(90 days)
Not Found
No
The summary describes a bone graft material and a syringe for mixing and delivery, with no mention of AI or ML technology in the intended use, device description, or performance studies.
Yes
The device, IGNITE™ Bone Graft products, are indicated for bony voids or gaps and are intended to be implanted into the skeletal system to fill defects, which is a therapeutic purpose. The associated syringe is used to prepare and deliver this material.
No
Explanation: The device, IGNITE™ Bone Graft products, is indicated for filling bony voids or gaps as a bone graft material and for preparing and delivering composite graft material, which are therapeutic and restorative functions, not diagnostic.
No
The device description clearly states the product is a combination of Human Demineralized Bone Matrix (DBM) with a binding medium, which is a physical substance, not software. The device also includes a bone graft syringe, which is a hardware component.
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 IGNITE™ Bone Graft products are for filling bony voids or gaps in the skeletal system. The bone graft syringe is for aspirating body fluids and delivering the mixed graft material to a surgical site. These are all procedures performed in vivo (within the body) or for preparing materials for in vivo use.
- Device Description: The device is a bone graft material and a syringe for mixing and delivery. These are used directly in a surgical context.
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose a condition, analyze a sample in vitro to provide information about a patient's health, or detect the presence of a disease or condition.
IVD devices are typically used to examine specimens (like blood, urine, or tissue) outside the body to provide diagnostic information. This device is used within the body or to prepare materials for use within the body.
N/A
Intended Use / Indications for Use
IGNITE™ Bone Graft products are indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. IGNITE™ Bone Graft products are 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
MQV
Device Description
The IGNITE™ powder is a combination of Human Demineralized Bone Matrix (DBM) with a binding medium of calcium sulfate and carboxymethylcellulose. The IGNITE™ powder is intended to be mixed with bone marrow aspirate (BMA) to form an injectable paste for implantation.
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
A mixing equivalency evaluation of the subject system was performed in bench top testing. Pyrogenicity testing was also performed. The subject syringe mixing and delivery systems are acceptable methods for the preparation of the IGNITE™ Bone Void Filler.
Key Metrics
Not Found
Predicate Device(s)
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath in a smaller font.
Wright Medical Technology, Inc. Alayne Melancon Regulatory Affairs Specialist 1023 Cherry Road Memphis, Tennessee 38117
Re: K190482
Trade/Device Name: IGNITETM Bone Void Filler Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: February 22, 2019 Received: February 27, 2019
Dear Alayne Melancon:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
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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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Laurence D. Coyne, Ph.D. Assistant Director DHT6C: Division of Stereotaxic, Trauma and Restorative Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K190482
Device Name IGNITE™ Bone Void Filler
Indications for Use (Describe)
IGNITE™ Bone Graft products are indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. IGNITE™ Bone Graft products are 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.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/1 description: The image is a logo for Wright. The logo has two trapezoids, one red and one orange, on the left side of the word "WRIGHT" in red font. Below the word "WRIGHT" is the phrase "FOCUSED EXCELLENCE" in a smaller, gray font.
1023 Cherry Road Memphis, TN 38117 wright.com
510(k) SUMMARY
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 CFR 807.92, this information serves as a Summary of Safety and Effectiveness for the use of the IGNITE™ Bone Void Filler.
(a)(1) MANUFACTURER IDENTIFICATION
| Submitted By: | Wright Medical Technology, Inc.
1023 Cherry Road
Memphis, TN 38117 |
|-----------------|----------------------------------------------------------------------------------------------------|
| Date: | February 25, 2019 |
| Contact Person: | Alayne Melancon
Regulatory Affairs Specialist II
Office: (901)290-5986
Fax: (901)867-4190 |
(a)(2) SUBJECT DEVICE INFORMATION
| Proprietary Name: | IGNITE™ Bone Void Filler |
|---|---|
| Common Name: | Bone Void Filler |
| Classification Name & Reference: | 21 CFR 888.3045 – Class II |
| Device Product Code & Panel: | MQV - Orthopedic |
(a)(3) PREDICATE DEVICE INFORMATION
IGNITE™ Bone Void Filler
(a)(4) DEVICE DESCRIPTON
The IGNITE™ powder is a combination of Human Demineralized Bone Matrix (DBM) with a binding medium of calcium sulfate and carboxymethylcellulose. The IGNITE™ powder is intended to be mixed with bone marrow aspirate (BMA) to form an injectable paste for implantation.
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(a)(5) INTENDED USE
IGNITE™ Bone Graft products are indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. IGNITE™ Bone Graft products are 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.
(a)(6) TECHNOLOGICAL CHARACTERISTICS COMPARISON
The subject implant material is identical to the predicate. The subject device includes new size offerings and modified accessories for the mixing and delivery of the graft material. The updated system is a syringe mix method for closed mixing.
(b)(1) SUBSTANTIAL EQUIVALENCE - NON-CLINICAL EVIDENCE
A mixing equivalency evaluation of the subject system was performed in bench top testing. Pyrogenicity testing was also performed. The subject syringe mixing and delivery systems are acceptable methods for the preparation of the IGNITE™ Bone Void Filler.
(b)(2) SUBSTANTIAL EQUIVALENCE - CLINICAL EVIDENCE N/A
(b)(3) SUBSTANTIAL EQUIVALENCE - CONCLUSIONS
The design characteristics of the subject device do not raise any new questions of safety or effectiveness. The subject devices can be expected to perform at least as well as the predicate system and are substantially equivalent.