(84 days)
The DEXIS / KaVo sensor is a USB-driven digital sensor which is intended to acquire dental intraoral radiographic images. The DEXIS / KaVo sensor shall be operated by healthcare professionals, who are educated and competent to perform the acquisition of dental intra-oral radiographs. The DEXIS / KaVo sensor can be used either in combination with special positioning devices to facilitate positioning and alignment with the x-ray beam or it may also be positioned by hand with the assistance of the patient.
The DEXIS Titanium, Kavo IXS HD (Size 1, Size 2) intraoral 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 Titanium, Kavo IXS HD (Size 1, Size 2) intraoral sensors supports USB2.0 connectivity to personal computers using a dedicated electronic assembly and a sensor software driver.
The provided text describes the KaVo Dental Technologies, LLC DEXIS Titanium, KaVo IXS HD (Size 1, Size 2) intraoral sensors. It concludes that clinical performance data was not needed to characterize performance and establish substantial equivalence. Therefore, there is no information about specific acceptance criteria related to clinical performance or a study proving the device meets such criteria.
The document focuses on non-clinical test data and substantial equivalence to a predicate device (DEXIS Sensor - K090458). It states that substantial equivalence is based on a comparison of intended use, indications, technological characteristics, principle of operation, features, and non-clinical performance data.
Here's an overview of the non-clinical performance testing and device characteristics provided, which indirectly serve as acceptance criteria for regulatory clearance:
1. Table of Acceptance Criteria (Implied Non-Clinical) and Reported Device Performance:
Since clinical performance criteria are explicitly stated as "not needed," the acceptance criteria are derived from the performance bench testing and conformance to international standards for extraoral source X-ray systems. The reported device performance is presented in the comparison table with the predicate device and in the list of standards met.
| Acceptance Criteria (Implied from Non-Clinical Testing) | Reported Device Performance (DEXIS Titanium, KaVo IXS HD) |
|---|---|
| Biocompatibility | Completed for applicable components, conforming to ISO 10993-1, ISO 10993-5, ISO 10993-10. |
| Software documentation level of concern | Moderate level of concern met per FDA Guidance Document. Conforming to AAMI / ANSI IEC 62304. |
| Electrical Safety | Testing performed by Intertek Testing Services, conforming to IEC 60601-1, AAMI/ANSI ES60601-1, CSA C22.2 # 60601-1. |
| Electromagnetic Compatibility (EMC) | Testing performed by Intertek Testing Services, conforming to IEC 60601-1-2. |
| Usability | Conforming to IEC 60601-1-6 and AAMI ANSI IEC 62366. |
| Particular requirements for dental intra-oral X-ray equipment | Conforming to IEC 60601-2-65. |
| Risk Management | Quality system processes implemented for risk assessment in compliance with ISO 14971:2007. |
| Comparative Performance of Accessories | Testing performed comparing functions of accessories to cleared stand-alone devices. |
| X-ray Resolution | 20+ visible lp/mm (matching predicate) |
| Scintillator Technology | Cesium Iodide (CsI) Scintillator (matching predicate) |
| Fundamental Technology | CMOS (matching predicate) |
| Communication Standard | USB 2.0 (predicate also supports USB 1.1) |
| Input Electrical Power | 5.0V / 0.5W via USB (predicate specifies 5.0V / 350mA max via USB) |
| Exposure Method | X-Ray Monitor Mode (matching predicate) |
| Motion Sensing Capability | Yes (predicate N/A) |
2. Sample Size Used for the Test Set and Data Provenance:
The document states "Clinical data is not needed to characterize performance." Therefore, there is no test set of patient data described for clinical validation. The testing described is non-clinical bench testing. The provenance of the data is not specified beyond being "non-clinical test data."
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable, as no clinical study with a test set requiring expert ground truth establishment was conducted. The assessment relied on engineering and scientific principles and adherence to recognized standards.
4. Adjudication Method for the Test Set:
Not applicable, as no clinical study with a test set requiring adjudication was conducted.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC study was performed or cited, as clinical data was deemed unnecessary for substantial equivalence. Therefore, there is no information on the effect size of AI assistance on human readers.
6. Standalone Performance Study:
A standalone performance assessment was effectively done through the non-clinical bench testing, where the device's technical specifications and adherence to international standards were evaluated independently. However, this is not a standalone clinical performance study in the sense of an algorithm-only evaluation against ground truth in a clinical context.
