The T-FIT is designed to provide a fixed anchorage point for attaching orthodontic appliances, facilitating the orthodontic movement of teeth. It is used temporarily and removed upon completion of the orthodontic treatment for use in patients aged 12 and older. The screws are intended for single use only.

Device Description

The T-FIT is designed to serve as a fixed anchorage point for attaching orthodontic appliances to facilitate the movement of teeth during orthodontic treatment. The system is intended for temporary use and is removed once treatment is complete. The T-FIT is available in thread diameters Ø1.4 mm, 1.6 mm, and 2.0 mm and thread lengths of 6.0 mm, 8.0 mm, 10.0 mm, 12.0 mm, and 14.0 mm. Thread lengths of 12.0 mm and 14.0 mm are only available with Ø2.0 mm diameter models. All screws are manufactured from Ti-6Al-4V ELI titanium alloy (ASTM F 136-13). The T-FIT is provided non-sterile and is intended for single use only. Additionally, the T-FIT is designed to be used with commonly available dental surgical instruments.

AI/ML Overview

The FDA 510(k) Premarket Notification for the T-FIT device does not contain information typically associated with acceptance criteria and studies for AI/ML-driven devices. The T-FIT is an orthodontic anchorage screw, a physical medical device, and the submission focuses on its material, dimensions, and mechanical performance compared to a predicate device.

Therefore, the requested information regarding acceptance criteria, reported performance, sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details are not applicable to this specific submission.

The document describes non-clinical performance testing for a physical device, primarily focusing on mechanical and biocompatibility aspects, as well as sterilization:

1. A table of acceptance criteria and the reported device performance:

The document describes performance testing conducted according to recognized standards, rather than providing a table of specific acceptance criteria and reported performance values. The objective of these tests is to demonstrate substantial equivalence to the predicate device.

Test Type	Standard Applied
Torsion Test	ISO 19023:2018, "Dentistry – Orthodontic Anchor Screws" & ASTM F543-17, "Standard Specification and Test Methods for Metallic Medical Anchor Screw"
Torque Test	ISO 19023:2018, "Dentistry – Orthodontic Anchor Screws" & ASTM F543-17, "Standard Specification and Test Methods for Metallic Medical Anchor Screw"
Pull-out Test	ISO 19023:2018, "Dentistry – Orthodontic Anchor Screws" & ASTM F543-17, "Standard Specification and Test Methods for Metallic Medical Anchor Screw"
Biocompatibility	ISO 10993-1:2018, ISO 7405:2018, ISO 10993-5:2009, ISO 10993-10:2010, ISO 10993-23:2021, ASTM F543-17
Sterilization	ISO 17665-1:2006, ISO/TS 17665-2:2009, AAMI/ANSI ST79:2017
MRI Compatibility	Scientific rationale and published literature (Woods, Terry O., et al., 2019)

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

The document does not specify sample sizes for the mechanical tests, nor does it provide details on data provenance as these are physical device tests, not clinical data sets. The tests are "nonclinical," meaning they were conducted in a laboratory setting.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

Not applicable. Ground truth, in the context of expert review, is not relevant for the mechanical and biocompatibility testing of a physical medical device.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. Adjudication methods are typically used for establishing ground truth in clinical imaging or diagnostic studies, which is not the nature of the tests described here.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This type of study is relevant for AI-assisted diagnostic devices, not for a physical orthodontic screw.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. The T-FIT is a physical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable. The "ground truth" for mechanical testing would be the physical properties measured under standardized conditions, and for biocompatibility, it would be the results from specified biological assays and tests against established safety limits for materials.

8. The sample size for the training set:

Not applicable. The T-FIT is a physical device; there is no "training set" in the context of machine learning.

9. How the ground truth for the training set was established:

Not applicable.

