(518 days)
No
The device description focuses on the biological and material properties of the bone graft and carrier, with no mention of AI or ML technologies.
No
The device, AlloFuse, is described as a bone graft extender and void filler for orthopedic applications, which addresses structural defects in bone rather than treating a disease or condition in the traditional sense of a therapeutic device.
No
AlloFuse is described as a bone graft extender and void filler, used to replace or augment bone structure, not to diagnose a condition.
No
The device description clearly states it is derived from human bone tissue and processed into particles combined with a carrier, indicating it is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that AlloFuse is for orthopedic applications as a filler for bone gaps and voids. This is a therapeutic use, not a diagnostic one.
- Device Description: The description details the composition of the device as processed human bone tissue combined with a carrier. This is a material intended to be implanted or used within the body, not a reagent or instrument used to examine specimens from the body.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze samples (blood, urine, tissue, etc.) from the human body to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to examine specimens. AlloFuse is used in vivo (within the body) for structural support and bone regeneration.
N/A
Intended Use / Indications for Use
AlloFuse is indicated for orthopedic applications as filler for gaps or voids that are not intrinsic to the stability of the bony structure. AlloFuse® is indicated to be packed gently into bony gaps in the skeletal system as a bone graft extender (extremities, spine, and pelvis) and as bony void filler of the extremities and pelvis. These defects may be surgically created or from the result of traumatic injury to the bone.
Product codes
MQV, MBP
Device Description
AlloFuse is derived from selected donated human bone tissue that has been processed into particles. The bone particles are subsequently demineralized using a hydrochloric acid process. The demineralized bone matrix (DBM) is combined with an inert reverse phase carrier and formulated into a gel or putty-like consistency.
The carrier is a solution of polyethylene oxide polypropylene oxide block copolymer dissolved in water exhibiting reverse phase characteristics (i.e. an increase in viscosity as temperature increases).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skeletal system (extremities, spine, and pelvis)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Performance of DBM in a reverse phase medium (RPM) carrier in accordance with the DynaGraft® II Gel and Putty formulations has been evaluated in rabbit and sheep models by radiographic and histological methods for the indications specified in the Premarket Notification.
Clinical studies using the predicate device (DynaGraft® II DBM Putty and Gel) have been performed for spinal fusions demonstrating acceptable outcomes.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
K07/849.
DEC 0 4 2008
Traditional 510(k) AlloFuse Gel and Putty
510(k) Summary
| Submitted by: | AlloSource
6278 S. Troy Circle
Centennial, CO 80111 USA
Telephone: 720-873-0213
Facsimile: 720-873-0212 | |
|----------------------|---------------------------------------------------------------------------------------------------------------------|--------------------|
| Contact Person: | Pamela L. Vetter | |
| Date Prepared: | December 1, 2008 | |
| Proprietary Name: | AlloFuse® Gel and AlloFuse® Putty | |
| Common Name: | Bone Void Filler | |
| Classification Name: | Resorbable calcium salt bone void filler device
(21 CFR 888.3045)
MQV, MBP | |
| Predicate Device: | DynaGraft® II
AlloMatrix® Putty | K040419
K041168 |
Device Description: AlloFuse is derived from selected donated human bone tissue that has been processed into particles. The bone particles are subsequently demineralized using a hydrochloric acid process. The demineralized bone matrix (DBM) is combined with an inert reverse phase carrier and formulated into a gel or putty-like consistency.
The carrier is a solution of polyethylene oxide polypropylene oxide block copolymer dissolved in water exhibiting reverse phase characteristics (i.e. an increase in viscosity as temperature increases).
Intended Use of Device: For orthopedic applications as filler for gaps or voids that are not intrinsic to the stability of the bony structure. AlloFuse is indicated to be packed gently into bony gaps in the skeletal system as a bone graft extender (extremities, spine, and pelvis) and as bony void filler of the extremities and pelvis. These defects may be surgically created or from the result of traumatic injury to the bone.
Technological Characteristics and Substantial Eguivalence: The proposed device is the same device in design, materials of construction and function as the previously cleared devices of 510(k) Notification K040419 cleared 25-March-2005. Through a contractual agreement with IsoTis Orthobiologics, AlloSource receives an exclusive license to use the intellectual property necessary to manufacture the predicate device in North America and a non-exclusive license to market the predicate device worldwide under the AlloFuse® name or that of private label partners.
The proposed and predicate devices are osteoconductive and osteoinductive. AlloFuse and DynaGraft® II provide an interconnected, porous scaffold and an environment for new bone ingrowth and stimulate bone growth. All products are provided sterile and for single patient use. The donor bone in the AlloFuse® product meets the requirements of the American Association of Tissue Banks (AATB). Product safety and effectiveness are adequately supported by the substantial equivalence information, materials data, and test results provided in this Premarket Notification.
1
Viral Inactivation Validation
villa method for processing the DBM contained in AlloFuse® was evaluated for its viral inactivation potential. A select panel of viruses representing various virus types, sizes, shapes, and genomes was evaluated. The DBM processing method was determined to provide significant viral inactivation potential for a wide range of potential human viruses.
Osteoinductive Potential
AlloFuse has shown to have osteoinductive potential in athymic rats. Every lot of final product is tested via an in vivo assay to ensure osteoinductive potential of the final product. Osteoinduction assay results in the athymic rat model should not be interpreted to predict clinical performance in human subjects.
Product Performance Testing
Performance of DBM in a reverse phase medium (RPM) carrier in accordance with the DynaGraft® II Gel and Putty formulations has been evaluated in rabbit and sheep models by radiographic and histological methods for the indications specified in the Premarket Notification.
Clinical studies using the predicate device (DynaGraft® II DBM Putty and Gel) have been performed for spinal fusions demonstrating acceptable outcomes.
Because AlloFuse is the same device in design, materials and function as the predicate device these data substantiate AlloFuse® Putty and Gel safety and effectiveness for the indications presented in this Premarket Notification.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Public Health Service -
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 0 4 2008
AlloSource, Inc. % Ms. Pamela Vetter Sr. Regulatory Affairs Specialist 6278 S. Troy Circle Centennial, Colorado 80111
Re: K071849
Trade Name: AlloFuse® GEL and AlloFuse® Putty Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MBP, MQV Dated: September 22, 2008 Received: September 24, 2008
Dear Ms. Vetter:
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 (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.
3
Page 2 - Ms. Pamela Vetter
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 Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark N. Mather
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosur
4
Indications for Use
510(k) Number (if known):
Device Name:
ALLOFUSE® GEL AND ALLOFUSE® PUTTY
Indications for Use:
AlloFuse is indicated for orthopedic applications as filler for gaps or voids that are not intrinsic to the stability of the bony structure. AlloFuse® is indicated to be packed gently into bony gaps in the skeletal system as a bone graft extender (extremities, spine, and pelvis) and as bony void filler of the extremities and pelvis. These defects may be surgically created or from the result of traumatic injury to the bone.
Prescription Use X (21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Milken
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number KO718