(33 days)
The BMOS is intended to be used by emergency response personnel in military and commercial fields to provide an emergency source of supplemental oxygen for one patient while being transported from a crisis situation to a health care facility. The BMOS is not intended to be a life sustaining or a life-supporting device.
The BMOS is a portable thermally insulated container that provides, when filled with liquid oxygen (LOX), an uninterrupted supply of supplemental oxygen gas to be inhaled by the patient. BMOS is operated by trained emergency response to administer patients with variable amounts of gaseous oxygen in doses measured in liters per minute (LPM).
This document (K071581) is a 510(k) premarket notification for a medical device called the "Backpack Medical Oxygen System (BMOS)". It aims to demonstrate substantial equivalence to a predicate device, not to prove specific clinical performance criteria for diagnosis or treatment. Therefore, many of the requested categories for AI/clinical studies are not applicable.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Bench/Engineering Specifications) | Reported Device Performance (Summary from Submission) | Notes |
|---|---|---|
| Maintain vacuum insulated cryogenic container for LOX storage | Device includes a vacuum insulated cryogenic container designed to store liquid oxygen. | Implied to meet this, as it's a core component. |
| Deliver gaseous oxygen at nominal 50-psi pressure. | Delivers gaseous oxygen at a nominal 50-psi pressure near ambient temperature. | Explicitly stated as met. |
| Operate without external power. | Operates without external power. | Explicitly stated. |
| No emission of ionizing, non-ionizing, sonic, or light radiation. | Neither design emits ionizing, non-ionizing, sonic, or light radiation. | Explicitly stated. |
| No sterilization required. | Unit does not require sterilization. | Explicitly stated. |
| Ability to provide uninterrupted supply of supplemental oxygen. | Provides an uninterrupted supply of supplemental oxygen gas to be inhaled by the patient. | Implied to meet through "capability, performance, and environmental testing". |
| Administer variable amounts of gaseous oxygen in LPM. | Administers patients with variable amounts of gaseous oxygen in doses measured in liters per minute (LPM). | Implied to meet through "capability, performance, and environmental testing". |
| Suitable for emergency response personnel in military and commercial fields. | Intended to be used by emergency response personnel in military and commercial fields. | Addressed by intended use and testing. |
| Safe and effective for intended use. | Extensive capability, performance, and environmental testing have been accomplished on the BMOS with no issues arising regarding its safety and efficacy. | Comprehensive statement of meeting safety and efficacy. |
| Meets specifications. | The combined testing and analysis of results provides assurance that the device meets its specifications. | Comprehensive statement. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The document states "Extensive capability, performance, and environmental testing have been accomplished," but does not provide details on the number of units tested, duration, or specific test configurations.
- Data Provenance: Not specified, but implied to be internal testing conducted by Essex Cryogenics of MO., Inc.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not applicable. This device is a hardware system, and the "ground truth" for its performance is derived from engineering and functional testing against specifications, not from expert interpretation of data like in an AI diagnostic device. The "ground truth" here is whether the device physically performs according to its design and regulatory requirements.
4. Adjudication Method for the Test Set
- Not applicable. See explanation for #3. Adjudication typically refers to resolving disagreements between human readers, which is not relevant for physical device testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. This is not an AI-assisted diagnostic or therapeutic device that requires human-in-the-loop performance evaluation.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Partially applicable, but not for an "algorithm". The "Testing" section describes standalone performance of the device itself against its specifications, but there is no "algorithm" in the context of AI. The device functions purely mechanically/physically.
7. Type of Ground Truth Used
- Engineering and Functional Specifications / Predicate Device Performance. The ground truth for the BMOS's performance is its ability to meet documented engineering specifications (e.g., pressure, flow, capacity) and to demonstrate substantial equivalence to the legally marketed predicate device (NPTLOX) in terms of its operational characteristics and safety/efficacy profile.
8. Sample Size for the Training Set
- Not applicable. This device does not use machine learning or AI models, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable. See explanation for #8.
§ 868.5655 Portable liquid oxygen unit.
(a)
Identification. A portable liquid oxygen unit is a portable, thermally insulated container of liquid oxygen that is intended to supplement gases to be inhaled by a patient, is sometimes accompanied by tubing and an oxygen mask. An empty portable liquid oxygen unit is a device, while the oxygen contained therein is a drug.(b)
Classification. Class II (performance standards).