(65 days)
OPTEFORM® Allograft Full Disk; OPTEFORM® Allograft Partial Disk; OPTEFORM® Moldable Allograft Paste, Syringe; OPTEFORM® RT Allograft Paste; OSTEOFIL® IC Moldable Allograft Syringe; OSTEOFIL® ICM Moldable Strip; OSTEOFIL® RT ICM Moldable Allograft; RTI Allograft Paste IC; and RTI Allograft Strip IC are indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. They are indicated to be placed into bony voids or gaps of the skeletal system (e.g., the extremities, spine and 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 remodels into the recipient's skeletal system.
These devices are bone paste products made by combining gelatin, dcmineralized bone matrix and cortical-cancellous bone chips.
The provided text is a 510(k) Summary for a medical device (bone void filler) and does not describe acceptance criteria or a study proving that the device meets such criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate device.
Therefore, I cannot fulfill the request to describe acceptance criteria and the study that proves the device meets them based on the provided input.
However, I can extract information related to the performance data provided:
- Non-Clinical Performance Data Supporting Substantial Equivalence Determination: Results from studies in animal models indicate that these products can be used as a bone void filler with equivalent or better healing results when compared to the predicate device. Healing was evaluated radiographically, histologically, and mechanically.
- Osteoinductivity Screening: DBM (demineralized bone matrix) and finished product were screened for osteoinductivity in a rat assay. The document notes that "Findings from an animal model are not necessarily predictive of human clinical results."
This information suggests that animal studies were conducted to assess healing and osteoinductivity, using radiographic, histologic, and mechanical evaluations. However, specific acceptance criteria, sample sizes for test sets, ground truth establishment, or details about the experts involved are not available in this document.
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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 on the left, followed by the word "Regeneration" in large, bold, black letters. Below "Regeneration" is the text "TECHNOLOGIES, INC." in smaller, black letters. The logo is simple and modern, and the use of black and white gives it a clean and professional look.
11621 Research Circle Post Office Box 2650 Alachua, FL 32616-2650 ાડિત Tel 386.418.8888 Toll Free 877.343.6832 Fax 386.418.0342 www.rtix.com
FEB 1 6 2005
510(K) Summary
December 9, 2004 Date:
Submitted by: Carrie Hartill Regeneration Technologies, Inc. 11621 Research Circle P.O. Box 2650 Alachua, FL 32616-2650 386-418-8888 Telephone: 386-462-3821 Facsimile:
Proprietary Name: OPTEFORM® Allograft Full Disk OPTEFORM® Allograft Partial Disk OPTEFORM® Moldable Allograft Paste, Syringe OPTEFORM® RT Allograft Paste OSTEOFIL® IC Moldable Allograft Syringe OSTEOFIL® ICM Moldable Strip OSTEOFIL® RT ICM Moldable Allograft RTI Allograft Paste IC RTI Allograft Strip IC
Common Name: Bone Void Filler
Classification Name: Filler, Calcium Sulfate Preformed Pellets (per 21CFR section 888.3045)
Predicate Devices:
The current devices have the same indications as and are substantially equivalent to the Pro Osteon™ Implant 500R Resorbable Bone Void Filler.
Description:
These devices are bone paste products made by combining gelatin, dcmineralized bone matrix and cortical-cancellous bone chips.
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Indications for Use:
OPTEFORM® Allograft Full Disk; OPTEFORM® Allograft Partial Disk; OPTEFORM® Moldable Allograft Paste, Syringe; OPTEFORM® RT Allograft Paste; OSTEOFIL® IC Moldable Allograft Syringe; OSTEOFIL® ICM Moldable Strip; OSTEOFIL® RT ICM Moldable Allograft; RTI Allograft Paste IC; and RTI Allograft Strip IC are indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. They are indicated to be placed into bony voids or gaps of the skeletal system (e.g., the extremities, spine and 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 remodels into the recipient's skeletal system.
Summary of Technological Characteristics:
These devices are composed of allograft demineralized bone and cortical-cancellous bone chips in a gelatin carrier matrix. These devices have been screened for osteoinductivity in an in vivo assay and also provide a scaffold for osteoconduction. The processed coral in the Pro Osteon® Implant 500R Resorbable Bone Void Filler provides a scaffold for osteoconduction.
Non-Clinical Performance Data Supporting Substantial Equivalence Determination: Results from studies in animal models indicate that these products can be used as a bone void filler with equivalent or better healing results when compared to the predicate device. Healing was evaluated radiographically, histologically, and mechanically.
1 DBM and finished product were screened for osteoinductivity in a rat assay. Findings from an animal model are not necessarily predictive of human clinical results.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo is circular in shape and features the department's name around the perimeter. In the center of the circle is a stylized image of an eagle with its wings spread.
FEB 1 6 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Carrie Hartill Vice President of Quality Assurance and Regulatory Affairs Regeneration Technologies, Inc. 11621 Research Circle P.O. Box 2650 Alachua, Florida 32616-2650
Re: K043421
Trade Name: OPTEFORM® Allograft Full Disk, OPTEFORM® Allograft Partial Disk, OPTEFORM® Moldable Allograft Paste, syringe, OPTEFORM® RT Allograft Paste, OSTEFOIL® IC Moldable Allograft Syringe, OSTEFOIL® ICM Moldable Strip, OSTEFOIL® RT ICM Moldable Allograft, RTI Allograft Paste IC, RTI Allograft Strip IC Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MQV Dated: February 4, 2005 Received: February 7, 2005
Dear Ms. Hartill:
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 - Ms. Carrie Hartill
This letter will allow you to begin marketing your device as described in your Section 5 10(k) I his letter will anow you to begin hanketing of substantial equivalence of your device to a legally premarket nothreation. The I DA mining of backannal vice and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (11 CFR Part 801), please If you desire specific advice for your as not 2007-01-20. Also, please note the regulation entitled, contact the Office of Comphalice at (2-10) 21-5 -12-7 Part 807.97). You may obtain other " Misoranding by relefelice to premarket nonnedation of Small Manufacturers,
general information on your responsibilities under the Act 2011 and 2012 442, 5507 or st general information on your responsibilities ander the revealer (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark A. Milburn
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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Indications for Use
K 043421 510(k) Number (if known):
Device Name:
OPTEFORM® Allograft Full Disk OPTEFORM® Allograft Partial Disk OPTEFORM® Moldable Allograft Paste, Syringe OPTEFORM® RT Allograft Paste OSTEOFIL® IC Moldable Allograft Syringe OSTEOFIL® ICM Moldable Strip OSTEOFIL® RT ICM Moldable Allograft RTI Allograft Paste IC RTI Allograft Strip IC
Indications for Use:
These products are indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. They are indicated to be placed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and 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 remodels into the recipient's skeletal system.
Over-The-Counter Use Prescription Use x AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Gene estorative.
800 New New Jua
510(k) Number K093921
§ 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.