(53 days)
Not Found
No
The summary describes a digital x-ray sensor and its associated drivers and utilities. It explicitly states that "Image analysis software is not part of the submission" and that "an optional image analysis software will be necessary" for image optimization and analysis. There is no mention of AI or ML in the description of the device or the included software.
No
The device is used to acquire dental intraoral radiography images, which aid in diagnosis but do not directly treat a condition.
Yes
Explanation: The "Intended Use / Indications for Use" states that the device is "intended to acquire dental intraoral radiography images," and the "Device Description" states that "Digital x-ray imaging is an aide for diagnosis and should always be confirmed by the doctor using additional Clio Prime or Clio Pedo procedures and other diagnostic aides for confirmation." Both statements indicate the device's role in providing information for diagnosis.
No
The device description explicitly states that Clio Prime and Clio Pedo are "USB-driven digital sensors" with a "CMOS x-ray imager." These are hardware components, not software. While software is mentioned for image analysis and sensor control, the core device is a physical sensor.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or treatment.
- Device Function: The Clio Prime and Clio Pedo are described as digital intraoral x-ray sensors. Their function is to acquire dental intraoral radiography images using x-rays. This is an imaging modality, not a test performed on a biological sample.
- Intended Use: The intended use is to acquire dental intraoral radiography images, which are then used as an "aide for diagnosis." This aligns with the use of medical imaging devices, not IVDs.
- Lack of Biological Sample Testing: There is no mention of the device analyzing or testing any biological samples from the patient.
Therefore, the Clio Prime and Clio Pedo fall under the category of medical imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Clio Prime and Clio Pedo are USB-driven, digital intraoral x-ray sensors which are intended to acquire dental intraoral radiography images. Clio Prime or Clio Pedo shall be operated by healthcare professionals who are educated and competent to perform the acquisition of dental intraoral radiographs. Clio Prime or Clio Pedo can be used either in combination with special positioning devices to facilitate positioning and alignment with an x-ray beam, or Clio Prime or Clio Pedo can 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
Clio Prime and Clio Pedo are USB-driven digital sensors designed for health care professionals already acquainted with the standard procedures for acquiring dental intra-oral radiographs. Digital x-ray imaging is an aide for diagnosis and should always be confirmed by the doctor using additional Clio Prime or Clio Pedo procedures and other diagnostic aides for confirmation. Clio Pedo is a smaller version of Clio Prime and is for pediatric use. The Clio Prime and Clio Pedo design uses advanced ergonomic principles with four beveled corners, a moderate profile, and a rounded casing providing enhanced comfort for patients. Clio Prime or Clio Pedo is positioned in the patient's mouth in the same manner as intra-oral film is positioned. Each of Clio Prime and Clio Pedo has a CMOS x-ray imager that creates a digital image from x-ray doses perceptible by the sensor. The digital image created is immediately visible on the screen of a personal computer connected to Clio Prime or Clio Pedo through the standard USB port. Image analysis software is not part of the submission. For Clio Prime or Clio Pedo to be used in a dental practice, an optional image analysis software will be necessary. Only with image analysis software can acquired images be optimized for specific diagnostic tasks, archived as image files, and printed out on a suitable printer. Software provides drivers and utilities for x-ray dose optimization, sensor activation and settings.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray
Anatomical Site
Intraoral (dental)
Indicated Patient Age Range
patients of any age
Intended User / Care Setting
healthcare professionals who are educated and competent to perform the acquisition of dental intraoral radiographs / dental practice
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)
Clinical Study: SOTA Imaging a clinical study performance testing to determine that Clio Prime, and Clio Pedo performed as well or better than did the DEXIS Platinum sensor and GENDEX GXS-700 sensors. SOTA Imaging has provided clinical images. These clinical images provide further evidence in addition to the laboratory performance data that shows that the complete system works as intended.
Bench Study: On behalf of SOTA Imaging Intertek performed an extensive bench testing on Clio Prime and Clio Pedo.
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 6, 2020
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: the Department of Health & Human Services seal on the left and the FDA acronym and name on the right. The Department of Health & Human Services seal is a stylized depiction of an eagle. The FDA acronym is in a blue square, and the words "U.S. FOOD & DRUG ADMINISTRATION" are in blue text.
Sota Precision Optics, Inc. dba SOTA Imaging % Mr. Ed Johansen Official Correspondent W. Edward Johansen 1239 Stanford Street. #205 SANTA MONICA CA 90404
Re: K202664
Trade/Device Name: Clio Prime and Clio Pedo Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: Class II Product Code: MUH Dated: September 12, 2020 Received: September 14, 2020
Dear Mr. Johansen:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's 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
1
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.
