Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The description details a simple pneumatic compression device with a fixed cycle and pressure, controlled by basic software and hardware components. There is no mention of adaptive learning, pattern recognition, or any other characteristics typically associated with AI/ML.

Therapeutic

Yes
The "Intended Use / Indications for Use" section explicitly states that VenaOne is prescribed for "stimulating blood flow... that aids in the prevention of DVT, enhances blood circulation, diminishes post-operative pain and swelling, reduces wound healing time, and aids 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." These are all therapeutic applications.

Diagnostic

No

The device is described as stimulating blood flow and aiding in the prevention and treatment of various conditions, not diagnosing them. Its function involves physical intervention (simulating muscle contractions) rather than detection or analysis of disease states.

SaMD (Software as a Medical Device)

No

The device description clearly outlines hardware components such as a battery, air pump, solenoid valve, plastic case, inflatable air bladder, ON/OFF button, display, battery icon, charging port, and USB cable port. While it mentions system software, it is integral to the operation of these physical components.

IVD (In Vitro Diagnostic)

Based on the provided information, the VenaOne device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
VenaOne's Function: The VenaOne device is a mechanical system that applies pneumatic pressure to the legs to stimulate blood flow. It works externally on the body and does not involve the analysis of biological samples.
Intended Use: The intended use clearly describes a physical intervention (stimulating blood flow) for therapeutic and preventative purposes related to circulatory issues.
Device Description: The description details a mechanical and electronic system with an inflatable bladder, pump, and controls, not a system for analyzing biological samples.

Therefore, the VenaOne falls under the category of a therapeutic or preventative medical device that acts on the body, rather than an in vitro diagnostic device that analyzes samples from the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

VenaOne is an easy to use system prescribed by healthcare professionals for stimulating blood flow in the legs (simulating muscle contractions) that aids in the prevention of DVT, enhances blood circulation, diminishes post-operative pain and swelling, reduces wound healing time, and aids 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.

Product codes (comma separated list FDA assigned to the subject device)

JOW

Device Description

The VenaOne is a lightweight, portable battery powered prescriptive device. It is intended for stimulating blood flow in the legs (simulating muscle contractions) that helps stimulate blood flow as an aid in the prevention of deep vein thrombosis (DVT). Its portable design allows patients to wear the unit during many clinical related activities, such as physical therapy sessions, wheel chair transportation, cafeteria sittings, and during general mobility throughout the clinic.

As an easy to use system. VenaOne utilizes the pneumatically controlled chamber cuff actuated by an electronically controlled air pump unit and solenoid valve. All the pump and control components are protectively housed in a plastic case of the control unit that is permanently attached to an inflatable air bladder. An ON/OFF button, a display, and a battery icon provide for user interface. There is also a charging port for connecting the battery charger/AC adapter plug, and a USB cable port for connecting the VenaOne device to the computer for tracking patient device use time. The detachable rechargeable battery could be mounted on the control unit or on the separate charging station for charging. Prior to use, the cut-resistant air bladder and control unit are placed inside a disposable medical fabric or equivalent medical material. The VenaOne devices are supplied clean and non-sterile.

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

Healthcare professionals / Hospital, Surgery Center, Altitude travel, areas of limited mobility

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.

K130174

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.

K161209

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

Regulation Number and Section

§ 870.5800 Compressible limb sleeve.

(a)
Identification. A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb.(b)
Classification. Class II (performance standards).

