(80 days)
Zippere™ - Bioabsorbable / Non-absorbable Polymer Sling and Surgical Mesh is an implant that is intended for the treatment of urinary incontinence resulting from urethral hypermobility or ISD and for implantation to reinforce soft tissue where weakness exists in the urological, gynecological or gastroentrological anatomy. This includes, but not limited to, the following procedures: pubourethral support and bladder support, urethral and vaginal prolapse repair, colon and rectal prolabse repair, reconstruction of the pelvic floor and secral colposuspension.
Zippere™ - Bioabsorbable/Non-absorbable Polymer Sling and Surgical Mesh
This document is a 510(k) clearance letter from the FDA to ProSurg, Inc. for their Zippere™ - Bioabsorbable/Non-absorbable Polymer Sling and Surgical Mesh. This type of document is a regulatory approval, not a study report. Therefore, it does not contain the information requested regarding acceptance criteria and study details for a device's performance.
To answer your questions, I would need a clinical study report or a pre-market approval (PMA) application summary, which typically includes such details. This 510(k) simply states that the device is substantially equivalent to a legally marketed predicate device, meaning it has similar indications for use and technological characteristics as a device already approved by the FDA, and thus does not require extensive new clinical studies to demonstrate safety and effectiveness for market entry.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 9 2003
Mr. Ashvin Desai Manager, Regulatory Affairs ProSurg, Inc. 2195 Trade Zone Boulevard San Jose, California 95131
Re: K030631
Trade/Device Name: Zippere™ - Bioabsorbable/Non-absorbable Polymer Sling
and Surgical Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: February 20, 2003 Received: February 28, 2003
Dear Ms. Desai:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 CFR Part 807); labeling (21 CFR Part 801); 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.
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Page 2 - Mr. Ashvin Desai
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Muriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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KO30631
Indications For Use:
Zippere™ - Bioabsorbable/ Non-absorbable Polymer Sling and Surgical Mesh
Zippere™ - Bioabsorbable / Non-absorbable Polymer Sling and Surgical Mesh is an implant that is intended for the treatment of urinary incontinence resulting from urethral hypermobility or ISD and for implantation to reinforce soft tissue where weakness exists in the urological, gynecological or gastroentrological anatomy. This includes, but not limited to, the following procedures: pubourethral support and bladder support, urethral and vaginal prolapse repair, colon and rectal prolabse repair, reconstruction of the pelvic floor and secral colposuspension.
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K030631
§ 878.3300 Surgical mesh.
(a)
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.(b)
Classification. Class II.