(185 days)
The 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:
- Air or Gas Embolism
- Carbon Monoxide / Smoke Inhalation
- Compromised Skin Grafts and Flaps
- Crush Injuries / Acute Traumatic Ischemias
- Decompression Sickness
- Enhanced Healing in Selected Problem Wounds
- Exceptional Blood Loss (Anemia)
- Gas Gangrene (Clostridial Myonecrosis)
- Intracranial Abscess
- Necrotizing Soft Tissue Infections
- Radiation Tissue Damage (Osteoradionecrosis)
- Refractory Osteomyelitis
- Thermal Burns
The Perry Baromedical Corporation SIGMA Plus Monoplace Hyperbaric Chamber is substantially equivalent to the Perry Baromedical Corporation SIGMA I Monoplace Hyperbaric Chamber, [510(k) K832127]. The SIGMA Plus has the same intended use and the same technological characteristics as the SIGMA I predicate device. The scope and operation of the SIGMA Plus is identical to that of the SIGMA I 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 I; 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 either compressed pure oxygen or compressed breathing air.
- Treatment capacity of the chamber is one (1) patient.
- Communication between the patients / attendants is through an intrinsically safe communications system.
- The SIGMA I and SIGMA Plus chambers are used to provide Hyperbaric Oxygen Therapy, prescribed by a licensed physician, where medical grade oxygen is administered to patients while under pressure; either by the patient breathing the chamber atmosphere, (when pressurized with oxygen), or by the patient breathing oxygen from a breathing hood or breathing mask, (when pressurized with breathing air); 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.
Differences do exist between the SIGMA Plus and the SIGMA I Monoplace chamber; they include:
- The PVHO-1 acrylic cylinder in the SIGMA Plus chamber is 40" inside diameter, and the PVHO-1 acrylic cylinder in the SIGMA I chamber is 25.25" inside diameter. Both acrylic cylinders are designed with a 20 to 1 safety factor.
- The pneumatic controls for the SIGMA Plus chamber are mounted in a control box that is suspended from a moveable arm, allowing use from either side of the chamber; while the pneumatic controls for the SIGMA I chamber are mounted in a panel on one side of the chamber.
- The SIGMA Plus Monoplace Hyperbaric Chamber has painted fiberglass cosmetic covers on the sides and ends of the chamber; the SIGMA I Monoplace Hyperbaric Chamber has a wheeled aluminum support chassis.
Here's an analysis of the provided text to extract the requested information. Please note that this document is a 510(k) summary for a hyperbaric chamber, which describes substantial equivalence to a predicate device, rather than a clinical study establishing performance against a new set of acceptance criteria for a novel device. Therefore, many of the requested categories (like sample size, ground truth, expert qualifications, MRMC studies) are not applicable or cannot be found in this type of submission.
Analysis of the Provided Text (K974868 - SIGMA Plus Monoplace Hyperbaric Chamber 510(k) Summary)
This document is a 510(k) Summary, which is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed predicate device. It focuses on demonstrating "substantial equivalence," not on new performance acceptance criteria or a dedicated study proving device performance against such new criteria.
Therefore, many of the questions asked are not directly addressed in this type of regulatory document. I will fill in what can be inferred or directly stated, and note when information is not available.
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable in the context of a 510(k) submission focused on substantial equivalence. The "acceptance criteria" here would be the FDA's regulatory criteria for determining substantial equivalence to a predicate device, which are inherent in the 510(k) process itself rather than defined performance metrics for a novel device. The "reported device performance" is implicitly that it performs equivalently to the predicate device.
| Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance (as demonstrated by substantial equivalence claim) |
|---|---|
| Same intended use | The SIGMA Plus has the same intended use as the SIGMA I. |
| Same technological characteristics | The SIGMA Plus has the same technological characteristics as the SIGMA I (e.g., ASME vessel, material construction, over-pressurization protection, pressurization medium, treatment capacity, communications, pneumatic control system). Specific differences in size and control mounting are noted but argued not to affect safety/effectiveness. |
| Does not adversely affect safety and effectiveness | The changes (increased chamber size, movable controls, cosmetic covers) "do not adversely effect the safety and effectiveness of the device." The basic treatment method is identical. |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This is a regulatory submission for substantial equivalence based on design and technical characteristics comparison, not a clinical trial or performance study involving a "test set" of patients or data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This submission does not involve "ground truth" derived from expert review of data/cases. It relies on established engineering and safety standards (ASME, PVHO-1) and the comparison to an already cleared predicate device.
4. Adjudication Method for the Test Set
Not applicable. No "test set" or adjudication process described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not applicable. This device is a monoplace hyperbaric chamber, not an AI-assisted diagnostic or therapeutic device that would involve human readers or MRMC studies.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a physical medical device (hyperbaric chamber), not an algorithm or software.
7. The Type of Ground Truth Used
Not applicable in the sense of expert consensus, pathology, or outcomes data for a performance study. The "ground truth" for this submission is implicitly the established safety and effectiveness of the predicate device (SIGMA I) and compliance with relevant engineering and safety standards (ASME codes, PVHO-1).
8. The Sample Size for the Training Set
Not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. (See #8)
§ 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).