(58 days)
No
The summary describes a digital dental x-ray sensor that converts photons to a digital signal for transfer to a computer and compatible software. There is no mention of AI or ML being used in the sensor itself or the described functionality. The compatible software is listed but not described as having AI/ML capabilities.
No.
The device is described as collecting and converting dental x-ray photons into electronic impulses for diagnostic use, not for treating or preventing a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the electronic impulses from the collected dental x-ray photons "may be stored, viewed, and manipulated for diagnostic use by dentists." This indicates that the device outputs information directly used in diagnostics.
No
The device description clearly states it is an "Intraoral Digital Imaging Sensor" that employs CMOS, optical fiber, and a scintillator to convert x-ray photons into a digital signal. This involves physical hardware components, not just software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: This device is a dental sensor that captures X-ray images of the human mouth and its structures. It converts X-ray photons into digital signals for viewing and manipulation.
- No Specimen Analysis: The device does not analyze any biological specimens taken from the patient. It directly interacts with the patient's body (inside the mouth) to capture an image.
Therefore, based on the provided information and the definition of an IVD, this dental sensor is not an In Vitro Diagnostic device. It is a medical imaging device.
N/A
Intended Use / Indications for Use
Dental Sensors, models Tuxdeluxe, 6100B-Size 1, and 6101B-Size 2 are intended to collect dental x-ray photons and convert them into electronic impulses that may be stored, viewed, and manipulated for diagnostic use by dentists. This device must only be used in hospital environments, clinics or dental offices by trained and qualified dental personnel, and not used in the oxygen rich environment. This device is suitable for providing dental radiography imaging for both adult and pediatric patients.
Product codes
MUH
Device Description
This Intraoral Digital Imaging Sensor employs CMOS (Complementary Metal-Oxide-Semiconductor), protective optical fiber and scintillator. This sensor was developed to obtain a high-quality x-ray image from the human mouth and its structures. The acquisition process is made by positioning the sensor inside the mouth, behind the structure you want to perform the exam. The structure must be exposed to an x-ray dose using an external source. Once exposed, the sensor performs a conversion of the x-ray photons into a digital signal and transfers it to a computer through USB connection (Universal Serial Bus). The x-ray generator (an integral part of a complete dental x-ray system) is not part of the device. Device sensor sizes:
Size 1: 24.1 x 36.2 x 5.9mm Size 2: 30.5 x 42.8 x 5.7mm
The I/O sensor is compatible with the following cleared software: Xray Vision / XV Capture (XV Web) / Curve / Sota. This software must be purchased separately by the end user.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray photons
Anatomical Site
human mouth and its structures
Indicated Patient Age Range
both adult and pediatric patients
Intended User / Care Setting
hospital environments, clinics or dental offices by trained and qualified dental personnel
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
Non-clinical Testing Performed: Safety, EMC, Biocompatibility and Performance Data
Safety testing: Electrical, mechanical, environmental safety and performance testing according to standards:
SAFETY TEST ACCORDING TO THE STANDARDS IEC 60601-1: 2005 + CORR. 1:2006 + CORR. 2:2007 + AM1:2012 (or IEC 60601-1: 2012 reprint) and EN 60601-1:2006+ A1:2013 + A12:2014, Recognition #19-49
ELECTROMAGNETIC COMPATIBILITY TESTS according to the standards: IEC 60601-1-2 Ed4.0 (2014) EN 60601-1-2 Ed4.0 (2015) Recognition 19-36 with a declaration of conformity to IEC TR 60601-4-2 Medical electrical equipment – Part 4-2: Guidance and interpretation – Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems Recognition 19-19.
USABILITY ACCORDING TO THE STANDARDS IEC 60601-1-6:2010 (Third Edition) + A1:2013 and EN 60601-1-6:2010 +A1:2015 Recognition 5-89
Verification of degrees of protection IP68 provided by the enclosure according to the standards IEC 60529: 2013 and NF EN 60529: 1992 + A1: 2000 + A2: 2014
Successful operation has been demonstrated with these previously cleared dental imaging software packages: XrayVision K983111 XVCapture/XVWeb K983111 Curve K110139 Sota K210682
Risk analysis was conducted. All test results were satisfactory. Cybersecurity concerns were addressed via labeling. We also had an image quality analysis performed by a USA Board Certified Dentist who reviewed the proposed device images. He concluded that the images are of good quality, clinically acceptable, and suitable for the intended use.
Clinical testing is not required for a finding of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K983111, K983111, K110139, K210682, K160232
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.1800 Extraoral source x-ray system.
(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is the Department of Health & Human Services logo, and on the right, there is the FDA logo. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".
October 20, 2023
Tuxedo Imaging LLC % Mr. Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Ct NAPLES FL 34114
Re: K232552
Trade/Device Name: Tuxdeluxe (Size 1 6100B, Size 2 6101B) Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: Class II Product Code: MUH Dated: August 20, 2023 Received: August 23, 2023
Dear Mr. Daniel Kamm:
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.
