(32 days)
AdvaCoat™ Sinus Gel and Stent are indicated for use in patients undergoing nasal/sinus surqery as a space-occupying dressing and/or stent intended to prevent adhesions in the nasal cavity, separate mucosal surfaces compromised by surgery or trauma, minimize edema and help control minimal bleeding following surgery or trauma, and act as an adjunct to aid in the natural healing process.
AdvaCoat™ Sinus Gel and Stent (AdvaCoat™) is a sterile, non-pyrogenic, non-swelling, viscoelastic, bioresorbable material composed of cross-linked polymers of a derivatized hyaluronan. AdvaCoat™ is produced from a nonanimal, non-pathogenic source using a highly purified hyaluronan. AdvaCoat™ Sinus Gel and Stent and its break down products are biocompatible, non-immunoqenic and non-toxic.
AdvaCoat™ Sinus Gel and Stent are provided in two formats, a gel and a stent. The gel is delivered using a syringe and the stent is applied dry as a packing material.
Due to its tissue adhesive properties, AdvaCoat™ will not migrate or be dislodged from the application site. AdvaCoat™ may be used as a space occupying dressing and/or stent to minimize bleeding. Upon application, AdvaCoat™ forms a viscous and transparent gel conforming to mucosal surfaces.
The final packaged product is sterilized with E-beam radiation to a Sterility Assurance Level (SAL) of 10th and intended for single use only.
This 510(k) premarket notification entry (K063308) does not describe a study involving an AI/ML device, but rather a medical device (AdvaCoat™ Sinus Gel and Stent) which is a non-AI device. Therefore, many of the questions regarding AI/ML specific criteria (like sample size for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance, etc.) are not applicable to this submission.
The acceptance criteria for this non-AI device are based on demonstrating "substantial equivalence" to predicate devices already on the market. This means the device's technological characteristics, intended use, and safety/effectiveness are comparable to existing, legally marketed devices.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Demonstrated Substantial Equivalence) | Reported Device Performance (AdvaCoat™ Sinus Gel and Stent) |
|---|---|
| Intended Use: Comparable indications for use in patients undergoing nasal/sinus surgery. | Intended Use: Indicated for use in patients undergoing nasal/sinus surgery as a space-occupying dressing and/or stent intended to prevent adhesions in the nasal cavity, separate mucosal surfaces compromised by surgery or trauma, minimize edema, help control minimal bleeding, and act as an adjunct to aid in the natural healing process. (Identical to predicate devices). |
| Technological Characteristics: Similar design, material composition, absorbant qualities, sterility method, resorption time, biocompatibility, method of action, and removal. | Technological Characteristics: |
- Material/Construction: Derivative hyaluronic acid (same as Hyalsine and Merogel, different from MeroPack which uses hyaluronic acid AND collagen).
- Absorbant Qualities: In excess of 10 times weight of the device (same as MeroPack and Merogel).
- Sterility: E-beam irradiation (different from Gamma irradiation used by MeroPack and Merogel, but considered substantially equivalent as confirmed by the FDA).
- Resorption Time: If material still seen at 14 days, may be removed by surgeon (same as predicate devices).
- Biocompatibility: ISO 10993-1 (same as predicate devices).
- Method of Action: Hygroscopic, forms gelatinous mass in contact with fluids (same as predicate devices).
- Method of Removal: Natural elimination or gentle irrigation of residues (same as predicate devices).
- Bioreabsorbable: Yes (same as predicate devices). |
| Safety and Effectiveness: No significant differences that adversely affect safety or effectiveness compared to predicate devices. | Safety and Effectiveness: Biocompatibility data supports safety. Technological characteristics, design, and intended use are "well known, low risk" and substantially equivalent to previously cleared predicate devices. The risks and benefits to the patient are the same as those normally attributed to the use of an intranasal splint. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not Applicable. This is a non-AI device submission. The "study" here is a demonstration of substantial equivalence to predicate devices, not a clinical trial with a test set of data in the context of AI/ML.
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. This is a non-AI device submission, and "ground truth" as it pertains to expert annotation of data is not relevant here. The ground for acceptance is based on regulatory assessment of substantial equivalence.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not Applicable. This is a non-AI device submission.
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
Not Applicable. This is a non-AI device submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable. This is a non-AI device submission.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not Applicable in the traditional AI sense. The "ground truth" for this submission is the regulatory standard of "substantial equivalence" to legally marketed predicate devices, supported by:
- Comparison of technological characteristics.
- Biocompatibility testing results (ISO 10993-1).
- Demonstration of similar intended use and safety/effectiveness profiles.
8. The sample size for the training set
Not Applicable. This is a non-AI device submission.
9. How the ground truth for the training set was established
Not Applicable. This is a non-AI device submission.
§ 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.