(106 days)
TYRX™ Neuro Absorbable Antibacterial Envelope is intended to hold a vagus nerve stimulator or spinal cord neuromodulator securely in order to create a stable environment when implanted in the body.
TYRX™ Neuro Absorbable Antibacterial Envelope contains the antimicrobial agents rifampin and minocycline which have been shown to reduce infection in an in vivo model of bacterial challenge following surgical implantation of a pulse generator. This device is intended to be used in conjunction with vagus nerve stimulators implanted in the infraclavicular fossa, or spinal cord neuromodulators implanted laterally to the body midline and slightly superior to the gluteal region.
TYRX™ Neuro Absorbable Antibacterial Envelope is intended for single patient, one-time use only.
TYRX ™ Neuro Absorbable Antibacterial Envelope is a fully absorbable , dual component sterile device designed to hold a vagus nerve stimulator or spinal cord neuromodulator securely to create a stable environment when implanted in the body. It is constructed of knitted filaments of a commercially available absorbable polymer, Glycoprene II, comprised of glycolide, caprolactone and trimethylene carbonate polymer, and coated with an absorbable polyarylate polymer mixture containing the antimicrobial agents rifampin and minocycline. Rifampin and minocycline have been shown to reduce infection in an in vivo model of bacterial challenge following surgical implantation of an implantable electronic device is to be used in a healthcare facility/hospital by personnel experienced in the procedure of vagus nerve or spinal cord neuromodulator implantation.
This document describes a 510(k) premarket notification for the TYRX™ Neuro Absorbable Antibacterial Envelope. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets new acceptance criteria through a dedicated study with specific performance metrics.
Therefore, many of the requested elements for a study proving acceptance criteria cannot be extracted directly from this document. The document primarily details comparative information with predicate devices and safety testing.
Here's an analysis of the provided information based on your questions:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not present a table of specific acceptance criteria (e.g., a certain percentage reduction in infection rate, a specific tensile strength at a given time point) that the new device was tested against in its own clinical study. Instead, it relies on demonstrating equivalence to predicate devices, which were previously cleared.
However, it does mention results from in vitro and in vivo studies that support the predicate devices' antimicrobial activity, which is a key performance aspect.
| Performance Characteristic | Acceptance Criteria (Implied from Predicate) | Reported Device Performance (Inherited/Demonstrated through Equivalence) |
|---|---|---|
| Antimicrobial Activity | Effective against common bacteria (MRSA, S. aureus, A. baumannii, S. epidermidis, S. lugdunensis, E. coli) | Demonstrated by predicate devices (K132699 and K130943). The subject device uses the identical antimicrobial coating at the same concentrations. |
| Biocompatibility | Biocompatible, non-pyrogenic | "Supplied sterile, biocompatible, and non-pyrogenic." Demonstrated for predicate devices (ISO 10993). |
| Sterility | Sterile | "TYRX follows the ISO 11137 standard for sterility." |
| Degradation | Glycoprene II mesh degrades into constituent monomers | "Bench testing demonstrated that the Glycoprene II mesh degrades into its constituent monomers." |
| No Chemical Interaction | No chemical or physical interaction between components | "Bench testing demonstrated... there is no chemical or physical interaction between the Glycoprene mesh, the polyarylate coating or the antibiotics." |
| Stable Environment | Ability to hold a neuromodulator securely and create a stable environment | Intended Use is identical to the predicate device, implying similar mechanical stability for holding the device. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated for any new clinical test set for the subject device. The document refers to "in vitro studies" and "in vivo efficacy testing" performed on the predicate devices. The sample sizes for these predicate studies are not provided in this document.
- Data Provenance: The "in vivo efficacy testing" was "previously submitted with the primary predicate, K132699" and "previously submitted with predicate K130943." This implies the data is likely retrospective relative to this 510(k) submission, as it comes from prior submissions. The country of origin is not specified, but given the FDA submission, it would adhere to US regulatory standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided. The document highlights laboratory (in vitro), animal (in vivo), and bench testing, not studies requiring human expert adjudication of clinical outcomes in the same way a diagnostic imaging device might.
4. Adjudication Method for the Test Set
Not applicable for the types of tests described (in vitro, in vivo efficacy in animals, bench testing).
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 device is a medical implant (envelope for neuromodulators) containing antibiotics, not an AI-powered diagnostic or assistive tool for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable, as this is not an algorithm. However, the in vitro and in vivo animal efficacy studies can be considered standalone performance assessments of the antimicrobial properties and safety profile.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
- For antimicrobial activity (in vitro): Direct observation of bacterial inhibition/killing.
- For in vivo efficacy (animal studies): Likely based on direct measurement of infection rates or bacterial counts at the surgical site in animal models, comparing treated groups to control groups. This would be considered "outcomes data" in an animal model.
- For biocompatibility: Standardized toxicological and immunological endpoints as per ISO 10993.
- For degradation and interaction: Bench testing and chemical analysis.
8. The Sample Size for the Training Set
Not applicable. This device does not involve machine learning or AI that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. This device does not involve machine learning or AI that requires a "training set."
§ 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.