(245 days)
Not Found
No
The provided text describes a bone void filler made of calcium sulfate and does not mention any AI or ML components or functionalities.
No
The device is described as a bone void filler that resorbs and is replaced with bone during the healing process, and as a temporary support media, rather than acting as a therapeutic agent itself.
No
The device is a bone void filler and temporary support media, not a device used to diagnose medical conditions.
No
The device description clearly states it consists of physical components (calcium sulfate, mixing solution, tools) that are mixed to form a paste/pellets, indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for diagnostic purposes.
- Device Function: The OSTEOSET® BVF is a bone void filler. Its function is to physically fill gaps in bone and provide a temporary scaffold for bone healing. It is applied directly to the bone defect within the body.
- Intended Use: The intended use clearly describes a surgical procedure where the material is injected or packed into bone voids. It does not involve the analysis of specimens taken from the body.
The device is a medical device used in a surgical setting, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The intended use for the OSTEOSET® BVF resultant paste is to be injected, digitally packed into open bone void/gap to cure in-situ; or molded into solid pellets that are gently packed into open bone voids/gap that are not intrinsic to the stability of bony structure of the skeletal system (i.e., the extremities, spine, and pelvis). These open bone voids may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The paste/pellets provide a bone void filler that resorbs and is replaced with bone during the healing process.
The OSTEOSET® paste cured in situ provides an open void/gap filler that can augment provisional hardware (e.g. K-Wires) to help support bone fragments during the surgical procedure. The cured paste acts only as a temporary support media and is not intended to provide structural support during the healing process.
The OSTEOSET® BVF Kit is provided sterile for single use only.
Product codes
MQV
Device Description
OSTEOSET® BVF Kits consist of pre-measured surgical grade calcium sulfate, premeasured mixing solution, and the tools necessary to mix the components into a paste. These products are provided sterile for single patient use. When mixed according to directions, the OSTEOSET® BVF Kit produces biodegradable, radiopaque paste/molded pellets that resorb in approximately 30-60 days, when used according to labeling.
After the powder is hydrated using all of the mixing solution supplied in each kit, the resultant paste can be injected, digitally packed into the bone void to cure in-situ; or molded into solid implants that are gently packed into non-load bearing voids or gaps of the skeletal system (i.e., the extremities, spine, and pelvis). These bone voids may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The implants provide a bone void filler that resorbs and is replaced with bone during the healing process.
The paste/beads are used to fill bone voids and may be used at an infected site.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skeletal system (i.e., the extremities, spine, and pelvis)
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)
Wright Plaster of Paris Bone Void Filler Kit
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
OCT 2 6 2001
1 of 2
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe In accelance mark of 1990 and in conformance with 21 CRF 807, this information serves as a Medical De Freeb Act of Effectiveness for the Use of the OSTEOSET® BVF Kit.
| Submitted By: | Wright Medical Technology, Inc. |
|---|---|
| Date: | February 22, 2001 |
| Contact Person: | Ehab M. Esmail |
| Manager of Regulatory Affairs | |
| Phone: 901-867-4732 Fax: 901-867 4630 | |
| Proprietary Name: | OSTEOSET® BVF Kit |
| Common Name: | Bone Void Filler |
| Classification Name and Reference: | Unclassified |
| Device Product Code and Panel Code: | Orthopedics/87/MOV |
DEVICE INFORMATION
INTENDED USES/ INDICATIONS A.
The intended use for the OSTEOSET® BVF resultant paste is to be injected, digitally packed into open bone void/gap to cure in-situ; or molded into solid pellets that are gently packed into open bone voids/gap that are not intrinsic to the stability of bony structure of the skeletal system (i.e., the extremities, spine, and pelvis). These open bone voids may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The paste/pellets provide a bone void filler that resorbs and is replaced with bone during the healing process.
The OSTEOSET® paste cured in situ provides an open void/gap filler that can augment provisional hardware (e.g. K-Wires) to help support bone fragments during the surgical procedure. The cured paste acts only as a temporary support media and is not intended to provide structural support during the healing process.
