(155 days)
The PAH-M3+1 Hyperbaric Chamber System is intended to be procured and used by physicians to treat a variety of medical conditions that respond to hyperbaric oxygen. The Undersea & Hyperbaric Medical Society (UHMS) produces a list of medical conditions that have been identified for the appropriate primary or adjunctive use of hyperbaric oxygen. These approved conditions include: air or gas embolism; carbon monoxide poisoning and smoke inhalation; clostridial myonecrosis (gas gangrene); crush injury, compartment syndrome and other acute traumatic ischemias; decompression sickness; enhanced healing of selected problem wounds: exceptional blood loss anemia: necrotizing soft tissue infections: osteomyelitis (refractory); radiation tissue damage (osteoradionecrosis); compromised skin flaps and grafts; thermal burns; and, intracranial abscess. Aggressive research into the beneficial effects of hyperbaric oxygen, when appropriately applied, will result in additional medical conditions being added to the list of indications by the UHMS.
It is the expressed, intended use of the Pan-America Hyperbarics' PAH-M3+1 Hyperbaric Chamber System to provide therapy to those patients with selected medical conditions that have been determined to respond to the application of hyperbaric oxygen. As a Class II prescriptive device, it is further intended for physician involvement in its procurement and routine use.
The conditions listed as appropriate for the use of HBO in the current edition of the Hyperbaric Oxygen Therapy Committee Report (1999) are as follows:
- Air or gas embolism
- Carbon monoxide poisoning and carbon monoxide poisoning complicated by cyanide poisoning
- Clostridial myositis and myonecrosis
- Crush injury, compartment syndrome, and other acute traumatic ischemias
- Decompression sickness
- Enhanced healing of selected problem wounds
- Exceptional blood loss anemia
- Necrotizing soft tissue infections
- Osteomyelitis (refractory)
- Delayed radiation injury (soft tissue and bony necrosis)
- Skin grafts and flaps (compromised)
- Thermal burns
- Intracranial abscess
The PAH-M3+1 Hyperbaric Chamber System is a Class A multiplace hyperbaric chamber designed to treat up to 4 patients at up to a maximum operating pressure of 3 Atmospheres Absolute (ATA) or 29.4 pounds per square inch gauge (psig). The chamber uses compressed air as the pressurization gas and 100% oxygen as the hyperbaric treatment gas.
The PAH-M3+1 Hyperbaric Chamber System is designed and fabricated in accordance with the requirements of the ANSI/ASME Boiler and Pressure Vessel Code, Section VIII, Division 1. Pressure Vessels: ANSI/ASME-PVHO-1 (American Society of Mechanical Engineers-Pressure Vessels for Human Occupancy); and, NFPA 99, Health Care Facilities, Chapter 19, Hyperbaric Facilities (Chapter 20, 2002 Edition). The overall external length of the chamber is 4500mm (approx. 14.76 ft). Its internal diameter is 1016mm (approx. 40 inches). There are two compartments: main compartment and transfer compartment. Three (3) removable seats and one fixed (1) seat are installed in main compartment and transfer compartment respectively. Two independent fire suppression systems, water deluge system and handline system, are installed in accordance with the requirements of NFPA 99, Chapter 19 (Chapter 20, 2002 Edition). Pressurization is provided by compressed air with 100% oxygen administered to the patient by using properly fitting oronasal masks or head tents. A lowvoltage patient intercommunication system designed and installed in accordance with NFPA 99. Chapter 19 (Chapter 20, 2002 Edition) and provides communications between the patients in the chamber and the outside chamber operator. A Teledyne TED-191 oxygen analyzer is installed to monitor the concentration of oxygen inside the chamber continually. The system consists of an operator control console that contains all of the controls and connection points. Single operator chamber pressure control is achieved via a simple manual pneumatic control. A penetrator plate is provided in the vessel wall to allow user supplied medical monitoring leads, etc., to be used as required. The patients are loaded and unloaded by a retractable gurney, which is equipped with a sliding transport chair. When supine position is needed, a sliding bunk will be used instead. The chamber is also equipped with safety switch for pressurization. There is no gas supply before the chamber's door is closed and secured thoroughly.
