(266 days)
The following indications which are listed on the Undersea and Hyperbaric Medical Society (UHMS) website: www.uhms.org are approved uses of hyperbaric oxygen therapy as defined by the Hyperbaric Oxygen Therapy Committee.
- Air or Gas Embolism
- Carbon Monoxide Poisoning
a. Carbon Monoxide Poisoning Complicated by Cyanide Poisoning - Clostridial Myositis and Myonecrosis (Gas Gangrene)
- Crush Injury, Compartment Syndrome and Other Acute Ischemias
- Decompression Sickness
- Arterial Insufficiencies
a. Central Retinal Artery Occlusion
b. Enhancement of Healing in Selected Problem Wounds - Severe Anemia
- Intracranial Abscess
- Necrotizing Soft Tissue Infections
- Osteomyelitis (Refractory)
- Delayed Radiation Injury (Soft Tissue and Bony Necrosis)
- Compromised Grafts and Flaps
- Acute Thermal Burn Injury
The OxyHeal® 5000, Rectangular Multiplace Hyperbaric Chamber System is comprised of a multiplace hyperbaric chamber and a number of major subsystems that support the overall system operation, control, and monitoring. An OxyHeal® 5000 multiplace hyperbaric chamber is a pressure vessel for human occupancy that is designed in a rectangular geometry. Configurations vary based on the needs of the end user and may consist of two (2), three (3), or more compartments. Capacities may range anywhere from six (6) to twenty-four (24) patients or more, dependent on chamber of compartments, or the direction of the customer to meet their needs. Lastly, maximum operating pressures range from 3ATA (~30psi) to 6ATA (~73.5psi), with each of the compartments designed to operate independently. Each OxyHeal® 5000 multiplace hyperbaric chamber is designed, inspected, tested, marked and stamped to meet the standards defined in the American Society of Mechanical Engineers / Pressure Vessel for Human Occupancy (ASME/PVHO-1). These chambers comply with the National Fire Protection Agency (NFPA) 99, Health Care Facilities. The OxyHeal 5000, Rectangular Multiplace Hyperbaric Chamber System consists of the hyperbaric chamber itself and the major subsystems briefly described below: Compressed Air System, Fire Suppression System, Bulk Oxygen System, Built-in Breathing System, HP Gas System, Environmental Control System (ECS), Control Console.
The provided text details the 510(k) summary for the OxyHeal® 5000 Rectangular Multiplace Hyperbaric Chamber System Product Family, demonstrating its substantial equivalence to predicate devices rather than proving it meets specific acceptance criteria through a "study" in the typical sense of a clinical trial or performance study comparing it against a predefined metric.
Instead, the "study" mentioned here refers to a comparison of the new device's technological characteristics, design, and operational parameters against those of legally marketed predicate devices. The acceptance criteria are implicit in meeting or exceeding the standards and performance of these predicate devices, as well as adherence to relevant industry standards like ASME and NFPA.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a substantial equivalence submission, the "acceptance criteria" are the characteristics of the predicate devices and relevant standards (ASME, NFPA). The "reported device performance" is the OxyHeal® 5000's characteristics in comparison to these.
| Characteristic | Acceptance Criteria (Predicate Devices & Standards) | Reported Device Performance (OxyHeal® 5000) |
|---|---|---|
| Product Code | CBF (Fink K031649, OxyHeal® 2000 K011866) | CBF |
| Regulation Number | 21 CFR 868.5470 (Fink K031649, OxyHeal® 2000 K011866) | 21 CFR 868.5470 |
| Regulation Name | Hyperbaric Chamber (Fink K031649, OxyHeal® 2000 K011866) | Hyperbaric Chamber |
| Indications for Use | As defined in the Hyperbaric Oxygen Therapy Committee Report, dated 1999 (for predicates) | As defined in the Hyperbaric Oxygen Therapy Committee Report, dated 2008 (Substantially equivalent, updated report) |
| Hyperbaric Chamber Code Design | ASME Section VIII, Div. 1; ASME PVHO-1 (for predicates) | ASME: Boiler and Pressure Code; ASME PVHO-1: Safety Standard for Pressure Vessels for Human Occupancy (Substantially equivalent) |
| Hyperbaric Chamber System Design | NFPA 99, Chapter 19 – Hyperbaric Facilities (for predicates) | NFPA 99, Chapter 14 – Hyperbaric Facilities (Substantially equivalent – different chapter but same core standard) |
| Operating Pressure | 3.0 ATA (OxyHeal® 2000) to 6.0 ATA (Fink DL8/TL20) | 3.0ATA – 6.0ATA (Substantially equivalent to Fink DL8/TL20; OxyHeal 2000 is lower pressure range) |
