The Currie Medical ALP Pediatric Calf Compression Sleeves (all sizes) are recommended for the use in pediatric patients for whom external compression 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® pediatric compression sleeves are compression devices, which when attached to the ALP® 501 Pump System, provide 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 the heart. After compression is complete, the sleeves deflate which allows the veins to reopen and bring oxygenated blood to the calf. The inflation and deflation sequence is predicated by the ALP® 501 Pump System controller.

AI/ML Overview

The provided document describes a 510(k) premarket notification for the "Currie Medical ALP Pediatric Calf Compression Sleeves (all sizes)." This is a medical device, and the submission aims to demonstrate substantial equivalence to a predicate device, not to prove clinical efficacy through a traditional clinical study with acceptance criteria often seen in AI/ML performance evaluations. Therefore, many of the requested categories (like MRMC study, effect size, number of experts, adjudication method, sample size for training set) are not applicable in this context.

Instead, the submission focuses on bench testing to ensure that design changes (specifically smaller sizing for pediatric use) do not negatively impact the device's fundamental performance, safety, and efficacy compared to the predicate device.

Here's an attempt to structure the information based on the provided document, acknowledging the limitations given the nature of the submission:

Acceptance Criteria and Study for Currie Medical ALP Pediatric Calf Compression Sleeves

The submission for the Currie Medical ALP Pediatric Calf Compression Sleeves (all sizes) is a 510(k) premarket notification, which establishes substantial equivalence to a predicate device (K955853 – Healthcare Service & Supply Pump ALP 501 System). The "acceptance criteria" and "study" are therefore focused on demonstrating that the new device, primarily due to smaller sizing for pediatric use, maintains the performance and safety characteristics of the predicate device through bench testing.

1. Table of Acceptance Criteria and Reported Device Performance

This table is constructed from the bench testing details provided. The acceptance criteria are implicitly that the performance of the pediatric sleeves should not be compromised compared to the predicate device, or meet specific thresholds to ensure functionality.

Acceptance Criteria (Implicit)	Reported Device Performance (Summary from Bench Testing)
No bladder leaks at 3 psi	Bladders did not leak at 3 psi
Bladder seal strength > 5 lbs	Bladder seal pulled apart at > 5 lbs of force
Velcro adhesion maintained at 2 psi	Velcro adhesion remained intact at 2 psi
Consistent inflation/deflation time to 40 mm Hg	Product integrity remained the same compared to the predicate device, demonstrating consistent inflation/deflation to 40 mm Hg.
Biocompatibility maintained	Biocompatibility not affected due to identical materials as predicate.

2. Sample size used for the test set and the data provenance

The document does not explicitly state the specific sample sizes (number of sleeves or bladders tested) for each bench test. The provenance is internal bench testing conducted by Currie Medical Specialties, Inc. (non-clinical, in-house testing).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This was bench testing against engineering specifications and predicate device performance, not a clinical study requiring expert ground truth for interpretation.

4. Adjudication method for the test set

Not applicable. This was bench testing against engineering specifications, not a clinical study requiring adjudication.

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 device is a compression sleeve, not an AI/ML-driven diagnostic or assistive device. No MRMC study was performed.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device (compression sleeve), not an algorithm or AI system.

7. The type of ground truth used

The "ground truth" for this submission is based on engineering specifications and the established performance characteristics of the legally marketed predicate device (K955853). The goal was to show that the new pediatric device performs equivalently to the predicate in key functional aspects.

8. The sample size for the training set

Not applicable. This refers to a medical device's engineering and performance evaluation, not an AI/ML model's training.

9. How the ground truth for the training set was established

Not applicable. See point 8.

Summary

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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

January 20, 2015

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

Re: K143317

Trade/Device Name: Currie Medical ALP Pediatric Calf Compression Sleeves (all sizes) Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: November 17, 2014 Received: November 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 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

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Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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. Hilleman

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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SPECIALTIES. INC

INDICATIONS FOR USE

Applicant:	Currie Medical Specialties, Inc.
510(k) Number (if known):	K143317
Device Name:	Currie Medical ALP Pediatric Calf Compression Sleeves (all sizes)
Indications for Use:

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

Concurrence of CDRH Office of Device Evaluation (ODE)

Prescription Use
Per 21 CFR 801.109

Over-the-Counter_

Page 18 of 19

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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:	Owen J. Bry, Director of Quality Assurance
Date Summary Prepared:	11/03/2014
Trade or Proprietary Name(s):	Currie Medical ALP Pediatric Calf Compression Sleeves (allsizes)
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 System

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.

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

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Indications for Use:

The Currie Medical ALP Pediatric Calf Compression Sleeves (all sizes) are recommended for the use in pediatric 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.

Technological characteristics of the CMS ALP Pediatric Calf Compression Sleeves:

The CMS ALP Pediatric Calf 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 the smaller sizing 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).

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 the design change. 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 the design change. 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 the design change. 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 design change did not affect the performance, or the safety and efficacy of the device.

Biocompatibility

Due to the materials used in the predicate and pediatric device(s) being identical to each other, biocompatibility of the CMS ALP® Pediatric Calf Compression sleeves is not affected.

Summary

The intended use and performance testing demonstrate that the Currie Medical ALP Pediatric Caff Compression Sleeves (all sizes) are substantially equivalent to the predicate device (K955853).

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).