(90 days)
Prevention of Deep Vein Thrombosis (DVT) in susceptible patients; Reduction of pain and swelling after injury and surgery; Enhancement of venous and arterial circulation; Prevention of venous stasis; Assist healing of cutaneous ulcers; Reduction of compartmental pressures.
The Model 601 Compression Therapy Device utilizes a software controlled air compression pump, which sequentially inflates and deflates cells within a compression garment (sleeve) that is put around a limb. This helps to push excessive interstitial fluid in the treated limb, back into the venous and lymphatic systems; improve limb circulation; and thus treat the symptoms of a variety of venous disorders and dysfunction of the "muscle pump". The device consists of a main console and compression garments. The main console contains an air compressor that is regulated by an electro-mechanical mechanism, including pressure sensors and solenoid valves. The regulated compressed air is transferred via an air distributor through a series of hoses to the sleeve garments. In the Model 601 device, each garment contains up to 4 overlapping pressure cells. The sleeve fits on the affected limb and can be easily adjusted to any limb size within the sleeve tolerance.
This 510(k) submission for the Mego Afek PHLEBOPRESS DVT MODEL 601A Compressible Limb Sleeve Device does not contain the kind of detailed information typically found in a study proving a device meets specific acceptance criteria that usually involves rigorous performance metrics and statistical analysis.
Instead, the submission focuses on demonstrating substantial equivalence to existing predicate devices. It relies on a comparison of features, intended use, and existing safety and performance standards.
Therefore, many of the requested sections (e.g., acceptance criteria table with reported performance, sample sizes for test/training sets, ground truth establishment, expert adjudication, MRMC studies) are not applicable or not provided in the given text.
Here's a breakdown based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Specific Performance Metrics (e.g., pressure accuracy, inflation/deflation timing, efficacy in DVT prevention as measured by clinical outcomes) | Not explicitly stated as quantifiable acceptance criteria within this document. |
| General Safety and Performance Testing (ensuring functional specifications are met and compliance with industry/safety standards) | "The Model 601A Compression Therapy device has been subjected to extensive safety, performance testing, and validation before release. Final testing of the Model 601A Compression Therapy device included various performance tests and software validation tests, designed to ensure that the device met all its functional specifications. Tests have been performed to ensure the device complies with industry and safety standards." |
| Similarity to Predicate Devices (in terms of inflation/deflation pressures, sequences, operating modes, and features) | "Inflation/ Deflation pressures and sequences are similar to those of predicate devices. Operating modes are similar to those of predicate devices. All of the above features are similar to these features in the predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified. This document refers to "various performance tests and software validation tests," but does not provide details on the number of subjects or test units involved.
- Data Provenance: Not specified. The testing was conducted by Mego Afek Ltd. in Israel, but no details about the origin of any clinical data (if collected) are provided. It appears to be product validation testing, not a clinical study involving human patients to prove efficacy against acceptance criteria.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not Applicable. The document describes device-level performance and software validation tests, not a clinical study requiring expert-established ground truth for disease detection or diagnosis.
4. Adjudication Method for the Test Set:
- Not Applicable. As there's no clinical test set with human data requiring expert review for ground truth, no adjudication method is mentioned.
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 physical compression therapy device, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Not Applicable. This is a physical medical device. While it has software controls, the "standalone performance" concept as applied to AI algorithms is not relevant here. The device's performance is inherently "standalone" in that it operates independently of human interpretation of its outputs for diagnosis.
7. The Type of Ground Truth Used:
- For the described "performance tests and software validation tests," the "ground truth" would be the engineering specifications and design requirements of the device (e.g., target pressure levels, cycle times, software logic correctness). There is no "ground truth" in the sense of clinical outcomes or disease states for a diagnostic AI.
8. The Sample Size for the Training Set:
- Not Applicable. This device does not use machine learning or AI that would require a "training set" of data in the conventional sense. The software validation tests ensure its programmed functions work correctly, not that it "learns" from data.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. As there is no training set, there's no ground truth to establish for it.
Summary of the Study/Evidence Provided:
The provided document describes a technical validation and substantial equivalence argument, rather than a clinical study with detailed performance metrics against specific acceptance criteria.
The "study" cited is:
- "extensive safety, performance testing, and validation before release."
- "various performance tests and software validation tests, designed to ensure that the device met all its functional specifications."
- Tests were performed to ensure compliance with "industry and safety standards."
The conclusions drawn are based on:
- This internal performance testing.
- A direct comparison of its features, intended use, and operating parameters (inflation/deflation pressures and sequences, operating modes) to currently legally marketed predicate devices (Mego Afek's PhleboPress Model 701A, Huntleigh Healthcare's Flowtron Excel Model AC550, and Flowtron Universal Model AC600).
The approval is based on the FDA's finding of substantial equivalence to these predicate devices in terms of safety and efficacy. Specific quantitative acceptance criteria or clinical outcome data from trials are not detailed in this 510(k) summary.
§ 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).