Summary

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Image /page/0/Picture/0 description: The image contains 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 the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 08, 2024

Techwin Co., Ltd. % Kyung-hwan Kim Representative Consultant SMB Korea #606, #607, 7, Boramae-ro 5ga-gil Donjak-gu Seoul, 07071 REPUBLIC OF KOREA

Re: K231913

Trade/Device Name: T-FIT Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous dental implant Regulatory Class: Class II Product Code: OAT Dated: January 9, 2024 Received: January 9, 2024

Dear Kyung-hwan Kim:

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 (the 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 available 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products: and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

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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,

Sherrill Lathrop Blitzer

for Andrew Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number K231913

Device Name T-FIT

Indications for Use (Describe)

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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TECHWIN Co., Ltd. Traditional 510(k) Premarket Submission T-FIT

Image /page/4/Picture/2 description: The image shows the logo for SMB Korea. The logo is in gray and features the text "SMB Korea" in a sans-serif font. Below the text is the tagline "A Member of the Consulting Expert Group" in a smaller font. A curved line extends from the bottom of the "S" in SMB to the top of the "K" in Korea.

510(k) Summary

For

T-FIT

[Complying with 21 CFR 807.92]

I. SUBMISSION SPONSOR

TECHWIN Co., Ltd. #401, Eungyenam-gil 40, Siheung-si, Gyeonggi-do, Republic of Korea Office Phone: +82-31-365-5601 Email: tw rnd@techwinkorea.com Contact Person: Mr. Min-jae Jo, QMR

II. SUBMISSION CORRESPONDENT

SMB Korea #606, #607, 7, Boramae-ro 5ga-gil, Donjak-gu, Seoul, 07071, Republic of Korea Cell Phone: +82-10-2247-5579 Office Phone: +82-6241-9001 Kyung-hwan Kim, Representative Consultant, RA/QA Contact: Email: info@smbkorea.com

III. DATE PREPARED

February 7, 2024

IV. DEVICE

Trade or Proprietary Name:	T-FIT
Common or Usual Name:	Orthodontic Anchorage Screw
Classification Name:	Endosseous dental Implant (872.3640)
Regulatory Class:	II
Product Code:	OAT
Classification Panel:	Dental

V. PREDICATE DEVICE

K161335, Dual Top Screw System for orthodontic anchor / Jeil Medical Corporation

VI. DEVICE DESCRIPTION

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TECHWIN Co., Ltd. Traditional 510(k) Premarket Submission T-FIT

Image /page/5/Picture/1 description: The image shows the logo for SMB Korea. The logo consists of the letters "SMB" in a bold, sans-serif font, with a stylized swoosh extending from the bottom of the "M" to the top of the "B". To the right of "SMB" is the word "Korea" in a similar font, but slightly smaller. Below the logo is the tagline "A Member of the Consulting Expert Group" in a smaller, lighter font.

Thread lengths of 12.0 mm and 14.0 mm are only available with Ø2.0 mm diameter models. All screws are manufactured from Ti-6Al-4V ELI titanium alloy (ASTM F 136-13). The T-FIT is provided non-sterile and is intended for single use only. Additionally, the T-FIT is designed to be used with commonly available dental surgical instruments.

VII. INDICATION FOR USE

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE VIII. DEVICE

	Primary PREDICATEDevice (K161335)	SUBJECT Device	Significant Difference
Manufacturer	Jeil MedicalCorporation	TECHWIN Co., Ltd.	-
Trade Name	Dual Top Screw System	T-FIT	-
Regulation Description	Endosseous dentalimplant	Endosseous dentalimplant	Same
Regulation Number	21 CFR 872.3640	21 CFR 872.3640	Same
Product Code	OAT	OAT	Same
Class	II	II	Same
Indications for Use	The Dual Top ScrewSystem is intended foruse as a temporaryanchor for orthodontictreatment for use inpatients aged 12 andolder.	The T-FIT is designed toprovide a fixedanchorage point forattaching orthodonticappliances, facilitatingthe orthodonticmovement of teeth. Itis used temporarily andremoved uponcompletion of theorthodontic treatmentfor use in patients aged12 and older. Thescrews are intendedfor single use only.	Difference: Althoughthe phrasing of theindication for use ofthe subject devicediffers slightly fromthat of the primarypredicate, thefundamental indicationremains the same.
Principle of Operation	Orthodontic anchorage	T-FIT is inserted into	Same
	Primary PREDICATEDevice (K161335)	SUBJECT Device	Significant Difference

