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510(k) Data Aggregation
(77 days)
PAP-Cap™ headgear is an accessory intended for patients using CPAP or bi-level devices in hospitals, institutions, sleep labs, and /or home environments. The headgear is single patient, multi-use.
The Pur-Sleep PAP-Cap™ is a simple alternative headgear (with an integrated but fully detachable chin strap) designed to be used with standard patient interfaces, i.e., full face mask, nasal mask and nasal pillow and cannula devices. It is designed to be adjusted to optimize fit and patient comfort. It is adaptable to many models of CPAP mask styles.
The Pur-Sleep PAP-Cap™ is a headgear device designed to be used with CPAP or bi-level devices. The provided documents focus on establishing substantial equivalence to a predicate device (Suiter - Slumbergear™ headgear - K042294) rather than presenting a study demonstrating the device meets explicit acceptance criteria through performance metrics.
1. Table of Acceptance Criteria and Reported Device Performance:
Based on the provided documents, there are no explicit quantitative acceptance criteria or performance metrics reported for the Pur-Sleep PAP-Cap™. The submission relies on demonstrating substantial equivalence to a predicate device. Therefore, the "reported device performance" is essentially that it is substantially equivalent to the predicate across various features.
| Feature | Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance (Pur-Sleep PAP-Cap™) |
|---|---|---|
| Indications for Use | Accessory for CPAP/bi-level, adult patients, in hospital, clinics, home environments, reusable, single use. | Accessory for CPAP/bi-level, patients (same as attached equipment), in hospitals, institutions, sleep labs, home environments, single patient, multi-use. (Minor wording differences, overall equivalent intent)* |
| Environment of Use | Hospital, clinics, and home use. | Hospital, institutions, sleep labs, and home use. (Minor wording differences, overall equivalent intent)* |
| Patient Population | Adults. | Same patient population as the equipment to which it is attached. (Consistent with predicate's adult focus for CPAP/bi-level)* |
| Prescriptive | Yes. | Yes. |
| Patient Interface Types | Mask, Nasal pillows, Cannulas. | Full face mask, Nasal mask, Nasal pillows, Cannulas. (Broader than predicate - implies sufficient compatibility)* |
| Design Features | One-piece, integrated chinstrap, Velcro® attachment, emergency exit method. | One-piece, integrated chinstrap, Velcro® attachment, emergency exit method. |
| Latex Free | Yes. | Yes. |
| Single patient, multi-use | Yes. | Yes. |
| Cleaning Method | Hand wash warm water and soap, air dry. | Standard washer or hand wash warm water and soap, air dry. (Broader than predicate - implies acceptable cleaning methods)* |
Note: The differences in wording for Indications for Use, Environment of Use, Patient Population, and Cleaning Method are considered minor by the FDA as they did not impact the substantial equivalence determination for safety or effectiveness.
2. Sample Size Used for the Test Set and Data Provenance:
No specific test set or clinical study data is presented in these documents. The submission is a 510(k) premarket notification, which primarily relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than new clinical trials for performance. Therefore, information on sample size or data provenance is not applicable in this context.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable, as no specific test set or clinical study requiring expert ground truth establishment is described.
4. Adjudication Method for the Test Set:
Not applicable, as no specific test set or clinical study is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done or reported in these documents. This type of study focuses on the diagnostic performance of human readers with and without AI assistance, which is not relevant for a simple headgear device being cleared via substantial equivalence.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
Not applicable. The PAP-Cap™ is a mechanical accessory (headgear), not an algorithm or software-based device. Therefore, "standalone performance" in the context of an algorithm is not relevant.
7. The Type of Ground Truth Used:
Not applicable. The basis for clearance is substantial equivalence to a predicate device based on comparison of intended use, technological characteristics, and safety/effectiveness, not on a ground truth derived from expert consensus, pathology, or outcomes data for performance evaluation.
8. The Sample Size for the Training Set:
Not applicable. As a physical medical device (headgear), there is no "training set" in the context of machine learning or algorithms. The design and validation would typically involve engineering tests, material biocompatibility, and user evaluations, but these are not explicitly detailed as "training sets" in the provided summary.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, for the reasons stated in point 8.
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