The OSTEOSET® BVF Kit is provided sterile for single use only.
DEVICE DESCRIPTION B.
OSTEOSET® BVF Kits consist of pre-measured surgical grade calcium sulfate, premeasured mixing solution, and the tools necessary to mix the components into a These products are provided sterile for single patient use. When mixed paste. according to directions, the OSTEOSET® BVF Kit produces biodegradable,
1
K01 0532
20F21
radiopaque paste/molded pellets that resorb in approximately 30-60 days, when used according to labeling.
After the powder is hydrated using all of the mixing solution supplied in each kit, the resultant paste can be injected, digitally packed into the bone void to cure in-situ; or molded into solid implants that are gently packed into non-load bearing voids or gaps of the skeletal system (i.e., the extremities, spine, and pelvis). These bone voids may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The implants provide a bone void filler that resorbs and is replaced with bone during the healing process.
The paste/beads are used to fill bone voids and may be used at an infected site.
C. MATERIALS
The materials used for the OSTEOSET® BVF Kit are identical to the materials used for previously submitted Wright Plaster of Paris Bone Void Filler:
- The powder supplied in the kit is 98.5% surgical grade calcium sulfate (CaSO4 . . 1/2 H2O) in conformance with USP/NF Standards for calcium Sulfate, and 1.5% medical grade calcium stearate (stearic acid) in conformance with USP/NF standards for calcium stearate (used as a molding aid). The powder will be supplied premeasured in a glass vial.
- The saline is 0.9% sterile NaCl, USP/NF for irrigation. The saline will be supplied . premeasured in a glass vial.
D. SUBSTANTIAL EQUIVALENCE INFORMATION
The intended use, material composition, and design features of the OSTEOSET® paste cured in situ are substantially equivalent to the intended use, material composition, and design features of the previously submitted Wright Plaster of Paris Bone Void Filler Kit.
The safety and effectiveness of the OSTEOSET® BVF Kit with the expanded claims is adequately supported by the substantial equivalence information, materials data, and testing results provided within this Premarket Notification.
2
Image /page/2/Picture/1 description: The image contains the words "Public Health Service" in bold, black font. The words are stacked on top of each other, with "Public Health" on the top line and "Service" on the bottom line. The text appears to be extracted from a document or sign.
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The bird is positioned within a circular border. Encircling the bird, along the border, is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a sans-serif font.
OCT 2 6 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Ehab M. Esmail Manager of Regulatory Affairs Wright Medical Technology, Inc. 5677 Airline Road Arlington, Tennessee 38002
Re: K010532
Trade/Device Name: OSTEOSET® BVF Kit Regulatory Class: unclassified Product Code: MQV Dated: July 27, 2001 Received: July 30, 2001
Dear Mr. Esmail:
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.
3
Page 2 - Mr. Ehab M. Esmail
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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
for Mark N. Millerson
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Devices Evaluation Center for Devices and Radiological Devices
Enclosure
4
OSTEOSET® BVF Kit
INDICATIONS STATEMENT
The intended use for the OSTEOSET® BVF resultant paste is to be injected, digitally packed into The micenced id/gap to cure in-situ; or molded into solid pellets that are gently packed into open open bollo volu gap to var intrinsic to the stability of bony structure of the skeletal system (i.e., the extremities, spine, and pelvis). These open bone voids may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The paste/pellets provide a bone void filler that resorbs and is replaced with bone during the healing process.
The OSTEOSET® paste cured in situ provides an open void/gap filler that can augment provisional hardware (e.g. K-Wires) to help support bone fragments during the surgical procedure. The cured paste acts only as a temporary support media and is not intended to provide structural support during the healing process.
The OSTEOSET® BVF Kit is provided sterile for single use only.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of General Restorative Devices 510(k) Number
Prescription Use (Per21 CFR 801.109) OR
Over-The Counter Use (Optional Format 1-2-96)
D. Mark A. Milleson
storative