(182 days)
Not Found
No
The description focuses on optical and electronic components for image capture and display, with no mention of AI/ML for image analysis or interpretation. The software provides controls for illumination and image capture but does not describe any automated analysis or detection features that would typically involve AI/ML.
No
The device is described as a "diagnostic aid for viewing the interproximal areas of dental anatomy to detect and monitor the progression of proximal carious lesions." It is used for visualization and detection, not for treating or preventing disease.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that "The TIA Tip is a diagnostic aid for viewing the interproximal areas of dental anatomy to detect and monitor the progression of proximal carious lesions above the gingiva." This clearly indicates its role in diagnosis.
No
The device description explicitly states that the system consists of a Dental Scanner, the TIA Tip, and a Computer with Software. The scanner and TIA Tip are described as hardware components with electrical and opto-mechanical parts, LEDs, and a mirror. The software is part of a larger system that includes significant hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The TIA Tip and the associated system are used for direct visualization of dental anatomy in situ (within the patient's mouth) using transillumination and color imaging. It does not analyze samples taken from the body.
- Intended Use: The intended use is to aid in viewing and detecting/monitoring proximal carious lesions above the gingiva through imaging, not through the analysis of biological samples.
- Device Description: The description details an optical imaging system that captures light reflected or transmitted through the tooth. There is no mention of sample collection or analysis.
Therefore, while it is a diagnostic aid, it falls under the category of medical devices used for imaging and visualization, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The TIA Tip is a diagnostic aid for viewing the interproximal areas of dental anatomy to detect and monitor the progression of proximal carious lesions above the gingiva.
Product codes (comma separated list FDA assigned to the subject device)
NTK
Device Description
The TIA Tip is an optional interchangeable component tip assembly that works with the Dental CAD/CAM System Scanner. With the TIA Tip installed the system allows for the simultaneous side by side visualization of live transilluminated and color imaging of the patient's dental anatomy, as well as providing the user with the ability to capture and save transilluminated static images to a patient digital file. The system consists of:
- Dental Scanner .
- TIA Tip ●
- Computer with Software ●
With one of the other provided interchangeable scanning tips installed, the system is also used to process dental restorations that are regulated under 21 CFR 872.3661, Optical Impression Systems for CAD/CAM of Dental Restorations.
The Scanner is a hand-held electronic device that consists of three parts: the scanner body, the TIA Tip and a custom USB data cable that connects the scanner to the computer. The scanner contains the electrical and opto-mechanical components.
The USB cable uses industry standard USB 3.0 type-A and type-C connectors, and the cable assembly is detachable making it easily replaceable.
The TIA tip must be connected to the scanner to work. It incorporates two "probes" containing Light Emitting Diodes (LEDs) that emit 727nm near infrared light.
In operation the probes conform to dental anatomy to direct light into the desired area of inspection. The light penetrates the tooth surface due to the translucent nature of dental anatomy. This allows a user to visualize the inner structure of the tooth and specifically to detect irreqularities like caries that show up as dark areas or spots on the transilluminated image. The scattering light of the illuminated anatomy is reflected by the tip mirror and directed toward the camera in the scanner which allows for a digital image to be captured.
The tooth is illuminated with light from both the scanner's laser projection system (RGB) and the TIA Tip LED's. Timing of the light is controlled through the electronics and is divided into separate frames. Collecting and presenting these images at many frames per second allows simultaneous "live" views of transilluminated image and full color view to the system operator. This allows the user to better visualize caries that cannot be detected with standard color imaging. For example, a proximal dental cavity becomes visible as a dark region in the transilluminated image.
The software will also allow for the capture of static images throughout the inspection process if the user wishes to document an area of interest and show the patient to discuss treatment options.
The software operates on a laptop or desktop pc. A network connection is required for interoperability.
