(190 days)
Not Found
No
The device description and performance studies focus on mechanical operation (pressure, cycle times) and do not mention any computational or data-driven features indicative of AI/ML. The "Mentions AI, DNN, or ML" section also explicitly states "Not Found".
Yes
The device is intended for the prophylaxis of DVT, stimulating venous and arterial circulation, aiding in prevention and healing of ulcers, and reducing edema and compartmental pressures, all of which are therapeutic indications.
No
Explanation: The device description states its purpose is for "prophylaxis" and "prevention" of DVT and related conditions, as well as "aiding in healing." There is no mention of the device being used to identify, detect, or diagnose any medical condition.
No
The device description explicitly states it consists of a pump, inflatable garments, and interconnection tubing, which are hardware components.
Based on the provided information, the VascuEase device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- VascuEase Function: The VascuEase device is described as a prescription device that applies intermittent pressure to the limbs using inflatable garments. Its intended use is for the prophylaxis of DVT, stimulating circulation, aiding in ulcer prevention and healing, and reducing edema.
- Mechanism of Action: The device works by physically applying pressure to the external surface of the body to influence blood flow. It does not analyze any biological samples taken from the patient.
Therefore, the VascuEase device falls under the category of a therapeutic or physical medicine device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
VascuEase is a prescription device intended for the prophylaxis of Deep Vein Thrombosis (DVT), stimulating venous and arterial circulation, aiding in prevention of venous stasis ulcers, aiding of cutaneous ulcers, reducing acute/ chronic edema and compartmental pressures. For use in home or hospital setting.
Product codes (comma separated list FDA assigned to the subject device)
JOW
Device Description
The VascuEase IC-1200-WH is a portable, rechargeable battery-powered, prescription device intended for home or hospital use to help prevent post-operative DVT in patients by stimulating blood flow as an aid in the prevention of DVT. The VascuEase IC-1200-WH (applicant device) provides intermittent pressure to the calf and thigh or foot through the use of inflatable garments.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
calf and thigh or foot, affected limb(s)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
For use in home or hospital setting.
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)
Before being released every device is tested and must meet all performance specifications. In addition to aesthetic acceptance criteria, functional testing includes cycle timing and inflation pressure. The results demonstrate comparable inflation cycle profiles (rise times, inflation pressures, deflation times and cycle times) between the applicant and predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 7, 2018
Bio Compression Systems, Inc. Jonathan Ross President 120 W Commercial Ave Moonachie. New Jersey 07074
Re: K180248
Trade/Device Name: VascuEase IC-1200-WH Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: June 18, 2018 Received: June 25, 2018
Dear Jonathan Ross:
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.
Fernando Aguel-
Fernando Aguel
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) K180248
Device Name VascuEase IC-1200-WH
Indications for Use (Describe)
VascuEase is a prescription device intended for the prophylaxis of Deep Vein Thrombosis (DVT), stimulating venous and arterial circulation, aiding in prevention of venous stasis ulcers, aiding of cutaneous ulcers, reducing acute/ chronic edema and compartmental pressures. For use in home or hospital setting.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| ☒ Research Use (Part 21 CFR 201. Subpart D) | ☒ Over-The-Counter Use (21 CFR 201. Subpart G) |
|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------ | --------------------------------------------------------------------------------------------------------------------------------------------- |
| > Prescription Use (Part 21 CFR 801 Subpart D)
|X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
APPLICANT'S INFORMATION APPLICANT'S INFORMATION:
Jonathan Ross President Bio Compression Systems, Inc 120 West Commercial Avenue Moonachie, NJ, 07074 PH: 201 939-0716 FX: 201 939-4503 E-mail: jross(@biocompression.com Internet: http://www.biocompression.com Medical Establishment Registration No.: 2424387
August 2, 2018 DATE:
DEVICE INFORMATION
| DEVICE NAME: | VascuEase IC-1200-WH |
|---|---|
| Classification Panel: | Cardiological and Respiratory Devices |
| Classification Number: | 870.5800 |
| Product Nomenclature: | Compressible Limb Sleeve |
| Product Code(s): | JOW |
| Trade/Proprietary Name: | VascuEase IC-1200-WH |
| Common Name: | Pneumatic intermittent compression device |
DEVICE CLASSIFICATION
Compressible Limb Sleeve Devices are classified as Class II devices, and reviewed by the Division of Cardiovascular Devices.
PREDICATE DEVICE
Vena Pro Vascular Therapy System, K133274 The secondary predicate device is the Bio Compression Systems IC-1545-DL Multi Flow, K131306
DEVICE DESCRIPTION
The VascuEase IC-1200-WH is a portable, rechargeable battery-powered, prescription device intended for home or hospital use to help prevent post-operative DVT in patients by stimulating blood flow as an aid in the prevention of DVT. The VascuEase IC-1200-WH (applicant device) provides intermittent pressure to the calf and thigh or foot through the use of inflatable garments.
4
There is no change in fundamental technology and no change in intended use from the predicate device, K133274.
The cycle times and pressure are preset at the factory and cannot be changed by the user. The user interface consists of an On/Off button and two-color LED indicating operational status of the unit. The device consists of a pump. inflatable garments, and interconnection tubing. The pump air compressor is capable of no more than 80 mmHg maximum pressure and has pre-set inflate/deflate cycle times. Default pressure and timing is pre-set at the factory to 50 mmHz. with a cycle of 15 seconds on and 45 seconds off, which is consistent with the majority of indications prescribed.
