(89 days)
No
The device description and intended use focus on its structural and antimicrobial properties, with no mention of AI/ML capabilities or data processing.
No.
The device is a sterile prosthesis intended to securely hold a vagus nerve stimulator or spinal cord neuromodulator and contains antimicrobial agents to reduce infection, rather than providing direct therapeutic treatment itself.
No
Explanation: The device description and intended use clearly state that AIGISRx N is designed to securely hold a vagus nerve stimulator or spinal cord neuromodulator and contains antimicrobial agents to reduce infection. It acts as a supportive and protective envelope for other implanted devices; it does not itself diagnose any condition or disease.
No
The device description explicitly states it is a "dual component (resorbable and non-resorbable) sterile prosthesis" constructed of "knitted filaments of polypropylene that are coated with a bioresorbable polyarylate polymer". This describes a physical, implantable medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to hold a vagus nerve stimulator or spinal cord neuromodulator securely and provide antimicrobial agents to reduce infection in vivo (within the body). This is a therapeutic and supportive function, not a diagnostic one performed in vitro (outside the body).
- Device Description: The description details a physical prosthesis designed for implantation, not a test or reagent used to examine samples outside the body.
- Performance Studies: The studies described focus on the device's functionality in holding the stimulator and the diffusion of the antimicrobial agents within a living organism (sheep model). There are no studies related to analyzing biological samples for diagnostic purposes.
IVD devices are used to examine specimens (like blood, urine, tissue) from the human body to provide information for diagnosis, monitoring, or screening. This device does not perform any such function.
N/A
Intended Use / Indications for Use
AIGISRx N is intended to hold a vagus nerve stimulator or spinal cord neuromodulator securely in order to create a stable environment when implanted in the body. AIGISRx N 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 pulse generator. This device is intended to be used in conjunction with vagus nerve stimulators implanted in the infraclavicular fossa, or spinal cord neuromodulators implanted laterally to the body midline and slightly superior to the qluteal region.
Product codes (comma separated list FDA assigned to the subject device)
FTL
Device Description
AIGISRs N is a dual component (resorbable and non-resorbable) sterile prosthesis designed to hold a vagus nerve stimulator or spinal cord neuromodulator securely to create a stable environment when implanted in the body. It is constructed of knitted filaments of polypropylene that are coated with a bioresorbable polyarylate polymer containing the antimicrobial agents rifampin and minocycline. Rifampin and minocycline have been shown to reduce infection in an in vivo model of bacterial challenge following surgical implantation of an implantable electronic device.
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)
To provide additional evidence on the safety of AIGIS N when implanted with SCNM, a study was conducted to address the question of minocycline diffusion from the AIGIS N device and possible CNS effects. The purpose of the study was to determine concentrations of minocycline and rifampin in the plasma and cerebrospinal fluid (CSF) of sheep implanted with a SCNM and an AIGISR: antibacterial envelope, with or without a spinal lead.
This study consisted of four (4) treatment groups: sheep in Group 1 received AIGIS or AIGIS R envelope with a SCNM: sheep in Groups 2 & 3 received AIGIS or AIGIS R and SCNM and a lead. Sheep in Group 4 were implanted with a single SCNM without the AIGIS device and received oral doses of minocycline and rifampin daily. Each group consisted of 2 sheep and the study duration was 7 days.
The study demonstrated that the AIGISRx N Antibacterial Envelope was safe in the sheep model as assessed by the absence of adverse clinical signs. There were no quantifiable concentrations of minocycline or rifampin in plasma and CSF samples collected up to 7 days after implantation of the SCNM enclosed in the AIGISRsN Antibacterial envelope. with or without leads. This study demonstrated that the amount of minocycline in CSF and plasma, as a result of AIGISRs N implantation, are not detectable and do not pose a significant risk for CNS side effects.
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.
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
KB2699
NOV 2 6 2013
510(k) Summary
In accordance with 21 CFR 807.92, TYRX Inc. provides this summary of the safety and effectiveness information available for AIGISRx® N, as well as the substantial equivalence decision making process used for the AIGISRs® N subject device.
Sponsor/Applicant Name and Address:
Establishment Registration Number:
Sponsor Contact Information:
TYRX Inc. 1 Deer Park Drive Suite G Monmouth Junction, N.J. 08852
3005619263
Regina Novak Manager, Regulatory Affairs Phone: 732-964-1492 Fax: 732-964-1490 Email: rnovak@tyrx.com
Alternate Contact: Susan Olinger, JD Vice President, Regulatory Affairs Phone: 732-964-1110 Fax: 732-964-1490 Email: solinger@tyrx.com
August 28, 2013
AIGISRx® N
Surgical Mesh, Class II PROCODE: FTL
Date of Preparation of 510(k) Summary: New Device Trade/Proprietary Name:
Device Common/Classification Name:
1
Predicate Device Name and 510(k) Number:
AIGISRS®N (K131007)
Device Description:
AIGISRs N is a dual component (resorbable and non-resorbable) sterile prosthesis designed to hold a vagus nerve stimulator or spinal cord neuromodulator securely to create a stable environment when implanted in the body. It is constructed of knitted filaments of polypropylene that are coated with a bioresorbable polyarylate polymer containing the antimicrobial agents rifampin and minocycline. Rifampin and minocycline have been shown to reduce infection in an in vivo model of bacterial challenge following surgical implantation of an implantable electronic device.
