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510(k) Data Aggregation
(255 days)
WIZARD 310/320 series CPAP Mask is intended to provide an interface for Continuous Positive Airway Pressure (CPAP) or bi-level therapy. These masks are intended for single-patient reuse in the home and multi-patient, multi-use in the hospital environment. These masks are to be used on patients greater than 30 kg for whom positive airway pressure (CPAP or bi-level system) has been prescribed.
The WiZARD 310 Nasal Mask and WiZARD 320 Full Face Mask provide an interface such that airflow from a positive pressure source is directed to the patient's nostril and mouth. The masks are held in place with adjustable headgear that straps the mask to the face. Series of vent are feature on the cushion that serves as an exhalation vent to purge the exhaled carbon dioxide from the mask. Air coming out from these holes is very diffuse and quiet. WiZARD 310/320 series CPAP mask are connected to the CPAP or bi-level system via standard 22 mm breathing tubing. A quickly-release mechanism also includes which allow the mask can be removed quickly.
The WiZARD 310 Nasal Mask and WiZARD 320 Full Face Mask are appropriate when used under the conditions and purposes intended as indicated in the labeling provided with the product. The WiZARD 310 Nasal Mask and WiZARD 320 Full Face Mask are the prescription device supplied non-sterile.
The provided text describes a CPAP mask and its FDA 510(k) clearance, which focuses on demonstrating substantial equivalence to a predicate device, not on presenting novel acceptance criteria or a study proving a device's performance against specific clinical acceptance criteria.
Therefore, I cannot create a table of acceptance criteria and reported device performance because the provided document does not contain this information in the context of a new study proving performance. The document primarily highlights:
- Comparison to a predicate device: The core of the submission is to show the WiZARD 310/320 series CPAP Mask is substantially equivalent to the WiZARD 210/220 Series CPAP Mask (K103174) and reference devices AirFit F20 (K170924) and AirFit N20 (K171212).
- Safety and Performance Testing: Non-clinical testing was performed to demonstrate equivalent performance to the predicate device, focusing on biocompatibility and reliability.
Here's a breakdown of the information that can be extracted based on the provided text, and what information is not available within this document:
1. Table of Acceptance Criteria and Reported Device Performance:
- Not explicitly provided as a set of clinical performance acceptance criteria with corresponding study results. The document focuses on demonstrating substantial equivalence through comparison to a predicate device and non-clinical testing.
- Instead, the document lists "performance characteristics" that are deemed similar to the predicate device. These are not acceptance criteria in the sense of demonstrating a certain level of efficacy or diagnostic accuracy. They are design and functional specifications.
Summary of "Similar Performance Characteristics" to Predicate Device:
| Item | Predicate Device (WiZARD 210/220 Series CPAP Mask, K103174) | Subject Device (WiZARD 310/320 Series CPAP Mask) | Remarks |
|---|---|---|---|
| Principles of Operation | Interface for airflow from positive pressure source | Same | Substantially equivalent |
| Patient Use Type | Adult >30 Kg | Same | Substantially equivalent |
| Indication | Obstructive sleep apnea | Same | Substantially equivalent |
| Environment | Home, Hospital | Same | Substantially equivalent |
| Reuse | Single patient multi-use for home; Multi-patient multi-use for hospital | Same | Substantially equivalent |
| Patient Support System | CPAP or bi-level system | Same | Substantially equivalent |
| Shelf Life | 5 years | Same | Substantially equivalent |
| Use of Life | 6 months | Same | Substantially equivalent |
| Mask Size | L/M/S | Same | Substantially equivalent |
| Sterility | Clean, non-sterile | Same | Substantially equivalent |
| Validated Cleaning | Warm water | Same | Substantially equivalent |
| Validated Disinfection | Thermal water/High level chemical disinfectant | Same | Substantially equivalent |
| Therapy Pressure Range | 4~20 cmH2O | WiZARD 310: 4 | Difference noted, but deemed not to raise new questions of safety/effectiveness. |
| Hose Connection | 22 mm hose | Same | Substantially equivalent |
| CPAP Tubing Connection Point | Port compliance to ISO 5356-1 | Same | Substantially equivalent |
| Swivel Connection | 360 degree rotation | Same | Substantially equivalent |
| Secure and Less-leak Interface | Single layer cushion | Same | Substantially equivalent |
| Operation Range | +5°C to +35°C, 15% to 95% R.H | Same | Substantially equivalent |
| Storage and Transport | -15°C to +60°C, 10% to 90% R.H | Same | Substantially equivalent |
| Noise (dB) |
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(109 days)
The Scone Mask is intended to be used by patients weighing more than 66 lb (30 kg) who have been prescribed noninvasive positive airway pressure (PAP) therapy such as CPAP or bi-level therapy. The mask is intended for single patient re-use in the home and multi-patient re-use in the hospital/institutional environment.
