(86 days)
The intended use of the Sechrist Model 3300H/HR and Model 3600H/HR Hyperbaric Chambers are to administer 100% oxygen at pressure greater than ambient, up to 3 atmospheres absolute (30 psi) of pressure.
Specific indication for use of the hyperbaric chambers have been established by the Committee on Hyperbaric Oxygen Therapy of the Undersea and Hyperbaric Medical Society (founded in 1967 to foster exchange of data on the physiology and medicine of commercial and military diving). The committee is comprised of practitioners and scientific investigations in the fields of internal medicine, infectious diseases, pharmacology, emergency medicine, general surgery, orthopedic surgery and aerospace medicine. The committee is responsible for continually reviewing research and clinical data in determining the safety and efficacy of hyperbaric oxygen. Currently, there are thirteen indications that are approved by the committee; these thirteen indications were accepted based on sound physiologic rationale, in vitro studies that demonstrate effectiveness, controlled animal studies, prospective controlled clinical studies and extensive clinical experience from multiple hyperbaric medicine centers. These thirteen indications have been recommended for third-party reimbursements and most insurance carriers have established reimbursement policy based on these recommendations.
The thirteen indications are:
- Air or Gas embolism 1.
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- Carbon Monoxide Poisoning
Carbon Monoxide Poisoning Complicated by Cyanide Poisoning
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- Clostridial Myonecrosis and Myonecrosis (Gas Gangrene)
- Crush Injury, Compartment Syndrome and Other Acute Traumatic Ischemia's 4.
- ನ. Decompression Sickness
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- Arterial Insufficiencies
Central Retinal Artery Occlusion
Enhancement of Healing In Selected Problem Wounds
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- Severe Anemia
- Intracranial Abscess 8.
- ರು Necrotizing Soft Tissue Infections
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- Osteomyelitis (Refractory)
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- Delayed Radiation Injury (Soft Tissue and Bony Necrosis)
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- Comprised Grafts and Flaps
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- Thermal Burns
A hyperbaric oxygen chamber is a pressure vessel and control system that is designed to provide patient exposure to a very high oxygen concentration at higher than normal atmospheric pressure. Titration of the oxygen exposure is controlled by selecting the pressure achieved within the pressure vessel. Pressurization and de-pressurization rates are selected to minimize patient discomfort while increasing and decreasing the chamber pressure. Typical monoplace chambers are capable of pressurizing to 3 ATA (29.4 psig above atmospheric pressure). The typical pressurization and de-pressurization rates are in the range of 0.4 to 5.0 psig/minute.
The Sechrist Models 3300H/HR and 3600H/HR Hyperbaric Chambers are monoplace pressure chambers designed to administer 100% oxygen at pressure greater than ambient, up to 3 atmospheres absolute (30 psig) of pressure. These hyperbaric chambers consist of a mechanical and pneumatic system capable of controlling the operator defined pressurization profiles.
These Hyperbaric Chambers are constructed with a horizontal seamless acrylic viewport which varying internal diameter sizes.
| Models | Internal Diameter |
|---|---|
| 3300H/HR Hyperbaric Chambers | 32.50 inches (83 cm) |
| 3600H/HR Hyperbaric Chambers | 35.50 inches (90 cm) |
Each model is equipped with a clear anodized aluminum cover on one end and the other end with a hard anodized door assembly, with access ports available for patient interface (such as patient monitoring, delivery of intravenous fluids, etc.) locking mechanism and interlocking safety device.
The cylinder, end cover and the door assembly are assembled together with stainless steel tie rods/nuts and hinge assembly. Each Hyperbaric Chamber Model comes in two configurations designated with a suffix of "H" and "HR". The suffix "H" is the Standard configuration where the control panel is located on the left of the chamber when facing the door and the door opens from left to right. The suffix "HR" is the Reverse configuration where the control panel is located on the right side of the chamber and the door opens from right to left.
The functional performance system and the safety features incorporated in the Models 3300H/HR and 3600H/HR Hyperbaric Chambers are the same that have been incorporated into the design of the Model 4100H/HR predicate device.
