(88 days)
No
The summary describes a system of titanium screws for bone fixation and does not mention any AI/ML components or functionalities.
No.
The explanation states it's for 'fixation' in procedures, not for treatment or therapy.
No
Explanation: The device description and intended use clearly state that this is a fixation system consisting of screws, intended for surgical procedures (selective trauma, reconstructive procedures, and general surgery). It does not describe any function related to identifying, measuring, or monitoring a disease or condition. The presence of MRI testing is for compatibility, not for diagnostic imaging capabilities of the device itself.
No
The device description explicitly states the device is manufactured from titanium and describes physical characteristics (headed, self-tapping, solid screws, diameter, length). The performance studies also involve physical testing (pull-out, torque, MRI force, torque, and image artifact testing), indicating a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. They are used outside the body.
- Device Description: The Arthrex Mini Comprehensive Fixation System consists of screws made of titanium, intended for surgical implantation in the hand and wrist. These are physical implants used inside the body to fix bones.
- Intended Use: The intended use is for "selective trauma, reconstructive procedures, and general surgery of the hand and wrist." This describes surgical procedures, not diagnostic testing of samples.
The information provided clearly describes a surgical implant, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Arthrex Mini Comprehensive Fixation System (1.0 mm solid) are intended for use in selective trauma, reconstructive procedures, and general surgery of the hand and wrist.
Product codes
HWC
Device Description
The Arthrex Mini Comprehensive Fixation System - 1.0mm Screws are manufactured from titanium. The screws are headed and self-tapping. The screws are available as fully threaded, solid screws. The screws are 1.0mm in diameter and from 6 mm to 14 mm in length (in 1 mm increments). The screws are sold non-sterile and single-use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand and wrist
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)
Pull-out and torque testing was conducted in accordance with ASTM F543 to demonstrate that the proposed Arthrex Mini Comprehensive Fixation System – 1.0mm Screws perform statistically equivalent to the predicate device, K030310. Arthrex performed an engineering analysis to conclude that the Insertion Torque/Failure Torque values of the Arthrex Mini Comprehensive Fixation System – 1.0mm Screws were acceptable.
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.
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
§ 888.3040 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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February 10, 2020
Image /page/0/Picture/1 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. The FDA logo is on the right, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. The logos are placed side by side.
Arthrex Inc. Rebecca R. Homan Senior Regulatory Affairs Associate 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K193156
Trade/Device Name: Arthrex Mini Comprehensive Fixation System - 1.0mm Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: November 11, 2019 Received: November 14, 2019
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
1
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, MPH Assistant Director DHT6C: Division of Restorative, Repair and Trauma 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) K193156
Device Name
Arthrex Mini Comprehensive Fixation System - 1.0 mm Screws
Indications for Use (Describe)
The Arthrex Mini Comprehensive Fixation System (1.0 mm solid) are intended for use in selective trauma, reconstructive procedures, and general surgery of the hand and wrist.
| 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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510(k) Summary
| Date Prepared | February 7, 2020 |
|---|---|
| Submitter | Arthrex Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 | |
| Contact Person | Rebecca R. Homan |
| Senior Regulatory Affairs Associate | |
| 1-239-643-5553, ext. 73429 | |
| rebecca.homan@arthrex.com | |
| Name of Device | Arthrex Mini Comprehensive Fixation System – 1.0mm Screws |
| Common Name | Screw, fixation, bone |
| Product Code | HWC |
| Classification Name | 21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener |
| Regulatory Class | II |
| Predicate Device | K030310: Synthes Stainless Steel Modular Hand System |
| Reference Devices | K191326: Arthrex Mini Comprehensive Fixation System - 1.4mm & 1.6mm Module |
| K191344: Arthrex Mini Comprehensive Fixation System - 2.0mm & 2.4mm Module | |
| K050607: Synthes 1.0mm Ti. Cortex, Self-drilling Screws (hand & Neuro) | |
| Purpose of | |
| Submission | This Traditional 510(k) premarket notification is submitted to obtain clearance for |
| the Arthrex Mini Comprehensive Fixation System – 1.0mm Screws. | |
| Device Description | The Arthrex Mini Comprehensive Fixation System - 1.0mm Screws are |
| manufactured from titanium. The screws are headed and self-tapping. The | |
| screws are available as fully threaded, solid screws. The screws are 1.0mm in | |
| diameter and from 6 mm to 14 mm in length (in 1 mm increments). The screws | |
| are sold non-sterile and single-use. | |
| Indications for Use | The Arthrex Mini Comprehensive Fixation System Screws (1.0mm solid) are |
| intended for use in selective trauma, reconstructive procedures, and general | |
| surgery of the hand and wrist. | |
| Performance Data | Pull-out and torque testing was conducted in accordance with ASTM F543 to |
| demonstrate that the proposed Arthrex Mini Comprehensive Fixation System – | |
| 1.0mm Screws perform statistically equivalent to the predicate device, K030310. | |
| Arthrex performed an engineering analysis to conclude that the Insertion | |
| Torque/Failure Torque values of the Arthrex Mini Comprehensive Fixation System | |
| – 1.0mm Screws were acceptable. |
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. |
| Technological
Comparison | The Arthrex Mini Comprehensive Fixation System - 1.0mm Screws are
substantially equivalent to the predicate devices in which the basic design
features, fundamental scientific technology, intended use, indications for use. |
| | The Arthrex Mini Comprehensive Fixation System – 1.0mm Screws are
manufactured from titanium; whereas the predicate device, K030310 is
manufactured from stainless steel. However, the titanium alloy used to
manufacture the Arthrex Mini Comprehensive Fixation System - 1.0mm Screws is
identical is identical to the titanium alloy cleared in K191326 and K191344. |
| | The Arthrex Mini Comprehensive Fixation System – 1.0mm Screws were
evaluated for MR Conditional labeling; whereas the predicate device was not
evaluated for MR Conditional labeling. |
| Conclusion | The Arthrex Mini Comprehensive Fixation System – 1.0mm Screws 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 Arthrex Mini Comprehensive Fixation System – 1.0mm Screws MR
compatibility testing supports the devices MR Conditional labeling. There is no
increased risk from this difference in technology. |
| | The submitted mechanical testing data demonstrates that the pull-out and
torque strength of the proposed devices are 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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