(90 days)
No
The description focuses on mechanical compression and pre-set inflation cycles, with no mention of adaptive algorithms, learning, or data analysis that would indicate AI/ML.
Yes
The device is intended to prevent deep vein thrombosis, which is a medical condition, by increasing venous blood flow and stimulating fibrinolysis. These actions classify it as a therapeutic device.
No
The device is described as a prophylactic system intended to prevent DVT by increasing venous blood flow and deterring thrombosis, not to diagnose a condition.
No
The device description explicitly states it is an "Intermittent Pneumatic Compression System" consisting of an "air pump and single-patient-use compression sleeve," which are hardware components. While it mentions "Software Validation" in the performance studies, the core functionality relies on physical compression via hardware.
Based on the provided information, the Caremed Supply Inc. VesoFlow Lite Deep Vein Thrombosis (DVT) Compression Device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "increase venous blood flow in at risk patients in order to help prevent deep vein thrombosis." This describes a therapeutic or prophylactic action on the patient's body, not an analysis of a sample taken from the body.
- Device Description: The description details a mechanical system that applies external pressure to the limbs. It does not involve the analysis of biological samples like blood, urine, or tissue.
- Lack of IVD Characteristics: The description does not mention any components or processes typically associated with IVDs, such as reagents, assays, sample collection, or laboratory analysis.
IVD devices are designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The VesoFlow Lite is a physical therapy device that acts externally on the patient.
N/A
Intended Use / 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.
Product codes
JOW
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
feet or legs, lower extremity, foot, calf, thigh
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.5800 Compressible limb sleeve.
(a)
Identification. A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image 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
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/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
2
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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3
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 Compression
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
Devices
Model Name: IPCS/SQS |
|------------------------------|------------------------------------------------------------------|
| Manufacturer: | Caremed Supply, Inc. |
| Classification Product Code: | JOW |
| Regulation number: | 870.5800 |
| Device Class: | II |
| 510(k) Number: | K141064 |
4
Traditional 510(k) Section 5 - 510 (k) Summary
5.6 Identification of the Reference Device:
| Reference Device Name: | VesoPress DVT System, Pump Model
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)
5
- . 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.
6
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
equivalence
determination |
|----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| Proprietary Name | VesoFlow Lite DVT
Compression Device | VESOFLOW PLUS DVT
Compression Devices | |
| Model Name | VesoFlow Lite | IPCS | |
| 510(k) No. | (to be assigned) | K141064 | |
| Intended 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. | The Caremed Supply Inc.
VESOFLOW® PLUS SQS and
IPCS Deep Vein Thrombosis (DVT)
Compression Devices are intended to
increase venous blood flow in at risk
patients in order to help prevent deep
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
not raise any new
issue of substantial
equivalence |
| | | | |
| Weight | 2.4 Kg | 2.8 Kg | Different but does
not raise any new
issue of substantial
equivalence |
| Pressure (mmHg) | Calf/Thigh: 40;
Foot: 120 | Calf/Thigh: 40;
Foot: 130 | Different but
Same as Reference
Device 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 does
not raise any 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 any new
issue of substantial
equivalence |
| Operation Humidity | 30% to 75% | 30 - 75% | Same |
| Operation
Temperature | 15°C - 40°C | 15°C - 35°C | Different but does
not raise any 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 | Different but
Same as Reference
Device K061814
(all 12 seconds) |
| Deflation time
per chamber | 48 seconds | 48 seconds for Calf/Thigh,
30 seconds for Foot | Different but
Same as Reference
Device K061814
(all 48 seconds) |
| Application | Non-invasive / external | Non-invasive / external | Same |
| Battery Pack | No | Yes | Different but does
not raise any new
issue of substantial
equivalence |
| Software /
Control panel | 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 any new
issue of substantial
equivalence |
| For Applied Part | | | |
| Calf Sleeves
(by calf
circumference) | 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 thigh
circumference) | 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), standard
extension of 118" (pair) | extension of 60" (pair), standard
extension of 118" (pair)
extension of 177" (pair) | Same |
7
Section 5 - Traditional 510(k)
Section 5 - 510 (k) Summary
8
Section 5 - 510 (k) Summary
9
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.