The Caremed Supply Inc. VesoFlow Lite Deep Vein Thrombosis (DVT) Compression Device is intended to increase venous blood flow in at risk patients in order to help prevent deep vein thrombosis.

Device Description

The VesoFlow Lite DVT Compression Device is an Intermittent Pneumatic Compression System that counteracts blood stasis and coagulation changes; two of the three major factors that promote deep vein thrombosis (DVT) a potentially life threatening condition which can lead to pulmonary embolism.

The VesoFlow Lite is a non-invasive mechanical prophylactic system that massages the feet or legs in a wavelike, milking motion that promotes blood flow and deters thrombosis, helping to empty pooled or static blood from the valve cusps of the femoral vein. Fibrinolytic activity is increased, stimulating the release of a plasminogen activator. This therapy typically complements other prophylactic measures, such as antiembolic stockings and anticoagulants.

Some exciting features include:

o User friendly master control unit that is designed so that its functions are self-explanatory
Power micro switch (ON/OFF)
. An alarm light displays a fault status with an audio alarm and LED display
. LED display that can monitor errors, sleeves statuses the device
User friendly hanging bracket that provides easy attachment

The system consists of an air pump and single-patient-use compression sleeve one for the foot, one for the calf and one for the thigh. The air pump and compression sleeve may be used on one lower extremity. If the air pump is used simultaneously on both lower extremities, it is important that the identical sleeve type be used on both legs (i.e. foot sleeve with foot sleeve, calf sleeve with calf sleeve, or thigh sleeve with thigh sleeve). The inflation pressure settings are pre-set by the manufacturer and cannot be changed. The compression level for the foot sleeve is 120mmHg (16kPa). The compression level for the calf and thigh sleeve is 40mmHg. The sleeve inflates and maintains compression for 12 seconds. Then, the sleeve deflates for a period of 48 seconds. As the sleeve inflates, it compresses the foot, calf or thigh which augments venous blood flow, thereby reducing stasis. This process also stimulates fibrinolysis: thus, reducing the risk of early clot formation. Regularly check the system while in use, assuring pump operation and sleeve fit.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the VesoFlow Lite DVT Compression Device, asserting its substantial equivalence to a predicate device. However, the document does not contain a study that proves the device meets specific acceptance criteria in the format you requested.

Instead, the document details a comparative performance test against a predicate device (VESOFLOW PLUS DVT Compression Devices Model Name: IPCS) and references another device (VesoPress DVT System, Pump Model VP500D) to establish "substantial equivalence" for market clearance.

Here's an analysis based on the information provided, highlighting what is present and what is missing concerning your request:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly defined or provided in a table. Instead, the "acceptance criteria" are implied to be that the VesoFlow Lite DVT Compression Device's performance, physical characteristics, and safety aspects are sufficiently similar or superior to the predicate device and comply with relevant standards.

Reported Device Performance:
The document provides a comparison table (Section 5.11) outlining various specifications of the subject device (VesoFlow Lite DVT Compression Device) against the predicate device (VESOFLOW PLUS DVT Compression Devices Model Name: IPCS) and, for certain parameters, the reference device (VesoPress DVT System, Pump Model VP500D).

