The Alternating Leg Pressure® (ALP®) VasQcare™ System is a non-invasive system for reducing the incidence of deep vein thrombosis. The application of external intermittent pneumatic compression has six effects:

Increases blood flow velocity
Reduces the risk of deep vein thrombosis
Enhances blood circulation
Reduces pain and swelling
Reduces wound healing time
Aids in the treatment and healing of stasis dermatitis, venous stasis, arterial and diabetic leg ulcers, chronic vein insufficiency and reduction of edema in the lower limbs

The ALP® VasQcare™ System consists of a pump and a pair of single use calf sleeves. The pump provides intermittent cycles of compressed air, which alternately inflate the calf sleeves. The compression, when applied properly to the patient, increases blood velocity back to the heart and helps to prevent deep vein thrombosis.

The pump operates on timed cycles consisting of approximately 12 seconds of inflation where the calf sleeve compresses the limb followed by approximately 48 seconds of deflation where there is no pressure applied to the limb. Each limb compresses once per minute.

The ALP® VasQcare™ System may be used on patients at risk for developing deep vein thrombosis and in conjunction with medical therapy for high-risk patients.

Device Description

Currie Medical Specialties (CMS) ALP® VasQcare™ System provides intermittent pneumatic pressure to a patient's leg for the prevention of deep vein thrombosis (DVT). When the compression sleeve is inflated, the veins collapse, which forces blood to move upward toward the heart. After compression is complete, the sleeves deflate which allows the veins to reopen and bring oxygenated blood to the calf. The VasQcare™ pump controller predicates the inflation and deflation sequence.

AI/ML Overview

This FDA 510(k) summary for the ALP® VasQcare™ System does not contain the level of detail typically found in a study demonstrating device performance against specific acceptance criteria in the manner requested.

The document states that "Bench testing was conducted to ensure that the new design did not compromise the performance or safety and efficacy of the device in a manner that is substantially equivalent to that of the predicate devices." It also mentions testing against standards like IEC 60601-1-1, 60601-1-6, and 60601-1-11 for electrical safety, EMC, mechanical integrity, and environmental/life cycle. However, it does not provide specific acceptance criteria or the reported device performance measurements for these tests.

The document explicitly states: "Per the requirements of 21 CFR 807, clinical data, non-clinical bench testing and the information provided within this 510(k) pre-market submission, Currie Medical Specialties, Inc., concludes that the ALP® VasQcare™ System performs in a manner that is substantially equivalent to the predicate devices listed above." This indicates clinical data was part of the submission, but its details are not included in this summary.

Given the information provided, I cannot populate the requested table or answer most of the specific questions about the study design, sample sizes, expert involvement, or adjudication methods, as these details are not present in the provided text.

Here's what can be inferred and what cannot:

Information NOT available in the provided text:

Specific Acceptance Criteria and Reported Device Performance: No explicit numerical acceptance criteria or performance metrics (e.g., specific pressure ranges, flow rates, failure rates) are mentioned. The document relies on a general statement of "no compromise" and "substantially equivalent."
Sample sizes used for the test set and data provenance: No information on the number of devices or subjects tested, or where the data came from.
Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable, as no ground truth establishment for a test set is described.
Adjudication method: Not applicable.
Multi-Reader Multi-Case (MRMC) comparative effectiveness study: No mention of such a study or any associated effect sizes.
Standalone (algorithm only) performance: Not applicable, as this is a medical device, not an AI algorithm in the typical sense.
Type of ground truth used: Not applicable, as specific clinical or performance studies with defined ground truth are not detailed.
Sample size for the training set: Not applicable, as this is not an AI/ML device in the context of a training set.
How the ground truth for the training set was established: Not applicable.

What little can be extracted from the document related to "acceptance criteria" and "study":

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred/General)	Reported Device Performance (Inferred/General)
Electrical Safety, EMC, Mechanical Integrity, Environmental, and Life Cycle Performance	"The ALP® VasQcare™ has performance characteristics that are substantially equivalent to the predicate devices." (Evaluated against IEC 60601-1-1, 60601-1-6, 60601-1-11)
Biocompatibility	"Biocompatibility of the ALP® VasQcare™ System is not affected" (Due to identical materials as predicate device K112311).
Functional Equivalence to Predicate Devices (especially in terms of pressure levels and cycles)	"This submission is intended for use of the pump at pressure levels of 45 mm Hg." (Implied acceptance that it meets this pressure. Predicate devices also operate at this pressure).
Pneumatic Compression Cycle Timing	"Approximately 12 seconds of inflation... followed by approximately 48 seconds of deflation... Each limb compresses once per minute." (Implied adherence to this operational spec).

