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The SIGMA Plus / II Multiplace hyperbaric System is indicated for use for the following indications, 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

The Perry Baromedical Corporation SIGNA Plus / II Multiplace Hyperbaric Chamber is substantially equivalent to the Perry Baromedical Corporation SIGMA II Dualplace Hyperbaric Chamber, [K862198/A]. The SIGMA Plus / Il has the same intended use and the same technological characteristics as the SIGMA II predicate device. The scope and operation of the SIGMA Plus/ II is identical to that of the SIGMA II 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 rolling boundary consists of an actylic cylinder in conformance with 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 compressed breathing quality air.
• Treatment capacity of the chamber is two (2) patients.
• Communication between the patients / attendants is through an intrinsically safe communications system.
• The SIGMA II and SIGMA Plus/ II 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 a breathing hood or breathing mask with the chamber 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.
• Both chambers are Class "A" multiplace hyperbaric systems, with Fire Suppression Systems and independent hand line fire extinguishing systems.

Differences do exist between the SIGMA Plus/ II and the SIGMA II Dualplace chamber; they include:

• The PVHO-1 acrylic cylinder in the SIGMA Plus / II chamber is 40" inside diameter and 65" long, and the PVHO-1 acrylic cylinder in the SIGMA II chamber is 40" inside diameter by 85" long. Both acrylic cylinders are designed with a 20 to 1 safety factor.
• The pneumatic controls for the SIGMA Plus / II 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 II chamber are mounted in a console panel mounted on one side of the chamber.
• The SIGMA Plus/ II Multilace Hyperbaric Chamber has painted fiberglass cosmetic covers on the sides and ends of the chamber; the SIGMA II Dualplace Hyperbaric Chamber has aluminum side cosmetic covers.
• The Built-In Breathing System controls for the SIGMA Plus / II are mounted in a pedestal mounted moveable control panel, allowing positioning to suit the operator location. The SIGMA II Built-In Breathing System controls are mounted in the control console positioned at the side of the chamber.
• The SIGMA II Dualplace chamber is available with an Entry Lock and a Medical Lock feature, which are not offered with the SIGMA Plus / II.

The provided document is a 510(k) summary for the SIGMA Plus/II Multiplace Hyperbaric Chamber, establishing its substantial equivalence to a predicate device (SIGMA II Dualplace Hyperbaric Chamber, K862198/A). It does not contain information about acceptance criteria or a study demonstrating the device meets such criteria in terms of performance metrics.

Instead, the document focuses on:

• Substantial Equivalence: Highlighting that the SIGMA Plus/II has the "same intended use and the same technological characteristics" as the SIGMA II predicate device, outlining numerous identical features.
• Differences: Listing minor differences between the two devices, primarily related to size of the acrylic cylinder, control panel mounting, cosmetic covers, and availability of an entry/medical lock.
• Safety and Effectiveness: Stating that these changes "enhance its ease of operation, and do not adversely effect the safety and effectiveness of the device."
• Indication for Use: Listing the medical conditions for which the hyperbaric system is indicated, in accordance with guidelines from the Undersea and Hyperbaric Medical Society.

Therefore, I cannot fill in the requested table and answer the study-related questions as this information is not present in the provided text. The document is a regulatory submission for substantial equivalence, not a performance study report.

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