(168 days)
Simultaneous use of GBR-membrane (BIO-GIDE®) and implants; augmentation around implants placed in immediate extraction sockets; augmentation around implants placed in delayed extraction sockets; localized ridge augmentation for later implantation; alveolar ridge reconstruction for prosthetic treatment; filling of bone defects after root resection, cystectomy, removal of retained teeth; guided bone regeneration in dehiscence defects; and guided tissue regeneration procedures in periodontal defects.
BIO-GIDE® resorbable bilayer membrane for guided tissue and bone regeneration. BIO-GIDE® is a pure collagen membrane obtained by a standardized controlled manufacturing process. The collagen is extracted from veterinary certified pigs and is carefully purified to avoid antigenic reactions. BIO-GIDE® is sterilized in double blisters by gamma irradiation. BIO-GIDE® has a bilayer structure. The porous surface facing the bone - allows the ingrowth of bone forming cells. The dense surface - facing the soft tissue - prevents the ingrowth of fibrous tissue into the bone defect. The membrane is made of collagen type I and type III without further cross-linking or chemical treatment.
The provided text does not contain information about acceptance criteria or a study demonstrating device performance against such criteria. The document is a 510(k) summary for the BIO-GIDE® resorbable bilayer membrane, which focuses on demonstrating substantial equivalence to previously cleared predicate devices (K960724 and K042197).
The key point of this 510(k) summary is the addition of a heating step (70℃ for at least 30 minutes) to the manufacturing process for assurance that organisms causing Transmissible Spongiform Encephalopathies Disease have been destroyed. The document explicitly states: "The revised manufacturing process has been validated and tests have been done that confirm that the additional heating step does not affect the final product and that, as such, there were no changes that would render the product not substantially equivalent to the previously cleared predicate product."
Therefore, the requested information cannot be extracted from this document, as it does not describe a study proving the device meets specific performance acceptance criteria. It focuses on validating a manufacturing process change and demonstrating substantial equivalence.
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Ko 50446
510(k) Summary
AUG 9 - 2005
BIO-GIDE®
SPONSOR 1.
Ed. Geistlich Soehne Ag für Chemische Industrie Geistlich Pharma Ag Bahnhofstrasse 40 CH-6110 Wolhusen SWITZERLAND
Contact Person: Peter S. Reichertz, (202) 408-9222 Date Prepared: February 18, 2005
DEVICE NAME 2.
| Proprietary Name: | BIO-GIDE® |
|---|---|
| Common/Usual Name: | Resorbable Bilayer Membrane for Guided Tissue and BoneRegeneration |
| Classification Name: | Barrier, Animal Source, Dental |
PREDICATE DEVICES 3.
BIO-GIDE® - K960724 and K042197
4. INTENDED USE
BIO-GIDE® is recommended for:
- Simultaneous use of GBR-membrane (BIO-GIDE®) and implants; .
- Augmentation around implants placed in immediate extraction sockets; �
- Augmentation around implants placed in delayed extraction sockets; .
- Localized ridge augmentation for later implantation; .
- Alveolar ridge reconstruction for prosthetic treatment; .
- Filling of bone defects after root resection, cystectomy, removal of retained teeth; .
- Guided bone regeneration in dehiscence defects; and .
- Guided tissue regeneration procedures in periodontal defects. .
DEVICE DESCRIPTION ട്.
BIO-GIDE® resorbable bilayer membrane for guided tissue and bone regeneration. BIO-GIDE® is a pure collagen membrane obtained by a standardized controlled manufacturing process. The collagen is extracted from veterinary certified pigs and is carefully purified to avoid antigenic reactions. BIO-GIDE® is sterilized in double blisters by gamma irradiation. BIO-GIDE® has a bilayer structure. The porous surface facing the bone - allows the ingrowth of bone forming cells. The dense surface - facing the soft tissue - prevents the ingrowth of fibrous tissue into the bone defect. The
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membrane is made of collagen type I and type III without further cross-linking or chemical treatment.
BASIS FOR SUBSTANTIAL EQUIVALENCE 6.
BIO-GIDE® resorbable bilayer membrane for guided tissue and bone regeneration is BIO-OIDE® Tesorbable onayst livel's existing product, BIO-GIDE® K960724 and Substantially cquiratelle to Gebarent on the new product and the BIO-GIDE® product K042197. The only unrecented boof heating step of 70℃ for at least 30 minutes. This previously cicared is the addition of heather will and Plant Health Inspection Service additional neating has been require of Agriculture as assurance that the organisms of the United States Department of Agains Disease have been destroyed as a condition of importation of the products.
The revised manufacturing process has been validated and tests have been done that I he revised manufacturing process itap does not affect the final product and that, as such, confirm that the addrivitial neating were wously cleared predicate product.
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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 image of a human face in profile, with three overlapping profiles creating a sense of depth. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular pattern around the image.
OCT 1 0 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville, Maryland 20850
Ed. Geistlich Soehne Ag Fuer Chemische Industrie C/O Mr. Peter S. Reichertz Official Correspondent/U.S. Agent Sonnenschein Nath & Rosenthal, LLP 1301 K Street NW. Suite 600 East Tower Washington, D.C. 20005
Re: K050446 Trade Name: BIO-GIDE® Resorbable Bilayer Membrane for Guided Tissue and Bone Regeneration Regulation Number: 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: 2 Product Code: NPL Dated: July 11, 2005 Received: July 12, 2005
Dear Mr. Reichertz:
This letter corrects our substantially equivalent letter of August 9, 2005.
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.
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Page 2 -
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 (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.
This letter will allow you to continue 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 vou desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. 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 from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Syrite Y. Mckinond.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Image /page/3/Picture/7 description: The image is a black and white circular logo. The logo has the letters FDA in large bold font in the center. Above the letters FDA are the numbers 1906-2006. Below the letters FDA is the word Centennial with three stars underneath. The text around the circle says "Food and Drug Administration Centennial Protection".
Protecting and Promoting Public Health
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Indications for Use
.
| K050446 | |
|---|---|
| 510(k) Number (if known): |
| Device Name: | BIO-GIDE® Resorbable Bilayer Membrane for Guided Tissue and BoneRegeneration. |
|---|---|
| Indications for Use: | Simultaneous use of GBR-membrane and implants; augmentation aroundimplants placed in immediate extraction sockets; augmentation aroundimplants placed in delayed extraction sockets; localized ridgeaugmentation for later implantation; alveolar ridge reconstruction forprosthetic treatment; filling of bone defects after root resection,cystectomy, removal of retained teeth; guided bone regeneration indehiscence defects; guided tissue regeneration procedures in periodontaldefects. |
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WANTE BELLOW HIS LINE-CONTINUE ON ANOTHER PAGE OF
Division Sieh Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K050446
§ 872.3930 Bone grafting material.
(a)
Identification. Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.(b)
Classification. (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.