(24 days)
Not Found
Not Found
No
The document describes a bone substitute material and its intended use and physical form. There is no mention of any software, algorithms, or data processing that would indicate the presence of AI or ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" fields are explicitly marked as "Not Found".
No
The device is described as a bone substitute and void filler, intended to fill gaps and augment hardware, but it is not intended to provide structural support during the healing process, nor does it deliver any therapeutic agent or energy.
No
The device, Cem-Ostetic™, is described as an osteoconductive bone substitute used to fill voids and gaps in bone, acting as a void filler and temporary support medium. Its intended use is therapeutic (filling voids, augmenting hardware), not for diagnosing medical conditions.
No
The device description clearly states that Cem-Ostetic™ consists of physical materials (granules, blocks, or putty) intended to be implanted into the body. This is a hardware medical device, 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 tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Cem-Ostetic™ Function: Cem-Ostetic™ is described as a bone substitute and void filler intended to be implanted directly into the body to support bone fragments and act as a temporary support medium during surgical procedures. It is a physical implant, not a test performed on a sample outside the body.
The intended use, device description, and lack of any mention of analyzing biological samples all indicate that Cem-Ostetic™ is a medical device for surgical implantation, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Cem-Ostetic™ is an osteoconductive bone substitute formulated as cancellous, cortical or cortico-cancellous granules, blocks as well as injectable putty 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 putty may be shaped and pressed into the void by hand or inserted into a syringe and injected into the surgical site. Cem-Ostetic™ provides a void filler that can augment hardware to support bone fragments during the surgical procedure and acts as a temporary support medium. This void filler is not yet intended to provide structural support during the healing process. The implant is radio-opaque. Cem-Ostetic™ is biocompatible and resorbs in the body as bone ingrowth occurs.
Product codes (comma separated list FDA assigned to the subject device)
MQV
Device Description
Cem-Ostetic™ consists of a pre-shaped ready-for-use formulation of cancellous, cortical or cortico-cancellous blocks or granules. The granules or blocks are supplied sterile for single patient use only.
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 (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
§ 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.
1933 Davis Street, Suite 307, San Leandro, CA 94577, USA Tel: (510) 883 1644; Fax: (510) 883 1315 Email: info@hydroxyapatite.com http://www.hvdroxyapatite.com
FEB 2 0 2003
Image /page/0/Picture/3 description: The image shows a black and white drawing of a UFO. The UFO has a dome-shaped top and a wide, flat bottom. The bottom of the UFO has a pointed edge. The drawing is simple and does not have a lot of detail.
KO30266
ISO9001:94/EN4600
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 Cem-Ostetic TM Bone Void Filler.
| Submitted By: | Berkeley Advanced Biomaterials, Inc. |
|---|---|
| Date: | 15 January 2003 |
| Contact Person: | François Génin, Ph.D. |
| Position: | President and CEO |
| Contact Information | Phone: 510-883-1644; |
| Fax: 510-883-1315 | |
| Proprietary Name: | Cem-Ostetic™ |
| Common Name: | Bone Void Filler (Granules and Blocks) |
| Classification Name and Reference | Unclassified |
| Device Product Code and Panel Code | Orthopedics/87/MQV |
DEVICE INFORMATION
A. INTENDED USES/INDICATIONS
Cem-Ostetic™ is an osteoconductive bone substitute formulated as cancellous, cortical or cortico-cancellous granules, blocks as well as injectable putty 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 putty may be shaped and pressed into the void by hand or inserted into a syringe and injected into the surgical site. Cem-Ostetic™ provides a void filler that can augment hardware to support bone fragments during the surgical procedure and acts as a temporary support medium. This void filler is not yet intended to provide structural support during the healing process. The implant is radio-opaque. Cem-Ostetic™ is biocompatible and resorbs in the body as bone ingrowth occurs.
B. DEVICE DESCRIPTION
Cem-Ostetic™ consists of a pre-shaped ready-for-use formulation of cancellous, cortical or cortico-cancellous blocks or granules. The granules or blocks are supplied sterile for single patient use only.
C. SUBSTANTIAL EQUIVALENCE INFORMATION
Cem-Ostetic TM granules and blocks are substantially equivalent to the legally marketed, predicate device Cem-Ostetic™ putty. The products have identical indications-for-use and identical contraindications. They also have the same warnings, precautions and potential adverse events. The technical characteristics of Cem-Ostetic™ are very similar to that of the predicate device. The safety and effectiveness of Cem-Osteric™ granules and blocks are adequately supported by the substantial equivalence information, materials data, and test results provided in the document submitted within the scope of this Premarket Notification.
1
Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of a human figure, represented by three curved lines that suggest a head and torso. The figure is facing to the right and appears to be in motion.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 0 2003
Francois Génin, Ph.D. President and CEO Berkeley Advanced Biomaterials, Inc. 1933 Davis Street, Suite 307 San Leandro, California 94577
Re: K030266
Trade/Device Name: Cem-Ostetic"™ Regulatory Class: Unclassified Product Code: MQV Dated: January 21, 2003 Received: January 27, 2003
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 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.
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 (301) 594-4660. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained 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/dsma/dsmamain.html
Sincerely yours,
sincerely yours,
Mark A. Milliken
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
510(k) Number (if known):
Device Name: Cem-Ostetic™ bone void filler
Indications for Use:
Cem-Ostetic™ is an osteoconductive bone substitute formulated as cancellous, cortical or cortico-cancellous granules, blocks as well as injectable putty 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.
VO 30266
The granules or blocks may be pressed into the void or into the surgical site by hand. The putty may be shaped and pressed into the void by hand or inserted into a syringe and intected into the surgical site. Cem-Ostetic™ provides a void filler that can augment hardware to support bone fragments during the surgical procedure and acts as a temporary support medium. This void filler is not yet intended to provide structural support during the healing process. The implant is radio-opaque. Cem-Ostetic™ is biocompatible and resorbs in the body as bone ingrowth occurs.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDER
Concurrence of CDRH, Office of Device Evaluation (ODE)
R. Mark N. Mulleus
Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number