LogoFDA 510(k) Search
K Number
K990927
Device Name
SIGMA 3400 MONOPLACE HYPERBARIC CHAMBER
Manufacturer
PERRY BAROMEDICAL CORP.
Date Cleared
1999-11-12

(238 days)

Product Code
CBF
Regulation Number
868.5470
Type
Traditional
Panel
AN
Reference & Predicate Devices
K832127
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The SIGMA 3400 Monoplace Hyperbaric Chamber is indicated for use for the following clinical medical conditions in accordance with guidelines established by the Undersea and Hyperbaric Medical Society, as follows:

  1. Air or Gas Embolism
  2. Carbon Monoxide / Smoke Inhalation
  3. Compromised Skin Grafts and Flaps
  4. Crush Injuries / Acute Traumatic Ischemias
  5. Decompression Sickness
  6. Enhanced Healing in Selected Problem Wounds
  7. Exceptional Blood Loss (Anemia)
  8. Gas Gangrene (Clostridial Myonecrosis)
  9. Intracranial Abscess
  10. Necrotizing Soft Tissue Infections
  11. Radiation Tissue Damage (Osteoradionecrosis)
  12. Refractory Osteomyelitis
  13. Thermal Burns
Device Description

The Perry Baromedical Corporation SIGMA 3400 Monoplace Hyperbaric Chamber is substantially equivalent to the Perry Baromedical Corporation SIGMA I Monoplace Hyperbaric Chamber, [510(k) K832127], and the Perry Baromedical Corporation SIGMA Plus Monoplace Hyperbaric Chamber, [510(k) 974863]. The SIGMA 3400 has the same intended use and the same technological characteristics as the SIGMA I and SIGMA Plus predicate devices. The scope and operation of the SIGMA 3400 is identical to that of the SIGMA I and SIGMA Plus in the following areas:

  • The critical component of both systems consists of an ASME pressure vessel that is designed, fabricated, and tested in accordance with the requirements of the ASME Boiler and Pressure Vessel Code, Section VIII, Division 1; and ASME PVHO-1, Safety Standard for Pressure Vessels for Human Occupancy.
  • The pressure vessel consists of certified metal components constructed of materials in conformance with the ASME Boiler and Pressure Vessel Code, Section II - Materials. In addition to the metal parts, the pressure retaining boundary consists of an acrylic plastic cylinder, designed and constructed to the requirements of ASME PVHO-1, Safety Standard for Pressure Vessels for Human Occupancy.
  • The pressure vessel is protected from accidental over pressurization by an ASME "UV" stamped pressure relief valve.
  • The medium used for pressurization of the chamber is medical grade oxygen.
  • Treatment capacity of the chamber is one patient.
  • Communication between the patient / attendants is through an intrinsically safe communications system.
  • The SIGMA I, SIGMA Plus and SIGMA 3400 chambers are used to provide Hyperbaric Oxygen Therapy, prescribed by a licensed physician, where medical grade oxygen is administered to patients while under pressure, by the patient breathing oxygen from the chamber atmosphere that is pressurized with pure oxygen. The breathing of oxygen at elevated pressure promotes the movement of oxygen into the patient's tissues.
  • The chamber pressurization and depressurization control system is completely pneumatic, with no electrical or electronic components.
  • Chambers are Class "B" monoplace hyperbaric systems.

Differences do exist between the SIGMA 3400, the SIGMA Plus and the SIGMA I chambers; they include:

  • The PVHO-1 acrylic cylinder in the SIGMA 3400 chamber is 33.3" inside diameter and 90" long; the PVHO-1 acrylic cylinder in the SIGMA Plus chamber is 40" inside diameter by 65" long, and the PVHO-1 acrylic cylinder in the SIGMA I chamber is 25.25" inside diameter by 80" long.
  • The acrylic cylinder of the SIGMA 3400 has been designed for a operational temperature range of 32 degrees F to 100 degrees F. The SIGMA I and SIGMA Plus cylinders were designed for a 32 degree F to 125 degree F operating range. Based on the actual operating environment of a hospital, the higher 125 degree temperature limit would never be reached in normal operation, as the chamber rooms are required to be maintained at temperatures less than 75 degrees F for patient comfort.
  • The pneumatic controls for the SIGMA 3400 chamber and the SIGMA I chamber are mounted in a panel mounted on one side of the chamber. The pneumatic controls for the SIGMA Plus chamber are mounted in a control box that is suspended from a moveable arm.
  • The SIGMA 3400 monoplace chamber has an aluminum chassis with integral side covers; the SIGMA Plus Chamber has gelcoated fiberglass cosmetic covers on the sides and ends of the chamber; and the SIGMA I Hyperbaric Chamber has aluminum side cosmetic covers as part of the chassis.
  • The SIGMA 3400 monoplace chamber has provision for changing from oxygen to air pressurization during treatment, which allows the operator more control of the environment inside the chamber. The SIGMA Plus and SIGMA I chambers are oxygen only pressurization.
AI/ML Overview

The provided text is a 510(k) summary for the PERRY BAROMEDICAL SIGMA 3400 Monoplace Hyperbaric Chamber. It aims to establish substantial equivalence to existing predicate devices (SIGMA I and SIGMA Plus Monoplace Hyperbaric Chambers) rather than proving the device meets specific performance acceptance criteria through a study.

Therefore, the document does not contain information on:

  1. A table of acceptance criteria and reported device performance: The document focuses on demonstrating substantial equivalence in design, intended use, and technological characteristics, not on presenting specific performance metrics that would be compared against acceptance criteria.
  2. Sample size used for the test set and data provenance: No testing or study data on the device's performance is provided.
  3. Number of experts used to establish the ground truth for the test set and their qualifications: No ground truth establishment is mentioned as no performance studies are detailed.
  4. Adjudication method for the test set: Not applicable as no test set performance is discussed.
  5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of how much human readers improve with AI vs without AI assistance: This device is a hyperbaric chamber, not an AI-assisted diagnostic tool. Therefore, MRMC studies and AI effect sizes are not relevant.
  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable for a hyperbaric chamber.
  7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable as no performance studies are detailed.
  8. The sample size for the training set: Not applicable as this is not an AI/machine learning device.
  9. How the ground truth for the training set was established: Not applicable as this is not an AI/machine learning device.

The document primarily focuses on demonstrating substantial equivalence by stating that the SIGMA 3400 has the same intended use and technological characteristics as its predicate devices, with minor differences in dimensions, operating temperature range, control panel mounting, chassis, and the addition of an oxygen to air pressurization change function. The claim is that these changes "enhance its ease of operation, and do not adversely effect the safety and effectiveness of the device."

The "Indications for Use" section lists the clinical medical conditions for which the SIGMA 3400 Monoplace Hyperbaric Chamber is indicated, in accordance with guidelines established by the Undersea and Hyperbaric Medical Society. This section serves as a statement of clinical utility rather than a report of performance against acceptance criteria.

§ 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).