A pressurization cycle counter is provided to maintain a record of the number of pressurization cycles the chamber experienced.
A two-way intercommunication system is used to maintain contact between patient and attendant.
The provided document is a 510(k) Summary for Sechrist Models 3300H/HR and 3600H/HR Hyperbaric Chambers. It focuses on demonstrating substantial equivalence to a predicate device (Sechrist Model 4100H/HR) rather than presenting a standalone study with acceptance criteria and device performance results in the format typically seen for novel medical devices or AI algorithms.
However, I can extract the relevant information regarding design changes, their requirements, and validation methods, which serve as the "acceptance criteria" and "study" in the context of demonstrating substantial equivalence for these modifications.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document describes modifications to existing hyperbaric chambers and compares them to a predicate device. The "acceptance criteria" in this context are the device specifications and regulatory standards the modified devices must meet, and "reported device performance" refers to the validation that these specifications are met, often demonstrating equivalence to the predicate.
| Device Change | Acceptance Criteria (Device Requirement) | Reported Device Performance (Validation/Testing Performed & Outcome) |
|---|---|---|
| Decreased Acrylic Window Size, Length and Width (Models 3300H/HR & 3600H/HR) | 1. Device specification (to operate to approved product specifications). |
- ASME Boiler & Pressure Vessels Code Section VIII Division 1.
- PVHO-1 Safety Standard for Pressure Vessels for Human Occupancy (Tested at 1.1 x MAWP). | 1. System Design Validation performed (Test Ref: 2009-0010).
- ASME "U" Certificate of Authorization for ASME Boiler & Pressure Vessels Code Section VIII Division 1.
- PVHO-1 testing (Appendix I, Enclosure 4) performed at 1.1 x MAWP.
Outcome: "The data indicates the change does not affect the devices ability to perform to its product specifications and performs equivalently to the Model 4100H/HR Hyperbaric Chamber (predicate device)." |
| Over-Pressure Relief Valve Pressure Change (Model 3300H/HR: 35 psig; Model 3600H/HR: 36 psig) | 1. Device Specification (35 psig ± 2 psig for 3300H/HR; 36 psig ± 2 psig for 3600H/HR). - Final Test and Calibration Procedures (Document 150156). | 1. System Design Validation performed (Test Ref: 2009-0010).
- Activation pressure of valves tested and verified (Document 150156, Section 5).
Outcome: "The data indicates that the Model 3300H/HR and Model 3600H/HR Hyperbaric Chambers activates the Relief Valves at the activation pressures as outlined in the product specifications and performs equivalently to the Model 4100H/HR Hyperbaric Chamber (predicate device)." |
| Gas Supply Flow Rate Change (Model 3300H/HR: 32 SCFM; Model 3600H/HR: 34 SCFM) | 1. Device Specification (32 SCFM for 3300H/HR; 34 SCFM for 3600H/HR). - Final Test and Calibration Procedures (Document 150156). | 1. System Design Validation performed (Test Ref: 2009-0010).
- Device performs to specification after calibration (Document 150156). Each model is tested 100% using recommended supply pressure settings during manufacturing.
Outcome: "The data indicates the change does not affect the devices ability to perform to its product specifications and performs equivalently to the Model 4100H/HR Hyperbaric Chamber (predicate device)." |
Remaining Information (NotApplicable / Not Provided for this Device Type)
The provided document describes modifications to a hyperbaric chamber, which is a physical medical device. The questions related to sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC comparative effectiveness studies, standalone algorithm performance, ground truth type for test/training sets, and training set sample size are typically applicable to software as a medical device (SaMD) or AI/ML-based diagnostic/screening tools.
Since this submission is for a physical device (Hyperbaric Chamber) and demonstrates substantial equivalence based on engineering changes and performance specification verification, these specific metrics for data-driven algorithms are not applicable and therefore not provided in the document.
The "study" that proves the device meets the acceptance criteria consists of engineering validation and verification tests, compliance with specified industry standards (ASME, PVHO-1), and internal calibration procedures, all aimed at showing that the modified device performs to its specifications and equivalently to the predicate device in terms of safety and efficacy.
§ 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).