(21 days)
No
The document describes a bone graft material and a syringe, which are physical medical devices. There is no mention of software, algorithms, or any form of data processing that would suggest the use of AI or ML. The performance studies focus on the biological properties of the material and viral inactivation, not on computational analysis.
Yes
The device is used to fill bony voids or gaps and promote healing in the skeletal system, which directly treats a condition affecting the body.
No
The device is a bone graft material intended for packing into bony voids or gaps and a syringe for aspirating and delivering fluids. Its intended use is for filling skeletal defects, which is a therapeutic application rather than a diagnostic one.
No
The device description explicitly states that the product is a "kit configuration" combining existing physical products (putty and syringe) and accessory components. There is no mention of software as a component or the primary function of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for filling bony voids or gaps in the skeletal system and for aspirating and delivering bone graft materials. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a kit containing bone graft materials and a syringe. These are used for surgical implantation and delivery, not for testing samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of the device being used to test samples like blood, urine, or tissue to diagnose a disease or condition. The performance studies focus on the osteoinductive potential of the bone graft material and viral inactivation, which are related to the safety and efficacy of the implanted material, not diagnostic testing.
Therefore, the IGNITE® Putty and Bone Graft Syringe are considered medical devices used in surgical procedures, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
IGNITE® Putty is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. IGNITE® Putty is intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.
The Bone Graft Syringe is intended for use as a piston syringe for aspiration of bone marrow, autologous blood, plasma, or other body fluids. The syringe can be used to mix bone graft materials with aspirated fluids and deliver the composite graft material to the orthopedic surgical site.
Product codes (comma separated list FDA assigned to the subject device)
MOV, MQV
Device Description
The IGNITE® product combines existing Wright Medical products into a kit configuration: ALLOMATRIX® Injectable Putty (K020895, K041168), and accessory Bone Graft Syringe (K023088) with accessory components which are exempt from 510(k) requirements pursuant to 21 CFR 878.4800. The IGNITE® convenience kit provides surgeons the option of mixing the ALLOMATRIX® powder with sterile water or mixing with autologous bone marrow aspirate (BMA).
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 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)
Osteoinductivity Potential: The DBM incorporated into IGNITE® Kits is assayed in vitro for its osteoinductive potential. The bioassay measures the proliferation of Saos human osteosarcoma cells in the presence of human DBM compared to positive and negative controls (osteoinductivity index). Results from the bioassay were correlated with results from implantation of DBM into athymic rat muscle", which demonstrated a correlation coefficient of 0.850 (p0.20 and
§ 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
NOV - 7 2005
Image /page/0/Picture/1 description: The image shows the logo for Wright Medical Technology. The logo consists of a stylized "W" symbol on the left, followed by the text "WRIGHT MEDICAL TECHNOLOGY" in a serif font. There is also a handwritten "K052" on the right side of the logo.
A Wright Medical Group Company
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CRF 807, this information serves as a Summary of Safety and Effectiveness for the IGNITE® Kit.
| Submitted By: | Wright Medical Technology, Inc. |
|---|---|
| Date: | October 14, 2005 |
| Contact Person: | Ehab M Esmail |
| Director, Regulatory Affairs | |
| Phone: 901-867-120 Fax: 901-867 4630 | |
| Proprietary Name: | IGNITE® Kit |
| Common Name: | Bone Void Filler |
| Classification Name and Reference: | Filler, calcium sulfate preformed pellets |
| Device Product Code and Panel Code: | Orthopedics/87/MOV |
DEVICE INFORMATION
INTENDED USES/ INDICATIONS A.
IGNITE® Putty is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. IGNITE® Putty is intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.
The Bone Graft Syringe is intended for use as a piston syringe for aspiration of bone marrow, autologous blood, plasma, or other body fluids. The syringe can be used to mix bone graft materials with aspirated fluids and deliver the composite graft material to the orthopedic surgical site
B. DEVICE DESCRIPTION
The IGNITE® product combines existing Wright Medical products into a kit configuration: ALLOMATRIX® Injectable Putty (K020895, K041168), and accessory
Image /page/0/Picture/12 description: The image shows the logo for Wright Medical Technology. The logo consists of a stylized "W" on the left, followed by the words "WRIGHT MEDICAL TECHNOLOGY" stacked on top of each other. Below the logo is the text "A Wright Medical Group Company".
Image /page/0/Picture/13 description: The image shows a black and white drawing of a planet. The planet has a rough, textured surface with dark and light areas. There is a ring around the planet, and a small object is visible below it. The drawing is simple and lacks detail, giving it a somewhat abstract appearance.
1
Bone Graft Syringe (K023088) with accessory components which are exempt from 510(k) requirements pursuant to 21 CFR 878.4800. The IGNITE® convenience kit provides surgeons the option of mixing the ALLOMATRIX® powder with sterile water or mixing with autologous bone marrow aspirate (BMA).
C. MATERIALS
The implant materials used for the IGNITE® Kit are substantially equivalent to the previously submitted and cleared ALLOMATRIX® implant materials.
D. SUBSTANTIAL EQUIVALENCE INFORMATION
The intended use, material composition, and design features of the IGNITE® Kit are substantially equivalent to the previously submitted and cleared ALLOMATRIX® product. The safety and effectiveness of the IGNITE® Kit is adequately supported by the substantial equivalence information, materials data, and testing results provided within this Premarket Notification.
Osteoinductivity Potential
The DBM incorporated into IGNITE® Kits is assayed in vitro for its osteoinductive potential. The bioassay measures the proliferation of Saos human osteosarcoma cells in the presence of human DBM compared to positive and negative controls (osteoinductivity index). Results from the bioassay were correlated with results from implantation of DBM into athymic rat muscle", which demonstrated a correlation coefficient of 0.850 (p0.20 and