(123 days)
The conditions listed as appropriate for the use of the Hyperbaric Oxygen Therapy in the current edition of Undersea and Hyperbaric Medical Society (UHMS) 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 .
- . Ostcomvelitis (refractory)
- Delayed radiation injury (soft tissue and bony necrosis) .
- Skin grafts and flaps (compromised) .
- Thermal burns .
- Intracranial abscess .
The system body is a hermetic cylindrical chamber, which consists of a welded hermetic shell and a quick-to-open cover, made of the AMg6 -ASME Code Case 2403 aluminum alloy. The cover lock ring is made of the SB-211 A 92024 material. The hyperbaric oxygen chamber is installed on a base, which is made of carbon steel, with four wheel castors attached to the base bottom. It can be moved within a treatment room if necessary. A control panel is located atop of on the pressure chamber, actuating pneumatic aggregates of the pressure system pneumatic system which are located under the chamber body. A patient's ingress/egress is performed by means of a retractable chamber bed that is wheeled out of the pressure chamber on a portable gurney, which is attached to the chamber at the time the patient is placed in and out of the chamber. The pressure system overall dimensions BI.KS-307-"Khrunichev" without the gurney: length - 100 in, width - 48 in, height - 70.9 in. The pressure system total weight BLKS-307-"Khrunichev" - 1102 lbs. Chamber pressure control is achieved by means of knobs and tumbler switches of a pneumatic control panel located atop of the chamber. Both the rates of pressurization and depressurization are variable to provide patient's comfort while in confined space and with regards to his/her individual tolerance to pressure rate change. The panel is equipped with an emergency decompression push button, which enables fast treatment session termination and egress of a patient in case of an emergency situation. If pressure inside the chamber exceeds maximal operating level of 43.5 PSI, two pressure-relief valves installed on the pressure chamber shell will open. This provides for the patient and personnel safety and prevents the chamber structure damage. In order to exclude possible electric spark formation in an oxygen atmosphere in case of transition of an accumulated electrostatic potential from a patient to the chamber shell, an antistatic bracelet is provided. The bracelet is put on a patient hand or foot. The system is equipped with a grounding cable, which is connected to the treatment room grounding system.
The provided text describes a 510(k) premarket notification for a medical device, the BLKS-307 MONOPLACE HYPERBARIC OXYGEN TREATMENT SYSTEM. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting new, independent clinical trials with formal acceptance criteria for device performance. Therefore, many of the requested categories (such as sample size for test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details) are not applicable to this type of regulatory submission.
The "acceptance criteria" here are essentially the comparison points and their values that demonstrate the new device is as safe and effective as the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in the traditional sense of a clinical study. Instead, it presents a comparison table showing that the BLKS-307's performance characteristics are either similar to or improved upon the predicate device (BLKS-303MK), thus demonstrating substantial equivalence. The "acceptance criteria" are implied to be that the new device's parameters are within a clinically acceptable range or at least as good as the predicate.
| Parameters | Units | Acceptance Criteria (Predicate: Khrunichev BLKS-303MK K011312) | Reported Device Performance (Khrunichev BLKS-307) |
|---|---|---|---|
| Internal Diameter | In (mm) | 28.7 (730) | 42.1 (1080) |
| Length | In (mm) | 93.7 (2380) | 90.4 (2300) |
| Internal Volume | Ft3 (m3) | 26.9 (0.95) | 56.5 (1.6) |
| Weight | Lbs (kg) | 770 (320) | 1102 (500) |
| Operating Pressure | ATA (Bar) | 1 - 4 | 1 - 4 |
| Compression / Decompression Rate | ATA/min (Bar/min) | 0.05 - 0.25 | 0.05 - 0.25 |
| Emergency Decompression Time from 4 to 1 ATA | Sec | 60 | 90 |
| Maximum Oxygen Consumption - Isopression (constant pressure) and decompression | l/min | 50 | 52.5 |
| Maximum Oxygen Consumption - Blowing and compression | l/min | 400 | 400 |
| Maximum Oxygen Consumption - One hour treatment | l (m3) | 6000 (6) | 9000 (9) |
| Lifetime | One-hour treatment sessions | 10,000 | 10,000 |
| Control System | Pneumatic | Pneumatic | |
| Chamber Type | Monoplace | Monoplace | |
| Electronic Patient Vitals and Environment Parameters Indication | Optional | Standard | |
| Chamber Door Lock | Manual | Pneumatic | |
| Material | Aluminum alloy/acrylic glass | Aluminum alloy/acrylic glass | |
| Intercom Device | Standard | Standard | |
| Built-In-Breathing System | Optional | Optional | |
| Standards and Regulatory Documents Compliant to | FDA 510(k), ASME, PVHO, NFPA 99, ISO 9001, ISO 13485, TUV, National Pressure Vessels Code, National Ministry of Healthcare Certificate, National Fire Protection Code | ASME, PVHO, NFPA 99, ISO 9001, ISO 13485, TUV, National Pressure Vessels Code, National Ministry of Healthcare Certificate, National Fire Protection Code |
Study Proving Acceptance Criteria (Substantial Equivalence):
The study proving the device meets the acceptance criteria (i.e., is substantially equivalent) is presented as a comparison between the new device (BLKS-307) and its predicate (BLKS-303MK). The document states: "The results of bench and clinical testing indicates that the new device is as safe and effective as the predicate device." and "After analyzing both bench and clinical testing data, it is the conclusion of Khrunichev State Research and Production Space Centre that the BLKS-307 MONOPLACE HYPERBARIC OXYGEN TREATMENT SYSTEM is as safe and effective as the predicate device, and has few technological differences, thus it substantially equivalent to the predicate device."
This is a comparative study against the specifications and performance of an already legally marketed device, not an independent clinical trial with defined "acceptance criteria" for a new, unproven technology.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable. This is a 510(k) submission based on substantial equivalence, primarily using a comparison of device specifications and "bench and clinical testing" results against a predicate device. There is no mention of a specific patient "test set" in the context of typical clinical trial methodology (e.g., a cohort of patients receiving treatment and being evaluated against an outcome). The "clinical testing" mentioned is likely in the context of device performance in a clinical setting rather than a formal human trial with a defined sample size for efficacy or safety endpoints.
- Data Provenance: The manufacturer is Khrunichev State Research and Production Space Centre, located in Moscow. The precise origin of the "bench and clinical testing data" is not specified beyond this. It's not explicitly stated if it was retrospective or prospective, but given the nature of a 510(k) for a known technology, it's likely a combination of existing data, design validation, and performance testing rather than a new prospective clinical trial.
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 as typically understood for diagnostic or AI devices is not relevant here. The evaluation is based on device specifications and performance characteristics compared to a predicate, and compliance with established standards (ASME, PVHO, NFPA 99, ISO 9001, ISO 13485, TUV, National Pressure Vessels Code, National Ministry of Healthcare Certificate, National Fire Protection Code).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no "test set" in the sense of patient data requiring expert adjudication.
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/diagnostic device. It is a monoplace hyperbaric oxygen treatment system.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI/diagnostic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable in the conventional sense. The "ground truth" for this submission is the established safety and effectiveness profile of the predicate device and the hyperbaric oxygen therapy itself, as codified in standards and the UHMS Hyperbaric Oxygen Therapy Committee Report (1999) for its indications for use. The BLKS-307 demonstrates "substantial equivalence" to this established predicate.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/machine learning 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).