(89 days)
Not Found
No
The document describes a bone graft material and its composition, with no mention of AI or ML technology.
No
The device is described as a bone void filler and autograft extender, used to repair bony defects. This indicates a restorative function rather than a therapeutic one addressing a disease or condition.
No
The device is described as a bone void filler and autograft extender, which are therapeutic uses, not diagnostic. Its purpose is to fill gaps and extend bone grafts in the skeletal system, not to identify or characterize medical conditions.
No
The device description clearly states that the device is derived from human bone tissue and combined with a carrier solution, indicating it is a physical product, 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 it's for orthopedic use as an autograft extender and bone void filler. This involves direct application to the patient's body to aid in bone healing.
- Device Description: The description details the composition of the device, which is derived from human bone tissue and a carrier. This is a biological and material-based product for surgical use.
- Lack of IVD Characteristics: An IVD is a medical device intended for use in vitro (outside the body) for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit this description. It is used in vivo (inside the body).
Therefore, AlloFuse Plus Paste and Putty is a surgical implant/device used in orthopedic procedures, not an IVD.
N/A
Intended Use / Indications for Use
For orthopedic use, AlloFuse Plus Paste and Putty are intended for use as an autograft extender (i.e. extremities, posterolateral spine and pelvis) and as a bone void filler (i.e. extremities and pelvis) for bony voids or gaps that are not intrinsic to the stability of the bony structure. The AlloFuse Plus products are indicated to be packed gently into bony defects of the skeletal system. These defects may be surgically created or from the result of traumatic injury to the bone.
Product codes (comma separated list FDA assigned to the subject device)
MQV, MBP
Device Description
AlloFuse Plus 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 a reverse phase carrier, cancellous chips from the same donor and formulated into a paste or putty-like consistency.
The carrier is a solution of polvethylene 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
extremities, posterolateral 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Product safety and effectiveness is adequately supported by the substantial equivalence information and test data including osteoinductive potential, viral inactivation and endotoxin/LAL provided in this Premarket Notification.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
103036
510(k) Summary
AlloSource® Submitted by: 6278 S. Troy Circle JAN 1 0 2011 Centennial, CO 80111 USA Telephone: 720-873-0213 Facsimile: 720-873-0212 Contact Person: Pamela L. Vetter Date Prepared: January 4, 2011 AlloFuse® Plus Paste and AlloFuse® Plus Putty Proprietary Name: Common Name: Bone Void Filler Classification Name: Resorbable calcium salt bone void filler device (21 CFR 888.3045) MQV, MBP OrthoBlast® II Predicate Device(s): 510(k) # K070751, K050642 AlloFuse Gel and Putty 510(k)# K071849
Device Description:
AlloFuse Plus 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 a reverse phase carrier, cancellous chips from the same donor and formulated into a paste or putty-like consistency.
The carrier is a solution of polvethylene 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 use, AlloFuse Plus Paste and Putty are intended for use as an autograft extender (i.e. extremities, posterolateral spine and pelvis) and as a bone void filler (i.e. extremities and pelvis) for bony voids or gaps that are not intrinsic to the stability of the bony structure. The AlloFuse Plus products are indicated to be packed gently into bony defects of the skeletal system. These defects may be surgically created or from the result of traumatic injury to the bone.
Technological Characteristics and Substantial Equivalence:
The proposed device is the same device in design, materials of construction and function as the previously cleared devices of 510(k) Notification K070751 cleared 15-Oct-2007 and K050642 cleared 05-Dec-2005. Through a contractual agreement with IsoTis Orthobiologics, AlloSource received 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 Plus name or that of private label partners.
The proposed and predicate devices are osteoconductive and exhibit osteoinductive.potential.
ﻟﻤ
1
Viral Inactivation Validation:
1
The methods for processing the DBM and cancellous chips contained in AlloFuse Plus were evaluated for their viral inactivation potential as well as the electron beam sterilization process for final product. A select panel of viruses representing various virus types, sizes, shapes, and genomes was evaluated. Both the DBM processing method (demineralization), the proprietary cleaning process for the cancellous bone and the sterilization process were determined to provide significant viral inactivation potential for a wide range of potential human viruses.
Osteoinductive Potential:
AlloFuse Plus Paste and Putty have been 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 Data:
Product safety and effectiveness is adequately supported by the substantial equivalence information and test data including osteoinductive potential, viral inactivation and endotoxin/LAL provided in this Premarket Notification.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002
AlloSource c/o Ms. Pamela L. Vetter Regulatory Affairs Manager 6278 South Troy Circle Centennial, Colorado 80111
JAN 1 0 201
Re: K103036
Trade/Device Name: AlloFuse Plus Paste and AlloFuse Plus Putty Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatorv Class: Class II Product Code: MQV, MBP Dated: October 11, 2010 Received: October 13, 2010
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. Iisting 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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 – Ms. Pamela L. Vetter
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.
ff you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to hilp://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.html fou the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (217)Fly Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K103036
Device Name: ____ ALLOFUSE® PASTE AND ALLOFUSE® PUTTY
Indications for Use:
For orthopedic use, AlloFuse Plus Paste and Putty are intended for use as an autograft extender (i.e. extremities, posterolateral spine and pelvis) and as a bone void filler (i.e. extremities and pelvis) for bony voids or gaps that are not intrinsic to the stability of the bony structure. The AlloFuse Plus products are indicated to be packed gently into bony defects of the skeletal system. 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)
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(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off
(Division Sig Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________