Ascend® Blue AC and Ascend® Blue PC are indicated for repair of pelvic organ prolapse, including anterior, posterior, vaginal vault and uterine prolapse.

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 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.

AI/ML Overview

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.

Summary

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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).

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

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K101462 Page 2/3

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 areindicated for repair of pelvic organprolapse, including anterior,posterior, vaginal vault and uterineprolapse.	same
Design/ Materials	Pre-shaped, sterile, single useimplant consisting of knitted large-pore monofilament polypropyleneclear mesh with clear polyesterheatshrink formed tips	Change: Central mesh is wovenwith blue tinted polypropyleneyarn for improved visualization.Change: Color coded molded tipsreplace heat-shrink formed tips.Mesh weave pattern is unchanged.
Mesh color additive	none	21 CFR 74.3045
Sterility	SAL $< 10-6$	same
Operating Principle	Supporting the pelvic region fortreatment of pelvic organ prolapse	same
Shelf Life	60 months	18 months

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K101462 Page 3/3

Image /page/2/Picture/1 description: The image shows the words "CALDERA MEDICAL" in a stylized font. The letters are composed of small dots, giving the text a textured appearance. The overall impression is of a logo or brand name, possibly for a medical company.

feature	Ascend® Mesh, K083722	Ascend® Blue Mesh
Packaging andlabeling	Tyvek inner and outer pouch,packaging card, IFU, labeling,packaging box and tamper-proofseal	same
ProductConfiguration	AC - anterior compartmentPC - posterior compartment	same
Design	Pre-shaped, sterile, single useproduct	same
Mesh	Polypropylene monofilament	same
Sleeve	Polyethylene	same
Suture	Polyester braided suture,size 0	same
Junction	Polyester	PE

Performance Summary

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.

Summary of Substantial Equivalence

The Ascend® Blue Mesh is safe and effective for its intended use and is substantially equivalent to the predicate device. Ascend® Mesh, also a product of Caldera Medical.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows a black and white drawing of a bird inside of a circle. The bird is facing to the right and has three lines that make up its body. The bird's head is on the left side of the circle, and its tail is on the right side. The circle is made up of small dots.

Public Health Service

Food and Drug Administration 10903 Now Hampshire Avenue Document Control Room - WO66-1 (6 Silver Spring, MI) 20993-0002

Caldera Medical, Inc. % Ms. Vicki Gail Manager, QA/RA 28632 Roadside Drive. Suite 260 Agoura Hills, California 91301-6099

Re: K101462

Trade/Device Name: Ascend® Blue Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: 11 Product Code: FTL Dated: July 20, 2010 Received: July 22, 2010

Dear Ms. Gail:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21

ANG 1 6 Ping

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Page 2 - Ms. Vicki Gail

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please the Colleged Marger for sont DA/CentersOffices/CDRH/Offices/ucm 1 5809.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Prair.)
907 07) - F 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its tolli the (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

http://www.fda.gov/MedicalDevices/ResourcesforYour/Industry/default.htm.

Sincerely yours.

ely yours,

For
N. Melkerson

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/5/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 circular graphic appears to be a stylized representation of a flower or sunburst. The text is in all caps and appears to be a sans-serif font.

Statement of Indications For Use

Indications For Use

510 (k) Number (if known):

Device Name: Ascend® Blue

Indications for Use:

Ascend® Blue AC and Ascend® Blue PC are indicated for repair of pelvic organ prolapse, including anterior, posterior, vaginal vault and uterine prolapse.

Prescription Use -- X --(Part 21 CFR 801 Subpart D) AND/OR

Over the Counter Use (Part 21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dail Knane for MXM
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K101462

Ascend® Blue Caldera Medical, Inc. Confidential

Regulation Number and Section

§ 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.