(206 days)
Not Found
No
The document describes a physical implantable envelope with antimicrobial properties, and there is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The device functions as an envelope to securely hold pacemakers or defibrillators and delivers antimicrobial agents to reduce infection; its primary role is not to treat a disease or medical condition itself, but rather to support the implantation of other therapeutic devices and prevent complications.
No
The device is an absorbable antibacterial envelope intended to securely hold pacemakers and implantable defibrillators and reduce infection, not to diagnose medical conditions.
No
The device description clearly states it is a sterile prosthesis comprised of a mesh and a polymer containing antimicrobial agents, which are physical components, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states the device is an "absorbable antibacterial envelope" intended to "hold a pacemaker pulse generator or defibrillator securely" and "reduce infection in an in vivo model of bacterial challenge following surgical implantation."
- Mechanism of Action: The device works by physically containing an implanted medical device and releasing antimicrobial agents within the body (in vivo) to prevent infection. It does not analyze samples taken from the body (in vitro).
The device is an implantable medical device with a drug-eluting component, not an IVD.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
FTL
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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
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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)
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:
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FORM FDA 3881 (7/17)
Page 1 of 1
PSC Publishing Services (301) 443-6740
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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. |
| Cardiac Rhythm and Heart Failure (CRHF) | |
| 8200 Coral Sea St. NE | |
| Mounds View, MN 55112 | |
| Contact Person: | Primary Contact: |
| Nancy Cameron | |
| Senior Principal Regulatory Affairs Specialist | |
| Medtronic Cardiac Rhythm Heart Failure | |
| 763.526.2355 | |
| nancy.e.cameron@medtronic.com | |
| Secondary Contact: | |
| Wendy Saunders | |
| Regulatory Affairs Director | |
| Medtronic Cardiac Rhythm Heart Failure | |
| 763.526.8134 | |
| wendy.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 |
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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) | |
| Product ID: CMRM6122 | 5.1 mg Minocycline |
| 8.0 mg Rifampin | |
| TYRX Absorbable Antibacterial Envelope (Large) | |
| Product ID: CMRM6133 | 7.6 mg Minocycline |
| 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.