EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEMS

K083499 · Coloplast A/S · OTP · May 8, 2009 · Obstetrics/Gynecology

Device Facts

• Record ID: K083499
• Device Name: EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEMS
• Applicant: Coloplast A/S
• Product Code: OTP · Obstetrics/Gynecology
• Decision Date: May 8, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5980
• Device Class: Class 3
• Attributes: Therapeutic

Indications for Use

The Coloplast Exair Anterior and Posterior Prolapse Repair Systems are indicated for tissue reinforcement and long-lasting stabilization of fascial structures of the pelvic floor in vaginal wall prolapse where surgical treatment is intended, either as mechanical support or bridging material for the fascial defect.

Device Story

Exair Anterior and Posterior Prolapse Repair Systems consist of precut NovaSilk surgical mesh and specialized instrumentation. Anterior system features mesh with enlarged body and four appendages; posterior system features elongated body and two appendages. Mesh arms are sleeved in 2-mil polyethylene to assist implantation and positioning; sleeves are removed post-placement. Instrumentation includes hollow introducer for tissue passage and retrievers for guiding/fixating mesh arms. Device is sterile, single-use, and intended for surgical use by physicians to provide mechanical support or bridging for fascial defects in pelvic floor prolapse repair.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Surgical mesh made of NovaSilk; polyethylene sleeves (2-mil thick). Includes hollow introducer and retrievers for implantation. Sterile, single-use. Mechanical support device.

Indications for Use

Indicated for patients requiring surgical treatment for vaginal wall prolapse; used for tissue reinforcement and stabilization of pelvic floor fascial structures.

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

• NovaSilk Mesh (K053414)
• Gynecare Prolift Total Pelvic Floor Repair System (K071512)

Submission Summary (Full Text)

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MAY - 8 2009

K083499.

ર્. 510(K) SUMMARY

510(K) Owner's Name:

Address:

Coloplast A/S

Holtedam l 3050 Humlebaek, Denmark Establishment Registration: 9610694 Owner/Operator: 8010144

Phone/Fax/Email:

Date Prepared:

[phone] Office: (୧୯୮) 387-1698 Mobile: [phone] Fax: [e-mail]

Name Of Contact Person:

Regulatory Affairs Manager

November 24, 2008

Janell A. Colley

Trade Or Proprietary Name:

Exair Anterior and Exair Posterior Prolapse Repair Systems

Surgical mesh Common Or Usual Name:

Classification Name: CFR section 878.3300)

Surgical Mesh, polymeric

# Legally Marketed Device To Which Your Firm Is Claiming Equivalence:

The Coloplast Exair Anterior and Exair Posterior Prolapse Repair Systems are substantially equivalent in performance, indications, design and materials to Coloplast's (formerly Mentor) NovaSilk Mesh, cleared under premarket notification number K053414 on 27 December 2005, and Ethicon Inc. Gynecare Prolift Total Pelvic Floor Repair System, cleared under Premarket notification number K071512 on 15 May 2008.

#### Device Description:

The Exair Anterior Prolapse Repair System is made of NovaSilk mesh precut into a shape with an enlarged body and four appendages extending out from the main body. The Exair Posterior Prolapse Repair System is made of NovaSilk mesh precut into a shape with an elongated body and two appendages extending out from the main body. The mesh arms for both Exair Anterior and Exair Posterior Prolapse Repair Systems are sleeved in 2-mil thick polyethylene to facilitate device arm implantation and positioning; sleeves are removed after proper

Exair Anterior & Posterior Prolapse Repair System

CONFIDENTIAL

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placement of implant is achieved. The System instrumentation includes a hollow introducer used to create a passage through the tissues and facilitate placement of the mesh arms, and four (4) anterior or two (2) posterior retrievers used to guide the mesh arms into place through the (1) and for positioning and fixating the mesh body. The System is provided sterile and for single use only.

### Intended Use Of The Device:

The Coloplast Exair Anterior and Posterior Prolapse Repair Systems are indicated for tissue reinforcement and long-lasting stabilization of fascial structures of the pelvic floor in vaginal wall prolapse where surgical treatment is intended, either as mechanical support or bridging material for the fascial defect.

## Technological Characteristics Compared To Predicate Device:

The Coloplast Exair Anterior and Posterior Prolapse Repair Systems are substantially equivalent in design, materials, performance characteristics, and indications to the predicates Coloplast (formerly Mentor) NovaSilk Mesh, cleared under premarket notification number K053414 on 27 December 2005, and Gynecare Prolift Total Pelvic Floor Repair System, cleared under Premarket notification number K071512 on 15 May 2008.

## Summary and Conclusions from the Nonclinical Tests Submitted:

Substantial equivalence is supported by bench testing comparing Exair to the predicate devices and biocompatibility testing performed on the Exair device and instrumentation.

CONFIDENTIAL

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with three wing strokes, symbolizing service to the nation. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle emblem.

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

Coloplast A/S % Ms. Janell A. Colley Regulatory Affairs Manager 1499 West River Road North MINNEAPOLIS MN 55411

SEP-28 2012

Re: K083499 Trade/Device Name: Exair Anterior & Posterior Prolapse Repair Systems Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTP Dated: May 1, 2009 Received: May 4, 2009

Dear Ms. Colley:

This letter corrects our substantially equivalent letter of May 8, 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

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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. Perkins

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 Coloplast logo. The logo consists of a circle on the left and the word "Coloplast" on the right. The circle is divided into two halves, with the top half containing horizontal lines and the bottom half containing a textured pattern. The word "Coloplast" is written in a bold, sans-serif font.

1601 Wast River Road North Minneapolis, MN 55411

[phone]

www.coloplast.com

K083499

#### Statement of Indications for Use

510(k) Number:

K083499

Device Nanie:

Exair Anterior & Posterior Prolapse Repair Systems

Indications for Use:

The Coloplast Exair Anterior and Posterior prolapse repair systems are indicated for tissue reinforcement and long-lasting stabilization of fascial structures of the pelvic floor in vaginal wall prolapse where surgical treatment is intended, either as mechanical support or bridging material for the fascial defect.

**Prescription Use**

Over The Counter Use

(Part 2) CIR 201 Subpart D)

AND/OR (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEBDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel Krause for NXm

(Division Sign-Off) Division of Surgici. I. Orthopedic, and Restorative Devices

510(k) Number K083499

Exair Prolapse Repair System K083499 / A1

- CONFIDENTIAL -