(112 days)
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Not Found
No
The provided text describes a bone substitute material and its intended use, with no mention of AI or ML technology.
No
The device is a bone substitute and void filler, which acts as a temporary support medium for bone ingrowth, rather than directly treating a disease or condition.
No
This device is a bone substitute intended to fill voids and gaps, acting as a temporary support medium for bone healing, not for diagnosing conditions.
No
The device description clearly states that GenerOs™ is a physical bone substitute material in the form of granules or blocks, which are hardware components.
Based on the provided information, GenerOs™ is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVDs are used to examine specimens from the human body. They are used to diagnose diseases, conditions, or determine the state of health. Examples include blood tests, urine tests, and genetic tests.
- GenerOs™ is a bone substitute. Its intended use is to fill voids and gaps in bone structure within the body. It is implanted directly into the patient.
The description clearly states that GenerOs™ is a "bone substitute" and a "bone void filler" that is "implanted" into the body. This is the definition of an implantable medical device, not an IVD.
N/A
Intended Use / Indications for Use
GenerOs (80 or 60) is an osteoconductive bone substitute shaped as granules or blocks 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 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. It is biocompatible and resorbs in the body as bone ingrowth occurs.
Product codes
MQV
Device Description
GenerOs (60 or 80) is a sterile osteoconductive bone void filler. This synthetic bone graft comes in the shape of granules or blocks. GenerOs (60 or 80) is supplied sterile for single patient use only. It 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
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
extremities, spine, pelvis, or cranium
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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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.
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BERKELEY ADVANCED BIOMATERIALS, INC.
Image /page/0/Picture/16 description: The image shows a circular pattern made up of black dots of varying sizes. The dots are arranged in concentric circles, with the smallest dots located at the center and the largest dots located at the outer edge. The dots are evenly spaced and create a visually appealing pattern. The image is simple and minimalist, with a focus on the geometric arrangement of the dots.
901 Grayson Street, Suite 101, Berkeley, CA 94710, USA Tel: (510) 883 0500; Fax: (510) 883 05 Email: info@hydroxyapatite.com http://www.hydroxyapatite.com
NOV - 3 2005
510(K) Summary Statement GenerOs Bone Void Filler
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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 GenerOs™ 80 and GenerOs 60 Bone Void Filler.
| Submitted By: | Berkeley Advanced Biomaterials, Inc. |
|---|---|
| Date: | 10 July 2005 |
| Contact Person: | François Génin, Ph.D. |
| Position: | Chief Executive Officer |
| Contact Information: | Phone: 510-883-0500; |
| Fax: 510-883-0511 | |
| Proprietary Name: | GenerOs™ 80, GenerOs™ 60 |
| Regulation Name: | Resorbable Calcium Salt Bone Void Filler Device |
| Regulation Number: | 888.3045 |
| Classification: | Class II |
| Device Product Code/ | |
| Panel Code: | Orthopedics/87/MQV |
DEVICE INFORMATION
A. INTENDED USES/INDICATIONS
GenerOs (80 or 60) is an osteoconductive bone substitute shaped as granules or blocks 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 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. It is biocompatible and resorbs in the body as bone ingrowth occurs.
B. DEVICE DESCRIPTION
GenerOs (60 or 80) is a sterile osteoconductive bone void filler. This synthetic bone graft comes in the shape of granules or blocks. GenerOs (60 or 80) is supplied sterile for single patient use only. It 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
The intended use, materials and design features of GenerOs 80 and GenerOs 60 are substantially equivalent to the predicate devices previously cleared for market. The safety
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and effectiveness of GenerOs are adequately supported by the substantial equivalence information provided within the Premarket Notification.
:
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, which is a traditional symbol of medicine.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 3 2005
François Génin, Ph.D. Chief Executive Officer Berkeley Advanced Biomaterials, Inc. 901 Grayson St., Suite 101 Berkeley, California 94710
Re: K051914 /S1
Trade/Device Name: GenerOs™ 80, GenerOsTM 60 Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MQV Dated: September 19, 2005 Received: October 6, 2005
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.
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
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Page 2 - François Génin, Ph.D.
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. 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,
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Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K051914
Device Name: GenerOs Bone Void Filler
Indications for Use:
GenerOs™ is an osteoconductive bone substitute shaped as granules or blocks 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 GenerOs™ 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. GenerOs™ is biocompatible and resorbs in the body as bone ingrowth occurs.
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 General, Restorative, and Neurological Devices | |
| 510(k) Number | K051914 |