(21 days)
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.
The Exair Anterior and Posterior Prolapse Repair System is composed of NovaSilk mesh precut into shape with an enlarged or elongated body with four appendages extending out from the main body. The mesh arms for both Exair Anterior and Posterior Prolapse Repair Systems are sleeved in 2-mil thick polypropylene to facilitate arm implantation and positioning: sleeves are removed after proper placement of the 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 in place the tissues for positioning and fixating the mesh body. The system provided sterile and for single use only.
This is a 510(k) summary for a surgical mesh device (K112386). It does not contain information about acceptance criteria or a study proving the device meets those criteria. The document states that the proposed changes described in the submission do not affect the materials, design, components, or technological features of the device, implying that no new performance studies were conducted for this specific submission to demonstrate compliance with new acceptance criteria. The submission is focused on demonstrating substantial equivalence to a predicate device (K083499) based on existing characteristics.
Therefore, I cannot provide the requested information from the provided text.
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PAGE I
510(k) Summary
SEP - 8 2011
| Submitter: | Coloplast A/S |
|---|---|
| Address | Holtedam 13050 Humlebaek, Denmark |
| Company Contact: | Tim CrabtreeRegulatory Affairs Manager612.302.4922 |
| Date Prepared: | August 15, 2011 |
| Device Name: | Exair® Anterior and Posterior Prolapse Repair System |
| Common Name: | Surgical mesh |
| Classification Name: | Surgical mesh, polymeric |
| Classification: | 21 CFR §878.3300 |
| Product Code: | OTP |
| Predicate Devices: | Exair Anterior and Posterior Prolapse Repair System(K083499) |
Description of Device: The Exair Anterior and Posterior Prolapse Repair System is composed of NovaSilk mesh precut into shape with an enlarged or elongated body with four appendages extending out from the main body. The mesh arms for both Exair Anterior and Posterior Prolapse Repair Systems are sleeved in 2-mil thick polypropylene to facilitate arm implantation and positioning: sleeves are removed after proper placement of the 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 in place the tissues for positioning and fixating the mesh body. The system provided sterile and for single use only.
Intended 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.
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Comparison of Technological Characteristics: The proposed changes in this submission do not affect the materials, design, components or technological features of the Exair Anterior and Posterior Prolapse Repair System. .
. . .
?
Substantial Equivalence: The changes cited in this submission do not affect substantial equivalence established in the original submission.
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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Coloplast A/S % Mr. Tim Crabtree Regulatory Affairs Manager Coloplast Corp. 1601 West River Road N MINNEAPOLIS MN 55411
SEP 2 8 2012
Re: K112386
Trade/Device Name: Exair® Anterior and Posterior Prolapse Repair System Regulation Number: 21 CFR§ 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTP Dated: August 17, 2011 Received: August 18, 2011
Dear Mr. Crabtree:
This letter corrects our substantially equivalent letter of September 8, 2011.
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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Page 2 -
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 Pour may of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Benjamin R. Fuchs
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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Indications for Use Statement
510(k) Number (if known): Kl | 2386
Device Name: Exair Anterior and Posterior Prolapse Repair System
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.
Over-The-Counter Use Prescription Use X AND/OR (Part 21 CFR 801 Subpart D). (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nica-h Herra
Division of Reproductive, Gastro-Renal, and
Urological Devices K112386
510(k) Number.
Page 2 of 14
§ 884.5980 Surgical mesh for transvaginal pelvic organ prolapse repair.
(a)
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).(b)
Classification. Class III (premarket approval).(c)
Date premarket application approval or notice of completion of a product development protocol is required. A premarket application approval or notice of completion of a product development protocol for a device is required to be filed with the Food and Drug Administration on or before July 5, 2018, for any surgical mesh described in paragraph (a) of this section that was in commercial distribution before May 28, 1976, or that has, on or before July 5, 2018, been found substantially equivalent to a surgical mesh described in paragraph (a) of this section that was in commercial distribution before May 28, 1976. Any other surgical mesh for transvaginal pelvic organ prolapse repair shall have an approved premarket application or declared completed product development protocol in effect before being placed in commercial distribution.