(135 days)
Glucamesh™/Glucatex™ Surgical Mesh is intended for the use as a prosthesis in general surgery for surgical treatment of abdominal wall reinforcement, hernia repairs, eventrations, rectal and genitourinary prolapse. The meshes are biocompatible and not biodegradable. The device is intended to be implanted by a qualified surgeon.
Glucatex mesh is constructed of polypropylene or polyester which is identical in composition to that used in Prolene Soft Mesh, Mersitence or Biomesh. The mesh affords excellent strength, durability and surgical adaptability, with sufficient porosity for necessary tissue ingrowth.
Here's an analysis of the provided information regarding the GlucaMesh and Glucatex (Polypropylene/Polyester) Mesh, focusing on acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Technological Characteristics | Similar to Prolene, Mersilene, and Biomesh (constructed of polypropylene and polyester) | "For technical characteristics, the values established for GlucaMesh and Glucatex are similar to those established by Prolene, Mersilene and Biomesh which were constructed of polypropylene and polyester." |
| Biocompatibility | Biocompatible (implied by substantial equivalence and predicate device characteristics) | "The meshes are biocompatible..." |
| Material Degradation | Not biodegradable (implied by substantial equivalence and predicate device characteristics) | "...and not biodegradable." |
| Mechanical Properties (Strength, Durability, Porosity) | Excellent strength, durability, sufficient porosity for tissue ingrowth (implied by substantial equivalence to predicate devices known for these properties) | "The mesh affords excellent strength, durability and surgical adaptability, with sufficient porosity for necessary tissue ingrowth." |
| Intended Use/Indications | Use as a prosthesis in general surgery for abdominal wall reinforcement, hernia repairs, eventrations, rectal and genitourinary prolapse. | "This mesh is intended for the use as a prosthesis in general surgery for surgical treatment of abdominal wall reinforcement, hernia repairs, eventrations, rectal and genitourinary prolapse." The FDA letter also confirms the indications for use. |
| Safety and Effectiveness | Substantially equivalent to predicate devices (Prolene Soft, Mersilene, Biomesh) | "Based on the 510(k) summaries and 510(k) statements (21 CFR 807) and the information provided herein, we conclude that the new device is substantially equivalent to the Predicate Device(s) under the Federal Food, Drug and Cosmetic Act." |
Study Information (Based on the provided K021835 documentation):
The provided documentation describes a 510(k) Premarket Notification for the GlucaMesh/Glucatex Surgical Mesh. This regulatory pathway primarily relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials for de novo approval.
Here's a breakdown of the study aspects based on the given text:
2. Sample Size Used for the Test Set and the Data Provenance:
- Sample Size for Test Set: Not applicable (N/A) in the context of a clinical test set. The submission refers to "Sufficient bench testing" and a comparison of technological characteristics to predicate devices. There is no mention of a clinical test set of patients or data in the provided documents.
- Data Provenance: The primary data provenance is bench testing and comparison to the known characteristics of predicate devices. There is no mention of a specific country of origin, nor whether any human data (if collected) was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
- Not applicable (N/A). There is no mention of a test set requiring expert ground truth in the provided summary. The substantial equivalence determination is based on a comparison of technical characteristics and intended use to established predicate devices.
4. Adjudication Method for the Test Set:
- Not applicable (N/A). No clinical test set or expert adjudication is described in the provided documents.
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. An MRMC comparative effectiveness study is not mentioned as part of this 510(k) submission. This type of study is typically associated with AI-driven diagnostic or screening devices, which is not the nature of a surgical mesh.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This device is a surgical mesh, not an algorithm. Therefore, a standalone algorithm performance study is not applicable.
7. The Type of Ground Truth Used:
- The "ground truth" in this context is the established physical and material characteristics, performance, and clinical history of the predicate devices (Prolene Soft, Mersilene, Biomesh), combined with the results of bench testing for the GlucaMesh/Glucatex. The substantial equivalence argument serves as the "truth" for regulatory purposes here.
8. The Sample Size for the Training Set:
- Not applicable (N/A). There is no "training set" in the context of an AI/machine learning model for this surgical mesh submission. The development relies on established engineering principles, material science, and comparison to existing devices.
9. How the Ground Truth for the Training Set was Established:
- Not applicable (N/A). As there is no training set for an AI model, this question does not apply.
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.