The garment consists of a discrete inflatable chamber, attached to the pump via interconnection tubing and Velcro. The garment is applied externally over the affected limb(s); unilateral or bilateral treatment can be applied. The garments are supplied non-sterile and are intended for single patient use.
INDICATIONS FOR USE
VascuEase is a prescription device intended for the prophylaxis of Deep Vein Thrombosis (DVT), stimulating venous and arterial circulation, aiding in prevention of venous stasis ulcers, aiding in the healing of cutaneous ulcers, reducing acute/chronic edema and compartmental pressures. For use in home or hospital setting.
TECHNOLOGICAL CHARACTERISTICS
The manufacturer believes that the technological characteristics of the VascuEase IC-1200-WH are substantially equivalent to those of the predicate devices. The user interface has been simplified and battery-powered operation provide convenience for the user.
PERFORMANCE DATA
Before being released every device is tested and must meet all performance specifications. In addition to aesthetic acceptance criteria, functional testing includes cycle timing and inflation pressure. The results demonstrate comparable inflation cycle profiles (rise times, inflation pressures, deflation times and cycle times) between the applicant and predicate devices.
5
STATEMENT OF SUBSTANTIAL EQUIVALENCE
Similarities
Both the applicant and the predicate devices provide continuous intermittent pneumatic pressure using inflatable garments. The applicant and predicate devices have the same indications for use, both operate within the same clinically-established parameters and both have the same performance specifications. The applicant and predicate devices use the same prescribed inflation pressures and cycle times.
Differences
The applicant and primary predicate device have no differences. Whereas the applicant and secondary predicate (K131306) are both manufactured by Bio Compression Systems, the applicant device is portable and battery-powered while the secondary predicate is mainspowered. The secondary predicate can be configured for different therapies (a higher-pressure foot version and a cryotherapy version), while the applicant device is not available in alternate configurations.
Both the predicate and the applicant devices operate within the same clinically-established parameters. The differences between the predicate and the applicant devices do not impact substantial equivalence. A table illustrating the similarities and differences is provided below.
| Parameter | VascuEase IC-1200-WH
(applicant device) | Vena Pro Vascular Therapy
System, K133274
(primary predicate) | IC-1545-DL, K131306 (secondary predicate) |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | VascuEase is a
prescription device
intended for the
prophylaxis of Deep
Vein Thrombosis
(DVT), stimulating
venous and arterial
circulation, aiding in
prevention of venous
stasis ulcers, aiding in
the healing of cutaneous
ulcers, reducing
acute/chronic edema and
compartmental
pressures. For use in
home or hospital setting. | The Vena Pro Vascular Therapy
System model VP-31111 is intended
to be an easy to use portable system,
prescribed by a physician, to help
prevent the onset of DVT in patients
by stimulating blood flow in the
extremities (simulating muscle
contractions). This device can be
used to: aid in the prevention of
DVT, enhance blood circulation,
diminish post-operative pain and
swelling, reduce wound healing time,
aid in the treatment of: stasis
dermatitis, venous stasis ulcers,
arterial and diabetic leg ulcers,
chronic venous insufficiency and
reduction of edema in the lower
limbs. The unit can also be used as
an aid in the prophylaxis for DVT by
persons expecting to be stationary for
long periods of time. | Prophylaxis of deep vein
thrombosis,
enhancement of venous
and arterial circulation,
prevention of venous
stasis ulcers, assist in
healing of cutaneous
ulcers, reduction of
acute or chronic edema,
reduction of lower limb
pain due to surgery or
trauma, reduction of
compartmental pressures |
| Principal of
Operation | Intermittent Pneumatic
Compression | Intermittent Pneumatic
Compression | Intermittent Pneumatic
Compression |
| Weight | 0.7 pounds | 0.7 pounds | 4.25 pounds |
Table of Similarities and Differences with the Predicate Device
6
| Parameter | VascuEase IC-1200-WH
(applicant device) | Vena Pro Vascular Therapy
System, K133274
(primary predicate) | IC-1545-DL, K131306
(secondary predicate) |
|-----------------------------|--------------------------------------------|---------------------------------------------------------------------|----------------------------------------------|
| Dimensions | 5.3 x 2.7 x 1.5 inches | 5.3 x 2.7 x 1.5 inches | 6.25 x 8 x 8.25 inches |
| # of Segments
in garment | 1 | 1 | 1 |
| Inflation Time | 15 seconds | 15 seconds | 15 seconds |
| Deflation Time | 45 seconds | 45 seconds | 45 seconds |
| Inflation
Pressure | 50 mmHg | 50 mmHg | 50 mmHg |
| Pressure
Adjustment | NA | NA | Digital, 1 mmHg
increments |
| Pressure
Display | No | No | Yes |
| Power
Requirements | Rechargeable battery | Rechargeable battery | Electric mains |
| Mobility | Portable, worn | Portable, worn | Stationary, placed |
CONCLUSION
Based upon safety and performance testing, compliance with voluntary standards, and comparison to the predicate devices, the manufacturer believes that the VascuEase IC-1200-WH device is substantially equivalent to the predicate devices.