Summary

0

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

July 2, 2020

Vena Group, LLC Bill Dai Consultant 14271 Jeffrey Rd. #246 Irvine, California 92620

Re: K200285 Trade/Device Name: VenaOne Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: June 1, 2020 Received: June 4, 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 mediation-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) K200285

Device Name VenaOne

Indications for Use (Describe)

VenaOne is an easy to use system prescribed by healthcare professionals for stimulating blood flow in the legs (simulating muscle contractions) that aids in the prevention of DVT, enhances blood circulation, diminishes post-operative pain and swelling, reduces wound healing time, and aids 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.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

1. Submitter's Information

Submitter: Vena Group, LLC Address: 10 Westelm Gardens San Antonio, TX 78230 Contact Person: Kasey Vukson Tel: 210-422-4613 Date of Preparation: 01/16/2020

2. Subject Device

Trade/Device Name: VenaOne 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: DVTCare CA5 510(k) Number: K130174 Clearance Date: May 2, 2013 Submitter: Ossur Americas Inc.

Predicate/Reference Device: Cirona 6400 Disposable Deep Vein Thrombosis Prevention System 510(k) Number: K161209 Clearance Date: May 31, 2016 Submitter: Devon Medical Products

4. Description of Subject Device

The VenaOne is a lightweight, portable battery powered prescriptive device. It is intended for stimulating blood flow in the legs (simulating muscle contractions) that helps stimulate blood flow as an aid in the prevention of deep vein thrombosis (DVT). Its portable design allows patients to wear the unit during many clinical related activities, such as physical therapy sessions, wheel chair transportation, cafeteria sittings, and during general mobility throughout the clinic.

As an easy to use system. VenaOne utilizes the pneumatically controlled chamber cuff actuated by an electronically controlled air pump unit and solenoid valve. All the pump and control components are protectively housed in a plastic case of the control unit that is permanently attached to an inflatable air bladder. An ON/OFF button, a display, and a battery icon provide for user interface. There is also a charging port for connecting the battery charger/AC adapter plug, and a USB cable port for connecting the VenaOne device to the computer for tracking patient device use time. The detachable rechargeable battery could be mounted on the control unit or on the separate charging station for charging. Prior to use, the cut-resistant air bladder and control unit are placed inside a disposable medical fabric or equivalent medical material. The VenaOne devices are supplied clean and non-sterile.

In operation, the device could be powered on via the single ON/OFF button. The control unit then fills

4

the air bladder to a pre-determined pressure (55 mmHg). The pressure of the air bladder is monitored by an internal pressure switch and system software. Once the pressure reaches the proper level, the pump is turned off, and the air bladder deflates to the ambient pressure through a valve inside the plastic case of the control unit. After the "rest" period of approximately 50 seconds, the cycle repeats until the unit is turned off.

5. Indications for Use

Prescription Use:

VenaOne is an easy to use system prescribed by healthcare professionals for stimulating blood flow in the legs (simulating muscle contractions) that aids in the prevention of DVT, enhances blood circulation, diminishes post-operative pain and swelling, reduces wound healing time, and aids 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.

