LogoFDA 510(k) Search
K Number
K990678
Device Name
PNEUMATIC DEMAND OXYGEN CONSERVER (PDOC)
Manufacturer
SALTER LABS
Date Cleared
1999-05-07

(66 days)

Product Code
NFB
Regulation Number
868.5905
Type
Traditional
Panel
AN
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Salter Labs Pneumatic Demand Oxygen Conserver (PDOC) is indicated for all respiratory or physiological problems where the requirement for supplemental oxygen therapy is indicated by a qualified physician or registered healthcare professional. The PDOC is indicated for use in both the hospital and home care environment where a demand oxygen delivery system is indicated.

The PDOC allows for the effective administration of high pressure medical grade or concentrated oxygen upon demand to a patient who has been diagnosed as requiring and which has been prescribed oxygen administration by a physician. Oxygen is administered only during the inhalation cycle, conserving oxygen during the exhalation cycle.

Device Description

The Salter Labs Pneumatic Demand Oxygen Conserver (PDOC) allows for the effective administration of high pressure medical grade or concentrated oxygen upon demand to a patient who has been diagnosed as requiring and which has been prescribed oxygen administration by a physician. Oxygen is administered only during the inhalation cycle, conserving oxygen during the exhalation cycle.

AI/ML Overview

This document, a 510(k) premarket notification letter for the Salter Labs Pneumatic Demand Oxygen Conserver (PDOC), does not contain the information requested in your prompt.

The document primarily focuses on:

  • A letter from the FDA confirming substantial equivalence to a predicate device.
  • The product code correction (from 73 BZD to 73 NFB).
  • General regulatory information regarding medical devices.
  • The Indications for Use statement for the PDOC.

There is no mention of:

  1. A table of acceptance criteria or reported device performance.
  2. Sample sizes for test sets, data provenance, or details about the study population.
  3. Number or qualifications of experts used for ground truth.
  4. Adjudication methods.
  5. Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes for AI assistance.
  6. Standalone algorithm performance.
  7. Type of ground truth used (e.g., pathology, outcomes data).
  8. Sample size for the training set.
  9. How ground truth for the training set was established.

This document is a regulatory approval letter, not a detailed technical study report or clinical trial summary that would typically contain such performance and validation data.

§ 868.5905 Noncontinuous ventilator (IPPB).

(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).