(15 days)
The Respironics Reusable Contour II Nasal Mask is intended to provide an interface for application of Respironics bi-level or CPAP therapy to patients.
The Reusable Contour II Nasal Mask is intended to provide a single-patient use interface for adult patients (>30 kg) receiving Respironics CPAP or bi-level therapy. It consists of a silicone skincontacting cushion, a polycarbonate faceplate and a polycarbonate elbow (to which 22 mm flexible tubing is attached). The mask elbow swivels 360 degrees relative to the faceplate. The Reusable Contour II Nasal mask has two permanently fixed exhalation ports (vent holes), one on each side of the mask elbow, which eliminate the need for a separate exhalation device. An accessory swivel allows rotation of the flexible tubing about its center axis. Thus the elbow swivels at both the faceplate and the tubing connection. The mask cushion material varies in thickness for better seal and fit. The cushion material is thinnest where the cushion contacts the nose. The faceplate has a streamlined, compact shape to reduce mask volume. The gel forehead spacer is mounted on the mask's forehead extension. Because it distributes force more evenly than the current foam spacer, it allows the patient or caregiver to increase strap tension without jeopardizing patient comfort. The Reusable Contour II Nasal Mask (with an optional headstrap) is available in three sizes to fit a broad range of facial structures.
This document describes the Reusable Contour II Nasal Mask and its comparison to a predicate device for 510(k) clearance. The focus of the provided text is on demonstrating substantial equivalence through design and material changes, rather than a detailed performance study with quantitative acceptance criteria typically associated with new algorithm development or significant device modifications requiring extensive clinical trials.
Therefore, the information regarding acceptance criteria and performance data is limited to what is typically found in a 510(k) submission for minor device modifications, which emphasizes equivalence to an already cleared device.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative "acceptance criteria" in the format of a table with specific numerical targets. Instead, it relies on demonstrating substantial equivalence to a predicate device. The "performance" reported is primarily in terms of maintaining functional and safety characteristics similar to the predicate.
| Acceptance Criteria Category (Implied) | Reported Device Performance |
|---|---|
| Intended Use | Same indicated use as predicate device |
| Operating Principle | Same operating principle as predicate device |
| Skin-Contacting Materials | Same skin-contacting mask cushion materials as predicate device |
| Technology | Same technology as predicate device |
| Manufacturing Process | Same manufacturing process as predicate device |
| Compliance to Standards | Complies with applicable standards referenced in "Draft FDA Reviewer Guidance for Premarket Notifications," November 1993. |
| Functionality (Design Changes) | Modified mask incorporates: |
- Permanently fixed exhalation ports.
- Accessory swivel for tubing rotation.
- Varied cushion thickness for better seal and fit.
- Streamlined, compact faceplate.
- Gel forehead spacer (replaces foam) for more even force distribution and improved comfort. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a numerical sample size for any testing, nor does it provide details on the data provenance (country of origin, retrospective/prospective). The statement is "Verification testing has shown the modified mask has the following similarities..." which indicates internal testing was performed, but no specifics are given.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This type of information is not relevant or provided for this 510(k) submission. "Ground truth" and expert adjudication are concepts typically associated with diagnostic algorithms or imaging evaluations, which are not the subject of this device (a nasal mask). The assessment here is based on engineering verification and comparison to an established predicate.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for this type of device submission. Adjudication methods are used in studies where subjective interpretation or classification by multiple experts is required to establish ground truth for a diagnostic or AI system.
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. An MRMC study is used to evaluate the performance of diagnostic imaging devices or AI algorithms often with human readers. This submission is for a medical device (a nasal mask) where such a study design is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical mask, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The concept of "ground truth" as typically applied to diagnostic studies is not directly applicable here. For this nasal mask, the "truth" or benchmark for demonstrating substantial equivalence is the performance and safety profile of the predicate device. Testing would have focused on engineering specifications, biocompatibility, fit, seal, and exhalation port performance to ensure they meet requirements similar to the predicate and applicable standards.
8. The sample size for the training set
Not applicable. There is no "training set" as this device is not an AI/ML algorithm.
9. How the ground truth for the training set was established
Not applicable. As there is no training set, there is no ground truth establishment for it.
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).