VesoFlow Lite DVT Compression Device

K181217 · Caremed Supply, Inc. · JOW · Aug 5, 2018 · Cardiovascular

Device Facts

• Record ID: K181217
• Device Name: VesoFlow Lite DVT Compression Device
• Applicant: Caremed Supply, Inc.
• Product Code: JOW · Cardiovascular
• Decision Date: Aug 5, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5800
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

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 Story

VesoFlow Lite is an intermittent pneumatic compression system for DVT prophylaxis. It consists of an air pump and single-patient-use compression sleeves (foot, calf, or thigh). The device operates by inflating sleeves in a wavelike, milking motion to augment venous blood flow, reduce stasis, and stimulate fibrinolysis. The pump is pre-set with fixed pressure (120mmHg for foot; 40mmHg for calf/thigh) and timing (12s inflation, 48s deflation). It is used in clinical settings to complement other measures like antiembolic stockings or anticoagulants. The system includes a control unit with a power switch, alarm light, and LED status display. Healthcare providers attach the sleeves to the patient's lower extremities and monitor the system for operation and fit. The device helps prevent DVT and associated pulmonary embolism by emptying pooled blood from femoral vein valve cusps.

Clinical Evidence

No clinical test data was used to support the decision of substantial equivalence. Evidence is based on non-clinical laboratory studies, including biocompatibility, software validation, electromagnetic compatibility, electrical safety, reliability, performance, and usability testing.

Technological Characteristics

Intermittent pneumatic compression system. Components: air pump, single-patient-use sleeves (foot, calf, thigh), air hoses. Energy: AC 100-240V, 50/60Hz. Pressure: 120mmHg (foot), 40mmHg (calf/thigh). Cycle: 12s inflation, 48s deflation. Class II, Type BF. Ingress protection: IP21. Operation: continuous. Software: embedded control logic for pump timing and alarm monitoring.

Indications for Use

Indicated for at-risk patients to increase venous blood flow and help prevent deep vein thrombosis (DVT).

Regulatory Classification

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.

Predicate Devices

• VESOFLOW PLUS DVT Compression Devices Model Name: IPCS/SQS (K141064)

Reference Devices

• VesoPress DVT System, Pump Model VP500D (K061814)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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.,<br>New Taipei City 23145, Taiwan, R.O.C. |
| Phone: | [phone] |
| Fax: | [phone] |
| Contact: | TSUNG-HSUAN LIU<br>([e-mail]) |

## 5.4 Identification of the Device:

| Proprietary/Trade name: | VesoFlow Lite DVT Compression<br>Device |
|------------------------------|-----------------------------------------|
| 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 Compression<br>Devices<br>Model 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 Model<br>VP500D |
|------------------------------|--------------------------------------------|
| 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

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)

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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

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.

#### 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 | Substantial<br>equivalence<br>determination |
|----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| Proprietary Name | VesoFlow Lite DVT<br>Compression Device | VESOFLOW PLUS DVT<br>Compression Devices | |
| Model Name | VesoFlow Lite | IPCS | |
| 510(k) No. | (to be assigned) | K141064 | |
| Intended Use | The Caremed Supply Inc.<br>VesoFlow Lite Deep Vein<br>Thrombosis (DVT) Compression<br>Device is intended to increase<br>venous blood flow in at risk<br>patients in order to help prevent<br>deep vein thrombosis. | The Caremed Supply Inc.<br>VESOFLOW® PLUS SQS and<br>IPCS Deep Vein Thrombosis (DVT)<br>Compression Devices are intended to<br>increase venous blood flow in at risk<br>patients in order to help prevent deep<br>vein 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 does<br>not raise any new<br>issue of substantial<br>equivalence |
| | | | |
| Weight | 2.4 Kg | 2.8 Kg | Different but does<br>not raise any new<br>issue of substantial<br>equivalence |
| Pressure (mmHg) | Calf/Thigh: 40;<br>Foot: 120 | Calf/Thigh: 40;<br>Foot: 130 | Different but<br>Same as Reference<br>Device K061814<br>(Calf/Thigh: 40;<br>Foot: 80-120) |
| Input Rating | AC 100-240V, 50/60Hz | AC 100-240V, 50/60Hz | Same |
| Fuse Rating | T2AL 250V | 1A/250V | Different but does<br>not raise any new<br>issue of substantial<br>equivalence |
| IEC Classification | Class II, Type BF<br>Not AP or AGP type | Class II, Type BF<br>Not AP or AGP type | Same |
| Ingress of Water<br>Protection | IP21 | IP22 | Different but does<br>not raise any new<br>issue of substantial<br>equivalence |
| Operation Humidity | 30% to 75% | 30 - 75% | Same |
| Operation<br>Temperature | 15°C - 40°C | 15°C - 35°C | Different but does<br>not raise any new<br>issue of substantial<br>equivalence |
| Operation<br>Atmospheric<br>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<br>Pressure | Intermittent | Intermittent | Same |
| | | | |
| Inflation time<br>per chamber | 12 seconds | 12 seconds for Calf/Thigh,<br>3 seconds for Foot | Different but<br>Same as Reference<br>Device K061814<br>(all 12 seconds) |
| Deflation time<br>per chamber | 48 seconds | 48 seconds for Calf/Thigh,<br>30 seconds for Foot | Different but<br>Same as Reference<br>Device K061814<br>(all 48 seconds) |
| Application | Non-invasive / external | Non-invasive / external | Same |
| Battery Pack | No | Yes | Different but does<br>not raise any new<br>issue of substantial<br>equivalence |
| Software /<br>Control panel | w/o Pressure and Timer display<br>w/o Mute, Caution, and Battery<br>symbols display<br>w/o Timer Reset function<br>w/o Alarm mute button<br>w/o Maintenance alarm light | w/ Pressure and Timer display<br>w/ Mute, Caution, and Battery<br>symbols display<br>w/ Timer Reset function<br>w/ Alarm mute button<br>w/ Maintenance alarm light | Different but does<br>not raise any new<br>issue of substantial<br>equivalence |
| For Applied Part | | | |
| Calf Sleeves<br>(by calf<br>circumference) | Small: up to 12"<br>Medium: up to 18"<br>Large: up to 24"<br>XL: up to 32" | XS: up to 12"<br>M: up to 18"<br>L: up to 24"<br>B: up to 32" | Same |
| Thigh Sleeves<br>(by thigh<br>circumference) | Medium: up to 29"<br>Large: up to 36"<br>XL: up to 42" | M: up to 29"<br>L: up to 36"<br>B: up to 42" | Same |
| Foot Sleeves<br>(by foot length) | Medium: 13"<br>Large: 16" | U: 13"<br>L: 16" | Same |
| Air Hose | extension of 60" (pair), standard<br>extension of 118" (pair) | extension of 60" (pair), standard<br>extension of 118" (pair)<br>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.