(44 days)
This device is intended to be used with positive airway pressure devices operating at or above 4cmH2O for the treatment of adult obstructive sleep apnea.
A nasal CPAP mask that is used with positive airway pressure equipment recommended by a physician, sleep technician, or respiratory therapist.
Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:
The provided document describes a 510(k) Premarket Notification for the iMask™ Nasal CPAP Mask. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than outright proving safety and effectiveness through extensive clinical trials for de novo approval. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are framed within the context of substantial equivalence to the predicate device, the SleepNet IQ™ Mask.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are essentially the characteristics and performance attributes of the predicate device (SleepNet IQ™ Mask). The "reported device performance" refers to how the iMask™ meets or is substantially equivalent to these attributes.
| Acceptance Criteria (Predicate: SleepNet IQ™ Mask) | Reported Device Performance (iMask™) |
|---|---|
| Use | |
| Intended for use in respiratory therapy | Yes |
| Intended to be used with any CPAP device | Yes |
| Indicated for single patient use in home, hospital, or sleep lab | Yes |
| Indicated for use with adult cases | Yes |
| Design/Performance | |
| Comfortable face cushion | Yes |
| 15mm swivel elbow connection | Yes |
| 3-point headstrap connection | Yes |
| Adequate venting to minimize rebreathing CO2 | Yes |
| Vent design to minimize noise | Yes |
| No latex materials | Yes |
| No sharp edges | Yes |
| Mask is lightweight (60 grams) | Yes - 64 grams |
| Polybag packaging (clean non-sterile) | Yes |
| Materials | |
| Polyurethane Housing | Yes |
| Polycarbonate & Acetal Copolymer 15mm Swivel Elbow | Yes |
| Wire Insert Molded Into Mask Housing | Yes |
| Soft Facial Contact Cushion | Yes |
| Polycarbonate 3-Point Headstrap Bracket | Yes |
| Airway & direct contact component materials meet USP Class VI standards | Yes |
| Performance Testing | |
| Meets ASTM F1054-87 & ISO 5356-1 Standards | Yes |
| Meets ISO 17510-2:2003 Standard | Yes |
| Minimum 12 lpm @ 4 cm H2O Mask Leakage To Prevent CO2 Rebreathing | Yes |
Study Proving Acceptance Criteria (Substantial Equivalence):
The "study" proving the device meets the acceptance criteria is a substantial equivalence comparison to the predicate device, the SleepNet IQ™ Mask. This is not a traditional efficacy study, but rather a demonstration that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness.
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: The document does not specify a "test set" in the context of clinical data for performance assessment of the iMask™ against specific patient outcomes. The evaluation is primarily a comparison of technical and material specifications against the predicate device and relevant standards.
- Data Provenance: The data primarily consists of bench testing results (e.g., meeting ASTM, ISO standards, leakage rates) and material biocompatibility testing. This is not patient-derived data in the typical sense. It is likely prospective for the iMask™'s own testing. The country of origin of the data is not explicitly stated but would be assumed to be from the manufacturer's testing facilities (Marquest Medical Products, Inc. in Englewood, CO, USA) or their chosen test labs.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
- Number of Experts & Qualifications: This information is not provided and is generally not applicable in this type of 510(k) submission. "Ground truth" in this context refers to established engineering standards (ASTM, ISO), material science standards (USP Class VI), and the characteristics of the predicate device. These are objectively measurable or documented attributes, not subjective expert interpretations of clinical data.
4. Adjudication Method for the Test Set:
- Adjudication Method: This information is not provided and is not typically relevant for a substantial equivalence determination based on technical specifications and bench testing. There is no ambiguous clinical data requiring adjudication.
5. If a Multi-Reader, Multi-Case (MRMC) Comparative Effectiveness Study was done:
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is used to assess the impact of a device on reader performance (e.g., radiologists interpreting images with or without AI assistance). The iMask™ is a physical medical device (CPAP mask), not an interpretive or diagnostic AI system.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: No, this concept is not applicable. The iMask™ is a physical medical device, not an algorithm, and doesn't operate in a "standalone" algorithmic capacity. Its performance is assessed through bench testing and material compatibility, and its intended use is with a human patient and CPAP machine.
7. The Type of Ground Truth Used:
- The "ground truth" for this device's validation is primarily based on:
- Established engineering standards: ASTM F1054-87, ISO 5356-1, ISO 17510-2:2003.
- Biocompatibility standards: USP Class VI for materials.
- Characteristics and performance of the legally marketed predicate device: SleepNet IQ™ Mask.
- Bench test results (e.g., mask leakage at specified pressure).
8. The Sample Size for the Training Set:
- Training Set Sample Size: This concept is not applicable. The iMask™ is a physical device, not an AI algorithm that undergoes a "training phase" with a dataset.
9. How the Ground Truth for the Training Set was Established:
- Ground Truth for Training Set: This concept is not applicable as there is no "training set" or AI component to the device.
In summary, the provided document details a substantial equivalence argument for a physical medical device (CPAP mask). The "acceptance criteria" are the characteristics of the predicate device and relevant industry standards, and the "study" demonstrating compliance involves bench testing and material biocompatibility assessments, not clinical trials with patient data or expert interpretation.
§ 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).