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.

Device Description

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).

AI/ML Overview

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.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 7, 2018 Medtronic, Inc. Nancy Cameron Senior Principal Regulatory Specialist 8200 Coral Sea St. NE Mounds View, Minnesota 55112

Re: K180122

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: January 12, 2018 Received: January 16, 2018

Dear Nancy Cameron:

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.

Additionally, we would like to inform you that, based on your product being a combination product, your shelf-life protocol cannot be considered approved. Therefore, any additional changes to the shelf-life of the device could warrant a new 510(k) premarket notification. We recommend that you submit a request for a Pre-Submission to discuss any future changes to the device. Your submission should reference this 510(k), identify any changes that you are proposing to make, and indicate your preferred feedback mechanism (i.e., email, meeting or teleconference). For additional information regarding Q-Submissions, please refer to the Guidance for Industry and FDA Staff on Medical Devices: The Pre-Submission Program and Meetings with FDA Staff at:

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidanceDocuments/UCM3 11176.pdf.

{1}------------------------------------------------

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 of medical device-related 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.

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.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

William J. Heetderks -S 2018.06.07 13:20:39 -04'00'

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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K180122

Device Name

TYRX Neuro Absorbable Antibacterial Envelope

Indications for Use (Describe)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) Summary

[As required by 21 CFR 807.92]

Date Prepared:	June 4, 2018
510(k) Owner / Address:	Medtronic, Inc.Cardiac Rhythm and Heart Failure (CRHF)8200 Coral Sea St. NEMounds View, MN 55112
Contact Person:	Primary Contact:Nancy CameronSenior Principal Regulatory Affairs SpecialistMedtronic Cardiac Rhythm Heart Failure763.526.2355nancy.e.cameron@medtronic.comSecondary Contact:Wendy SaundersSenior Regulatory Affairs ManagerMedtronic Cardiac Rhythm Heart Failure763.526.8134wendy.a.saunders@medtronic.com
Submission Type:	Traditional 510(k): Shelf Life Extension and ModifiedPackaging
Device Trade Name:	TYRXTM Neuro Absorbable Antibacterial Envelope
Device Common Name:	Surgical Mesh
Regulation Number:	CFR 878.3300
Product Code:	FTL
Classification:	Class II
Classification Panel:	Neurological and Physical Medicine Devices
Special Controls:	None
Predicate Devices:	TYRXTM Neuro Absorbable Antibacterial Envelope,K150291

{4}------------------------------------------------

Device Description

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). The appropriate size should be selected based on the external dimensions of the vagus nerve stimulator, the spinal cord neuromodulator, the deep brain stimulator, or the sacral neuro stimulator that is to be implanted. Details for the TYRX Neuro Envelopes are provided below.

Description of Device/ Part Number	Label Claim
TYRX Neuro Absorbable Antibacterial Envelope (Medium)Product ID: NMRM6122	5.1 mg Minocycline8.0 mg Rifampin
TYRX Neuro Absorbable Antibacterial Envelope (Large)Product ID: NMRM6133	7.6 mg Minocycline11.9 mg Rifampin

Indications for Use

There are no changes to the Indications for Use as a result of this submission. The Indications for Use are provided below:

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 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.

Technological Characteristics

TYRX Neuro Envelope is a biocompatible, sterile device intended to hold a vagus nerve stimulator, a spinal cord neuromodulator, a deep brain stimulator or a sacral nerve stimulator

{5}------------------------------------------------

securely in order to create a stable environment when implanted in the body. TYRX Neuro Envelope with extended shelf life is identical to its predicate device. The change in packaging and extension of product shelf life presented in this submission does not impact the technical characteristics of the device as compared to the predicate device.

Summary of Testing

The extended shelf life TYRX Neuro Envelopes incorporate a modified packaging configuration (dual chamber foil pouch with desiccant) relative to the predicate device. 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 device is exposed to the same materials as the currently marketed device. The change in packaging provides greater protection from moisture, allowing an extension of the labeled shelf life. The modified packaging has been validated for use and demonstrated to meet the same sterility assurance level as the currently marketed package.

Extension of the TYRX Neuro Envelope shelf life is supported by stability study data collected per ICH guidelines. 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. There are no changes to the finished product specification as a result of the modifications described in this submission. Other than modified packaging, the extended shelf life TYRX Neuro Envelope design, materials, mechanism of action, patient contact and intended use are the same as the predicate device.

Substantial Equivalence

Substantial equivalence of the TYRX Neuro Envelope with the proposed shelf life is based on package verification/validation activities and ICH stability studies conducted using the dual foil pouch package with desiccant. Other minor manufacturing changes have been incorporated per Quality System processes. There are no changes to the finished product TYRX Neuro Envelope specification and other than modified packaging, there are no changes to the TYRX Neuro Envelope design, materials, mechanism of action, patient contact or intended use. The individual and cumulative impact of these changes does not alter the risk profile of the TYRX Neuro Envelopes. The modified device meets the same finished goods specification, using the same analytical test methodologies, as the currently marketed device. Therefore, the TYRX Neuro Envelope device, as modified with extended shelf life and dual pouch with desiccant packaging, is substantially equivalent to the predicate device.

Conclusion

The TYRX Neuro Absorbable Antibacterial Envelope, as modified, is substantially equivalent to the predicate device.

Overall, these modifications do not affect the intended use of the device or alter the fundamental scientific technology. There are no changes to the physical design, principles of operation, or mechanism of action of the current TYRX Neuro Envelope. Modified packaging has been validated for use and product labeling updated to reflect the extended shelf life.

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.