The description details a pneumatically controlled cuff actuated by an electronically controlled air pump unit with pre-determined or adjustable pressure settings. The operation is based on simple inflation/deflation cycles monitored by a pressure switch and system software. There is no mention of learning, adaptation, or complex pattern recognition that would indicate AI/ML. The performance studies focus on electrical safety, electromagnetic compatibility, and software verification according to standard FDA guidance, not on AI/ML performance metrics.
Yes
The device is intended for "treatment of lymphedema," "treatment of chronic venous insufficiency," and "treatment and promotion of healing of stasis dermatitis and venous stasis ulcers," among other therapeutic uses.
No
The device description indicates that the ManaFlow system is used for treatment (e.g., of lymphedema, chronic venous insufficiency, edema, and for enhancing venous return), not for diagnosis.
No
The device description explicitly states it includes hardware components such as a gradient compression sleeve, a portable intermittent pump, a plastic case housing pump, battery, and control components, an ON/OFF button, a SET button, a display, a port for a battery charger, and an inflatable cuff/sleeve with air chambers/bladders. While it mentions system software, it is integral to the operation of the hardware.
Based on the provided text, the ManaFlow system is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- ManaFlow's Function: The ManaFlow system is a mechanical device that applies external pressure to the body (specifically the legs, arms, or vest area) using a pump and compression sleeve. It treats conditions like lymphedema and chronic venous insufficiency by enhancing venous return and reducing edema.
- No Specimen Analysis: The description of the ManaFlow system does not mention any analysis of biological specimens. Its function is entirely external and mechanical.
Therefore, the ManaFlow system falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The ManaFlow system, part numbers MFLOW51 and MFLOW52, is comprised of a gradient compression sleeve and a portable intermittent pump to provide graduated compression in both sustained and intermittent settings for use in both the hospital and outpatient setting. ManaFlow 51 is pre-set to the default setting of 50 mmHg and cannot be adjusted, whereas the ManaFlow 52 can be adjusted by the physician to a pressure within the specified range. It is intended for use in:
- Treatment of lymphedema
- Treatment of chronic venous insufficiency
- Treatment and promotion of healing of stasis dermatitis and venous stasis ulcers
- Reducing venous leg ulcer healing time
- Reducing edema due to venous stasis
- Enhancing venous return
The device is intended for home, and hospital use.
Product codes (comma separated list FDA assigned to the subject device)
JOW
Device Description
The ManaFlow system, part numbers MFLOW51 and MFLOW52, is a portable and rechargeable prescriptive device. It is intended to be used in the home or clinical/hospital setting by or under the direction of a medical professional to apply pressure to treat lymphedema and other edematous conditions and to prevent Deep Vein Thrombosis (DVT).
The ManaFlow, supplied clean and non-sterile, utilizes the pneumatically controlled cuff actuated by an electronically controlled air pump unit. All pump, battery and control components are protectively housed in a plastic case of the control unit that is attached to an inflatable cuff/sleeve. An ON/OFF button, a SET button, and a display provide for user interface. There is also a port for connecting the battery charger/AC adapter plug. The cuff component consists of multiple (four or so) air chambers/bladders encased inside a soft medical fabric or equivalent medical for increased patient comfort and biocompatibility compliance.
In operation, the user simply turns the power on via the ON/OFF button. A cuff containing air chambers/bladders is connected to the control unit. And the control unit then inflates the cuff to the default pre-determined pressure (50 mmHg), which could be adjusted/calibrated via the SET button. The cuff pressure is monitored by an internal pressure switch and system software. Once the cuff pressure of the multiple air chambers/bladders reaches the pre-determined or adjusted level, the pump is turned OFF for a rest period, and the cuff deflates to ambient pressure through a valve inside the plastic case. After the rest period, the cycle of inflation and deflation repeats until the device is turned off.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Leg
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
Intended for use in both the hospital and outpatient setting.
The device is intended for home, and hospital use.
