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510(k) Data Aggregation
(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) < 10-6. | Same as predicate device (SAL < 10-6). |
| Operating Principle | Same as predicate device (Supporting the pelvic region for treatment of pelvic organ prolapse). | Same as predicate device. |
| Shelf Life | Acceptable shelf life for a medical device. (Predicate: 60 months). | 18 months. (While different from the predicate's 60 months, this is an acceptable shelf life demonstrated through testing, and doesn't negate substantial equivalence given the context of other equivalency findings). |
| Packaging and Labeling | Same as predicate device. | Same as predicate device. |
| Product Configuration | Same as predicate device (AC - anterior compartment, PC - posterior compartment). | Same as predicate device. |
| Design (Overall) | Same as predicate device (Pre-shaped, sterile, single use product). | Same as predicate device. |
| Mesh (Material) | Polypropylene monofilament. | Same as predicate device (Polypropylene monofilament). |
| Sleeve (Material) | Polyethylene. | Same as predicate device (Polyethylene). |
| Suture (Material) | Polyester braided suture, size 0. | Same as predicate device (Polyester braided suture, size 0). |
| Junction (Material) | Material for junctions (Predicate: Polyester). | PE. (This is a change from polyester to PE for the junction material, but, similar to the tips, it's evaluated within the context of overall substantial equivalence and performance testing). |
| Performance (Bench/Cadaver) | Equivalent mesh characteristics, junction strength, and device function based on intended use to the predicate device. Parameters assessed: Mesh thickness, pore size, mesh density area, flexural rigidity, tear resistance, burst strength, suture pullout, pyrogen levels. Passed all testing requirements demonstrating substantial equivalence. | Demonstrated equivalent mesh characteristics, junction strength, and device function. Found substantially equivalent concerning: Mesh thickness, pore size, mesh density area, flexural rigidity, tear resistance, burst strength, suture pullout, pyrogen levels. |
| Biocompatibility | Compliance with ISO 10993-1 tissue implant biocompatibility. | Passed ISO 10993-1 tissue implant biocompatibility. |
| Aging | Demonstrated substantial equivalence to predicate in terms of aging. | Demonstrated substantial equivalence to predicate in terms of aging. |
| Shipping Challenge | Compliance with ISTA Class C1 shipping challenge. | Passed ISTA Class C1 shipping challenge. |
| Sterilization | Demonstrated substantial equivalence to predicate in terms of sterilization. | Demonstrated substantial equivalence to predicate in terms of sterilization. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific "sample size" for a discrete test set in terms of patient data or a clinical study. Instead, the testing demonstrating acceptance relies on:
- Bench testing: Involves physical and mechanical tests on the mesh materials and device components. The document doesn't provide specific numbers of samples tested for each mechanical property.
- Cadaver lab testing: Involves evaluating device function and handling in a cadaveric setting. The number of cadavers or specific tests performed is not detailed.
- Validation testing: This broadly refers to all the tests (e.g., sterilization, aging, biocompatibility) demonstrating the device's adherence to specifications.
Data Provenance: Not applicable in the traditional sense of patient data. The testing is based on laboratory and material science evaluation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided. The study focuses on demonstrating technical and performance equivalence to a predicate device through bench and cadaver testing, rather than establishing a diagnostic "ground truth" based on expert clinical consensus.
4. Adjudication Method for the Test Set
Not applicable. There's no indication of an adjudication method as the study is not a clinical trial with ambiguous cases requiring expert review.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document describes pre-market notification for a medical device (surgical mesh), not an AI-assisted diagnostic tool. Therefore, the concept of "human readers improving with AI vs without AI assistance" is not relevant here.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No, a standalone study in the context of algorithm performance was not done. This device is a surgical implant, not an algorithm, and does not involve human-in-the-loop performance in the sense of AI assistance.
7. Type of Ground Truth Used
The "ground truth" in this context is defined by the established performance and safety characteristics of the predicate device (Ascend® Mesh, K083722). The goal of the study was to demonstrate that the Ascend® Blue Mesh performs equivalently. Therefore, the ground truth is essentially the predicate device's validated specifications and performance data, as well as relevant industry standards and regulatory requirements (e.g., ISO 10993-1, ISTA Class C1).
8. Sample Size for the Training Set
Not applicable. This device is a physical medical implant, not a machine learning model. There is no concept of a "training set" for an algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an algorithm.
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