(110 days)
Nasopore is a fragmentable nasal dressing and is indicated for use in patients undergoing nasal/sinus surgery as a space occupying stent to separate and prevent adhesions between mucosal surfaces; to help control minimal bleeding following surgery or nasal trauma by tamponade effect and blood absorption.
Nasopore is composed of a fragmentable poly(DL-lactide-co-e-caprolactone) urethane that fragments within several days after insertion in the nasal cavity, whereafter it is drained from the nasal cavity via the natural mucus flow. The Nasopore size and type are indicated on the label and are packed in a Tyvek pouch. Nasopore is indicated for single-use.
The provided 510(k) submission for POLYGANICS' KOS2099 Nasopore® nasal dressing is a submission for a Class I device and relies primarily on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study with defined endpoints.
Here's a breakdown of the requested information based on the provided text, highlighting what is available and what is not typically required or present for a Class I device 510(k) relying on substantial equivalence:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety | Demonstrated via biocompatibility testing per ISO 10993. |
| No adverse events reported in summary, implied safe based on preclinical testing and equivalence to predicates. | |
| Effectiveness | In vitro fragmentation testing: Fragments within several days after insertion and is drained via natural mucus flow. |
| Shelf life testing: Demonstrated acceptable shelf life. | |
| Space occupying stent: Functions to separate and prevent adhesions between mucosal surfaces (by comparison to predicates). | |
| Control minimal bleeding: Provides tamponade effect and blood absorption (by comparison to predicates). | |
| Biocompatibility | Conforms to ISO 10993. |
| Mechanical/Physical Properties | Tested (details not specified, but implied to be comparable to predicates). |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated for specific tests. The submission mentions "design verification tests and analyses" and "biocompatibility, mechanical and physical property testing and in vitro fragmentation testing." These are typically conducted on a limited number of device samples in a lab setting, not a clinical "test set" in the context of human subjects.
- Data Provenance: The device's performance data is derived from in-vitro testing and pre-clinical analyses (e.g., biocompatibility) conducted by the manufacturer, Polyganics BV, likely in The Netherlands (their submitted address). It is retrospective in the sense that it's laboratory testing and comparisons, not a prospective clinical trial on human subjects for this 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable and not provided in this type of 510(k) submission. For a Class I device demonstrating substantial equivalence, especially one relying on pre-clinical data and comparison to predicates, external experts determining ground truth for a clinical test set are not typically involved or required. The "ground truth" for the device's technical specifications and performance characteristics would be established by Polyganics' internal R&D and QA teams based on established test methods and standards (e.g., ISO 10993).
4. Adjudication Method for the Test Set:
This information is not applicable and not provided. Adjudication methods (like 2+1, 3+1) are relevant for clinical studies where multiple readers interpret clinical data (e.g., medical images) and their disagreements need resolution to establish a consensus ground truth. This 510(k) relies on lab-based testing and performance verification, not clinical interpretation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:
No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic devices involving human interpretation of results and is not relevant for this device (a nasal dressing). The submission's focus is on the device's physical and biological properties and its equivalence to existing products.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
This concept is not applicable to this device. "Standalone" performance is usually refers to the accuracy of an AI algorithm in performing a task without human intervention. The Nasopore® nasal dressing is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used:
The "ground truth" for this device's safety and effectiveness is established through:
- Pre-clinical verification testing: This includes in-vitro fragmentation testing, shelf-life testing, biocompatibility testing (ISO 10993 standards), and mechanical/physical property testing. The results of these tests and their adherence to accepted scientific methods and standards form the basis of the "ground truth" for the device's functional characteristics.
- Comparison to predicate devices: The "ground truth" for its clinical utility (e.g., separating adhesions, controlling bleeding) is established through its substantial equivalence to legally marketed predicate devices with proven clinical histories.
8. The Sample Size for the Training Set:
This information is not applicable and not provided. The concept of a "training set" (used for machine learning algorithms) does not apply to this physical medical device. The device was designed and developed based on scientific and engineering principles, not trained on a dataset.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable and not provided for the same reasons as point 8.
§ 874.4780 Intranasal splint.
(a)
Identification. An intranasal splint is intended to minimize bleeding and edema and to prevent adhesions between the septum and the nasal cavity. It is placed in the nasal cavity after surgery or trauma. The intranasal splint is constructed from plastic, silicone, or absorbent material.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.