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K Number
K023800
Device Name
VENAFLOW REUSABLE CALF AIRCELL, MODEL 3018, VENAFLOW DISPOSABLE CALF COVER, MODEL 3017
Manufacturer
AIRCAST, INC.
Date Cleared
2003-02-10

(88 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 DVT (Deep Vein Thrombosis)

Device Description

VenaFlow Reusable Calf Aircell

AI/ML Overview

This device is a Class II compression limb sleeve, and the document is a 510(k) premarket notification. The FDA's 510(k) clearance process focuses on demonstrating substantial equivalence to a predicate device, rather than requiring extensive clinical trials with detailed performance criteria and statistical analyses common for novel high-risk devices or software as a medical device (SaMD).

Therefore, based solely on the provided text, the specific information requested about acceptance criteria, detailed study design, sample sizes, expert qualifications, and ground truth establishment is not available. The document pertains to the regulatory clearance of a physical medical device, the Aircast VenaFlow System, based on its equivalence to previously marketed devices.

The text does not contain:

  • A table of acceptance criteria and reported device performance.
  • Details on sample sizes, provenance, or specific test sets used.
  • Information about the number or qualifications of experts for ground truth.
  • Adjudication methods.
  • Multi-reader multi-case (MRMC) comparative effectiveness studies.
  • Standalone algorithm performance.
  • Type of ground truth used (e.g., pathology, outcomes data).
  • Sample size for the training set.
  • How ground truth for the training set was established.

The FDA's review for this type of device typically focuses on aspects like:

  • Intended Use: The indicated use for prophylaxis of DVT is stated.
  • Technological Characteristics: How the device functions (e.g., compression) and its materials.
  • Performance Data (Bench and/or limited clinical): Often involves testing against recognized standards or comparing performance to the predicate device in a more limited scope than a full clinical trial. However, the details of these tests are not provided in this summary letter.

In summary, the provided document is a regulatory clearance letter, not a detailed study report. It confirms the device's substantial equivalence to a predicate, allowing it to be marketed, but does not offer the granular information requested about specific acceptance criteria and detailed study methodologies.

§ 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).