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/Reference Device	Equivalence
510(k) Number	K200285	K130174	K161209	N/A
Submitter	Vena Group, LLC	Ossur Americas Inc.	Devon Medical Products	N/A
Device
Name/Model	VenaOne	DVTCare CA5	Cirona 6400 Disposable Deep
Vein Thrombosis Prevention
System	N/A
Intended Use	VenaOne is an easy to use
system prescribed by
healthcare professionals for
stimulating blood flow in the
legs (simulating muscle
contractions) that aids in the
prevention of DVT, enhances
blood circulation, diminishes
post-operative pain and
swelling, reduces wound
healing time, and aids 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 DVTcare CA5 is intended
to be a portable system that is
prescribed by healthcare
professionals to help prevent
the onset of DVT in patients,
by stimulating blood flow in
the legs (simulating muscle
contractions). Furthermore, the
unit can be used as an aid in the
prophylaxis for DVT by
persons traveling, or those
expecting to be stationary for
long periods of time (> 4
hours). This device can also be
used to: aid in the prevention of
DVT, enhance blood
circulation, diminish post-
operative pain and swelling.
reduce wound healing time,
and 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 Cirona 6400 disposable
deep vein thrombosis
prevention system is intended
to be an easy to use portable
system, prescribed by a
physician, to help prevent the
onset of DVT in patients by
stimulating blood flow in the
extremities (stimulating muscle
contractions).
This device can be used in the
home or clinical setting 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	Identical
			• As a prophylaxis for DVT by
persons expecting to be
stationary for long periods of
time
Prescription or OTC	Prescription	Prescription	Prescription	Identical
Power Source(s)	Rechargeable battery	Rechargeable battery	Rechargeable battery	Identical
Battery
Specifications	3.7V rechargeable battery	7.4V rechargeable battery	3.7V rechargeable battery	Identical or similar. The
voltage difference of
batteries will not raise
any new issue of the
safety or effectiveness.
Battery Charge	Takes approximately 4 hours
(from depleted state).	Takes approximately 3 - 5
hours (from depleted state).	Takes approximately 3 hours
(from depleted state).	Similar. The difference
of charging time does
not change the product
performance or
parameters, which will
not raise any new issue
of the safety or
effectiveness.
Power Supply	Input: 100 - 240 Vac, 50 - 60
Hz,
Output: 12 Vdc @ 2 Amp)	Input: 100 - 240 Vac, 50 - 60
Hz,
Output: 10 Vdc @ 1.1 Amp)	Input: 100 - 240 Vac, 50 - 60
Hz,
Output: 5 Vdc @ 2 Amp)	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.
Internal
rechargeable
batteries	Yes	Yes	Yes	Identical
Compliance with
Voluntary
Standards?	Yes	Yes	Yes	Identical
Electrical Safety
Mechanical Safety
Chemical Safety
Thermal Safety
Radiation Safety?	Yes	Yes	Yes	Identical
Functions and
design	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).	Aids venous return by using
cyclic,
intermittent, pneumatic
pressure application (inflation
followed by deflation) to
compress the lower
limb(s).	Identical
Contraindication(s)	The VenaOne 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 DVTCare CA5 System
should not be used by persons
with the following conditions:
suspected, active or untreated
deep vein thrombosis, ischemic
vascular disease, severe
arteriosclerosis, pulmonary
edema, severe congestive heart
failure, thrombophlebitis, or an
active infection.
Not recommended for use on a
leg where the 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 Cirona® 6400 series
system should NOT be used in
the following conditions:
• Severe arteriosclerosis or
other ischemic vascular
diseases
• Acute or active deep vein
thrombosis
• Existing pulmonary edema,
pulmonary embolisms, and/or
congestive cardiac failure
• On patients with neuropathy,
active infections, and/or
thrombophlebitis
• On extremities that are
extremely deformed,
insensitive to pain, or where	Identical
	On extremities that are
insensitive to pain.
Where increased venous or
lymphatic return is undesirable.	Not for use with patines with
neuropathy.
Do not use on extremities that
are insensitive to pain.
Do not use where increased
venous or lymphatic return is
undesirable.
Leg cuffs may cause irritation
when used in direct contact
with skin.	increased venous or lymphatic
return is undesirable
• Any local skin or tissue
condition in which the
garments would interfere
including but not limited to:
Vein ligation, Recent skin
graft, Gangrene, Dermatitis,
Open wounds, Massive edema
Target Population /
Intended Users	Patients who need venous
return.	Patients who need venous
return.	Patients who need venous
return.	Identical
Where Used	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 or Similar
