(82 days)
Not Found
No
The device description and performance studies focus on the material properties and mechanical performance of a surgical mesh for pelvic organ prolapse repair. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is indicated for the repair of pelvic organ prolapse, which is a medical condition, and the device directly treats or alleviates this condition.
No
The device is a surgical mesh used for the repair of pelvic organ prolapse. It is an implantable device designed for treatment, not for diagnosing a condition.
No
The device description clearly describes a physical mesh implant made of polypropylene, along with introducers and other physical components used for surgical implantation. It is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the repair of pelvic organ prolapse through surgical implantation. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a surgical mesh designed to be implanted in the body to provide structural support. This is a medical device used in vivo (within the living body).
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body to provide diagnostic information. This device is a surgical implant used to treat a physical condition.
N/A
Intended Use / Indications for Use
The Ascend® Blue AC (anterior compartment) and Ascend® Blue PC (posterior compartment) are indicated for repair of pelvic organ prolapse, including anterior, vaginal vault and uterine prolapse.
Product codes (comma separated list FDA assigned to the subject device)
FTL
Device Description
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 device is implanted using reusable Caldera Medical introducers, which are also produced by Caldera Medical. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pelvic region
Indicated Patient Age Range
Not Found
Intended User / Care Setting
inpatient or outpatient surgery setting
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
In accordance with FDA's Guidance for the Preparation of a Premarket Notification Application for Surgical Mesh, the results of bench, cadaver lab and validation testing has shown the Ascendo Blue Mesh to be equivalent to the predicate device.
The results of bench and cadaver testing demonstrated equivalent mesh characteristics, junction strength, and device function based upon its intended use to the predicate device.
The following parameters were assessed measured against the predicate device and found to be substantially equivalanet: Mesh thickness, pore size, mesh density area, flexural rigidity, tear resistance, burst strength, suture pullout, pyrogen levels.
In addition, the new Ascend® Blue Mesh has passed all testing requirements and demonstrated substantial equivalence to the predicate device in terms of aging, ISO 10993-1 tissue implant biocompatibility, ISTA Class C1 shipping challenge and sterilization.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo for Caldera Medical. The logo consists of a circular graphic on the left and the text "CALDERA MEDICAL" on the right. The graphic is a complex pattern of small circles or dots, creating a textured effect. The text is in a simple, sans-serif font.
K101462 Page 1/3
510(k) Summary
AUG 16 2010
Date of Summary:
· Submitter:
Address:
Contact:
Facsimile:
Phone:
June 16, 2010
Submitted by:
Caldera Medical, Inc. 28632 Roadside Drive, Suite 260 Agoura Hills, CA 91301 Vicki Gail, Manger QA/RA (818) 879-6555 x 102 (818) 276-8400
Device Name:
| Trade Names: | Ascend® |
|---|---|
| Ascend® | |
| Ascend® | |
| Common Name: | Surgical |
| Classification Name | Mesh, Su |
| Regulation No. | 878.3300 |
| Product Code | FTL |
Blue Mesh AC Blue Mesh PC Mesh rgical, Polymeric
510(k) Number K101462
Predicate Device: Ascend® Mesh (Caldera Medical, Inc.) K083722
Description of Device:
Ascend® Blue Mesh is designed to be used in the inpatient or outpatient surgery setting for use in women suffering from pelvic or accean and inpatient of outpatient of outpatible for used.
introducers, which are and in implanted using reusable Caldera Medical introducers, which are regal produced in is migranced using tedsable Calibra Medical
designess and for a transmission in 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. A visual reference of the product is provided below.
| Bladder neck end of mesh positioned at bladder neck | |
|---|---|
| Superior Obturator arm | Superior Obturator arm |
| Inferior Obturator arm | Inferior Obturator arm |
| Apical arm | |
| Ascend o Blue AC mesh implant |
1
K101462 Page 2/3
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.
Image /page/1/Figure/3 description: The image shows a diagram of an arm with a polyethylene sleeve cover and suture. The arm is depicted as a horizontal line with a thicker section in the middle. The polyethylene sleeve covers are shown on either side of the thicker section, and the suture is visible at the end of the arm. The image also includes the text "Arm" on the left side and "Arm with polyethylene sleeve covers and suture" on the right side.
Ascend® Blue PC mesh implant
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.
Intended Use of Device:
The Ascend® Blue AC (anterior compartment) and Ascend® Blue PC (posterior compartment) are indicated for repair of pelvic organ prolapse, including anterior, vaginal vault and uterine prolapse.
Technological Characteristics Comparison
The Ascend® Blue Mesh is a modification of the predicate mesh device comprised of the same knit pattern, sleeve and suture materials. The Ascend® Blue Mesh has the same intended use and does not change the fundamental scientific technology of the predicate device.
| feature | Ascend® Mesh, K083722 | Ascend® Blue Mesh |
|---|---|---|
| Indications for Use | Ascend® AC and Ascend® PC are | |
| indicated for repair of pelvic organ | ||
| prolapse, including anterior, | ||
| posterior, vaginal vault and uterine | ||
| prolapse. | same | |
| Design/ Materials | Pre-shaped, sterile, single use | |
| implant consisting of knitted large- | ||
| pore monofilament polypropylene | ||
| clear mesh with clear polyester | ||
| heatshrink formed tips | Change: Central mesh is woven | |
| with blue tinted polypropylene | ||
| yarn for improved visualization. | ||
| Change: Color coded molded tips | ||
| replace heat-shrink formed tips. | ||
| Mesh weave pattern is unchanged. | ||
| Mesh color additive | none | 21 CFR 74.3045 |
| Sterility | SAL $ |