This 510(k) summary describes a hyperbaric chamber system, not an AI/ML device. Therefore, the specific criteria for AI/ML device evaluation such as sample sizes for test and training sets, ground truth establishment methods, expert qualifications, adjudication methods, and MRMC studies are not applicable to this document. The provided text does not contain information about the performance evaluation of an AI-powered diagnostic or therapeutic device.
The acceptance criteria for the PAH-M3+1 Hyperbaric Chamber System are based on compliance with established engineering and medical standards for such devices. The "study" that proves the device meets these criteria is the design and manufacturing process adhering to these standards, as well as the 510(k) submission and FDA's substantial equivalence determination.
Here's a breakdown of the relevant information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Compliance with Standards/Characteristics) | Reported Device Performance (as per submission) |
|---|---|
| Design & Fabrication Standards: | |
| ANSI/ASME Boiler and Pressure Vessel Code, Section VIII, Division 1 (Pressure Vessels) | Designed and fabricated in accordance with this standard. |
| ANSI/ASME-PVHO-1 (Pressure Vessels for Human Occupancy) | Designed and fabricated in accordance with this standard. |
| NFPA 99, Health Care Facilities, Chapter 19 (Hyperbaric Facilities - Chapter 20, 2002 Edition) | Designed and fabricated in accordance with this standard. Fire suppression systems and low-voltage patient intercommunication system installed in accordance with this standard. |
| Physical Characteristics: | |
| Maximum operating pressure | 3 Atmospheres Absolute (ATA) / 29.4 pounds per square inch gauge (psig) |
| Number of patients | Up to 4 patients |
| Pressurization gas | Compressed air |
| Hyperbaric treatment gas | 100% oxygen |
| Overall external length | 4500mm (approx. 14.76 ft) |
| Internal diameter | 1016mm (approx. 40 inches) |
| Compartments | Two: main compartment and transfer compartment |
| Seating | 3 removable seats (main), 1 fixed seat (transfer) |
| Fire Suppression Systems | Two independent: water deluge system and handline system |
| Oxygen Monitoring | Teledyne TED-191 oxygen analyzer installed |
| Control Console | Operator control console with all controls and connection points |
| Pressure Control | Simple manual pneumatic control for single operator |
| Medical Monitoring Access | Penetrator plate for user-supplied leads |
| Patient Loading/Unloading | Retractable gurney with sliding transport chair, sliding bunk for supine position |
| Safety Switch for Pressurization | Equipped; no gas supply before door is closed/secured |
| Intended Use/Indications for Use (Medical Conditions): | |
| Approved medical conditions for hyperbaric oxygen therapy (as listed by UHMS, 1999) | The device is intended to treat the 13 specific medical conditions listed in the document (e.g., Air or gas embolism, Carbon monoxide poisoning, Decompression sickness, various wound healing issues, etc.) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a hyperbaric chamber, not an AI/ML device that uses a test set of data. The "testing" involves engineering and functional validation against established safety and performance standards for mechanical and medical devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. Ground truth, in the context of AI/ML, refers to validated diagnostic labels or outcomes for data. For a hyperbaric chamber, the "ground truth" is defined by the technical specifications and clinical indications established by regulatory bodies and medical societies (like UHMS).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are used to resolve disagreements in expert labeling of data, which is not relevant for this device.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a medical apparatus, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for the device's acceptable performance is its demonstrated compliance with design and manufacturing standards (ANSI/ASME, NFPA 99) and its intended use for specific medical conditions as recognized by organizations like the Undersea & Hyperbaric Medical Society (UHMS). The FDA's substantial equivalence determination implies that its safety and effectiveness are comparable to legally marketed predicate devices.
8. The sample size for the training set
Not applicable. There is no training set as this is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. There is no training set.
§ 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).