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510(k) Data Aggregation
(69 days)
NASOPORE-FD
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 |
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