Device Intended Use:
AIGIS& "N is intended to hold a vagus nerve stimulator or spinal cord neuromodulator securely in order to create a stable environment when implanted in the body. AIGISRS® N 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 pulse generator. This device is intended to be used in conjunction with vagus nerve stimulators implanted in the infraclavicular fossa, or spinal cord neuromodulators implanted laterally to the body midline and slightly superior to the gluteal region.
The only difference between the subject and predicate devices is that the subject device has an expanded indication for use to include spinal cord neuromodulators (SCNM).
Technological Characteristics:
The physical, chemical and mechanical properties of the AIGIS N subject device, such as mesh knit characteristics, suture retention strength and burst strength and burst strength are the same as the AIGISRs N predicate device. There is no change to the design, materials of construction, or manufacturing processes for the subject device. There are no technological differences between the subject and predicate devices, and there are no design changes to the predicate device.
2
Performance Data:
AIGISRs N is designed to be a biocompatible, sterile device intended to hold a vagus nerve stimulator or spinal cord neuromodulator securely in order to create a stable environment when implanted in the body. The AIGISRs N subject device is identical to the AIGISRs N predicate device. Information on the cleared predicate device, K131007, is included by reference in this 510(k).
AIGISRx N is sterile, biocompatible, and non-pyrogenic. Sterility conforms to ISO 11137, and bench testing shows that gamma sterilization has no detrimental effect on the chemical structure or thermal properties of the polypropylene substrate mesh. Standard ISO 10993 testing demonstrated the biocompatibility and safety of the device. An in vivo functionality study showed that AIGIS devices do not alter or interfere with an implantable pulse generator. The AIGISR: device (K063091) was the device used in the aforementioned studies and it was the predicate for AIGIS N (K131007). which was cleared on July 10, 2013. The AIGISRx N subject device is identical to the AIGIS&x N predicate device (K131007), there is no change to the design, materials of construction or manufacturing processes for the subject device. There are no technological differences or design changes. AIGIS N (K131007) is the predicate for our subject device, therefore, we believe that these studies are directly applicable to this new 510K. Information on the cleared predicate device. K131007, is included by reference in this 510(k).
To provide additional evidence on the safety of AIGIS N when implanted with SCNM, a study was conducted to address the question of minocycline diffusion from the AIGIS N device and possible CNS effects. The purpose of the study was to determine concentrations of minocycline and rifampin in the plasma and cerebrospinal fluid (CSF) of sheep implanted with a SCNM and an AIGISR: antibacterial envelope, with or without a spinal lead.
This study consisted of four (4) treatment groups: sheep in Group 1 received AIGIS or AIGIS R envelope with a SCNM: sheep in Groups 2 & 3 received AIGIS or AIGIS R and SCNM and a lead. Sheep in Group 4 were implanted with a single SCNM without the AIGIS device and received oral doses of minocycline and rifampin daily. Each group consisted of 2 sheep and the study duration was 7 days.
The study demonstrated that the AIGISRx N Antibacterial Envelope was safe in the sheep model as assessed by the absence of adverse clinical signs. There were no quantifiable concentrations of minocycline or rifampin in plasma and CSF samples collected up to 7 days after implantation of the SCNM enclosed in the AIGISRsN Antibacterial envelope. with or without leads. This study demonstrated that the amount of minocycline in CSF
3
and plasma, as a result of AIGISRs N implantation, are not detectable and do not pose a significant risk for CNS side effects.
Conclusions:
Both the AIGISRs N predicate and the AIGISRx N subject devices are safe and effective for their intended uses.
4
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 26, 2013
TYRX, Inc. c/o Regina Novak Manager, Regulatory Affairs 1 Deer Park Drive, Suite G Monmouth Junction, NJ 08852
Re: K132699
Trade/Device Name: AIGISRx N Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: FTL Dated: September 4, 2013 Received: September 5, 2013
Dear Ms. Novak:
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). and Cosmetic Prox (100) the the device, subject to the general controls provisions of the Act. 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 misicading.
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 that i Dri has intacted and regulations administered by other Federal agencies. You must
5
Page 2 - Ms. Regina Novak
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Joyce M. Whang -S
Victor Krauthamer, Ph.D. for Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known): K132699
Device Name: AIGISRx N Antibacterial Envelope
Indications For Use:
AIGISRx N is intended to hold a vagus nerve stimulator or spinal cord neuromodulator securely in order to create a stable environment when implanted in the body. AIGISRx N 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 pulse generator. This device is intended to be used in conjunction with vagus nerve stimulators implanted in the infraclavicular fossa, or spinal cord neuromodulators implanted laterally to the body midline and slightly superior to the qluteal region.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
Joyce M. Whang -S
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