(226 days)
BioSet™ XC is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. These products are indicated to be packed into bony voids or gaps of the skeletal system (e.g., the extremities, spine, ilium and/or pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.
BioSet™ XC is a combination of bovine bone processed with the BioCleanse Tissue Sterilization Process, human demineralized bone matrix, and porcine gelatin. BioSet™ XC is available in volumes from 1 to 32cc.
The provided text is a 510(k) summary for the BioSet™ XC device and an FDA clearance letter. It does not contain information about acceptance criteria, device performance, a study to prove acceptance criteria, sample sizes, expert involvement, adjudication methods, multi-reader multi-case studies, or standalone algorithm performance.
The document describes the device, its intended use, and its technological characteristics, primarily focusing on its composition and how it relates to predicate devices for demonstrating substantial equivalence. The FDA letter confirms the device's clearance based on this substantial equivalence.
Therefore, I cannot fulfill the request for information regarding acceptance criteria and study details based on the provided text.
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Image /page/0/Picture/0 description: The image shows the logo for Regeneration Technologies, Inc. The logo consists of a black square with a textured pattern on the left, followed by the word "Regeneration" in bold, black letters. Below "Regeneration" is the text "TECHNOLOGIES, INC." in a smaller, sans-serif font. The logo appears to be for a technology company.
11621 Research Circle Alachua, FL 32615 Post Office Box 2650 Alachua, FL 32616-2650 Tel 386.418.8888 Toll Free 877.343.6832 Fax 386.418.0342 www.rtix.com
510(K) Summary
Date: January 20, 2006
Submitted by: Lisa Simpson Regeneration Technologies, Inc. 11621 Research Circle Alachua, FL 32615 Phone: 386-418-8888 Fax: 386-462-3821
Proprietary Name: BioSet™ XC
Common Name: Filler, bone void, calcium compound
Classification: MQV, Orthopedics Panel
Code Section: 21 CFR 888.3045
Substantial Equivalence:
Data demonstrating substantial equivalence of BioSet™ XC to predicate devices has been submitted.
Description:
BioSet™ XC is a combination of bovine bone processed with the BioCleanse Tissue Sterilization Process, human demineralized bone matrix, and porcine gelatin. BioSet™ XC is available in volumes from 1 to 32cc.
Intended Use:
BioSet™ XC is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. These products are indicated to be packed into bony voids or gaps of the skeletal system (e.g., the extremities, spine, ilium and/or pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.
Summary of Technological Characteristics:
BioSet™ XC is composed of bovine bone chips, human demineralized bone matrix (DBM) and porcine gelatin. The DBM and porcine gelatin are processed in the same manner as the predicate RTI Allograft Paste IC. The bovine bone is processed in the same manner as the predicate STERLING® Cancellous Chips. BioSet™ XC is simply a substitution of bovine bone chips for the human bone chips in the RTI Allograft Paste IC product. The source of bovine bone used in BioSet™ XC is a closed herd located in the U.S.A. Viral inactivation studies of the manufacturing process demonstrate a significant reduction of a representative panel of viruses.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS) in the United States. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" around the perimeter. Inside the circle is a stylized image of a human figure, represented by flowing lines, suggesting a sense of well-being and care.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Regeneration Technologies, Inc. c/o Ms. Lisa Simpson Director of Regulatory Affairs 11621 Research Circle P.O. Box 2650 Alachua, FL 32615
SEP - 6 2006
Re: K060180
Trade/Device Name: BioSet™ XC Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV, MBP Dated: July 14, 2006 Received: July 14, 2006
Dear Ms. Simpson:
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
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Page 2 - Ms. Lisa Simpson
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. 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 (240) 276-0120. 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/industry/support/index.html.
Sincerely vours.
Barbara Brehup
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Devices Evaluation Center for Devices and Radiological Devices
Enclosure
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Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name:
. Indications for Use: BioSet™ XC is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. These products are indicated to be packed into bony voids or gaps of the skeletal system (e.g., the extremities, spine, ilium and/or pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.
Prescription Use Over-The-Counter 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)
barbara huchinson
sion Sign-Off) Division of General, Restorative, and Neurological Devices
KOLOI 80 510(k) Number_
§ 888.3045 Resorbable calcium salt bone void filler device.
(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.