7. Type of Ground Truth Used:
For the non-clinical testing, the "ground truth" was based on established engineering principles, reference standards (e.g., test phantoms for X-ray resolution if applicable, though not explicitly stated), and regulatory compliance requirements for medical devices. There was no clinical ground truth (e.g., pathology, outcomes data) used in this submission.
8. Sample Size for the Training Set:
Not applicable, as this device is a hardware sensor, not an AI/ML algorithm that requires a training set in the conventional sense.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as it is a hardware device and not an AI/ML algorithm that requires a training set.
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December 18, 2017
Image /page/0/Picture/1 description: The image shows 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, which features an abstract image of people. On the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The word "FDA" is in a blue square.
KaVo Dental Technologies, LLC % Mr. Frank Ray Regulatory Affairs Manager 11727 Fruehauf Drive CHARLOTTE NC 28273
Re: K172918
Trade/Device Name: DEXIS Titanium, KaVo IXS HD (Size 1, Size 2) Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: September 15, 2017 Received: November 16, 2017
Dear Mr. Ray:
We have reviewed vour 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. 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
K172918
Device Name DEXIS Titanium, KaVo IXS HD (Size 1, Size 2)
Indications for Use (Describe)
The DEXIS / KaVo sensor is a USB-driven digital sensor which is intended to acquire dental intraoral radiographic images. The DEXIS / KaVo sensor shall be operated by healthcare professionals, who are educated and competent to perform the acquisition of dental intra-oral radiographs. The DEXIS / Ka Vo sensor can be used either in combination with special positioning devices to facilitate positioning and alignment 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)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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KAVO-Kerr
Section V - 510(k) Summary for
Digital Intraoral Sensor DEXIS Titanium, Kavo IXS HD (Size 1, Size 2)
- Submitter Information:
KaVo Dental Technologies, LLC 11727 Fruehauf Drive Charlotte, NC 28273
Contact Person: Frank Ray - Telephone Number: (704) 587-7227 (704) 587-7250 Fax Number:
Date Prepared: November 15, 2017
2. Device Name:
- Proprietary Name: DEXIS Titanium, Kavo IXS HD (Size 1, Size 2) .
- . Common Name: System, x-ray, extraoral source, digital
- Classification Name: Extraoral source x-ray system .
II
- CFR Number: 872.1800 .
- Device Class: .
- Product Code: . MUH
3. Predicate Device:
.
- Proprietary Name: DEXIS Sensor - (K090458) .
- Common Name: System, x-ray, extraoral source, digital ●
- Classification Name: Extraoral source x-ray system
- . CFR Number: 872.1800
- Device Class: II ●
- Product Code: мин ●
4. Device Description:
The DEXIS Titanium, Kavo IXS HD (Size 1, Size 2) intraoral 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 Titanium, Kavo IXS HD (Size 1, Size 2) intraoral sensors supports USB2.0 connectivity to personal computers using a dedicated electronic assembly and a sensor software driver.
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Per the Guidance for Industry and FDA Staff; Bundling Multiple Devices or Multiple Indications in a Single Submission, dated June 22, 2007, KaVo Dental Technologies, LLC is bundling the 3 sensor models listed below in Table 5.1. These 3 models of digital intraoral sensor only differ in branding, size and external industrial design (e.g. chamfered corners, angled USB cable exit), the main components are identical, though the layering is slightly adjusted due to the size of the housing and are cosmetic in nature. The device description and intended use are identical for all 3 proposed models listed below.
| Table | 5.1 |
|---|---|
| ------- | ----- |
| Brand | Model Name | SizeDifferentiation | Housing Design Differentiation |
|---|---|---|---|
| DEXIS | DEXIS Titanium | Size 1.5 | Chamfered corners, angled USB cable exit |
| KaVo | KaVo IXS HD - Size 1 | Size 1 | Rounded Corners, parallel USB cable exit |
| KaVo | KaVo IXS HD - Size 2 | Size 2 | Rounded Corners, parallel USB cable exit |
Accessories:
The DEXIS Titanium, Kavo IXS HD (Size 1, Size 2) intraoral sensors have optional accessories/devices as listed in table 5.2 below. The barrier/sheaths have already been cleared by the FDA and contain their own labeling indicating they are disposable devices and the six Holders are Class I Exempt devices. Performance Bench Testing has been performed on all Device / Accessories. Also, KaVo Dental Technologies, LLC has quality system processes implemented for risk assessment for devices manufactured in compliance with ISO 14971:2007. This includes the DEXIS Titanium, Kavo IXS HD (Size 1, Size 2) intraoral sensors with the Devices / Accessories listed below in Table 5.2. The Risk Management File was reviewed by our test house Intertek as part of obtaining 60601-1 certification. All Devices/Accessories in table 5.2 are non-electrical.
