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510(k) Data Aggregation
(82 days)
MEROGEL INJECTABLE BIORESORBABLE NASAL DRESSING AND SINUS STENT AND OTOLOGIC GEL
MeroGel Injectable Bioresorbable Nasal Dressing and Sinus Stent and Otologic Gel is a space occupying gel stent intended to separate and prevent adhesions between mucosal surfaces, help control minimal bleeding following surgery or nasal trauma, and act as an adjunct to aid in the natural healing process.
MeroGel Injectable Bioresorbable Nasal Dressing and Sinus Stent and Otologic Gel is indicated for use in the middle ear and external ear canal following canalplasty, myringoplasty, tympanoplasty, and stapes and mastoid surgery. The device is indicated following nasal / sinus surgery or trauma to prevent lateralization of the middle turbinate and nasal adhesions during the post operative period.
MeroGel is a sterile, transparent, viscoelactic, bioresorbable gel composed of cross-linked polymers of hyaluronic acid. The MeroGel device fills ENT cavities following surgery or trauma to keep tissues or structures separate during the healing process. During this time, the tamponade effect helps control minimal bleeding normally associated with routine ENT surgery. MeroGel leaves the site of placement by natural elimination, or it may be aspirated from the cavity earlier at the discretion of the physician.
This is a 510(k) premarket notification for a medical device (MeroGel Injectable Bioresorbable Nasal Dressing and Sinus Stent and Otologic Gel), not an AI/ML-driven diagnostic device. Therefore, the information typically found in a study proving the device meets AI/ML acceptance criteria (such as sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance) is not applicable here.
The "study" in this context refers to the testing performed to demonstrate substantial equivalence to a predicate device.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative performance metric sense (e.g., sensitivity, specificity). Instead, it focuses on demonstrating substantial equivalence to a predicate device (K070886) by showing that the proposed device performs identically or similarly across key characteristics. The "performance" is implicitly deemed acceptable if it matches the predicate or meets established standards for safety and effectiveness for such a device.
| Characteristic/Test | Acceptance Criteria (Implied: Equivalent to Predicate K070886 or established standards) | Reported Device Performance |
|---|---|---|
| Formulation | Viscosity and HA concentration to be equivalent to predicate. | Tested; results support equivalence. |
| Filling Process | To ensure consistent product characteristics and safety. | Tested; results support equivalence. |
| Terminal Sterilization Processes (primary and secondary) | To achieve sterility assurance level (SAL). | Tested; results support equivalence. |
| Assembly | To ensure proper device construction and functionality. | Tested; results support equivalence. |
| Biocompatibility | To ensure safety for use in the body (e.g., non-toxic, non-irritating, non-sensitizing per ISO 10993). | Tested; results support equivalence. |
| Labeling and Packaging | To meet regulatory requirements and ensure product integrity. | Tested; results support equivalence. |
| Intended Use / Indication | Identical to K070886. | Identical to K070886. |
| Material | Derivative hyaluronic acid (identical to K070886). | Derivative hyaluronic acid. |
| Bioresorbable | Yes (identical to K070886). | Yes. |
| Sterile | Yes (identical to K070886). | Yes. |
| Product Matrix | Gel in a syringe (identical to K070886). | Gel in a syringe. |
2. Sample Size Used for the Test Set and the Data Provenance
This information is not provided in the document. The document describes tests performed on the device itself and its manufacturing processes, not a "test set" of patient data for evaluating an AI algorithm.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided and is not applicable to this type of device submission. Ground truth, in the context of AI/ML, refers to labels for data, which wasn't established for this device.
4. Adjudication Method for the Test Set
This information is not provided and is not applicable.
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 provided and is not applicable. This device is a physical medical implant/dressing, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not provided and is not applicable. This device is not an algorithm.
7. The Type of Ground Truth Used
This information is not provided and is not applicable. The assessment is based on physical and chemical properties and functional equivalence, not on a "ground truth" derived from patient outcomes or pathology.
8. The Sample Size for the Training Set
This information is not provided and is not applicable. This device is a manufactured product, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not provided and is not applicable.
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