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 tests were performed on the subject device in order to validate the design and to assure conformance with the following voluntary design standards in connection with medical device electrical safety, and electromagnetic compatibility.
- (a) ANSI AAMI ES60601-1 "Medical Electrical Equipment Part 1: General requirements for basic safety and essential performance (IEC 60601-1)".
- (b) IEC 60601-1-2 "Medical Electrical Equipment Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral standard: Electromagnetic Compatibility - Requirements and Tests".
In addition to the compliance of voluntary standards, bench tests have been performed on the physical requirements, electrical requirement, and performance requirement; the verification of software used in the subject device has been carried out according to the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
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.
K131193, K160318, K183631, K142640
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.
Not Found
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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 6, 2020
ManaMed, Inc Bill Dai Consultant 14271 Jeffrey Rd. #246 Irvine, California 92620
Re: K200353
Trade/Device Name: ManaFlow Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: July 3, 2020 Received: July 7, 2020
Dear Bill Dai:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Fernando Aguel Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K200353
Device Name ManaFlow
Indications for Use (Describe)
The ManaFlow system, part numbers MFLOW51 and MFLOW52, is comprised of a gradient compression sleeve and a portable intermittent pump to provide graduated compression in both sustained and intermittent settings for use in both the hospital and outpatient setting. ManaFlow 51 is pre-set to the default setting of 50 mmHg and cannot be adjusted, whereas the ManaFlow 52 can be adjusted by the physician to a pressure within the specified range. It is intended for use in:
- · Treatment of lymphedema
- · Treatment of chronic venous insufficiency
- · Treatment and promotion of healing of stasis dermatitis and venous stasis ulcers
- · Reducing venous leg ulcer healing time
- · Reducing edema due to venous stasis
- Enhancing venous return
The device is intended for home, and hospital use.
| 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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3
510(k) Summary
1. Submitter's Information
Submitter: ManaMed. Inc. Address: 5240 W. Charleston Blvd. Las Vegas, NV 89146 Contact Person: Trevor Theriot Tel : 702-781-1117 Date of Preparation: 12/20/2019
2. Subject Device
Trade/Device Name: ManaFlow Common Name: Compressible Limb Sleeve Regulation Medical Specialty: Cardiovascular Review Panel: Cardiovascular Product Code: JOW Regulation Number: 21 CFR 870.5800 Device Class: II Use: Prescription
3. Predicate device
Primary Predicate Device: ACTitouch™ Adaptive Compression Therapy system 510(k) Number: K131193 Clearance Date: June 18, 2013 Submitter: Tactile Systems Technology, Inc.
Predicate Device: PlasmaFlow 510(k) Number: K160318 Clearance Date: April 1, 2016 Submitter: ManaMed. Inc.
Predicate Device: medi pneumatic compression system (pcs) - brio (Model 651) 510(k) Number: K183631 Clearance Date: January 25, 2019 Submitter: Medi USA, LP
Predicate Device: SC-3004FC-DL Sequential Circulator 510(k) Number: K142640 Clearance Date: November 6, 2014 Submitter: Bio Compression Systems, Inc.
4. Description of Subject Device
The ManaFlow system, part numbers MFLOW51 and MFLOW52, is a portable and rechargeable prescriptive device. It is intended to be used in the home or clinical/hospital setting by or under the direction of a medical professional to apply pressure to treat lymphedema and other edematous conditions and to prevent Deep Vein Thrombosis (DVT).
The ManaFlow, supplied clean and non-sterile, utilizes the pneumatically controlled cuff actuated by an electronically controlled air pump unit. All pump, battery and control components are protectively
4
housed in a plastic case of the control unit that is attached to an inflatable cuff/sleeve. An ON/OFF button, a SET button, and a display provide for user interface. There is also a port for connecting the battery charger/AC adapter plug. The cuff component consists of multiple (four or so) air chambers/bladders encased inside a soft medical fabric or equivalent medical for increased patient comfort and biocompatibility compliance.
