(63 days)
BioCELLECT™-perio is a bioabsorbable implantable membrane intended for use in the surgical management and treatment of periodontal defects to aid in the regeneration and integration of tissue components in guided tissue regeneration procedures. It is also used as a membrane that provides a stable barrier for the containment of bone graft material. Its composition allows a relative short term resorption.
BioCELLECT™ is composed of a porous structure of synthetic bioabsorbale compressed L (-)Glycolide homopolymer fibers. The porous structure is designed to attach to surrounding soft tissue and inhibit epithelial migration during wound healing. It is a biocompatible, cell occlusive, clinically manageable device that allows for tissue integration without further surgical intervention.
The provided text does not contain information about acceptance criteria or a study that proves the device meets those criteria. The document is a 510(k) summary for a medical device called BioCELLECT™-perio, which details its classification, predicate device, and a brief description. The remaining pages are an FDA letter granting substantial equivalence and an "Indications For Use" statement.
Therefore, I cannot extract the requested information.
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APR 1 0 2002
510 (k) SUMMARY
SUBMITTED BY:
M. K. Patterson, Jr. PhD Sr Vice President Regulatory Affairs IMTEC Corporation 2401 North Commerce Ardmore, Oklahoma 73401
(580) 223-4456
F.D.A Registration Number: 1645158 Owner / Operator Number: 9003407
Date Submitted: January 30,2002
CLASSIFICATION/COMMON OR USUAL NAME/ DEVICE NAME:
Classification Name: Unclassified Device. Code:LYC Common/ Usual Name:GTR Proprietary Name: BioCELLEC'T™-perio.
PREDICATE DEVICE:
Epi-Guide™ (K940643)
DEVICE DESCRIPTION:
BioCELLECT™ is composed of a porous structure of synthetic bioabsorbale compressed L (-)Glycolide homopolymer fibers. The porous structure is designed to attach to surrounding soft tissue and inhibit epithelial migration during wound healing. It is a biocompatible, cell occlusive, clinically manageable device that allows for tissue integration without further surgical intervention.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the most prominent. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular pattern around the image.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 0 2002
Mr. K. Patterson Senior Vice President IMTEC, Corporation 2401 North Commerce Ardmore, Oklahoma 73401
Re: K020396
Trade/Device Name: BioCELLECT™- perio Regulation Number: None Regulation Name: GTR Barrier Regulatory Class: Unclassified Product Code: LYC Dated: January 30, 2002 Received: February 6, 2002
Dear Mr. Patterson:
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.
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Page 2 - Mr. Patterson
You must comply with all the Act's requirements, including, but not limited to: registration r ou interest compry was as a manufacturing (21 CFR Part 801); good manufacturing practice and listing (21 er read 007), equality systems (QS) regulation (21 CFR Part 820); and if roquiceller the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 If you desire pochlo ad for a 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and the Ree may be country 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,
Timothy A. Ulatowski
A. Ulatowski Timo Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page
510(k) Number (if known): K020396
Device Name: BioCELLECT™ -perio
Indications For Use:
BioCELLECT™-perio is a bioabsorbable implantable membrane intended for use in the surgical management and treatment of periodontal defects to aid in the regeneration and integration of tissue components in guided tissue regeneration procedures. It is also used as a membrane that provides a stable barrier for the containment of bone graft material. Its composition allows a relative short term resorption.
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| Concurrance of CDRH, Office of Device Evaluation (ODE) | |
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Prescription Use
OR
Over-The-Counter Use (Optional Format 1-2-96)
Susan Runne
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices F (0(k) Number __
§ 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.