(198 days)
The 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.
The envelope contains the antimicrobial agents, rifampin and minocycline, which have been shown 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.
TYRX™ Neuro Absorbable Antibacterial Envelope (TYRX Neuro 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 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 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 device, the TRYX Neuro Envelope is supplied in two sizes, a 2.5 in. x 2.7 in. (Medium), and a 2.9 in. x 3.3 in. (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.
This document is a 510(k) summary for the TYRX Neuro Absorbable Antibacterial Envelope, seeking an extension of its shelf life. The submission does not involve changes to the device's design, materials, or intended use, but rather demonstrates its continued performance over a longer period.
Based on the provided text, the device itself (TYRX Neuro Absorbable Antibacterial Envelope) is not an AI/ML powered medical device. It is a physical medical device designed to hold nerve stimulators and contains antimicrobial agents. Therefore, many of the requested criteria related to AI/ML device performance (like multi-reader multi-case studies, effect size of human improvement with AI, standalone performance, ground truth for training sets, etc.) are not applicable to this submission.
However, I can extract information related to the acceptance criteria for the shelf-life extension and the study supporting it.
1. A table of acceptance criteria and the reported device performance
The document states: "Results of this study demonstrate the TYRX Neuro Envelope, both medium and large size, continue to meet all product requirements through the proposed shelf life." And "The modified device meets the same finished goods acceptance criteria, using the same analytical test methodologies, as the currently marketed device."
While specific numerical acceptance criteria are not explicitly listed in this summary, the core acceptance criterion is that the device continues to meet all product requirements throughout the extended shelf life. This implies that critical performance parameters (e.g., integrity of the absorbable mesh, stability and release profile of the antimicrobial agents, mechanical properties to securely hold the stimulator) remain within their pre-defined specifications.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| All product requirements (e.g., chemical stability of drugs, structural integrity of mesh, mechanical properties) met for proposed shelf-life. | Device continues to meet all product requirements through the proposed shelf life. |
2. Sample size used for the test set and the data provenance
The document mentions "stability study data collected per ICH guidelines." ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) guidelines typically require specific numbers of lots and time points for stability studies. However, the specific sample size (number of envelopes tested) is not detailed in this 510(k) summary.
Regarding data provenance: The study was conducted by Medtronic, Inc. for products intended for the U.S. market. The study design (stability study) is inherently prospective with respect to the shelf life assessment.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable as the submission relates to a physical device's shelf-life stability, not an AI/ML diagnostic or prognostic tool requiring expert ground truth for interpretation of images or clinical data. Device performance is assessed through analytical testing.
4. Adjudication method for the test set
This question is not applicable for the same reasons as point 3.
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 question is not applicable as the device is a physical medical implant, not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is a physical medical implant, not an algorithm.
7. The type of ground truth used
For this shelf-life extension, the "ground truth" is established by the pre-defined quality specifications and performance requirements for the TYRX Neuro Absorbable Antibacterial Envelope. The stability study aims to demonstrate that the device continues to meet these specifications over the extended shelf life, using analytical methods.
8. The sample size for the training set
This question is not applicable as there is no "training set" in the context of a physical device's shelf-life stability testing.
9. How the ground truth for the training set was established
This question is not applicable as there is no "training set" for this type of submission.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
April 8, 2020
Medtronic, Inc. Nancy Cameron Senior. Principal Regulatory Specialist 8200 Coral Sea St. NE Mounds View, Minnesota 55112
Re: K192636
Trade/Device Name: TYRX Neuro Absorbable Antibacterial Envelope (Medium), TYRX Neuro Absorbable Antibacterial Envelope (Large) Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTL Dated: September 20, 2019 Received: September 23, 2019
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
{1}------------------------------------------------
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 medical devices and radiation-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,
Timothy Marjenin Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K192636
Device Name
TYRX Neuro Absorbable Antibacterial Envelope
Indications for Use (Describe)
The 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.
The envelope contains the antimicrobial agents, rifampin and minocycline, which have been shown 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.
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: | 30 March 2020 |
|---|---|
| 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: | 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 EnvelopeK180122 |
{4}------------------------------------------------
Device Description
TYRX™ Neuro Absorbable Antibacterial Envelope (TYRX Neuro 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 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 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 device, the TRYX Neuro Envelope is supplied in two sizes, a 2.5 in. x 2.7 in. (Medium), and a 2.9 in. x 3.3 in. (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:
The 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.
The envelope contains the antimicrobial agents, rifampin and minocvcline, which have been shown to reduce infection in an in vivo model of bacterial challenge following surgical implantation of a pulse generator. The envelope 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 is identical to its predicate device, cleared under K180122. 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 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, continue to meet all product requirements through the proposed shelf life. There are no changes to the finished product analytical testing requirements as a result of the modifications described in this submission. 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 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 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 Neuro 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 Neuro Envelope device, as modified with extended shelf life, 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.
§ 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.