(78 days)
Not Found
No
The provided text describes a synthetic bone graft material and its intended use. There is no mention of AI, ML, image processing, or any computational analysis of data, which are typical indicators of AI/ML technology in medical devices.
No
The device is a bone void filler that provides temporary support and aids in bone ingrowth; it is not designed to treat a disease or medical condition directly.
No
Explanation: The device, BioPlus, is described as an osteoconductive bone substitute intended to fill voids and gaps in bone. Its purpose is to provide a temporary support medium and facilitate bone ingrowth, not to diagnose medical conditions or diseases.
No
The device description clearly states that BioPlus is a physical bone substitute material in the form of granules or blocks, made of calcium-based compounds. This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use of BioPlus is to fill voids and gaps in bone structure during surgical procedures. This is a therapeutic and structural application within the body.
- Device Description: The description confirms it's a sterile bone void filler made of calcium-based compounds, designed to be implanted and resorb within the body.
- 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 samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. BioPlus is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
BioPlus is an osteoconductive bone substitute shaped as granules or blocks (cancellous, cortical or cortico-cancellous) that are intended to be used to fill voids and gaps that are not intrinsic to the stability of the bone structure. These gaps or voids may be located in the extremities, spine, pelvis, or cranium.
The granules or blocks may be pressed into the void or into the surgical site by hand. The BioPlus granules or blocks provide void filling material that acts as a temporary support medium. The granules or blocks are not intended to provide structural support during the healing process. The implant is radio-opaque. BioPlus is biocompatible and resorbs in the body as bone ingrowth occurs.
Product codes
MQV
Device Description
BioPlus is a sterile osteoconductive bone void filler. It consists of a formulation of calcium-based compounds. This synthetic bone graft comes in the shape of granules or blocks. BioPlus is supplied sterile for single patient use only. BioPlus is biocompatible and resorbs in the human body as bone ingrowth occurs when applied according to its indications-for-use. The implant is bioresorbable and radio-opaque.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
extremities, spine, pelvis, or cranium
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
The safety and effectiveness of BioPlus are adequately supported by the substantial equivalence information, materials data, and test results provided in the full document submitted within the scope of this Premarket Notification.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
DEC 1 4 2004
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 BioPlus Bone Void Filler.
| Submitted By: | Berkeley Advanced Biomaterials Inc. |
|---|---|
| Date: | 09-20-04 |
| Contact Person: | François Génin, Ph.D. |
| Phone: 510-883-0500; Fax: 510-883-0511 | |
| Proprietary Name: | BioPlus |
| Common Name: | Bone Void Filler |
| Classification Name and Reference: | Class II |
| Device Product Code and Panel Code: | Orthopedics/87/MQV |
DEVICE INFORMATION
A. INTENDED USES/INDICATIONS
BioPlus is an osteoconductive bone substitute shaped as granules or blocks (cancellous, cortical or cortico-cancellous) that are intended to be used to fill voids and gaps that are not intrinsic to the stability of the bone structure. These gaps or voids may be located in the extremities, spine, pelvis, or cranium.
The granules or blocks may be pressed into the void or into the surgical site by hand. The BioPlus granules or blocks provide void filling material that acts as a temporary support medium. The granules or blocks are not intended to provide structural support during the healing process. The implant is radio-opaque. BioPlus is biocompatible and resorbs in the body as bone ingrowth occurs.
B. DEVICE DESCRIPTION
BioPlus is a sterile osteoconductive bone void filler. It consists of a formulation of calcium-based compounds. This synthetic bone graft comes in the shape of granules or blocks. BioPlus is supplied sterile for single patient use only. BioPlus is biocompatible and resorbs in the human body as bone ingrowth occurs when applied according to its indications-for-use. The implant is bioresorbable and radio-opaque.
C. SUBSTANTIAL EQUIVALENCE INFORMATION
BioPlus is substantially equivalent to legally marketed, predicate device Bi-Ostetic™ (K023703). The products have identical indications-for-use, identical or very similar composition, and equivalent contraindications. They also have similar warnings, precautions and potential adverse events. The safety and effectiveness of BioPlus are adequately supported by the substantial equivalence information, materials data, and test results provided in the full document submitted within the scope of this Premarket Notification.
1
Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a stylized image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 4 2004
François Génin, Ph.D. Chief Executive Officer Berkeley Advanced Biomaterials, Inc. 1933 Davis Street Suite 307 San Leandro, California 94577
Re: K042636
Trade Name: BioPlus Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler Regulatory Class: II Product Code: MQV Dated: November 19, 2004 Received: November 23, 2004
Dear Dr. Génin:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your been wind the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for associated in the May 28, 1976, the enactment date of the Medical Device Amendments, or to conninered prof to May 20, 1978, are examance with the provisions of the Federal Food, Drug, do noos that have been that do not require approval of a premarket approval application (PMA). and Cosmeter For (. 10) was the device, subject to the general controls provisions of the Act. The r ou may, diererere, mains 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 may or subject to Sacer as Sateral 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 r loase of actived that i Drimination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any I oderal 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 Orth 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 - François Génin, Ph.D.
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will unow you to organ maing of substantial equivalence of your device to a legally premaired 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 If you desire specific advice 101 Jour as 101) 276-0120. Also, please note the regulation entitled, Contact the Office of County of County of Cation" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general miorination of Jour Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours,
Sincerely, yours,
Mark A. Millman
Celia M. Witten, Ph.D., M.D. 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): K_04z 636
Device Name: BioPlus
Indications For Use:
BioPlus is an osteoconductive bone substitute shaped as granules or blocks (cancellous, cortical Dior ras is an obtoberient are intended to be used to fill voids and gaps that are not intrinsic to or corner of the bone structure. These gaps or voids may be located in the extremities, spine, pelvis, or cranium.
The granules or blocks may be pressed into the void or into the surgical site by hand. The The granules or blocks provide void filling material that acts as a temporary support medium. Diol tas Lianares or blocks are not intended to provide structural support during the healing process. The implant is radio-opaque. BioPlus is biocompatible and resorbs in the body as bone ingrowth occurs.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(Please Do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Millican
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
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510(k) Number K042636