The Healthcare Service and Supply ALP® 501 Pump and Limb Garments are recommended for use in patients for whom external compression therapy using the ALTERNATING LEG PRESSURE SYSTEM® (ALP®) is indicated to reduce the incidence of deep vein thrombosis and resulting pulmonary embolism due to the presence of risk factors for thrombosis formation.

The Healthcare Service and Supply garments are attachable to the ALP® Pump as well as to the Huntleigh Flowtron® pump.

Device Description

The ALP consists of an electrically-operated pump and controller with inflatable limb garments (or limb compression sleeves). The ALP® 501 pump, when used in connection with the Limb Garments, supplies a measured, intermittent, fully adjustable pressure into the limb garments worn by the patient. The pump and controller rhythmically squeeze the limb in a simulation of normal muscle contraction, by pumping air into the air bladder garments wrapped around the leg.

The ALP® Pump and Limb Garments are provided non-sterile

AI/ML Overview

Acceptance Criteria and Study for ALP® (Alternating Leg Pressure) Pump and Garments

This document describes the acceptance criteria and study proving the device meets these criteria for the Healthcare Service and Supply ALP® (Alternating Leg Pressure) Pump and Garments, based on the provided 510(k) summary (K974318).

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary primarily focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel performance criteria through a specific clinical study with predefined acceptance metrics. Therefore, the "acceptance criteria" are implicitly defined by the safety and effectiveness of the predicate devices. The "reported device performance" is the demonstration that the ALP® Pump and Garments achieve this equivalence.

Acceptance Criterion (Implicit)	Reported Device Performance (Demonstrated Equivalence)
Safety: Device operates without introducing new or increased risks compared to predicate devices for external limb compression.	Equivalence Claim: "The ALP® Pump and Limb Garments has the same technological characteristics as its predicate devices. The materials used in the limb garments are the operation of the pumps and the garments is also the same.""No new technology is being introduced in the design of the ALP® Pump and Limb Garments.""Healthcare Service and Supply has performed a variety of tests which demonstrate that the use of the Healthcare Service and Supply compression garments with the Huntleigh pump is equivalent in effectiveness and safety to the use of these garments with the ALP® 501 pump."
Effectiveness: Device effectively provides external limb compression to: 1. Artificially imitate the pumping action of leg muscles. 2. Prevent venous stasis and subsequent thrombosis and embolism. 3. Stimulate deep venous blood flow. 4. Reactivate or increase the body's fibrinolytic system. 5. Reduce the incidence of deep vein thrombosis and resulting pulmonary embolism. 6. Increase circulation in patients with restricted mobility.	Equivalence Claim: "This submission is intended to demonstrate equivalence in the use of the ALP® limb garments with the Huntleigh Healthcare Flowtron® DVT AC500 pump. The ALP® limb garments, when used with either the ALP® 501 pump or the Huntleigh AC500 pump, are safe and effective for their intended use for reducing the incidence of deep vein thrombosis and resulting pulmonary embolism, and increasing the circulation of blood in patients with restricted mobility through the use of external intermittent limb compression.""The two referenced pumps are equivalent in specifications and in performance, and the performance of the compression garments with either pump is the same."
Technological Characteristics: Device shares fundamental technological characteristics with predicate devices (materials, operation).	Equivalence Claim: "The ALP® Pump and Limb Garments has the same technological characteristics as its predicate devices. The materials used in the limb garments are the operation of the pumps and the garments is also the same."

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

The provided 510(k) summary for K974318 does not detail a specific clinical test set with a reported sample size or data provenance (e.g., country of origin, retrospective/prospective). The submission relies on "a variety of tests" to demonstrate equivalence, but the nature, scope, and results of these tests (e.g., in-vitro, engineering bench tests, or limited human trials) are not explicitly described in the provided text. The focus is on the substantial equivalence argument based on shared technological characteristics and intended use with established predicate devices.

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

Since a specific clinical test set with explicit performance metrics and ground truth establishment is not detailed in the provided K974318 summary, there is no information on the number or qualifications of experts used to establish ground truth. The substantial equivalence argument relies on the established safety and effectiveness of the predicate devices.

4. Adjudication Method for the Test Set

As no specific clinical test set with individual case adjudication is described, no adjudication method (e.g., 2+1, 3+1) is mentioned or applicable within the scope of the provided document.

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

No, an MRMC comparative effectiveness study is not mentioned in the provided 510(k) summary. The submission focuses on demonstrating substantial equivalence of the device itself (pump and garments) to predicate devices, rather than evaluating the comparative effectiveness of human readers assisted by AI.

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

The device is a physical medical device (pump and garments) that requires patient application and operates independently of direct human intervention during its cycle. Therefore, the concept of "standalone algorithm performance" as typically applied to AI/software as a medical device (SaMD) is not applicable to this type of device. The device's performance is inherently its "standalone" operation.

