(261 days)
Not Found
Not Found
No
The summary describes a bone void filler material 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" and "provides a scaffold around which new bone can grow," directly supporting the healing and restoration of bone tissue.
No
The device is described as a "bone void filler" and its function is to provide a scaffold for new bone growth, indicating a therapeutic or restorative purpose, not a diagnostic one.
No
The device description clearly states it is a "bone void filler consisting of a mineralized collagen matrix," which is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Description and Intended Use: The description clearly states that Bi-Ostetic Foam (or Putty) is a "bone void filler" that is "gently packed into bony voids or gaps of the skeletal system." This is a device that is implanted within the body to aid in bone healing.
Therefore, this device falls under the category of an implantable medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Bi-Ostetic Foam (or Putty) 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, 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. In weight bearing situations, the graft is to be used in conjunction with internal or external fixation devices. The fracture defect treated should not exceed 30 mL.
Product codes (comma separated list FDA assigned to the subject device)
MQV
Device Description
The device is a bone void filler consisting of a mineralized collagen matrix. The bovine fibrillar collagen component is biocompatible. The device provides a scaffold around which new bone can grow.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skeletal system (i.e., the extremities, posterolateral spine and pelvis)
Indicated Patient Age Range
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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
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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.
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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
K092046 MAR 24 2010
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
Image /page/0/Picture/3 description: The image shows a circular arrangement of circles that vary in size. The circles are arranged in concentric rings, with the smallest circles located at the center and the largest circles located at the periphery. The size of the circles gradually increases from the center to the periphery. The arrangement of the circles creates a visual effect of depth and perspective.
510(K) Summary Statement for Bi-Ostetic Foam and Putty
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: | 2 July 2009 |
| 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 and Putty |
| 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 (or Putty) 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, 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. In weight bearing situations, the graft is to be used in conjunction with internal or external fixation devices. The fracture defect treated should not exceed 30 mL.
B. DEVICE DESCRIPTION
The device is a bone void filler consisting of a mineralized collagen matrix. 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 the device are substantially equivalent to the predicate devices previously cleared for market. The safety and effectiveness of the devices 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 & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or feathers. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in all caps and appears to be in a sans-serif font.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Berkeley Advanced Biomaterials, Inc. c/o Francois Genin, Ph.D. Chief Executive Officer 901 Grayson St., Suite 101 Berkeley, CA 94710
MAR 2 4 2010
Re: K092046
Trade/Device Name: Bi-Ostetic Foam and Putty Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: January 19, 2010 Received: February 22, 2010
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(fict 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 899. In 11 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 otheron wour not of the Act or any Federal statutes and regulations administered by other Foderal eqencies. 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.
2
Page 2 - Francois Genin, Ph.D.
(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 53) -542 of the Act); 21 CFR 1000-1050.
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/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, (2) OED Beach Foregulation 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 http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Sincerely yours,
FGR
N. M.
Mark N. Melker Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number: K092046
Device Names: Bi-Ostetic Foam and Putty
Indications for Use:
Bi-Ostetic Foam (or Putty) 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, 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. In weight bearing situations, the graft is to be used in conjunction with internal or external fixation devices. The fracture defect treated 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 CDRH, Office of Device Evaluation (ODE)
signature
(Division Sigh-Qiry). Orthopedic.
Division of Suryical, Orthopedic. Division of Sive Devices
510(k) Number
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