(38 days)
MQV
Not Found
No
The description focuses on the material properties and intended use of a bone void filler, with no mention of AI or ML capabilities.
No.
The device is a bone void filler and does not claim to treat or cure a disease or condition. It acts as a temporary support medium for bone fragments, which is a structural or supportive role rather than a therapeutic one.
No
Explanation: The device, Tri-Ostetic, is described as an osteoconductive putty intended to fill voids and gaps in bone and acts as a temporary support medium. It is a therapy/treatment device, not one that identifies or diagnoses a condition.
No
The device description clearly states it is a physical putty made of calcium-based compounds and water, intended to fill bone voids. It is a physical implant, 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.
- Tri-Ostetic's Intended Use: The intended use of Tri-Ostetic is to fill voids and gaps in bone structure within the body (in vivo). It is a surgical implant used to support bone fragments and provide a temporary scaffold for bone ingrowth.
- Device Description: The device description confirms it is a bone void filler applied directly to the surgical site.
There is no mention of Tri-Ostetic being used to test samples taken from the body or to provide diagnostic information based on such tests. Its function is purely as a physical material implanted into the body to aid in bone healing.
N/A
Intended Use / Indications for Use
Tri-Ostetic is an osteoconductive putty that is intended 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 putty may be shaped and pressed into the void by hand or inserted into a syringe and injected into the surgical site. The Tri-Ostetic paste set in situ provides a void 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 Tri-Ostetic is biocompatible and resorbs in the body as bone ingrowth occurs.
Product codes
MQV
Device Description
Tri-Ostetic is a sterile osteoconductive bone void filler. Tri-Ostetic consists of a pre-measured formulation of distilled water and calcium-based compounds in a container that can be used to prepare a putty. Tri-Ostetic forms a paste when mixed with sterile distilled water. Both powder and water are supplied pre-measured in separate containers. The putty can be shaped into an implant or inserted into a syringe and injected into the surgical site (i.e., bony voids or gaps of skeletal system). Tri-Ostetic powder and the water are supplied sterile for single patient use only. Tri-Ostetic is biocompatible, bioresorbable and radio-opaque. Tri-Ostetic resorbs in the human body as bone ingrowth occurs when applied according to its indications for use.
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)
Cem-Ostetic™
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
AUG 1 9 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 use of the Tri-Ostetic Bone Void Filler.
| Submitted By: | Berkeley Advanced Biomaterials Inc. |
|---|---|
| Date: | 07-06-04 |
| Contact Person: | François Génin, Ph.D. |
| Phone: 510-883-0500; Fax: 510-883-0511 | |
| Proprietary Name: | Tri-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
Tri-Ostetic is an osteoconductive putty that is intended 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 putty may be shaped and pressed into the void by hand or inserted into a syringe and injected into the surgical site. The Tri-Ostetic paste set in situ provides a void 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 Tri-Ostetic is biocompatible and resorbs in the body as bone ingrowth occurs.
B. DEVICE DESCRIPTION
Tri-Ostetic is a sterile osteoconductive bone void filler. Tri-Ostetic consists of a pre-measured formulation of distilled water and calcium-based compounds in a container that can be used to prepare a putty. Tri-Ostetic forms a paste when mixed with sterile distilled water. Both powder and water are supplied pre-measured in separate containers. The putty can be shaped into an implant or inserted into a syringe and injected into the surgical site (i.e., bony voids or gaps of skeletal system). Tri-Ostetic powder and the water are supplied sterile for single patient use only. Tri-Ostetic is biocompatible, bioresorbable and radio-opaque. Tri-Ostetic resorbs in the human body as bone ingrowth occurs when applied according to its indications for use.
C. SUBSTANTIAL EQUIVALENCE INFORMATION
Tri-Ostetic is substantially equivalent to the legally marketed, predicate device Cem-Ostetic™. 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 Tri-Ostetic are very similar to that of the predicate device. The safety and effectiveness of Tri-Ostetic are adequately supported by the substantial equivalence information, materials data, and test results provided in the document submitted within the scope of this Pre-Market 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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, with three stylized lines representing the body and wings.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 9 2004
Francois Génin, Ph.D. Chief Executive Officer Berkeley Advanced Biomaterials, Inc. 1933 Davis Street, Suite 307 San Leandro, California 94577
Re: K041889
Trade/Device Name: Tri-Ostetic Regulation Number: 21 CFR 888.3034 Regulation Name: Bone Void Filler Regulatory Class: II Product Code: MQV Dated: August 1, 2004 Received: August 3, 2004
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
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) 594-4659. 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/dsma/dsmamain.html
Sincerely yours,
Mark A Milken
Celia M. Witten, PhD, MD 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): K041889
Device Name: Tri-Ostetic
Indications For Use:
Tri-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 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 injected into the surgical site. The Tri-Ostetic paste set in situ or ex situ provides a void 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. Tri-Ostetic is biocompatible and resorbs in the body as bone ingrowth occurs.
| Prescription Use | |
|---|---|
| ------------------ | ---------------------------------------------- |
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(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) | |
|---|---|
| -------------------------------------------------------- | -- |
O Mark A Milhurn
Restorative, and Neurological Devices
510(k) Number_
Page 1 of 1