7. The Type of Ground Truth Used

Given the nature of the device and the substantial equivalence pathway, the "ground truth" is implicitly derived from:

Established safety and effectiveness of the predicate devices (Huntleigh Technology DVT System AC500 and Healthcare Service and Supply ALP® 501 Pump System). This relies on prior regulatory clearances and possibly clinical data supporting those predicate devices.
Technological equivalence: The "ground truth" for the device's design and materials matching the predicate devices.
Functional equivalence: The "ground truth" that the ALP® garments perform comparably when used with either the ALP® 501 pump or the Huntleigh AC500 pump, which would have been established through a "variety of tests" (though not detailed).

There is no indication of pathology, specific outcomes data, or expert consensus on individual cases for the ALP® Pump and Garments itself within this 510(k) summary.

8. The Sample Size for the Training Set

The provided 510(k) summary does not mention a training set or a sample size for it. As this is a traditional medical device (pump and garments) and not an AI/machine learning device, the concept of a "training set" in that context does not apply.

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

Since no training set is mentioned or applicable, no information on how ground truth for a training set was established is provided.

Summary

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K974318

FEB 1 3 1998

HEALTHCARE SERVICE AND SUPPLY 510(k) SUMMARY ALP® (Alternating Leg Pressure) Pump and Garments

I. NAME OF SUBMITTER

Healthcare Service and Supply P.O. Box 1788 Tustin, CA 92681 Phone: (714) 669-8803

Contact person: Rick Roeder Establishment Registration Number: 2030561

II. DEVICE NAME AND CLASSIFICATION

Proprietary Name:	Healthcare Service and Supply ALP® Alternating LegPressure Pump and Garments for the Limb
Common or Usual Name:	Compression Sleeve, Limb
Classification:	Class II; CV JOW 870.5800

III. PREDICATE DEVICES

The Healthcare Service and Supply ALP® Pump and Limb Garments are substantially equivalent to devices in commercial distribution by the following companies:

Healthcare Service and Supply ALP® 501 Pump System, Tustin, CA 992681; . K955823
Huntleigh Technology DVT System AC500, L501 Garment, Manalapan, NJ, . 07726; K881632

IV. DESCRIPTION

The ALP® Pump and Limb Garments are provided non-sterile

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V. INTENDED USE

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

This submission is intended to demonstrate equivalence in the use of the ALP® limb garments with the Huntleigh Healthcare Flowtron® DVT AC500 pump. The ALP® limb garments, when used with either the ALP® 501 pump or the Huntleigh AC500 pump, are safe and effective for their intended use for reducing the incidence of deep vein thrombosis and resulting pulmonary embolism, and increasing the circulation of blood in patients with restricted mobility through the use of external intermittent limb compression.

VI. TECHNOLOGICAL CHARACTERISTICS

The ALP® Pump and Limb Garments has the same technological characteristics as its predicate devices. The materials used in the limb garments are the operation of the pumps and the garments is also the same.

No new technology is being introduced in the design of the ALP® Pump and Limb Garments. The limb garments are to be used as part of an external compression pump system. where intermittent pneumatic compression is provided through the use of a pump/controller and limb garment system. The two referenced pumps are equivalent in specifications and in performance, and the performance of the compression garments with either pump is the same. Healthcare Service and Supply has performed a variety of tests which demonstrate that the use of the Healthcare Service and Supply compression garments with the Huntleigh pump is equivalent in effectiveness and safety to the use of these garments with the ALP® 501 pump.

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Image /page/2/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an abstract eagle design with three stylized human profiles within the eagle's body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

FEB 1 3 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Rick Roeder President Healthcare Service and Supply P.O. Box 1788 Tustin, CA 92681

Re: K974318 ALP® Alternating Leg Pressure) Pump and Garments Regulatory Class: II (Two) Product Code: JOW Dated: November 17, 1997 November 17, 1997 Received:

Dear Mr. Rick Roeder:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions of the Act. The qeneral controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) , it may be subject to such Existing major regulations affecting your device additional controls. can be found in the Code of Federal Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Rick Roeder

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html."

Sincerely yours,

Thomas J. Callahan

Thomas J. Callah Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Include the following "Indications For Use" page that contains the applicant's name, name of the device and the intended use of the device. The information, data and labeling claims in the entire the 510(k) submission must support and agree with the "indications for use" statement.

*For a new submission, do NOT fill in the 510(k) number blank.

INDICATIONS FOR USE

Healthcare Service and Supply Applicant:

510(k) Number (if known): N/A*

Device Name: ALP® (Alternating Leg Pressure) Pump and Garments

Indications For Use:

The Healthcare Service and Supply garments are attachable to the ALP® Pump as well as to the Huntleigh Flowtron® pump.

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

Concurrence of CDRH Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number	K974318

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

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).