In operation, the user simply turns the power on via the ON/OFF button. A cuff containing air chambers/bladders is connected to the control unit. And the control unit then inflates the cuff to the default pre-determined pressure (50 mmHg), which could be adjusted/calibrated via the SET button. The cuff pressure is monitored by an internal pressure switch and system software. Once the cuff pressure of the multiple air chambers/bladders reaches the pre-determined or adjusted level, the pump is turned OFF for a rest period, and the cuff deflates to ambient pressure through a valve inside the plastic case. After the rest period, the cycle of inflation and deflation repeats until the device is turned off.
5. Indications for Use
Prescription Use:
The ManaFlow system, part numbers MFLOW51 and MFLOW52, is comprised of a gradient compression sleeve and a portable intermittent pump to provide graduated compression in both sustained and intermittent settings for use in both the hospital and outpatient setting. ManaFlow 51 is pre-set to the default setting of 50 mmHg and cannot be adjusted, whereas the ManaFlow 52 can be adjusted by the physician to a pressure within the specified range. It is intended for use in:
- Treatment of lymphedema
- Treatment of chronic venous insufficiency
- Treatment and promotion of healing of stasis dermatitis and venous stasis ulcers
- Reducing venous leg ulcer healing time
- Reducing edema due to venous stasis
- Enhancing venous return
The device is intended for home, and hospital use.
6. Summary of Substantial Equivalence
The following comparison Table 1 summarizes the comparison between the subject device and the predicate device, indicating the intended use and technical characteristics of the subject device are substantially equivalent to those of the predicate device.
| | Subject Device | Primary
Predicate Device | Predicate Device | Predicate Device | Predicate Device | Equivalence | Prescription or
OTC | numbers
MFLOW51 and
MFLOW52, is
comprised of a
gradient
compression sleeve
and a portable
intermittent pump to
provide graduated
compression in both
sustained and
intermittent settings
for use in both the
hospital and
outpatient setting.
ManaFlow 51 is
pre-set to the default
setting of 50 mmHg
and cannot be
adjusted, whereas
the ManaFlow 52
can be adjusted by
the physician to a
pressure within the
specified range. It is
intended for use in: | Compression
Therapy system
provides graduated
compression in
both sustained and
intermittent
settings for use in: | 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: | (pcs)-brio is a
compression device
based on sequential
pneumatic
compression
technique which is
intended for the
treatment of the
following
conditions:
-Lymphedema
-Venous stasis
ulcers
-Venous
insufficiency
-Peripheral edema
The device is
intended for home,
and hospital use. | Systems' SC-3008-
DL, SC-3004-DL,
SC-3004FC-DL and
SC-2008-DL pumps
and associated
garments are
sequential,
pneumatic
compression
devices intended for
the primary or
adjunctive treatment
of primary or
secondary
lymphedema. These
devices are also
intended for the
additional or
alternate treatment
of venous
insufficiency and
chronic venous
stasis ulcers
associated with
venous
insufficiency, as
well as general
treatment for
swelling of the
extremities. The
devices are intended
for home or hospital
use. | Identical | | | | | | | raise any new
issue of the safety
or effectiveness. |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|-----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|-------------------------------------------------------------------|-----------------------------------------------------------------------|-------------------------------------------------------------------|------------------|------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K200353 | K131193 | K160318 | K183631 | K142640 | N/A | Prescription | Treatment
of lymphedema
Treatment
of chronic venous
insufficiency
Treatment
and promotion of
healing of stasis
dermatitis and
venous stasis ulcers
Reducing
venous leg ulcer
healing time
Reducing
edema due to
venous stasis
