(244 days)
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No
The device description and intended use focus on the material properties and function as a bone void filler, with no mention of AI or ML technology.
Yes
The device is a bone void filler that resorbs and is replaced with bone during the healing process, falling under the definition of a therapeutic device as it treats a condition (bony voids/gaps).
No
Explanation: The device is a bone void filler intended for use in the skeletal system, providing structural support and resorbing over time to be replaced by bone. Its function is therapeutic, not diagnostic.
No
The device is a physical product (pellets made of calcium sulfate and stearic acid) intended for surgical implantation, not a software application.
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 used to fill bony voids or gaps in the skeletal system. This is a therapeutic and structural application, not a diagnostic one.
- Device Description: The description details the composition and function of the pellets as a bone void filler that resorbs and is replaced by bone. This is consistent with a medical device used for treatment or repair, not for testing samples from the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
Therefore, the Wright Plaster of Paris Pellets are a medical device used for bone repair, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Wright Plaster of Paris Pellets are indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. Wright Plaster of Paris Pellets are indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The pellets provide a bone void filler that resorbs and is replaced with bone during the healing process. Because the pellets are biodegradable and biocompatible, they may be used at an infected site.
Product codes
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Device Description
Wright Plaster of Paris Pellets are provided sterile for single patient use. The biodegradable, radiopaque pellets are resorbed in approximately 30-60 days when used according to labeling. Wright Plaster of Paris Pellets are made of medical grade calcium sulfate and stearic acid (as a tableting aid).
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
skeletal system (i.e., the extremities, spine and pelvis)
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Since a determination of substantial equivalence was not based on an sssessment of performance data, no performance data was submitted.
Key Metrics
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Predicate Device(s)
Plaster of Paris Pellets (Ethicon)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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/4 description: The image shows a partial view of a company logo or letterhead. The text "WRIGHT" is prominently displayed, with the words "MEDICAL TECHNOLOGY" underneath. Below that, the text "5677 AIRLINE" and "ARLINGTON, TN" are visible, suggesting an address. The phone number "901-867-99" is also present.
510(k) Summary
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92.
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Submitter's name: (1) Submitter's address: Submitter's telephone number: Contact person: Date summary prepared:
Wright Medical Technology, Inc. 5677 Airline Road, Arlington, Tennessee 38002 901/867-9971 Robert Churinetz May 6, 1997 -
Trade or proprietary device name: Common or usual name: Classification name:
Wright Plaster of Paris Pellets Calcium sulfate Unknown -
Legally marketed predicate device: Plaster of Paris Pellets (Ethicon)
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Subject device description: (4)
Wright Plaster of Paris Pellets are provided sterile for single patient use. The biodegradable, radiopaque pellets are resorbed in approximately 30-60 days when used according to labeling. Wright Plaster of Paris Pellets are made of medical grade calcium sulfate and stearic acid (as a tableting aid).
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Subject device intended use:
Wright Plaster of Paris Pellets are indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. Wright Plaster of Paris Pellets are indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The pellets provide a bone void filler that resorbs and is replaced with bone during the healing process. Because the pellets are biodegradable and biocompatible, they may be used at an infected site. -
Technological characteristics: (6)
The new device and the predicate device as described in (a) (3) are identical. In summary, the subject device has the same technological characteristics (i.e., design, material, and chemical composition) when compared to the predicate device.
(b) Performance data
Since a determination of substantial equivalence was not based on an assessment of performance data, no performance data was submitted.