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K Number
K992454
Device Name
VENAFLOW SYSTEM, MODEL 30A
Manufacturer
AIRCAST, INC.
Date Cleared
2000-01-13

(174 days)

Product Code
JOW
Regulation Number
870.5800
Type
Traditional
Panel
CV
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Prophylaxis for Deep Vein Thrombosis (DVT)

Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) clearance letter from the FDA for a device called the "VenaFlow System Model 30A." This type of letter indicates that the device has been found substantially equivalent to a legally marketed predicate device, thereby permitting its market entry.

However, the document does not contain any information about specific acceptance criteria or a study that proves the device meets such criteria.

The 510(k) pathway primarily relies on demonstrating substantial equivalence to a predicate device, meaning it has the same intended use and technological characteristics as a predicate device, or if it has different technological characteristics, that the new device is as safe and effective as the predicate device and does not raise different questions of safety and effectiveness. This often involves comparing device specifications, materials, and intended use to a previously cleared device, rather than requiring extensive clinical trials with predefined performance metrics like those for a Premarket Approval (PMA) application or a de novo classification.

Therefore, I cannot provide the requested information, including:

  1. A table of acceptance criteria and the reported device performance: This information is not present in the 510(k) clearance letter.
  2. Sample size used for the test set and the data provenance: No test set information is provided.
  3. Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable, as no such study is described.
  4. Adjudication method for the test set: Not applicable.
  5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not applicable.
  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
  7. The type of ground truth used: Not applicable.
  8. The sample size for the training set: Not applicable.
  9. How the ground truth for the training set was established: Not applicable.

The document only states the device's name ("VenaFlow System Model 30A"), its indication for use ("Prophylaxis for Deep Vein Thrombosis (DVT)"), and its regulatory class (Class II). It confirms that the FDA reviewed the 510(k) notification and determined substantial equivalence.

§ 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).