(57 days)
Not Found
No
The description explicitly states the software performs only basic image capture and transfer, and does not perform image manipulation or enhancements, which are common applications of AI/ML in medical imaging. There is no mention of AI, ML, or related terms.
No
The device is used for acquiring diagnostic images (radiographs) of dental intra-oral structures and does not provide any treatment or therapy.
No
The device is an x-ray sensor used to acquire dental intra-oral radiographic images. It captures images but does not perform image manipulation or provide a diagnosis itself. The images are then used by healthcare professionals for diagnostic purposes.
No
The device description explicitly states it is a "USB-driven digital sensor" and an "indirect converting x-ray detector" with "CMOS technology," indicating it is a hardware device that captures images. While it includes software and firmware, it is not solely software.
Based on the provided text, the DEXIS sensor is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "acquire dental intra-oral radiographic images." This is a medical imaging device used for diagnostic purposes in vivo (within the living body), not in vitro (outside the living body, typically on biological samples).
- Device Description: The description clearly states it's an "indirect converting x-ray detector" for "dental intra oral applications." It captures images generated by X-rays passing through the patient's mouth.
- Lack of IVD Characteristics: IVD devices typically involve analyzing biological samples (blood, urine, tissue, etc.) to provide information about a patient's health status. The DEXIS sensor does not interact with or analyze biological samples.
Therefore, the DEXIS sensor falls under the category of a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The DEXIS sensor is a USB- driven digital sensor which is intended to acquire dental intra- oral radiographic images. The DEXIS sensor shall be operated by healthcare professionals, who are educated and competent to perform the acquisition of dental intra-oral radiographs. The DEXIS sensor can be used either in combination with special positioning devices to facilitate positioning and aligmment with the x-ray beam or it may also be positioned by hand with the assistance of the patient.
Product codes (comma separated list FDA assigned to the subject device)
MUH
Device Description
The DEXIS Sensors are an indirect converting x-ray detector, e.g. incident x-rays are converted by a scintillating material into (visible) light, this light is coupled optically to a light detection imager based on CMOS technology. The design of the sensor assembly supports the automatic detection of the incident x-rays to generate digital images for dental intra oral applications. The DEXIS Sensors support USB2.0 and USB 3.x connectivity to personal computers using a dedicated electronic assembly and a sensor software driver. The software and firmware for the subject device are similar to the software and firmware for the predicate device and both have a Moderate level of concern. The software performs only basic functions of image capture and transfer to a computer. The software does not perform any medical image manipulation such as image enhancements as these are expected to be performed in the dental viewing software(s) used in conjunction with the subject device.
The subject device DEXIS sensor refers to the dental intra-oral detector. The x-ray generator (an essential component for a fullyfunctional dental x-ray system) is not part of the submission.
Mentions image processing
The software performs only basic functions of image capture and transfer to a computer. The software does not perform any medical image manipulation such as image enhancements as these are expected to be performed in the dental viewing software(s) used in conjunction with the subject device.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray
Anatomical Site
dental intra-oral
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare professionals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Testing Bench:
Non-Clinical performance bench testing according to international standards and FDA recognized consensus standards for Extraoral source x-ray system has been conducted to determine conformance in regards to:
• ANSI AAMI ES60601-1:2005/(R)2012 and A2:2012, C1:2009/(R)2012 (Consolidated Text); Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
• IEC 60601-1-2 Edition 4.0 2014-02; Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
v EC 60601-1-6 Edition 3.2 2020-07 CONSOLIDATED VERSION; Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
v IEC 62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION; Medical devices - Part 1: Application of usability engineering to medical devices
v EC 60601-2-65 Edition 1.1 2017-05 CONSOLIDATED VERSION; Medical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral-X-ray equipment
• IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION; Medical device software - Software life cycle processes
• ISO 10993-5 Third edition 2009-06-01; Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
v ISO 10993-10 Third Edition 2010-08-01; Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
• ISO 14971 Third Edition 2019-12; Medical devices - Application of risk management to medical devices
v EC 61223-3-4 First edition 2000-03; Evaluation and routine testing in medical imaging departments - Part 3-4: Acceptance tests -Imaging performance of dental X-ray
• EC /TR 60601-4-2 Edition 1.0 2016-05; Medical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems
Also, the subject device has an X-ray Resolution of 20+ visible lp/mm which meets the device specification. Furthermore, the MTF analysis indicates that maximum resolution of 22 lg/mm is achieved by the subject device specification.