TABLE 5.2
| Device /Accessory | Device Description | Manufacturer | ProductCode | 510(k)Clearance |
|---|---|---|---|---|
| Sheath, PositioningSystem Barrier | Dental barriers andsleeves | Pac-Dent International | PEM | K151123 |
| Sheath, UniversalSensor Barrier | Dental barriers andsleeves | Pac-Dent International | PEM | K151123 |
| Anterior Holder | Dental X-ray filmholder | KaVo Dental Technologies,LLC | EGZ | 510(k)Exempt |
| Posterior Holder | Dental X-ray filmholder | KaVo Dental Technologies,LLC | EGZ | 510(k)Exempt |
| Horizontal BitewingHolder | Dental X-ray filmholder | KaVo Dental Technologies,LLC | EGZ | 510(k)Exempt |
| Vertical BitewingHolder | Dental X-ray filmholder | KaVo Dental Technologies,LLC | EGZ | 510(k)Exempt |
| Hand-Held Holder | Dental X-ray filmholder | KaVo Dental Technologies,LLC | EGZ | 510(k)Exempt |
| Endo Holder | Dental X-ray filmholder | KaVo Dental Technologies,LLC | EGZ | 510(k)Exempt |
| DEXIS ImagingSuite | System, ImagingAcquisition Software | DEXIS, LLC | LLZ | K090431 |
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Principle of Operation:
The DEXIS Titanium, Kavo IXS HD (Size 1, Size 2) intraoral sensors are a digital intraoral sensor that utilizes scintillating material to convert incident x-rays into visible light coupled optically to a light detection imager based on CMOS technology. X-ray images are acquired when x-ray photons generated by an external x-ray source penetrate a patient's facial structure and impinae on the sensor which is then transferred via USB to a computer running an imaging software program. The digital x-ray sensor serves the same basic function as traditional x-ray film. The firmware controls the on-board function of the FPGA, and the software drivers provides image reconstruction, data transmission through USB, and interface with a dental imaging software for basic sensor management functionality.
The basic sensor management SW functionality contains the following:
- USB plug-n-play event handling for connected sensor(s) to PC .
- Monitor sensor status .
- . Activate sensor for x-ray detection
- . Monitor sensor for x-ray detection
- Transfer image from sensor to PC ●
- Basic Image Correction .
:
The DEXIS Titanium, Kavo IXS HD (Size 1, Size 2) intraoral require Dental Imaging Acquisition Software such as DEXIS Imaging Suite (K090431) to be operational. The Dental Imaging Acquisition Software is the Graphic User Interface (GUI) used by healthcare professionals to collect images and perform clinical diagnosis.
Indications for Use: 5.
The DEXIS Titanium, Kavo IXS HD (Size 1, Size 2) intraoral sensor is a USB-driven digital sensor which is intended to acquire dental intraoral radiographic images. The DEXIS / KaVo sensor shall be operated by healthcare professionals, who are educated and competent to perform the acquisition of dental intra-oral radiographs. The DEXIS / KaVo sensor can be used either in combination with special positioning devices to facilitate positioning and alignment with the x-ray beam or it may also be positioned by hand with the assistance of the patient.
Description of Substantial Equivalence: 6. Technological Characteristics:
The device comparison table below (Table 5.3) compares the DEXIS Titanium, Kavo IXS HD (Size 1, Size 2) intraoral sensors to one (1) other legally marketed Class II device DEXIS Sensor (K090458) which was granted marketing clearance by the FDA.
The DEXIS Titanium, Kavo IXS HD (Size 1, Size 2) intraoral sensors has the same intended use and technological characteristics as compared to the predicate device DEXIS Sensor (K090458). The changes raise no new questions of substantial equivalence.
There are 3 models of digital intraoral sensor described in this 510(k) submission and the only differences between the models are the sizes and external industrial design (e.q. chamfered corners, angled USB cable exit), the main components are identical, though the layout is slightly adjusted due to the size of the housing.