Enhancing
venous return
The device is
intended for home,
and hospital use. | Enhancin
g venous return
Reducin
g venous leg ulcer
healing time
Treatme
nt and promotion
of healing of stasis
dermatitis and
venous stasis
ulcers
Treatme
nt of chronic
venous
insufficiency
Reducin
g edema due to
venous stasis
Treatme
nt of lymphedema | 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. | Prescription | Prescription | Identical | Power Supply | Input: 100 - 240
Vac, 50 - 60 Hz,
Output: 5 Vdc @ 2
Amp) | Input: 100 - 240
Vac, 50 - 60 Hz,
Output: 7.5 Vdc @
0.9 Amp) | Input: 100 - 240
Vac, 50 - 60 Hz,
Output: 5 Vdc @ 1
Amp) | 115V AC, 50-60Hz | 115V AC, 50-60Hz | Identical or
Similar. The
voltage difference
of power supply
used does not
change the
product
performance or
parameters,
which will not
raise any new
issue of the safety
or effectiveness. |
| Submitter | ManaMed, Inc. | Tactile Systems
Technology, Inc. | ManaMed, Inc. | Medi USA, LP | Bio Compression
Systems, Inc. | N/A | Power Source(s) | 5V DC power
supply (100-240
VAC input) and
3.7V rechargeable
battery | 5V DC power
supply (100-240
VAC input) and
3.7V rechargeable
battery | 5V DC power
supply (100-240
VAC input) and
3.7V rechargeable
battery | 115V AC, 50-60Hz | 115V AC, 50-60Hz | Identical or
similar | Internal
rechargeable
batteries | Yes | Yes | Yes | N/A | No | Identical |
| Device
Name/Model | ManaFlow | ACTitouchTM
Adaptive
Compression
Therapy system | PlasmaFlow | medi pneumatic
compression system
(pcs) - brio (Model
651) | SC-3004FC-DL
Sequential
Circulator | N/A | Battery Charge | Takes
approximately 4
hours (from
depleted state). | Takes
approximately 4
hours (from
depleted state). | Takes
approximately 2.5
hours (from
depleted state). | N/A | N/A | Identical or
similar. The
difference of
charging time
does not change
the product
performance or
parameters,
which will not | Compliance
with Voluntary
Standards? | Yes | Yes | Yes | Yes | Yes | Identical |
| Intended Use | The ManaFlow
system, part | The ACTitouchTM
Adaptive | The PlasmaFlow,
model PF0001, is | The medi pneumatic
compression system | The Bio
Compression | Identical | Electrical Safety
Mechanical
Safety Chemical
Safety Thermal
Safety Radiation
Safety? | Yes | Yes | Yes | Yes | Yes | Identical | | | | | | | |
| Functions and
design | Aids venous return
by using cyclic,
intermittent,
pneumatic pressure
application
(inflation followed
by deflation) to
compress the
extremities. | Aids venous return
by using cyclic,
intermittent,
pneumatic pressure
application
(inflation followed
by deflation) to
compress the
extremities. | Aids venous return
by using cyclic,
intermittent,
pneumatic pressure
application
(inflation followed
by deflation) to
compress the
extremities. | Aids venous return
by using cyclic,
intermittent,
pneumatic pressure
application
(inflation followed
by deflation) to
compress the
extremities. | Aids venous return
by using cyclic,
intermittent,
pneumatic pressure
application
(inflation followed
by deflation) to
compress the
extremities. | Identical | | | | | | | | | | | | | | |
| Contraindication
(s) | 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. | The ACTitouch
System is
contraindicated if
the patient has:
• An Ankle
Brachial Pressure
Index of less than
0.8;
• Diagnosed or
suspected acute
Deep Vein
Thrombosis (DVT)
or pulmonary
embolism;
• Pulmonary
edema;
• Leg gangrene;
• Acute
thrombophlebitis;
• Decompensated
/Congestive
Cardiac Failure;
• Severe
arteriosclerosis or
other ischemic
vascular disease;
• Diabetes in | 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. | Contraindicated for
patients with acute
Deep Vein
Thrombosis. | Compression IS
NOT recommended
in the following
conditions:
• Infections in the
limb, including
cellulitis without
appropriate
antibiotic
coverage
• The presence of
lymphangiosarcoma
• Deep vein
thrombosis (DVT)
• Inflammatory
phlebitis or episodes
of pulmonary
embolism
• Congestive heart
failure (CHF) | Identical or
similar | | | | | | | | | | | | | | |
Table 1. Comparison between the subject device and the predicate device
5
6
7
| | On extremities that
are insensitive to
pain.
