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510(k) Data Aggregation
(60 days)
TYRX Neuro Non-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 Non-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 or deep brain 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 Non-Absorbable Antibacterial Envelope is intended for single-patient, one-time use only.
TYRX TM Neuro Non-Absorbable Antibacterial Envelope is a dual component (absorbable and non-absorbable) sterile device designed to hold a vagus nerve stimulator (VNS), a deep brain stimulator (DBS), a spinal cord neuromodulator (SCN) or a sacral nerve stimulator (SNS) securely to create a stable environment when implanted in the body. The device is available in 2 sizes, Medium (2.5" x 2.7" ) and Large (2.9" x 3.3"). The device is constructed of knitted filaments of polypropylene (mesh substrate) that are coated with an absorbable polyarylate polymer mixture containing the antimicrobial agents rifampin and minocvcline. Rifampin and minocycline have been shown to reduce infection in an in vivo model of bacterial challenge following surgical implantation of an implantable pulse generator. This device is to be used in a healthcare facility/hospital by personnel experienced in the implantation of VNS, DBS, SCN, or SNS.
This is a 510(k) premarket notification for a medical device called the "TYRX™ Neuro Non-Absorbable Antibacterial Envelope". The document establishes the device's substantial equivalence to previously cleared predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance:
Based on the provided document, the acceptance criteria are primarily related to substantial equivalence to predicate devices, particularly regarding safety and effectiveness, antimicrobial activity, and biocompatibility.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Substantial Equivalence | Identical physical construct to predicate (K132699). | "The TYRX Neuro Non-Absorbable Antibacterial Envelope is identical in terms of physical construct to the cleared primary predicate, AIGIS Neuro Antibacterial Envelope,(K132699)." |
| Identical polymer coating concentration of antibiotics. | "The polymer coating concentration of the antibiotics rifampin and minocycline remains unchanged." (Compared to predicate K132699). | |
| Identical physical, chemical, mechanical properties. | "The physical, chemical and mechanical properties of the TYRX Neuro Non-Absorbable Antibacterial Envelope, subject device, are the same as the predicate device (K132699)." | |
| Expanded Indications for Use consistent with another predicate (K150291). | "The only difference is that the subject device has an expanded Indications for Use to include use with Deep Brain Stimulators and Sacral Nerve Stimulators, which is identical to predicate K150291." The original predicate (K132699) had a more limited indication for use which did not include DBS and SNS. | |
| Biocompatibility | Meets ISO 10993 series standards. | "Biocompatibility testing in accordance to the current ISO 10993 series was conducted and the results indicate that the device is biocompatible, per the standards." |
| Antimicrobial Activity | Demonstrates antimicrobial activity against pathogens. | "In vitro studies referenced in the predicate devices K132699 and K150291 demonstrated antimicrobial activity against methicillin resistant Staphylococcus aureus (MRSA), Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus lugdunensis, Escherichia coli, Acinetobacter baumannii, Enterobacter aerogenes, and Proteus Mirabilis." |
| Demonstrates effectiveness in reducing infections in vivo. | "In vivo efficacy testing referenced in the predicate devices K132699 and K150291, demonstrated effectiveness in reducing infections. The bacteria tested were methicillin-resistant Staphylococcus aureus (MRSA), Staphylococcus aureus, Staphylococcus epidermidis, Acinetobacter baumannii, Escherichia coli and Staphylococcus lugdunensis." (Note: The document also states "the in vivo and in vitro activity... is variable against non-epidermidis and non-lugdunensis strains of coagulase-negative Staphylococci.") | |
| Safety (CNS Effects) | No quantifiable minocycline/rifampin in plasma/CSF; no adverse clinical signs. | "The study demonstrated that the TYRX Neuro Antibacterial Envelope was safe in the sheep model as assessed by the absence of adverse clinical signs. There were no quantifiable concentrations of minocycline or rifampin in plasma and cerebrospinal fluid samples collected up to 7 days after implantation..." This study was conducted for both absorbable (K150291) and non-absorbable (K132699) envelopes. |
| Functionality (No Interference with IPG) | Does not alter or interfere with an implantable pulse generator. | "An in vivo functionality study showed that TYRX devices do not alter or interfere with an implantable pulse generator." |
2. Sample Size Used for the Test Set and Data Provenance:
- Antimicrobial Activity (In vitro/In vivo efficacy testing): The document references studies from predicate devices (K132699 and K150291). The specific sample sizes for these in vitro and in vivo tests are not provided in this document. The provenance is from previous studies submitted for the predicate devices.
- CNS Effects (Sheep Study): The sample size for the sheep study is not explicitly stated beyond "a study in sheep." The data provenance is a prospective animal study conducted to address specific safety concerns related to minocycline diffusion into the CNS.
- Biocompatibility: The document states that "Biocompatibility testing in accordance to the current ISO 10993 series was conducted." The specific sample size for these tests is not provided. Data provenance is from biocompatibility tests.
- Functionality (IPG Interference): The document states "An in vivo functionality study showed..." The specific sample size for this study is not provided. Data provenance from an in vivo functionality study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This document describes pre-clinical testing and substantial equivalence claims, not clinical efficacy studies with human experts establishing ground truth for diagnostics. Therefore, this information is not applicable in the context of this 510(k) submission.
4. Adjudication Method for the Test Set:
This information is not applicable as the document describes pre-clinical testing and substantial equivalence, not a clinical study requiring adjudication of expert readings.
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:
This information is not applicable. This document is for a physical medical device (an antibacterial envelope), not an AI/software device, and thus no MRMC study involving human readers and AI assistance was conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
This information is not applicable as the device is a physical antibacterial envelope, not an algorithm.
7. The Type of Ground Truth Used:
- Antimicrobial Activity: The ground truth would be established by microbiological laboratory analyses (e.g., inhibition zones in in vitro studies, bacterial counts/infection rates in in vivo animal models) demonstrating effectiveness against specific bacterial strains.
- Biocompatibility: Ground truth is established by conformance to ISO 10993 standards for biological evaluation of medical devices, involving various in vitro and in vivo tests to assess cytotoxicity, sensitization, irritation, etc.
- Safety (CNS Effects): Ground truth was established by analytical chemistry methods (to detect minocycline/rifampin concentrations in plasma and CSF) and clinical observation (for adverse clinical signs) in the sheep model.
- Functionality (IPG Interference): Ground truth would be established by direct measurement of IPG function/parameters in the presence of the device in an in vivo model.
8. The Sample Size for the Training Set:
This information is not applicable. This submission concerns a physical medical device, not a machine learning or AI algorithm that requires a training set. The "studies" mentioned are pre-clinical tests, not training for an algorithm.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as no training set for an algorithm was used.
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