Item	Subject device (VesoFlow Lite DVT Comp. Device)	Predicate device (VESOFLOW PLUS DVT Comp. Devices IPCS)	Reference Device (K061814) (where applicable)	Substantial equivalence determination (Comment)
Intended Use	Same as predicate	Intended to increase venous blood flow in at-risk patients to prevent DVT	-	Same
Type of use	Prescription Use	Prescription Use	-	Same
Size	9.83" x 4.37" x 8.28"	7.54" x 5.12" x 7.95"	-	Different but does not raise new issue of substantial equivalence
Weight	2.4 Kg	2.8 Kg	-	Different but does not raise new issue of substantial equivalence
Pressure (mmHg)	Calf/Thigh: 40; Foot: 120	Calf/Thigh: 40; Foot: 130	Calf/Thigh: 40; Foot: 80-120	Different but Same as Reference Device K061814
Input Rating	AC 100-240V, 50/60Hz	AC 100-240V, 50/60Hz	-	Same
Fuse Rating	T2AL 250V	1A/250V	-	Different but does not raise new issue of substantial equivalence
IEC Classification	Class II, Type BF Not AP or AGP type	Class II, Type BF Not AP or AGP type	-	Same
Ingress of Water Protection	IP21	IP22	-	Different but does not raise new issue of substantial equivalence (likely due to other safety measures)
Operation Humidity	30% to 75%	30 - 75%	-	Same
Operation Temperature	15°C - 40°C	15°C - 35°C	-	Different but does not raise new issue of substantial equivalence
Operation Atmospheric Pressure Range	700 hPa to 1060 hPa	700 hPa to 1060 hPa	-	Same
Mode of Operation	Continuous	Continuous	-	Same
Applied Part	Sleeve and Air Hose	Garment and Air Hose	-	Same
Applied Mode of Pressure	Intermittent	Intermittent	-	Same
Inflation time per chamber	12 seconds	12 seconds for Calf/Thigh, 3 seconds for Foot	All 12 seconds	Different but Same as Reference Device K061814
Deflation time per chamber	48 seconds	48 seconds for Calf/Thigh, 30 seconds for Foot	All 48 seconds	Different but Same as Reference Device K061814
Application	Non-invasive / external	Non-invasive / external	-	Same
Battery Pack	No	Yes	-	Different but does not raise new issue of substantial equivalence (implies AC power is sufficient or design choice)
Software / Control panel complexity	w/o Pressure and Timer display, w/o Mute, Caution, and Battery symbols display, w/o Timer Reset function, w/o Alarm mute button, w/o Maintenance alarm light	w/ Pressure and Timer display, w/ Mute, Caution, and Battery symbols display, w/ Timer Reset function, w/ Alarm mute button, w/ Maintenance alarm light	-	Different but does not raise new issue of substantial equivalence (simpler UI, likely cost-related)
Sleeve Sizes (Calf, Thigh, Foot)	Equivalent ranges and types	Equivalent ranges and types	-	Same
Air Hose	extension of 60" (pair), standard; extension of 118" (pair)	extension of 60" (pair), standard; extension of 118" (pair); extension of 177" (pair)	-	Same (for the available types)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document states "A series of safety and performance tests were conducted on the subject device..." (Section 5.9). These typically involve engineering design verification tests and compliance with recognized standards.
No sample size for a clinical test set is provided because "No clinical test data was used to support the decision of substantial equivalence" (Section 5.10).
Data Provenance: The tests mentioned (Biocompatibility, Software Validation, EMC/Electrical Safety, Reliability, Performance, Usability) are non-clinical (laboratory/bench testing). The country of origin of the data is not explicitly stated but is implicitly Taiwan, given the submitter's address. The data is prospective as it was generated specifically for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. Since no clinical test data was used and the evaluation was based on non-clinical comparative performance, there was no "ground truth" established by medical experts in the context of patient outcomes. The "ground truth" for non-clinical tests is established by engineering specifications, recognized standards, and the performance of the predicate device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This refers to methods for resolving discrepancies among expert readers in clinical studies. No clinical studies were conducted for this submission.

5. 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

Not applicable. This device is a mechanical DVT compression device, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device, not an algorithm or software-only device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical performance tests, the "ground truth" was based on:
- Engineering specifications and design requirements: The device had to perform within specified parameters (e.g., pressure, inflation/deflation times).
- Compliance with recognized standards: (e.g., biocompatibility standards, electrical safety standards IEC 60601-1, EMC standards IEC 60601-1-2).
- Performance of the predicate device: The subject device's performance was compared to that of the legally marketed predicate device to demonstrate substantial equivalence.

8. The sample size for the training set

Not applicable. As the submission did not involve AI/machine learning, there is no concept of a "training set."

9. How the ground truth for the training set was established

Not applicable. As the submission did not involve AI/machine learning, there is no "training set" or corresponding ground truth establishment.

In summary: The FDA clearance for the VesoFlow Lite DVT Compression Device was based on demonstration of substantial equivalence through comprehensive non-clinical testing (bench testing, safety, and performance evaluations) against a legally marketed predicate device, rather than new clinical trials or studies with explicit acceptance criteria for human performance or diagnostic accuracy. The key "study" was the comparative performance testing and verification of compliance with various safety and performance standards.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left, and the FDA logo is on the right. The FDA logo includes the agency's name, "U.S. Food & Drug Administration," in blue text.