Where increased
venous or lymphatic
return is
undesirable. | peripheral arterial
disease;
• Acute infections
of the skin such as
cellulitis;
• Any lower limb
malignancy. | On extremities that
are insensitive to
pain.
Where increased
venous or lymphatic
return is
undesirable. | | | Identical |
|-----------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|
| Target
Population /
Intended Users | Patients who need
venous return and
lymphedema
treatment | Patients who need
venous return and
lymphedema
treatment | Patients who need
venous return | Patients who need
venous return and
lymphedema
treatment | Patients who need
venous return and
lymphedema
treatment | Identical |
| Where Used | Home, Hospital,
Surgery Center,
Altitude travel,
areas of limited
mobility | Home, Hospital,
Surgery Center,
Altitude travel,
areas of limited
mobility | Home, Hospital,
Surgery Center,
Altitude travel,
areas of limited
mobility | Home, Hospital,
Surgery Center,
Altitude travel,
areas of limited
mobility | Home, Hospital,
Surgery Center,
Altitude travel,
areas of limited
mobility | Identical |
| Application | Non-invasive /
external | Non-invasive /
external | Non-invasive /
external | Non-invasive /
external | Non-invasive /
external | Identical |
| Portability | Portable, ambulant | Portable, ambulant | Portable, ambulant | Portable, ambulant | Portable, ambulant | Identical |
| Basis of
operation | Aids venous return
by using cyclic,
intermittent,
pneumatic pressure
application
(inflation followed
by deflation) to
compress the
extremities | Aids venous return
by using cyclic,
intermittent,
pneumatic pressure
application
(inflation followed
by deflation) to
compress the
extremities | Aids venous return
by using cyclic,
intermittent,
pneumatic pressure
application
(inflation followed
by deflation) to
compress the
extremities | Aids venous return
by using cyclic,
intermittent,
pneumatic pressure
application
(inflation followed
by deflation) to
compress the
extremities | Aids venous return
by using cyclic,
intermittent,
pneumatic pressure
application
(inflation followed
by deflation) to
compress the
extremities | Identical |
| Anatomical Site
/ Location of
treatment
application | Leg | Leg | Lower limb(s)
(Calf) | Leg, Arm | Leg, Arm, Vest | Identical |
| System
management | Microprocessor | Microprocessor | Microprocessor | Microprocessor | Microprocessor | Identical |
| Pressure Source | Micro pump
controlled by
microprocessor | Micro pump
controlled by
microprocessor | Micro pump
controlled by
microprocessor | Micro pump
controlled by
microprocessor | Micro pump
controlled by
microprocessor | Identical |
| Operating
Modes | Preset and
adjustable modes | Two preset modes | Two preset modes | Adjustable modes | Preset and
adjustable modes | Identical |
| Working
Pressure | Preset at 50 mmHg
and adjustable from
20 - 80 mmHg | Preset at 20 - 50
mmHg | Preset at
approximately 55
mmHg | Adjustable at 20 -
80 mmHg | Preset at 60 mmHg
and adjustable from
30 – 120 mmHg | Identical or
similar |
| Cycle Time | In the preset
50mmHg mode,
each chamber will
inflate in sequence,
starting at the foot
and working up
toward the knee
until all of the
chambers reach the
intended pressure
levels. All four
chambers will then
deflate to the low
pressure level. This
cycle of inflation
and deflation will
continue until the
device is turn off.
In the adjustable 20 | When it is first
switched on in the
Sustained
Compression
Mode, the device
gradually inflates,
starting at the foot
and working up
toward the knee.
Each chamber will
stop inflating when
the correct
pressures are
achieved and will
hold these
pressures until the
device is turned
off.