When the TIA Tip is installed, it is automatically detected by the scanner and the operator is presented with both a transilluminated view and a live view simultaneously. The operator is provided with controls on the scanner to start/stop and toggle TIA illumination from Both/Right/Left LEDs to enhance TIA viewing. Additionally, on screen controls allow for TIA illumination intensity control for further TIA view optimization. Image capture of simultaneous TIA and live view images is provided which can be used for later reference. No digitization occurs during TIA viewing.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Transillumination; Visible Light (Laser projection system)
Anatomical Site
interproximal areas of dental anatomy, tooth, gingiva
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Dentist
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)
The TIA Tip was evaluated to demonstrate substantial equivalence based on similar performance to the predicate device, the CamX Triton HD Proxi. Key performance attributes tested and compared include:
- a. LED illumination and output power
- b. Image Quality
Validation and verification test results showed that the subject device and the predicate device are substantially equivalent, and that illumination and image quality of potential caries detection products are similar for both Duerr Dental AG's CamX Triton HD Proxi and E4D's TIA Tip.
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
§ 872.1745 Laser fluorescence caries detection device.
(a)
Identification. A laser fluorescence caries detection device is a laser, a fluorescence detector housed in a dental handpiece, and a control console that performs device calibration, as well as variable tone emitting and fluorescence measurement functions. The intended use of the device is to aid in the detection of tooth decay by measuring increased laser induced fluorescence.(b)
Classification. Class II, subject to the following special controls:(1) Sale, distribution, and use of this device are restricted to prescription use in accordance with § 801.109 of this chapter;
(2) Premarket notifications must include clinical studies, or other relevant information, that demonstrates that the device aids in the detection of tooth decay by measuring increased laser induced fluorescence; and
(3) The labeling must include detailed use instructions with precautions that urge users to:
(i) Read and understand all directions before using the device,
(ii) Store probe tips under proper conditions,
(iii) Properly sterilize the emitter-detector handpick before each use, and
(iv) Properly maintain and handle the instrument in the specified manner and condition.
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 and 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 29, 2022
D4D Technologies, LLC Eddie Anderson Regulatory Affairs Manager 2920 Telecom Parkway, Suite 100 Richardson, Texas 75082
Re: K213482
Trade/Device Name: TIA Tip, Cariosity, Transillumination Accessory Tip Regulation Number: 21 CFR 872.1745 Regulation Name: Laser Fluorescence Caries Detection Device Regulatory Class: Class II Product Code: NTK Dated: March 30, 2022 Received: March 31, 2022
Dear Eddie Anderson:
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,
Michael E. Adjodha, M.ChE. 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
2
Indications for Use
510(k) Number (if known)
Device Name
TIA Tip, Cariosity, Transillumination Accessory Tip, P/N 156930xx
Indications for Use (Describe)
The TIA Tip is a diagnostic aid for viewing the interproximal areas of dental anatomy to detect and monitor the progression of proximal carious lesions above the gingiva.
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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3
Image /page/3/Picture/0 description: The image is a logo for E4D Technologies. The logo is a blue circle with a green plus sign in the middle. The circle is broken in four places. The text "E4D TECHNOLOGIES" is below the logo.
E4D TECHNOLOGIES
510(k) Summary-K213482
Sponsor / 510(k) Owner 5.1
D4D Technologies, LLC (dba E4D Technologies) 2920 Telecom Parkway, Suite 100 Richardson, Texas 75082 USA Main: 972-534-3101
Contact:
Eddie Anderson Regulatory Affairs Manager Direct: 972.534.3101 Email: eanderson@e4d.com
5.2 Date Summary Prepared:
March 16, 2022
5.3 Device Name
| Trade Name(s): | Cariosity; TIA Tip, Transillumination Accessory Tip |
|---|---|
| Common Name: | Caries Detector, Laser Light, Transmission |
| Classification Name: | Laser fluorescence caries detection device |
| Regulation Number: | 872.1745 |
| Product Code: | NTK |
| Device Class: | Class 2 |
| Medical Specialty: | Dental |
Predicate Device(s) 5.4
CamX Triton HD Proxi Head (K172007); Duerr Dental AG
5.5 Device Description
The TIA Tip is an optional interchangeable component tip assembly that works with the Dental CAD/CAM System Scanner. With the TIA Tip installed the system allows for the simultaneous side by side visualization of live transilluminated and color imaging of the patient's dental anatomy, as well as providing the user with the ability to capture and save transilluminated static images to a patient digital file. The system consists of:
- Dental Scanner .
