The envelope is intended to hold a pacemaker pulse generator or defibrillator securely in order to provide a stable environment when implanted in the body. The 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 the generator or defibrillator. The envelope is intended to be used in conjunction with pacemakers and implantable defibrillators.

Device Description

TYRXTM Absorbable Antibacterial Envelope (TYRX Envelope, or the envelope) is a sterile prosthesis comprised of two components; an absorbable substrate mesh, and an absorbable tyrosine based polyarylate polymer containing the antimicrobial agents, rifampin and minocycline, and is designed to hold a Cardiovascular Implantable Electronic Devices. CIED. (pacemaker or Implantable Cardioverter Defibrillator, ICD), securely to create a stable environment when the device is implanted in the body.

The TYRX Envelope is constructed of multifilament knitted mesh composed of glycolide, caprolactone, and trimethylene carbonate polymer, which is coated with an absorbable polyarylate polymer containing the drug substances rifampin and minocycline.

Like its predicate, the TYRX 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

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text.

This submission is for a shelf-life extension of an existing device, the TYRX Absorbable Antibacterial Envelope. Therefore, the "acceptance criteria" and "device performance" primarily revolve around the device's stability over an extended period.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (What the device must continue to meet)	Reported Device Performance (Summary of study results)
All product requirements through the proposed shelf life	"Results of this study demonstrate the TYRX Envelope, both medium and large size, continue to meet all product requirements through the proposed shelf life."
Same finished goods acceptance criteria (as currently marketed device)	"The modified device meets the same finished goods acceptance criteria, using the same analytical test methodologies, as the currently marketed device."
No change to design, materials, mechanism of action, patient contact, intended use, or risk profile.	"The extended shelf life TYRX Envelope design, materials, mechanism of action, patient contact and intended use are the same as the predicate device." "The individual and cumulative impact of these changes does not alter the risk profile of the TYRX Envelopes."

2. Sample size used for the test set and the data provenance:

Sample Size for Test Set: The text does not explicitly state the numerical sample size used for the stability study itself (e.g., number of envelopes tested, or individual data points). It refers to "stability study data collected."
Data Provenance: The data was gathered from a "stability study" conducted by Medtronic, Inc. It can be inferred as prospective given it's a stability study to support a shelf-life extension. There is no information about the country of origin of the data provided in this document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable to this submission. The "ground truth" for a shelf-life extension study is typically established by predetermined specifications and analytical methods for the product's physical, chemical, and functional properties, not by expert consensus or interpretations in the way one might evaluate diagnostic images or clinical outcomes. The device's performance is measured against these established specifications.

4. Adjudication method for the test set:

This information is not applicable. Adjudication methods like 2+1 or 3+1 are used for consensus-building among human reviewers, typically for clinical endpoints or image interpretation. For a stability study, the assessment is based on analytical test results against predefined specifications.

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 submission is for a medical device (surgical mesh with antimicrobial agents), not an AI/imaging diagnostic device. Therefore, no MRMC study involving human readers or AI assistance would have been conducted or reported here.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This information is not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

The ground truth used for this shelf-life extension study is established product specifications and analytical test methodologies. The device's performance (e.g., drug content, mechanical integrity, sterility if applicable, and other "all product requirements") is measured directly against these predefined quantitative and qualitative standards.

8. The sample size for the training set:

This information is not applicable. This is not an AI/machine learning product that requires a "training set."

9. How the ground truth for the training set was established:

This information is not applicable as it's not an AI/machine learning product.

Summary

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

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 27, 2020

Medtronic, Inc. Nancy Cameron Senior Principal Regulatory Specialist 8200 Coral Sea Street NE Mounds View, Minnesota 55112

Re: K192389

Trade/Device Name: TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope (large) Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: FTL Dated: March 2, 2020 Received: March 3, 2020

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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

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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Hetal Odobasic Assistant Director Implantable Electrophysiology Devices Team Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) TBD K192389

R172309

Device Name TYRX Absorbable Antibacterial Envelope

Indications for Use (Describe)

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)

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."

FORM FDA 3881 (7/17)

Page 1 of 1

PSC Publishing Services (301) 443-6740

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

510(k) Summary

[As required by 21 CFR 807.92]

Date Prepared:	28 August 2019
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.com
	Secondary Contact:
	Wendy SaundersRegulatory Affairs DirectorMedtronic Cardiac Rhythm Heart Failure763.526.8134wendy.a.saunders@medtronic.com
Submission Type:	Traditional 510(k): Shelf Life Extension
Device Trade Name:	TYRX™ Absorbable Antibacterial Envelope
Device Common Name:	Surgical Mesh
Regulation Number:	CFR 878.3300
Product Code:	FTL
Classification:	Class II
Classification Panel:	Cardiovascular
Special Controls:	None
Predicate Device:	TYRX™ Absorbable Antibacterial Envelope, K180030

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

Device Description

Like its predicate, the TYRX 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). Details for the TYRX Envelopes are provided below.

Description of Device/ Part Number	Label Claim
TYRX Absorbable Antibacterial Envelope (Medium)Product ID: CMRM6122	5.1 mg Minocycline8.0 mg Rifampin
TYRX Absorbable Antibacterial Envelope (Large)Product ID: CMRM6133	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:

The envelope is intended to hold a pacemaker pulse generator or defibrillator securely in order to create a stable environment when implanted in the body. The 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 pacemaker or defibrillator. The envelope is intended to be used in conjunction with pacemakers or defibrillators.

Technological Characteristics

TYRX Envelope is a biocompatible, sterile device intended to hold a pacemaker or defibrillator securely in the surgically created tissue pocket in order to create a stable environment for the pacemaker or defibrillator when implanted in the body. The TYRX Envelope is identical to its predicate device, cleared under K180030. The further 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

Extension of the TYRX Envelope shelf life is supported by stability study data collected per ICH guidelines. Results of this study demonstrate the TYRX Envelope, both medium and large size, continue to meet all product requirements through the proposed shelf life. There are no changes

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

to the finished product TYRX Envelope analytical testing requirements as a result of the modifications described in this submission. The extended shelf life TYRX 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 Envelope with the proposed shelf life is based on 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 Envelope analytical testing requirements, design, materials, mechanism of action, patient contact or intended use associated with the extended shelf life. The individual and cumulative impact of these changes does not alter the risk profile of the TYRX Envelopes. The modified device meets the same finished goods acceptance criteria, using the same analytical test methodologies, as the currently marketed device. Therefore, the TYRX Envelope device, as modified with extended shelf life, is substantially equivalent to the predicate device.

Conclusion

The TYRX 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 Envelope.

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.