Details of the "Study" (Bench Testing and Equivalence Rationale):

Study Type: Non-clinical bench testing. The document states "clinical data" was part of the 510(k) submission, but details of any clinical study are not provided in this summary.
Objective: To ensure the new design "did not compromise the performance or safety and efficacy of the device in a manner that is substantially equivalent to that of the predicate devices."
Specific Tests Mentioned:
- Electrical safety
- EMC (Electromagnetic Compatibility)
- Mechanical integrity
- Environmental testing
- Life cycle testing
- Biocompatibility assessment (based on material equivalence)
Standards Used: IEC 60601-1-1, 60601-1-6, and 60601-1-11.
Accreditation: Tests were "confirmed by an accredited third-party."

In summary, this document is a 510(k) summary for FDA submission, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed study results with specific acceptance criteria and performance metrics for a novel technology. The "study" described is primarily bench testing to ensure the new device performs similarly and safely to existing, legally marketed devices.

Summary

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Image /page/0/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in a bold, sans-serif font. The text is arranged on a single line and is likely a header or title. The words are all capitalized and evenly spaced.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 09, 2015

Currie Medical Specialties, Inc. Owen Bry Director Of Quality Assurance 8758 Hellman Ave Rancho Cucamonga, California 91730

Re: K151158

Trade/Device Name: ALP® VasOcare™ System Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: November 30, 2015 Received: December 1, 2015

Dear Owen Bry:

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. 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 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

M. A. Hillebrand

for

for 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) K151158

Device Name ALP® VasQcare™ System

Indications for Use (Describe)

1. Increases blood flow velocity
1. Reduces the risk of deep vein thrombosis
1. Enhances blood circulation
1. Reduces pain and swelling
1. Reduces wound healing time

Aids in the treatment and healing of stasis dermatitis, venous stasis, arterial and diabetic leg ulcers, chronic vein insufficiency and reduction of edema in the lower limbs

The ALP® VasQcare™ System may be used on patients at risk for developing deep vein thrombosis and in conjunction with medical therapy for high-risk patients.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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Section 11: 510(k) Summary

Submitters Name and Address:	Currie Medical Specialties, Inc.8758 Hellman AvenueRancho Cucamonga, CA 91730Phone: (909) 912-0900Fax: (909) 944-3030
FDA Registration Number:	2023637
Contact Person:	Craig Lynch, Director of Quality
Date Summary Prepared:	12/10/2015
Trade or Proprietary Name(s):	ALP® VasQcare™ System
Common Name:	Compression sleeve limb
Product Code:	JOW
Panel:	Cardiovascular
Regulation Number:	870.5800
Classification:	Class II
Predicate Device(s):	K112311 – Currie Medical Specialties, ALP 501RB SystemK133274 – Innovamed Health LLC, Vena ProK061125 – Doctors Order, DVTcare CA5

Device Description:

Intended Use:

The intended use of this device, as well as the predicate device, is to provide external limb compression in order to artificially imitate the pumping action of the leg muscles. This provides muscle contraction required by the venous return system, thereby helping to prevent venous stasis and subsequent thrombosis and embolism. The cyclic and alternating inflation of the garments closely simulates the normal healthy pumping action of the limb muscles to stimulate deep venous blood flow and the reactivation or increase in the body's fibrinolytic system.

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This submission is intended for use of the pump at pressure levels of 45 mm Hg.

Indications for Use:

1. Increases blood flow velocity
1. Reduces the risk of deep vein thrombosis
1. Enhances blood circulation
1. Reduces pain and swelling
1. Reduces wound healing time
1. Aids in the treatment and healing of stasis dermatitis, venous stasis, arterial and diabetic leg ulcers, chronic vein insufficiency and reduction of edema in the lower limbs

The ALP® VasQcare™ System may be used on patients at risk for developing deep vein thrombosis and in conjunction with medical therapy for high-risk patients.

Technological characteristics of the ALP VasQcare System:

The ALP VasQcare™ System indications for use, fundamental scientific technology, overall design, materials, energy source, mode of operation, performance characteristics are similar and no different than the predicate devices.

Summary of Comparison Tests (Non-Clinical Tests):

Bench testing was conducted to ensure that the new design did not compromise the performance or safety and efficacy of the device in a manner that is substantially equivalent to that of the predicate devices.

Bench testing was conducted to demonstrate a electrical safety, EMC, mechanical integrity and environmental and life cycle testing has shown that the ALP® VasQcare™ has performance characteristics that are substantially equivalent to the predicate devices. The ALP®

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VasQcare™ System and its accessories have been evaluated based on the requirements of IEC 60601-1-1, 60601-1-6 and 606061-1-11 (Appendix 8), which were confirmed by an accredited third-party.

Biocompatibility

Due to the materials used in the predicate device (K112311) and ALP® VasQcare™ System being identical to each other, biocompatibility of the ALP® VasQcare™ System is not affected.

Summary

Per the requirements of 21 CFR 807, clinical data, non-clinical bench testing and the information provided within this 510(k) pre-market submission, Currie Medical Specialties, Inc., concludes that the ALP® VasQcare™ System performs in a manner that is substantially equivalent to the predicate devices listed above.

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).