VERTESSA LITE 10 X20CM, VERTESSA LITE 11 X 30CM, VERTESSA LITE Y-MESH

K123028 · Caldera Medical, Inc. · OTO · Apr 25, 2013 · General, Plastic Surgery

Device Facts

• Record ID: K123028
• Device Name: VERTESSA LITE 10 X20CM, VERTESSA LITE 11 X 30CM, VERTESSA LITE Y-MESH
• Applicant: Caldera Medical, Inc.
• Product Code: OTO · General, Plastic Surgery
• Decision Date: Apr 25, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Vertessa™ Lite Y-Mesh may be used as a bridging material for sacrocolposuspension/sacrocolpopexy (laparotomy; laparoscopic, or robotically-assisted approach) where surgical treatment for vaginal vault prolapse is warranted.

Device Story

Vertessa Lite Y-Mesh is a non-absorbable, macroporous, monofilament polypropylene warp knit mesh in a Y-shape configuration. It is intended for use as a bridging material during sacrocolposuspension/sacrocolpopexy procedures to treat vaginal vault prolapse. The device is implanted or affixed by a surgeon using sutures of their choice during open, laparoscopic, or robotically-assisted surgery. It provides structural support to the vaginal vault. The device is provided sterile.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing, including mesh thickness, knit characteristics, pore size, density, tensile strength, stiffness, flexural rigidity, tear resistance, burst strength, suture pullout, and pyrogen levels. Biocompatibility testing performed per ISO-10993. Sterility and shelf-life validated per ASTM F-1980-07.

Technological Characteristics

Non-absorbable macroporous monofilament polypropylene warp knit mesh; Y-shape configuration. Evaluated for thickness, density, tensile strength, stiffness, flexural rigidity, tear resistance, burst strength, and suture pullout. Sterile, single-use device.

Indications for Use

Indicated for women requiring surgical treatment for vaginal vault prolapse; used as a bridging material for sacrocolposuspension/sacrocolpopexy via laparotomy, laparoscopic, or robotically-assisted approach.

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

• Alyte Y-Mesh Graft (K101722)
• Restorelle Y-Mesh (K112322)

Submission Summary (Full Text)

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### 510(k) Summary

## APR 2 5 2013

Date of Summary:

April 24, 2013

Submitted by:

- Submitter: Caldera Medical, Inc. Address: 5171 Clareton Drive Agoura Hills, CA 91301 Contact: Vicki Gail, Manager QA/RA Phone: [phone] x 102 Fascimile: [phone]
#### Device Information:

Trade Name: Vertessa Lite Y-Mesh Classification: Class II, Product Code: OTO, Surgical Mesh, Gynecologic, 21 CFR 878.3300, General and Plastic Surgery Alyte Y-Mesh Graft (K101722), C.R. Bard, Inc. Predicates: Restorelle Y-Mesh (K112322), Coloplast A/S

Description of Device:

Vertessa Lite Y-Mesh is designed to be used in women suffering from uterine or vaginal vault prolapse and is implanted or affixed using suture of the surgeon's choice. Vertessa Lite Y-Mesh is provided sterile and is comprised of non-absorbable macroporous monofilament polypropylene warp knit blue mesh in a y-shape design.

Intended Use of Device:

Vertessa Lite Y-Mesh may be used as a bridging material for sacrocolposuspension/sacrocolpopexy (laparotomy; laparoscopic, or robotically-assisted approach) where surgical treatment for vaginal vault prolapse is warranted.

Technological Characteristics

Vertessa Lite Y-Mesh a modification of the predicate mesh devices, Alyte Y-Mesh Graft (K101722) by C.R. Bard, Inc. and Restorelle Y-Mesh (K112322) by Coloplast A/S. The device design is a Y-shape configuration, which is similar to that of the predicate mesh devices, has a similar intended use as that of the predicate devices and does not change the fundamental scientific technology of the predicate devices.

Performance Summary

In accordance with the FDA's Guidance for Industry and FDA Staff "Format for Traditional and Abbreviated 510/k/s the results of non-clinical bench, simulated use, surgeon feedback and validation testing has shown the Vertessa Lite Y-Mesh device to be substantially equivalent to that of the predicate device in its intended use, function, technological characteristics and performance.

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In accordance with the FDA's Guidance for the Preparation of a Premarket Notification for Surgical Mesh, the following mesh characteristics were assessed: mesh thickness, mesh knit characteristics, pore size, mesh density, tensile strength, mesh stiffness, flexural rigidity, tear resistance, burst strength, suture pullout and Pyrogen levels.

Vertessa Lite Y-Mesh has passed all biocompatibility testing as indicated per the FDA guidance documents, FDA Device Advice, Guidance Documents (Medical Device and Radiation Emitting Product), 3. Biocompatibility and FDA Blue Book Memorandum #G95-1 Entitled "Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part-1: Evaluation and Testing".

In accordance with the FDA Guidance, Updated 510(k) Sterility Review Guidance K90-1; Final Guidance for Industry, FDA, FDA Device Advice, Guidance Documents (Medical Device and Radiation Emitting Product), 4. Labeling and FDA Consensus standard, ASTM F-1980-07, Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices, Vertessa Lite Y-Mesh has passed all testing requirements in terms of aging, shelf life, transportation and sterilization.

Bench and failure mode testing demonstrates that the performance of Vertessa Lite Y-Mesh is substantially equivalent to that of the predicate devices, Alyte Y-Mesh Graft (K101722) by C.R. Bard and Restorelle Y-Mesh (K112322) by Coloplast A/S.

#### Summary of Substantial Equivalence

Vertessa Lite Y-Mesh has demonstrated that it is substantially equivalent to that of the predicate devices, Alyte Y-Mesh Graft, (K101722), a product of Bard Medical and Restorelle Y-Mesh (K112322) a product of Coloplast A/S.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The seal is presented in black and white.

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

April 25, 2013

Caldera Medical, Inc. % Ms. Vicki Gail OA/RA Manager 5171 Clareton Drive AGOURA HILLS CA 91301

Re: K123028

Trade/Device Name: Vertessa™ Lite Y-Mesh Regulation Number: 21 CFR§ 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTO Dated: April 16, 2013 Received: April 18, 2013

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. Iisting 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.

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Page 2 - Ms. Vicki Gail

You must 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 (OS) 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" (21CFR 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/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 toll-free number [phone] or [phone] or at its Internet address

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

Sincerely yours,

Herbert P.Lerner -S

for 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

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Image /page/4/Picture/0 description: The image shows the logo for Caldera Medical. The logo consists of a circular graphic on the left, followed by the text "CALDERA MEDICAL" in all capital letters. The font appears to be sans-serif.

## Statement of Indications For Use

### Indications For Use

510 (k) Number (if known): #K123028

Device Name: Vertessa™ Lite Y-Mesh

Indications for Use:

Vertessa™ Lite Y-Mesh may be used as a bridging material for sacrocolposuspension/sacrocolpopexy (laparotomy; laparoscopic, or robotically-assisted approach) where surgical treatment for vaginal vault prolapse is warranted.

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)

# Herbert ஜூட்ஜோer -S

(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices K123028 510(k) Number