(84 days)
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, posterolateral 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 resorbs and is replaced by the growth of new bone during the healing process. The bone graft can be mixed with autogenous blood prior to use at the physician's discretion.
B-GENIN is a bone void filler consisting of resorbable purified fibrillar bovine collagen and demineralized bone matrix (DBM). The device is an implant where new bone can grow.
R-GENIN is a bone void filler consisting of resorbable purified fibrillar bovine collagen, hydroxyapatite, tri-calcium phosphate, and DBM. The device is an implant where new bone can grow.
This regulatory submission (K113791) for B-GENIN and R-GENIN indicates that the device's safety and effectiveness are supported by its substantial equivalence to a previously cleared device (K091912). Therefore, a detailed study proving the device meets specific acceptance criteria in the manner typically seen for novel devices is not present in the provided text.
Instead, the submission relies on demonstrating that the new devices are essentially the same as a device already on the market. The "Acceptance Criteria" in this context are primarily related to the manufacturing and testing of the DBM component, ensuring its osteoconductive potential and viral inactivation.
Here's an breakdown based on the information provided, emphasizing that the "study" is more about process validation and equivalence than a clinical performance trial:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Process/Material) | Reported Device Performance (as per submission) |
|---|---|
| Viral Inactivation: Demonstrates suitable viral inactivation potential for a panel of representative viruses (HIV-1, Hepatitis A, Hepatitis C, Porcine Parvovirus, 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." |
| Osteoconductive Potential (for DBM component): Histopathological evidence of new bone formation after intramuscular implantation in an athymic nude-mouse model, scored on a five-point linear scale (0-4) at 28 days. | "Each batch of DBM used in production is tested for osteoinductive potential using an athynic nude-mouse model... The product and 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." Note: Specific scores are not reported, only that the test is performed. |
| Substantial Equivalence: Intended use, materials, and design features are substantially equivalent to predicate device K091912. | "The intended use, materials and design features of the devices described above are substantially equivalent to B-GENIN and R-GENIN (K091912) previously cleared for market. The safety and effectiveness of the devices are adequately supported by the substantial equivalence information provided within the Premarket Notification." |
Regarding the study and its details:
The primary "study" described here is more of a process validation and comparability assessment rather than an independent clinical trial.
2. Sample size used for the test set and the data provenance:
- Viral Inactivation: The sample size is not explicitly stated. The "test set" would be the panel of viruses used ("human immunodeficiency virus (HIV-1), hepatitis A virus, hepatitis C virus (bovine viral diarrhea as model), porcine parvovirus, and pseudorabies virus"). Data provenance is not specified, but this would typically be laboratory-generated data from studies conducted by the manufacturer or a contract lab.
- Osteoconductive Potential: The sample size for each batch of DBM is not specified, but involves an athymic nude-mouse model. The reference to "Edwards, J. T., Diegmann M. N., Scarborough, N. L.; Osteoinduction of human deminerslized bone: characterization in a rat model, Clin. Orthopaedies, Vol. 357, pp. 219-28 (1998)" suggests the methodology is based on established scientific literature, likely from a lab setting. The data would be proprietary to the manufacturer or a contracted lab. It's a prospective test for each batch.
- Substantial Equivalence: This is a comparison to a retrospective set of information (K091912) rather than a test set with a specific sample size.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Viral Inactivation & Osteoconductive Potential: The document does not specify the number or qualifications of experts involved in establishing ground truth for these lab tests. These are typically assessed by qualified laboratory personnel following established protocols.
- Substantial Equivalence: The ground truth is the prior FDA clearance of K091912. The experts involved in that initial clearance (FDA reviewers) are not detailed here, and for this submission, the ground truth is the established equivalence to that device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- None explicitly stated. For lab tests like viral inactivation and osteoinduction, internal quality control and peer review within the lab would be assumed, but no formal adjudication method like a "2+1" or "3+1" approach is mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This submission is for a bone void filler product, not an AI/software device that would involve human readers or image interpretation. Therefore, an MRMC study and AI-related effect sizes are not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Viral Inactivation: Laboratory assay results demonstrating a reduction in viral load using established scientific methods.
- Osteoconductive Potential: Histopathological evidence of new bone formation in an animal model, observed and scored by qualified laboratory personnel, based on a reference standard (Edwards, et al. 1998).
- Substantial Equivalence: Prior FDA clearance of the predicate device (K091912) based on its documented safety and effectiveness.
8. The sample size for the training set:
- Not applicable. This submission does not describe an AI/ML device that requires a training set. The "training" for this device would be its manufacturing process and quality controls.
9. How the ground truth for the training set was established:
- Not applicable. As above, no training set for an algorithm is discussed. The "ground truth" for the overall device's safety and effectiveness relies on its similarity to the predicate device and validation of its manufacturing processes for viral inactivation and osteoinductive potential.
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K113791
PAGE 1 OF 2
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
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AR 1 5 2012
510(K) Summary
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: | 20 December 2011 |
| 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 |
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, posterolateral spine, and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the product provides a bone void filler that resorbs and is replaced by the growth of new bone during the healing process. The bone graft can be mixed with autogenous blood prior to use at the physician's discretion.
B, DEVICE DESCRIPTION
B-GENIN is a bone void filler consisting of resorbable purified fibrillar bovine collagen and demineralized bone matrix (DBM). The device is an implant where new bone can grow.
R-GENIN is a bone void filler consisting of resorbable purified fibrillar bovine collagen, hydroxyapatite, tri-calcium phosphate, and DBM. The device is an implant where new bone can grow.
C. 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.
D. OSTEOCONDUCTIVE POTENTIAL:
Each batch of DBM used in production is tested for osteoinductive potential using an athynic nude-
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K113791
PAGE 2 OF 2
mouse model. The test involves an evaluation for histopathological evidence of new bone formation after intramuscular implantation of the test article. The product and 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., Scarborough, N. L.; Osteoinduction of human deminerslized bone: characterization in a rat model, Clin. Orthopaedies, Vol. 357, pp. 219-28 (1998),
E. SUBSTANTIAL EQUIVALENCE INFORMATION
The intended use, materials and design features of the devices described above are substantially equivalent to B-GENIN and R-GENIN (K091912) previously cleared for market. The safety and effectiveness of the devices are adequately supported by the substantial equivalence information provided within the Premarket Notification.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002
Berkeley Advanced Biomaterials, Incorporated % Francois Génin, Ph.D. Chief Executive Officer 901 Grayson Street, Suite 101 Berkeley, California 94710
MAR 1 5 2012
Re: K113791
Trade/Device Name: B-GENIN, R-GENIN Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV, MBP Dated: December 20, 2011 Received: December 22, 2011
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 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 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 - François Génin, Ph.D.
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/CDRHOffices/ucm115809.htm 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 notification" (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-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
Sincerely you
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number: K113791
Device Name: B-GENIN, 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, posterolateral 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 resorbs and is replaced by the growth of new bone during the healing process. The bone graft can be mixed with autogenous blood prior to use at the physician's discretion.
Prescription Use X (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 Evaluation (ODE)
(Division Sign-Off)
Division of Surgical, Orthopedic, . . 1 Restorative Devices
510(k) Number K113791
Page 1 of 1
§ 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.