(250 days)
Sepragel ENT packing/stent is indicated for use in patients undergoing nasal/sinus, middle ear and external ear canal surgery as a space-occupying dressing and/or stent intended to prevent adhesions in the nasal cavity, separate mucosal surfaces, help control minimal bleeding following surgery or trauma, and act as an adjunct to aid in the natural healing process. The device is indicated for use in the middle ear following canalplasty, myringoplasty, tympanoplasty, stapes and mastoid surgery. The device is indicated following nasal/sinus surgery or trauma to prevent lateralization of the middle turbinate during the post operative period.
Sepragel ENT is a sterile, non-pyrogenic, transparent, viscoelastic, bioresorbable gel composed of cross-linked molecules of hyaluronan. It is indicated for use in patients undergoing nasal/sinus, middle ear and external ear canal surgery as a space-occupying dressing and/or gel stent intended to separate and prevent adhesions between mucosal surfaces, to help control minimal bleeding following surgery or trauma, and act as an adjunct to aid in the natural healing process.
SeprageI™ ENT hylan B gel, is a sterile, non-pyrogenic, transparent, viscoelastic gel composed of cross-linked molecules of hyaluronan. This hyaluronan is a bioresorbable material that functions to fill the sinus cavity, middle ear and external ear canal following surgery and to keep mucosal surfaces separate during the healing process. During this time, the tamponade effect helps control minimal bleeding normally associated with routine Otologic surgery. Sepragel ENT leaves the site of placement by natural elimination. In nasal/sinus applications it may be aspirated from the cavity earlier at the discretion of the physician.
The provided text describes a 510(k) premarket notification for the Sepragel™ ENT Bioresorbable Packing/Stent. A 510(k) submission is primarily for demonstrating substantial equivalence to a legally marketed predicate device, not necessarily for proving that a device meets specific clinical performance acceptance criteria through the types of studies typically associated with clinical trials of AI/ML devices or novel therapies.
Based on the provided text, there is no information about:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for a test set or data provenance for a performance study.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication methods.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
- Standalone (algorithm only) performance studies.
- Type of ground truth used (e.g., pathology, outcomes data).
- Sample size for a training set.
- How ground truth for a training set was established.
The document demonstrates regulatory approval based on substantial equivalence to predicate devices. The key aspects of the submission are:
1. Acceptance Criteria and Device Performance:
No specific quantitative acceptance criteria or reported device performance metrics (e.g., sensitivity, specificity, accuracy) are mentioned. The approval is based on demonstrating that the Sepragel™ ENT is substantially equivalent in terms of intended use, technological characteristics, and safety to already marketed devices.
2. Study/Evidence for Substantial Equivalence:
The "study" or evidence provided is a comparison of technological characteristics to predicate devices, as detailed in Table 4. This table highlights similarities and some differences in:
- Manufacturer
- Product Classifications/Codes
- Intended Use/Indications
- Material Composition (Derivative hyaluronic acid for all)
- Bioresorbability (YES for all)
- Product matrix (Gel in a syringe for Sepragel ENT and Hylasine™, Non-woven pad for MeroGel™)
The document asserts that Sepragel™ ENT is "substantially equivalent" to these predicates because it shares material composition (hyaluronan), bioresorbability, similar intended uses (with Sepragel ENT having an expanded indication to middle and external ear applications not explicitly listed for Sepragel Sinus, but listed for MeroGel Otologic Pack), and a similar product matrix to Sepragel Sinus.
3. Other Requested Information (Not Applicable/Not Provided):
All other requested points (sample sizes, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, type of ground truth, training set size, training ground truth establishment) are not relevant or not provided in this type of 510(k) submission. These details are typically found in clinical trials or performance studies designed to evaluate the efficacy or accuracy of a device, especially for AI/ML or diagnostic tools, which is not the nature of this submission. The submission is focused on demonstrating that the device is as safe and effective as devices already on the market through comparison.
§ 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.