	screw is inserted intojaw and palatal to helpthe orthodontist movethe correct teeth andstop the wrong teethfrom moving in thewrong direction.	either jaw to help theorthodontist move thecorrect teeth and stopthe wrong teeth frommoving in the wrongdirection.
Raw material	Ti-6Al-4V ELI TitaniumAlloy (ASTM F 136)	Ti-6Al-4V ELI TitaniumAlloy (ASTM F 136)	Same
Form	OrthodonticAnchorage Screw	OrthodonticAnchorage Screw	Same
Head Structure	[JA]Image: Screw JA	[TA]Image: Screw TA	Difference: The headshape design of thesubject device differsslightly from that ofthe predicate device.
	[JF]Image: Screw JF	[TB]Image: Screw TB
	[JB]Image: Screw JB	[TG]Image: Screw TG
	[G1]Image: Screw G1	[TS]Image: Screw TS
	[G2]Image: Screw G2
	[JK]Image: Screw JK
	[JD]Image: Screw JD
	[MIM]Image: Screw MIM
	Primary PREDICATEDevice (K161335)	SUBJECT Device	Significant Difference

Image: [JS]
Thread Diameter ×Length	Length: 5.0 mm to 16.0 mmDiameter: Ø1.3 mm toØ2.5 mm	Diameter by thread length:Ø1.4 mm × 6.0 mm to10.0 mmØ1.6 mm × 6.0 mm to10.0 mmØ1.8 mm × 6.0 mm to10.0 mmØ2.0 mm × 6.0 mm to14.0 mm	Difference: The diameter and length of the design of the subject device differ slightly from those of the predicate device, but they are within the range of the predicate device.
Surface Treatment	Anodized	No surface treatment	Difference: The subject device has no surface treatment. Although this is different from the predicate device, this does not impact performance as demonstrated by bench testing.
Sterilization	Non-Sterile (Steam sterilized by user) orGamma-Sterilized	Non-Sterile (Steam sterilized by user)	Same
Single Use/Reuse	Single use Only	Single use Only	Same
Biocompatibility	Biocompatibleaccording to ISO10993-1	Biocompatibleaccording to ISO10993-1	Same
Performance Testing	ASTM F543-17	ASTM F543-17	Same

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Image /page/6/Picture/1 description: The image shows the logo for SMB Korea. The logo is in gray and features the text "SMB Korea" in a stylized font. Below the text is the phrase "A Member of the Consulting Expert Group" in a smaller font. A curved line extends from the bottom of the "S" in SMB, adding a dynamic element to the logo.

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Image /page/7/Picture/1 description: The image shows the logo for SMB Korea. The logo is in gray and features the text "SMB Korea" in a stylized font. Below the text, there is a tagline that reads "A Member of the Consulting Expert Group" in a smaller font. A curved line extends from the bottom of the "S" in SMB, adding a dynamic element to the logo.

The information provided in these 510(k) submissions demonstrates that the T-FIT is substantially equivalent to the predicate devices in terms of indications for use, function, and performance related to technological characteristics. The predicate device is made of the same material as the subject device, Ti-6Al-4V ELI titanium alloy (ASTM F 136-13). The differences between the subject and predicate devices are not expected to affect the overall performance of the device.

