(84 days)
No
The summary describes a standard digital X-ray sensor and its basic image correction capabilities. There is no mention of AI, ML, or any advanced image analysis or processing that would typically involve these technologies.
No.
The device is used to acquire dental intraoral radiographic images, not to treat a condition or disease.
Yes
The device is described as acquiring "dental intraoral radiographic images" and performing "Basic Image Correction (Gain/Offset/Pixel Calibration)," which are steps in creating diagnostic images for healthcare professionals to interpret for dental health.
No
The device description explicitly states it is a USB-driven digital sensor that converts x-rays into light using a scintillating material and then detects this light with a CMOS imager. This involves significant hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "acquire dental intraoral radiographic images." This is a diagnostic imaging device, not a device used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description details an x-ray detector that converts x-rays into digital images. This aligns with imaging technology, not in vitro testing.
- Input Imaging Modality: The input is X-ray, which is an imaging modality, not a method for analyzing biological samples.
- Anatomical Site: The anatomical site is "Dental intra-oral," which is a location within the body being imaged, not a source of a biological specimen.
IVD devices are specifically designed to perform tests on samples taken from the body. This device is designed to capture images of the body.
N/A
Intended Use / Indications for Use
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.
Product codes
MUH
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray
Anatomical Site
dental intraoral
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)
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. Clinical data is not needed to characterize performance and establish substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
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.
1
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
2
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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3
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.
4
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 | Size
Differentiation | 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 | Product
Code | 510(k)
Clearance |
|---------------------------------------|-----------------------------------------|----------------------------------|-----------------|---------------------|
| Sheath, Positioning
System Barrier | Dental barriers and
sleeves | Pac-Dent International | PEM | K151123 |
| Sheath, Universal
Sensor Barrier | Dental barriers and
sleeves | Pac-Dent International | PEM | K151123 |
| Anterior Holder | Dental X-ray film
holder | KaVo Dental Technologies,
LLC | EGZ | 510(k)
Exempt |
| Posterior Holder | Dental X-ray film
holder | KaVo Dental Technologies,
LLC | EGZ | 510(k)
Exempt |
| Horizontal Bitewing
Holder | Dental X-ray film
holder | KaVo Dental Technologies,
LLC | EGZ | 510(k)
Exempt |
| Vertical Bitewing
Holder | Dental X-ray film
holder | KaVo Dental Technologies,
LLC | EGZ | 510(k)
Exempt |
| Hand-Held Holder | Dental X-ray film
holder | KaVo Dental Technologies,
LLC | EGZ | 510(k)
Exempt |
| Endo Holder | Dental X-ray film
holder | KaVo Dental Technologies,
LLC | EGZ | 510(k)
Exempt |
| DEXIS Imaging
Suite | System, Imaging
Acquisition Software | DEXIS, LLC | LLZ | K090431 |
5
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
6
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 Device
DEXIS Sensor - K090458 |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------|----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Information | DEXIS
Titanium | KaVo IXS HD
Size 1 | KaVo IXS HD
Size 2 | |
| Regulation No. | | 21 CFR 872.1800 | | 21 CFR 872.1800 |
| Classification Name
Regulation Class | Extraoral source x-ray system
II | | Extraoral source x-ray system
II | |
| 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-driven
digital sensor which is intended to acquire
dental intra-oral 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 Sensor is a USB-
driven digital sensor which is
intended to acquire dental intra-
oral radiography 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 alignment with
the x-ray beam or it may also
be positioned by hand with the
assistance of the patient. |
| Device Description | The DEXIS Titanium / KaVo IXS HD 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 Intraoral
Sensors supports USB2.0 connectivity to
personal computers using a dedicated electronic
assembly and a sensor software driver. | | | The DEXIS sensor is 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 sensor supports
USB2.0 and USB 1.1
connectivity to personal
computers using a dedicated
electronic assembly and a
sensor software driver. |
| Fundemental
Technology | | 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 Active
Imaging Area | 33.0mm x
26.0mm
with four
clipped
corners | 30.1mm x
20.2mm with
four clipped
corners | 36.0mm x
26.0mm with
four clipped
corners | 33.0 mm x 25.8 mm with four
clipped corners |
| Pixel Size | | 19.5um | | 19.5um |
| Dynamic Range | | 4,096:1 | | 16,384:1 |
| Image Resolution | 1692 x
1324 pixels | 1539 x 1026
pixels | 1842 x 1324
pixels | 1692 x 1324 pixels |
| USB Cable exit | 35° angled
cable exit | 0º parallel
cable exit | 0º parallel
cable exit | 35° angled cable exit |
| Corner design | Chamfered
corners | Rounded
corners | Rounded
corners | Chamfered corners |
| Sensor Cable Length | | 3 m | | 2.8 m |
| X-ray Resolution | | 20+ visible lp/mm | | 20+ visible lp/mm |
| Scintillator
Technology | Cesium Iodide (CsI) Scintillator | | | Cesium Iodide (CsI)
Scintillator |
| SW Features | USB 2.0 Communication
●
Noise Filtering
Binning
Basic Image Correction (Gain/Offset/Pixel
●
Calibration)
Monitoring Sensor Health/State
●
Image Transmission
● | | | USB 2.0 Communication
Noise Filtering
0
Binning
●
Basic Image Correction
0
(Gain/Offset/Pixel
Calibration)
Monitoring Sensor
0
Health/State
Image Transmission |
| Interface to PC | USB Type A Plug | | | USB Type A Plug |
Table 5.3
7
8
| Input electrical
| power | 5.0V / 0.5W via USB | 5.0V / 350mA max via USB |
|---|---|---|
| Exposure method | X-Ray Monitor Mode | X-Ray Monitor Mode |
| Communication | ||
| standard | USB 2.0 | USB 1.1 and 2.0 |
| Motion sensing | ||
| capability | Yes | N/A |
| Consensus Standards | IEC 60601-1 | |
| IEC 62366-1 | ||
| IEC 60601-2-65 | ||
| IEC 60601-1-2 | ||
| IEC 62304 | IEC 60601-1 | |
| IEC 60601-2-65 | ||
| IEC 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 essential | ||
| performance | |||
| 2. | AAMI / ANSI | ||
| ES60601-1 | 2005/(R)2012 and | ||
| C1:2009/ (R)2012 | |||
| and, A2:2010/(r)2012 | Medical electrical equipment Part 1: General requirements for basic safety and essential | ||
| performance | |||
| 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 and | ||
| essential performance - Collateral standard: Electromagnetic compatibility - Requirements | |||
| and tests. | |||
| 5. | IEC 60601-1-6 | 2010 | Medical electrical equipment - part 1-6: general requirements for basic safety and essential |
| performance - 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 and | ||
| essential 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 risk | ||
| management process [including: technical corrigendum 1 (2010)]. | |||
| 8. | ISO 10993-5 | 2009 – AAMI ANSI | |
| ISO | 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 skin | ||
| sensitization. | |||
| 10. | AMMI / ANSI | ||
| IEC 62304 | 2006 | Medical device software - Software life cycle processes. | |
| 11. | AMMI ANSI | ||
| IEC 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. |
9
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.