QVL · Absorbable Gel For Intraoperative Use In Spine Surgery
Orthopedic · 21 CFR 888.3047 · Class 2
Overview
| Product Code | QVL |
|---|---|
| Device Name | Absorbable Gel For Intraoperative Use In Spine Surgery |
| Regulation | 21 CFR 888.3047 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
| Implant | Yes |
Identification
Oxiplex® is a synthetic, absorbable gel implant for intraoperative use in spinal procedures that is applied to nerve roots after hemostasis has been achieved and prior to closure. It is intended as an adjunct to lumbar spinal surgery in adult patients with leg pain, back pain, and neurological symptoms undergoing discectomy to reduce leg pain and neurological symptoms.
Classification Rationale
FDA has determined that, for the previously stated indications for use, Oxiplex® 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.
Special Controls
(1) Clinical performance data must demonstrate that the device performs as intended under anticipated conditions for use and include the following: (i) Evaluation of clinically relevant endpoints, such as reduction in pain or neurological symptoms, in comparison to a clinically justified comparator (e.g., the surgical procedure itself); and (ii) Evaluation of relevant adverse events, including impaired wound healing, pain, neurological deterioration, any unanticipated adverse device effects, and subsequent surgical interventions. (2) Animal performance testing must evaluate the safety of the device when used as intended under anticipated conditions of use. Animal testing must include histology to assess healing and tissue response at relevant timepoints over the course of healing, as well as an evaluation of device breakdown/absorption. (3) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions for use and include the following: (i) Characterization of the device materials; (ii) Characterization of gel properties, including flow properties and homogeneity; (iii) Evaluation of gel swelling behavior and analysis of the impact of device swelling; and (iv) Evaluation of byproducts from incomplete gel formation and/or device breakdown and an analysis of any adverse effects. (4) The patient-contacting components of the device must be demonstrated to be biocompatible. (5) Performance data must support the sterility and pyrogenicity of the device components intended to be sterile. (6) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life. (7) Labeling must include the following: (i) A shelf life; (ii) Identification of material composition; (iii) A detailed summary of the clinical testing pertinent to use of the device, including population studied, clinical outcomes and observed adverse events; (iv) Information regarding any limitations of the clinical data; and (v) Instructions for use, including specific instructions regarding surgical site observation for achieving hemostasis prior to device use, surgical site preparation, and device placement.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| DEN240038 | Oxiplex® | Fziomed, Inc. | Jun 17, 2025 | DENG |
Top Applicants
- Fziomed, Inc. — 1 clearance
