(363 days)
Not Found
No
The 510(k) summary describes a bone void filler composed of biological materials and does not mention any computational or analytical capabilities, let alone AI/ML.
Yes
The device is described as a "bone void filler" that "resorbs and is replaced by the growth of new bone during the healing process," indicating its therapeutic purpose in bone regeneration.
No
The device is described as a bone void filler that resorbs and is replaced by new bone growth, functioning as an implant. It is not used to detect, diagnose, or monitor a medical condition.
No
The device description clearly states that the devices (B-GENIN and R-GENIN) are bone void fillers consisting of physical materials (collagen, DBM, hydroxyapatite-tricalcium phosphate granules) and are implants. This indicates a physical medical device, not a software-only one.
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 B-GENIN and R-GENIN are "indicated for use in bony voids or gaps" and "provides a bone void filler that resorbs and is replaced by the growth of new bone during the healing process." This describes a device used in vivo (within the body) to facilitate bone healing.
- Device Description: The device is described as an "implant where new bone can grow." This further reinforces its function as an internal medical device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used outside the body to analyze samples and provide diagnostic information. This device is used inside the body as a therapeutic implant.
N/A
Intended Use / Indications for Use
B-GENIN and R-GENIN are indicated for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. The product should be gently packed into bony voids or gaps of the skeletal system (i.e. the extremities 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 resorbs and is replaced by the growth of new bone during the healing process.
Product codes (comma separated list FDA assigned to the subject device)
MQV, MBP
Device Description
B-GENIN is a bone void filler consisting of resorbable purified fibrillar bovine collagen and demineralized bone matrix (DBM) powder. The device is an implant where new bone can grow.
R-GENIN is a bone void filler consisting of resorbable purified fibrillar bovine collagen, demineralized bone matrix (DBM) and hydroxyapatite-tricalcium phosphate granules. The device is an implant where new bone can grow.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skeletal system (i.e. the extremities 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
An athymic nudemouse model is used to test for osteoinductive potential. The test involves an evaluation for histopathological evidence of new bone formation after intramuscular implantation of the test article. The process consistency is confirmed with this athymic nude-mouse model that utilizes a five-point linear scale (0,1,2,3,4) to score bone formation at 28 days.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Product safety and effectiveness is supported by the substantial equivalence information, the materials data and the in vivo and in vitro test results provided in this Premarket Notification. The processing methods were evaluated for their viral inactivation potential using a select panel of viruses (human immunodeficiency virus (HIV-1), hepatitis A virus, hepatitis C virus (bovine viral diarrhea as model), porcine parvovirus, and pseudorabies virus). The tests demonstrated suitable viral inactivation potential of the processing methods. The product is also terminally sterilized by gamma sterilization to also ensure its biological sterility. Each batch of DBM used in production is tested for osteoinductive potential using an athymic nudemouse model, evaluating for histopathological evidence of new bone formation after intramuscular implantation.
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
X091912
BERKELEY ADVANCED BIOMATERIALS, INC.
901 Grayson Street, Suite 101, Berkeley, CA 94710, USA Tel: (510) 883 0500; Fax: (510) 883 0511 Email : info@hydroxyapatite.com http://www.hydroxyapatite.com
JUN 2 3 2010
510(K) Summary Statement
In accordance with the Food and Drug Admisnistration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807, this information serves as a Summary of Safety and Effectiveness for the use of the device.
| Submitted By: | Berkeley Advanced Biomaterials, Inc. |
|---|---|
| Date: | 17 June 2009 |
| Contact Person: | François Génin, Ph.D. |
| Position: | Chief Executive Officer |
| Contact Information: | Phone: 510-883-0500; Fax: 510-883-0511 |
| Proprietary Name: | B-GENIN, R-GENIN |
| Regulation Name: | Resorbable Calcium Salt Bone Void Filler |
| Regulation Number: | 888.3045 |
| Classification: | Class II |
| Device Code/ Panel Code: | Orthopedics/87/MQV, MBP |
DEVICE INFORMATION
A. INTENDED USE
B-GENIN and R-GENIN are indicated for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. The product should be gently packed into bony voids or gaps of the skeletal system (i.e. the extremities 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 resorbs and is replaced by the growth of new bone during the healing process.