Performance Testing Clinical:
Clinical data is not needed to characterize performance and establish substantial equivalence. The non-clinical test data characterize all performance aspects of the device based on well-established scientific and engineering principles. Clinical testing has not been conducted on this product.
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
§ 872.1800 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
November 21, 2023
Image /page/0/Picture/1 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Dental Imaging Technologies Corporation % Ms. Anuradha Moholkar Regulatory Affairs Specialist 450 Commerce Drive QUAKERTOWN, PA 18951
Re: K233053
Trade/Device Name: DEXIS Ti2 Intraoral Sensor, DEXIS IXS Size 1 Intraoral Sensor, DEXIS IXS Size 2 Intraoral Sensor Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: Class II Product Code: MUH Dated: September 25, 2023 Received: September 25, 2023
Dear Ms. Moholkar:
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).
1
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 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 (QS) 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,
Smita Kakar
for
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
Enclosure
2
Indications for Use
510(k) Number (if known) K233053
Device Name
DEXIS Ti2 Intraoral Sensor, DEXIS IXS Size 1 Intraoral Sensor, DEXIS IXS Size 2 Intraoral Sensor
Indications for Use (Describe)
The DEXIS sensor is a USB- driven digital sensor which is intended to acquire dental intra- oral radiographic images. The DEXIS sensor shall be operated by healthcare professionals, who are educated and competent to perform the acquisition of dental intra-oral radiographs. The DEXIS sensor can be used either in combination with special positioning devices to facilitate positioning and aligmment with the x-ray beam or it may also be positioned by hand with the assistance of the patient.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
| K233053 | 510(k) Summary | Prepared on: 2023-10-12 |
|---|---|---|
| Contact Details | 21 CFR 807.92(a)(1) | |
| Applicant Name | Dental Imaging Technologies Corporation | |
| Applicant Address | 450 Commerce Drive Quakertown PA 18951 United States | |
| Applicant Contact Telephone | 2678102911 | |
| Applicant Contact | Ms. Anuradha Moholkar | |
| Applicant Contact Email | anuradha.moholkar@envistaco.com | |
| Device Name | 21 CFR 807.92(a)(2) | |
| Device Trade Name | DEXIS Ti2 Intraoral Sensor; | |
| DEXIS IXS Size 1 Intraoral Sensor; | ||
| DEXIS IXS Size 2 Intraoral Sensor | ||
| Common Name | Extraoral source x-ray system | |
| Classification Name | System, X-Ray, Extraoral Source, Digital | |
| Regulation Number | 872.1800 | |
| Product Code | MUH | |
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) | |
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
| K172918 | DEXIS Titanium, KaVo IXS HD (Size 1, Size 2) | MUH |
| Device Description Summary | 21 CFR 807.92(a)(4) |
Device Description Summary:
The DEXIS Sensors are an indirect converting x-ray detector, e.g. incident x-rays are converted by a scintillating material into (visible) light, this light is coupled optically to a light detection imager based on CMOS technology. The design of the sensor assembly supports the automatic detection of the incident x-rays to generate digital images for dental intra oral applications. The DEXIS Sensors support USB2.0 and USB 3.x connectivity to personal computers using a dedicated electronic assembly and a sensor software driver. The software and firmware for the subject device are similar to the software and firmware for the predicate device and both have a Moderate level of concern. The software performs only basic functions of image capture and transfer to a computer. The software does not perform any medical image manipulation such as image enhancements as these are expected to be performed in the dental viewing software(s) used in conjunction with the subject device.
The subject device DEXIS sensor refers to the dental intra-oral detector. The x-ray generator (an essential component for a fullyfunctional dental x-ray system) is not part of the submission.
4
Intended Use/Indications for Use
The DEXIS sensor is a USB-driven digital sensor which is intraoral radiographic images. The DEXIS sensor shall be operated by healthcare professionals, who are educated and competent to perform the acquisition of dental intra-oral radio-graphs. The DEXIS sensor can be used either in combination with special positioning devices to facilitate positioning and alignment with the xray beam or it may also be positioned by hand with the assistance of the patient.