When in
Intermittent | The PlasmaFlow
utilizes
microprocessor
controlled pumps to
deliver
approximately 55
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 | Stays on in a
pulsing manner and
then release until
the user turns it off
or can be set up to
turn off in a range
of 10 to 180 minutes | In the preset
60mmHg mode,
each chamber will
inflate in sequence,
starting at the foot
and working up
toward the knee
until all of the
chambers reach the
intended pressure
levels. All four
chambers will then
deflate to the low
pressure level. This
cycle of inflation
and deflation will
continue until the
device is turn off.
In the adjustable 30 | Identical or
similar |
| | the pressure of each
chamber could be
adjusted first, and
each chamber will
inflate in sequence,
starting at the foot
and working up
toward the knee
until all of the
chambers reach the
intended pressure
levels. All four
chambers will then
deflate to the low
pressure level. This
cycle of inflation
and deflation will
continue until the
device is turn off. | Pneumatic
Compression
Mode, the device
will
perform cyclic
inflation/
deflation
sequences
to preset gradient
pressures. Once
the starting
pressure is
reached, each
chamber will
inflate in sequence,
starting at the foot
and working up
toward the knee
until all of the
chambers reach the
intended pressure
levels. All four (4)
chambers will then
deflate to the low
pressure level.
This cycle of
inflation and
deflation will
continue until the
device is either
unplugged from
the Power
Adapter/Charger
or after
two (2) hours of
use. | bladder deflates and
the limb relaxes
without any
compression. | | the pressure of each
chamber could be
adjusted first, and
each chamber will
inflate in sequence,
starting at the foot
and working up
toward the knee
until all of the
chambers reach the
intended pressure
levels. All four
chambers will then
deflate to the low
pressure level. This
cycle of inflation
and deflation will
continue until the
device is turn off. | |
| System
diagnostics | Audible and visual
alarms prompt
recognition of
system faults | Audible and visual
alarms prompt
recognition of
system faults | Audible and visual
alarms prompt
recognition of
system faults | Audible and visual
alarms prompt
recognition of
system faults | Audible and/or
visual alarms
prompt recognition
of system faults | Identical |
| Air delivery
from pump to
cuff bladder | Via flexible plastic
tube(s) connected
directly to the air
bladder | Via flexible plastic
tube(s) connected
directly to the air
bladder | Via flexible plastic
tube(s) connected
directly to the air
bladder | Via flexible plastic
tube(s) connected
directly to the air
bladder | Via flexible plastic
tube(s) connected
directly to the air
bladder | Identical |
| Sterility | Clean / non-sterile | Clean / non-sterile | Clean / non-sterile | Clean / non-sterile | Clean / non-sterile | Identical |
| Leg cuff usage | Single Patient Use | Single Patient Use | Single Patient Use | Single Patient Use | Single Patient Use | Identical |
| Material Used | Air bladder
chambers encased in
a covering of soft
and nonlatex
medical fabric or
equivalent medical
material for
increased patient
comfort and
biocompatibility
compliance. | Air bladder
chambers encased
in a covering of
soft and nonlatex
medical fabric or
equivalent medical
material for
increased patient
comfort and
biocompatibility
compliance. | Air bladder
chambers encased in
a covering of soft
and nonlatex
medical fabric or
equivalent medical
material for
increased patient
comfort and
biocompatibility
compliance. | Air bladder
chambers encased in
a covering of soft
and nonlatex
medical fabric or
equivalent medical
material for
increased patient
comfort and
biocompatibility
compliance. | Air bladder
chambers encased in
a covering of soft
and nonlatex
medical fabric or