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).
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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 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,
Lu Jiang
Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K232552
Device Name Tuxdeluxe (Size 1 6100B, Size 2 6101B)
Indications for Use (Describe)
Dental Sensors, models Tuxdeluxe, 6100B-Size 1, and 6101B-Size 2 are intended to collect dental x-ray photons and convert them into electronic impulses that may be stored, viewed, and manipulated for diagnostic use by dentists. This device must only be used in hospital environments, clinics or dental offices by trained and qualified dental personnel, and not used in the oxygen rich environment. This device is suitable for providing dental radiography imaging for both adult and pediatric patients.
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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510(k) Summary K232552 Tux Deluxe Intraoral Dental Digital Imaging Sensors
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 872.1800. Date prepared: September 18, 2023
1. Company and Correspondent making the submission:
Tuxedo Imaging, LLC 313 S. High Street, Suite 200 Akron, OH 44308 Contact: Patrick Williams, President, Tel 330 382-5733
2. Trade /Proprietary Names: Tuxdeluxe (Size 1 6100B, Size 2 6101B)
Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: Class II Product Code: MUH
3. Legally Marketed Predicate Device Information: K220422
| Manufacturer: | iRay Technology Taicang Ltd. |
|---|---|
| Trade/Device Name: | Dental Sensors NanoPix1, NanoPix2 |
| Regulation Number: | 21 CFR 872.1800 |
| Regulation Name: | Extraoral source x-ray system |
| Regulatory Class: | Class II |
| Product Code: | MUH |
4. Description:
This Intraoral Digital Imaging Sensor employs CMOS (Complementary Metal-Oxide-Semiconductor), protective optical fiber and scintillator. This sensor was developed to obtain a high-quality x-ray image from the human mouth and its structures. The acquisition process is made by positioning the sensor inside the mouth, behind the structure you want to perform the exam. The structure must be exposed to an x-ray dose using an external source. Once exposed, the sensor performs a conversion of the x-ray photons into a digital signal and transfers it to a computer through USB connection (Universal Serial Bus). The x-ray generator (an integral part of a complete dental x-ray system) is not part of the device. Device sensor sizes:
Size 1: 24.1 x 36.2 x 5.9mm Size 2: 30.5 x 42.8 x 5.7mm
The I/O sensor is compatible with the following cleared software: Xray Vision / XV Capture (XV Web) / Curve / Sota. This software must be purchased separately by the end user.
5. Indications for use:
Dental Sensors, models Tuxdeluxe, 6100B-Size 1, and 6101B-Size 2 are intended to collect dental x-ray photons and convert them into electronic impulses that may be stored, viewed, and manipulated for diagnostic use by dentists. This device must only be used in hospital environments, clinics or dental offices by trained and qualified dental personnel, and not used in the oxygen rich environment. This device is suitable for providing dental radiography imaging for both adult and pediatric patients
4
6. Comparison with predicate device:
The new devices Tuxdeluxe Sensors (and its predicate) are small digital imaging receptors that may be used in place of dental x-ray film.
Predicate sensor sizes: Size 1: 25 x 38.5 mm , Size 2: 31 x 40 mm Subject device sensor sizes: Size 1: 24.1 x 36.2 mm Size 2: 30.5 x 42.8. mm
The images are displayed on a computer workstation. The technologies employed by the predicate and our new device are almost identical. The proposed sensors have greater resolution than the predicate via smaller pixel size and greater numbers of total pixels. The same sensor sizes are available, and the computer interface is the same (USB). Both sensors use CMOS technology. Similarities: Indications for Use, available sizes, USB interface, CMOS technology employed. Differences: New device has greater resolution via smaller pixel size and greater number of pixels. The sensor sizes are nearly identical. A comparison table follows:
| PRODUCT | K220422 Trade/Device Name: Dental
Sensors NanoPix1, NanoPix2 | Tuxdeluxe Intraoral Dental Digital
Imaging Sensor |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications
for use | Dental Sensors, models NanoPix1 and
NanoPix2 are intended to collect dental xray
photons and convert them into electronic
impulses that may be stored, viewed, and
manipulated for diagnostic use by dentists.
This device must only be used in hospital
environments, clinics or dental offices by
trained and qualified dental personnel, and
not used in the oxygenrich environment.
