(216 days)
The MEDICYL-E-Lite is an integrated portable oxygen delivery system intended to provide supplemental oxygen to adults. The device is MRI safe, MRIcompatible, and intended for use during MR imaging for MRI systems up to 3.0T.
For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical applications, Rx only. Compressed gas cylinders in service or in storage shall be stabilized or otherwise secured to prevent falling and rolling.
The MEDICYL-E-Lite is an integrated portable oxygen delivery system intended to provide supplemental oxygen to adults. The device is MRI safe, MRI-compatible, and intended for use during MR imaging for MRI systems up to 3.0T. For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical applications, Rx only. Compressed gas cylinders in service or in storage shall be stabilized or otherwise secured to prevent falling and rolling.
The intearated system includes an aluminum cylinder, valve, requlator and flow meter. The device offers low flow settings that may be clinically appropriate for certain classes of patients.
This document describes a 510(k) submission for the AGA Linde Healthcare MEDICYL-E-Lite Portable Oxygen Delivery System. This is a medical device, and the information provided is for regulatory clearance based on substantial equivalence to predicate devices, rather than a study proving the device meets specific performance criteria in the way an AI/ML device would be assessed.
Therefore, many of the requested categories for AI/ML device performance studies are not directly applicable to this document. I will extract the information that is present and explain why other sections are not covered.
1. Table of acceptance criteria and the reported device performance
For a medical device like the MEDICYL-E-Lite, "acceptance criteria" are typically related to meeting regulatory standards, safety requirements, and functional specifications, often demonstrated through testing and comparison to predicate devices. The document focuses on showing substantial equivalence and compliance with relevant regulations.
| Parameter | Acceptance Criteria (Predicate) | Reported Device Performance (MEDICYL-E-Lite MRI) |
|---|---|---|
| Valve/Regulator | ||
| Low Flow Settings | Yes (MEDICYL-E-Lite) / No (Praxair Grab n' Go) | Yes |
| Flow Between Settings | No (MEDICYL-E-Lite & Praxair Grab n' Go) | No |
| Cylinder On/Off | Yes (MEDICYL-E-Lite) / No (Praxair Grab n' Go) | Yes |
| Filling Port | Active (MEDICYL-E-Lite & Praxair Grab n' Go) | Active |
| Contents Gauge | Non-active (MEDICYL-E-Lite) / Active (Praxair Grab n' Go) | Non-active |
| Filters | 3 (MEDICYL-E-Lite) / 1 (Praxair Grab n' Go) | 3 |
| Pressure Design | 4350psi (MEDICYL-E-Lite) / 3000psi (Praxair Grab n' Go) | 4350psi |
| Excess Flow Device | Yes (MEDICYL-E-Lite) / No (Praxair Grab n' Go) | Yes |
| Single stage piston style | Yes (MEDICYL-E-Lite & Praxair Grab n' Go) | Yes |
| Guard | ||
| Hand grip | 2 grip (MEDICYL-E-Lite) / 1 grip (Praxair Grab n' Go) | 2 grip |
| Access Ports | Yes (MEDICYL-E-Lite) / No (Praxair Grab n' Go) | Yes |
| Flow selector/hose barb/gauge aligned | Yes (MEDICYL-E-Lite) / No (Praxair Grab n' Go) | Yes |
| Color | Green (MEDICYL-E-Lite & Praxair Grab n' Go) | Green |
| Height | 6.75" (MEDICYL-E-Lite) / 8" (Praxair Grab n' Go) | 6.75" |
| Cylinder | ||
| Sizes | D, E (MEDICYL-E-Lite) / E (Praxair Grab n' Go) | D, E |
| Weight (E) | 900gr (MEDICYL-E-Lite) / 1060gr (Praxair Grab n' Go) | 900gr |
| Materials/construction | Aluminum (MEDICYL-E-Lite) / Steel (Praxair Grab n' Go) | Aluminum |
| MRI Compatibility | ||
| MRI Safe | No (Predicate MEDICYL-E-Lite & Praxair Grab n' Go) | Yes; tested up to 3.0T |
| MRI Compatible | No (Predicate MEDICYL-E-Lite & Praxair Grab n' Go) | Yes; tested up to 3.0T |
The primary "acceptance criteria" here is substantial similarity to the predicate devices, with the added functionality of MRI compatibility for the "MEDICYL-E-Lite (MRI)" version. The document explicitly states: "The manufacturer believes that the technological characteristics of the MEDICYL-E-Lite portable oxygen system is substantially similar to those of the predicate devices."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. For a device like an oxygen delivery system, "test set" would typically refer to the units tested for physical performance and safety. The document mentions "safety and performance testing" and compliance with "voluntary standards" and "21 CFR49 § 178.46, Specification SAL seamless aluminum cylinders." It also states the MRI compatibility was "tested up to 3.0T" and evaluated "in accordance with the draft CDRH Magnetic Resonance Working Group document, A Primer on Medical Device Interactions with Magnetic Resonance Imaging Systems, dated February 7, 1997." However, the sample size of devices tested or the specific provenance of that test data is not detailed.
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 mechanical device, not an AI/ML diagnostic tool requiring expert ground truth for image interpretation or similar. The "truth" here relates to physical specifications and safety standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable for this type of device submission. Adjudication methods are typically used in clinical trials or studies for diagnostic devices where subjective interpretations might differ.
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
This is not applicable. This is a physical medical device, not an AI/ML system, and therefore no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as this is a physical medical device, not an algorithm or AI system.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this device is based on engineering specifications, regulatory compliance, performance testing results against predefined standards, and demonstration of substantial equivalence to legally marketed predicate devices. For example:
- Physical dimensions and materials: Measured against design specifications.
- Pressure design: Tested to meet the stated psi.
- Flow settings: Verified to operate as specified.
- MRI compatibility: Tested against established protocols outlined in the CDRH Magnetic Resonance Working Group document.
- Cylinder specifications: Conformity to "21 CFR49 § 178.46, Specification SAL seamless aluminum cylinders."
8. The sample size for the training set
This is not applicable. There is no AI/ML model for which a "training set" would be used for this device.
9. How the ground truth for the training set was established
This is not applicable as there is no AI/ML model and therefore no "training set."
§ 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.