There are slight differences in the diameter, length, and head shape of the design between the subject and predicate devices. However, the screw diameter and length range of the subject device fall within the range of the predicate devices, and the differences in head design are minor and do not introduce significant differences in design. The technological differences between the subject device and predicate device do not raise questions of safety or effectiveness, and substantial equivalence is

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TECHWIN Co., Ltd. Traditional 510(k) Premarket Submission T-FIT

Image /page/8/Picture/1 description: The image shows the logo for SMB Korea. The logo is in gray and consists of the text "SMB Korea" in a sans-serif font. Below the text is the tagline "A Member of the Consulting Expert Group" in a smaller font. A curved line extends from the left side of the "S" in SMB, arching over the letters and ending near the "K" in Korea.

demonstrated through testing in accordance with ISO 19023 and ASTM F543, as described below:

	Subject device	Primary predicate (K161335)
Torsion	Ø1.4 mm × 10.0 mm	Ø1.4 mm × 10.0 mm
Torque	Ø2.0 mm × 14.0 mm	Ø2.0 mm × 10.0 mm
Pull-out	Ø1.4 mm × 6.0 mm	Ø1.4 mm × 6.00 mm

Based on the information provided above, the T-FIT is determined to be substantially equivalent (SE) to the predicate device.

IX. NONCLINICAL TEST

The following performance data were provided in support of the substantial equivalence determination.

Mechanical Testing

The following tests were conducted on the T-FIT in accordance with ISO 19023:2018, "Dentistry – Orthodontic Anchor Screws", and ASTM F543-17, "Standard Specification and Test Methods for Metallic Medical Anchor Screw", to demonstrate substantial equivalence in terms of safety and efficacy with the predicate device:

Torsion Test
Torque (Insertion/fracture) Test
Pull-out Test

Biocompatibility

The biocompatibility evaluation for the T-FIT was conducted in accordance with the FDA guidance document titled "Use of International Standard ISO 10993-1, Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process" and the following standards, as recognized by the FDA:

ISO 7405:2018, Dentistry Evaluation of biocompatibility of medical devices used in dentistry
ISO 10993-1:2018, Biological evaluation of medical devices Part 1: Evaluation and testing
ISO 10993-5:2009, Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity
ISO 10993-10:2010, Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
ISO 10993-23:2021, Biological evaluation of medical devices Part 23: Tests for irritation
ASTM F543-17, Standard Specification and Test Methods for Metallic Medical Bone Screws

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Image /page/9/Picture/1 description: The image shows the logo for SMB Korea. The logo is in gray and features the text "SMB Korea" in a sans-serif font. Below the text is the tagline "A Member of the Consulting Expert Group" in a smaller font. A curved line extends from below the "S" in SMB to above the "K" in Korea.

Sterilization Testing

Sterilization validation testing was conducted in accordance with the following standards: ISO 17665-1:2006, "Sterilization of Health Care Products - Moist Heat - Part 1: Requirements for the Development, Validation, and Routine Control of a Sterilization Process for Medical Devices"; ISO/TS 17665-2:2009, "Sterilization of Health Care Products – Moist Heat – Part 2: Guidance on the Application of ISO 17665-1"; and AAMI/ANSI ST79:2017, "Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities". These standards were referenced from K161335.

A non-clinical worst-case MRI review was performed to evaluate the subject device components in the MRI environment using scientific rationale and published literature (e.g., Woods, Terry O., Jana G. Delfino, and Sunder Rajan. "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices." Journal of Testing and Evaluation 49.2 (2019): 783-795), based on the entire system including all variations and material composition. The rationale addresses recommended parameters for MR Conditional devices according to the FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment", including magnetically induced displacement force and torque.

X. CLINICAL TESTS

No clinical performance data were provided to demonstrate substantial equivalence.

XI. CONCLUSIONS

The T-FIT has been compared to the predicate device with regard to substantial equivalence. The information provided in this premarket notification demonstrates that the subject device is determined to be substantially equivalent (SE) to the predicate device.

Regulation Number and Section

§ 872.3640 Endosseous dental implant.

(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.