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K Number
K013223
Device Name
PATIENT VENTILATION OXYGEN CONCENTRATING SYSTEM (PVOCS)
Manufacturer
LITTON SYSTEMS, INC.
Date Cleared
2002-02-11

(137 days)

Product Code
CAW
Regulation Number
868.5440
Type
Traditional
Panel
AN
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The PVOCS is intended to supply medical grade air and oxygen (USP oxygen 99%) at 50 psig nominal and lower output pressures in hospitals, surgical suites, and other clinical settings in military facilities only.

Device Description

Not Found

AI/ML Overview

I'm sorry, but without further details about specific acceptance criteria and the study that proves the device meets them, I cannot provide the requested information. The provided text is a 510(k) clearance letter from the FDA for a Patient Ventilation Oxygen Concentrating System (PVOCS), which confirms its substantial equivalence to a predicate device. However, it does not include the details of acceptance criteria or performance study results.

To answer your request, I would need a document that outlines:

  • Specific performance metrics for the PVOCS (e.g., oxygen concentration accuracy, flow rate stability, noise levels, reliability, safety parameters).
  • Target thresholds or ranges for these metrics that define "acceptance."
  • The details of a study conducted to evaluate the PVOCS against these criteria. This study description would typically include:
    • Study design (e.g., bench testing, animal study, clinical trial)
    • Methodology
    • Results for each acceptance criterion
    • Sample sizes (if applicable)
    • Ground truth establishment and adjudication (if applicable, for clinical studies)
    • Expert qualifications (if applicable)
    • Details about training sets (if AI/ML components were involved, which is unlikely for this type of device from 2002).

The 510(k) clearance process focuses on demonstrating substantial equivalence to a legally marketed predicate device, often relying on existing standards and predicate device performance, rather than requiring a detailed report of a new, comprehensive performance study with explicit acceptance criteria for this specific submission. While the manufacturer would have conducted internal testing to ensure the device met its own specifications and relevant standards, those detailed reports are typically not part of the FDA's public 510(k) clearance letter.

§ 868.5440 Portable oxygen generator.

(a)
Identification. A portable oxygen generator is a device that is intended to release oxygen for respiratory therapy by means of either a chemical reaction or physical means (e.g., a molecular sieve).(b)
Classification. Class II (performance standards).