equivalent medical
material for
increased patient
comfort and
biocompatibility
compliance. | Identical or
similar |
| Fastening
between the
plastic case and
the fabric wrap | Snap and screw | Snap and screw | Snap and screw | Snap and tube | Snap and tube | Identical or
similar |
8
9
| Biocompatibility | Biocompatible | Biocompatible | Biocompatible | Biocompatible | Biocompatible | Identical |
|---|---|---|---|---|---|---|
| Software | Moderate | Moderate | Moderate | Moderate | Moderate | Identical |
| Dimensions | 165x83x55mm | 187x69x32mm | 116x65x19mm | N/A | 114x298x197mm | Similar |
| Weight Approx. | 0.80kg | 0.22kg | 0.23kg | N/A | 2.5kg | Similar |
| Temperature | +10 °C (50 °F) to | |||||
| +40 °C (104 °F) | +10 °C (50 °F) to | |||||
| +40 °C (104 °F) | +10 °C (50 °F) to | |||||
| +40 °C (104 °F) | +5 °C (41 °F) to +40 | |||||
| °C (104 °F) | +10 °C (50 °F) to | |||||
| +37 °C (100 °F) | Identical or | |||||
| similar | ||||||
| Humidity | 30%-75% | 0%-75% | 30%-75% | 15%-93% | 30%-75% | Identical or |
| similar | ||||||
| Cleaning and | ||||||
| Disinfecting | • 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. | Switch off and | |||||
| disconnect the | ||||||
| Power Adapter | ||||||
| /Charger before | ||||||
| cleaning or | ||||||
| disinfecting. | ||||||
| It is recommended | ||||||
| that the ACTitouch | ||||||
| Undersock be | ||||||
| replaced after a | ||||||
| maximum of 60 | ||||||
| washes. Machine | ||||||
| wash hot on a | ||||||
| gentle cycle. Air | ||||||
| dry or tumble dry | ||||||
| on a low- | ||||||
| temperature | ||||||
| setting. | ||||||
| To clean the | ||||||
| ACTitouch | ||||||
| Compression | ||||||
| Sleeve, wipe down | ||||||
| with a soft cloth | ||||||
| dampened with | ||||||
| mild soap and | ||||||
| water. Do not | ||||||
| immerse in fluids. | ||||||
| Air dry | ||||||
| thoroughly. | ||||||
| To disinfect the | ||||||
| ACTitouch | ||||||
| Compression | ||||||
| Sleeve between | ||||||
| patient use, or if | ||||||
| there are visible | ||||||
| biological | ||||||
| contaminants or | ||||||
| visible stains, the | ||||||
| following steps are | ||||||
| recommended: |
- Clean any
visible blood or
body fluids from
the surface of the
sleeve. - Thoroughly wet
surface with
DisCide ULTRA
Disinfecting Spray. - Allow surfaces
to remain wet for
one minute and | • 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. | To clean the Control
Unit:
• Wipe down the
system with a damp,
clean cloth.
• Dry thoroughly
with a fresh, clean
cloth.
Cleaning the single
person-use
inflatable cuff:
• Wipe down the
cuff inside and out
with a damp, clean
cloth. Dry
thoroughly with a
fresh, clean cloth.
• Do not machine
wash or dry!
• Do not dry clean! | • Clean the exterior
case and tubing with
a damp (not wet)
cloth using mild
soap and water
solution once per
month or as needed.
• Open garment to
expose all sides
either by separating
Velcro type hook
and loop or by
unzipping
(depending on type
of garment).
• Cleaning solution
should consist of
1/3 cup of laundry
detergent per 1
gallon of warm tap
water. Use either a
large sink or plastic
tub able to hold
enough solution
(depending on size
and quantity of
garments) to
completely
submerge the
garment leaving the
latch connector bars
out of the water.
• Garment should be
soaked for 30
minutes with mild
agitation every 5 to
10 minutes while
keeping it below
water surface.
• Thoroughly rinse
garment with warm
tap water and allow
to air dry.
• Harder to remove
soil on surface of
garment may
require additional
washing by hand
with a clean towel
while submerged.
Avoid using any
abrasive materials | Identical or
similar |
| | | then allow to air
dry.
To clean the
ACTitouch
Control Unit, wipe
down with a soft
cloth dampened
with mild soap and
water. Do not
immerse in fluids.
