(27 days)
MeroGel Injectable Bioresorbable Stent 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 Stent 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 Injectable Bioresorbable Stent is a sterile, transparent, viscoelactic, bioresorbable gel composed of cross-linked polymers of hyaluronic acid. The MeroGel Injectable Bioresorbable Stent fills ENT cavities following surgery or trauma to keep to 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 Injectable 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 an application for a 510(k) premarket notification for a medical device, which typically establishes substantial equivalence to a predicate device rather than strictly proving acceptance criteria through a standalone study with specific performance metrics and statistical analyses as might be seen for novel devices or AI/software.
The document describes a MeroGel Injectable Bioresorbable Dressing (Stent). The key to its acceptance is demonstrating substantial equivalence to already legally marketed devices. Therefore, the "acceptance criteria" are primarily related to conforming to the characteristics and intended use of its predicate devices, rather than predefined performance thresholds against a ground truth dataset.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) for a physical medical device (a bioresorbable dressing) rather than an AI/software device, the concept of "acceptance criteria" and "device performance" in the context of accuracy, sensitivity, or specificity against a ground truth as described in the prompt is not directly applicable.
Instead, the acceptance criteria are met by demonstrating substantial equivalence to predicate devices across several key characteristics. The "reported device performance" is essentially the device's characteristics aligning with those of the predicates.
| Feature/Criterion (Acceptance Criteria are implied by equivalence to predicates) | MeroGel Injectable Bioresorbable Stent (Proposed Device) | Sepragel™ ENT Nasal/Sinus and Otologic Dressing (Predicate 1) | MeroGel™ Otologic Pack (Predicate 2) |
|---|---|---|---|
| Intended Use/Indications | - Space occupying gel stent | - Space-occupying gel stent | - Space occupying dressing/stent |
| - Separate & prevent adhesions | - Separate & prevent adhesions | - Separate mucosal surfaces | |
| - Help control minimal bleeding | - Help control minimal bleeding | - Help control minimal bleeding | |
| - Act as adjunct to aid natural healing | - Act as adjunct to aid natural healing | - Act as adjunct to aid natural healing | |
| - Use in middle/external ear (canalplasty, | - Use in middle/external ear (canalplasty, | - Use in middle/external ear (canalplasty, | |
| myringoplasty, tympanoplasty, stapes/mastoid surgery) | myringoplasty, tympanoplasty, stapes/mastoid surgery) | myringoplasty, tympanoplasty, stapes/mastoid surgery) | |
| - Use in nasal/sinus (prevent lateralization, adhesions) | - Use in nasal/sinus (prevent lateralization, adhesions) | - (Not explicitly listed for nasal/sinus - pack) | |
| Material | Derivative hyaluronic acid | Derivative hyaluronic acid | Derivative hyaluronic acid |
| Bioresorbable | YES | YES | YES |
| Sterile | YES | YES | YES |
| Product Matrix | Gel in a syringe | Gel in a syringe | Non-woven pad in a protective folded sheet |
| Product Code | 77NHB | 77KHJ | 77KHJ |
Summary of Device Performance: The proposed MeroGel Injectable Bioresorbable Stent matches its primary predicate (Sepragel™ ENT) very closely in intended use, indications, material, bioresorbability, sterility, and product matrix (gel in a syringe). It also shares similar features with the secondary predicate (MeroGel™ Otologic Pack) concerning material, bioresorbability, sterility, and some ear indications, although the form factor (gel vs. pad) differs. The differences in product code (NHB vs KHJ) likely reflect minor classification distinctions, but the fundamental properties for demonstrating substantial equivalence are present.
The subsequent points (2-9) are not applicable to this 510(k) submission, as it relates to a physical medical device and not an AI/software-based diagnostic or prognostic tool. The document does not describe any study involving AI, machine learning, image analysis, or any process that would require a "test set," "training set," "ground truth established by experts," "adjudication," or "MRMC comparative effectiveness study."
This 510(k) is a regulatory filing for a device based on its physical and chemical properties and intended use, demonstrating equivalence to already approved devices. The "study" here is essentially the comparison presented in the table above and supporting documentation (not provided in full here, but typically includes biocompatibility, sterilization validation, material characterization, etc.).
§ 874.3620 Ear, nose, and throat synthetic polymer material.
(a)
Identification. Ear, nose, and throat synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is used, for example, in augmentation rhinoplasty and in tissue defect closures in the esophagus. The device is shaped and formed by the suregon to conform to the patient's needs. This generic type of device is made of material such as polyamide mesh or foil and porous polyethylene.(b)
Classification. Class II.