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.

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

AI/ML Overview

The provided text is a 510(k) Summary for the VenaOne device, a compressible limb sleeve, which is a Class II medical device. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study. Substantial equivalence means that the device is as safe and effective as a legally marketed device that is not subject to premarket approval (PMA).

Therefore, the document does not contain the acceptance criteria and study details as requested for a performance claim based on clinical data or defined acceptance criteria for such a study.

Instead, it provides a comparison table between the VenaOne device and two predicate devices (DVTCare CA5 and Cirona 6400 Disposable Deep Vein Thrombosis Prevention System) to show that their indications for use, technological characteristics, and performance are substantially equivalent.

Here's an analysis based on the information provided, highlighting why it doesn't fit the requested format for acceptance criteria and study proof:

A table of acceptance criteria and the reported device performance:
The document includes "Table 1. Comparison between the subject device and the predicate device" (pages 4-6). This table compares various attributes (e.g., intended use, power source, battery specifications, working pressure, cycle time, contraindications, materials, etc.) of the subject device (VenaOne) with the two predicate devices. For each attribute, it states whether the VenaOne is "Identical," "Similar," or "Identical or similar" to the predicates. This is a comparison for substantial equivalence, not a list of acceptance criteria with measured performance against those criteria.

Example of a comparison from the document (not acceptance criteria):

Feature	Acceptance Criteria (Not present as such)	Reported Device Performance (as comparison)
Intended Use	N/A	Identical (to predicate devices)
Working Pressure	N/A	Preset at 55 mmHg (Similar to predicates, which are 50 mmHg adjustable and 40 mmHg)
Cycle Time	N/A	Approximately 60 seconds (Identical to predicates)
Tolerances	N/A	± 5 mmHg (Similar to predicates, which are ± 4 mmHg and ± 5 mmHg)

Sample sized used for the test set and the data provenance:
The document does not describe a test set, sample size, or data provenance from a performance study. It references "non-clinical tests" (bench tests) to validate design and assure conformance with electrical safety and electromagnetic compatibility standards, and software verification. These are engineering/device-specific tests, not clinical performance studies with a "test set" in the context of patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as there is no described clinical test set requiring expert ground truth establishment.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable as there is no described clinical test set requiring adjudication.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This information is not applicable. The VenaOne is a mechanical device for DVT prevention and improved circulation; it is not an AI-assisted diagnostic or therapeutic tool that would involve human readers or MRMC studies.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable. Again, VenaOne is a mechanical device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The document mentions that "bench tests have been performed on the physical requirements, electrical requirement, and performance requirement," and "verification of software." These tests conform to voluntary standards (ANSI AAMI ES60601-1, IEC 60601-1-2). The "ground truth" for these tests would be the specifications and requirements defined by these standards, along with the device's own design specifications, rather than clinical outcomes or expert consensus.
The sample size for the training set:
This information is not applicable as the device is not an AI/machine learning product that requires a training set.
How the ground truth for the training set was established:
This information is not applicable as the device is not an AI/machine learning product and therefore has no training set.

In summary, the provided document is a 510(k) summary demonstrating substantial equivalence, not a clinical study report proving performance against specific acceptance criteria for a new clinical claim. It relies on comparisons to already cleared predicate devices and non-clinical engineering tests to support its safety and effectiveness.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K200285

Device Name VenaOne

Indications for Use (Describe)

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

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

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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:

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
DeviceName/Model	VenaOne	DVTCare CA5	Cirona 6400 Disposable DeepVein Thrombosis PreventionSystem	N/A
Intended Use	VenaOne is an easy to usesystem prescribed byhealthcare professionals forstimulating blood flow in thelegs (simulating musclecontractions) that aids in theprevention of DVT, enhancesblood circulation, diminishespost-operative pain andswelling, reduces woundhealing time, and aids in thetreatment and healing of: stasisdermatitis, venous stasis ulcers,arterial and diabetic leg ulcers,chronic venous insufficiency,and reduction of edema in thelower limbs.	The DVTcare CA5 is intendedto be a portable system that isprescribed by healthcareprofessionals to help preventthe onset of DVT in patients,by stimulating blood flow inthe legs (simulating musclecontractions). Furthermore, theunit can be used as an aid in theprophylaxis for DVT bypersons traveling, or thoseexpecting to be stationary forlong periods of time (> 4hours). This device can also beused to: aid in the prevention ofDVT, enhance bloodcirculation, diminish post-operative pain and swelling.reduce wound healing time,and aid in the treatment andhealing of stasis dermatitis,venous stasis ulcers, arterialand diabetic leg ulcers, chronicvenous insufficiency, andreduction of edema in the lowerlimbs	The Cirona 6400 disposabledeep vein thrombosisprevention system is intendedto be an easy to use portablesystem, prescribed by aphysician, to help prevent theonset of DVT in patients bystimulating blood flow in theextremities (stimulating musclecontractions).This device can be used in thehome or clinical setting to:• Aid in the prevention of DVT• Enhance blood circulation• Diminish post-operative painand swelling• Reduce wound healing time• Aid in the treatment andhealing of stasis dermatitis,venous stasis ulcers, arterialand diabetic leg ulcers, chronicvenous insufficiency andreduction of edema in the lowerlimbs	Identical
			• As a prophylaxis for DVT bypersons expecting to bestationary for long periods oftime
Prescription or OTC	Prescription	Prescription	Prescription	Identical
Power Source(s)	Rechargeable battery	Rechargeable battery	Rechargeable battery	Identical
BatterySpecifications	3.7V rechargeable battery	7.4V rechargeable battery	3.7V rechargeable battery	Identical or similar. Thevoltage difference ofbatteries will not raiseany new issue of thesafety or effectiveness.
Battery Charge	Takes approximately 4 hours(from depleted state).	Takes approximately 3 - 5hours (from depleted state).	Takes approximately 3 hours(from depleted state).	Similar. The differenceof charging time doesnot change the productperformance orparameters, which willnot raise any new issueof the safety oreffectiveness.
Power Supply	Input: 100 - 240 Vac, 50 - 60Hz,Output: 12 Vdc @ 2 Amp)	Input: 100 - 240 Vac, 50 - 60Hz,Output: 10 Vdc @ 1.1 Amp)	Input: 100 - 240 Vac, 50 - 60Hz,Output: 5 Vdc @ 2 Amp)	Similar. The voltagedifference of powersupply used does notchange the productperformance orparameters, which willnot raise any new issueof the safety oreffectiveness.
Internalrechargeablebatteries	Yes	Yes	Yes	Identical
Compliance withVoluntaryStandards?	Yes	Yes	Yes	Identical
Electrical SafetyMechanical SafetyChemical SafetyThermal SafetyRadiation Safety?	Yes	Yes	Yes	Identical
Functions anddesign	Aids venous return by usingcyclic,intermittent, pneumaticpressure application (inflationfollowed by deflation) tocompress the lowerlimb(s).	Aids venous return by usingcyclic,intermittent, pneumaticpressure application (inflationfollowed by deflation) tocompress the lowerlimb(s).	Aids venous return by usingcyclic,intermittent, pneumaticpressure application (inflationfollowed by deflation) tocompress the lowerlimb(s).	Identical
Contraindication(s)	The VenaOne MUST NOT beused to treat the followingconditions: Persons withsuspected, active or untreateddeep vein thrombosis, ischemicvascular disease, severearteriosclerosis, pulmonaryedema, severe congestive heartfailure, thrombophlebitis, or anactive infection.On the legs where cuffs wouldinterfere with the followingconditions: vein ligation,gangrene, dermatitis, openwounds, a recent skin graft,massive edema or extremedeformity of the leg.	The DVTCare CA5 Systemshould not be used by personswith the following conditions:suspected, active or untreateddeep vein thrombosis, ischemicvascular disease, severearteriosclerosis, pulmonaryedema, severe congestive heartfailure, thrombophlebitis, or anactive infection.Not recommended for use on aleg where the cuffs wouldinterfere with the followingconditions: vein ligation,gangrene, dermatitis, openwounds, a recent skin graft,massive edema or extremedeformity of the leg.	The Cirona® 6400 seriessystem should NOT be used inthe following conditions:• Severe arteriosclerosis orother ischemic vasculardiseases• Acute or active deep veinthrombosis• Existing pulmonary edema,pulmonary embolisms, and/orcongestive cardiac failure• On patients with neuropathy,active infections, and/orthrombophlebitis• On extremities that areextremely deformed,insensitive to pain, or where	Identical
	On extremities that areinsensitive to pain.Where increased venous orlymphatic return is undesirable.	Not for use with patines withneuropathy.Do not use on extremities thatare insensitive to pain.Do not use where increasedvenous or lymphatic return isundesirable.Leg cuffs may cause irritationwhen used in direct contactwith skin.	increased venous or lymphaticreturn is undesirable• Any local skin or tissuecondition in which thegarments would interfereincluding but not limited to:Vein ligation, Recent skingraft, Gangrene, Dermatitis,Open wounds, Massive edema