Air dry
thoroughly.
To disinfect the
ACTitouch
Control Unit
between patient
use, or if there are
visible biological
contaminants or
visible stains, the
following steps are
recommended: - Clean any
visible blood or
body fluids from
the surface of the
controller. - Thoroughly wet
surface with
DisCide ULTRA
Disinfecting Spray. - Allow surfaces
to remain wet for
one minute and
then allow to air
dry. | | | such as scrubbing
pads or chemicals
that could cause
damage to the
exterior surface of
garment.
• Re-Submerge
garment for 30
minutes (with
exception of tubing
connectors) in solu-
tion consisting of 1
cup of bleach per 1
gallon of warm tap
water, again
agitating garment
every 5 to 10
minutes while
keeping garment
below water
surface. Rinse
garment thoroughly
with warm tap water
and allow to air dry.
This completes the
disinfecting step. | |
| Disposal | This unit is an
electromechanical
device that includes
printed circuit
boards and
rechargeable
batteries.
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 ManaMed,
Inc. | For disposal of any
components of the
ACTitouch
System, please
follow local waste
regulations or
consult your local
institutional waste-
management
service or
municipal waste
authority. | This unit is an
electromechanical
device that includes
printed circuit
boards and
rechargeable
batteries.
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 ManaMed,
Inc. | Dispose of this
product in
accordance with
local regulations. | Medical equipment
and devices should
be disposed of in
proper containers
that meet
Environmental
Protection Agency
standards. Check
with your local,
regional and
national laws and
regulations to see
what is required. | Identical or
similar |
10
7. Substantial Equivalence
11
As shown in the above table of comparison, the subject device in this submission has the identical performance and parameter to the predicate device. And the differences between the subject device and the predicate device do not raise any new issues of safety or effectiveness.
The subject device is substantially equivalent to the predicate devices listed in function and operating principals to achieve identical results. The predicate device utilizes microprocessor controlled pumps to deliver pressurized air to bladders that are attached to the patient's extremities. Each cycle consists of inflation of air bladders, followed by a rest period during which the bladders deflate and relax without any compression.
Identical to the predicate device, the subject device has multiple audible and visual safety alarms built into the system, including low pressure alarm and low battery alarm. In addition, the cuff is comprised of multiple air bladder chambers encased in a covering of soft and non-latex medical fabric or equivalent medical material for increased patient comfort and biocompatibility compliance. The microprocessor and pump units are powered by internal rechargeable batteries, and can be connected to the main AC power line (through the battery charger / AC adaptor) while in use, allowing uninterrupted prolonged service.
The skin contact components and materials of the subject device are identical to those of the legally marketed device in K160318 and K142640 in formulation, suppliers, processing, and geometry and no other chemicals have been added (e.g., plasticizers, fillers, cleaning agents, mold release agents, etc.). Therefore, there is no issue or concern of biocompatibility.
The subject device is designed for the same intended use as the predicated device. The comparison of the specifications demonstrates the functional equivalence of the products, concluding that the subject device is substantially equivalent to the predicate device.
8. Non-Clinical Tests Performed
Non-clinical tests were performed on the subject device in order to validate the design and to assure conformance with the following voluntary design standards in connection with medical device electrical safety, and electromagnetic compatibility.
- (a) ANSI AAMI ES60601-1 "Medical Electrical Equipment Part 1: General requirements for basic safety and essential performance (IEC 60601-1)".
- (b) IEC 60601-1-2 "Medical Electrical Equipment Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral standard: Electromagnetic Compatibility - Requirements and Tests".
In addition to the compliance of voluntary standards, bench tests have been performed on the physical requirements, electrical requirement, and performance requirement; the verification of software used in the subject device has been carried out according to the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
9. Conclusion
The tests and comparison performed demonstrate the subject device is substantially equivalent to the predicate device. Therefore, the subject device is as safe and effective as the predicate device that has been legally marketed in the United States.