(58 days)
The DARCO® Locking Bone Plate System is intended for use in stabilization of fresh fractures, joint fusion, and reconstruction of small bones of the feet, ankles and toes. The system can be used in both adult and pediativ patients.
The DARCO® Locking Bone Plate System is designed with rhombus (parallelogram) plates of biocompatible titanium. The plates use either 2.7mm or 3.5mm screws which intersect each other in pairs. The drill holes of the plates are aligned to assure the screws do not touch. The plates vary essentially through different curvatures, material strengths, number of plate holes and through different grades or bridge widths.
This document is a 510(k) premarket notification for the DARCO® Locking Bone Plate System. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove acceptance criteria for device performance. Therefore, many of the requested details, particularly those related to a clinical study (like sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance), are not available in this document.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in terms of numerical performance metrics for the device. Instead, it relies on demonstrating substantial equivalence in technological characteristics and performance to a predicate device.
| Acceptance Criteria Category | Specific Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Not worse than predicate device for bone fixation. | "Analysis has shown that the performance of the subject bone locking plate system is not a worse case construct of the predicate DARCO® Locking Bone Plate family..." |
| Material Composition | Identical material composition to predicate. | "Both of these plates have identical indications, identical material composition and similar design features compared to other plates of the DARCO® System." |
| Design Features | Similar design features to predicate. | "Both of these plates have identical indications, identical material composition and similar design features compared to other plates of the DARCO® System." |
| Intended Use | Identical indications for use as predicate. | "Both of these plates have identical indications..." |
| Biocompatibility | Biocompatible materials. | "The DARCO® Locking Bone Plate System is designed with rhombus (parallelogram) plates of biocompatible titanium." |
2. Sample size used for the test set and the data provenance
Not applicable. This document describes a submission for a medical device that relies on substantial equivalence to a predicate device based on mechanical testing and design comparison, not a clinical study with a "test set" of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No ground truth based on expert review of a test set is mentioned.
4. Adjudication method for the test set
Not applicable. No adjudication method is described as there is no test set of clinical data.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This document describes a physical medical device (bone plate system), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This document describes a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not describe the use of a "ground truth" derived from clinical data in the context of a performance study. For the mechanical testing, the "ground truth" would implicitly be engineering standards and established mechanical properties, benchmarked against the predicate device.
8. The sample size for the training set
Not applicable. This document describes a physical medical device, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
Not applicable. No training set is mentioned.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 29, 2015
Wright Medical Technology, Inc. Ms. Jeanine Redden Director, Regulatory Affairs 1023 Cherry Road Memphis, Tennessee 38117
Re: K150520 Trade/Device Name: DARCO® Locking Bone Plate System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS Dated: March 31, 2015 Received: April 3, 2015
Dear Ms. Redden:
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. 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 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Ms. Jeanine Reddden
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K150520
K150520 Page 1 of 1
Device Name DARCO Locking Bone Plating System
Indications for Use (Describe)
The DARCO® Locking Bone Plate System is intended for use in stabilization of fresh fractures, joint fusion, and reconstruction of small bones of the feet, ankles and toes. The system can be used in both adult and pediativ patients.
| 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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Headquarters Wright Medical Technology, Inc.
1023 Cherry Road Memphis, TN 38117
901 867 9971 mt.com
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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 CFR 807.92, this information serves as a Summary of Safety and Effectiveness for the use of the DARCO® Locking Bone Plate System.
| (a)1. Submitted By: | Wright Medical Technology, Inc.1023 Cherry RoadMemphis, TN 38117 | |
|---|---|---|
| Date: | February 26, 2015 | |
| Contact Person: | Jeanine ReddenDirector, Regulatory AffairsOffice (901) 867-4522Fax (901) 867-4190 | |
| (a)2. | Proprietary Name: | DARCO® Locking Bone Plate System |
| Common Name: | Single/Multiple component metallic BoneFixation Plate | |
| Classification Name and Reference: | Single/Multiple component metallic BoneFixation Plate | |
| Device Product Code, Device Panel: | HRS - Orthopedic | |
| (a)3. | Predicate Device: | K061808 DARCO® Locking Bone Plate System |
| (a)(4). Device Description |
The DARCO® Locking Bone Plate System is designed with rhombus (parallelogram) plates of biocompatible titanium. The plates use either 2.7mm or 3.5mm screws which intersect each other in pairs. The drill holes of the plates are aligned to assure the screws do not touch. The plates vary essentially through different curvatures, material strengths, number of plate holes and through different grades or bridge widths.
E2 - 1
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(a)(5). Intended Use
The DARCO® Locking Bone Plate System is intended for use in stabilization of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the feet, ankles and toes. The system can be used in both adult and pediatric patients.
(a)(6). Technological Characteristics Comparison
The DARCO® Locking Bone Plate System is substantially equivalent to the predicates. Two additional locking bone plates are being added to the subject DARCO® Locking Bone Plate System: the TOM Plate (Step) and the Rahmanzadeh plate (General). Both of these plates have identical indications, identical material composition and similar design features compared to other plates of the DARCO® System.
(b)(1). Substantial Equivalence- Non-Clinical Evidence
The DARCO® Locking Bone Plate System is substantially equivalent to the predicates. Analysis has shown that the performance of the subject bone locking plate system is not a worse case construct of the predicate DARCO® Locking Bone Plate family which is equivalent to the original predicate Normed Titanium Osteotomy Plating system design. The safety and effectiveness of the DARCO® Locking Plate System is adequately supported by the testing rationales, substantial equivalence information, and comparison of design characteristics provided within this premarket notification.
(b)(2). Substantial Equivalence- Clinical Evidence
N/A
(b)(3). Substantial Equivalence- Conclusions
The design characteristics of the subject devices do not raise affect the safety or effectiveness of the system. From the evidence submitted in this 510(k), the subject devices can be expected to perform substantially equivalent to the predicate system.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.