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510(k) Data Aggregation
(69 days)
NASOPORE ® FD 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 "FD is composed of a bioresorbable poly(DL-lactide-co-s-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® FD size and type are indicated on the label and are packed in a blister. NASOPORE "FD is indicated for single-use.
The modification in this submission concerns a line extension to the predicate device NASOPORE "with a NASOPORE" FD that fragments faster than the cleared predicate device.
The document provided describes the NASOPORE FD nasal dressing, a line extension of the NASOPORE nasal dressing. The purpose of this submission is to demonstrate substantial equivalence to the predicate device (K052099; NASOPORE nasal dressing). The performance data presented focuses on in vitro testing to show that the technological characteristics and performance criteria of the new NASOPORE FD are comparable to the currently cleared predicate device.
1. Table of Acceptance Criteria and Reported Device Performance:
The document outlines "Performance Data" from in vitro testing to demonstrate comparability. While not explicitly termed "acceptance criteria," these are the parameters used to establish substantial equivalence.
| Properties | Method | Current NASOPORE® Performance (Predicate Device) | New NASOPORE FD Performance (New Device) | Acceptance Criteria (Implied: Comparable to Predicate) |
|---|---|---|---|---|
| Shape integrity (shape intact in saline at 37°C) | Visual | >36 hours (in Saline) | >36 hours (in Saline) | >36 hours |
| Fragmentation time (In saline at 37°C) | Fragmentation test | 96 hours | 48 hours | N/A (Intentionally faster fragmentation) |
| Compression | Compressive strength measurement | >3 kPa (Firm) | >3 kPa | >3 kPa |
| Porosity | Porosity measurement | 95-98 % | 95-98 % | 95-98 % |
| Color | Visual | Off-white | Blue/Green | N/A (Color is a difference, deemed not to raise safety/effectiveness issues) |
| IV (intrinsic viscosity) | IV measurement | IV ≥ 0.8 dl/g | IV ≥ 0.8 dl/g | IV ≥ 0.8 dl/g |
| Biocompatibility | ISO 10993 | Biocompatible: Non-cytotoxic, Non-irritating (intracutaneous and oral), Non-sensitive | Biocompatible: Non-cytotoxic, Non-irritating (intracutaneous and oral), Non-sensitive | Biocompatible |
| Sterility | ISO11135-1 | SAL 10-6 (half cycle validation) | SAL 10-6 (rationale, identical blister pack and density) | SAL 10-6 |
| EtO Residuals | ISO10993-7 | < 2 mg/device | < 2 mg/device | < 2 mg/device |
| Composition | In process verification | Conform Polyurethane specification | Conform Polyurethane specification, additionally blended with PEG20.000 and D&C Green | Conform Polyurethane specification |
| Package integrity | ISO11607 | Qualified, Sterilized blisterpack | Qualified, Sterilized blisterpack | Qualified, Sterilized blisterpack |
| Shelf-life | ASTM F1980: Real time aging | 18 months | 6 months (interim results) | N/A (Shorter shelf-life is a difference, deemed not to raise safety/effectiveness issues) |
Note: The "Acceptance Criteria" column is implied based on the comparison to the predicate device. The goal of a 510(k) is to demonstrate substantial equivalence, meaning the new device performs as safely and effectively as a legally marketed predicate device. For most parameters, this means matching or exceeding the predicate's performance. For fragmentation time, the change is intentional and a defining characteristic of the "FD" (fragmentable) line extension.
2. Sample size used for the test set and the data provenance:
- Sample size: The document does not specify the exact sample sizes for each in vitro test. It generally refers to "in vitro testing" without providing specific numbers of samples tested for, for example, compressive strength or porosity measurements.
- Data Provenance: The data is generated from in vitro testing of the device. The country of origin for the data is implicitly The Netherlands, as the submitter, Polyganics BV, is located in Groningen, The Netherlands. The study is a comparative in vitro study rather than clinical retrospective or prospective data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable to the provided document. The performance data is based on in vitro physical and chemical property testing, not on clinical evaluation requiring expert interpretation or ground truth establishment by medical professionals.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable as the testing is in vitro and does not involve adjudication by multiple human experts.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This information is not applicable. The device is an intranasal splint, a physical medical device, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study with human readers and AI assistance is not relevant to this submission.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not applicable. The device is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the in vitro tests is the direct measurement of the physical and chemical properties of the device according to established test methods and standards (e.g., ISO 10993 for biocompatibility, ISO 11135-1 for sterility, ASTM F1980 for shelf-life, and internal methods for fragmentation, compression, porosity, etc.). The reference point (or "ground truth" in terms of performance comparison) is the performance of the legally marketed predicate device, NASOPORE® (K052099).
8. The sample size for the training set:
This information is not applicable. The device is not an AI algorithm and therefore does not involve a training set.
9. How the ground truth for the training set was established:
This information is not applicable as there is no training set for this device.
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