(165 days)
BioSet™ XCh 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™ XCh is a combination of bovine bone chips processed with the BioCleanse Tissue Sterilization Process, human demineralized bone matrix, and a carrier derived from DBM from the same donor. BioSet™ XCh is available in volumes from 1 to 32cc.
The provided text does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria.
This document is a 510(k) summary for a medical device (BioSet™ XCh), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting performance acceptance criteria or results from a dedicated study.
Here's why the requested information cannot be extracted from the provided text:
- Acceptance Criteria/Device Performance: These are typically quantitative metrics (e.g., sensitivity, specificity, accuracy, mechanical strength, biocompatibility test results) that the device must meet. The document only describes the device's components and intended use.
- Study Details: There's no mention of a clinical trial, in-vitro study, or any other type of study designed to evaluate the BioSet™ XCh's performance against specific endpoints.
- Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone Performance, Ground Truth, Training Set: All of these relate to the methodology and results of a performance study, which is absent from this 510(k) summary.
Instead, the document focuses on:
- Substantial Equivalence: Stating that "Data demonstrating substantial equivalence of BioSet™ XCh to predicate devices has been submitted."
- Technological Characteristics Comparison: Highlighting that "The DBM and bovine bone chips are processed in the same manner as the predicate BioSet™ XC. BioSet™ XCh is simply a substitution of human DBM-derived carrier for the porcine gelatin carrier in the BioSet™ XC product."
- Safety Aspects: Mentioning "Viral inactivation studies of the manufacturing process demonstrate a significant reduction of a representative panel of viruses." (While this is a study, it's specific to viral inactivation, not overall device performance or acceptance criteria in the context of efficacy or clinical outcomes).
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and performance studies based on the provided text.
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510(K) Summary
Date: August 10, 2007
Submitted by: Lisa Simpson Regeneration Technologies, Inc. 11621 Research Circle Alachua, FL 32615 Phone: 386-418-8888 Fax: 386-418-1627
Proprietary Name: BioSet™ XCh
Common Name: filler, bone void, osteoinduction (w/o human growth factor) JAN 25 140
Product Code: MBP, Orthopedics Panel
Code Section: 21 CFR 888.3045
Substantial Equivalence:
Data demonstrating substantial equivalence of BioSet™ XCh to predicate devices has been submitted.
Description:
BioSet™ XCh is a combination of bovine bone chips processed with the BioCleanse Tissue Sterilization Process, human demineralized bone matrix, and a carrier derived from DBM from the same donor. BioSet™ XCh is available in volumes from 1 to 32cc.
Intended Use:
BioSet™ XCh 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:
The DBM and bovine bone chips are processed in the same manner as the predicate BioSet™ XC. BioSet™ XCh is simply a substitution of human DBM-derived carrier for the porcine gelatin carrier in the BioSet™ XC product. The source of bovine bone used in BioSet™ XCh 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/12 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines forming the staff and a snake winding around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
JAN 25 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Regeneration Technologies, Incorporated c/o Mr. Travis Arola Regulatory Affairs Manager 11621 Research Circle P.O. Box 2650 Alachua, FL 32616-2650
Re: K072238
Trade/Device Name: Bioset XCh Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV, MPB Dated: December 21, 2007 Received: December 26, 2007
Dear Mr. Arola:
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 (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.
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Page 2 - Mr. Travis Arola
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark M Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
K072238 510(k) Number (if known):
Device Name:
BioSet™ XCh
Indications for Use:
BioSet™ XCh 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 X Over-The-Counter Use 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)
Mark A. Milburn
(Divisio) Sign-Off (Division of General, Restorative, and Neurologica
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.