AIGISRx® R is intended to hold a pacemaker pulse generator or defibrillator securely in order to create a stable environment when implanted in the body. AIGISRx R contains the antimicrobial agents rifampin and minocycline which have been shown to reduce infection in in vivo models of bacterial challenge following surgical implantation of the generator or defibrillator. This device is only intended to be used in conjunction with pacemakers and implantable defibrillators.

AIGISRx® R is intended for single patient, one-time use only.

Device Description

AIGISRx® R (AIGIS R) is a fully resorbable, dual component sterile prosthesis designed to hold and stabilize a cardiovascular electronic implantable device (CIED), such as a pacemaker or an implantable cardioverter- defibrillator (ICD), when the electronic device is implanted in the body. AlGIS R is constructed of knitted filaments of a commercially available resorbable polymer, Glycoprene II, comprised of glycolide, caprolactone, trimethylene carbonate polymer, and coated with a bioresorbable polyarylate polymer mixture containing the antimicrobial agents rifampin and minocycline in concentrations of 102 ug/cm.2

AI/ML Overview

The AIGISRx® R (AIGIS R) is a medical device designed to securely hold and stabilize cardiovascular electronic implantable devices (CIEDs) like pacemakers or implantable cardioverter-defibrillators (ICDs) when implanted in the body. It is a fully resorbable, dual-component sterile prosthesis containing the antimicrobial agents rifampin and minocycline.

The device's acceptance criteria and the study proving it meets these criteria are primarily based on demonstrating substantial equivalence to a predicate device, the AIGISRx® (AIGIS) antibacterial envelope (K063091), rather than setting specific performance metrics for sensitivity, specificity, or similar outcome measures typically seen in AI/diagnostic device submissions. The core of the study is to prove that the new device, AIGIS R, performs similarly to the predicate device, despite a change in the surgical mesh substrate from non-resorbable polypropylene to bioresorbable Glycoprene II.

Here's a breakdown of the information based on the provided text, addressing your specific questions:

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of this 510(k) summary (a medical device rather than an AI/diagnostic software), the acceptance criteria are not in terms of traditional metrics like sensitivity/specificity. Instead, they focus on equivalence to a predicate device regarding safety and efficacy aspects.

Acceptance Criteria Category	Specific Criteria	Reported Device Performance (AIGIS R)
Material Composition Equivalence	The resorbable mesh (Glycoprene II) and its interaction with other components (polyarylate coating, antibiotics) should be safe and functionally equivalent to the predicate's non-resorbable mesh regarding degradation and chemical properties.	Bench testing demonstrated that AIGIS R degrades into its constituent monomers without chemical or physical interaction between the Glycoprene mesh, polyarylate coating, or antibiotics. Also, gamma sterilization has no effect on the chemical structure or thermal properties of Glycoprene II mesh.
Antimicrobial Effectiveness (AME) Equivalence	The AME of AIGIS R should be equivalent to that of the predicate device (AIGIS), demonstrating similar infection reduction capabilities.	Anti-microbial effectiveness (AME) studies (both in vivo and in vitro) demonstrated that the AME of AIGIS R is equivalent to AIGIS.
Biocompatibility & Safety	The device must be biocompatible and safe according to established standards.	Testing, according to ISO Standard 10993, demonstrated the biocompatibility and safety of the device. All forms of the AIGISRx family of devices are supplied sterile, biocompatible, and nonpyrogenic, following ISO 11137 for sterility.
Functional Equivalence	The device should not interfere with the functioning of the implantable cardiovascular electronic device and should securely hold the CIED.	In vivo studies demonstrated that the AIGIS R device does not interfere with the functioning of the implantable cardiovascular electronic device. The device is designed to "hold a pacemaker pulse generator or defibrillator securely in order to create a stable environment."
Drug Content Equivalence (Label Claim)	The drug content (rifampin and minocycline) for AIGIS R should be within acceptable ranges, comparable to the predicate device’s established efficacy.	AIGIS R PM size: Rifampin - 8.0 mg, Minocycline - 5.1 mg.AIGIS R ICD size: Rifampin - 11.9 mg, Minocycline - 7.6 mg.(Predicate AIGIS: up to 11 mg each for PM size, up to 16 mg each for ICD size. The new values are specified, implying they are deemed acceptable for efficacy.)

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

The summary does not explicitly state a "test set" in the context of clinical trials with human participant numbers for assessing diagnostic performance. The studies mentioned are primarily in vitro (bench testing) and in vivo (animal models, general biocompatibility, and AME).

Sample Size: Not specified in terms of human subjects or a defined "test set" for a diagnostic/AI device. The in vivo studies likely refer to animal models, but specific numbers are not provided.
Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be pre-clinical (bench and animal in vivo) conducted by the sponsor (TYRX, Inc., Monmouth Junction, NJ, USA). The studies are retrospective/prospective in the sense that they were conducted to support the 510(k) submission for this new device.

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

This section is not applicable for this type of medical device submission. Ground truth, in the context of diagnostic or AI devices, typically refers to expert interpretation of data or pathological findings. The assessment here is based on physical, chemical, and biological performance characteristics, verified by standard laboratory and in vivo animal testing, rather than human expert interpretation of a "test set" of images or patient data.

4. Adjudication Method for the Test Set

This is not applicable for this type of medical device submission. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in expert interpretations within diagnostic studies, which is not relevant here.

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

This is not applicable for this type of medical device submission. MRMC studies are used to evaluate the diagnostic performance of human readers, often comparing performance with and without AI assistance. This device is a physical implantable medical device, not an AI or diagnostic software.

