(162 days)
The LIV is an integrated portable oxygen delivery system intended to provide supplemental oxygen to pediatrics and adults. The device is MR-conditional (per ASTM standard 2503-05), 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 rah Uized or otherwise secured to prevent falling and rolling.
The Linde Integrated Valve™ ("LIV") is a portable oxyqen delivery system, consisting of a fully integrated cylinder, valve, requlator, flow meter, and shock-absorbing quard. A range of user-selectable flow settings is available, including low flows that may be clinically appropriate for certain classes of patients. An additional DISS-1240 connection provides standard 50psig oxygen delivery, while an optional bed hanger allows the LIV to be readily attached to a bed. The LIV is suitable for use in all healthcare settings, including, but not limited to, hospital, outpatient, imaging center, ambulatory, and home healthcare.
The Linde Integrated Valve (LIV) is a portable oxygen delivery system. The provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with detailed acceptance criteria and performance metrics in the way one might for a novel AI/software device.
Here's the breakdown based on the provided information, addressing your points where possible:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary for the LIV primarily relies on demonstrating substantial equivalence to a predicate device (MEDICYL-E-Lite K033897) rather than setting specific quantitative acceptance criteria for novel performance, as one would for an AI/software device. The "acceptance criteria" here are implicitly met by showing the device's technical characteristics are substantially similar and that it conforms to relevant standards.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Technological Characteristics Substantially Similar to Predicate Device (K033897) | The LIV shares key features with the MEDICYL-E-Lite, including: |
- Flowrate Selector and Flow Outlet (yes)
- Cylinder On/Off (yes)
- Filling Port (active; w/ non-return valve)
- Excess Flow Device (yes)
- Residual Pressure Valve (yes)
- Burst Disk (yes)
- Single stage piston style (yes)
- Guard (2 grip, Access Ports, green color)
- Cylinder Sizes (D, E)
- Materials/construction (Aluminum)
- MRI Compatibility (yes; tested up to 3.0T) |
| Compliance with 21CFR49 § 178.46 | Aluminum cylinders conform to the requirements of 21CFR49 § 178.46, Specification SAL seamless aluminum cylinders. |
| MRI Compatibility (ASTM standard 2503-05 and CDRH document) | 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.
MR-conditional (per ASTM standard 2503-05). Intended for use during MR imaging for MRI systems up to 3.0T. |
| Safety and Effectiveness (Implicit) | The manufacturer believes that the LIV is substantially equivalent to the predicate device and "does not raise any new questions of safety or effectiveness" based on safety and performance testing and compliance with voluntary standards. |
| Intended Use Alignment with Predicate | Both devices are portable oxygen delivery systems. The LIV's indications for use: "integrated portable oxygen delivery system intended to provide supplemental oxygen to pediatrics and adults. The device is MR-conditional (per ASTM standard 2503-05), 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." |
| Additional Features (no new safety/effectiveness concerns) | The LIV includes features not in the predicate: Pressure Outlet (yes) and Contents Gauge (active), which are implicitly deemed not to raise new safety or effectiveness concerns. |
2. Sample Size Used for the Test Set and Data Provenance
This is not applicable in the context of this 510(k) summary. This document does not describe a "test set" or data provenance in the way one would for a clinical study comparing AI performance against ground truth. The evaluation is primarily based on engineering design, materials, and compliance with standards, along with a comparison of technological characteristics to a predicate device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is a medical device (hardware) submission, not an AI/software device submission requiring expert-established ground truth for a test set.
4. Adjudication Method for the Test Set
Not applicable for the same reasons as above.
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. The LIV is a hardware device for oxygen delivery, 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. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. The "ground truth" for this type of device submission revolves around engineering specifications, material properties, and functionality meeting established standards and being comparable to a legally marketed predicate device.
8. The sample size for the training set
Not applicable. No AI/machine learning training set is involved.
9. How the ground truth for the training set was established
Not applicable. No AI/machine learning training set is involved.
In summary:
The provided document is a 510(k) summary for a physical medical device (an oxygen delivery system). It demonstrates the device's safety and effectiveness by establishing substantial equivalence to an already legally marketed predicate device, rather than through a standalone performance study with clinical endpoints or AI-specific validation metrics. The "study" implicitly referenced is the "safety and performance testing and compliance with voluntary standards" conducted by the manufacturer, which is deemed sufficient to demonstrate this equivalence. The "acceptance criteria" are met by matching or exceeding the predicate's characteristics and complying with relevant engineering and safety standards.
§ 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.