(88 days)
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.
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
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: |
- Artificially imitate the pumping action of leg muscles.
- Prevent venous stasis and subsequent thrombosis and embolism.
- Stimulate deep venous blood flow.
- Reactivate or increase the body's fibrinolytic system.
- Reduce the incidence of deep vein thrombosis and resulting pulmonary embolism.
- 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.
§ 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).