VascuEase IC-1200-WH
Device Facts
| Record ID | K180248 |
|---|---|
| Device Name | VascuEase IC-1200-WH |
| Applicant | Bio Compression Systems, Inc. |
| Product Code | JOW · Cardiovascular |
| Decision Date | Aug 7, 2018 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.5800 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
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.
Device Story
VascuEase IC-1200-WH is a portable, rechargeable battery-powered pneumatic intermittent compression device; used in home or hospital settings to prevent post-operative DVT. Device consists of a pump, inflatable garments, and interconnection tubing. Pump delivers intermittent pressure to calf, thigh, or foot via inflatable garments; factory-preset to 50 mmHg with 15-second inflation and 45-second deflation cycles. User interface is limited to an On/Off button and two-color LED status indicator; pressure and timing are non-adjustable by the user. Device stimulates blood flow to mimic muscle contractions, aiding circulation and reducing edema/compartmental pressures. Healthcare providers prescribe the device; patients use it to manage venous/arterial conditions and prevent DVT. Benefits include improved circulation and reduced risk of venous stasis and ulcers.
Clinical Evidence
Bench testing only. Functional testing confirmed cycle timing and inflation pressure profiles (rise times, inflation pressures, deflation times, and cycle times) are comparable to predicate devices.
Technological Characteristics
Portable, battery-powered pneumatic compression pump. Single-chamber inflatable garments applied via Velcro and tubing. Maximum pressure 80 mmHg; factory-preset to 50 mmHg. Fixed cycle: 15s inflation, 45s deflation. Non-sterile, single-patient use garments. User interface: On/Off button, two-color LED status indicator. No digital pressure adjustment or display.
Indications for Use
Indicated for prophylaxis of DVT, stimulation of venous/arterial circulation, prevention of venous stasis ulcers, healing of cutaneous ulcers, and reduction of acute/chronic edema and compartmental pressures in patients in home or hospital settings.
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
Submission Summary (Full Text)
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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
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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.
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
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## 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) |
|-------------------------------------------------|
|-------------------------------------------------|
| <div style="display:inline-block;"> <span style="text-decoration: overline;">☒</span> Research Use (Part 21 CFR 201. Subpart D) </div> | <div style="display:inline-block;"> <span style="text-decoration: overline;">☒</span> Over-The-Counter Use (21 CFR 201. Subpart G) </div> |
|------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|
|------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| > Prescription Use (Part 21 CFR 801 Subpart D)
|X Over-The-Counter Use (21 CFR 801 Subpart C)
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# 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.
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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.
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#### 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<br>(applicant device) | Vena Pro Vascular Therapy<br>System, K133274<br>(primary predicate) | IC-1545-DL, K131306 (secondary predicate) |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | VascuEase is a<br>prescription device<br>intended for the<br>prophylaxis of Deep<br>Vein Thrombosis<br>(DVT), stimulating<br>venous and arterial<br>circulation, aiding in<br>prevention of venous<br>stasis ulcers, aiding in<br>the healing of cutaneous<br>ulcers, reducing<br>acute/chronic edema and<br>compartmental<br>pressures. For use in<br>home or hospital setting. | The Vena Pro Vascular Therapy<br>System model VP-31111 is intended<br>to be an easy to use portable system,<br>prescribed by a physician, to help<br>prevent the onset of DVT in patients<br>by stimulating blood flow in the<br>extremities (simulating muscle<br>contractions). This device can be<br>used to: aid in the prevention of<br>DVT, enhance blood circulation,<br>diminish post-operative pain and<br>swelling, reduce wound healing time,<br>aid in the treatment of: stasis<br>dermatitis, venous stasis ulcers,<br>arterial and diabetic leg ulcers,<br>chronic venous insufficiency and<br>reduction of edema in the lower<br>limbs. The unit can also be used as<br>an aid in the prophylaxis for DVT by<br>persons expecting to be stationary for<br>long periods of time. | Prophylaxis of deep vein<br>thrombosis,<br>enhancement of venous<br>and arterial circulation,<br>prevention of venous<br>stasis ulcers, assist in<br>healing of cutaneous<br>ulcers, reduction of<br>acute or chronic edema,<br>reduction of lower limb<br>pain due to surgery or<br>trauma, reduction of<br>compartmental pressures |
| Principal of<br>Operation | Intermittent Pneumatic<br>Compression | Intermittent Pneumatic<br>Compression | Intermittent Pneumatic<br>Compression |
| Weight | 0.7 pounds | 0.7 pounds | 4.25 pounds |
#### Table of Similarities and Differences with the Predicate Device
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| Parameter | VascuEase IC-1200-WH<br>(applicant device) | Vena Pro Vascular Therapy<br>System, K133274<br>(primary predicate) | IC-1545-DL, K131306<br>(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<br>in garment | 1 | 1 | 1 |
| Inflation Time | 15 seconds | 15 seconds | 15 seconds |
| Deflation Time | 45 seconds | 45 seconds | 45 seconds |
| Inflation<br>Pressure | 50 mmHg | 50 mmHg | 50 mmHg |
| Pressure<br>Adjustment | NA | NA | Digital, 1 mmHg<br>increments |
| Pressure<br>Display | No | No | Yes |
| Power<br>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.
