(108 days)
HEMOPORE® is intended for use in patients undergoing nasal/simus surgery as a temporary wound dressing.
HEMOPORE® functions as a topical hemostatic aid to control mild bleeding by tamponade effect, blood absorption, platelet activation and aggregation.
It acts as an adjunct to aid in the natural healing process as a space occupying stent to separate and support tissues. It prevents adhesions and minimizes edema.
HEMOPORE® is a sterile fragmentable nasal dressing of 8 cm composed of poly(DL-lactide-cos-caprolactone) urethane and blended with a chitosan derivate and a violet color additive.
After insertion of HEMOPORE®in the nasal cavity, fluids will be absorbed by the dressing, which helps to control bleeding after surgery.
The dressing fragments within several days by hydrolyzing ester bonds, whereafter it is drained from the nasal cavity via the natural mucus flow.
The HEMOPORE® is sterilized in a blister package. The device is single-use, cannot be resterilized, and is a prescription product.
This document is a 510(k) Pre-market Notification for the HEMOPORE® device. The provided text describes the device, its indications for use, and a summary of performance testing to demonstrate substantial equivalence to predicate devices. However, it does not contain specific acceptance criteria, detailed study results with reported device performance metrics against those criteria, or information regarding sample sizes, data provenance, expert involvement, or MRMC studies that would be typically found in a clinical study report or a more comprehensive technical document.
Therefore, many of the requested items cannot be extracted from this document.
Here's what can be extracted based on the provided text, and where information is missing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Biocompatibility: Complies with ISO 10993 and FDA guidance (G95-1) for biological evaluation. | HEMOPORE® complies with the biocompatibility requirements for their intended use. |
| Degradation: (Implicit: Fragments within several days by hydrolyzing ester bonds) | Degradation test performed, criteria met (specifics of criteria not provided). |
| Shelf-life: (Implicit: Maintains functionality over stated shelf-life) | Shelf-life test performed, criteria met (specifics of criteria not provided). |
| Absorption: (Implicit: Absorbs fluids to control bleeding) | Absorption test performed, criteria met (specifics of criteria not provided). |
| Thrombogenicity/Hemostasis: (Implicit: Has appropriate hemostatic properties, at least equivalent to predicates) | Thrombogenicity testing demonstrated HEMOPORE® has appropriate hemostatic properties to assure effectiveness and performs at least equivalent to predicate devices. |
| Technological Characteristics: Similar to predicate devices, with color additive not raising safety/effectiveness concerns. | HEMOPORE shares the same indications for use, device operation, and overall technical and functional capabilities. Performance test data demonstrated at least adequate device performance. |
| Safety and Effectiveness: As safe and effective as predicate devices. | Results of all testing demonstrate substantial equivalence and no concerns about safety and/or effectiveness. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: Not provided. The document mentions "in vitro testing" and "biocompatibility testing" but does not specify the number of samples used for these tests.
- Data provenance: Not provided. The type of study (e.g., retrospective or prospective) is not mentioned beyond "in vitro testing."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Not provided. The testing described (biocompatibility, degradation, shelf-life, absorption, thrombogenicity) appears to be laboratory-based physical and chemical performance testing, not human-read clinical data that would require expert ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided, for the same reasons as item 3.
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
- No. This is not an AI/imaging device. No MRMC study was conducted or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a medical device (intranasal splint/dressing), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the performance testing mentioned (biocompatibility, degradation, shelf-life, absorption, thrombogenicity), the "ground truth" would be established by standardized laboratory methods, physical/chemical measurements, and potentially comparison to predicate devices' known performance characteristics. There is no mention of clinical ground truth such as pathology or outcomes data in this summary.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device that would require a training set.
9. How the ground truth for the training set was established
- Not applicable. (See item 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.