(673 days)
Not Found
No
The summary describes a mechanical implant system and does not mention any software, algorithms, or AI/ML terms.
Yes
The device is described as a system for fixation of bone fractures, which directly aligns with the definition of a therapeutic device designed to treat a medical condition.
No
The device is described as a "Locking Plate and Screw System" intended for "fixation of fractures." This indicates it is a surgical implant used for treatment, not for diagnosing medical conditions.
No
The device description clearly states it is a "Plate and Screw System" and describes physical components like "anatomically contoured plates," "non-locking and locking screws," and "holes for cortex screws." This indicates a hardware-based medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the system is for "fixation of fractures to the various bones". This is a surgical procedure performed in vivo (within the body), not a diagnostic test performed in vitro (outside the body, typically on biological samples).
- Device Description: The description details plates and screws used for bone fixation, which are implantable medical devices.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
The device is a surgical implant used to treat bone fractures.
N/A
Intended Use / Indications 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, and acetabulum for adults. This system is not indicated for use in the spine.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
clavicle, radius, ulna, humerus, femur, tibia, fibula, and acetabulum
Indicated Patient Age Range
adults
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)
Performance of the Intai Anatomical Locking Plate and Screw System has been demonstrated substantial equivalence through the test parameters outlined in ASTM F382 to conduct Single Cycle Bend and Bending fatigue testing. In addition, Torsional Properties, Driving Torque, and Axial Pullout testing was conducted on the screws per ASTM F543.
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.
K092609, K073186, K061753, K040022, K082078, K041860, K082078, K030597, K013248, K073460, K062564, K033805, K093928, K042377, K043185, K060710
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.
Not Found
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.
0
March 11, 2022
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that 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.
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
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,
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
2
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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.3011187779
No.9 Jingke Rd., Nantun District, Taichung City, Taiwan, R.O.C.
Tel. +886 4 23595336
Fax.+886 4 36013076 | | | | |
|-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|----------------------|----------------------------------------------------------------------------------|--|
| Contact Person | Kevin Wang | | | | |
| Date Prepared | March 11th, 2022 | | | | |
| Device Name | Intai Anatomical Locking Plate and Screw System | | | | |
| Classifications
Product Codes | Class II, 21 CFR 888.3030 - Single/multiple component metallic bone
fixation appliances and accessories. (primary)
Class II, 21 CFR 888.3040 - Smooth or threaded metallic bone fixation
fastener.
HRS (primary), HWC | | | | |
| Predicate Devices
Information | The device is substantially equivalent to the marketed: | | | | |
| | No. | Premarket
Notification
Number | Name | Device Name | |
| | 013 | K092609 | Synthes | 3.5mm/4.5mm Curved Narrow and
Broad Locking Compression Plates
(LCP) | |
| | | Other Predicate Devices | | | |
| | 001 | K073186 | Synthes | 3.5mm LCP Clavicle Plate System | |
| | 002 | K061753 | Synthes | Clavicle Hook Plate | |
| | 003 | K040022 | Stryker
Leibinger | Universal Distal Radius System | |
| | 004 | K082078 | Zimmer | Periarticular Locking Plate System:
Distal Humeral and Proximal Ulna
Plate | |
| | 005 | K041860 | Synthes | LCP® Proximal Humerus Plates,
Long | |
| | 006 | K082078 | Zimmer | Periarticular Locking Plate System:
Distal Humeral and Proximal Ulna
Plate | |
| | 007 | K030597 | Synthes | 3.5mm Titanium LCP Proximal Tibia
Plate | |
| | 008 | K013248 | Synthes | LCP Distal Tibia Plate | |
| | 009 | K073460 | Synthes | 2.7 mm/ 3.5 mm LCP Distal Fibula
Plates | |
| | 010 | K062564 | Synthes | Synthes LCP Distal Femur Plates | |
| | 011 | K033805 | Synthes | 3.5mm/4.5mm LCP Metaphyseal
Plate | |
| | 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, 3.5mm
Plates And Screws-4936
Plates, 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 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. | | | | |
| 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, and
acetabulum for adults. This system is not indicated for use in the spine. | | | | |
| Summary of
Technological
Characteristics: | The subject device and the predicate devices have the same intended use and
have the same or similar technological characteristics. The subject and
predicate devices are all fabricated from the same or similar materials and
share similar design characteristics. Any differences in the technological
characteristics do not raise new issues of safety or efficacy. Intended Use: Both the subject and predicate devices are intended for
use in fixation fracture of bones. Materials: Use similar material.
-Stainless Steel
-Titanium Alloy Design Features: Both the subject and predicate devices include
Locking Compression Plates. | | | | |
| Performance Data
(Non-clinical) discussion | Performance of the Intai Anatomical Locking Plate and Screw System has
been demonstrated substantial equivalence through the test parameters
outlined in ASTM F382 to conduct Single Cycle Bend and Bending fatigue
testing. In addition, Torsional Properties, Driving Torque, and Axial Pullout
testing was conducted on the screws per ASTM F543. | | | | |
| Conclusion | The subject device has been compared to the predicate devices with respect
to intended use, materials, design features, and non-clinical tests. The
technological characteristics of the subject device do not raise new type of
questions regarding safety and efficacy. These comparison demonstrate that
the Intai Anatomical Locking Plate and Screw System is substantially
equivalence to the predicate devices. | | | | |
Intai Anatomical Locking Plate and Screw System for 510(k)
4
Image /page/4/Picture/1 description: The image shows the logo for INTAI. The logo consists of a blue stylized "i" with three curved lines inside the left side of the "i". There is a yellow circle above the "i" and a yellow vertical line on the right side of the "i". The word "INTAI" is written in blue next to the "i".