(224 days)
Not Found
No
The 510(k) summary describes a purely mechanical device (orthodontic anchorage screws) and contains no mention of AI, ML, image processing, or data sets typically associated with AI/ML technologies.
Yes.
The device is designed to facilitate the orthodontic movement of teeth, which is a therapeutic treatment.
No
The device is an orthodontic appliance used for fixed anchorage to facilitate tooth movement, not for diagnosing conditions.
No
The device description clearly states it is a physical screw made of titanium alloy, intended for surgical implantation. It also describes physical dimensions and materials, and the performance studies are focused on mechanical and biocompatibility testing of a physical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide a fixed anchorage point for attaching orthodontic appliances to facilitate tooth movement. This is a mechanical function performed directly on the patient's body.
- Device Description: The device is a screw made of titanium alloy, designed for temporary implantation in the jaw and palate. This is a surgical implant, not a device used to examine specimens derived from the human body.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze samples (blood, urine, tissue, etc.) from the human body to provide information about a physiological state, health, disease, or congenital abnormality.
IVD devices are used in vitro (outside the body) to examine specimens. This device is used in vivo (inside the body) as a temporary implant.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
OAT
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
jaw and palatal
Indicated Patient Age Range
12 and older
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)
Nonclinical testing was conducted, including Mechanical Testing (Torsion Test, Torque (Insertion/fracture) Test, Pull-out Test) in accordance with ISO 19023:2018 and ASTM F543-17. Biocompatibility testing was performed according to ISO 10993-1, ISO 7405:2018, ISO 10993-5:2009, ISO 10993-10:2010, ISO 10993-23:2021, and ASTM F543-17. Sterilization validation testing was conducted per ISO 17665-1:2006, ISO/TS 17665-2:2009, and AAMI/ANSI ST79:2017. A non-clinical worst-case MRI review was performed. No clinical performance data were provided. The tests demonstrated substantial equivalence in terms of safety and efficacy.
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.
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
§ 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.
0
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.
1
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.
2
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
3
Indications for Use
510(k) Number K231913
Device Name T-FIT
Indications for Use (Describe)
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.
| 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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4
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
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.
5
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
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.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE VIII. DEVICE
| | Primary PREDICATE
Device (K161335) | SUBJECT Device | Significant Difference |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Jeil Medical
Corporation | TECHWIN Co., Ltd. | - |
| Trade Name | Dual Top Screw System | T-FIT | - |
| Regulation Description | Endosseous dental
implant | Endosseous dental
implant | 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 Screw
System is intended for
use as a temporary
anchor for orthodontic
treatment for use in
patients aged 12 and
older. | 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. | Difference: Although
the phrasing of the
indication for use of
the subject device
differs slightly from
that of the primary
predicate, the
fundamental indication
remains the same. |
| Principle of Operation | Orthodontic anchorage | T-FIT is inserted into | Same |
| | Primary PREDICATE
Device (K161335) | SUBJECT Device | Significant Difference |
| | | | |
| | screw is inserted into
jaw and palatal to help
the orthodontist move
the correct teeth and
stop the wrong teeth
from moving in the
wrong direction. | either jaw to help the
orthodontist move the
correct teeth and stop
the wrong teeth from
moving in the wrong
direction. | |
| Raw material | Ti-6Al-4V ELI Titanium
Alloy (ASTM F 136) | Ti-6Al-4V ELI Titanium
Alloy (ASTM F 136) | Same |
| Form | Orthodontic
Anchorage Screw | Orthodontic
Anchorage Screw | Same |
| Head Structure | [JA]
Image: Screw JA | [TA]
Image: Screw TA | Difference: The head
shape design of the
subject device differs
slightly from that of
the 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 PREDICATE
Device (K161335) | SUBJECT Device | Significant Difference |
| | | | |
| Image: [JS] | | | |
| Thread Diameter ×
Length | Length: 5.0 mm to 16.0 mm
Diameter: Ø1.3 mm to
Ø2.5 mm | Diameter by thread length:
Ø1.4 mm × 6.0 mm to
10.0 mm
Ø1.6 mm × 6.0 mm to
10.0 mm
Ø1.8 mm × 6.0 mm to
10.0 mm
Ø2.0 mm × 6.0 mm to
14.0 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) or
Gamma-Sterilized | Non-Sterile (Steam sterilized by user) | Same |
| Single Use/Reuse | Single use Only | Single use Only | Same |
| Biocompatibility | Biocompatible
according to ISO
10993-1 | Biocompatible
according to ISO
10993-1 | Same |
| Performance Testing | ASTM F543-17 | ASTM F543-17 | Same |
6
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.
7
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
8
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
9
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.