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K Number
K163109
Device Name
OxyHeal 4000 Multiplace Hyperbaric Chamber Family
Manufacturer
OXYHEAL MEDICAL SYSTEMS, INC.
Date Cleared
2017-03-22

(135 days)

Product Code
CBF
Regulation Number
868.5470
Type
Special
Panel
AN
Reference & Predicate Devices
K152223
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The intended use of the OxyHeal® 4000 Cylindrical Multiplace Hyperbaric Chamber System Product Family is to administer hyperbaric oxygen therapy (HBOT) to treat patients with any of the below listed indications.

The following indications which are listed on the Undersea & Hyperbaric Medical Society (UHMS) web site: www.uhms.org.are approved uses of hyperbaric oxygen therapy as defined by the Hyperbaric Oxygen Therapy Committee.

    1. Air or Gas Embolism
    1. Carbon Monoxide Poisoning
  • a. Carbon Monoxide Poisoning Complicated by Cyanide Poisoning
    1. Clostridial Myositis and Myonecrosis (Gas Gangrene)
    1. Crush Injury, Compartment Syndrome and Other Acute Ischemias
    1. Decompression Sickness
    1. Arterial Insufficiencies
  • a. Central Retinal Artery Occlusion
  • b. Enhancement of Healing in Selected Problem Wounds
    1. Severe Anemia
    1. Intracranial Abscess
    1. Necrotizing Soft Tissue Infections
    1. Osteomyelitis (Refractory)
    1. Delayed Radiation Injury (Soft Tissue and Bony Necrosis)
    1. Compromised Grafts and Flaps
    1. Acute Thermal Burn Injury
Device Description

The OxyHeal® 4000 Cylindrical Multiplace Hyperbaric Chamber System Product Family is comprised of a multiplace hyperbaric chamber of major subsystems that support the overall system operation, control, and monitoring.

The OxyHeal® 4000 Cylindrical Multiplace Hyperbaric Chamber is a pressure vessel for human occupancy (PVHO) that is designed in a horizontally orientated cylindrical geometry. Chamber configurations vary based on the needs of the end user, and may be designed and manufactured in one (1), two (2), or three (3), compartment configurations. Patient capacities may range anywhere from four (4) to twenty-four (24) dependent on chamber size, number of compartments, or the direction provided by the customer to meet their needs. Lastly, maximum operating pressures range from 3ATA (~30psi) to 6ATA (~73.5psi), with each of the compartments designed to operate independently.

The OxyHeal® 4000 Cylindrical Multiplace Hyperbaric Chamber System design also complies with the hyperbaric facilities requirements specified in the FDA recognized consensus standard NFPA 99 and satisfies the requirements for protection against electrical, explosive, and fire hazards and associated facilities used for medical procedures at gauge pressures within the ranges: 0psi to 100psi.

The OxyHeal® 4000 Cylindrical Multiplace Hyperbaric Chambers consists of the hyperbaric chamber itself and the major subsystems briefly described below. Each substantially equivalent to that which is contained in the OxyHeal® 5000 Rectangular Multiplace Hyperbaric Chamber System Product Family predicate device (K152223).

AI/ML Overview

The provided document is a 510(k) premarket notification for a hyperbaric chamber system. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving that a new, AI-based device meets acceptance criteria.

Therefore, the requested information about acceptance criteria, device performance, sample sizes, expert ground truth, MRMC studies, standalone performance, and training set details for an AI/ML medical device cannot be extracted from this document.

This document describes a change in the shape of a hyperbaric chamber (from rectangular to cylindrical) and demonstrates that it adheres to existing safety and manufacturing standards, mirroring the predicate device. It is a traditional medical device submission, not one pertaining to AI/ML.

No information regarding AI-specific acceptance criteria or a study proving an AI device meets them is present in the provided text.

The document details:

  • Device: OxyHeal® 4000 Cylindrical Multiplace Hyperbaric Chamber System Product Family
  • Predicate Device: OxyHeal® 5000 Rectangular Multiplace Hyperbaric Chamber System Product Family (K152223)
  • Key Modification: Change from rectangular to cylindrical geometry.
  • Demonstration of Equivalence: Through adherence to recognized industry standards (ASME PVHO-1, NFPA 99, ISO 14971), non-clinical testing (Non-destructive Testing, Hydrostatic Testing, Fire Suppression System Testing, First Operational System Test, Software Validation Testing - note: "software validation" in this context refers to confirming the chamber's control software functions as intended, not AI/ML inference), and factory acceptance testing.

The document explicitly states: "The fundamental technology for this minor modification consists of a change in dimensional specifications; i.e. the predicate device (K152223) is a multiplace hyperbaric chamber with a rectangular geometry. The modified device is a multiplace hyperbaric chamber with a cylindrical geometry. This modification does not change the intended use, indications for use, and product labeling." It also says, "The validation / verification efforts performed for the OxyHeal® 4000 Cylindrical Multiplace Hyperbaric Chamber System Product Family are identical to those performed for the OxyHeal® 5000 Rectangular Multiplace Hyperbaric Chamber System Product Family (K152223) predicate device."

§ 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).