- TIA Tip ●
- Computer with Software ●
With one of the other provided interchangeable scanning tips installed, the system is also used to process dental restorations that are regulated under 21 CFR 872.3661, Optical Impression Systems for CAD/CAM of Dental Restorations.
The Scanner is a hand-held electronic device that consists of three parts: the scanner body, the TIA Tip and a custom USB data cable that connects the scanner to the computer. The scanner contains the electrical and opto-mechanical components.
The USB cable uses industry standard USB 3.0 type-A and type-C connectors, and the cable assembly is detachable making it easily replaceable.
4
Image /page/4/Picture/0 description: The image shows the logo for E4D Technologies. The logo consists of a stylized letter "E" and "D" formed by a blue circle that is partially broken. Inside the circle, there is a green vertical bar and a horizontal bar that forms the letter "E" and "D". Below the logo, the text "E4D TECHNOLOGIES" is written in bold.
510(k) Summarv
The TIA tip must be connected to the scanner to work. It incorporates two "probes" containing Light Emitting Diodes (LEDs) that emit 727nm near infrared light.
In operation the probes conform to dental anatomy to direct light into the desired area of inspection. The light penetrates the tooth surface due to the translucent nature of dental anatomy. This allows a user to visualize the inner structure of the tooth and specifically to detect irreqularities like caries that show up as dark areas or spots on the transilluminated image. The scattering light of the illuminated anatomy is reflected by the tip mirror and directed toward the camera in the scanner which allows for a digital image to be captured.
The tooth is illuminated with light from both the scanner's laser projection system (RGB) and the TIA Tip LED's. Timing of the light is controlled through the electronics and is divided into separate frames. Collecting and presenting these images at many frames per second allows simultaneous "live" views of transilluminated image and full color view to the system operator. This allows the user to better visualize caries that cannot be detected with standard color imaging. For example, a proximal dental cavity becomes visible as a dark region in the transilluminated image.
The software will also allow for the capture of static images throughout the inspection process if the user wishes to document an area of interest and show the patient to discuss treatment options.
The software operates on a laptop or desktop pc. A network connection is required for interoperability.
When the TIA Tip is installed, it is automatically detected by the scanner and the operator is presented with both a transilluminated view and a live view simultaneously. The operator is provided with controls on the scanner to start/stop and toggle TIA illumination from Both/Right/Left LEDs to enhance TIA viewing. Additionally, on screen controls allow for TIA illumination intensity control for further TIA view optimization. Image capture of simultaneous TIA and live view images is provided which can be used for later reference. No digitization occurs during TIA viewing.
5.5.1. Scientific Concept
The underlying scientific concept is the use of transillumination, shining light through a body area or organ to check for abnormalities. The 727nm near IR LEDs in the TIA Tip illuminate the internal layers (enamel, dentin, pulp) of a tooth and the imaging sensor in the scanner captures the images in real time. The software displays the black and white 2D transillumination images on a computer screen as a live view and can also store the images for later use. A dentist can then use the images as an aid in the detection and monitoring of caries, or other abnormalities inside the tooth.
5.6 Indications for Use
The TIA Tip is a diaqnostic aid for viewing the interproximal areas of dental anatomy to detect and monitor the progression of proximal carious lesions above the gingiva.
5.7 Summary of technological characteristics / Substantial Equivalence Discussion
The following Table compares the Transillumination Accessory (TIA) Tip, P/N 156930xx to the predicate device with respect to indications for use, principles of operation, technological characteristics, materials, and performance testing. The comparison of the devices provides more detailed information regarding the basis for the determination of substantial equivalence.
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Image /page/5/Picture/0 description: The image shows the logo for E4D Technologies. The logo features a stylized design with blue and green elements, resembling a combination of the letters 'E' and 'D'. Below the logo, the text "E4D TECHNOLOGIES" is written in a simple, sans-serif font.
