Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a bone void filler material and its intended use, with no mention of software, algorithms, or any technology that would typically incorporate AI or ML.

Therapeutic

Yes
The device is a bone void filler that aids in the healing process by providing a scaffold for new bone growth, which directly treats an injury or condition.

Diagnostic

No

This device is a bone void filler intended for surgical repair of bone defects, not for diagnosing medical conditions.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a bone void filler consisting of physical materials (collagen and hydroxyapatite/tri-calcium phosphate granules), indicating it is a physical medical device, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use describes the device being used in vivo (within the body) to fill bony voids and promote bone growth. IVDs are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
Device Description: The device description details the materials used to create a bone void filler that is implanted into the body. This is consistent with a medical device used for treatment or repair, not for diagnostic testing of samples.

The information provided clearly indicates this is a medical device intended for surgical implantation and bone regeneration, not for in vitro diagnostic testing.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Bi-Ostetic Foam is 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, 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 bone marrow prior to use at the physician's discretion. In weight bearing situations, Bi-Ostetic Foam is to be used in conjunction with internal or external fixation devices. The fracture defect treated with Bi-Ostetic Foam should not exceed 30 mL.

Product codes (comma separated list FDA assigned to the subject device)

MQV

Device Description

Bi-Ostetic Foam is a bone void filler consisting of resorbable purified fibrillar collagen and resorbable hydroxyapatite/tri-calcium phosphate granules. The bovine fibrillar collagen component is biocompatible. The device provides a scaffold around which 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, 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)

Not Found

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.

Not Found

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

Regulation Number and Section

§ 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.

Summary

0

Image /page/0/Picture/1 description: The image shows a logo and a code. The logo is a circular pattern of dots, with the dots increasing in size from the center outwards. To the right of the logo is the code "K0532/3". The code is written in a handwritten style.

JUL - 6 2006

510(K) Summary Statement for Bi-Ostetic™ Foam

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 Bi-Ostetic Foam.

Submitted By:	Berkeley Advanced Biomaterials, Inc.
Date:	10 October 2005
Contact Person:	François Génin, Ph.D.
Position:	Chief Executive Officer
Contact Information	Phone: 510-883-0500; Fax: 510-883-0511
Proprietary Name:	Bi-Ostetic Foam
Regulation Name:	Resorbable Calcium Salt Bone Void Filler Device
Regulation Number:	888.3045
Classification:	Class II
Device Code/ Panel Code:	Orthopedics/87/MQV

DEVICE INFORMATION

A. INTENDED USE

Bi-Ostetic Foam is 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, 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 bone marrow prior to use at the physician's discretion. In weight bearing situations, Bi-Ostetic Foam is to be used in conjunction with internal or external fixation devices. The fracture defect treated with Bi-Ostetic Foam should not exceed 30 mL.

B. DEVICE DESCRIPTION

Bi-Ostetic Foam is a bone void filler consisting of resorbable purified fibrillar collagen and resorbable hydroxyapatite/tri-calcium phosphate granules. The bovine fibrillar collagen component is biocompatible. The device provides a scaffold around which new bone can grow.

C. SUBSTANTIAL EQUIVALENCE INFORMATION

The intended use, materials and design features of Bi-Ostetic Foam are substantially equivalent to the predicate devices previously cleared for market. The safety and effectiveness of Bi-Ostetic Foam are adequately supported by the substantial equivalence information provided within the Premarket Notification.

1

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or feathers. The bird is positioned above a circular arrangement of text that reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA".

JUL - 6 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Berkeley Advanced Biomaterials, Inc. c/o Francois Genin. Ph.D. Chief Executive Officer 901 Grayson Street. Suite 101 Berkeley, California 94710

Re: K053213/S1 Trade/Device Name: Bi-Ostetic Foam Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MOV Dated: June 9, 2006 Received: June 13, 2006

Dear Dr. Genin:

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 (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.

2

Page 2 - Francois Genin, Ph.D.

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 Office of Compliance at (240) 276-0120 . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Barbara Buehrig

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

3

Indications for Use

510(k) Number (if known):

Device Name: Bi-Ostetic Foam

Indications for Use:

Bi-Ostetic Foam is 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, 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 bone marrow prior to use at the physician's discretion. In weight bearing situations, Bi-Ostetic Foam is to be used in conjunction with internal or external fixation devices. The fracture defect treated with Bi-Ostetic Foam should not exceed 30 mL.

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

Olea, Bare Bulchup for MXM

and I

510(k) Nu