(155 days)
OsteoSet BVF Kit, Osteoplast
Not Found
No
The description focuses on the material properties and physical handling of a bone void filler putty, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is described as an osteoconductive putty used to fill voids and gaps in bone, acting as a temporary support medium. While it aids in the bone healing process by providing a scaffold for bone ingrowth, its primary function is not to treat a specific disease or condition in a therapeutic sense, but rather to physically support bone structure during repair.
No
The device description indicates that Cem-Ostetic™ is an osteoconductive putty used to fill voids and gaps in bone, acting as a temporary support medium. It does not mention any function related to diagnosing a disease, condition, or state of being.
No
The device description clearly states it is a physical putty made from calcium-based compounds and water, intended to be implanted into the body. It is a physical 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. They are used to provide information for diagnosis, monitoring, or screening.
- Cem-Ostetic™'s Intended Use: The intended use of Cem-Ostetic™ is to fill voids and gaps in bone structure within the body (in situ). It is a material implanted into the patient.
- Device Description: The device description details the preparation and application of a putty that hardens in the body to fill bone defects.
Cem-Ostetic™ is a medical device intended for surgical implantation and bone repair, not for testing samples taken from the body.
N/A
Intended Use / Indications for Use
Cera-Ostetic™ is an osteoconductive putty that is 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 locuted in the extremities, spine, pelvis, or cranium.
The putty may be shaped and pressed into the void by hand or inserted into a syringe and injected into the surgical site. The Cem-Ostetic™ paste set in situ or ex situ provides a voil filler that can augment hardware to support bone fragments during the surgical procedure. The set putty acts as a temporary support medium and is not intended to provide structural support during the healing process. The implant is radio-opaque. Cem-Ost tic ™ 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
Cen-Ostetic™ consists of a pre-measured formulation of distilled water and calciumbased compounds in a container that can be used to prepare a putty, Cent-Ostetic™ forms a p iste when mixed with sterile distilled water. When 4 centimeter cubes (cc) of water are mixed with 10 cc of powder, the paste becomes hard after 5 minutes. Both powder and water are supplied pre-measured in separate containers. To prepare the putty, the water is firs: poured into the jar containing the powder and mixed with it for 60 seconds. For the next two minutes, the putty can be shaped into an implant or inserted into a syringe and injo cted into the surgical site (i.e., bony voids or gaps of skeletal system). The putty will har len on average within 5 minutes of contact between powder and water. The Cem-Ostetic "M powder and the water 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.
OsteoSet BVF Kit, Osteoplast
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
BE RKELEY ADVANCED BIOMATERIALS, INC.
1933 Davis Street, Suite 307, . San Leandro, CA 94577, USA Tel: 510) 883 1644: Fax: (510) 883 1315 Ema l: info@hydroxyapatite.com http://www.livdroxyapatite.com
Image /page/0/Picture/3 description: The image shows the date 0 9 2003 and the number 1022622. There is a logo in the image that is difficult to make out. The text ISO9001 - ISO13485 is also present in the image.
510(K) Summary
In ¿ ccordance with the Food and Drug Admisnistration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CPR 807, this information serves as a Summary of Safety and Effectiveness for the use of the Cem-Ost tic TM Bone Void Filler.
| Submitted By: | Berkeley Advanced Biomaterials, Inc. |
|---|---|
| Date: | 5 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 |
| Classification Name and Reference: | Unclassified |
| Device Product Code and Panel Code: | Orthopedics/87/MQV |
DEVICE INFORMATION
A. INTENDED USES/INDICATIONS
Cera-Ostetic™ is an osteoconductive putty that is 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 locuted in the extremities, spine, pelvis, or cranium.
The putty may be shaped and pressed into the void by hand or inserted into a syringe and injected into the surgical site. The Cem-Ostetic™ paste set in situ or ex situ provides a voil filler that can augment hardware to support bone fragments during the surgical procedure. The set putty acts as a temporary support medium and is not intended to provide structural support during the healing process. The implant is radio-opaque. Cem-Ost tic ™ is biocompatible and resorbs in the body as bone ingrowth occurs.
B. DEVICE DESCRIPTION
Cen-Ostetic™ consists of a pre-measured formulation of distilled water and calciumbased compounds in a container that can be used to prepare a putty, Cent-Ostetic™ forms a p iste when mixed with sterile distilled water. When 4 centimeter cubes (cc) of water are mixed with 10 cc of powder, the paste becomes hard after 5 minutes. Both powder and water are supplied pre-measured in separate containers. To prepare the putty, the water is firs: poured into the jar containing the powder and mixed with it for 60 seconds. For the next two minutes, the putty can be shaped into an implant or inserted into a syringe and injo cted into the surgical site (i.e., bony voids or gaps of skeletal system). The putty will har len on average within 5 minutes of contact between powder and water. The Cem-Ostetic "M powder and the water are supplied sterile for single patient use only.
C. SUBSTANTIAL EQUIVALENCE INFORMATION
Cenn-Ostetic™ is substantially equivalent to legally marketed, predicate devices OsteoSet BVF Kit and Osteoplast. The products have identical indications-for-use and identical cor traindications. They also have the same warnings, precautions and potential adverse events. The technical characteristics of Cem-OsteticTM are very similar to that of the predicate devices. The safety and effectiveness of Cem-Ostetic™ are adequately supported by the substantial equivalence information, materials data, and test results provided in the fill document submitted within the scope of this Premarket Notification.
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its wings and body. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 0 9 2003
François Génin, Ph.D. President and CEO Berkeley Advanced Biomaterials, Inc. 1933 Davis Street Suite 307 San Leandro, California 94577
Re: K022622
Trade/Device Name: Cem-Ostetic™ Regulatory Class: Unclassified Product Code: MQV Dated: November 22, 2002 Received: December 3, 2002
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.
2
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,
Mark N Matthews
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): K022622
Device Name: Cem-Ostetic™ bone void filler
indications for Use:
Cem-Ostetic™ is an osteoconductive putty that is intended to be used to fill voids and raps that are not intringic to the stability of the bone structure. These gaps or voids may be located in the extremities, spine, pelvis, or cranium.
The putty may be shaped and pressed into the void by hand or inserted into a syringe and njected into the surgical site. The Cem-Ostetic™ paste set in situ or ex situ provides a void filler that can augment hardware to support bone fragments during the surgical orocedure. The set putty acts as a temporary support medium and is not intended to orovide 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 NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark H. Milliken
(Division Sign-Off) (Division Sign-Ord), Restorative Division of General DIVIsion of Neurological Devices
510(k) Number -