B. DEVICE DESCRIPTION
B-GENIN is a bone void filler consisting of resorbable purified fibrillar bovine collagen and demineralized bone matrix (DBM) powder. The device is an implant where new bone can grow.
R-GENIN is a bone void filler consisting of resorbable purified fibrillar bovine collagen, demineralized bone matrix (DBM) and hydroxyapatite-tricalcium phosphate granules. The device is an implant where new bone can grow.
C. PREDICATE DEVICE
Osteofill (K043420) for B-GENIN and Allomatrix (K041168) for R-GENIN.
D. TECHNOLOGICAL CHARACTERISTICS
B-GENIN is substantially equivalent to Ostetofill (K043420). Both devices utilize ground human cortical demineralized bone combine with a carrier from animal origin. The devices have the same intended use, are provided sterile and for single patient only. Both devices are formulated so as to provide a putty-like product with similar consistency and handling characteristics.
R-GENIN is substantially equivalent to Allomatrix (K041168). Both devices utilize ground human cortical demineralized bone combined with synthetic calcium-based salts. The devices have the same intended use, are provided sterile and for single patient only.
E. PERFORMANCE DATA
1
Product safety and effectiveness is supported by the substantial equivalence information, the materials data and the in vivo and in vitro test results provided in this Premarket Notification.
F. VIRAL INACTIVATION
The processing methods were evaluated for their viral inactivation potential. A select panel of viruses representing various virus types, shapes and genomes were evaluated. The panel included human immunodeficiency virus (HIV-1), hepatitis A virus, hepatitis C virus (bovine viral diarrhea as model), porcine parvovirus, and pseudorabies virus. The tests demonstrated suitable viral inactivation potential of the processing methods. The product is also terminally sterilized by gamma sterilization to also ensure its biological sterility.
G. OSTEOCONDUCTIVE POTENTIAL:
Each batch of DBM used in production is tested for osteoinductive potential using an athymic nudemouse model. The test involves an evaluation for histopathological evidence of new bone formation after intramuscular implantation of the test article. The process consistency is confirmed with this athymic nude-mouse model that utilizes a five-point linear scale (0,1,2,3,4) to score bone formation at 28 days*. The osteoinduction assay results using this assay should not be interpreted to predict clinical performance in human subject.
- Edwards, J. T., Diegmann M. N., Scurborough, N. L.: Osteoinduction of human demineralized bone: characterization in a rat model, Clin. Orthopaedics, Vol. 357, pp. 219-28 (1998).
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with its wings spread, symbolizing protection and care. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the circle's perimeter.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Berkeley Advanced Biomaterials, Inc. % François Génin, Ph.D. Chief Executive Officer 901 Grayson Street, Suite 101 Berkeley, California 94710
JUN 2 3 2010
Re: K091912
Trade/Device Name: B-GENIN and R-GENIN . Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MQV, MBP Dated: June 15, 2010 Received: June 16, 2010
Dear Dr. Génin:
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 includions 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 In microco in microadic 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 registmation, ince nece devices, good manufacturing practice, labeling, and prohibitions against misbrandi, ifsulf adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not maylers)
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 not 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
3
Page 2 - François Génin, Ph.D.
device-related adverse events) (21 CFR 803); 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 100-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRH0ffices/ucm11.5809.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance Also, please note the regulation entitled, "Misbranding by reference to premarket notfication" (21CFR 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 the (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
yours,
Melkerson
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: K091912
Device Name: B-GENIN and R-GENIN
Indications for Use:
B-GENIN and R-GENIN are indicated for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. The product should be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities 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 resorbs and is replaced by the growth of new bone during the healing process.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 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 OF NEEDED)
Concurrence of CDRH, Office of Device Evalration (ODE)
(Division Sign-Off)
Division of Suryal, Orthopedic,
and Restorative Devices
Page 1 of 1
510(k) Number K04