(331 days)
The Equinox® Advantage Nitrous Oxide/Oxygen Analgesic Gas Mixing and Delivery System is indicated for administering an adjustable mixture of Nitrous Oxide analgesic gas and Oxygen, on demand, to a conscious, spontaneously breathing patient.
Equinox® Advantage Nitrous Oxide/Oxygen Analgesic Gas Mixing and Delivery System is a portable pneumatically powered device intended to administer an adjustable mixture of Nitrous Oxide analgesic gas and Oxygen mixture to provide pain relief, on demand, to a conscious, spontaneously breathing, patient.
The device provides two input connection with nitrous oxide and oxygen cylinders through pressure regulators. The device has a control knob for turning ON or OFF the device. When it is turned ON, the output of N2O/O2 gas mixture will only be administered by an inspiratory effort by the patient.
A selection knob is used to select desired N20/02 gas mixture. The adjustable range is from 25% O2 (NJO 75%) to 100% O2 (N3O 0%), with the minimum of 25% oxygen output to eliminate the possibility of delivering a hypoxic mixture.
The Oxygen Enrichment Function is designed to provide 30 L/min of 100% oxygen in order to flush any residual gas from the patient circuit following the completion of the patient treatment.
The built-in pneumatically powered alarm system will generate both visual and audible alarms should either nitrous oxide or oxygen input fall below 40 PSI, and the device will be automatically shut off should oxygen input falls below 35 PSI.
The main accessories for the proposed device are a disposable Patient Circuit and a Mouth Piece or a universal Face Mask.
The provided text describes the regulatory clearance of a medical device, the Equinox® Advantage Nitrous Oxide/Oxygen Analgesic Gas Mixing and Delivery System, and its substantial equivalence to a predicate device, the Equinox® Relieve (K113687). However, the document does not contain the typical comprehensive study report details that would allow for a complete answer to all parts of your request. This document is a 510(k) Summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a de novo clinical trial.
Here's an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" in the format typically seen for algorithm performance (e.g., specific sensitivity, specificity, or AUC thresholds). Instead, it relies on demonstrating equivalence to a predicate device and adherence to relevant standards. The "performance" reported is primarily comparative.
| Characteristic / Test | Acceptance Criteria (Implied by Predicate Equivalence & Standards) | Reported Device Performance (Equinox® Advantage) |
|---|---|---|
| Intended Use | Administer adjustable N2O/O2, on demand, to a conscious, spontaneously breathing patient (comparable to predicate's 50/50% N2O/O2, on demand, to a conscious, spontaneously breathing patient) | Administers adjustable mixture of N2O/O2, on demand, to a conscious, spontaneously breathing patient. (Meets) |
| Environments of Use | Pre-hospital and in-hospital use (equivalent to predicate) | Pre-hospital and in-hospital environment. (Meets) |
| Patient Population | Conscious, spontaneous breathing patients requiring pain relief (equivalent to predicate) | Conscious, spontaneous breathing patients requiring pain relief. (Meets) |
| Contra-Indications | Same as predicate | Same as predicate. (Meets) |
| Gas input and regulating | 50-70 PSI Oxygen and Nitrous Oxide regulated by internal regulators (equivalent to predicate) | 50-70 PSI Oxygen and Nitrous Oxide regulated by internal regulators. (Meets) |
| Gas mixing | Oxygen and Nitrous Oxide equalized and mixed (predicate was 1:1 ratio, proposed is variable ratios) | Oxygen and Nitrous Oxide equalized and mixed at variable ratios. (Meets, with modification) |
| Gas delivery | Proportional to patient's demand (equivalent to predicate) | Proportional to patient's demand. (Meets) |
| Monitoring and alarms | Audible/Visual alarms activated if N2O or O2 input below 40 PSI (equivalent to predicate) | Audible/Visual alarms activated if N2O or O2 input below 40 PSI. (Meets) |
| Safety features (O2 supply failure) | Protection circuit shuts off device in event of O2 supply failure (equivalent to predicate) | Protection circuit shuts off the device in the event of O2 supply failure. (Meets) |
| Safety features (N2O supply failure) | Predicate: Shuts off device. Proposed: Continues with higher O2 output / 100% O2 if no N2O input, as per ISO 11195:1995 Sec.12.4. | Continues to operate with higher oxygen output; delivers 100% oxygen if no N2O input. (Meets ISO 11195:1995 Sec.12.4) |
