(137 days)
The Equinox Relieve® Nitrous Oxide/Oxygen Analgesic Gas Mixing and Delivery System is indicated for delivering a 50%/ 50% mixture of nitrous oxide and oxygen, on demand, to a conscious, spontaneously breathing patient.
The proposed Equinox Relieve® Nitrous Oxide/Oxygen Analgesic Gas Mixing and Delivery System is a portable pneumatically powered device designed to provide a 50/50% nitrous oxide and oxygen mixture. The device provides two input connection with nitrous oxide and oxygen cylinders through pressure regulators. The device has only one control for turning ON or OFF the device. When it is turned ON, the output of N20/02 gas mixture will only be activated by an inspiratory effort by the patient. The out put of N20/O2 gas mixture is pre-set at 50/50%. Neither the patient nor medical personnel are able to adjust, eliminating the risk of delivering a hypoxic mixture. The gas specific built-in alarm system will generate both visual and audible alarms should either nitrous oxide or oxygen input fall below 40 PSI, and the device will automatically shut off should either nitrous oxide or oxygen input fall below 35 PSL. The device is also equipped with a secondary "fail safe" circuit that will activate an alarm and shut off the device should internal malfunction occur in the mixer or any internal hoses rupture or kink. The main accessories for the proposed device are a disposable Patient Circuit and a universal Face Mask.
The provided text is a 510(k) Premarket Notification summary for the Equinox Relieve® Nitrous Oxide/Oxygen Analgesic Gas Mixing and Delivery System. It is a regulatory document and does not contain details about a study to prove acceptance criteria or device performance in the way typically associated with AI/ML devices.
The document primarily focuses on establishing "substantial equivalence" to predicate devices, which is a common regulatory pathway for medical devices. This involves demonstrating that the new device is as safe and effective as a legally marketed device.
Therefore, many of the requested sections (sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, training set details) are not applicable to this type of regulatory submission and are not present in the provided text.
However, I can extract the acceptance criteria as implied by the substantial equivalence comparison and the device's reported characteristics.
Here's the information that can be extracted from the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
For a device like the Equinox Relieve®, "acceptance criteria" are generally derived from the specifications and performance of legally marketed predicate devices, along with relevant safety standards. The "reported device performance" is the device's design specifications and claimed capabilities that are compared to these in the context of substantial equivalence.
| Characteristic | Acceptance Criteria (Implied from Predicates) | Reported Device Performance (Equinox Relieve®) |
|---|---|---|
| Intended Use | Provide 50/50% N2O/O2 mixture, on demand, to a conscious, spontaneously breathing patient for the relief of pain. | Provide 50/50% N2O/O2 mixture, on demand, to a conscious, spontaneously breathing patient for the relief of pain. |
| Environments of Use | Emergency settings (Predicate K883833) / Pre-hospital and in-hospital environment (Predicate K991195) | Pre-hospital use and in-hospital environment (ER, Labor and Delivery etc.) |
| Patient Population | Spontaneous breathing patients requiring pain relief (Predicate K883833) / Spontaneous breathing patients (Predicate K991195) | Spontaneous breathing patients requiring relief from moderate to severe pain due to trauma, childbirth etc. |
| Operating Principles | Pneumatic, demand flow system. | Pneumatic, demand flow system. |
| Input Gas | O2 and N2O (Predicate K883833) / O2 (Predicate K991195 - Note: Predicate K991195 is for ventilatory support, not N2O mixing) | O2 and N2O. |
| Input Pressure | 40 - 65 PSI (Predicate K883833) / 45 to 70 PSI (Predicate K991195) | 50 to 70 PSI. |
| Built-in Mixer | Yes (Predicate K883833) | Yes. |
| Output Mixture Concentration | Preset 50/50% (V/V) N2O /O2 (Predicate K883833) | Preset 50/50% (V/V) N2O /O2. |
| Displays (Alarms) | Low input visual alarms for both O2 and N2O gases / O2 and N2O Mixture pressure gauge (Predicate K883833) | Low input visual alarms for both O2 and N2O gases (O2 and N2O). |
| Safety Features | Preset 50/50% N2O /O2; Activated only by patient inspiratory effort; CGA connection to prevent misconnection of gas supply; Audible alarm; Oxygen Fail Safe: Shut off mixer output if O2 pressure drops. (Predicate K883833) | Preset 50/50% N2O /O2; Activated only by patient inspiratory effort; CGA connection to prevent misconnection of gas supply; Audible & visual alarms; Oxygen Fail Safe: Shut off mixer output if O2 pressure drops; Input Gas Fail Safe: Shut off the device if supply of either N2O or O2 dropped below 35 PSI. |
| Alarms | Audible alarm triggered if N2O supply is depleted (Predicate K883833) / Audible/Visual (Green) alarms if O2 supply is below 40 PSI (Predicate K991195) | Audible/Visual (Red indicator) alarms if N2O input is below 40 PSI; Audible/Visual (Green indicator) alarms if O2 input is below 40 PSI; Audible alarm if device is shut off due to low O2 output. |
| Patient Support Mode | Demand valve. | Demand valve. |
| Demand Valve Function | Realized by extended handheld supply valve (Predicate K883833) / Built-in (Predicate K991195) | Built-in. |
| Peak Flow on Demand (L/min) | 140 (Predicate K883833) / 120 minimum (Predicate K991195) | 120 minimum. |
| Materials in Gas Pathway | Compatible with O2 & N2O (Implied from K883833) | Compatible with O2 & N2O. |
Study Proving Acceptance Criteria:
The document describes a "comparative table" which is the primary evidence used to demonstrate substantial equivalence, rather than a stand-alone clinical study with explicit acceptance criteria and statistical analysis. The "study" here is essentially the comparison of the proposed device's specifications and features against those of the predicate devices. The conclusion presented is: "There are no significant differences that affect the safety or effectiveness of the intended device as compared to the predicate devices."
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not applicable. This is not a study involving patient data or a test set in the conventional sense. The "test set" is the proposed device's design specifications.
- Data Provenance: Not applicable.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- Not applicable. The ground truth, in the context of substantial equivalence, is established by the performance and safety characteristics of the legally marketed predicate devices, which have already undergone regulatory review. There is no mention of external experts establishing a ground truth for a test set for this 510(k) submission.
4. Adjudication Method for the Test Set:
- Not applicable. No adjudication process is described for a test set. The FDA's review process serves as the adjudication for the substantial equivalence claim.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No, an MRMC comparative effectiveness study was not done. This type of study is common for diagnostic imaging AI, but not for a physical device like a gas mixing and delivery system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Not applicable. This device is a physical medical device, not an algorithm. Its operation is standalone in the sense that it functions automatically based on patient inspiratory effort, but this isn't analogous to "standalone algorithm performance" as typically discussed in AI/ML medical devices.
7. The Type of Ground Truth Used:
- The "ground truth" for this submission is implicitly the established safety and effectiveness of the legally marketed predicate devices (Nitronox® K883833 and CAREvent ALS+ K991195). The substantial equivalence pathway relies on demonstrating that the new device is "as safe and effective" as these known devices, based on their design, indications, and performance characteristics.
8. The Sample Size for the Training Set:
- Not applicable. This is not an AI/ML device that uses a training set.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. This is not an AI/ML 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).