(198 days)
Not Found
No
The device description focuses on the physical structure and antimicrobial properties of an envelope designed to hold implanted nerve stimulators. There is no mention of any computational or analytical functions, let alone AI/ML.
No.
The device acts as an envelope to hold other therapeutic devices (nerve stimulators/neuromodulators) and provides an antimicrobial environment, but it does not directly perform a therapeutic function on the patient. Its primary role is to secure and protect another medical device, and its antibacterial agents are for preventing infection related to that device's implantation.
No
Explanation: The device is an absorbable antibacterial envelope designed to hold implanted neurostimulators securely and create a stable environment, not to diagnose medical conditions. Its function is to prevent infection and stabilize therapeutic devices.
No
The device description clearly states it is a sterile prosthesis comprised of physical components (absorbable substrate mesh, absorbable polymer) and contains antimicrobial agents. It is a physical implantable device, 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.
- Device Function: The description clearly states the device is an "absorbable antibacterial envelope" 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." It also contains antimicrobial agents to reduce infection risk at the implant site.
- No Sample Analysis: The device does not analyze any samples taken from the body. Its function is purely mechanical support and local drug delivery at the implant site.
Therefore, the TYRX Neuro Absorbable Antibacterial Envelope is an implantable medical device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
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.
Product codes
FTL
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
infraclavicular fossa, laterally to the body midline and slightly superior to the gluteal region
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 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
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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)
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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. 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: | 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 |
| K180122 |
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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 Minocycline |
| 8.0 mg Rifampin | |
| TYRX Neuro Absorbable Antibacterial Envelope (Large) | |
| Product ID: NMRM6133 | 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 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
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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.