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K202664
Device Name
Clio Prime and Clio Pedo
Indications for Use (Describe)
Clio Prime and Clio Pedo are USB-driven, digital intraoral x-ray sensors which are intended to acquire dental intraoral radiography images. Clio Prime or Clio Pedo shall be operated by healthcare professionals who are educated and competent to perform the acquisition of dental intraoral radiographs. Clio Prime or Clio Pedo can be used either in combination with special positioning devices to facilitate positioning and alignment with an x-ray beam, or Clio Prime or Clio Pedo can 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
510(k) Summary
510(k) Premarket Notification No. K202664
October 29, 2020
I. Corporation Information
Name: Sota Precision Optics, Inc. dba SOTA Imaging Address: 1073 North Batavia Street, Suite B Orange, California 92867 Telephone: (714) 532-6100 Official Correspondent: W. Edward Johansen Telephone: (310) 795-7425
E-mail address: wedjohansen@msn.com
- Main address:
Address: 1600 Stewart Street, #905, Santa Monica, California
Address: 1239 Stanford Street, #205, Santa Monica, California 90404
II. Identification of New Device
Owner/Operator: Sota Precision Optics, Inc. dba SOTA Imaging Establishment Registration Number: 3000190675 Trade Name: Clio Prime and Clio Pedo 510(k) Premarket Notification Number: K202664 Common Name: Dental digital x-ray sensor Classification Name: Extra-oral source x-ray system Product Code: MUH Class: II Panel: Radiology Regulation Number: 21 C.F.R. §872.1800 Manufacturer: SOTA Imaging Contract Manufacturer: BAE Systems Imaging Solutions, a division of BAE Systems Inc. Sterilization Facility: Not Applicable
4
III. Identification of Predicate Device
Owner/Operator/Manufacturer: Dental Imaging Technologies Corporation
Establishment Registration Number: 2530069
510(k) Premarket Notification Number: K090458
Contract Manufacturer: BAE Systems Imaging Solutions, a division of BAE Systems Inc.
Trade Name: DEXIS Platinum sensor and GENDEX GXS-700 sensors
Common Name: Dental intraoral x-rav sensor
Classification Name: Extra-oral source x-ray system
Product Code: MUH
Classification: Class II
Panel: Radiology
Requlation Number: 21 C.F.R. §872.1800
IV. Device Description
Clio Prime and Clio Pedo are USB-driven digital sensors designed for health care professionals already acquainted with the standard procedures for acquiring dental intra-oral radiographs. Digital x-ray imaging is an aide for diagnosis and should always be confirmed by the doctor using additional Clio Prime or Clio Pedo procedures and other diagnostic aides for confirmation. Clio Pedo is a smaller version of Clio Prime and is for pediatric use. The Clio Prime and Clio Pedo design uses advanced ergonomic principles with four beveled corners, a moderate profile, and a rounded casing providing enhanced comfort for patients. Clio Prime or Clio Pedo is positioned in the patient's mouth in the same manner as intra-oral film is positioned. Each of Clio Prime and Clio Pedo has a CMOS x-ray imager that creates a digital imaqe from x-ray doses perceptible by the sensor. The digital image created is immediately visible on the screen of a personal computer connected to Clio Prime or Clio Pedo through the standard USB port. Image analysis software is not part of the submission. For Clio Prime or Clio Pedo to be used in a dental practice, an optional image analysis software will be necessary. Only with image analysis software can acquired images be optimized for specific diagnostic tasks, archived as image files, and printed out on a suitable printer. Software provides drivers and utilities for x-ray dose optimization, sensor activation and settings.
5
Clio Prime and Clio Pedo capture x-ray imaqes suitable for recognition of normal anatomical structures, dental pathologies, and abnormal conditions. Inadequate images may result in misdiagnosis thereby subjecting the patient to incorrect or unnecessary dental procedures that would present an unacceptable risk to the patient.
V. Indications for Use
Clio Prime and Clio Pedo are USB-driven, digital intraoral x-ray sensors which is intended to acquire dental intraoral radiography imaqes. Clio Prime or Clio Pedo shall be operated by healthcare professionals, who are educated and competent to perform the acquisition of dental intraoral radiographs. Clio Prime or Clio Pedo can be used either in combination with special positioning devices to facilitate positioning and alignment with an x-ray beam, or Clio Prime or Clio Pedo can also be positioned by hand with the assistance of the patient.
VI. Intended Use
Clio Prime and Clio Pedo are intended for any dental practice that uses x-ray equipment for intraoral diagnostic purposes. It can be used by trained dental professionals for patients receiving intraoral x-ray examinations and produces digital images for patients receiving intraoral x-ray examinations for diagnostic purposes. An image analysis software is not part of this submission. When Clio Prime or Clio Pedo is to be used in a dental practice, an optional software will be necessary.
VII. Performance Testing-Animal Study
SOTA Imaging did not perform an animal study performance testing.
VIII. Performance Testing-Clinical Study
SOTA Imaging a clinical study performance testing to determine that Clio Prime, and Clio Pedo performed as well or better than did the DEXIS Platinum sensor and GENDEX GXS-700 sensors. SOTA Imaging has provided clinical images. These clinical images provide further evidence in addition to the laboratory performance data that shows that the complete system works as intended.
