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.

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. 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.

AI/ML Overview

The provided text
describes the acceptance criteria and study proving a medical device, the VascuEase IC-1200-WH, meets these criteria for FDA 510(k) clearance. This is a Class II device, specifically a "Compressible Limb Sleeve," intended for the prophylaxis of Deep Vein Thrombosis (DVT) and other circulatory benefits.

Here's a breakdown of the requested information based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the VascuEase IC-1200-WH are based on its similarity and performance comparability to predicate devices. The document states that the device must meet "all performance specifications" and has undergone "functional testing," which "includes cycle timing and inflation pressure."

Acceptance Criteria (Predicate-based Comparability)	Reported Device Performance (VascuEase IC-1200-WH)
Intended Use: Consistent with predicate devices for DVT prophylaxis, circulation stimulation, ulcer prevention/healing, edema reduction.	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." (Identical to primary predicate in core indications).
Principal of Operation: Intermittent Pneumatic Compression.	Principal of Operation: "Intermittent Pneumatic Compression."
Inflation Time: Consistent with predicate devices (e.g., 15 seconds).	Inflation Time: "15 seconds."
Deflation Time: Consistent with predicate devices (e.g., 45 seconds).	Deflation Time: "45 seconds."
Inflation Pressure: Consistent with predicate devices (e.g., 50 mmHg).	Inflation Pressure: "50 mmHg" (Pre-set at factory).
Cycle Times: "Results demonstrate comparable inflation cycle profiles (rise times, inflation pressures, deflation times and cycle times)" to predicate devices.	Cycle Times: "Cycle times and pressure are preset at the factory and cannot be changed by the user. ... Default pressure and timing is pre-set at the factory to 50 mmHz, with a cycle of 15 seconds on and 45 seconds off."
Maximum Pressure: No more than 80 mmHg.	Maximum Pressure: "The pump air compressor is capable of no more than 80 mmHg maximum pressure."
Aesthetic Acceptance Criteria: Met.	"In addition to aesthetic acceptance criteria, functional testing includes cycle timing and inflation pressure." (Implies aesthetic criteria were met).
No change in fundamental technology or intended use from predicate.	"There is no change in fundamental technology and no change in intended use from the predicate device, K133274."

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state a specific "test set" or its sample size in the context of a clinical study with patients. The performance data presented refers to internal product testing.

Sample Size for Test Set: Not explicitly stated as a separate clinical "test set" with a specific patient count. The performance data relates to testing of the manufactured devices themselves. The document states, "Before being released every device is tested and must meet all performance specifications." This indicates an ongoing quality control process for each manufactured unit rather than a single pre-market clinical test set.
Data Provenance: The data appears to be from internal testing by the manufacturer, Bio Compression Systems, Inc., within their typical manufacturing and quality control processes. There is no mention of country of origin for any clinical data (as there is no explicit clinical data presented). The testing described is intrinsic to the device's design and manufacturing rather than patient-derived.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Since the "test set" refers to internal performance testing of the device's operational parameters (pressure, cycle times, etc.) rather than a diagnostic or clinical efficacy study requiring human expert interpretation, the concept of "ground truth" established by external experts in this context is not applicable. The measurements taken (e.g., mmHgpressure, seconds for cycle times) are objective parameters.

4. Adjudication Method for the Test Set

As the "test set" pertains to objective performance metrics of the device (e.g., pressure, timing), and not a study requiring subjective interpretation or diagnosis, an adjudication method for establishing ground truth is not applicable. The device's performance is measured against engineering specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done or described in this 510(k) summary. The submission focuses on substantial equivalence based on technological characteristics and functional performance parameters, not on comparative clinical efficacy or how human readers (or users) improve with AI assistance. The device is a physical therapeutic device, not an AI-assisted diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable. The VascuEase IC-1200-WH is a physical medical device (pneumatic intermittent compression device), not an algorithm or software. Its performance is inherent to its mechanical and electronic function, which is tested directly. There is no AI component or algorithm that would operate "standalone."

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is established by the engineering specifications and design requirements of the device and its predicate. The device's function (e.g., inflation pressure of 50 mmHg, inflation time of 15 seconds) are objective, pre-defined parameters. There is no "expert consensus," "pathology," or "outcomes data" directly used to establish the ground truth for these specific performance characteristics in the sense of a diagnostic or treatment outcome study.

8. The Sample Size for the Training Set

The document does not mention a "training set." This term is typically used for machine learning or AI models. Since the VascuEase IC-1200-WH is a physical medical device, not an AI algorithm, the concept of a training set is not applicable here.

9. How the Ground Truth for the Training Set Was Established

As there is no "training set" for an AI or machine learning model, this question is not applicable to the VascuEase IC-1200-WH.

Summary

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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)
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☒ Research Use (Part 21 CFR 201. Subpart D)	☒ Over-The-Counter Use (21 CFR 201. Subpart G)
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| > 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

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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

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(applicant device)	Vena Pro Vascular TherapySystem, K133274(primary predicate)	IC-1545-DL, K131306 (secondary predicate)
Intended Use	VascuEase is aprescription deviceintended for theprophylaxis of DeepVein Thrombosis(DVT), stimulatingvenous and arterialcirculation, aiding inprevention of venousstasis ulcers, aiding inthe healing of cutaneousulcers, reducingacute/chronic edema andcompartmentalpressures. For use inhome or hospital setting.	The Vena Pro Vascular TherapySystem model VP-31111 is intendedto be an easy to use portable system,prescribed by a physician, to helpprevent the onset of DVT in patientsby stimulating blood flow in theextremities (simulating musclecontractions). This device can beused to: aid in the prevention ofDVT, enhance blood circulation,diminish post-operative pain andswelling, reduce wound healing time,aid in the treatment of: stasisdermatitis, venous stasis ulcers,arterial and diabetic leg ulcers,chronic venous insufficiency andreduction of edema in the lowerlimbs. The unit can also be used asan aid in the prophylaxis for DVT bypersons expecting to be stationary forlong periods of time.	Prophylaxis of deep veinthrombosis,enhancement of venousand arterial circulation,prevention of venousstasis ulcers, assist inhealing of cutaneousulcers, reduction ofacute or chronic edema,reduction of lower limbpain due to surgery ortrauma, reduction ofcompartmental pressures
Principal ofOperation	Intermittent PneumaticCompression	Intermittent PneumaticCompression	Intermittent PneumaticCompression
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(applicant device)	Vena Pro Vascular TherapySystem, 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 Segmentsin garment	1	1	1
Inflation Time	15 seconds	15 seconds	15 seconds
Deflation Time	45 seconds	45 seconds	45 seconds
InflationPressure	50 mmHg	50 mmHg	50 mmHg
PressureAdjustment	NA	NA	Digital, 1 mmHgincrements
PressureDisplay	No	No	Yes
PowerRequirements	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.

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).