Application	Non-invasive / external	Non-invasive / external	Non-invasive / external	Identical
Portability	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 lower limb(s).	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
Anatomical Site /
Location of
treatment
application	Lower limb(s) (Calf)	Lower limb(s) (Calf)	Lower limb(s) (Calf)	Identical
System
management	Electronic, microprocessor
controlled	Electronic, microprocessor
controlled	Electronic, microprocessor
controlled	Identical
Pressure Source	Micro pump controlled by
electronic processor	Micro pump controlled by
electronic processor	Micro pump controlled by
electronic processor	Identical
Operating Modes	Default mode one	'Single leg' mode
'Double leg' mode	Default mode one	Identical or similar
Working Pressure	Preset at 55 mmHg	Preset at 50 mmHg, and
adjustable 20 - 65 mmHg	preset at 40 mmHg	Identical or similar
Cycle Time	Approximately 60 seconds	Approximately 60 seconds	Approximately 60 seconds	Identical
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	Identical
Modes	1 Modality	2 Modality	1 Modality	Identical or similar
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.	Identical
Sterility	Clean / non-sterile	Clean / non-sterile	Clean / non-sterile	Identical
Leg cuff usage	Single Patient Use	Single Patient Use	Single Patient Use	Identical
Material Used	A single air bladder encased in
a covering of soft, nonlatex,
non-woven medical fabric or
equivalent medical material for
increased patient comfort and
biocompatibility compliance.	A single air bladder encased in
a covering of soft, nonlatex,
non-woven medical fabric or
equivalent medical material for
increased patient comfort and
biocompatibility compliance.	A single air bladder encased in
a covering of soft, nonlatex,
non-woven medical fabric or
equivalent medical material for
increased patient comfort and
biocompatibility compliance.	Identical or similar
Biocompatibility	Biocompatible	Biocompatible	Biocompatible	Identical
Software	Moderate	Moderate	Moderate	Identical
Dimensions	190x44x36.3 mm	150x99x41mm	130x70x30mm	Identical of similar
Weight Approx.	0.33kg	0.43kg	0.33kg	Identical or similar
Temperature	Operate in a dry location
between +10 °C (50 °F) and
+40 °C (104 °F).
Store in a dry location between
-25 °C (-13 °F) and +70 °C
(158 °F).	+10 °C (50 °F) to +40 °C (104
°F)	+5 °C (41 °F) to +40 °C (104
°F)	Identical or similar
Humidity	15%-93%	30%-75%	15%-93%	Identical or similar
Tolerances	± 5 mmHg	± 4 mmHg	± 5 mmHg	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.	• Clean the outer surface of the
pump unit using a soft cloth,
moistened with soapy water or
70% isopropyl alcohol.
• Do not use bleach on any
item.
• Do not use abrasive or
volatile cleaners - display
could become scratched and
hard to read.
• Do not place cuff or carry
pouch in dryer, as the bladder
could melt.
• Hand wash exterior of cuff
and carry pouch using a soft
cloth moistened with soapy
water or 70% isopropyl alcohol
and let air dry.
• To ensure product is
completely dry prior to use,
leave unit in the off condition
and disconnected from power
(wall outlet) for 30 minutes
after cleaning or disinfecting.	SWITCH OFF AND
DISCONNECT THE POWER
CORD FROM THE MAIN
SUPPLY BEFORE
CLEANING AND
INSPECTION.
• The unit casing is made from
plastic and can be cleaned
using a soft damp cloth and a
mild detergent free from harsh
chemicals to avoid
deterioration.
• Sleeves are designed for
single patient use and cleaning
is not recommended.	Identical or similar
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.	This unit is an
electromechanical device that
includes printed circuit boards
and rechargeable batteries. Do
not discard in landfill. Consult
local, state, federal and country
requirements for proper
disposal instructions.
Cuffs may be discarded in US
landfills.	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.	Identical or similar

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

5

6

7

7. Substantial Equivalence

As shown in the above table of comparison, the subject device in this submission has the identical performance and parameter to the predicate device. The updated and optimized circuit board in the subject device does not change any product performance. 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 lower limbs, using a cycle time of

8

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.

Identical to the predicate device, the subject device has multiple and visual safety alarms built into the system, including low pressure alarms, low battery alarm and system malfunction overpressure safety alarm. In addition, the cuff is comprised of a single air bladder encased in a covering of soft, nonlatex, non-woven medical fabric or equivalent medical 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 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.