(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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 17, 2015
Tyrx, Inc. % Regina Novak Senior Regulatory Affairs Specialist Medtronic TYRX, Inc. 1 Deer Park Drive Suite G Monmouth Junction, New Jersey 08852
Re: K152678
Trade/Device Name: Tyrx Neuro Antibacterial Envelope Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: FTL Dated: September 17, 2015 Received: September 18, 2015
Dear Ms. Novak:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
William J. Heetderks -S
for
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| Form Approved: OMB No. | 0910-0120 |
|---|---|
| Expiration Date: | January 31, 2017 |
| See PRA Statement below. |
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
| 510(k) Number (if known) | K152678 |
|---|---|
| Device Name | TYRX Neuro Non-Absorbable Antibacterial Envelope |
| Indications for Use (Describe) | 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. |
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------ | ----------------------------------------------------------- |
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Image /page/3/Picture/0 description: The image shows the Medtronic logo. The logo features a stylized human figure in motion, depicted in a circular frame. Below the figure is the word "Medtronic" in a bold, blue font.
510(k) Summary
Medtronic, Inc. Medtronic TYRX 1 Deer Park Drive, Suite G Monmouth Junction, NJ 08852 www.tvrx.com
el 732.246.8676 ax 732.246.8677
In accordance with 21 CFR 807.92, TYRX, Inc. provides this summary of the safety and effectiveness information available for TYRX™ NeuroNon-Absorbable Antibacterial Envelope, as well as the substantial equivalence decision making process used for the TYRX™ Neuro Antibacterial Envelope subject device.
Sponsor/Applicant Name and Address:
TYRX Inc. DBA Medtronic TYRX, Inc. 1 Deer Park Drive Suite G Monmouth Junction, N.J. 08852
Establishment Registration Number:
Sponsor Contact Information:
Date of preparation of 510(k) Summary
New Device Trade/Proprietary Name:
Device Common Name:
3005619263
Regina Novak Senior Regulatory Affairs Specialist Phone: 732-964-1492 732-246-8677 Fax: Email:regina.novak(@medtronic.com
Alternate Contact: Susan Olinger, JD Director, Regulatory Affairs Phone: 732-964-1110 763-246-8677 Fax: Email:susan.olinger@medtronic.com
September 17, 2015
TYRX™ Neuro Non-Absorbable Antibacterial Envelope
Surgical Mesh
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Regulatory Classification: PROCODE:
Class II FTL
Predicate Device Name and 510(k) Number
Primary Predicate AIGISRx N Antibacterial Envelope K132699
TYRX™ Neuro Absorbable Antibacterial Envelope K150291
Device Description:
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.
Indications for Use
TYRX TM Neuro Non-Absorbable Antibacterial Envelope is intended to hold a vagus nerve stimulator, deep brain stimulator, spinal cord neuromodulator, or sacral nerve stimulator securely in order to create a stable environment when implanted in the body.
TYRX TM 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
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infraclavicular fossa and spinal cord neuromodulators or sacral nerve stimulators implanted laterally to the body midline and slightly superior to the gluteal region.
TYRX 110 Neuro Non-Absorbable Antibacterial Envelope is intended for single-patient, one-time use only.
Technological Characteristics
The technological characteristics of the TYRX Neuro Non-Absorbable Antibacterial Envelope are identical to the predicate (K132699). Both devices have intended use which is to create a stable environment for the implanted neurostimulator.
The only difference between the subject and predicate device (K132699) is that the subject device will have an expanded Indications for Use to include deep brain stimulators and sacral nerve stimulators, the same indications for use as K1250291.
The TYRX 114 Neuro Non-Absorbable Antibacterial Envelope is constructed of knitted filaments of polypropylene and coated with an absorbable polyarylate polymer coating containing the antibiotics rifampin and minocycline each in concentrations of 102ug/cm2.
The physical, chemical and mechanical properties of the TYRX Neuro Non-Absorbable Antibacterial Envelope, subject device, are the same as the predicate device (K132699). There is no technological difference between the subject and predicate device, and there are no design changes to the predicate device. The difference is only an expansion of the Indications for Use to include use with Deep Brain Stimulators and/or Sacral Nerve Stimulators, the same as the Indications for Use for K150291.
Biocompatability Results
Biocompatibility testing in accordance to the current ISO 10993 series was conducted and the results indicate that the device is biocompatible, per the standards.
An in vivo functionality study showed that TYRX devices do not alter or interfere with an implantable pulse generator.
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Animal Studies
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,
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. It should be noted that the in vivo and in vitro activity of the TYRX TM Neuro Non-Absorbable Antibacterial Envelope antimicrobials is variable against non-epidermidis and non-lugdunensis strains of coagulase-negative Staphylococci.
To provide additional evidence on the safety of TYRX™ Neuro Antibacterial Envelopes when implanted with neuromodulators, a study in sheep was conducted to address the question of minocycline diffusion with the TYRX™ Neuro Antibacterial Envelope (absorbable and non absorbable) and possible central nervous system (CNS) effects. The purpose of the study was to determine the concentration of minocycline and rifampin in the plasma and cerebrospinal fluid of sheep implanted with a neuromodulator and a TYRX Neuro Antibacterial Envelope (absorbable (K150291) or non absorbable (K132699), with or without a lead.
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 of the neuromodulator enclosed in the TYRX Neuro Antibacterial Envelope, with or without leads. This study demonstrated that the amount of minocycline in CSF and plasma, as a result of the TYRX Neuro Antibacterial Envelope implantation is not detectable and does not pose a significant risk for CNS side effects.
CONCLUSION:
In summary, the TYRX Neuro Non-Absorbable Antibacterial Envelope is identical in terms of physical construct to the cleared primary predicate, AIGIS Neuro Antibacterial Envelope,(K132699). The polymer coating concentration of the antibiotics rifampin and
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minocycline remains unchanged. The device is supplied sterile. 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.
Based on the 510(k) summaries and the information provided, we conclude that TYRX TM Neuro Non-Absorbable Antibacterial Envelope is safe and effective for its intended use, and is substantially equivalent to the primary predicate device (K132699).
§ 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.