Indications for Use Comparison
The Indications for Use is identical to the Indications for Use of the predicate device.
Technological Comparison
DEXIS Ti 2, DEXIS IXS (Size 1, Size 2) design or technical features have not been significantly modified since its clearance in 2017 (Predicate Device K172918).
This section provides the substantial equivale for DEXIS Ti 2, DEXIS IXS (Size 1, Size 2) and the respective predicate device with regards to Indications for Use, Technology, and Performance Testing, the differences between the subject device and the predicate do not raise different questions of substantial equivalence.
Details of the similarities between subject and predicate devices:
The similarities between Subject Device are the Indications for Use as well as the Subject Device uses CMOS as Fundamental Technology which is same as the Predicate Device has same Sensor Exterior Dimensions and Sensor Active Imaging Area as the Predicate Device. Also, the of 19.5um, dynamic range, and Scintillator Technology for Subject Device is same as the Predicate Device.
At all points of MTF measurement (2, 5, 10, 15, 20 lp/mm), both the subject and predication. Also, both the subject and predicate devices have an X-ray Resolution of 20+ visible lp/mm which meets the device specification. Furthermore, the MTF analysis indicates that maximum resolution of 22 lp/mm is achieved by both predicate and subiect device specification.
Details of the differences between subject and predicate devices:
There are no major differences however there are two minor differences between Subject Device. The Sensor cable length of the Subject Device is reduced from 3m to 2.5m and the Subject Device supports USB 3.x connectivity in addition to USB 2.0 connectivity to personal computers.
Conclusion:
Based on a comparison of intended use, indications for use, technological characteristics, principle of operation, features, and performance data, DEXIS Ti 2, DEXIS IXS (Size 1, Size 2) are deemed to the predicate devices as it satisfies as it satisfies all criteria of substantial equivalence and does not raise new concerns regarding substantial equivalence: (1) Indications for Use, (2) Technological Characteristics, and (3) Performance Data. DEXIS Ti 2, DEXIS XS (Size 1, Size 2) do not introduce a fundamentally new scientific technology and the nonclinical tests demonstrate that the device is substantial equivalent.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
Performance Testing Bench:
Non-Clinical performance bench testing according to international standards and FDA recognized consensus standards for Extraoral source x-ray system has been conducted to determine conformance in regards to:
• ANSI AAMI ES60601-1:2005/(R)2012 and A2:2012, C1:2009/(R)2012 (Consolidated Text); Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
• IEC 60601-1-2 Edition 4.0 2014-02; Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
v EC 60601-1-6 Edition 3.2 2020-07 CONSOLIDATED VERSION; Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
v IEC 62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION; Medical devices - Part 1: Application of usability engineering to medical devices
v EC 60601-2-65 Edition 1.1 2017-05 CONSOLIDATED VERSION; Medical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral-X-ray equipment
21 CFR 807.92(a)(6)
5
• IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION; Medical device software - Software life cycle processes
• ISO 10993-5 Third edition 2009-06-01; Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
v ISO 10993-10 Third Edition 2010-08-01; Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
• ISO 14971 Third Edition 2019-12; Medical devices - Application of risk management to medical devices
v EC 61223-3-4 First edition 2000-03; Evaluation and routine testing in medical imaging departments - Part 3-4: Acceptance tests -Imaging performance of dental X-ray
• EC /TR 60601-4-2 Edition 1.0 2016-05; Medical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems
Also, the subject device has an X-ray Resolution of 20+ visible lp/mm which meets the device specification. Furthermore, the MTF analysis indicates that maximum resolution of 22 lg/mm is achieved by the subject device specification.
Performance Testing Clinical:
Clinical data is not needed to characterize performance and establish substantial equivalence. The non-clinical test data characterize all performance aspects of the device based on well-established scientific and engineering principles. Clinical testing has not been conducted on this product.
Conclusion:
Based on a comparison of intended use, indications, material composition, technological characteristics, principle of operation, features and performance data, the DEXIS Ti 2, DEXIS (Size 1, Size 2) Sensors are deemed to be substantially equivalent to the predicate device.