(75 days)
No
The document describes a passive implant (mesh plates) and testing related to its physical properties and compatibility with MRI. There is no mention of any software, algorithms, or data processing that would suggest the use of AI/ML.
Yes
The device is intended for the stabilization of fractures and reconstruction of bone fragments, which are direct interventions to treat and manage a medical condition.
No
Explanation: The device description and intended use clearly state that the Arthrex Mesh Plates are used for stabilization of fractures and reconstruction of bone fragments. This is a therapeutic or reconstructive function, not a diagnostic one. The mentions of MRI testing are safety tests for the implant itself within an MRI environment, not an indication that the device performs imaging or diagnosis.
No
The device description clearly states the device is a physical mesh plate made of titanium alloy or stainless steel, which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bone fragments...". This describes a surgical implant used directly on the patient's body to provide structural support.
- Device Description: The description details a physical plate made of titanium or stainless steel, designed to be surgically implanted.
- Lack of Diagnostic Function: An IVD is a device used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of biological samples.
- Testing: While the testing includes MRI compatibility (which involves imaging), the core function of the device is mechanical stabilization, not diagnostic interpretation of images. The MRI testing is to ensure the implant is safe and doesn't interfere with imaging, not to use the imaging for a diagnostic purpose related to the device itself.
In summary, the Arthrex Mesh Plates are a surgical implant, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Arthrex Mesh Plates are intended for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bone fragments of the hand/wrist, foot/ankle, osteopenic bone and patella fractures.
Product codes
HRS, HWC, HTY
Device Description
The Arthrex Mesh Plates are manufactured from either titanium alloy or stainless steel. The plates are 1.3 mm thick in a semi-contoured, mesh-like design. The plates are available in long and short versions ranging from 50 mm to 115 mm in length. The plates are designed for the surgeon to cut to a desired length as needed. The Arthrex Mesh Plates are intended to be used with existing FDA cleared Arthrex screws. The Arthrex Mesh Plates are sold sterile and non-sterile and are single use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand/wrist, foot/ankle, patella
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)
Tensile and cyclic testing was conducted to demonstrate that the Arthrex Mesh Plates perform statistically equivalent to the predicate device cleared under K143702.
MRI force, torque, and image artifact testing were conducted in accordance with FDA guidance Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment, ASTM F2052 Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment, ASTM F2119 Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants, ASTM F2182 Standard Test Method for Measurement of Measurement of Radio Frequency Induced Heating Near Passive Implants During Magnetic Resonance Imaging and ASTM F2213 Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment.
Bacterial Endotoxins Test (BET) was performed on the Arthrex Mesh Plates utilizing the Kinetic Chromogenic Method in accordance with ANSI/AAMI ST72:2011/(R)2016, USP , USP , EP 2.6.14. The testing conducted demonstrates that the Arthrex Mesh Plates meet pyrogen limit specifications.
Cytotoxicity, Sensitization, Irritation, Genotoxicity, Systemic Toxicity, Subchronic/Subacute Toxicity, Implantation and Material Characterization testing was conducted on the Arthrex Mesh Plates in accordance with ISO 10993-1:2018.
Assessment of physical product attributes including product design, size, and materials as well as the conditions of manufacture and packaging has determined that the Arthrex Mesh Plates do not introduce additional risks or concerns regarding sterilization and shelf-life.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG' and 'ADMINISTRATION' in blue text.
Arthrex Inc. Rebecca Homan Regulatory Affairs Specialist 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K201677
Trade/Device Name: Arthrex Mesh Plates Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS, HWC, HTY Dated: June 15, 2020 Received: June 19, 2020
Dear Rebecca Homan:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 (OS) 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 mediation-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,
On behalf of 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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Indications for Use
510(k) Number (if known) K201677
Device Name Arthrex Mesh Plates
Indications for Use (Describe)
The Arthrex Mesh Plates are intended for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bone fragments of the hand/wrist, foot/ankle, osteopenic bone and patella fractures.
