LogoFDA 510(k) Search
K Number
K092991
Device Name
O.S.C.A.R. (OPERATING SYSTEM FOR CONTROL AND RECORD KEEPING)
Manufacturer
ENVIRONMENTAL TECTONICS CORP.
Date Cleared
2010-08-13

(319 days)

Product Code
CBF
Regulation Number
868.5470
Type
Traditional
Panel
AN
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Indications For Use:

The O.S.C.A.R. system is intended for use as an ancillary device for the support of whole-body oxygen administration to a patient at greater than ambient atmospheric pressure (hyperbaric oxygen) as prescribed by a physician. It is a device intended to provide control of Pressure Vessels for Human Occupancy without change to their established indications for use. The specific manufacturer's devices intended for use are Environmental Tectonics Corp.'s BARAMED 30" and XD monoplace models.

The FDA has cleared the use of hyperbaric chambers under 13 specific medical conditions that are based on the Undersea and Hyperbaric Medicine Society (UHMS)'s indications. These are:

  • Air or Gas Embolism .
  • Carbon Monoxide Poisoning and Carbon Monoxide Poisoning complicated by Cyanide Poisoning
  • Clostridial Myositis and Myonecrosis (Gas Gangrene)
  • Crush Injury, Compartment Syndrome and other Acute Traumatic Ischemias
  • Decompression Sickness
  • Enhancement of Healing in Selected Problem Wounds
  • Exceptional Blood Loss (Anemia)
  • Intracranial Abscess
  • Necrotizing Soft Tissue Infections
  • Osteomvelitis (Refractory)
  • Delayed Radiation Injury (Soft Tissue and Bony Necrosis)
  • Skin Grafts and Flaps (Compromised)
  • Thermal Burns

It is a prescription device that is intended for sale and use by or on the order and under the medical supervision of a physician.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain the information requested in your prompt. The document is a 510(k) clearance letter from the FDA for a hyperbaric chamber system called O.S.C.A.R. It does not describe any acceptance criteria or studies related to device performance in the context of an AI/ML device as your prompt implies.

Therefore, I cannot extract the following information:

  • A table of acceptance criteria and the reported device performance
  • Sample size used for the test set and the data provenance
  • Number of experts used to establish the ground truth for the test set and their qualifications
  • Adjudication method for the test set
  • If a multi-reader multi-case (MRMC) comparative effectiveness study was done
  • If a standalone (algorithm only) performance was done
  • The type of ground truth used
  • The sample size for the training set
  • How the ground truth for the training set was established

§ 868.5470 Hyperbaric chamber.

(a)
Identification. A hyperbaric chamber is a device that is intended to increase the environmental oxygen pressure to promote the movement of oxygen from the environment to a patient's tissue by means of pressurization that is greater than atmospheric pressure. This device does not include topical oxygen chambers for extremities (§ 878.5650).(b)
Classification. Class II (performance standards).