(199 days)
The BestFit™ and BestFit™2 Nasal Masks are intended for multiple use on adult patients (body weight >30kg) prescribed with using continuous positive airway pressure (CPAP) or bilevel ventilator system in hospital, clinic and/or home environment.
The BestFit™ Nasal Masks are patient interface devices used on adult patients prescribed with CPAP and Bi-Level Positive Airway Pressure therapy. The BestFit product family consists of two models, BestFit and and BestFit 2. Both models have same function and performance, except for a slight difference in the forehead design. Both devices are vented and can be used multiple times in a hospital, clinical and/or home environment. The nasal mask style covers and seals around the patient's nose and delivers positive pressure from the therapy device to the patient via the patient air circuit of the CPAP device. The BestFit Nasal Masks include the following accessories: headgear and Instructions for Use (IFU). The model BestFit Nasal mask is available in 4 different sizes: Small (S), Medium (M), Large (L), and Medium Wide (MW). The model BestFlt 2 Nasal mask is available in 3 different sizes: Small (S), Medium (M), and Large (L).
The provided K130663 submission describes the BestFit™ Nasal Masks and their substantial equivalence to a predicate device, Resmed Ultra Mirage II (K050359). The submission outlines various tests performed to demonstrate compliance with product specifications and relevant standards.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly present a discrete "acceptance criteria" table for the BestFit Nasal Mask models. Instead, it provides a comparative table where the predicate device's performance is the de facto acceptance criterion for several parameters. The "Comparison" column in the table implicitly indicates whether the BestFit models meet or are comparable to the predicate.
Here's a summarized table derived from the "Comparison" section, highlighting parameters where specific performance values are listed:
| Parameter | Acceptance Criteria (Predicate: Resmed Ultra Mirage II (K050359)) | Reported Device Performance (BestFit / BestFit 2) | Comparison / Outcome |
|---|---|---|---|
| Therapy Pressure | 4 - 20 cmH20 | 4 - 20 cmH20 | Same (Meets) |
| Pressure-Flow Curve | Flow: 18-54 lpm (at 4-20 cmH2O) | BestFit: 17.87-52.12 lpm (at 4-20 cmH2O) | |
| BestFit 2: 16.59-49.28 lpm (at 4-20 cmH2O) | Less flow with constant pressure - compliant with internal spec and ISO 17510-2 test procedure (Meets) | ||
| Dead Space | 135 mL | BestFit: 30kg) prescribed with CPAP or bi-level ventilator system in hospital, clinic and/or home environment | Essentially identical (Meets) |
Other tests, like Sound Test, Packaging Testing, System Test Protocol, Cleaning and Disinfection, and Biocompatibility, are stated to have been conducted in accordance with relevant standards (e.g., ISO 17510-2, ISO 10993 series) and confirmed that "the products met the pre-defined acceptance criteria." However, specific numerical acceptance criteria and reported performances for these tests are not detailed in the provided text. The "acceptance criteria" here implicitly refer to compliance with the standards mentioned.
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide specific sample sizes for any of the performance tests mentioned (e.g., Pressure-Flow, Dead Space, Sound Level, Resistance to Flow, etc.). The provenance of the data (e.g., country of origin, retrospective or prospective) is also not explicitly stated. It can be inferred that the testing was conducted by the manufacturer, Curative Medical Inc., but the location of the testing laboratories is not given.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the submission. The submission relies on objective engineering and performance testing against industry standards and a predicate device, rather than subjective expert assessment to establish ground truth.
4. Adjudication Method for the Test Set
Since the ground truth was established through engineering and performance testing against standards and a predicate device, an adjudication method typically used for subjective assessment (e.g., 2+1, 3+1) is not applicable and not mentioned.
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 type of study is typically used for diagnostic devices involving human interpretation of images or other data. The BestFit Nasal Mask is a patient interface device, and its performance is evaluated through engineering and physical tests.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, standalone testing was performed. The performance data presented (e.g., pressure-flow curves, dead space, sound level, resistance to flow) are all results of the device's inherent physical properties and design, tested independently without human interaction influencing the core function being measured. The "System Test Protocol and Report" and "Predicate Comparison Testing" are examples of standalone performance evaluations.
7. The Type of Ground Truth Used
The ground truth used for evaluating the BestFit Nasal Masks is based on:
- Compliance with established international and national standards: ISO 17510-2, ISO 10993 series, ISO 5356-1, and ISTA - 2A - 2008.
- Performance of a legally marketed predicate device: The Resmed Ultra Mirage II (K050359) serves as the benchmark for several key performance parameters.
- Internal specifications and risk analysis: As stated, "All tests confirmed the products met the pre-defined acceptance criteria."
8. The Sample Size for the Training Set
This information is not applicable and not provided. The BestFit Nasal Mask is a physical medical device, not an algorithm or AI model that requires a training set in the conventional sense.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. As explained in point 8, there is no "training set" for this type of device.
§ 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).