The proposed DEXIS Titanium, Kavo IXS HD (Size 1, Size 2) intraoral sensors has been determined to be substantially equivalent to the predicate device, the DEXIS Sensor (K090458) and shares the same intended use and fundamental technology as the predicate. The
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differences do not render the device NSE because the performance tests demonstrate that the differences in technological characteristics do not raise different questions regarding substantial equivalence to the predicate device. Hence, the DEXIS Titanium, Kavo IXS HD (Size 1, Size 2) intraoral sensors are substantial equivalent to the DEXIS Sensor (K090458).
| Descriptive | Proposed Device | Predicate DeviceDEXIS Sensor - K090458 | ||
|---|---|---|---|---|
| Information | DEXISTitanium | KaVo IXS HDSize 1 | KaVo IXS HDSize 2 | |
| Regulation No. | 21 CFR 872.1800 | 21 CFR 872.1800 | ||
| Classification NameRegulation Class | Extraoral source x-ray systemII | Extraoral source x-ray systemII | ||
| Product Code | MUH | MUH | ||
| Trade Name | DEXIS | KaVo | DEXIS Sensor | |
| Common Name | Digital Intraoral X-ray Sensor | Digital Intraoral X-ray Sensor | ||
| Indications for Use | The DEXIS / KaVo sensor is a USB-drivendigital sensor which is intended to acquiredental intra-oral radiographic images. TheDEXIS / KaVo sensor shall be operated byhealthcare professionals, who are educated andcompetent to perform the acquisition of dentalintra-oral radiographs. The DEXIS / KaVosensor can be used either in combination withspecial positioning devices to facilitatepositioning and alignment with the x-ray beamor it may also be positioned by hand with theassistance of the patient. | The DEXIS Sensor is a USB-driven digital sensor which isintended to acquire dental intra-oral radiography images. TheDEXIS Sensor shall beoperated by healthcareprofessionals, who are educatedand competent to perform theacquisition of dental intra-oralradiographs. The DEXISSensor can be used either incombination with specialpositioning devices to facilitatepositioning and alignment withthe x-ray beam or it may alsobe positioned by hand with theassistance of the patient. | ||
| Device Description | The DEXIS Titanium / KaVo IXS HD IntraoralSensors are an indirect converting x-raydetector, e.g. incident x-rays are converted by ascintillating material into (visible) light, thislight is coupled optically to a light detectionimager based on CMOS technology. The designof the sensor assembly supports the automaticdetection of the incident x-rays to generatedigital images for dental intra oral applications.The DEXIS Titanium / KaVo IXS HD IntraoralSensors supports USB2.0 connectivity topersonal computers using a dedicated electronicassembly and a sensor software driver. | The DEXIS sensor is anindirect converting x-raydetector, e.g. incident x-raysare converted by a scintillatingmaterial into (visible) light, thislight is coupled optically to alight detection imager based onCMOS technology.The design of the sensorassembly supports theautomatic detection of theincident x-rays to generatedigital images for dental intraoral applications.The DEXIS sensor supportsUSB2.0 and USB 1.1connectivity to personalcomputers using a dedicatedelectronic assembly and asensor software driver. | ||
| FundementalTechnology | CMOS | CMOS | ||
| Sensor Exterior | 39.9mm x | 37.0mm x | 42.3mm x | |
| Dimension (mm) | 29.8mm | 25.2mm | 30.4mm | 38.9mm x 29.7mm |
| Sensor ActiveImaging Area | 33.0mm x26.0mmwith fourclippedcorners | 30.1mm x20.2mm withfour clippedcorners | 36.0mm x26.0mm withfour clippedcorners | 33.0 mm x 25.8 mm with fourclipped corners |
| Pixel Size | 19.5um | 19.5um | ||
| Dynamic Range | 4,096:1 | 16,384:1 | ||
| Image Resolution | 1692 x1324 pixels | 1539 x 1026pixels | 1842 x 1324pixels | 1692 x 1324 pixels |
| USB Cable exit | 35° angledcable exit | 0º parallelcable exit | 0º parallelcable exit | 35° angled cable exit |
| Corner design | Chamferedcorners | Roundedcorners | Roundedcorners | Chamfered corners |
| Sensor Cable Length | 3 m | 2.8 m | ||
| X-ray Resolution | 20+ visible lp/mm | 20+ visible lp/mm | ||
| ScintillatorTechnology | Cesium Iodide (CsI) Scintillator | Cesium Iodide (CsI)Scintillator | ||
| SW Features | USB 2.0 Communication●Noise FilteringBinningBasic Image Correction (Gain/Offset/Pixel●Calibration)Monitoring Sensor Health/State●Image Transmission● | USB 2.0 CommunicationNoise Filtering0Binning●Basic Image Correction0(Gain/Offset/PixelCalibration)Monitoring Sensor0Health/StateImage Transmission | ||
| Interface to PC | USB Type A Plug | USB Type A Plug |
Table 5.3
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| Input electricalpower | 5.0V / 0.5W via USB | 5.0V / 350mA max via USB |
|---|---|---|
| Exposure method | X-Ray Monitor Mode | X-Ray Monitor Mode |
| Communicationstandard | USB 2.0 | USB 1.1 and 2.0 |
| Motion sensingcapability | Yes | N/A |
| Consensus Standards | IEC 60601-1IEC 62366-1IEC 60601-2-65IEC 60601-1-2IEC 62304 | IEC 60601-1IEC 60601-2-65IEC 60601-1-2 |
Non-Clinical Test Data:
Performance bench testing according to international standards for Extra-oral source x-ray system (Sensors) has been conducted to determine conformance in regards to:
- Biocompatibility has been completed for the applicable components. .