Sec510(k) Summary
Table 5A – Comparison of Characteristics
| Description | TIA Tip,
P/N 156930xx
K213482
(Subiect Device) | CamX Triton HD Proxi
Head
K172007
(Predicate Device) | Device Comparison |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | NTK | NTK | Same |
| Regulation Number | 872.1745 | 872.1745 | Same |
| Indications for Use | The TIA Tip is a diagnostic
aid for viewing the
interproximal areas of
dental anatomy to detect
and monitor the
progression of proximal
carious lesions above the
gingiva. | The CamX Triton HD Proxi
Head is a diagnostic aid for
the detection of
interproximal caries lesions
above the gingiva and for
monitoring the progress of
such lesions. | Equivalent – Proximal and
Interproximal are used
interchangeably. The
subject device and the
predicate device both use
transillumination to view
the same area of the dental
anatomy and for the same
purposes. The difference is
that when viewing from the
occlusal position, the
subject device projects
transilluminated light from
the buccal/linqual position
of the tooth whereas the
predicate device projects
the transilluminated light
from the occlusal position
of the teeth. |
| Design | Handheld device | Handheld device | Same |
| Functional Principle | Transillumination:
Based on the principle that
tooth enamel is translucent
to NIR light. If the light
transmission is interrupted
due to caries lesions a dark
area appears, in normal
mode. (Inverse CamX
Triton HD Proxi Head) | Transillumination:
It makes use of the tooth
structure which has the
ability of light transmission.
If the light transmission is
interrupted due to caries
lesions a bright area
appears. | Equivalent: Both use the
principle of
transillumination. The
difference is that the
predicate device indicates
the potential carious lesions
as bright spots and the TIA
Tip provides alternate
views in normal, inverted
and color. |
| Device Components | Handheld device with USB,
cable and software installed
on a computer. | Handheld device with USB,
cable and software installed
on a computer. | Same |
| Light Source | Two LEDs are used to
generate the exact
wavelength being
detectable by the CMOS
sensor. | Two LEDs are used to
generate the exact
wavelength being
detectable by the CMOS
sensor. | Same |
| Installation | The computer-based
installation enables the
customer to update the
software | The computer-based
installation enables the
customer to update the
software | Same |
| Power Source | USB-5V | USB-5V | Same |
| Compatibility | USB 3.0 connection | USB connection | Same |
| Compliance to Standards | IEC 60601-1 | IEC 60601-1 | Same |
| Description | TIA Tip,
P/N 156930xx
K213482
(Subject Device) | CamX Triton HD Proxi
Head
K172007
(Predicate Device) | Device Comparison |
| Cross Contamination
Control | Autoclave (tip of the
device)
The scanner body (operator
contact) is covered with an
FDA cleared disposable
sheath or barrier material. | Camera cover (single
patient disposable sheath,
K132953) is placed over
the distal
end, and an autoclave-able
spacer | The entire TIA Tip is
autoclavable whereas the
predicate device uses a
combination of a single
patient disposable sheath
together with an
autoclavable spacer. |
| Available Configurations | One Configuration:
Handpiece and proprietary
software. The handpiece
can be connected via USB
to a computer. | One Configuration:
Handpiece and proprietary
software. The handpiece
can be connected via USB
to a computer (customer
provided). | Same |
| Software | The software is a
computer-based software,
which is controlling:
- Show / display the
pictures - Store / save the pictures
- Live Stream (side by side
for transilluminated and
live color image)
– Controlling of camera
functions | The software is a
computer-based software,
which is controlling: - Show / display the
pictures - Store / save the pictures
- Live Stream
– Controlling of camera
functions | Equivalent – the TIA Tip
has the added feature of
being able to show the
transilluminated live image
and the color live view
images side by side,
whereas the predicate
device only displays the live
transilluminated image. |
| Intended Users | Dentist | Dentist | Same |
| Wavelength | 727 nm | 850 nm | the predicate device uses
LEDs with a slightly higher
wavelength. The higher
wavelength will naturally
penetrate better into the
tooth. However, this is
easily compensated for by
adjusting the driving
current for LEDs on the
subject device to achieve
optimal image quality. |
| Output Power | 2 LED Sources
(transillumination) – Max
3.74mW/cm2 (1.8-1.9
mW/cm² for each LED)
measured at the 3.845 mm
measuring distance
Laser (live color view) -
Max 1.12mW/cm² at
100mm measuring distance
through a 7mm aperture. | 2 LED sources - Max 2.00
mW/cm² at 7mm
measuring distance | Considering the difference
in measuring distance of
3.845 vs. 7mm, the LED
output power for TIA Tip
and CamX Triton are
almost the same as
measured in side-by-side
testing using the same
measurement equipment
and in the same test
environment.
