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.

The Currie Medical Reprocessed ALP Calf, Thigh and Foot Compression Sleeves (all sizes) are recommended for the use in patients for whom external compression therapy using the ALTERNATING LEG PRESSURE® (ALP®) SYSTEM is indicated to reduce the incidence of deep vein thrombosis and resulting pulmonary embolism due to the presence of risk factors for thrombosis formation.

Device Description

Currie Medical Specialties (CMS) ALP reprocessed compression sleeves are compression devices, which when attached to the ALP 501 Pump System, provide intermittent, sequentially gradient pressure to a patients leg/foot for the prevention of deep vein thrombosis (DVT). When the compression sleeve is inflated, the veins collapse which forces blood to move upward the heart. After compression is complete, the sleeves deflate which allows the veins to reopen and bring oxygenated blood to the calf, thigh or foot. The inflation and deflation sequence is predicated by the ALP 501 Pump System controller.

AI/ML Overview

This document is a 510(k) summary for the Currie Medical Reprocessed ALP® Calf, Thigh and Foot Compression Sleeves. It describes the device's technical characteristics, intended use, and the "Summary of Comparison Tests (Non-Clinical Tests)" conducted to demonstrate substantial equivalence to predicate devices.

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the comparison to the predicate device and the specified performance characteristics that were tested.

Acceptance Criteria (Implied)	Reported Device Performance
Bladder Leak Test: Bladders do not leak when pressurized to 3 psi.	"Bladders were pressurized to 3 psi to ensure the bladders did not leak at this pressure and were not affected by reprocessing." (Implied: Passed, no leaks detected)
Bladder Seal Pull Test: Bladder seals remain intact at > 5 lbs of force.	"Bladder seal was pulled apart at > 5 lbs of force to demonstrate the seals wore intact and were not affected by reprocessing." (Implied: Passed, seals intact at > 5 lbs)
Velcro Functionality Test: Velcro adhesion remains intact when bladders are pressurized to 2 psi.	"Velcro functionality test was performed where bladders were pressurized to 2 psi to determine velcro adhesion remained intact at this pressure and were not affected by reprocessing." (Implied: Passed, velcro adhesion remained intact)
Inflation-Deflation Time Test: Product integrity (inflation to 40 mm Hg and pressure monitoring over time) remains the same as the predicate device.	"Inflation-deflation time test was performed to demonstrate product integrity remained the same in comparison to the predicate device. This required the devices to be inflated to 40 mm Hg and monitor the pressure over time. The series of data demonstrated that the reprocessing did not affect the performance, or the safety and efficacy of the device." (Implied: Passed, consistent with predicate)
Biocompatibility: Reprocessing does not affect biocompatibility.	"Reprocessing did not affect the biocompatibility of the device." (Implied: Passed)
Overall Performance/Safety/Efficacy: Substantially equivalent to predicate devices (K955853 & K964188).	"The Currie Medical Specialties ALP® Reprocessed Calf, Thigh, and Foot Compression Sleeves have demonstrated that they perform as safe and effective as the ALP® non-sterile predicate devices (K955853 & K964188) and are substantially equivalent to the predicate devices." (Claimed)

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

Sample Size: The document does not explicitly state the sample size (number of devices) used for each bench test. It refers to "bladders," "bladder seal," and "bladders" for the respective tests, implying multiple units were tested, but no specific number is given.
Data Provenance: The document describes "Bench testing was conducted." This implies the tests were performed in a laboratory or controlled setting. There is no information regarding country of origin for the data or if it was retrospective/prospective, as it's not clinical data.

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

Not applicable. This document describes non-clinical bench testing for device reprocessing validation, not a study involving human experts for ground truth establishment.

4. Adjudication Method for the Test Set

Not applicable. This document describes non-clinical bench testing. Adjudication methods are typically associated with human review or clinical study endpoints.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

Not applicable. This document describes non-clinical bench testing of a reprocessed medical device, not an AI-powered diagnostic or assistive tool.

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

Not applicable. This document pertains to a physical medical device (compression sleeves), not an algorithm or AI.

7. The Type of Ground Truth Used

The "ground truth" for this study is the performance of the predicate device. The reprocessed device's performance was compared against the known performance characteristics of the original, new device to demonstrate substantial equivalence. The tests also established "ground truth" for specific mechanical properties (no leaks at 3 psi, seals intact at > 5 lbs force, velcro intact at 2 psi).

