B-GENIN, R-GENIN

K113791 · Berkeley Advanced Biomaterials, Inc. · MQV · Mar 15, 2012 · Orthopedic

Device Facts

• Record ID: K113791
• Device Name: B-GENIN, R-GENIN
• Applicant: Berkeley Advanced Biomaterials, Inc.
• Product Code: MQV · Orthopedic
• Decision Date: Mar 15, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

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 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.

Device Story

B-GENIN and R-GENIN are resorbable bone void fillers used to fill skeletal defects. B-GENIN consists of purified fibrillar bovine collagen and demineralized bone matrix (DBM); R-GENIN adds hydroxyapatite and tri-calcium phosphate. Devices are implanted by physicians in surgical settings to fill voids not critical to structural stability. The material acts as a scaffold for new bone growth and resorbs over time. Physicians may mix the graft with autogenous blood before application. The device benefits patients by facilitating bone healing in surgically created or trauma-induced osseous defects.

Clinical Evidence

No clinical data provided. Bench testing includes viral inactivation validation for HIV-1, hepatitis A, hepatitis C, porcine parvovirus, and pseudorabies. Osteoinductive potential is assessed via an athymic nude-mouse model using a five-point linear scale for histopathological evidence of bone formation at 28 days.

Technological Characteristics

Materials: purified fibrillar bovine collagen, demineralized bone matrix (DBM), hydroxyapatite, tri-calcium phosphate. Form factor: bone void filler. Sterilization: gamma sterilization. Viral inactivation: validated for multiple virus types.

Indications for Use

Indicated for patients with bony voids or gaps in the skeletal system (extremities, posterolateral spine, pelvis) not intrinsic to structural stability. Defects may be surgically created or result from traumatic injury.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• B-GENIN and R-GENIN (K091912)

Submission Summary (Full Text)

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K113791
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BERKELEY ADVANCED BIOMATERIALS, INC. 901 Grayson Street, Suite 101, Berkeley, CA 94710, USA Tel: [phone]; Fax: [phone] Email: [e-mail] 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: [phone]; Fax: [phone] |
| 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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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 [phone] or [phone] 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

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