(46 days)
Not Found
No
The device description and intended use focus on the physical properties of the resorbable mesh and the antimicrobial coating. There is no mention of any computational or analytical functions that would typically involve AI/ML.
No
The device is described as a sterile prosthesis designed to hold and stabilize a cardiovascular electronic implantable device (CIED) and to reduce infection with antimicrobial agents. It does not directly treat a disease or condition, but rather supports the function of other therapeutic devices (pacemakers/defibrillators) and prevents complications.
No
The device is described as a resorbable prosthesis designed to hold and stabilize a cardiovascular electronic implantable device (CIED) and contains antimicrobial agents to reduce infection. Its intended use is to provide a stable environment for implanted pacemakers or defibrillators, not to diagnose medical conditions by detecting, measuring, or analyzing physiological parameters.
No
The device description clearly states it is a "fully resorbable, dual component sterile prosthesis" constructed of "knitted filaments of a commercially available resorbable polymer" and coated with a "bioresorbable polyarylate polymer mixture containing the antimicrobial agents rifampin and minocycline". This describes a physical, implantable medical device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is "intended to hold a pacemaker pulse generator or defibrillator securely in order to create a stable environment when implanted in the body." This describes a device used in vivo (within the body) to support an implanted medical device.
- Device Description: The description details a "fully resorbable, dual component sterile prosthesis designed to hold and stabilize a cardiovascular electronic implantable device (CIED)... when the electronic device is implanted in the body." This further reinforces its use within the body.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples from the human body (blood, urine, tissue, etc.).
- Providing information about a patient's health status, diagnosis, or disease.
- Performing tests or assays.
The device's function is mechanical support and local antimicrobial delivery within the body, not diagnostic testing outside the body.
N/A
Intended Use / Indications for Use
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.
Product codes
FTL
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
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.
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
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
Or
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:
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
000181
MAY 2 0 2013
1
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:
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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
5
Indication for Use Statement
K130943 510(k) number (if known):
Indication for Use:
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.
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'