(49 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 Antiqacterial Envelope is intended for single patient, one-time use only.
TYRX 110 Neuro Absorbable Antibacterial Envelope is a fully absorbable, dual component 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. 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 minocvcline have been shown to reduce infection in an in vivo model of bacterial challenge following surgical implantation of an implantable electronic device. This device is to be used in a healthcare facility/hospital by qualified personnel experienced in the procedure of VNS, DBS, SCN, or SNS implantation.
This document is a 510(k) summary for the TYRX Neuro Absorbable Antibacterial Envelope. It describes the device and its indications for use, and argues for its substantial equivalence to a predicate device (K142611).
Here's an analysis of the provided text in relation to acceptance criteria and supporting studies, based on the specific questions:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with corresponding performance metrics. Instead, it describes various studies and results to demonstrate safety and effectiveness for its expanded indications for use. The overall acceptance criterion is demonstrating substantial equivalence to the predicate device.
Here's a summary of the performance claims based on the provided text, linked to the implicit acceptance criteria for establishing substantial equivalence:
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Technological Characteristics Identical to Predicate | The technological characteristics of the TYRX™ Neuro Absorbable Antibacterial Envelope are identical to the predicate (TYRX™ Neuro Absorbable Antibacterial Envelope K142611). Both devices have the same intended use: to create a stable environment for the implanted device. The device is fully absorbable with the same Glycoprene II substrate mesh and coated with the same polyarylate polymer containing rifampin and minocycline at 102ug/cm². Manufacturing processes are also identical. |
| Expanded Indications for Use Safety | The animal study demonstrated that the device was safe, with no adverse clinical signs. Minocycline and rifampin in plasma and cerebrospinal fluid were not detectable, indicating no significant risk for CNS side effects from drug diffusion. |
| Biocompatibility | The device is supplied sterile, biocompatible, and non-pyrogenic. Biocompatibility testing of the predicate device (K142611) in accordance with ISO 10993 demonstrated the safety of the subject device. |
| Antimicrobial Activity (In vitro) | Referenced from predicate K142611: Demonstrated antimicrobial activity against Methicillin-resistant Staphylococcus aureus (MRSA), Staphylococcus aureus, Acinetobacter baumannii, Staphylococcus epidermidis, Staphylococcus lugdunensis, and Escherichia coli. |
| Infection Reduction (In vivo) | Referenced from predicate K142611: Demonstrated effectiveness in reducing infections. Bacteria tested: Staphylococcus aureus, Acinetobacter baumannii, Staphylococcus epidermidis, Escherichia coli, Methicillin-resistant Staphylococcus aureus (MRSA), and Staphylococcus lugdunensis. The activity of antimicrobials against non-epidermidis strains of coagulase-negative Staphylococci is noted as variable. |
| Sterility | TYRX follows the ISO 11137 standard for sterility. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
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Animal Study (for expanded indications):
- Sample Size: 8 sheep (2 sheep per treatment group across 4 treatment groups).
- Data Provenance: Not explicitly stated, but animal studies are typically prospective. No country of origin is mentioned.
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In vitro and In vivo efficacy testing (referenced from predicate K142611):
- Sample Size: Not specified in this document, as these studies belong to the predicate device.
- Data Provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This device is a physical medical device (an absorbable antibacterial envelope), not an AI/imaging device requiring expert interpretation for ground truth establishment in the traditional sense. The "ground truth" here relates to objective measures like drug concentrations (in the animal study), microbial inhibition (in vitro), and infection rates (in vivo), or material properties. Therefore, there are no explicitly mentioned "experts" establishing ground truth in the way described for diagnostic AI.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As this is not an AI/imaging device with human reader evaluations, there is no adjudication method for a test set of interpretations.
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 a diagnostic AI device, so no MRMC study involving human readers and AI assistance was conducted or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or software device. The product is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Animal Study: Ground truth was based on objective measurements:
- Absence of adverse clinical signs (clinical observation).
- Quantifiable concentrations of minocycline and rifampin in plasma and cerebrospinal fluid samples (laboratory analysis).
- In vitro studies (referenced from predicate K142611): Ground truth would be based on laboratory methods for demonstrating antimicrobial activity (e.g., zones of inhibition, minimum inhibitory concentrations).
- In vivo studies (referenced from predicate K142611): Ground truth would be based on outcomes data related to infection rates/reduction in animal models.
8. The sample size for the training set
Not applicable. This device is not an AI/machine learning model, so there is no training set in the context of AI development. The studies performed are for device safety and efficacy, not for training a model.
9. How the ground truth for the training set was established
Not applicable, as there is no 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.