(85 days)
No
The device description and performance studies focus on the mechanical properties and biocompatibility of a physical implant, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended for stabilization of patella fractures, which indicates a therapeutic purpose by physically supporting the healing process.
No
The device is described as Patella SuturePlates used for stabilization of patella fractures, which indicates a therapeutic or surgical purpose, not a diagnostic one.
No
The device description clearly states the device is a physical implant made of titanium alloy, intended for surgical stabilization of patella fractures. It is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "stabilization of patella fractures." This is a surgical procedure performed on a patient's body, not a test performed on a sample taken from the body.
- Device Description: The device is a physical implant (plate and screws) made of titanium alloy. IVDs are typically reagents, kits, or instruments used to analyze biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
This device is a surgical implant used to treat a physical injury.
N/A
Intended Use / Indications for Use
The Arthrex Patella SuturePlates are intended for use in stabilization of patella fractures.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC, HTY
Device Description
The Arthrex Patella SuturePlates are manufactured from titanium alloy conforming to ASTM F136. The plates are 1.6 mm thick in a semi-contoured, mesh-like design. The plates are available in Arrow, Star and Star Pole configurations. Each plate provides locking screw fixation along with suture holes for fixation of the surrounding soft tissue to the plate. The Arthrex Patella SuturePlates are intended to be used with existing FDA cleared Arthrex screws. The Arthrex Patella SuturePlates 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
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)
Biomechanical (tensile and cyclic) and static four-point bend (ASTM F382) testing was conducted to demonstrate that the Arthrex Patella SuturePlates perform statistically equivalent to the predicate devices cleared under K201677 and K170547.
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 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 Patella SuturePlates 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 Patella SuturePlates meet pyrogen limit specifications.
Cytotoxicity, Sensitization, Irritation, Genotoxicity, Systemic Toxicity, Subchronic/Subacute Toxicity, Implantation and Material Characterization testing was conducted on the Arthrex Patella SuturePlates 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 Patella SuturePlates do not introduce additional risks or concerns regarding sterilization and shelf-life.
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
§ 888.3030 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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March 25, 2021
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the logo is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Arthrex Inc. Rebecca Homan Senior Regulatory Affairs Specialist 1370 Creekside Boulevard Naples. Florida 34108-1945
Re: K203834
Trade/Device Name: Arthrex Patella SuturePlates 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: December 23, 2020 Received: December 30, 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 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
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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,
For: 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) K203834
Device Name
Arthrex Patella SuturePlates
Indications for Use (Describe)
The Arthrex Patella SuturePlates are intended for use in stabilization of patella fractures.
Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
| Date Prepared | February 26, 2021 |
|---|---|
| Submitter | Arthrex Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 | |
| Contact Person | Rebecca R. Homan |
| Senior Regulatory Affairs Specialist | |
| 1-239-643-5553, ext. 73429 | |
| rebecca.homan@arthrex.com | |
| Name of Device | Arthrex Patella SuturePlates |
| Common Name | Plate, fixation, bone |
| Product Code | HRS, HWC, HTY |
| Classification Name | 21 CFR 888.3030: Single/multiple component metallic bone fixation appliances |
| and accessories | |
| 21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener | |
| Regulatory Class | II |
| Predicate Device | K201677: Arthrex Mesh Plates |
| Reference Device | K170547: Arthrex Mesh Plate System |
| Purpose of Submission | This Traditional 510(k) premarket notification is submitted to obtain clearance for |
| the Arthrex Patella SuturePlates. | |
| Device Description | The Arthrex Patella SuturePlates are manufactured from titanium alloy |
| conforming to ASTM F136. The plates are 1.6 mm thick in a semi-contoured, | |
| mesh-like design. The plates are available in Arrow, Star and Star Pole | |
| configurations. Each plate provides locking screw fixation along with suture holes | |
| for fixation of the surrounding soft tissue to the plate. The Arthrex Patella | |
| SuturePlates are intended to be used with existing FDA cleared Arthrex screws. | |
| The Arthrex Patella SuturePlates are sold sterile and non-sterile and are single | |
| use. | |
| Indications for Use | The Arthrex Patella SuturePlates are intended for use in stabilization of patella |
| fractures. | |
| Performance Data | Biomechanical (tensile and cyclic) and static four-point bend (ASTM F382) testing |
| was conducted to demonstrate that the Arthrex Patella SuturePlates perform | |
| statistically equivalent to the predicate devices cleared under K201677 and | |
| K170547. |
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 Patella
SuturePlates 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 Patella SuturePlates meet pyrogen |
| | limit specifications. |
| | Cytotoxicity, Sensitization, Irritation, Genotoxicity, Systemic Toxicity, |
| | Subchronic/Subacute Toxicity, Implantation and Material Characterization testing |
| | was conducted on the Arthrex Patella SuturePlates 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 Patella SuturePlates do not introduce additional risks or
concerns regarding sterilization and shelf-life. |
| Technological
Comparison | The Arthrex Patella SuturePlates are substantially equivalent to the predicate
devices cleared under K201677and K170547 in which the basic design features,
intended use, fundamental scientific technology, materials, sterility, packaging
and shelf-life are identical. |
| | The Arthrex Patella SuturePlates are intended to be used with existing FDA
cleared Arthrex screws (K103705, K111253, K123241, K143614, and K150456)
with the optional use of the 4.0 mm Titanium Cannulated Screw (cleared under
K103705 and K143614) to augment the patella fracture repair; whereas the
predicate Arthrex Mesh Plates and Arthrex Mesh Plate System 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. |
| | The Arthrex Patella SuturePlates were evaluated for MR Conditional labeling as
were the predicate devices cleared under K201677. |
| | The Arthrex Patella SuturePlates are substantially equivalent to the predicate
devices cleared under K201677 and K170547, with minor dimensional
modifications with no change to intended use or function. Any differences
between the Arthrex Patella SuturePlates and the predicate devices are
considered minor and do not raise different questions of safety or effectiveness. |
| Conclusion | The Arthrex Patella SuturePlates are substantially equivalent to the predicate
devices 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, cyclic fatigue, bending strength and bending structural
stiffness of the proposed device is substantially equivalent to that of the
predicate devices 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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