(190 days)
No
The 510(k) summary describes a mechanical device (cannulated screws) and its performance testing focuses on mechanical properties and MR safety, with no mention of AI or ML.
No.
The device is an orthopedic screw used for bone fixation and reconstruction, which is a surgical tool rather than a therapeutic device in the sense of delivering therapy (e.g., drug delivery, rehabilitation).
No
Explanation: The provided text describes a medical device (cannulated screws) used for bone reconstruction and fracture fixation. Its intended use is therapeutic/surgical, not diagnostic (i.e., identifying or characterizing a disease or condition).
No
The device description explicitly states that the device is a system of cannulated screws manufactured from titanium alloy, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for surgical procedures involving bone reconstruction, fracture repair, etc., within the foot and ankle. This is a therapeutic and structural application, not a diagnostic test performed on samples outside the body.
- Device Description: The device is a physical implant (cannulated screws) made of titanium alloy. This is consistent with a surgical implant, not a diagnostic reagent or instrument used for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The DART-FIRE EDGE Cannulated Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of foot and ankle bones appropriate for the device. Screws gre intended for single use only.
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
The DART-FIRE EDGE Cannulated Screw System contains partially and fully threaded, cannulated screws offered in a variety of diameters and lengths. The screws are manufactured from titanium alloy (ASTM F136).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
foot and ankle bones
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)
Performance testing and analysis demonstrated substantial equivalence to the predicate device in insertion torque, removal torque, pull out, ultimate torque, yield torque strength per ASTM F543 and simulated MR Safety testing per ASTM F2182 (RF Heating/Image Artifact) and ASTM F2052 (Induced Force/Torques).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
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Wright Medical Michael Mullins SR Regulatory Affairs Specialist 1023 Cherry Road Memphis, Tennessee 38117
Re: K203228
Trade/Device Name: DART-FIRE EDGE Cannulated Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: April 9, 2021 Received: April 12, 2021
Dear Michael Mullins:
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.
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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); 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K203228
Device Name DART-FIRE EDGE Cannulated Screw System
Indications for Use (Describe)
The DART-FIRE EDGE Cannulated Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of foot and ankle bones appropriate for the device. Screws gre intended for single use only.
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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K203228 Page 1 of 2
1023 Cherry Road Memphis, TN 38117 USA
901 867 9971 800 238 7117 wright.com
Image /page/3/Picture/3 description: The image shows the Wright logo. The logo consists of two overlapping trapezoids, one red and one orange, on the left side of the logo. To the right of the trapezoids is the word "WRIGHT" in red, and below that is the phrase "FOCUSED EXCELLENCE" in gray.
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 DART-FIRE EDGE Cannulated Screw System.
| (a)(1). Submitted By: | Wright Medical Technology, Inc.
1023 Cherry Road
Memphis, TN 38117 |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | October 30, 2020 |
| Contact Person: | Michael Mullins
Regulatory Affairs Specialist
Phone - (901) 867-4142
Fax - (901) 867-4190 |
| (a)(2). Proprietary Name: | DART-FIRE EDGE Cannulated Screw System |
| Common Name: | Bone Screw |
| Classification Name and Regulation: | Smooth or threaded metallic bone fixation
fastener, 21 CFR 888.3040 – Class II |
| Device Product Code, Device Panel: | HWC - Orthopedic |
| (a)(3). Predicate Device: | K082320: Wright Compression Screws
(primary)
K080850: DARCO Headless Compression
Screw (reference)
K183696: PERFORM Reverse (reference) |
(a)(4). Device Description
The DART-FIRE EDGE Cannulated Screw System contains partially and fully threaded, cannulated screws offered in a variety of diameters and lengths. The screws are manufactured from titanium alloy (ASTM F136).
4
(a)(5). INTENDED USE
The DART-FIRE EDGE Cannulated Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of foot and ankle bones appropriate for the size of the device. Screws are intended for single use only.
(a)(6). Technological Characteristics Comparison
The DART-FIRE EDGE Screw System is a new screw system. Compared to the legally marketed primary predicate, the subject system has identical indications, similar design features, the same sterilization method, and similar performance characteristics.
(b)(1). Substantial Equivalence - Non-Clinical Evidence
Performance testing and analysis demonstrated substantial equivalence to the predicate device in insertion torque, removal torque, pull out, ultimate torque, yield torque strength per ASTM F543 and simulated MR Safety testing per ASTM F2182 (RF Heating/Image Artifact) and ASTM F2052 (Induced Force/Torques).
(b)(2). Substantial Equivalence - Clinical Evidence
N/A
(b)(3). Substantial Equivalence - Conclusions
The design characteristics of the subject system do not raise any new types of questions of safety or effectiveness. From the evidence submitted in this 510(k), the subject devices can be expected to perform at least as well as the predicate device.