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510(k) Data Aggregation
(212 days)
The Hard Shell Vented Nasal Mask is intended to provide an interface for application of positive airway pressure therapy, such as CPAP or bi-level.
The mask is intended for:
- Single use, disposable .
- . Single patient, multi-use in the home setting
- . Multi-patient, multi- use in the hospital or institutional settings
- Single patient, short-term use (up to 7 days) in the hospital or institutional settings ●
The masks are to be used on adult patients (>66 lbs. />30 kg) for whom CPAP or bi-level therapy has been prescribed.
The SleepNet Innova Nasal Vented Mask is similar to other CPAP mask. The Innova Nasal Vented mask is nearly identical to our iQ Nasal mask, K102317, except for the following changes:
- Slightly different indications for use, but the predicate is Respironics ComfortGel Blue . Nasal mask, K092835.
- . A range of durations of use for marketing purposes only
- o single use, disposable
- single patient, multi-use up to 7 days o
- single patient, multi-use in home setting o
- o multi-patent, multi-use in institutional settings
- . material for shell, hard vs. soft
- a new exhaust elbow design .
Here's an analysis of the provided 510(k) summary for the SleepNet Innova Nasal Vented Mask, addressing your specific questions:
Device Name: Innova Nasal Vented Mask (also referred to as Hard Shell Vented Nasal Mask)
510(k) Number: K121321
Predicate Device: Respironics ComfortGel Blue Nasal Mask (K092835)
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Innova Nasal Vented Mask are based on demonstrating equivalence or being "well within" the established limits of the predicate device (Respironics ComfortGel Blue Nasal Mask, K092835) or relevant ISO standards.
| Acceptance Criteria / Performance Aspect | Acceptance Criteria | Reported Device Performance (Innova Nasal Vented Mask) | Discussion/Conclusion |
|---|---|---|---|
| CO2 Washout | Per ISO 17510-2: changes in CO2 at various pressures to be < 20% and < 60% from baseline. | 4 cm H2O: 6.0 (15%) 5 cm H2O: 5.9 (14%) 10 cm H2O: 5.8 (11%) Occluded: 6.7 (30%) | "The performance of the proposed device is well within the pass/fail criteria as stated in ISO 17510-2." (The predicate device's measured CO2 washout was: 4 cm H2O: 5.6 (6%), 5 cm H2O: 5.5 (3%), 10 cm H2O: 5.4 (2%), Occluded: 6.3 (19%)) |
| Exhaust Flow (Pressure vs. Flow) | Comparable to the predicate device (no specific pass/fail criteria, reportable values only). | 4 cm H2O: 18.2 lpm 10 cm H2O: 30.4 lpm 20 cm H2O: 43.8 lpm | "The proposed device has equivalent 'Leak or Flow' rate at all pressure vs. the predicate. The differences do not have any clinical significance." (Predicate device: 4 cm H2O: 17.3 lpm, 10 cm H2O: 27.0 lpm, 20 cm H2O: 38.7 lpm) |
| Pressure Drop (Resistance to Flow) | Equivalent to the predicate device (no specific pass/fail criteria, reportable values only). | 30 lpm: 0.04 cm H2O 50 lpm: 0.16 cm H2O 60 lpm: 0.24 cm H2O 100 lpm: 0.82 cm H2O | "The proposed device is equivalent to the predicate." (Predicate device: 30 lpm: 0.04 cm H2O, 50 lpm: 0.15 cm H2O, 60 lpm: 0.22 cm H2O, 100 lpm: 0.74 cm H2O) |
| Internal Volume / Deadspace | Comparable to the predicate device (no specific pass/fail criteria, reportable values only). "Key performance features for CPAP mask performance." | Small: 82 ml Medium: 100 ml Large: 108 ml | "The proposed device is equivalent and CO2 washout and Pressure vs. Flow are the key performance features for CPAP mask performance. The difference4s are not clinically significant and do not raise any new safety or effectiveness concerns." (Predicate device: Small: 97 ml, Medium: 99 ml, Large: 118 ml) |
| Cleaning Validation | Visual and performance testing post-cleaning found to be similar to pre-cleaning. Meeting performance specifications. | Repeated cleaning performed per recommended instructions. Visual and performance testing post-cleaning confirmed similarity to pre-cleaning. | "The proposed mask can be cleaned as intended and meet its performance specifications." |
| Environmental/Mechanical Testing | Meet performance specifications after conditioning (high/low temperatures, drop test). | Samples subjected to high/low temperatures and a drop test. Met performance specifications after conditioning and cleaning. | "The proposed device met the performance specifications after conditioning and cleaning." |
| Biocompatibility (Materials) | Materials in patient contact are identical to previously cleared predicate devices (Minime K090935 or iQ Nasal K102317). | Gel Bladder, Bladder film, Shell, Elbow assembly, Headgear materials are "Identical" to materials used in Sleepnet MiniMe Pediatric mask (K090935) or Sleepnet iQ Ventilation mask (K102317). | "The materials are identical to the cited predicates." This implies that prior biocompatibility assessments for those predicate devices are leveraged for the Innova mask. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes (number of devices tested) for the performance tests (Exhaust Flow, Pressure Drop, Internal Volume/Deadspace, CO2 Washout, Cleaning validation, Environmental/Mechanical testing). It generally refers to "samples" or "largest size tested" for CO2 washout.
The data provenance is laboratory testing conducted by SleepNet Corporation ("We have performed comparative performance testing..."). There is no mention of country of origin for data or whether it was retrospective or prospective in a clinical sense, as these are physical performance tests of the device rather than clinical data from human subjects.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable to this 510(k) summary. This document describes the testing of a medical device (CPAP mask) for its physical and functional performance characteristics against established engineering standards (e.g., ISO 17510-2) and comparison to a predicate device. It does not involve human expert interpretation of images or diagnostic data where "ground truth" would be established by experts. The "ground truth" here is the measured physical properties and performance against validated methods and a predicate.
4. Adjudication Method for the Test Set
Not applicable for the same reasons as #3. Adjudication methods like 2+1 or 3+1 are used in studies where human readers are making subjective judgments (e.g., classifying medical images), and a consensus is needed to establish ground truth. The tests described are objective, quantitative measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This 510(k) pertains to a physical medical device (a CPAP mask), not an AI algorithm or a diagnostic tool that would typically involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
No, a standalone (algorithm only) performance study was not done. This 510(k) relates to a physical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the tests described is based on:
- International Standards: Specifically, ISO 17510-2 for CO2 washout.
- Comparison to a Predicate Device: Many performance metrics (Exhaust Flow, Pressure Drop, Deadspace) were deemed acceptable by demonstrating "equivalence" or "comparability" to the Respironics ComfortGel Blue Nasal Mask (K092835).
- Internal Specifications/Validated Test Methods: Cleaning validation and Environmental/Mechanical testing adhered to internal performance specifications and standard test methods.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" mentioned or implied, as this is a physical device going through performance and comparability testing, not a machine learning 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 to establish for it in this context.
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