The Laser power was
measured by TUV in report
7169004049-100. (See
page 17-480) |
| Description | TIA Tip,
P/N 156930xx
K213482
(Subject Device) | CamX Triton HD Proxi
Head
K172007
(Predicate Device) | Device Comparison |
| Illumination Type | Pulsed Illumination –
method of illumination that
consists of periodical light
source activation. I.e.
alternating ON(pulse)/OFF
states. | Continuous Illumination –
method of illumination in
which the source is
activated continuously. | The TIA Tip uses sequential
pulses of RBG laser light
and NIR LED light to
produce side by side
transillumination and color
live stream images. |
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Image /page/6/Picture/0 description: The image shows a circular logo with a combination of blue and green colors. The logo appears to be abstract, with the shapes suggesting a stylized representation of a cross or a plus sign within the circle. The design is modern and clean, with a small swoosh extending from the right side of the circle.
D4D Technologies, LLC 510 Trounnorogios, 220
Transillumination Accessory (TIA) Tip, P/N 156930xx
Traditional 510(k) - K213482/Supplement
E4D TECHNOLOGIES
510(k) Summary
7
Image /page/7/Picture/0 description: The image shows a logo for a company called "E4D TECHNOLOGIES". The logo is a stylized circle with a green plus sign in the middle. The circle is blue, and the plus sign is green. The company name is written in black letters below the logo. The logo is simple and modern, and it is likely intended to convey a sense of technology and innovation.
E4D TECHNOLOGIES
510(k) Summarv
5.8 Summary of Nonclinical Performance Testing
The TIA Tip was evaluated to demonstrate substantial equivalence based on similar performance to the predicate device, the CamX Triton HD Proxi. Key performance attributes tested and compared include:
- a. LED illumination and output power
- b. Image Quality
Validation and verification test results showed that the subject device and the predicate device are substantially equivalent, and that illumination and image quality of potential caries detection products are similar for both Duerr Dental AG's CamX Triton HD Proxi and E4D's TIA Tip. The TIA Tip complies with the following:
- . IEC 60601-1 Edition 3.1 - Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance
- . IEC 60601-1-2:2014 – Medical Electrical Equipment – Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests
- Sterilization validation was conducted in accordance with ISO 17665-1 Sterilization of Health . Care Products – Moist Heat-Part 1
- . Biocompatibility Testing in accordance with the reguired parts of the ISO 10993 series; derived from the ISO 10993-1, Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing
There are no known biocompatibility issues associated with any patient contact materials used to manufacture the TIA Tip. The assembled tip was tested and complies with ISO 10993-10 for Irritation and Delayed Hypersensitivity, and ISO 10993-5 for Cytotoxicity.
5.9 Summary of Clinical Testing
Clinical testing is not required and has not been performed.
5.10 Conclusion
A comparison of the indications for use, construction materials, and principle of operations, features and technical data show that the TIA Tip is safe and effective for its intended use. Evaluation of the minor technological differences between the subject device and the predicate do not raise any new issues of safety or effectiveness.
Based on similarities in indications for use and technological characteristics, together with results of non-clinical performance testing, it is concluded that the TIA Tip is substantially equivalent to the CamX Triton HD Proxi Head system.