(178 days)
The Medipure Oxygen-LC System is an integrated delivery system intended to provide supplemental oxygen, by Rx only, to neonates, pediatrics, and adults. The device is intended for limited duration use, such as would be necessary during patient transport.
The Medipure Oxygen-LC System is an integrated medical gas delivery system. The Medipure Oxygen-LC System is comprised of the Cavagna MVA2 series oxygen Valve Integrated Pressure Regulator (VIPR) permanently mounted to a large steel cylinder, either K or T size, and protected by a plastic guard. The Medipure Oxygen-LC System is a result of a design modification to the previously cleared Praxair Grab 'n Go Plus System (K132778).
This document describes the Medipure Oxygen-LC System, an integrated medical gas delivery system, and its substantial equivalence to a predicate device (Grab 'n Go Plus System, K132778). The modification involves using a high-strength Cr Mo steel cylinder (K or T size) instead of an aluminum one, and a new plastic shroud.
The information provided focuses on demonstrating substantial equivalence rather than a detailed clinical effectiveness study with acceptance criteria and performance statistics of a novel medical device. The data presented is primarily non-clinical performance data to verify that the design changes do not negatively impact safety and effectiveness compared to the predicate.
Here's an analysis based on the provided text, addressing your points where information is available:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly provide a table of acceptance criteria with specific numerical targets and matching device performance statistics in the way a clinical study evaluating a novel diagnostic or therapeutic device would. Instead, it refers to compliance with established standards and specifications for medical gas delivery systems.
| Test Category | Acceptance Criteria (Implicit from standards) | Reported Device Performance |
|---|---|---|
| Mechanical/Physical | - ISO 11117:2008: "Gas cylinders Valve protection caps and valve guards-Design, construction and tests" (Ensuring valve protection and structural integrity of the plastic guard). |
- 49 CFR §173.301(h)(3) DOT: "Cylinder valve protection" (Ensuring compliance with Department of Transportation regulations for cylinder valve protection). | The device "passed all testing" and is compliant with ISO 11117-2008 and DOT Title 49 CFR Part 173.301(h)(3). |
| Functional/Gas Delivery | - ISO 10524-3: "Pressure regulators for use with medical gases -- Part 3: Pressure regulators integrated with cylinder valves" (Ensuring proper function, pressure regulation, and safety of the integrated valve pressure regulator). - Product specifications of the Medipure Oxygen-LC System (equivalent to the predicate device). | The device "passed all testing". Internal verification and validation testing confirms that product specifications are met and are equivalent to the predicate device. |
| Purity/Safety | - Total Suspended Particulate, Odor and Oxygen Analysis: (Ensuring the delivered oxygen is free from contaminants and meets purity standards). | The device "passed all testing". |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify the number of units or cylinders tested. It refers to "verification testing of the Medipure Oxygen-LC System," implying a device-level testing approach rather than a population-based study.
- Data Provenance: The testing was "Internal verification and validation testing," which indicates it was conducted by the manufacturer (Praxair Distribution, Incorporated).
- Retrospective or Prospective: The testing described is prospective as it was conducted on the newly designed Medipure Oxygen-LC System.
- Country of Origin of the Data: Not explicitly stated, but given the manufacturer's location (Tonawanda, New York, U.S.A.) and the US regulatory context (FDA submission), it's highly likely the testing was conducted in the US or by facilities compliant with US standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This type of information is not applicable to the non-clinical performance and engineering validation tests described. Ground truth for these tests is established by objective measurements against engineering specifications and regulatory standards, not by expert consensus on clinical findings.
4. Adjudication Method for the Test Set
This is not applicable for the engineering and functional tests performed. Adjudication methods are typically used in clinical trials or studies where there are subjective interpretations of data (e.g., medical image reading).
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
No, an MRMC comparative effectiveness study was not done. The device is a medical gas delivery system, not an AI-powered diagnostic or assistive tool for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not Applicable. The device is a physical integrated delivery system, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical performance tests was:
- Compliance with International Standards: ISO 11117:2008, ISO 10524-3.
- Compliance with Federal Regulations: 49 CFR §173.301(h)(3) DOT.
- Internal Product Specifications: The device's design specifications, which are stated to be equivalent to the previously cleared predicate device.
- Objective Measurements: Such as pressure regulation, particulate analysis, odor analysis, and oxygen analysis.
8. The Sample Size for the Training Set
Not Applicable. This is not a machine learning or AI device that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not Applicable. As above, no training set was used.
§ 868.2700 Pressure regulator.
(a)
Identification. A pressure regulator is a device, often called a pressure-reducing valve, that is intended for medical purposes and that is used to convert a medical gas pressure from a high variable pressure to a lower, more constant working pressure. This device includes mechanical oxygen regulators.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.