| Operating Temperature | 62°F - 100°F (Fink); Capable of operating within design temperature ranges based on patient comfort (OxyHeal® 2000) | 50°F-125°F (Substantially equivalent, OxyHeal 2000 designed for lower pressure range) |
| Design Temperature | 62°F - 100°F (Fink); 50°F - 120°F (OxyHeal® 2000) | 50°F - 125°F (Substantially equivalent) |
| Design Pressure | 30psig (OxyHeal® 2000) to 80.0 psi (Fink DL8/TL20) | 30psig - 75psig (Substantially equivalent to Fink DL8/TL20; OxyHeal 2000 for lower pressure) |
| Design Life | ≥ 30 years (Fink, OxyHeal® 2000) | 90,000 cycles or 60 years, whichever happens first (≥ 30 years: Substantially equivalent) |
| Hydrostatic Pressure | 45psi (OxyHeal® 2000) to 104.0 psi (Fink) | 39psi - 97.5psi (Substantially equivalent to Fink DL8/TL20; OxyHeal 2000 for lower pressure) |
| Inspection Authority | ASME "U" Stamp (Fink); Independent 3rd Party ASME Authorized Inspector (AI) (OxyHeal® 2000) | Independent 3rd Party ASME Authorized Inspector (AI). Affix ASME Stamp on chamber data plate (Substantially equivalent) |
| Weight (lbs.) | ~ 7,000 (OxyHeal® 2000) to ~110,231 (Fink) | 15,000lbs to 120,000lbs (Substantially equivalent to Fink DL8/TL20; OxyHeal 2000 is smaller) |
| Dimensions (Main Compartment) | 8.1'W x 7'H x 11'L to 10.3'W x 7'H x 19.3'L (Fink); Dia. = 6'; H = 7' (OxyHeal® 2000) | Min: 8' W x 7' H x 10'L; Max: 11'W x 8'H x 20'L (Substantially equivalent to Fink DL8/TL20; OxyHeal 2000 intentionally smaller) |
| Total Volume | 197.8ft³ (OxyHeal® 2000) to 2,546.2ft³ (Fink) | 600ft³ to 2,600ft³ (Substantially equivalent to Fink DL8/TL20; OxyHeal 2000 intentionally smaller) |
| Medical Lock | 10" ID x 10"L (OxyHeal® 2000) to 13.8" x 13.8" x 19.7" (Fink) | Cylindrical Min: 10 inch diameter; Max: 16 inch diameter (Substantially equivalent) |
| Main Doorway Size | 32" x 83" (OxyHeal® 2000) to 39.4" x 75.6" (Fink) | Minimum door frame size: 44" x 80"; Maximum 52" x 80" (Substantially equivalent in terms of safety and effectiveness of operation) |
| Lighting | One (1) internally mounted light (OxyHeal® 2000) to Six (6) to fourteen (14) external dimmable lights (Fink) | LED lights Min: 4; Max: 15 (Comply with NFPA-99 and are substantially equivalent in terms of safety and effectiveness of operation) |
| Viewports (PVHO-1) | 16" ID - Qty. 2 each (OxyHeal® 2000) to various (Fink) | Minimum: One (1) per hyperbaric chamber. Maximum: Six (6) per compartment. Minimum: 8" Diameter, Maximum: 30" Diameter (Substantially equivalent) |
| Capacity Main Compartment | From eight (8) seated patients / Four (4) wheelchairs (Fink) to Six (6) upright seated patients (OxyHeal® 2000) | 4 Patients Up to 24 Patients (Substantially equivalent to Fink DL8/TL20; OxyHeal 2000 is smaller) |
| Fire Suppression | IAW NFPA 99 (Fink, OxyHeal® 2000) | IAW NFPA 99 (Substantially equivalent) |
| Life Support Controls | Manual electropneumatic (pressurization/depressurization) (Fink); Automatic pressurization & depressurization with manual back-up from both inside and outside the chamber (OxyHeal® 2000) | Automatic pressurization & depressurization with manual back-up from both inside and outside each chamber compartment (Substantially equivalent to OxyHeal 2000) |
| Environmental Control | Heating (Fink); Heating and cooling (OxyHeal® 2000) | Heating & cooling (Substantially equivalent to OxyHeal 2000) |
| Ventilation | Constant air flow (Fink); Automatic chamber ventilation with manual back-up (OxyHeal® 2000) | Automatic chamber ventilation with manual back-up. Min 6 cfm, Max 48cfm with a +/- 1 fsw stability (Substantially equivalent) |
| BIBS with Overboard Dump | Two (2) - Four (4) (Fink); Four (4) (OxyHeal® 2000) | Four (4) to Twenty-Four (24), on demand gas delivery (Substantially equivalent in terms of safety and effectiveness) |
| Hoods with Overboard Dump | Six (6) to Twenty two (22) (Fink); Four (4) (OxyHeal® 2000) | Four (4) to Twenty-Four (24) 1-100LPM delivery flow meters. Minimum flow for hoods: 40-lpm (Substantially equivalent in terms of safety and effectiveness) |
| Depth Measurement | Digital with analog backup (Fink, OxyHeal® 2000) | Digital with analog backup (Substantially equivalent) |
| Gas Analysis | Oxygen (O2) and carbon dioxide (CO2) (Fink, OxyHeal® 2000) | Oxygen (O2) 1-100% and carbon dioxide (CO2) 0-5000ppm (Substantially equivalent) |