The Scone Mask is an externally placed vented respiratory mask. Positive air pressure (PAP) source is directed to the patient's airway non-invasively, via the nose. The mask connects to the positive pressure flow source through conventional air tubing via an industry standard conical connector. The mask is held in place with adjustable head straps.
The Scone Mask comprises 4 subassemblies: headgear, frame, cushion and elbow. The exhaust ports are incorporated into the elbow and cushion assemblies. The cushion and frame are available in various sizes to fit a wide patient population.
The Scone Mask is a prescription device supplied non-sterile.
Here's a breakdown of the acceptance criteria and study details for the Scone Mask, based on the provided document. It's important to note that this is a medical device (mask), not an AI/algorithm-based device, so many of the typical AI/ML study questions (like MRMC, standalone algorithm performance, training set details) are not applicable to this submission. The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing.
Acceptance Criteria and Device Performance for Scone Mask
The provided document describes the FDA 510(k) submission for the Scone Mask, a non-invasive positive airway pressure (PAP) therapy mask. The "acceptance criteria" and "device performance" in this context refer to the mask's ability to meet established safety and performance standards for such devices, primarily by demonstrating substantial equivalence to a legally marketed predicate device (AirFit N20, K171212).
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Requirements) | Reported Device Performance (Demonstrated by Testing) |
|---|---|
| Applicable Performance and Safety Tests (ISO 17510:2015): | Met all intended performance requirements. |
| - CO2 rebreathing | Verified to be within acceptable limits. |
| - Total mask flow | Verified to be within acceptable limits. |
| - Flow resistance | Verified to be within acceptable limits. |
| Other Bench Tests: | Met all intended performance requirements. |
| - Physical dead space | Verified to be within acceptable limits. |
| - Functional tests | Passed. |
| - Mechanical integrity performance following relevant environmental exposure (Home cleaning, Transportation, Operation environment, Relevant abuse use case tests) | Maintained mechanical integrity and performance. |
| Biocompatibility Evaluation (ISO 10993 series): | Components shown to be biocompatible. |
| Validation of Reprocessing Claims: | Successfully validated. |
| - Cleaning efficacy | Demonstrated effective cleaning. |
| - Disinfection efficacy | Demonstrated effective disinfection. |
| - Residual toxicity | Confirmed acceptable levels. |
| - Mechanical integrity testing | Maintained integrity after reprocessing. |
| Substantial Equivalence to Predicate (AirFit N20): | Concluded to be substantially equivalent. |
| - Same intended use | Confirmed. |
| - Similar technological characteristics | Confirmed. |
| - Similar performance characteristics | Confirmed. |
| - Differences do not raise new safety/effectiveness questions | Confirmed by non-clinical testing. |
| - At least as safe and effective as predicate | Confirmed by non-clinical testing. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a "sample size" in terms of subject counts for a clinical trial, as this was a non-clinical verification and validation study. The "samples" referred to are the actual Scone Mask prototypes and their components used for the various bench and laboratory tests. The number of masks/components tested for each specific test (e.g., CO2 rebreathing, flow resistance, mechanical integrity) is not detailed.
- Data Provenance: This was an internal validation study conducted by ResMed Ltd. The location of the test facility is not explicitly stated beyond ResMed Ltd's address being in Bella Vista, NSW, Australia. The data is non-clinical (bench testing), not collected from human subjects.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not Applicable. This submission is for a medical device (mask) based on non-clinical engineering and performance testing, not an AI/ML device requiring clinical expert review to establish ground truth from medical images/data. The "ground truth" here is objective physical and chemical measurements (e.g., CO2 levels, flow rates, material composition, mechanical properties) against established industry standards (ISO).
4. Adjudication Method for the Test Set
- Not Applicable. As this is a non-clinical device performance study, there's no need for an adjudication method by medical experts. The results are derived from objective measurements and laboratory analyses, compared against predetermined acceptance limits derived from international standards (e.g., ISO 17510, ISO 10993 series).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. An MRMC study is relevant for diagnostic AI devices where human reader performance is being evaluated with and without AI assistance. This document describes the testing for a PAP mask, which is a physical medical device, not a diagnostic AI.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an AI/algorithm-based device.
7. The Type of Ground Truth Used
- The "ground truth" for this device is based on engineering specifications, industry standards (ISO 17510 for masks, ISO 10993 for biocompatibility), and established scientific principles for device safety and performance. This includes:
- Objective measurements: CO2 levels, airflow, pressure, mechanical strength, chemical composition.
- Compliance with published standards: Meeting the specified requirements of ISO standards.
- Performance equivalence: Demonstrating that the device performs similarly to a legally marketed predicate device under tested conditions.
8. The Sample Size for the Training Set
- Not Applicable. This is not an AI/ML device that requires a training set of data.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. Given that this is not an AI/ML device, there is no "training set" or "ground truth" in that context.
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