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.

Device Description

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.

AI/ML Overview

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)

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.
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.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 27, 2015

Medtronic Tyrx, Inc. Regina Novak Senior Regulatory Affairs Specialist 1 Deer Park Drive Suite G Monmouth Junction, New Jersey 08852

Re: K150291

Trade/Device Name: TYRX Neuro Absorbable Antibacterial Envelope Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: FTL Dated: February 4, 2015 Received: February 6, 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 the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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,

Felipe Aguel -S

Carlos L. Peña, PhD, MS

for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K150291

Device Name

TYRX Neuro Absorbable Antibacterial Envelope

Indications for Use (Describe)

TYRX Neuro Absorbable Antiqacterial 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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510(k) Summary

In accordance with 21 CFR 807.92, Medtronic TYRX, Inc. provides this summary of the safety and effectiveness information available for TYRX™ Neuro Absorbable Antibacterial Envelope, as well as the substantial equivalence decision making process used for the TYRX™ Neuro Absorbable Antibacterial Envelope subject device.

Sponsor/Applicant Name and Address:	Medtronic TYRX, Inc.1 Deer Park Drive Suite GMonmouth Junction, N.J. 08852
Establishment Registration Number:	3005619263
Sponsor Contact Information:	Regina NovakSenior Regulatory Affairs SpecialistPhone: 732-964-1492Fax: 732-246-8677Email:regina.novak@medtronic.com
Alternate Contact:	Susan Olinger, JDDirector, Regulatory AffairsPhone: 732-964-1110Fax: 763-246-8677Email:susan.olinger@medtronic.com
Date of preparation of 510(k) Summary	February 4, 2015
New Device Trade/Proprietary Name:	TYRX™ Neuro AbsorbableAntibacterial Envelope
Device Common Name:Regulatory Classification:PROCODE:	Surgical MeshClass IIFTL
Predicate Device Name and 510(k) Number	TYRX ™ Neuro AbsorbableAntibacterial EnvelopeK142611

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Device Description:

Indications for Use

TYRX ™ Neuro 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 "1" 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 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.

The only difference between the subject and predicate device is that the subject device has an expanded Indication for Use to include use in conjunction with deep brain stimulators and sacral nerve stimulators.

TYRX™ Neuro Absorbable Antibacterial Envelope is intended for single-patient, one-time use only.

Technological Results

The technological characteristics of the TYRX™ Neuro Absorbable Antibacterial Envelope are identical to the predicate. Both devices have the same intended use which is to create a stable environment for the implanted device.

The TYRX™ Neuro Absorbable Antibacterial Envelope is fully absorbable containing the absorbable Glycoprene II substrate mesh and coated with an absorbable polyarvlate polymer coating containing the antibiotics rifampin and minocycline in concentrations of 102ug/cm².

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There is no difference in the manufacturing processes for the subject device. The difference is only an extension of the Indications for Use to include use in conjunction with Deep Brain Stimulators or Sacral Nerve Stimulators.

Biocompatability Results

TYRX™ Neuro Absorbable Antibacterial Envelope is supplied sterile, biocompatible, and nonpyrogenic. TYRX follows the ISO 11137 standard for sterility.

Biocompatability testing of the predicate device in accordance with ISO 10993 demonstrated the safety of the subject device.

Animal Studies

In vitro studies referenced in the predicate device 510(k). K142611. demonstrated antimicrobial activity against Methicillin-resistant Staphylococcus aureus (MRSA), Staphylococcus aureus, Acinetobacter baumannii, Staphylococcus epidermidis, Staphylococcus lugdunensis and Escherichia coli.

In vivo efficacy testing, referenced in the predicate device 510(k), K142611, demonstrated effectiveness in reducing infections. The bacteria tested were Staphylococcus aureus, Acinetobacter baumannii, Staphylococcus epidermidis and Escherichia coli, Methicillinresistant Staphylococcu aureus (MRSA), and Staphylococcus lugdunensis. It should be noted that the in vivo and in vitro activity of the TYRX TM Antibacterial Envelope antimicrobials is variable against non-epidermidis strains of coagulase-negative Staphylococci.

To provide additional evidence on the safety of TYRX Neuro Absorbable Antibacterial Envelope when implanted with neuromodulators, an animal study was conducted to address the question of minocycline diffusion with the TYRX Neuro Antibacterial Envelope (absorbable and nonabsorbable) 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 or non-absorbable), with or without a lead.

The study consisted of four (4) treatment groups: sheep in Group 1 received either a TYRX Neuro Envelope or TYRX Neuro Absorbable envelope with a neuromodulator: sheep in Groups 2 and 3 received either a TYRX Neuro Envelope or TYRX Neuro Absorbable Envelope and neuromodulator and a lead. Sheep in Group 4 were implanted with a single neuromodulator without the TYRX Neuro Envelopes and received oral doses of minocycline and rifampin daily. Each group consisted of 2 sheep and the study duration was for 7 days.

The study demonstrated that the TYRX Neuro Absorbable 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 Absorbable Antibacterial Envelope, with or without leads. This study demonstrated that the amount of

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minocycline in CSF and plasma, as a result of the TYRX Neuro Absorbable Antibacterial Envelope implantation, are not detectable and do not pose a significant risk for CNS side effects.

CONCLUSION:

In summary, the TYRX Neuro Absorbable Antibacterial Envelope is identical in terms of physical construct to the cleared predicate, TYRX Neuro Absorbable Antibacterial Envelope. The polymer coating containing the antibiotics rifampin and minocycline in concentrations of 102ug/cm² applied to the substrate remains unchanged. The device is sterile and non-pyrogenic. The implantation site is the same anatomical location as the currently cleared predicate device, the infraclavicular fossa for spinal cord neuromodulators and laterally to the body midline and slightly superior to the gluteal region for the currently cleared vagus nerve stimulators. The only difference is that the subject device has an expanded Indications for Use to include use in conjunction with Deep Brain Stimulators and Sacral Nerve Stimulators.

Based on the 510(k) summaries and the information provided, we conclude that TYRX 110 Neuro Absorbable Antibacterial Envelope is safe and effective for its intended use, and is substantially equivalent to the predicate device TYRX Neuro Absorbable Antibacterial Envelope (K142611).

Regulation Number and Section

§ 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.