(224 days)
CPAP Cannulaide is indicated to aid in securing and positioning the nasal interface for neonates and infants undergoing non-invasive ventilation in an acute care setting.
CPAP Cannulaide is a disposable device and is for single patient use only.
The CPAP Cannulaide® is a die-cut hydrocolloid-coated polyurethane film with an integral hook strip (i.e., Velcro) to allow for the use of a loop material to help secure a nasal interface for non-invasive ventilation. The Cannulaide® is applied above the lip and over the nose to provide a protective barrier between the nasal cannula and the patient's skin. It is available in multiple sizes that vary the external geometry and nare hole size and spacing to allow for use on neonates and infants. It is a non-sterile, single-patient use, disposable device.
The provided document describes a 510(k) premarket notification for the "CPAP Cannulaide®" device and focuses on establishing substantial equivalence to a predicate device. It is not a study report demonstrating the device meets specific acceptance criteria based on performance metrics as typically seen in AI/ML validation studies.
Therefore, many of the requested details about acceptance criteria, study methodologies, ground truth establishment, expert adjudication, and sample sizes for training/test sets are not present in this type of regulatory submission. This document primarily outlines the device's intended use, features, and how it compares to existing, legally marketed devices to demonstrate that it does not raise new questions of safety or efficacy.
However, I can extract the information that is available and explain why other information is missing.
Device: CPAP Cannulaide®
Regulation Number: 21 CFR 868.5905 (Noncontinuous Ventilator (IPPB) Accessory)
Regulatory Class: Class II
Product Code: BZD
Predicate Device: K100011, headgear accessory as part of Patient Nasal Interface of Fisher & Paykel Bubble CPAP System
Reference Device: K903539, Salter Labs Model # 1015 (Tender Grip)
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state "acceptance criteria" in the format of quantitative performance metrics (e.g., accuracy, sensitivity, specificity, AUC) for an AI/ML algorithm. Instead, the "acceptance criteria" for this 510(k) submission are based on demonstrating substantial equivalence to a predicate device, meaning the new device is as safe and effective as a legally marketed device.
The "reported device performance" is described through non-clinical performance testing intended to show that differences from the predicate device do not raise new safety or efficacy concerns. These are typically engineering and materials tests, not clinical performance metrics against a "ground truth" derived from patient data for diagnostic or treatment-guidance AI.
| Acceptance Criterion (Implicit for 510(k) Equivalence) | Reported Device Performance / Evidence |
|---|---|
| Biocompatibility: Materials are safe for skin contact. | - Evaluated via ISO 10993-1 testing (Surface Contact, Skin, Prolonged Duration (> 24 h to 30 d)). |
- Tests performed: Cytotoxicity, Sensitization, Irritation.
- Additionally, exhaustive Extractable and Leachable testing including a risk-based assessment.
- Result: Materials found to be biocompatible and have limited reactivity. Supports no new safety/efficacy concerns compared to predicate. |
| Securement Performance: Ability to secure nasal interface. | - Comparative securement (peel) testing performed. - Result: Testing done to demonstrate changes do not raise new safety or efficacy concerns and support claims. (Specific peel force values are not provided in this summary but would have been in the full submission).
- Claim: Helps to prevent movement of the interface to maintain proper positioning. |
| Sealing Performance: Ability to aid in sealing nasal prongs. | - Comparative sealing of nasal prongs testing performed. - Seal maintenance testing performed.
- Result: Testing done to demonstrate changes do not raise new safety or efficacy concerns and support claims. (Specific seal metrics are not provided).
- Claim: Provides a secondary seal around the nasal prongs. |
| Durability/Shelf-Life: Device maintains performance over time. | - Age / Shelf-life for 2 years testing performed. - Performance in high humidity conditions testing performed.
- Result: Testing done to demonstrate changes do not raise new safety or efficacy concerns. (Specific stability data not provided). |
| Overall Equivalence: Device is as safe and effective as the predicate. | - Substantial Equivalence Conclusion: The CPAP Cannulaide® based upon testing has been found to be substantially equivalent to the predicate accessory bonnet and straps of the F&P Infant Interface (K100011). The differences do not raise new questions of safety or efficacy. |
2. Sample Sizes Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not applicable/Not provided. This document describes engineering and biocompatibility testing for a medical device (a physical product), not a data-driven AI/ML model that would have a "test set" of patient data in the conventional sense. The "performance testing" refers to physical tests on the device's material properties and mechanical function, not a dataset of patient cases.
- Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable/Not provided. As above, there isn't medical "data" in the context of patient images or clinical records for an AI/ML model. The tests are on the device itself.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- Not applicable. There is no "ground truth" established by experts for a "test set" in the context of an AI/ML algorithm's diagnostic or predictive performance. The ground truth for biocompatibility is established by adherence to ISO standards and laboratory testing. The ground truth for mechanical performance (e.g., peel strength, seal integrity) is established through engineering test methods.
4. Adjudication Method for the Test Set:
- Not applicable. No expert adjudication method is mentioned, as there is no human interpretation of a "test set" to establish ground truth for an AI/ML clinical application.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No. An MRMC study is not relevant for this type of physical medical device. MRMC studies are typically performed to assess the impact of an AI/ML system on human reader performance for diagnostic tasks (e.g., radiologists reading images).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Not applicable. This device is a physical product, not a standalone algorithm.
7. The Type of Ground Truth Used:
- Biocompatibility: Established by published international standards (ISO 10993-1) and laboratory testing methods (e.g., cytotoxicity assays, sensitization studies).
- Performance: Established by engineering test methods (e.g., peel force measurements, seal integrity tests) designed to quantify the physical properties and functional aspects of the device against predefined specifications (though the numerical specifications themselves are not in this summary).
8. The Sample Size for the Training Set:
- Not applicable/Not provided. This is a physical device, not an AI/ML model that is "trained" on a dataset.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As above, no training set or associated ground truth.
Summary of Device and its Role:
The CPAP Cannulaide® is a disposable, non-sterile device for neonates and infants undergoing non-invasive ventilation. Its purpose is to aid in securing and positioning the nasal interface and provide a protective barrier between the nasal cannula/interface and the patient's skin. It utilizes a hydrocolloid-coated polyurethane film with an integral hook strip.
The document demonstrates substantial equivalence to predicate devices by comparing:
- Indications for Use
- Environment of Use
- Patient Population
- Technology
- Materials
- Non-clinical performance testing (material biocompatibility, comparative securement, comparative sealing, seal maintenance, age/shelf-life, performance in high humidity).
The core of this 510(k) submission is to ensure the safety and effectiveness of this new physical device in its intended use, primarily through demonstrating that its materials and mechanical function are equivalent to or do not raise new concerns compared to legally marketed devices. It is not an AI/ML software device requiring performance metrics based on analysis of clinical data.
§ 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).