- . Software documentation for moderate level of concern per the FDA Guidance Document for Software Contained in Medical Devices.
- . Electrical Safety testing, including Electromagnetic Compatibility, have been performed by Intertek Testing Services.
- . Comparative performance testing of the functions of the accessories as compared to the cleared stand-a-lone device.
Furthermore, the performance of the DEXIS Titanium, Kavo IXS HD (Size 1, Size 2) intraoral sensors has been verified utilizing the following standards in Table 5.4 below:
| TABLE 5.4 | |||
|---|---|---|---|
| Item | Standard | Year & Edition | Description |
| 1. | IEC 60601-1 | 2005 + CORR.1:2006 + CORR.2:2007 + AM1:2012 | Medical electrical equipment Part 1: General requirements for basic safety and essentialperformance |
| 2. | AAMI / ANSIES60601-1 | 2005/(R)2012 andC1:2009/ (R)2012and, A2:2010/(r)2012 | Medical electrical equipment Part 1: General requirements for basic safety and essentialperformance |
| 3. | CSA C22.2 #60601-1 | 2014 (3rd) 2014-01-01 | Medical Electrical Equipment - Part 1: General Req. for Basic Safety & Essential Perf.;Cor. 2: 2011 |
| 4. | IEC 60601-1-2 | 2014 (4th Ed.) 2014-02 | Medical electrical equipment - Part 1-2: General requirements for basic safety andessential performance - Collateral standard: Electromagnetic compatibility - Requirementsand tests. |
| 5. | IEC 60601-1-6 | 2010 | Medical electrical equipment - part 1-6: general requirements for basic safety and essentialperformance - collateral standard: usability. |
| 6. | IEC 60601-2-65 | 2012 (1st Ed.) 2012-09 | Medical electrical equipment Part 2-65: Particular requirements for the basic safety andessential performance of dental intra-oral X-ray equipment. |
| 7. | ISO 10993-1 | 2009 (4th) 2009-10-15 | Biological evaluation of medical devices - Part 1: Evaluation and testing within a riskmanagement process [including: technical corrigendum 1 (2010)]. |
| 8. | ISO 10993-5 | 2009 – AAMI ANSIISO | Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity. |
| 9. | ISO 10993-10 | 2010 (3rd ed) 2010-08-01 | Biological evaluation of medical devices - Part 10: Tests for irritation and skinsensitization. |
| 10. | AMMI / ANSIIEC 62304 | 2006 | Medical device software - Software life cycle processes. |
| 11. | AMMI ANSIIEC 62366 | 2007/(R)2013 +A1 | Medical devices - Application of usability engineering to medical devices. |
| 12. | ISO 14971 | 2007 | Medical devices - Application of risk management to medical devices. |
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Hence the DEXIS Titanium, Kavo IXS HD (Size 1, Size 2) intraoral sensors demonstrates substantial equivalence.
Clinical Performance Data:
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 as to Substantial Equivalence:
Based on a comparison of intended use, indications, technological characteristics, principle of operation, features and performance data, the DEXIS Titanium, Kavo IXS HD (Size 1, Size 2) intraoral sensors are deemed to be substantially equivalent to the predicate device.
§ 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.