21 CFR 882.5270 — In Situ Polymerizing Peripheral Nerve Repair Device
Neurology (NE) · Part 882 Subpart F—Neurological Therapeutic Devices · § 882.5270
Identification
COAPTIUM CONNECT with TISSIUM LIGHT is an in situ polymerizing peripheral nerve repair device indicated for the sutureless repair of peripheral nerve injuries not in continuity in which a gap closure ≤ 1 cm is present or can be achieved with flexion of the extremity. It is composed of, in whole or in part, starting materials that polymerize when delivered to a peripheral nerve injury.
Classification Rationale
FDA has determined that, for the previously stated indications for use, the COAPTIUM CONNECT with TISSIUM LIGHT can be classified in class II with the establishment of special controls for class II. FDA believes that class II (special) controls provide reasonable assurance of the safety and effectiveness of the device type.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| SFD | In Situ Polymerizing Peripheral Nerve Repair Device | 2 | 2 | Implant |
Special Controls
SFD — In Situ Polymerizing Peripheral Nerve Repair Device
In combination with the general controls of the FD&C Act, the in situ polymerizing peripheral nerve repair device is subject to the following special controls: (1) In vivo performance testing in a clinically relevant model and defect size must demonstrate that the device performs as intended for the repair of peripheral nerve injuries and assess device preparation and deliverability, tissue reactions to the device or degradation products, device migration, and all adverse effects. (2) A characterization of the following chemical characteristics of the polymerization process must describe how the in situ application of the precursor materials will result in a consistent final device. All physico-chemically relevant changes to parts (iii)-(vi) below are determined to significantly affect the safety or effectiveness of the device (21 CFR 807.81(a)(3)(i)) and must be described in a premarket notification: (i) The technical specifications of the precursor materials and polymerization initiators including the chemical formulation, chemical analysis, appearance, and physical characteristics; (ii) The delivery mechanism of the precursor materials to the site of application; (iii) The polymerization mechanism and polymer structure; (iv) The intermediates or side products produced; (v) The degradation pathway and degradants; and (vi) The contribution of any initiators or quenchers to the polymer, intermediates or side products, and degradants. (3) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be evaluated: (i) Characterization of the polymerized final device must be performed. Physico-chemically relevant changes to the characteristics below are determined to significantly affect the safety or effectiveness of the device (21 CFR 807.81(a)(3)(i)) and must be described in a premarket notification: (A) The polymerization mechanism and polymer structure; (B) The intermediates or side products produced; (C) The degradation pathway and degradants; and (D) The contribution of any initiators or quenchers to the polymer, intermediates or side products, and degradants. (ii) Mechanical integrity testing, including elastic modulus, compression, swelling, and rebound testing, must be performed. (iii) Physico-chemical testing of the polymerized device including dimensions, chemical analysis, and reaction temperature must be performed. (iv) Device deliverability testing with any applicator(s), initiator(s), or delivery system(s) must be performed. (4) Human factors/usability testing must demonstrate that the intended user(s) in the intended use environment can correctly and safely use the device following the instructions for use. (5) The tissue-contacting components of the precursor materials, intermediate or side products, degradants, and final polymerized device must be demonstrated to be biocompatible. (6) Performance data must demonstrate the sterility of all tissue-contacting components of the device and any delivery systems. (7) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life. (8) Labeling must include: (i) Instructions on proper device preparation and implantation; (ii) Description of the device technical parameters and all components; and (iii) A shelf life.
De Novo Order DEN240066