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

This is not applicable for this type of medical device submission. "Standalone performance" refers to the performance of an AI algorithm on its own. The AIGIS R is a physical implantable device.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established through:

Bench Testing Results: Demonstrating material degradation, chemical structure integrity post-sterilization, and absence of interactions between components.
ISO Standard Compliance: Adherence to ISO 10993 for biocompatibility and ISO 11137 for sterility.
In vivo Model Results: Demonstrating antimicrobial effectiveness (AME) in an animal model of bacterial challenge and demonstrating that the device does not interfere with CIED function.

8. The Sample Size for the Training Set

This is not applicable. The AIGIS R is a physical medical device, not an AI algorithm. Therefore, there is no "training set" in the computational sense. The "training" or development of the device would involve materials science, engineering, and preclinical testing, not machine learning.

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

This is not applicable as there is no "training set" for an AI algorithm. For the development and testing of the physical device, the "ground truth" (i.e., the desired properties and performance) was established through:

Regulatory Standards: Compliance with ISO standards for biocompatibility and sterility.
Predicate Device Performance: Benchmarks set by the established safety and efficacy profile of the AIGISRx® (K063091) predicate device.
Scientific and Engineering Principles: Underlying principles for material science, chemical stability, and antimicrobial efficacy testing.

Summary

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K130943 510(k) Summary

510(k) Summary

In accordance with the regulations, TYRX provides this summary of the safety and effectiveness information for the AIGISRX (AIGIS R) device. This summary includes the substantial equivalence decision algorithm used for AIGIS R.

Sponsor/Applicant Name and Address: ·

Establishment Registration Number:

Sponsor Contact Information:

TYRX, Inc. One Deer Park Drive Monmouth Junction, NJ 08852

3005619263

Susan Olinger, JD Vice President, Regulatory Affairs Phone: 732.962.1110 Fax: 732.964.1490 Email: solinger@tvrx.com

Regina Novak Regulatory Affairs Manager Phone: 731.964.1492 Email: rnovak@tyrxpharma.com

Date of Preparation of 510(k) Summary:

New Device Trade/Proprietary Name:

Device Common Name:

Classification Name:

Predicate Devices Names and 510(k) Numbers:

March 29, 2013

AIGISRx®R

Surgical Mesh, Class II

Procode: FTL

AIGISrx® K063091

Device Description:

000181

MAY 2 0 2013

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Device Intended Use:

AIGIS R is intended to hold a pacemaker pulse generator or defibrillator securely in order to create a stable environment when implanted in the body. AIGIS R 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 of defibrillator. This device is intended to be used only in conjunction with pacemakers or defibrillators.

AIGIS R is intended for single-patient, one-time use only.

Performance Data:

AIGIS R 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. AIGIS R is identical to its predicate device, the FDA cleared AIGISRY (AIGIS) antibacterial envelope, [information is incorporated by reference into this 510(k)], except that the AIGIS R device's surgical mesh substrate is the bioresorbable mesh Glycoprene II, and the AIGIS substrate is a nonresorbable polypropylene polymer mesh. The change from a polypropylene substrate mesh to the Glycoprene mesh renders the AIGIS R device completely resorbable, while with the AIGIS device, only the polyarylate polymer coating is resorbable.

The drug content label claim for AIGIS is up to 11 mg each of rifampin and minocycline (PM size) and up to 16 mg each of rifampin and minocycline (ICD size). The label claim for AIGIS R is:

PM size (Medium): Rifampin - -8.0 mg Minocycline - 5.1 mg ICD size (Large): Rifampin - 11.9mg Minocycline - 7.6 mg

All forms of the AIGISRx family of devices are supplied sterile, biocompatible, and nonpyrogenic. TYRX follows the ISO 11137 standard for sterility. Furthermore, bench testing of the AIGIS family of devices demonstrated that gamma sterilization has no effect on the chemical structure or thermal properties of Glycoprene II mesh. Bench testing also demonstrated that AIGIS R degrades into its constituent monomers, and that there is no chemical or physical interaction between the Glycoprene mesh, the polyarylate coating, or the antibiotics. Testing, according to ISO Standard 10993, demonstrated the biocompatibility and safety of the device. In vivo studies demonstrated that the AIGIS R device does not interfere with the functioning of the implantable cardiovascular electronic device. Moreover, anti-microbial effectiveness (AME) studies, both in vivo and in vitro, demonstrated that the AME of AIGIS R is equivalent to AIGIS.

Conclusions:

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AIGIS R is safe and effective for its intended use, and is substantially equivalent to the predicate device, AIGIS. 1. 1. : 上一篇: 上一篇:

..............................................................................................................................................................................

. . . . . . . .

000133

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Image /page/3/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in bold, uppercase letters. The text is arranged on a single line and appears to be a header or title. The font is a sans-serif typeface, and the overall impression is one of official documentation or signage.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 20, 2013

Tyrx, Inc. c/o Ms. Susan Olinger 1 Deer Park Drive, Suite G Monmouth Junction, NJ 08854

Re: K130943

Trade/Device Name: AIGISRx R Device Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: FTL Dated: March 29, 2013 Received: April 04, 2013

Dear Ms. Olinger:

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. The general controls provisions of the Act include requirements for annual registration. Iisting 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. You must

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Page 2 - Ms. Susan Olinger

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 (OS) 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/Resourcesfor You/Industry/default.htm.

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm

for

Sincerely yours.

Owen P. Faris -S

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indication for Use Statement

K130943 510(k) number (if known):

Indication for Use:

AIGISRx® R is intended for single patient, one-time use only.

Prescription use X (21 CFR $801 Subpart D)

Over the counter use and/or (21 CFR §801 Subpart C)

PLEASE DO NOT WRITE ABOVE THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Owen P. Faris -S
2013.05.20
15:06:16 -04'00'

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.