ASCEND BLUE AC MESH; ASCEND BLUE PC MESH

K101462 · Caldera Medical, Inc. · FTL · Aug 16, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K101462
• Device Name: ASCEND BLUE AC MESH; ASCEND BLUE PC MESH
• Applicant: Caldera Medical, Inc.
• Product Code: FTL · General, Plastic Surgery
• Decision Date: Aug 16, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Ascend® Blue Mesh is a surgical implant for pelvic organ prolapse repair. Available in anterior (AC) and posterior (PC) configurations, it consists of macroporous monofilament polypropylene warp knit mesh. The central portion features blue-tinted polypropylene fibers for intraoperative and postoperative visualization, while clear fibers form the remainder. The device includes polyethylene sleeves and sutures as a delivery mechanism, which are removed after implantation; only the mesh remains in the body. Used in inpatient or outpatient surgical settings by physicians, the device is implanted using reusable Caldera Medical introducers. The mesh provides direct support for the prolapsed organ, while lateral arms facilitate tension-free fixation. The blue tinting improves surgical visualization compared to the predicate device. Benefits include structural support for pelvic organs and improved intraoperative identification of the implant's central portion.

Clinical Evidence

No clinical data. Substantial equivalence was demonstrated through bench testing, cadaver lab testing, and validation testing. Parameters assessed included mesh thickness, pore size, mesh density, flexural rigidity, tear resistance, burst strength, suture pullout, and pyrogen levels. Biocompatibility was evaluated per ISO 10993-1. The device also underwent ISTA Class C1 shipping challenge and sterilization validation.

Technological Characteristics

Materials: Macroporous monofilament polypropylene warp knit mesh, polyethylene sleeves, polyester braided suture. Features: Multi-zone construction with blue-tinted polypropylene fibers in the central portion. Energy: None (mechanical implant). Connectivity: None. Sterilization: SAL < 10^-6. Form factor: Pre-shaped, single-use implant. Color additive: 21 CFR 74.3045.

Indications for Use

Indicated for women requiring surgical repair of pelvic organ prolapse, including anterior, posterior, vaginal vault, and uterine prolapse.

Regulatory Classification

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.

Predicate Devices

• Ascend® Mesh (K083722)

Submission Summary (Full Text)

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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.

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# 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 [phone] x 102 [phone]

#### 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 | |

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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<br>indicated for repair of pelvic organ<br>prolapse, including anterior,<br>posterior, vaginal vault and uterine<br>prolapse. | same |
| Design/ Materials | Pre-shaped, sterile, single use<br>implant consisting of knitted large-<br>pore monofilament polypropylene<br>clear mesh with clear polyester<br>heatshrink formed tips | Change: Central mesh is woven<br>with blue tinted polypropylene<br>yarn for improved visualization.<br>Change: Color coded molded tips<br>replace heat-shrink formed tips.<br>Mesh weave pattern is unchanged. |
| Mesh color additive | none | 21 CFR 74.3045 |
| Sterility | SAL $< 10-6$ | same |
| Operating Principle | Supporting the pelvic region for<br>treatment of pelvic organ prolapse | same |
| Shelf Life | 60 months | 18 months |

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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 and<br>labeling | Tyvek inner and outer pouch,<br>packaging card, IFU, labeling,<br>packaging box and tamper-proof<br>seal | same |
| Product<br>Configuration | AC - anterior compartment<br>PC - posterior compartment | same |
| Design | Pre-shaped, sterile, single use<br>product | same |
| Mesh | Polypropylene monofilament | same |
| Sleeve | Polyethylene | same |
| Suture | Polyester braided suture,<br>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 [phone] or [phone] 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