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.

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.

AI/ML Overview

This document describes the AIGISRx N Antibacterial Envelope, a surgical mesh designed to secure nerve stimulators. The submission is a 510(k) for an expanded indication for use to include spinal cord neuromodulators (SCNM).

Here's an analysis of the acceptance criteria and supporting studies based on the provided text, focusing on the expanded indication:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance	Evidence Source (if specified)
Biocompatibility	Device is biocompatible and safe.	Standard ISO 10993 testing demonstrated biocompatibility and safety.	Standard ISO 10993 testing
Sterility	Device is sterile.	Sterility conforms to ISO 11137. Bench testing shows gamma sterilization has no detrimental effect on chemical structure or thermal properties.	ISO 11137, Bench testing
Purity	Device is non-pyrogenic.	Device is non-pyrogenic.	(Implicit in biocompatibility/sterility, no separate test cited)
Functionality (No Interference)	Device does not alter or interfere with an implantable pulse generator.	An in vivo functionality study showed that AIGIS devices do not alter or interfere with an implantable pulse generator.	In vivo functionality study (using AIGISRx, K063091)
Antimicrobial Agent Diffusion (CNS Effects)	Minocycline and rifampin diffusion from the device, particularly in relation to the Central Nervous System (CNS), should not pose significant risk.	Criterion Met: No quantifiable concentrations of minocycline or rifampin were detected in plasma and CSF samples up to 7 days after implantation in sheep model. This demonstrated that the amount of minocycline in CSF and plasma, as a result of AIGISRx N implantation, are not detectable and do not pose a significant risk for CNS side effects.	In vivo study in sheep
Clinical Safety (Expanded Indication - SCNM)	Safe when implanted with SCNM.	Criterion Met: The study demonstrated that the AIGISRx N Antibacterial Envelope was safe in the sheep model as assessed by the absence of adverse clinical signs.	In vivo study in sheep

Note: The core physical, chemical, and mechanical properties (mesh knit characteristics, suture retention strength, burst strength) are stated to be identical to the predicate device (K131007), implying they meet prior acceptance criteria for those aspects, though specific values are not provided in this document.

2. Sample Size Used for the Test Set and Data Provenance

Expanded Indication Study for Minocycline/Rifampin Diffusion and CNS Effects:
- Sample Size: 8 sheep (2 sheep per treatment group across 4 groups).
- Data Provenance: Prospective, animal (sheep) model data. The country of origin is not specified but it's an in vivo model.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

For the expanded indication study (minocycline/rifampin diffusion and safety in SCNM model), the "ground truth" would be the direct measurement of drug concentrations in plasma and CSF, and observation of clinical signs. This does not typically involve human expert adjudication in the same way image analysis or diagnostic studies do.
The assessment of "absence of adverse clinical signs" would likely be performed by veterinary professionals or study personnel trained in animal welfare and observation. Their specific qualifications are not detailed in the document.

4. Adjudication Method for the Test Set

For the expanded indication study, an adjudication method (like 2+1, 3+1) is not applicable. The outcome measures (drug concentrations, clinical signs) are objective measurements or direct observations rather than subjective interpretations requiring multiple expert reviewers.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This type of study is typical for diagnostic algorithms (e.g., in radiology) to assess whether AI assistance improves human reader performance. The AIGISRx N is a physical medical device (surgical mesh), not a diagnostic algorithm, so this type of study is not relevant to its evaluation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. The AIGISRx N Antibacterial Envelope is a physical medical device, not an algorithm. Its performance is assessed directly through bench testing and in vivo studies, not as an algorithm's standalone performance.

7. The Type of Ground Truth Used

For the expanded indication study, the ground truth was based on:
- Direct Analytical Measurement: Quantifiable concentrations of minocycline and rifampin in plasma and cerebrospinal fluid (CSF) samples.
- Direct Observation/Clinical Assessment: Absence of adverse clinical signs in the sheep model.

8. The Sample Size for the Training Set

Not applicable. As the device is a physical medical device and not an AI/ML algorithm, there is no "training set" in the context of machine learning. The studies mentioned (biocompatibility, sterility, functionality, and the sheep model) are performance and safety validation studies.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

Summary

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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:

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Predicate Device Name and 510(k) Number:

AIGISRS®N (K131007)

Device Description:

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.

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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

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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.

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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

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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

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Indications for Use

510(k) Number (if known): K132699

Device Name: AIGISRx N Antibacterial Envelope

Indications For Use:

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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Regulation Number and Section

§ 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.