August 5, 2018

Caremed Supply, Inc. Tsung-Hsuan Liu General Manager 7F., No. 2. Lane 235, Baoqiao Rd., Xindien, Dist. New Taipei City, 23145 Tw

Re: K181217

Trade/Device Name: VesoFlow Lite DVT Compression Device Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: April 26, 2018 Received: May 7, 2018

Dear Tsung-Hsuan Liu:

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/cdrl/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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Fernande Aguel Fernando Aguel -S

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K181217

Device Name VesoFlow Lite DVT Compression Device

Indications for Use (Describe)

The Caremed Supply Inc. VesoFlow Lite Deep Vein Thrombosis (DVT) Compression Device is intended to increase venous blood flow in at risk patients in order to help prevent deep vein thrombosis.

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Traditional 510(k) Section 5 - 510 (k) Summary

510(k) SUMMARY

5.1 Type of Submission:	Traditional
5.2 Date of Summary:	May 3, 2018
5.3 Submitter:	Caremed Supply, Inc.
Address:	7F., No. 2, Lane 235, Baoqiao Rd., Xindien Dist.,New Taipei City 23145, Taiwan, R.O.C.
Phone:	+886-2-2917-9808
Fax:	+886-2-2918-6505
Contact:	TSUNG-HSUAN LIU(oscar@caremed.com.tw)

5.4 Identification of the Device:

Proprietary/Trade name:	VesoFlow Lite DVT CompressionDevice
Classification Product Code:	JOW
Regulation Number:	870.5800
Regulation Description:	Compressible limb sleeve
Review Panel:	Cardiovascular
Device Class:	II

5.5 Identification of the Predicate Device:

Predicate Device Name:	VESOFLOW PLUS DVT CompressionDevicesModel Name: IPCS/SQS
Manufacturer:	Caremed Supply, Inc.
Classification Product Code:	JOW
Regulation number:	870.5800
Device Class:	II
510(k) Number:	K141064

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Traditional 510(k) Section 5 - 510 (k) Summary

5.6 Identification of the Reference Device:

Reference Device Name:	VesoPress DVT System, Pump ModelVP500D
Applicant:	Compression Therapy Concepts, Inc.
Manufacturer:	Caremed Supply, Inc.
Classification Product Code:	JOW
Regulation number:	870.5800
Device Class:	II
510(k) Number:	K061814

5.7 Intended Use/ Indications for Use of the Device

The Caremed Supply Inc. VesoFlow Lite Deep Vein Thrombosis (DVT) Compression Device is intended to increase venous blood flow in at risk patients in order to help prevent deep vein thrombosis.

5.8 Device Description

Some exciting features include:

o User friendly master control unit that is designed so that its functions are self-explanatory
Power micro switch (ON/OFF)

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. An alarm light displays a fault status with an audio alarm and LED display
. LED display that can monitor errors, sleeves statuses the device
User friendly hanging bracket that provides easy attachment

5.9 Non-clinical Testing

A series of safety and performance tests were conducted on the subject device, VesoFlow Lite DVT Compression Device.

. Biocompatibility
. Software Validation
Electromagnetic compatibility and electrical safety ●
. Reliability
Performance ●
. Usability

All the test results demonstrate VesoFlow Lite DVT Compression Device meets the requirements of its pre-defined acceptance criteria and intended use, and is substantially equivalent to the predicate device.

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5.10 Clinical Testing

No clinical test data was used to support the decision of substantial equivalence.

5.11 Substantial Equivalence Determination

The VesoFlow Lite DVT Compression Device submitted in this 510(k) file is substantially equivalent in intended use, design, technology/principles of operation, materials and performance to the cleared VESOFLOW PLUS DVT Compression Devices Model Name: IPCS/SQS (K141064), especially IPCS. We conducted comparative performance test with IPCS, and also compared with referenced VesoPress DVT System, Pump Model VP500D (K061814) for the specifications of Pressure, Inflation time, and Deflation time. Differences between the devices cited in this section do not raise any new issue of substantial equivalence.

