AIGIS RX N MEDIUM; AIGIS RX N LARGE

K131007 · Tyrx, Inc. · FTL · Jul 10, 2013 · General, Plastic Surgery

Device Facts

• Record ID: K131007
• Device Name: AIGIS RX N MEDIUM; AIGIS RX N LARGE
• Applicant: Tyrx, Inc.
• Product Code: FTL · General, Plastic Surgery
• Decision Date: Jul 10, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

AIGISRx® N is intended to hold a vagus nerve stimulator 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 the pulse generator or defibrillator. This device is only intended to be used in conjunction with vagus nerve stimulators implanted in the infraclavicular fossa or anterolateral abdominal wall.

Device Story

AIGISRx N is a sterile, dual-component surgical mesh prosthesis; constructed of knitted polypropylene filaments coated with a bioresorbable polyarylate polymer containing antimicrobial agents rifampin and minocycline. Device is implanted by a surgeon during vagus nerve stimulator placement in the infraclavicular fossa or anterolateral abdominal wall. Mesh holds the stimulator securely, creating a stable environment; antimicrobial coating elutes to reduce infection risk following surgical implantation. Device is passive; no electronic or software components. Benefits include improved device stability and reduced post-surgical infection risk.

Clinical Evidence

No clinical data. Evidence consists of bench testing and in vivo functionality studies. Bench testing confirmed sterility (ISO 11137) and biocompatibility (ISO 10993). In vivo studies demonstrated that the device does not interfere with implantable pulse generators or defibrillators and that the antimicrobial agents reduce infection in a bacterial challenge model.

Technological Characteristics

Knitted polypropylene mesh coated with bioresorbable polyarylate polymer containing rifampin and minocycline. Sterile, biocompatible, non-pyrogenic. Sterilization via gamma radiation (ISO 11137). Mechanical properties include suture retention, tear, and burst strength. Passive implantable device.

Indications for Use

Indicated for patients requiring secure implantation of a vagus nerve stimulator in the infraclavicular fossa or anterolateral abdominal wall to create a stable environment and reduce infection risk via rifampin and minocycline elution.

Regulatory Classification

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.

Predicate Devices

• AIGISRx® (K063091)

Submission Summary (Full Text)

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# 131007

### 510(k) Summary

## JUL 1 0 2013

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 AIGISRx N subject device.

Sponsor/Applicant Name and Address:

TYRX. Inc. 1 Deer Park Drive Monmouth Junction, NJ 08852

#### Establishment Registration Number:

Sponsor Contact Information:

3005619263

Susan Olinger Vice President, Regulatory Affairs Phone: [phone] Fax: [phone] Email: [e-mail]

Alternate Contact: Regina Novak Manager, Regulatory Affairs Phone: [phone] Fax: [phone] Email: [e-mail]

April 11, 2013

AIGISRx® N

Surgical Mesh, Class II PROCODE: FTL

Predicate Device Name and 510(k) Number

Date of Preparation of 510(k) Summary:

New Device Trade/Proprietary Name:

Device Common/Classification Name:

AIGISRx® -(K063091)

Device Description:

AIGISRx® N is a dual component (resorbable and non-resorbable) sterile prosthesis designed to hold a vagus nerve stimulator 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

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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:

AIGISRx® N is intended to hold a vagus nerve stimulator 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 the pulse generator or defibrillator. This device is only intended to be used in conjunction with vagus nerve stimulators implanted in the infraclavicular fossa or anterolateral abdominal wall.

#### Technological Characteristics:

The physical, chemical, and mechanical properties of the AIGIS N subject device, such as mesh knit characteristics, suture retention strength, tear strength and burst strength are the same as the AIGISRx® 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.

#### Performance Data:

AIGIS N is designed to be a biocompatible, sterile device intended to hold a vagus nerve stimulator securely in order to create a stable environment when implanted in the body. The AIGIS N subject device is identical to the AIGIS predicate device. Information on the cleared predicate device, K063091, is included by reference in this 510(k).

AIGIS 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 pacemaker or defibrillator.

#### Conclusions:

Both the AIGISRx predicate and AIGISRx N subject devices are safe and effective for their intended uses.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an abstract symbol that resembles a stylized caduceus or a bird-like figure with three wing-like shapes.

July 10,2013

TYRX Inc. Susan Olinger 1 Deer Park Drive Monmouth Junction, NJ, 08852

Re: K131007

Trade/Device Name: AIGISRx N Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: FTL Dated: April 11, 2013 Received: April 11, 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, 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 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 (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.

Public Health Service

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

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Page 2 - Ms. Susan Olinger

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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Victor Krauthamer -S

Victor Krauthamer, Ph.D. 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): K131007

#### Device Name: AIGISRx N Antibacterial Envelope

Indications For Use:

AIGISRx® N is intended to hold a vagus nerve stimulator 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 or defibrillator. This device is only intended to be used in conjunction with vagus nerve stimulators implanted in the infraclavicular fossa.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Victor Krauthamer 2013.07.10 18:51:02 =04'00'

Division Sign Off) Division of Neurological and Physical Medicine Devices (DNPMD)

510(k) Number K131007

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