(196 days)
Not Found
No
The device description and intended use are for a bone void filler made of plaster of paris pellets, with no mention of AI or ML technology.
Yes
Explanation: The device is intended to treat osseous defects and aid the healing process by providing a bone void filler that resorbs and is replaced by bone. This therapeutic action qualifies it as a therapeutic device.
No
The device is described as a bone void filler that resorbs and is replaced with bone during the healing process. It treats a condition rather than diagnosing one.
No
The device description clearly states it is a "Bone Void Filler Kit" consisting of physical components like a mixing bowl, premeasured quantities of material, and a mold to form pellets. This is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "bone void filler" intended to be "gently packed into non-loadbearing voids in osseous defects." This describes a device used in vivo (within the body) to fill a physical space and aid in bone healing.
- Device Description: The description details a kit used to create pellets that are then placed into the body. It discusses the material properties (resorption, replacement with bone) and how it functions within the body.
- Lack of IVD Characteristics: An IVD is a medical device used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any such use or interaction with bodily specimens for diagnostic purposes.
Therefore, the Wright Plaster of Paris Pellets are a surgical implant/device used for bone void filling, not an IVD.
N/A
Intended Use / Indications for Use
Wright Plaster of Paris Pellets are intended to be gently packed into non-loadbearing voids in osseous defects or osseous defects or osseous and is from traumatic injury to the bone. The pellets provide a bone void filler that resorbs and is replaced with bone during the healing process.
Product codes
Not Found
Device Description
Wright Plaster of Paris Bone Vold Finel Kit comment of the mixing bown provided, then placed premeasured quantities, so that when mixed together in the missing bown provided, into the mold provided, the mixute sets to form Wright Plaster of Paris Pellets. The into the mold provided, the mixtite sols to resorbed in 30-60 days when used according to labeling. The kit is provided sterile for single patient use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Dissolution studies demonstrate Wright Plaster of Paris Bone Void Filler Litter demonstrated the Dissolution studies demonstrate Wirgit I haste of the bulant to the cast of equivalent dissolution rates to the production in the compressed pellets and to pellets have a compressive innute rate substants of easy volume rato within 15% of the trabecular bone. Testing indicates the product to be non-pyrogenic following the calcining Drocess.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Wright Plaster of Paris Pellets
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
Image /page/0/Picture/2 description: The image shows a stylized letter "W" logo. The "W" is formed by three triangles that are stacked on top of each other. The logo is black and is set against a white background. The logo has a registered trademark symbol in the bottom right corner.
MAR 2 4 1997
5 6 7 7 - A I R L I N E - R O A D
A R L I N G T O N , T N 3 8 0 0 2
9 0 I - 8 6 7 - 9 0 I - 8 6 7 - 9 9 7 1
CAL TECHNOLOGY, INC.
Contact Person: Robert Churinetz Date Prepared: March 14, 1997
510(k) Summary
Trade/Proprietary Name: Common Name: Product Classification: Predicate Device:
Wright Plaster of Paris Bone Void Filler Kit Calcium Sulfate Unclassified Wright Plaster of Paris Pellets
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
Description/Intended Use
Description/Intended Use Wright Plaster of Paris Bone Vold Finel Kit comment of the mixing bown provided, then placed
premeasured quantities, so that when mixed together in the missing bown provided, into the mold provided, the mixute sets to form Wright Plaster of Paris Pellets. The into the mold provided, the mixtite sols to resorbed in 30-60 days when used according to labeling. The kit is provided sterile for single patient use.
Wright Plaster of Paris Pellets are intended to be gently packed into non-loadbearing voids in Wright Plaster of Paris Pellers are interest to be gainer defects or osseous defects or osseous defects or osseous and is from traumatic injury to the bone. The pellets provide a bone void filler that resorbs and is replaced with bone during the healing process.
Material
Material
When mixed according to directions, the kit produced calcium sulfate (plaster of Paris) pellets.
Testing Summary
Dissolution studies demonstrate Wright Plaster of Paris Bone Void Filler Litter demonstrated the Dissolution studies demonstrate Wirgit I haste of the bulant to the cast of equivalent dissolution rates to the production in the compressed pellets and to pellets have a compressive innute rate substants of easy volume rato within 15% of the trabecular bone. Testing indicates the product to be non-pyrogenic following the calcining Drocess.