(169 days)
The Kangaroo Nasal Mask is intended to provide an interface for Continuous Positive Airway Pressure (CPAP) or bi-level therapy. This mask is intended for single-patient reuse in the home and multi-patient, multi-use in the hospital/institutional environment. This mask is to be used on patients greater than 66 Ibs /30 kg.
The Kangaroo Nasal Mask is intended to be used with positive airway pressure devices such as CPAP or bi-level systems. It provides a seal such that positive pressure from the positive pressure source is directed into the patient's nose. It is held in place with an adjustable headgear. It may be cleaned by the patient in the home (single patient use) or cleaned by the professional in the hospital/institutional environment through high-level disinfection processes (multi-patient use).
The Kangaroo Nasal Mask consists of a frame with a gel cushion is designed in such a way that it minimizes leaks and is comfortable for the patient. An elbow is connected to the cushion and includes integrated exhalation features. The elbow can rotate freely through 360 degrees and is connected to 15 mm tubing that includes an integrated 22 mm swivel connector. The mask is designed in such a way that it can be easily disassembled for cleaning or to replace several of the mask components.
The 22 mm swivel connector on the 15 mm tubing is used to connect the mask to a conventional 22 mm air delivery hose that is in turn connected to the positive airway pressure source. The swivel connector can rotate freely through 360 degrees.
The provided text describes a 510(k) submission for the "Kangaroo Nasal Mask." This submission does not include an AI-powered device or a study involving AI integration. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the non-clinical performance testing conducted to demonstrate safety and effectiveness, and substantial equivalence to predicate devices, as typically required for medical devices.
Here's a breakdown of the requested information based on the provided text, focusing on the device's substantial equivalence through non-clinical testing, as no AI component, MRMC study, or standalone algorithm performance is mentioned:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Performance & Functionality | Device performance and functionality remain unaffected after cleaning and disinfection processes. | "Extensive performance testing was performed pre and post cleaning and disinfection treatments to demonstrate performance and functionality was unaffected as a result of these changes." |
| Disinfection Efficacy | Disinfection efficacy meets established standards. | "Disinfection efficacy testing was performed in accordance with AAMI TIR No.12-2010, AAMI TIR No. 30-2011 and ASTM E1837-96 (2007) and the 'Content and Format of Premarket Notification [510(k)] Submissions for Liquid Chemical Sterilants/High Level Disinfectants' – FDA CDRH, January 3, 2000." |
| Biocompatibility | All patient-contacting and gas path materials are biocompatible. | "All patient contacting or gas path materials used in the mask have been previously cleared by the FDA or biocompatibility tested in accordance with the guidance provided by ISO 10993-1." |
| Safety and Effectiveness | Device raises no new issues of safety or effectiveness compared to predicate devices. | "Results from this testing demonstrate that the Kangaroo Nasal Mask meets its performance specifications, raises no new issues of safety or effectiveness, and is substantially equivalent to the identified device predicates." |
| Substantial Equivalence | Device is substantially equivalent to predicate devices based on intended use, operating principle, scientific concepts, technology, materials, design, and physical properties. | The device was found substantially equivalent to Respironics GoLife Nasal Mask (K110008) and Respironics TrueBlue Nasal Mask (K110405) despite minor differences in cushion design (gel inclusion), frame, elbow, headgear, materials, and disinfection methods. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The document states "extensive performance testing" and the execution of various standards, but does not provide specific sample sizes (e.g., number of masks tested per condition).
- Data Provenance: Not applicable in the traditional sense of patient data. The provenance relates to laboratory testing of the physical device and its materials, conducted by the manufacturer, Respironics, Inc. (USA). This testing is retrospective in the sense that it evaluates the manufactured product against predefined specifications and regulatory standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This is not applicable as the "ground truth" for the non-clinical performance and safety testing is based on established engineering specifications, industry standards (e.g., AAMI TIR, ASTM, ISO 10993-1), and regulatory guidance from the FDA. The "experts" involved would be the testing engineers and scientists at Respironics, and potentially third-party labs if specialized testing was outsourced, whose qualifications would involve expertise in materials science, mechanical engineering, microbiology, and regulatory compliance, but they are not adjudicating clinical cases for ground truth.
4. Adjudication Method for the Test Set
- Not applicable in the context of clinical adjudication. The "adjudication" for this type of submission involves comparing test results against predefined thresholds and criteria outlined in the referenced standards and internal performance specifications. It's a binary outcome (pass/fail) based on objective measurements, not a consensus among clinical experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. The document explicitly states: "Use of nasal masks with CPAP or bi-level therapy is proven technology and is well accepted by the medical community. Bench testing is sufficient to demonstrate safety and efficacy of the Kangaroo Nasal Mask, as was the case with the predicate devices." This indicates that no clinical studies, including MRMC comparative effectiveness studies, were conducted or deemed necessary for this 510(k) submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No. This product is a physical medical device (a nasal mask) and does not involve any algorithms or AI for performance. Therefore, no standalone algorithm performance testing was conducted.
7. The Type of Ground Truth Used
- The "ground truth" for this submission is based on engineering specifications, industry standards, and regulatory guidelines. For example:
- Performance & Functionality: Meeting pre-defined operational parameters (e.g., airflow, pressure integrity, fitting) after various treatments.
- Disinfection Efficacy: Achieving specified log reductions of microorganisms as per AAMI/ASTM standards.
- Biocompatibility: Conforming to ISO 10993-1 requirements for biological safety.
- Substantial Equivalence: Alignment with predicate devices in key technological characteristics and safety/effectiveness profiles.
8. The Sample Size for the Training Set
- Not applicable. This is a physical medical device, not an AI model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable for the same reason as above.
§ 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).