This device is suitable for providing dental
radiography imaging for both adult
and pediatric. | Dental Sensors, models Tuxdeluxe, 6100B-Size
1, and 6101B-Size 2 are intended to collect
dental x-ray photons and convert them into
electronic impulses that may be stored,
viewed, and manipulated for diagnostic use by
dentists. This device must only be used in
hospital environments, clinics or dental offices
by trained and qualified dental personnel, and
not used in the oxygenrich environment. This
device is suitable for providing dental
radiography imaging for both adult and
pediatric patients. SAME |
| Where Used | Clinics, hospitals, dental offices | SAME |
| Operating
Temperature
Range | 10°C to 30°C | +5°C to +35°C
Greater operating temperature range. |
| Supply Voltage | +5 Vdc (USB) | +5 Vdc (USB) |
| Technology | CMOS | CMOS |
| Contrast | 12 bits | 12 bits |
| Gray Level | 4096 | 4096 |
| Pixel Size | 20 μm | 14 μm |
| Number of pixels | Size 1 1000 x 1500
Size 2 1300 x 1800 | Size 1: 1404 x 2104 pixels
Size 2: 1852 x 2574 pixels |
| Line pairs/mm | 16 Line pairs/mm | 35 Line pairs/mm |
| MTF | 0.1 at 12.5lp/mm | 0.095 at 12.5lp/mm (Essentially the same) |
| PRODUCT | K220422 Trade/Device Name: Dental
Sensors NanoPix1, NanoPix2 | Tuxdeluxe Intraoral Dental Digital
Imaging Sensor |
| DQE | DQE @ RQA5: >61.3% @ 0 lp/mm | DQE @ RQA5: >65% @ 0 lp/mm |
| Active Sensor
Area | Size 1: 25 x 38.5 mm ,
Size 2: 31 x 40 mm | Size 1: 24.1 x 36.2 mm
Size 2: 30.5 x 42.8. mm
SIMILAR |
| Imaging Software | NanoPix included | Not included. Compatibility verified with
these previously cleared software packages:
XrayVision K983111
XVCapture/XVWeb K983111
Curve K110139
Sota K210682 |
| Target Computer
System Type | Windows with USB | SAME |
| Connection type | USB 2 or 3 | SAME |
| Cable Length | 10 ft. | 2 or 3 m (6 ft or 9 ft) SIMILAR |
| Patient
Protection | Single Use Patient Protective Barrier, FDA
ckeared | Single Use Patient Protective Barrier, FDA
ckeared SAME |
| Photo | Image: NanoPix 1 and NanoPix 2 | Image: Tuxdeluxe Intraoral Dental Digital Imaging Sensor |
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- Non-clinical Testing Performed: Safety, EMC, Biocompatibility and Performance Data: Safety testing: Electrical, mechanical, environmental safety and performance testing according to standards:
SAFETY TEST ACCORDING TO THE STANDARDS IEC 60601-1: 2005 + CORR. 1:2006 + CORR. 2:2007 + AM1:2012 (or IEC 60601-1: 2012 reprint) and EN 60601-1:2006+ A1:2013 + A12:2014, Recognition #19-49
- Non-clinical Testing Performed: Safety, EMC, Biocompatibility and Performance Data: Safety testing: Electrical, mechanical, environmental safety and performance testing according to standards:
ELECTROMAGNETIC COMPATIBILITY TESTS according to the standards: IEC 60601-1-2 Ed4.0 (2014) EN 60601-1-2 Ed4.0 (2015) Recognition 19-36 with a declaration of conformity to IEC TR 60601-4-2 Medical electrical equipment – Part 4-2: Guidance and interpretation – Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems Recognition 19-19. USABILITY ACCORDING TO THE STANDARDS IEC 60601-1-6:2010 (Third Edition) + A1:2013 and EN 60601-1-6:2010 +A1:2015 Recognition 5-89
6
Verification of degrees of protection IP68 provided by the enclosure according to the standards IEC 60529: 2013 and NF EN 60529: 1992 + A1: 2000 + A2: 2014
The main patient contact material is the FDA cleared barrier sheath (K160232, Disposable Barrier Sleeves and Covers), not supplied by us.
Successful operation has been demonstrated with these previously cleared dental imaging software packages: XrayVision K983111 XVCapture/XVWeb K983111 Curve K110139 Sota K210682 The user must purchase one of these software programs separately.
Risk analysis was conducted. All test results were satisfactory. Cybersecurity concerns were addressed Reference: Content of Premarket Submissions for Management of Cybersecurity in via labeling. Medical Devices. We also had an image quality analysis performed by a USA Board Certified Dentist who reviewed the proposed device images. He concluded that the images are of good quality, clinically acceptable, and suitable for the intended use.
8. Clinical Testing Performed: Clinical testing is not required for a finding of substantial equivalence.
-
- Conclusions: Our conclusions drawn from the nonclinical tests (discussed above) are that we have demonstrated that the proposed device is as safe, as effective, and performs as well as or better than the legally marketed predicate device identified according to 807.92(b)(3), 57 FR 18066, Apr. 28, 1992, as amended at 59 FR 64295, Dec. 14, 1994, According to the Federal Food, Drug and Cosmetic Law, 21 CFR Part 872. Based on the information provided in this pre-marketing notification, Tuxedo Imaging, LLC concludes that Intraoral Dental Digital Imaging Sensor is safe and effective and substantially equivalent to predicated devices, as described in this document.