(191 days)
It is the expressed, intended use of the Fink Engineering SL8/DL8 and TL20 Hyperbaric Oxygen Treatment Facilities 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 their 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 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 SL/DL8 and TL20 Hyperbaric Oxygen Treatment Facilities are Class A multiplace hyperbaric chambers designed to treat up to 8 (SL/DL8) or 20 (TL20) patient at up to a maximum operating pressure of 3 Atmospheres Absolute (ATA) or 29.4 pounds per square inch gauge (psig) for the SL8 and up to 6 Atmospheres Absolute (ATA) or 73.5 psig for the DL8 and TL20. Each facility utilizes air as the pressurization gas and 100% oxygen as the hyperbaric treatment gas.
The SL/DL8/TL20 rectangular hyperbaric chamber(s) include as a key component a new and very user-friendly rectangular chamber designed and manufactured specifically for the medical community to be used for hyperbaric oxygen treatment. The design of this unique ASME PVHO chamber has been driven by comments from hyperbaric physicians, technicians and nurses who require their equipment to be simple, easy to use and to simulate clinical conditions found elsewhere in their working environment.
The SL/DL8/TL20 facilities place major emphasis on patient comfort and user-friendly operator controls and incorporate several innovative and unique features including:
- A large, comfortable rectangular hyperbaric chamber that has been outfitted to appear like any other clinical room in a hospital to reduce patient anxiety
- A rectangular medical lock with a unique locking system enabling single-handed operation
- Large walk-trough rectangular sliding doors that fit flush with the floor so that patients can be wheeled into the chamber without bumping over a door jam
- An easy to use control panel with large VDU display to monitor the treatment profile including the internal chamber pressure, temperature, humidity, oxygen and carbon dioxide parameters
- An oxygen delivery system with venturi assisted overboard exhaust to eliminate the possibility of "shrink wrapping" patients with their oxygen hoods
- Whisper quiet ventilation system to pneumatically control temperature, humidity and upper oxygen limit without the need for internal electrical blowers
- Aesthetically pleasing external chamber cladding
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the SL8/DL8 and TL20 Hyperbaric Oxygen Treatment Facilities:
Based on the provided 510(k) summary, the device is a Multiplace Hyperbaric Chamber, and the review focuses on substantial equivalence to predicate devices, rather than a de novo clinical study with specific acceptance criteria in the manner typically applied to novel diagnostic or therapeutic AI algorithms.
Therefore, many of the requested categories for AI-based device studies are not directly applicable to this type of submission. However, an attempt has been made to interpret the available information relative to your request.
Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are primarily based on demonstrating substantial equivalence to legally marketed predicate devices and adherence to relevant industry standards for safety and performance of hyperbaric chambers. The "performance" here refers to meeting design specifications and intended use as a hyperbaric oxygen treatment facility, rather than a diagnostic accuracy or treatment efficacy metric that would typically be seen in AI studies.
| Acceptance Criteria Category | Reported Device Performance/Meeting Criteria |
|---|---|
| Design and Manufacturing Standards | Adherence to: |
- ANSI/ASME Boiler and Pressure Vessel Code, Section VIII, Division 1, Pressure Vessels
- ANSI/ASME-PVHO-1 (Pressure Vessels for Human Occupancy)
- NFPA 99, Health Care Facilities, Chapter 19 (or 20, 2002 Edition), Hyperbaric Facilities |
| Intended Use | The facilities are intended to provide hyperbaric oxygen therapy for medical conditions identified by the Undersea and Hyperbaric Medical Society (UHMS) as appropriate for HBO. The listed indications for use are identical to those established by UHMS. |
| Operating Pressure | SL8: 3.0 ATA (Maximum operating pressure up to 3 ATA or 29.4 psig)
DL8/TL20: 6.0 ATA (Maximum operating pressure up to 6 ATA or 73.5 psig for DL8 and TL20) |
| Operating Temperature | 62°F to 100°F (across all models) |
| Design Life | 70,000 cycles (30 years) (across all models) |
| Safety Features | Includes fire suppression (IAW NFPA 99), medical lock, communication systems, oxygen delivery systems to prevent "shrink wrapping" patients, quiet ventilation. |
| Operational Controls | Manual electropneumatic pressurization/depressurization, digital depth measurement with analog backup, oxygen and carbon dioxide gas analysis, environmental control (heating). |
Study Information
Given this is a 510(k) for a multiplace hyperbaric chamber, it is not a clinical study in the sense of comparing a new AI algorithm's performance against a reference standard using patient data. Instead, it's an engineering and regulatory demonstration of substantial equivalence.
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- This is not applicable as there is no "test set" of patient data or algorithm performance evaluation. The submission refers to the design, manufacturing, and technical specifications of the hyperbaric chambers themselves. The "study" is the manufacturing process adhering to established standards and the comparison of the device's specifications to those of predicate devices.
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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. There is no ground truth, test set, or expert panel in the context of an AI study. The "ground truth" for this device's utility is the established medical practice of hyperbaric oxygen therapy for the listed indications, as defined by the UHMS.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. There is no test set or adjudication method as described for AI studies.
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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 physical hyperbaric chamber, not an AI-assisted diagnostic or therapeutic tool for human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for the intended use of the device is the list of medical conditions for which hyperbaric oxygen therapy has been "clearly established as appropriate primary or adjunctive use," as defined and continuously updated by the Undersea and Hyperbaric Medical Society (UHMS). This relies on extensive data collection, validation, and scientific pursuit by a professional medical organization.
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The sample size for the training set:
- Not applicable per the typical definition for AI models. The "training" for this device would be analogous to the cumulative engineering knowledge, design principles, and manufacturing processes that conform to established safety and performance standards for hyperbaric chambers.
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How the ground truth for the training set was established:
- Not applicable in the AI context. The "ground truth" for the device's design and functionality is established through international and national engineering codes and standards (ASME, NFPA) and the medical consensus on hyperbaric therapy indications (UHMS). The manufacturer's design approach and method of control are compared to well-established predicate devices.
§ 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).