| 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) |
[x] Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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K201677 Page 1 of 2
510(k) Summary
| Date Prepared | September 1, 2020 |
|---|---|
| Submitter | Arthrex Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 | |
| Contact Person | Rebecca R. Homan |
| Regulatory Affairs Specialist | |
| 1-239-643-5553, ext. 73429 | |
| rebecca.homan@arthrex.com | |
| Name of Device | Arthrex Mesh Plates |
| Common Name | Plate, fixation, bone |
| Product Code | HRS, HWC |
| Classification Name | 21 CFR 888.3030: Single/multiple component metallic bone fixation appliances |
| and accessories | |
| Regulatory Class | II |
| Predicate Device | K170547: Arthrex Mesh Plate System (Primary Predicate) |
| K143702: Arthrex Blunt Tip Screws with FiberTape (Secondary Predicate) | |
| Purpose of | |
| Submission | This Traditional 510(k) premarket notification is submitted to obtain clearance for |
| patella fracture indications for the Arthrex Mesh Plates. | |
| Device Description | The Arthrex Mesh Plates are manufactured from either titanium alloy or stainless |
| steel. The plates are 1.3 mm thick in a semi-contoured, mesh-like design. The | |
| plates are available in long and short versions ranging from 50 mm to 115 mm in | |
| length. The plates are designed for the surgeon to cut to a desired length as | |
| needed. The Arthrex Mesh Plates are intended to be used with existing FDA | |
| cleared Arthrex screws. The Arthrex Mesh Plates are sold sterile and non-sterile | |
| and are single use. | |
| Indications for Use | The Arthrex Mesh Plates are intended for use in stabilization of fresh fractures, |
| revision procedures, osteotomies, joint fusion and reconstruction of small bones | |
| and bone fragments of the hand/wrist, foot/ankle, osteopenic bone and patella | |
| fractures. | |
| Performance Data | Tensile and cyclic testing was conducted to demonstrate that the Arthrex Mesh |
| Plates perform statistically equivalent to the predicate device cleared under | |
| K143702. | |
| MRI force, torque, and image artifact testing were conducted in accordance with | |
| FDA guidance Testing and Labeling Medical Devices for Safety in the Magnetic | |
| Resonance (MR) Environment, ASTM F2052 Standard Test Method for | |
| Measurement of Magnetically Induced Displacement Force on Medical Devices in | |
| the Magnetic Resonance Environment, ASTM F2119 Standard Test Method for | |
| Evaluation of MR Image Artifacts from Passive Implants, ASTM F2182 Standard | |
| Test Method for Measurement of Measurement of Radio Frequency Induced | |
| Heating Near Passive Implants During Magnetic Resonance Imaging and ASTM | |
| F2213 Standard Test Method for Measurement of Magnetically Induced Torque | |
| on Medical Devices in the Magnetic Resonance Environment. | |
| Bacterial Endotoxins Test (BET) was performed on the Arthrex Mesh Plates | |
| utilizing the Kinetic Chromogenic Method in accordance with ANSI/AAMI | |
| ST72:2011/(R)2016, USP , USP , EP 2.6.14. The testing conducted | |
| demonstrates that the Arthrex Mesh Plates meet pyrogen limit specifications. | |
| Cytotoxicity, Sensitization, Irritation, Genotoxicity, Systemic Toxicity, | |
| Subchronic/Subacute Toxicity, Implantation and Material Characterization testing | |
| was conducted on the Arthrex Mesh Plates in accordance with ISO 10993-1:2018. | |
| Assessment of physical product attributes including product design, size, and | |
| materials as well as the conditions of manufacture and packaging has determined | |
| that the Arthrex Mesh Plates do not introduce additional risks or concerns | |
| regarding sterilization and shelf-life. | |
| Technological | |
| Comparison | The Arthrex Mesh Plates are substantially equivalent to the predicate devices |
| cleared under K170547 and K143702 in which the basic design features, intended | |
| use, fundamental scientific technology, materials, sterility, packaging and shelf- | |
| life are identical. | |
| The Arthrex Mesh Plates are used with existing FDA cleared Arthrex screws | |
| (K143614, K150456 and K170547) with the optional use of the Arthrex Blunt Tip | |
| Screws (K143702) for patella fractures; whereas the predicate Arthrex Blunt Tip | |
| Screws with FiberTape (K143702) consists of standalone screws used in | |
| conjunction with FiberTape Suture for patella fractures. | |
| The Arthrex Mesh Plates were evaluated for MR Conditional labeling; whereas | |
| the predicate devices cleared under K170547 and K143702 were not evaluated | |
| for MR Conditional labeling. | |
| The Arthrex Mesh Plates are substantially equivalent to the predicate devices | |
| cleared under K170547 and K143702, with minor dimensional modifications with | |
| no change to intended use or function. Any differences between the Arthrex | |
| Mesh Plates and the predicate devices are considered minor and do not raise | |
| different questions of safety or effectiveness. | |
| Conclusion | The Arthrex Mesh Plates are substantially equivalent to the predicate device in |
| which the basic design features and intended uses are the same. Any differences | |
| between the proposed device and the predicate device are considered minor and | |
| do not raise different questions concerning safety or effectiveness. | |
| The submitted mechanical testing data demonstrates that the ultimate tensile | |
| strength, stiffness and cyclic fatigue of the proposed device is substantially | |
| equivalent to that of the predicate device for the desired indications. | |
| Based on the indications for use, technological characteristics, and the summary | |
| of data submitted, Arthrex Inc. has determined that the proposed device is | |
| substantially equivalent to the currently marketed predicate device. |
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