(673 days)
The Intai Anatomy Locking Plate and Screw System is provided non-sterile. The system is intended for use in fixation of fractures to the various bones, including; clavicle, radius, ulna, humerus, femur, tibia, fibula, and acetabulum for adults. This system is not indicated for use in the spine.
The Intai Anatomical Locking Plate and Screw System offers anatomically contoured plates for use with non-locking and locking screws. The plates are provided with locking holes as well as holes for cortex screws to enhance compression pressure. With the combination of locking and compression technology, the system further ensures the stability of the implant devices.
The provided text is a 510(k) Premarket Notification for the "Intai Anatomical Locking Plate and Screw System." This document is a regulatory submission for a medical device and does not describe:
- Acceptance criteria for an AI/ML powered medical device. The device is a physical bone fixation system.
- A study involving a test set, ground truth, experts, or AI/ML performance. The performance data discussed relates to biomechanical testing of the physical plates and screws (e.g., bend, fatigue, torque, pullout testing) against ASTM standards, not a clinical or AI-driven performance study.
- Training sets or adjudication methods for AI/ML models.
Therefore, I cannot extract the requested information regarding AI/ML device performance, ground truth, expert adjudication, or MRMC studies from the provided text. The document focuses on demonstrating substantial equivalence of a bone fixation system to existing predicate devices based on its intended use, materials, design features, and biomechanical non-clinical tests.
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March 11, 2022
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Intai Technology Corporation Dale Chang Head of Implant Business Unit No. 9 Jingke Rd., Nantun Dist. Taichung, Taichung 40852 Taiwan
Re: K201229
Trade/Device Name: Intai Anatomic Locking Plate and Screw 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, HWC Dated: April 14, 2020 Received: May 7, 2020
Dear Dale Chang:
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
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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,
Shumaya Ali, MPH 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) K201229
Device Name
Intai Anatomical Locking Plate and Screw System
Indications for Use (Describe)
The Intai Anatomy Locking Plate and Screw System is provided non-sterile.
The system is intended for use in fixation of fractures to the various bones, including; clavicle, radius, ulna, humerus, femur, tibia, fibula, and acetabulum for adults.
This system is not indicated for use in the spine.
| 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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Image /page/3/Picture/1 description: The image shows the logo for INTAI. The logo features a stylized "i" with a yellow circle above it and a blue curved shape to the left. The word "INTAI" is written in blue, bold letters to the right of the "i". The logo has a reflection effect below it.
K201229 - 510(k) SUMMARY
This summary regarding 510(k) information is being submitted in accordance with the requirements of 21 CFR 807.92.
| Submitted By | Intai Technology Corp.Registration No.3011187779No.9 Jingke Rd., Nantun District, Taichung City, Taiwan, R.O.C.Tel. +886 4 23595336Fax.+886 4 36013076 | ||||
|---|---|---|---|---|---|
| Contact Person | Kevin Wang | ||||
| Date Prepared | March 11th, 2022 | ||||
| Device Name | Intai Anatomical Locking Plate and Screw System | ||||
| ClassificationsProduct Codes | Class II, 21 CFR 888.3030 - Single/multiple component metallic bonefixation appliances and accessories. (primary)Class II, 21 CFR 888.3040 - Smooth or threaded metallic bone fixationfastener.HRS (primary), HWC | ||||
| Predicate DevicesInformation | The device is substantially equivalent to the marketed: | ||||
| No. | PremarketNotificationNumber | Name | Device Name | ||
| 013 | K092609 | Synthes | 3.5mm/4.5mm Curved Narrow andBroad Locking Compression Plates(LCP) | ||
| Other Predicate Devices | |||||
| 001 | K073186 | Synthes | 3.5mm LCP Clavicle Plate System | ||
| 002 | K061753 | Synthes | Clavicle Hook Plate | ||
| 003 | K040022 | StrykerLeibinger | Universal Distal Radius System | ||
| 004 | K082078 | Zimmer | Periarticular Locking Plate System:Distal Humeral and Proximal UlnaPlate | ||
| 005 | K041860 | Synthes | LCP® Proximal Humerus Plates,Long | ||
| 006 | K082078 | Zimmer | Periarticular Locking Plate System:Distal Humeral and Proximal UlnaPlate | ||
| 007 | K030597 | Synthes | 3.5mm Titanium LCP Proximal TibiaPlate | ||
| 008 | K013248 | Synthes | LCP Distal Tibia Plate | ||
| 009 | K073460 | Synthes | 2.7 mm/ 3.5 mm LCP Distal FibulaPlates | ||
| 010 | K062564 | Synthes | Synthes LCP Distal Femur Plates | ||
| 011 | K033805 | Synthes | 3.5mm/4.5mm LCP MetaphysealPlate | ||
| 012 | K093928 | Synthes | 3.5 mm Quadrilateral Surface Plates | ||
| 014 | K042377 | Synthes | Low Profile Reconstruction Plates | ||
| 015 | K043185 | Synthes | 3.5mm Cortex Screw | ||
| 016 | K060710 | Zimmer | Universal Locking System, 3.5mmPlates And Screws-4936Plates, 4835 Screws | ||
| Material | Titanium-alloy per ASTM F136 or Stainless Steel per ASTM F138/F139 | ||||
| Device Description | The Intai Anatomical Locking Plate and Screw System offers anatomicallycontoured plates for use with non-locking and locking screws. The plates areprovided with locking holes as well as holes for cortex screws to enhancecompression pressure. With the combination of locking and compressiontechnology, the system further ensures the stability of the implant devices. | ||||
| Indication for use | The Intai Anatomy Locking Plate and Screw System is provided non-sterile.The system is intended for use in fixation of fractures to the various bones,including: clavicle, radius, ulna, humerus, femur, tibia, fibula, andacetabulum for adults. This system is not indicated for use in the spine. | ||||
| Summary ofTechnologicalCharacteristics: | The subject device and the predicate devices have the same intended use andhave the same or similar technological characteristics. The subject andpredicate devices are all fabricated from the same or similar materials andshare similar design characteristics. Any differences in the technologicalcharacteristics do not raise new issues of safety or efficacy. Intended Use: Both the subject and predicate devices are intended foruse in fixation fracture of bones. Materials: Use similar material.-Stainless Steel-Titanium Alloy Design Features: Both the subject and predicate devices includeLocking Compression Plates. | ||||
| Performance Data(Non-clinical) discussion | Performance of the Intai Anatomical Locking Plate and Screw System hasbeen demonstrated substantial equivalence through the test parametersoutlined in ASTM F382 to conduct Single Cycle Bend and Bending fatiguetesting. In addition, Torsional Properties, Driving Torque, and Axial Pullouttesting was conducted on the screws per ASTM F543. | ||||
| Conclusion | The subject device has been compared to the predicate devices with respectto intended use, materials, design features, and non-clinical tests. Thetechnological characteristics of the subject device do not raise new type ofquestions regarding safety and efficacy. These comparison demonstrate thatthe Intai Anatomical Locking Plate and Screw System is substantiallyequivalence to the predicate devices. |
Intai Anatomical Locking Plate and Screw System for 510(k)
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§ 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.