TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope (large)

K192389 · Medtronic, Inc. · FTL · Mar 27, 2020 · General, Plastic Surgery

Device Facts

• Record ID: K192389
• Device Name: TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope (large)
• Applicant: Medtronic, Inc.
• Product Code: FTL · General, Plastic Surgery
• Decision Date: Mar 27, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

Sterile, absorbable mesh envelope designed to house cardiovascular implantable electronic devices (CIEDs), specifically pacemakers or ICDs. Constructed from a multifilament knitted mesh of glycolide, caprolactone, and trimethylene carbonate, coated with an absorbable tyrosine-based polyarylate polymer containing antimicrobial agents (rifampin and minocycline). Implanted by a physician during CIED surgery to secure the generator within the tissue pocket. The envelope provides a stable environment and releases antimicrobial agents to reduce infection risk. No electronic components or software; purely mechanical/chemical function.

Clinical Evidence

Bench testing only. Stability study data collected per ICH guidelines confirms the device meets all product requirements through the proposed extended shelf life.

Technological Characteristics

Multifilament knitted mesh composed of glycolide, caprolactone, and trimethylene carbonate. Coated with absorbable tyrosine-based polyarylate polymer containing rifampin and minocycline. Sterile, biocompatible. Supplied in two sizes: Medium (2.5 in x 2.7 in) and Large (2.9 in x 3.3 in). No electronic components, software, or energy source.

Indications for Use

Indicated for patients receiving a pacemaker or implantable cardioverter defibrillator (ICD) to hold the device securely and provide a stable environment in the tissue pocket.

Regulatory Classification

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.

Predicate Devices

• TYRX Absorbable Antibacterial Envelope (K180030)

Submission Summary (Full Text)

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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.

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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 ([e-mail]) or phone [phone] 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

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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)

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.

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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FORM FDA 3881 (7/17)

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# 510(k) Summary

[As required by 21 CFR 807.92]

| Date Prepared: | 28 August 2019 |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Owner / Address: | Medtronic, Inc.<br>Cardiac Rhythm and Heart Failure (CRHF)<br>8200 Coral Sea St. NE<br>Mounds View, MN 55112 |
| Contact Person: | Primary Contact: |
| | Nancy Cameron<br>Senior Principal Regulatory Affairs Specialist<br>Medtronic Cardiac Rhythm Heart Failure<br>763.526.2355<br>[e-mail] |
| | Secondary Contact: |
| | Wendy Saunders<br>Regulatory Affairs Director<br>Medtronic Cardiac Rhythm Heart Failure<br>763.526.8134<br>[e-mail] |
| 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 |

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### 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). Details for the TYRX Envelopes are provided below.

| Description of Device/ Part Number | Label Claim |
|-------------------------------------------------------------------------|----------------------------------------|
| TYRX Absorbable Antibacterial Envelope (Medium)<br>Product ID: CMRM6122 | 5.1 mg Minocycline<br>8.0 mg Rifampin |
| TYRX Absorbable Antibacterial Envelope (Large)<br>Product ID: CMRM6133 | 7.6 mg Minocycline<br>11.9 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

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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.