(266 days)
All of the contemporary substantially equivalent systems listed in Attachment 12 are used for the same indications as listed in the Hyperbaric Oxygen Therapy: Committee Report, Undersea and Hyperbaric Medical Society, Inc., Revised 1999.
- Air or Gas Embolism .
- Carbon Monoxide Poisoning and Carbon Monoxide Poisoning complicated by Cyanide . Poisoning
- Clostridial Myositis and Myonecrosis (Gas Gangrene) ●
- Crush Injury, Compartment Syndrome and other Acute Traumatic Ischemias .
- Decompression Sickness .
- Enhancement of Healing in Selected Problem Wounds ●
- Exceptional Blood Loss (Anemia) .
- . Intracranial Abscess
- Necrotizing Soft Tissue Infections .
- Osteomyelitis (Refractory) .
- Delayed Radiation Injury (Soft Tissue and Bony Necrosis) .
- Skin Grafts and Flaps (Compromised) ●
- Thermal Burns .
The BARA-MED® and its predicate devices have the same intended use: to promote the movement of oxygen into a patient's tissues by causing him to resvire oxygen at a pressure that is greater than that of the earth's atmosphere (i.e., 1 ATA). Specifically, the BARA-MED® and the predicate devices are indicated for air or gas embolism; carbon monoxide poisoning and carbon monoxide poisoning complicated by cyanide poisoning; clostridial myositis and myonecrosis (gas gangrene); crush injury, compartment syndrome, and other acute traumatic ischemias; decompression sickness; enhancement of healing in selected problem wounds; exceptional blood loss (anemia); intracranial abscess; necrotizing soft tissue infections; refractory osteomyelitis; delayed radiation injury (soft tissue and bony necrosis); compromised skin grafts and flaps; thermal burns. These indications for use are in accordance with the recommendations made by the Undersea and Hyperbaric Medical Society for the medical application of hyperbaric chambers.
The BARA-MED® and its predicate devices have very similar general principles of operation. All of these chambers are pressurized and ventilated continuously with pure oxygen, and the patient breathes the chamber atmosphere. Also, in each of the chambers, the pressure-time profile i.e., the rate and direction of pressure change and the time held at any particular pressure), as well as the oxygen ventilation rate of any treatment, are controlled by the chamber's operator, either directly by means of a pneumatic or electronic system, or indirectly by means of an automatic electronic system. The purposes of such controls are to be able to conduct the particular hyperbaric oxygen treatment prescribed by the physician in a way that is save and comfortable for the patient, and to be able to respond appropriately and effectively to any contingency circumstance.
The ETC BARA-MED® is designed and manufactured in accordance with the applicable sections of:
- ASME Boiler and Presser Vessel Code, Section VII, Rules for ● Construction of Pressure Vessels, Division 1, 1998 Edition.
- . ASME PVHO-1-1997, Safety Standard for Pressure Vessels for Human Occupancy.
- NFPA 99, Standard for Health Care Facilities, Chapter 19, 199 . Edition.
In all respects, the BARA-MED® is substantially equivalent to one or more clinical monoplace hyperbaric chambers that are legally marketed for the conduct of hyperbaric oxygen therapy.
This K993010 premarket notification describes a hyperbaric chamber, which is a medical device and not an AI/ML device. Therefore, the requested information on acceptance criteria and study details related to AI/ML device performance (e.g., sample sizes for test/training sets, expert qualifications, ground truth establishment, MRMC studies, standalone performance) is not applicable and cannot be extracted from the provided text.
The provided text focuses on demonstrating the substantial equivalence of the "BARA-MED® Acrylic Monoplace Hyperbaric Chamber" to predicate devices, based on intended use, principles of operation, and compliance with engineering standards.
Here's the relevant information that can be extracted from the document:
1. Acceptance Criteria and Reported Device Performance (as related to a non-AI/ML device):
| Acceptance Criteria (based on existing standards) | Reported Device Performance |
|---|---|
| Intended Use: Promote oxygen movement into patient tissues at pressures greater than 1 ATA for specific indications (as listed in Section {1} and {5}) | The BARA-MED® and its predicate devices have the same intended use. (Section {1}) |
| General Principles of Operation: Pressurized and ventilated continuously with pure oxygen, patient breathes chamber atmosphere, operator controls pressure-time profile and oxygen ventilation rate. | The BARA-MED® and its predicate devices have very similar general principles of operation. (Section {1}) |
| Design and Manufacturing Standards Compliance: | ETC BARA-MED® is designed and manufactured in accordance with: (Section {1}) |
| - ASME Boiler and Pressure Vessel Code, Section VII, Division 1, 1998 Edition | Meets this standard. |
| - ASME PVHO-1-1997, Safety Standard for Pressure Vessels for Human Occupancy | Meets this standard. |
| - NFPA 99, Standard for Health Care Facilities, Chapter 19, 1999 Edition | Meets this standard. |
| Substantial Equivalence: To one or more legally marketed clinical monoplace hyperbaric chambers. | In all respects, the BARA-MED® is substantially equivalent to one or more clinical monoplace hyperbaric chambers. (Section {1}) |
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 medical device submission based on substantial equivalence to existing devices and compliance with engineering standards, not a data-driven AI/ML study. Performance testing indicated "to demonstrate that the device meets the standards referenced above" (Section {2}) would refer to engineering and safety performance, not diagnostic accuracy on a dataset.
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. This is not an AI/ML device study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This is not an AI/ML device study.
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/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable. The "ground truth" in this context is adherence to established engineering and safety standards, and conformity to the intended use and operational principles of legally marketed predicate devices.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/ML 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).