| Input pressure | 50 to 70 PSI (equivalent to predicate) | 50 to 70 PSI. (Meets) |
| Output mixture concentration | Predicate: Preset 50/50% (V/V) O2 / N2O. Proposed: Adjustable 25%-100% Oxygen. | Adjustable Oxygen: 25%-100%. (Meets, with new feature) |
| Oxygen Enrichment | Not available on predicate. Proposed: 30 L/min oxygen. | 30 L/min oxygen. (New feature, meets ISO 80601-2-13:2011 Sec. 201.101.8) |
| Output failure shutoff | Predicate: Shut off if O2 much lower than N2O. Proposed: Removed function; minimum 25% oxygen setting prevents hypoxic mixture. | "Output failure shutoff" function removed; minimum 25% oxygen setting prevents delivering a hypoxic mixture. (Meets ISO 11195:1995 Sec.11.1) |
| Inspiratory Resistance | Equivalent to predicate | Equivalent to predicate. (Meets) |
| Expiratory Resistance | Equivalent to predicate | Equivalent to predicate. (Meets) |
| Volume-time waveforms | Equivalent to predicate | Equivalent to predicate. (Meets) |
| Pressure-time waveforms | Equivalent to predicate | Equivalent to predicate. (Meets) |
| Flow-time waveforms | Equivalent to predicate | Equivalent to predicate. (Meets) |
| "Low Oxygen supply" alarm characteristics | Equivalent to predicate | Equivalent to predicate. (Meets) |
| "Low Nitrous Oxide supply" alarm characteristics | Equivalent to predicate | Equivalent to predicate. (Meets) |
| "Oxygen Failure Shutoff" characteristic | Equivalent to predicate | Equivalent to predicate. (Meets) |
| Oxygen concentration (at 50% setting) | Equivalent to predicate (when predicate is 50%) | Equivalent to predicate. (Meets) |
| Nitrous Oxide concentration (at 50% setting) | Equivalent to predicate (when predicate is 50%) | Equivalent to predicate. (Meets) |
| Electrical Safety & Essential Performance | Compliance with ISO 11195 and other applicable standards | Bench testing performed as per ISO 11195 and other applicable standards. (Meets) |
2. Sample size used for the test set and the data provenance
The document describes "comparative performance testing" and "bench testing." These are laboratory-based tests comparing the proposed device against the predicate and against standards. It does not involve human subjects or patient data in the sense of a clinical trial. Therefore, specific "sample sizes" of a test set derived from patient data are not applicable here.
- Sample size for test set: Not applicable (bench testing, not patient data).
- Data provenance: Bench testing results, comparing the proposed device to the predicate device and relevant international standards (e.g., ISO 11195, ISO 80601-2-13). The country of origin for the test data is not specified but is presumably where the manufacturing and R&D for O-Two Medical Technologies Inc. takes place (Canada, as per the address). The testing is prospective for the purpose of demonstrating equivalence for the new device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided. For bench testing, ground truth is established by objective measurements against known physical and chemical standards and the specifications of the predicate device. Experts in this context would likely be engineers and testers.
4. Adjudication method for the test set
Not applicable. The testing described is objective, physical measurement and comparison, not expert adjudication of a diagnostic outcome.
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. This device is a medical gas mixing and delivery system, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to an algorithm's performance without human intervention. This concept is not applicable to a physical gas mixing and delivery system. Its "performance" is inherent in its mechanical and pneumatic operation.
7. The type of ground truth used
For the aspects involving comparison to the predicate device, the "ground truth" for equivalence was the performance and specifications of the legally marketed predicate device (Equinox® Relieve/K113687). For aspects related to safety and functionality specifications, the ground truth was defined by international standards such as ISO 11195:1995 and ISO 80601-2-13:2011.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
§ 868.5330 Breathing gas mixer.
(a)
Identification. A breathing gas mixer is a device intended for use in conjunction with a respiratory support apparatus to control the mixing of gases that are to be breathed by a patient.(b)
Classification. Class II (performance standards).