(237 days)
The Rollins 7 Oxygen Mask is placed over the nose and mouth to administer oxygen and aerosol therapy via nebulizer only. The Rollins7 Oxygen Mask is for adult use only.
The Rollins 7 Oxygen Mask consists of the following features: 1) mask, 2) strap holes, 3) swivel, 4) oxygen inlet, 5)oxygen inlet cap, 6) oxygen outlet diverter, 7) adapter body, 8) fenestration opening slits on both sides of the mask, 9) opening at the chin area, 10) MDI (metered dose inhaler) port hole inlet and insert locks in place, 11) adapter inlet bottom cap, 12) nebulizer inlet, 13) oxygen tubing, 14) oxygen mask inlet for connecting the adapter, and 15) design nipples (left and right) 16) oxygen tubing with one end universal connector and the other end standard oxygen connector 17) oxygen flow rate to FiO2 label attached to universal connector end.
The Rollins 7 Oxygen Mask is a Class II medical device intended for administering oxygen and aerosol therapy via a nebulizer to adults. The device has been deemed substantially equivalent to the predicate device, Neb-U-Mask® (K080230), manufactured by Teleflex Medical, Inc. The evaluation did not involve human intervention in the device's performance, as no clinical tests were conducted.
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Similar FIO2 delivery at various flow rates | Rollins7 Oxygen Mask delivers similar FIO2 at all settings. |
| Similar respirable particle dose delivery | Rollins7 Oxygen Mask had similar delivery of respirable particle dose compared to the predicate device for several highly used respiratory drugs. |
| Compliance with ISO 10993-5 (Cytotoxicity) | Demonstrated compliance with ISO 10993-5 Cytotoxicity Test Agar Diffusion. |
2. Sample Size and Data Provenance
The study involved non-clinical testing only. There is no information regarding sample sizes for the test set or training set related to "data" in the context of human data.
The studies were conducted on the device itself and compared its performance to the predicate device.
3. Number of Experts and their Qualifications
Not applicable. No experts were used to establish ground truth for a test set, as no clinical studies were performed.
4. Adjudication Method
Not applicable. No adjudication method was used, as no clinical studies were performed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was conducted, as the evaluation relied solely on non-clinical performance and comparative technical characteristics. There is no information on human readers or AI assistance.
6. Standalone Performance Study
Yes, a standalone performance study was done in the sense that the device's performance was evaluated independently through non-clinical laboratory testing. The device's ability to deliver oxygen and aerosol was assessed in a controlled environment without human interaction.
7. Type of Ground Truth Used
The ground truth used was established through objective laboratory measurements and comparisons to the predicate device's established performance.
- FIO2 Delivery: Measurements of fractional inspired oxygen (FIO2) at various flow rates were compared against the predicate device.
- Respirable Particle Dose Delivery: Cascade impactor studies were performed to measure and compare the respirable particle dose of common respiratory drugs aerosolized through the device versus the predicate device.
- Biocompatibility: Compliance with ISO 10993-5 (Cytotoxicity) was assessed.
8. Sample Size for the Training Set
Not applicable. This device is a physical medical device, and the evaluation was based on non-clinical performance testing. No machine learning or AI models were used, thus no training set was involved.
9. How the Ground Truth for the Training Set was Established
Not applicable, as no training set was used.
§ 868.5630 Nebulizer.
(a)
Identification. A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.(b)
Classification. Class II (performance standards).