Target Population /Intended Users	Patients who need venousreturn.	Patients who need venousreturn.	Patients who need venousreturn.	Identical
Where Used	Hospital, Surgery Center,Altitude travel, areas of limitedmobility	Home, Hospital, SurgeryCenter, Altitude travel, areas oflimited mobility	Home, Hospital, SurgeryCenter, Altitude travel, areas oflimited 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 usingcyclic, intermittent, pneumaticpressure application (inflationfollowed by deflation) tocompress the lower limb(s).	Aids venous return by usingcyclic, intermittent, pneumaticpressure application (inflationfollowed by deflation) tocompress the lower limb(s).	Aids venous return by usingcyclic, intermittent, pneumaticpressure application (inflationfollowed by deflation) tocompress the lower limb(s).	Identical
Anatomical Site /Location oftreatmentapplication	Lower limb(s) (Calf)	Lower limb(s) (Calf)	Lower limb(s) (Calf)	Identical
Systemmanagement	Electronic, microprocessorcontrolled	Electronic, microprocessorcontrolled	Electronic, microprocessorcontrolled	Identical
Pressure Source	Micro pump controlled byelectronic processor	Micro pump controlled byelectronic processor	Micro pump controlled byelectronic 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, andadjustable 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 alarmsprompt recognition of systemfaults	Audible and visual alarmsprompt recognition of systemfaults	Audible and visual alarmsprompt recognition of systemfaults	Identical
Modes	1 Modality	2 Modality	1 Modality	Identical or similar
Air delivery frompump to cuffbladder	Via flexible plastic tube(s)connected directly to the airbladder.	Via flexible plastic tube(s)connected directly to the airbladder.	Via flexible plastic tube(s)connected directly to the airbladder.	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 ina covering of soft, nonlatex,non-woven medical fabric orequivalent medical material forincreased patient comfort andbiocompatibility compliance.	A single air bladder encased ina covering of soft, nonlatex,non-woven medical fabric orequivalent medical material forincreased patient comfort andbiocompatibility compliance.	A single air bladder encased ina covering of soft, nonlatex,non-woven medical fabric orequivalent medical material forincreased patient comfort andbiocompatibility 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 locationbetween +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 andDisinfecting	• Clean the outer surface of thepumpunit using a soft cloth,moistened with soapy water or70% isopropyl alcohol.• Do not use abrasive orvolatile cleaners.• Do not place cuffs in dryer.• NEVER remove the unit fromthe cuff.• Hand wash the exterior of thecuffs using a soft cloth,moistened with soapy water or70% isopropyl alcohol and letair dry.• To ensure the unit IScompletely dry prior to use,leave unit in the OFFcondition and disconnectedfrom the wall outlet for 30minutes after cleaning ordisinfecting.	• Clean the outer surface of thepump unit using a soft cloth,moistened with soapy water or70% isopropyl alcohol.• Do not use bleach on anyitem.• Do not use abrasive orvolatile cleaners - displaycould become scratched andhard to read.• Do not place cuff or carrypouch in dryer, as the bladdercould melt.• Hand wash exterior of cuffand carry pouch using a softcloth moistened with soapywater or 70% isopropyl alcoholand let air dry.• To ensure product iscompletely dry prior to use,leave unit in the off conditionand disconnected from power(wall outlet) for 30 minutesafter cleaning or disinfecting.	SWITCH OFF ANDDISCONNECT THE POWERCORD FROM THE MAINSUPPLY BEFORECLEANING ANDINSPECTION.• The unit casing is made fromplastic and can be cleanedusing a soft damp cloth and amild detergent free from harshchemicals to avoiddeterioration.• Sleeves are designed forsingle patient use and cleaningis not recommended.	Identical or similar
Disposal	This unit is anelectromechanical device thatincludes printed circuit boardsand rechargeable batteries.Do not discard in landfill.Consult local countyrequirements for properdisposal instructions. Pumpcontrol units containrechargeable batteries. Do notdiscard the pump unit inregular waste.	This unit is anelectromechanical device thatincludes printed circuit boardsand rechargeable batteries. Donot discard in landfill. Consultlocal, state, federal and countryrequirements for properdisposal instructions.Cuffs may be discarded in USlandfills.	This unit is anelectromechanical device thatincludes printed circuit boardsand rechargeable batteries.Do not discard in landfill.Consult local countyrequirements for properdisposal instructions. Pumpcontrol units containrechargeable batteries. Do notdiscard the pump unit inregular waste.	Identical or similar

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

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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

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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.

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).