8. The Sample Size for the Training Set

Not applicable. This document describes validation testing for a reprocessed medical device, not a machine learning model that requires a training set.

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

Not applicable, as there is no training set for a machine learning model in this context.

Summary

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Section 11: 510(k) Summary		K140092 pg. 1 of 2
Submitters Name and Address:	Currie Medical Specialties, Inc.8758 Hellman AvenueRancho Cucamonga, CA 91730Phone: (909) 912-0900Fax: (909) 944-3030	APR 16 201
FDA Registration Number:	2023637
Contact Person:	Owen J. Bry, Director of Quality Assurance
Date Summary Prepared:	12/17/2013
Trade or Proprietary Name(s):	Currie Medical Reprocessed ALP° Calf, Thigh and FootCompression Sleeves (all sizes) .
Common Name:	Compression sleeve limb
Product Code:	JOW
Panel:	Cardiovascular
Regulation Number:	870.5800
Classification:	Class II
Predicate Device(s):	K955853 - Healthcare Service & Supply Pump ALP 501 SystemK964188 - Healthcare Service & Supply PVA (Pneumatic VenousAugmentation) Foot Garment

Device Description:

Intended Use:

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CURRIE
MEDICAL
SPECIALTIES, INC.

This submission is intended for use of the pump at pressure levels of 40 mm Hg.

Indications for Use:

Technological characteristics of the CMS Reprocessed ALP Calf, Thigh and Foot Compression Sleeves: The CMS ALP Reprocessed Calf, Thigh and Foot Compression Sleeves indications for use, fundamental scientific technology, overall design, materials, energy source, mode of operation, performance characteristics are identical and no different than the predicate device.

Summary of Comparison Tests (Non-Clinical Tests):

Bench testing was conducted to ensure that reprocessing 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 (K955853 & K964188).

Bench testing was conducted to demonstrate a bladder leak test where the bladders were pressurized to 3 psi to ensure the bladders did not leak at this pressure and were not affected by reprocessing. A bladder seal pull test was performed, where the bladder seal was pulled apart at > 5 lbs of force to demonstrate the seals were intact and were not affected by reprocessing. A velcro functionality test was performed where bladders were pressurized to 2 psi to determine velcro adhesion remained intact at this pressure and were not affected by reprocessing. Finally, an inflation-deflation time test was performed to demonstrate product integrity remained the same in comparison to the predicate device. This required the devices to be inflated to 40 mm Hg and monitor the pressure over time. The series of data demonstrated that the reprocessing did not affect the performance, or the safety and efficacy of the device.

Biocompatibility

Reprocessing did not affect the biocompatibility of the device.

Conclusion

The Currie Medical Specialties ALP® Reprocessed Calf, Thigh, and Foot Compression Sleeves have demonstrated that they perform as safe and effective as the ALP® non-sterile predicate devices (K955853 & K964188) and are substantially equivalent to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

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

April 16, 2014

Currie Medical Specialties, Inc. Mr. Owen J. Bry Director of Quality Assurance 8758 Hellman Ave Rancho Cucamonga, CA 91730

Re: K140092

Trade/Device Name: Currie Medical Reprocessed ALP® Calf, Thigh and Foot Compression Sleeves (all sizes) Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: February 18, 2014 Received: February 19, 2014

Dear Mr. 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 I ou may on ontrols provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulterstion. 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 I heast be advised that i Dr i issualite of our device complies with other requirements of the Act

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Page 2 - Mr. Owen J. Bry

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 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Bram D. Zuc

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

Applicant:	Currie Medical Specialties, Inc.
510(k) Number (if known):	K140092
Device Name:	Currie Medical Reprocessed ALP. Calf, Thigh and Foot Compression Sleeves (all sizes)
Indications for Use:

The Currie Medical Reprocessed ALP Calf, Thigh and Foot Compression Sleeves (all sizes) are recommended for the use in patients for whom external compression therapy using the ALTERNATING LEG ·PRESSURE® (ALP®) SYSTEM is indicated to reduce the incidence of deep vein thrombosis and resulting pulmonary embolism due to the presence of risk factors for thrombosis formation.

(Please DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH Office of Device Evaluation (ODE)

Prescription Use		OR	Over-the-Counter
Per 21 CFR 801.109

Bram D. Zuckerman -S
2014.04.16 10:20:46 -04'00'

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).