(305 days)
The Grab 'n Go system is an integrated delivery system intended to provide supplemental oxygen, by Rx only, to neonates, pediatrics, and adults. The device is MR Conditional, and suitable for use during MR imaging for MRI systems up to 3.0 Tesla. The device is intended for limited duration use, such as would be necessary during patient transports.
The Grab 'n Go Plus / Grab 'n Go Digital (collectively referred to as the Grab 'n Go system) integrated delivery system supplies oxygen using a device comprising an integrated valve-regulator with pressure gauge, flow meter and oxygen gas cylinder with protective shroud all integrated into a single unit. The device is able to provide a range of user selectable flow settings, including low and high flows that may be clinically appropriate for certain classes of patients. An additional DISS connection provides standard 50-PSI oxygen gas delivery. The optional digital pressure gauge (Grab 'n Go Digital) provides both audible and visual low contents alerts and alarms as well as estimated time of use. The system must only be used by trained medical personnel.
Here's an analysis of the acceptance criteria and study detailed in the provided 510(k) summary for the Praxair Grab 'n Go Plus / Grab 'n Go Digital device:
The provided document describes a medical gas delivery system, which is generally a mechanical device, not typically an AI/ML-driven software device. Therefore, many of the typical acceptance criteria and study elements associated with AI/ML devices (like sample sizes for test/training sets, expert consensus for ground truth, MRMC studies, or standalone algorithm performance) are not applicable or not explicitly detailed in this submission.
Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (LIV Portable Oxygen System) through non-clinical testing against established industry and international standards, and a single "end-user evaluation."
Let's break down what is available in the document:
1. Table of Acceptance Criteria and Reported Device Performance
The submission primarily focuses on compliance with established safety and performance standards for medical gas regulators and MR-conditional devices, rather than specific numerical acceptance criteria with corresponding performance metrics from a dedicated clinical study as would be seen for a diagnostic AI device.
| Parameter/Criteria | Acceptance Criteria (Implied by Standards Compliance) | Reported Device Performance |
|---|---|---|
| Functional Safety & Performance | Compliance with ISO 13485 (Quality Management), ISO 14971 (Risk Management), IEC 60601-1 (Basic Safety), IEC 60601-1-2 (EMC), IEC 60601-1-8 (Alarm Systems), IEC 60529 (IP Code), IEC 60086-4 (Lithium Batteries), CGA E-18 (Med Gas Valve Regulators), ISO 10524-3 (Pressure Regulators), ISO 9170-1 (Terminal Units), ISO 11117 (Valve Protection), ASTM G175 (Oxygen Regulator Ignition Sensitivity). | The Grab 'n Go system "complies with the following industry and international standards" (listed above). |
| MR-Compatibility | MR-Conditional up to 3.0 Tesla, adhering to ASTM F2052 (Magnetically Induced Displacement), ASTM F2213 (Magnetically Induced Torque), ASTM F2503 (Marking for MR Safety), ASTM F2119 (MR Image Artifacts). | The Grab 'n Go system is "MR-conditional and complies with" the listed ASTM standards, and is "Yes, up to 3.0 T." |
| End-User Usability/Safety (Usability Study) | End-users able to understand the user manual, properly use the device, and understand alarm functionality. Responses from end-users met established acceptance criteria. | "Data shows that responses from end-users met the established acceptance criteria. End users were able to understand the user manual, properly use the device and understand the alarm functionality. Therefore, the Grab 'n Go system met the validation requirements." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The "end-user evaluation" indicates that "end-users" participated, implying a test set of human users interacting with the device. However, the number of users is not mentioned.
- Data Provenance: Not specified. The document does not indicate the country of origin for the end-user evaluation or whether it was retrospective or prospective. Given the nature of a 510(k) submission for a physical device, it's highly likely this was a prospective evaluation conducted by the manufacturer for regulatory purposes.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Not Applicable in the traditional sense for this device. The "ground truth" for this device's performance is adherence to engineering standards and a usability assessment. The "end-user evaluation" described seems to validate user interaction and understanding, rather than a diagnostic accuracy based on expert ground truth. Therefore, the document does not mention experts establishing "ground truth" for the test set.
4. Adjudication Method for the Test Set
- Not Applicable. Since there's no clinical diagnostic "test set" and no expert ground truth establishment, there is no mention of an adjudication method like 2+1 or 3+1. The end-user evaluation likely involved observing user interaction and collecting feedback, then comparing against predetermined usability criteria.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. An MRMC study is relevant for diagnostic imaging devices where human readers interpret cases, and AI assistance might improve their performance. This device is a medical gas delivery system, which does not involve diagnostic interpretation by human readers.
6. Standalone (Algorithm Only) Performance Study
- No. This device is a hardware system; there is no standalone algorithm to evaluate. Its "performance" is assessed through engineering tests (compliance with standards) and a usability evaluation of the integrated system.
7. Type of Ground Truth Used
- For engineering performance: The "ground truth" is defined by the objective pass/fail criteria of the referenced industry and international standards (e.g., pressure output accuracy, leak rates, material compatibility, MR safety thresholds, alarm specifications).
- For end-user evaluation: The "ground truth" relates to predefined usability criteria, such as successfully operating the device, correctly interpreting alarms, and understanding the user manual. This is typically established by device design and human factors engineering principles.
8. Sample Size for the Training Set
- Not Applicable. This is a hardware device; there is no "training set" in the context of machine learning. The design and manufacturing processes are informed by engineering principles, predicate device evaluation, and standards, not data training.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no training set, there is no ground truth established for it.
§ 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.