ASCEND

K083722 · Caldera Medical, Inc. · OTP · Mar 31, 2009 · Obstetrics/Gynecology

Device Facts

• Record ID: K083722
• Device Name: ASCEND
• Applicant: Caldera Medical, Inc.
• Product Code: OTP · Obstetrics/Gynecology
• Decision Date: Mar 31, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5980
• Device Class: Class 3
• Attributes: Therapeutic

Intended Use

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

Device Story

Ascend Pelvic Floor Repair System comprises macroporous, monofilament, polypropylene mesh implants and reusable introducers. Device used by surgeons to facilitate mesh placement during pelvic organ prolapse repair. Mesh provides structural support to pelvic floor tissues; introducers assist in precise anatomical positioning. System intended for clinical use in surgical settings to treat anterior, posterior, vaginal vault, and uterine prolapse.

Clinical Evidence

No clinical data provided. Substantial equivalence established via bench testing, including mechanical testing and biocompatibility evaluation.

Technological Characteristics

Macroporous, monofilament, polypropylene mesh. Includes reusable stainless steel or similar material introducers. Tested per FDA Guidance for the Preparation of a Premarket Notification Application for Surgical Mesh.

Indications for Use

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

Regulatory Classification

Identification

Surgical mesh for transvaginal pelvic organ prolapse repair is a prescription device intended to reinforce soft tissue in the pelvic floor. This device is a porous implant that is made of synthetic material, non-synthetic material, or a combination of synthetic and non-synthetic materials. This device does not include surgical mesh for other intended uses (§ 878.3300 of this chapter).

Predicate Devices

• AMS Apogee Vault Suspension System (K040537)
• AMS Perigee System (K040623)

Submission Summary (Full Text)

{0}------------------------------------------------

K083722 Page 1/2

& CALDERA MEDICAL

## 510(k) Summary

| Date of Summary: | December 12, 2008 | MAR 31 2009 |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Applicant: | Caldera Medical, Inc.<br>28632 Roadside Drive, Suite 260<br>Agoura Hills, CA 91301<br>P 866.422.5337<br>F 818.879.6556 | |
| Contact: | Mara Korsunsky<br>Quality Assurance and Regulatory Affairs Manager<br>P 818.879.6555 x 105<br>F 818.879.6556<br>E [e-mail] | |
| Device Name: | Surgical Mesh (878.3300) | |
| Trade Name: | Ascend | |
| Common Name: | Surgical Mesh | |
| Predicate Device: | AMS Apogee Vault Suspension System K040537<br>AMS Perigee System K040623 | |
| Description of Device: | The Ascend Pelvic Floor Repair System consists of<br>macroporous, monofilament, polypropylene mesh implants<br>and a set of reusable introducers to facilitate mesh implant<br>placement. The reusable introducers are available<br>separately. | |
| Intended Use of Device: | Ascend AC (anterior compartment) and Ascend PC<br>(posterior compartment) are indicated for repair of pelvic<br>organ prolapse, including anterior, posterior, vaginal vault<br>and uterine prolapse. | |

{1}------------------------------------------------

K083722 page 2/2

## CALDERA MEDICAL

Summary of Technological Characteristics:

The mesh used in the Ascend device has been tested in accordance with FDA's Guidance for the Preparation of a Premarket Notification Application for Surgical Mesh and has been shown to be equivalent to the listed predicate devices. In addition, the other components have demonstrated substantial equivalence to the predicate devices in terms of mechanical testing and biocompatibility.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized abstract symbol resembling an eagle or bird in flight. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the symbol. The text is in a simple, sans-serif font.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Caldera Medical, Inc. c/o Ms. Mara Korsunsky QA/RA Manager 28632 Roadside Drive, Suite 260 AGOURA HILLS CA 91301

SEP 2 8 2012

Re: K083722

Trade/Device Name: Ascend Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTP Dated: March 18, 2009 Received: March 19, 2009

Dear Ms. Korsunsky:

This letter corrects our substantially equivalent letter of March 31, 2009.

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 (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.

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

{3}------------------------------------------------

comply with all the Act's requirements, including, but not limited to: registration and listing (21 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm 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" (21 CFR Part 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/ReportaProblem/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 toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Sincerely yours,

Benjamin R. Civiletti

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Image /page/4/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 text is in a bold, sans-serif font and is all uppercase.

## Indications for Use

510(k) Number (if known): K083722

Device Name: Ascend

Indications for Use:

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

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

Over-The-Counter Use [] (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David Kraefer for MXM March 31, 2009

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

**510(k) Number** K083722

Page 1 of 1