(142 days)
TYRX Neuro Absorbable Antibacterial Envelope is intended to hold a vagus nerve stimulator, a spinal cord neuromodulator, a deep brain stimulator or a sacral nerve stimulator 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 in conjunction with spinal cord neuromodulators or sacral nerve stimulators implanted laterally to the body midline and slightly superior to the gluteal region.
TYRX™ Neuro Absorbable Antibacterial Envelope (TYRX Neuro Envelope) is a sterile prosthesis comprised of two components; an absorbable substrate mesh, and a resorbable tyrosine based polyarylate polymer containing the antimicrobial agents, rifampin and minocycline, and is designed to hold a vagus nerve stimulator, a spinal cord neuromodulator, a deep brain stimulator, or a sacral nerve stimulator securely to create a stable environment when the device is implanted in the body.
The TYRX Neuro Envelope is constructed of knitted filaments of Glycoprene II, a polymer composed of glycolide, caprolactone, and trimethylene carbonate polymer, which are coated with a bioresorbable polyarylate polymer containing the drug substances rifampin and minocycline.
Like its predicate device , the TRYX Neuro Envelope is supplied in two sizes, a 2.5 in. x 2.7 in. pacemaker size (Medium), and a 2.9 in. x 3.3 in. ICD size (Large).
This document is a 510(k) summary for a medical device (TYRX Neuro Absorbable Antibacterial Envelope). It focuses on demonstrating substantial equivalence to a predicate device, primarily due to changes in packaging and an extended shelf life.
It does not describe a study that involves software with acceptance criteria and device performance in the way typically associated with diagnostic or AI/ML devices. Therefore, a table of acceptance criteria and device performance, as well as several other requested points (sample sizes, expert qualifications, MRMC studies, standalone performance, training set details), are not applicable to this type of submission.
The core of this submission is about physical device stability and packaging integrity rather than the performance of a diagnostic or AI algorithm.
However, I can extract the relevant information that is present in the document regarding the "study" that proves the device meets its core claims (which, in this context, relate to shelf life).
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria / Performance Requirement (Implied/Stated) | Reported Device Performance / Study Finding |
|---|---|---|
| Shelf Life | Continued to meet all product requirements through the proposed extended shelf life. | "Results of this study demonstrate the TYRX Neuro Envelope, both medium and large size, in modified foil pouch packaging continue to meet all product requirements through the proposed shelf life." The document states "stabilty study data collected per ICH guidelines" supports this claim. The exact duration of the extended shelf life is not explicitly stated in the provided text, but it is implied to be longer than the predicate device's shelf life. |
| Packaging Integrity | Modified packaging validated for use and demonstrated to meet the same sterility assurance level as the current package. | "The modified foil pouch packaging is constructed of similar materials (layered polyethylene and foil) and the foil pouch peel strength is the same as the current package." |
| "The modified packaging has been validated for use and demonstrated to meet the same sterility assurance level as the currently marketed package." | ||
| Drug Component Stability | Stability of antimicrobial agents (rifampin and minocycline) throughout the extended shelf life. | Implied by "continue to meet all product requirements through the proposed shelf life." The product specifications, including drug content, must remain within defined limits. |
| Sterility | Maintenance of sterility assurance level within proposed shelf life. | "The modified packaging has been validated for use and demonstrated to meet the same sterility assurance level as the currently marketed package." Implied that this sterility is maintained for the extended shelf life. |
| Functional Performance | Ability to securely hold a nerve stimulator and create a stable environment. | "Overall, these modifications do not affect the intended use of the device or alter the fundamental scientific technology." and "There are no changes to the physical design, principles of operation, or mechanism of action of the current TYRX Neuro Envelope." The original function of the envelope is assumed to be maintained because the physical structure and materials (apart from packaging) are unchanged. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in the provided text. The stability study would have involved a number of manufactured units of the device.
- Data Provenance: Not specified, but implied to be internal testing conducted by Medtronic, Inc. This is a technical (benchtop/laboratory) study, not a clinical study involving patient data. This would be prospective data collection, specifically designed to test the extended shelf life.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This submission does not involve expert review or "ground truth" establishment in the context of diagnostic performance. The "ground truth" for shelf life testing is determined by laboratory measurements against predefined product specifications.
4. Adjudication method for the test set
- Not Applicable. No human adjudication of results is described, as this is a technical/engineering study for shelf life.
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 is not an AI/ML or diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an AI/ML or algorithm-based device.
7. The type of ground truth used
- For the shelf-life extension: Product Specifications. The "ground truth" is that samples tested at various time points during the stability study must continue to meet established finished product specifications for properties like drug content, sterility, physical integrity (e.g., peel strength), etc.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML or algorithm-based device that undergoes a "training" process.
9. How the ground truth for the training set was established
- Not Applicable.
§ 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.