(82 days)
Ascend® Blue AC and Ascend® Blue PC are indicated for repair of pelvic organ prolapse, including anterior, posterior, vaginal vault and uterine prolapse.
Ascend® Blue Mesh is designed to be used in the inpatient or outpatient surgery setting for use in women suffering from pelvic organ prolapse. The mesh is implanted using reusable Caldera Medical introducers, which are surgically removed once the mesh is in place. Ascend® Blue Mesh is available in two different designs – one for anterior compartment defects (AC) and one for posterior compartment defects (PC).
Ascend® Blue Mesh AC design is composed of macroporous monofilament polypropylene warp knit mesh in a multi-zone construction, which includes blue polypropylene fibers in the central portion and clear polypropylene fibers on the remainder of the device. This formation improves the visualization of the central portion intraoperatively and postoperatively. The central portion provides direct support for the prolapsed organ, while the lateral arms will aid in delivery of the implant and provide tension free fixation.
The Ascend® Blue product, PC configuration, consists of the same material components as the AC design: macroporous monofilament polypropylene warp knit mesh in a multizone construction, polyethylene sleeves, suture, and polyethylene tips. Each arm is covered by a polyethylene sleeve to protect the arm and reduce tissue resistance during positioning. The suture, sleeves and tips are removed from the device once the unit has been surgically implanted, for this construction serves as a delivery mechanism only. The only component to remain within the body is a portion of mesh.
Here's a breakdown of the acceptance criteria and the study information for the Ascend® Blue Mesh, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Ascend® Blue Mesh are primarily based on demonstrating substantial equivalence to its predicate device, Ascend® Mesh (K083722). The reported device performance indicates that the Ascend® Blue Mesh met these equivalency criteria through various tests.
| Acceptance Criteria Category | Specific Criteria/Outcome | Reported Device Performance (Ascend® Blue Mesh) |
|---|---|---|
| Indications for Use | Same as predicate device (repair of pelvic organ prolapse, including anterior, posterior, vaginal vault and uterine prolapse). | Same as predicate device. |
| Design/Materials | Substantially equivalent design/materials to predicate. (Predicate: Pre-shaped, sterile, single use implant of knitted large-pore monofilament polypropylene clear mesh with clear polyester heatshrink formed tips). | Changes: Central mesh is woven with blue tinted polypropylene yarn for improved visualization. Color-coded molded tips replace heat-shrink formed tips. Mesh weave pattern is unchanged. Despite these changes, the overall material (macroporous monofilament polypropylene warp knit mesh) is the same, and the changes are deemed to maintain substantial equivalence. |
| Mesh Color Additive | Compliance with relevant regulations (e.g., 21 CFR 74.3045). | Utilizes a blue tinted polypropylene yarn, implying compliance with 21 CFR 74.3045. |
| Sterility | Sterility Assurance Level (SAL) |
§ 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.