Aigis Rx R Pm/ Aigis Rx R Icd
by Tyrx, Inc. 510(k)
Active
510(k) K130943
Overview
The AIGIS RX R PM / AIGIS RX R ICD is a surgical mesh, classified as a polymeric device designed for use in cardiac implant applications. It functions as an antibacterial envelope intended to reduce infection risk in pacemaker and implantable cardioverter defibrillator (ICD) lead placements, providing a protective barrier against microbial colonization.
This device is supplied sterile and intended for single-use, adhering to 21 CFR 878.3300 for surgical mesh. It is regulated under FDA 510(k) clearance (K130943) and is classified as a Class II medical device. The envelope is positioned around pacemaker or ICD leads during implantation, requiring aseptic handling and storage in a clean, dry environment prior to use.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK130943 | Date20 May 2013 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- FTL
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.3300
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Other devices from Tyrx, Inc.
Questions
What is the primary purpose of the AIGIS RX R PM/AIGIS RX R ICD device in cardiac implant procedures?
The AIGIS RX R PM/AIGIS RX R ICD is designed as an antibacterial envelope made from polymeric surgical mesh. Its main purpose is to create a protective barrier around pacemaker or ICD leads during implantation, helping to reduce the risk of microbial colonization and infection at the implant site.
Is the device intended for single-use or can it be reused after sterilization?
The AIGIS RX R PM/AIGIS RX R ICD is explicitly intended for single-use only. The manufacturer specifies it must be used once and discarded, adhering to standard surgical mesh guidelines under 21 CFR 878.3300. Reuse is not recommended or supported.
How should the device be stored before use to maintain its sterility and integrity?
The device is supplied sterile and must be stored in a clean, dry environment to preserve its sterility. Aseptic handling is critical, as the envelope is positioned around leads during implantation to prevent contamination. Avoid exposure to moisture, direct sunlight, or extreme temperatures.
What regulatory pathway does this device follow, and what classification does it hold?
The AIGIS RX R PM/AIGIS RX R ICD is classified as a Class II medical device under FDA regulations. It received 510(k) clearance (K130943) via a traditional review pathway, with a decision of *Substantially Equivalent* to a predicate device. The advisory committee involved was the General, Plastic Surgery (SU) Committee.
Are there specific sizing or model variations for pacemaker vs. ICD applications?
The provided data does not specify distinct sizing or model variations for pacemaker (PM) vs. ICD applications—both are referred to collectively as *AIGIS RX R PM/AIGIS RX R ICD*. However, the envelope is designed to accommodate the respective lead sizes for each procedure. Consult manufacturer documentation for precise fitment guidance based on lead diameter.