| Communications | Internal/external PA system, Sound powered backup (Fink); Primary: Wireless telephone, Secondary: Intercom (OxyHeal® 2000) | Primary: Wireless telephone, Secondary: Intercom, Tertiary: Sound powered backup (Substantially equivalent) |
| Entertainment | Individual 4-channel selection for eight (8) persons (Fink); Individual 4-channel selection for up to six (6) persons (OxyHeal® 2000) | Individual up to 4-channels. Varies based on customer specification for number of compartments and number of patients to be treated (Substantially equivalent) |
| TV System | External color with remote control AM/FM tuner/CD & DVD player (Fink); One (1) internally mounted TV System. AM/FM tuner/CD & DVD player (OxyHeal® 2000) | 24VDC LED TV Monitor. AM/FM Tuner/CD, DVD, and Cable TV Tuner (Comply with NFPA-99 and are substantially equivalent in terms of safety and effectiveness of operation) |
| Compartment Relief | ASME certified pressure relief valve (Fink, OxyHeal® 2000) | One (1) ASME certified pressure relief valve per compartment. 30 psig to 75 psig (Substantially equivalent) |
| Compartment Drain | One (1) manual drain in each compartment (Fink, OxyHeal® 2000) | Minimum One (1) manual drain in each compartment (Substantially equivalent) |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This document describes engineering tests and a comparison to predicate devices, not a clinical study on a patient test set in the conventional sense. The "test set" for the non-clinical testing comprises the physical components and integrated system of the OxyHeal® 5000 chamber itself.
- Sample Size: The sample size is essentially one (the OxyHeal® 5000 Rectangular Multiplace Hyperbaric Chamber System Product Family, representing its design). The testing applies to the specific device models being submitted. The document evaluates the design and performance characteristics of new models within this product family against established standards and predicate devices.
- Data Provenance: The testing details suggest that tests were conducted by the manufacturer (OxyHeal Medical Systems, Inc.) or by independent bodies (like ASME authorized inspectors) as part of the manufacturing and verification process. This is prospective testing for the submitted device design. The origin would be the manufacturing site or testing facilities. No country of origin for specific testing data is explicitly mentioned, but the manufacturer is based in National City, CA, USA.
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)
This is not applicable as this is a device engineering and performance validation against standards and predicate devices, not an AI or diagnostic device requiring expert interpretation for "ground truth" establishment in a clinical imaging context. The "ground truth" for compliance to standards comes from the ASME and NFPA codes themselves, and expert judgment is inherent in the design, engineering, and inspection processes by qualified engineers and ASME authorized inspectors.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for this type of device submission. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies, especially those involving multiple readers interpreting data where a consensus or tie-breaking mechanism is needed to establish ground truth.
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 is not an AI-assisted diagnostic device, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm-based device. The device itself is the hyperbaric chamber system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this context refers to established engineering standards, safety requirements, and the validated performance of predicate devices. Specifically:
- Engineering Standards: ASME/PVHO-1 for pressure vessels, NFPA 99 for health care facilities (including fire suppression, electrical design, etc.).
- Performance Specifications: User Design Specifications for the OxyHeal® 5000, which are verified through various tests (structural, fire suppression, operational, software validation, factory acceptance).
- Predicate Device Characteristics: The established and legally marketed performance and design features of the Fink Engineering PTY LTD SL8, DL8, and TL20 Hyperbaric Oxygen Facility (K031649) and the OxyHeal Health Group®, Inc. OxyHeal® 2000 Hyperbaric Chamber Series (K011866).
8. The sample size for the training set
Not applicable. This is not an AI or machine learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this type of device.
§ 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).