Item	Subject device	Predicate device	Substantialequivalencedetermination
Proprietary Name	VesoFlow Lite DVTCompression Device	VESOFLOW PLUS DVTCompression Devices
Model Name	VesoFlow Lite	IPCS
510(k) No.	(to be assigned)	K141064
Intended Use	The Caremed Supply Inc.VesoFlow Lite Deep VeinThrombosis (DVT) CompressionDevice is intended to increasevenous blood flow in at riskpatients in order to help preventdeep vein thrombosis.	The Caremed Supply Inc.VESOFLOW® PLUS SQS andIPCS Deep Vein Thrombosis (DVT)Compression Devices are intended toincrease venous blood flow in at riskpatients in order to help prevent deepvein thrombosis.	Same
Type of use	Prescription Use	Prescription Use	Same
For Control Unit
Size	9.83" x 4.37" x 8.28"	7.54" x 5.12" x 7.95"	Different but doesnot raise any newissue of substantialequivalence

Weight	2.4 Kg	2.8 Kg	Different but doesnot raise any newissue of substantialequivalence
Pressure (mmHg)	Calf/Thigh: 40;Foot: 120	Calf/Thigh: 40;Foot: 130	Different butSame as ReferenceDevice K061814(Calf/Thigh: 40;Foot: 80-120)
Input Rating	AC 100-240V, 50/60Hz	AC 100-240V, 50/60Hz	Same
Fuse Rating	T2AL 250V	1A/250V	Different but doesnot raise any newissue of substantialequivalence
IEC Classification	Class II, Type BFNot AP or AGP type	Class II, Type BFNot AP or AGP type	Same
Ingress of WaterProtection	IP21	IP22	Different but doesnot raise any newissue of substantialequivalence
Operation Humidity	30% to 75%	30 - 75%	Same
OperationTemperature	15°C - 40°C	15°C - 35°C	Different but doesnot raise any newissue of substantialequivalence
OperationAtmosphericPressure Range	700 hPa to 1060 hPa	700 hPa to 1060 hPa	Same
Mode of Operation	Continuous	Continuous	Same
Applied Part	Sleeve and Air Hose	Garment and Air Hose	Same
Applied Mode ofPressure	Intermittent	Intermittent	Same

Inflation timeper chamber	12 seconds	12 seconds for Calf/Thigh,3 seconds for Foot	Different butSame as ReferenceDevice K061814(all 12 seconds)
Deflation timeper chamber	48 seconds	48 seconds for Calf/Thigh,30 seconds for Foot	Different butSame as ReferenceDevice K061814(all 48 seconds)
Application	Non-invasive / external	Non-invasive / external	Same
Battery Pack	No	Yes	Different but doesnot raise any newissue of substantialequivalence
Software /Control panel	w/o Pressure and Timer displayw/o Mute, Caution, and Batterysymbols displayw/o Timer Reset functionw/o Alarm mute buttonw/o Maintenance alarm light	w/ Pressure and Timer displayw/ Mute, Caution, and Batterysymbols displayw/ Timer Reset functionw/ Alarm mute buttonw/ Maintenance alarm light	Different but doesnot raise any newissue of substantialequivalence
For Applied Part
Calf Sleeves(by calfcircumference)	Small: up to 12"Medium: up to 18"Large: up to 24"XL: up to 32"	XS: up to 12"M: up to 18"L: up to 24"B: up to 32"	Same
Thigh Sleeves(by thighcircumference)	Medium: up to 29"Large: up to 36"XL: up to 42"	M: up to 29"L: up to 36"B: up to 42"	Same
Foot Sleeves(by foot length)	Medium: 13"Large: 16"	U: 13"L: 16"	Same
Air Hose	extension of 60" (pair), standardextension of 118" (pair)	extension of 60" (pair), standardextension of 118" (pair)extension of 177" (pair)	Same

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Section 5 - Traditional 510(k)
Section 5 - 510 (k) Summary

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Section 5 - 510 (k) Summary

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5.12 Similarity and Difference

The VesoFlow Lite DVT Compression Device has been compared with "VESOFLOW PLUS DVT Compression Devices Model Name: IPCS" and referred to "VesoPress DVT System, Pump Model VP500D". The subject device has same intended use, principle of operation and similar technological characteristics as model: IPCS of the predicate device and reference device. Although there are some specifications that are different between two devices, the performance test has been completed to demonstrate that the differences between these parameters would not impact the safety and effectiveness of the subject device, and the specifications of Pressure. Inflation time, and Deflation time are the same as those of reference device. The subject device has also undergone safety and performance tests, and the results complied with the test requests. Therefore, the differences between the subject device and the predicate device do not raise any problem of substantial equivalence. The subject device is substantially equivalent to the predicate device in intended use, design, and performance claims.

5.13 Conclusion

After analyzing non-clinical laboratory studies and safety testing data, it can be concluded that the VesoFlow Lite DVT Compression Device is substantially equivalent to the predicate device.

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).