IX. Performance Testing-Bench Study
On behalf of SOTA Imaging Intertek performed an extensive bench testing on Clio Prime and Clio Pedo.
6
X. Comparison Table
The following comparison table compares Clio Prime and Clio Pedo to the predicates, the DEXIS Platinum sensor and the GENDEX GXS-700 sensors with respect to intended use, indications of use, environment of use, limitations of use, technical performance and technological characteristics, and provides more detailed information regarding the basis for the determination of substantial equivalence.
7
Comparison Table
| Descriptive
Information | DEXIS Platinum
sensor and GENDEX
GXS-700 sensors | Clio Prime and Clio
Pedo |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K090458 | K202664 |
| Manufacturer | Dental Imaging
Technologies
Corporation | Sota Precision Optics,
Inc. doing business as
SOTA Imaging |
| Trade Name | DEXIS Platinum
sensor and GENDEX
GXS-700 sensors | Clio Prime and Clio
Pedo |
| Classification Name | System, x-ray,
extraoral source | System, x-ray,
extraoral source |
| Classification Panel | Radiology | Radiology |
| Classification | Class II | Class II |
| Regulation Number | 21 C.F.R. § 872.1800 | 21 C.F.R. § 872.1800 |
| Indication for Use | The DEXIS Platinum
sensor or the GENDEX
GXS-700 sensors are
USB-driven, digital
intraoral x-ray sensors
which are intended to
acquire dental intraoral
radiography images.
The DEXIS Platinum
sensor or the GENDEX
GXS-700 sensors shall
be operated by
healthcare
professionals who are
educated and
competent to perform
the acquisition of dental
intraoral radiographs.
The DEXIS Platinum
sensor or the GENDEX
GXS-700 sensors can
be used either in
combination with | Clio Prime and Clio
Pedo are USB-driven,
digital intraoral x-ray
sensors which are
intended to acquire
dental intraoral
radiography images.
Clio Prime or Clio
Pedo shall be operated
by healthcare
professionals who are
educated and
competent to perform
the acquisition of
dental intraoral
radiographs. Clio
Prime or Clio Pedo can
be used either in
combination with
special positioning |
| | GXS-700 sensors can
be used either in
combination with | devices to facilitate
positioning and
alignment with an x-ray
beam, or Clio Prime or |
| | | |
| | special positioning
devices to facilitate
positioning and
alignment with an x-ray
beam or the intraoral
radiography images.
The DEXIS Platinum
sensor or the GENDEX
GXS-700 sensors shall
be operated by
healthcare
professionals who are
educated and
competent to perform
the acquisition of
dental intraoral
radiographs. The
DEXIS Platinum
sensor or the GENDEX
GXS-700 sensors can
be used either in
combination with
special positioning
devices to facilitate
positioning and
alignment with an x-ray
beam, or the DEXIS
Platinum sensor or the
GENDEX GXS-700
sensors can also be
positioned by hand
with the assistance of
the patient. | Clio Pedo can also be
positioned by hand
with the assistance of
the patient. |
| Intended Use | The DEXIS Platinum
sensor and the
GENDEX GXS-700
sensors are indirect
converting x-ray
detectors, e.g.
incident x-rays are | Clio Prime and Clio
Pedo are USB-driven
digital sensors which
are intended to
acquire dental
intraoral radiography |
| converted by a | images. Clio Prime or | |
| scintillating material | Clio Pedo shall be | |
| into (visible) light, this | operated by healthcare | |
| light is coupled | professionals who are | |
| optically to a light | educated and | |
| detection imager | competent to perform | |
| based on CMOS | the acquisition of | |
| technology. The | dental intraoral | |
| design of the sensor | radiographs. Clio | |
| assembly supports the | Prime or Clio Pedo can | |
| automatic detection of | be used either in | |
| the incident x-rays to | combination with | |
| generate digital images | positioners | |
| for dental intra-oral | manufactured to | |
| applications. The | facilitate the | |
| DEXIS Platinum | positioning and | |
| sensor or the | alignment with an x- | |
| GENDEX GXS-700 | ray beam, or it may | |
| sensors supports USB | also be positioned by | |
| 2.0 and USB 1.1 | hand with the | |
| connectivity to | assistance of the | |
| personal computers | patient. Clio Prime or | |
| using a dedicated | Clio Pedo can be used | |
| electronic assembly | with patients of any | |
| and a sensor software | age, providing the | |
| driver. The DEXIS | correct positioning of | |
| Platinum sensor and | the sensor in the | |
| the GENDEX GXS-700 | patient mouth can be | |
| sensors are USB- | realized. Using Clio | |
| driven digital sensors | Prime or Clio Pedo is | |
| which are intended to | a suitable diagnostic | |
| acquire dental intra- | method and may offer | |
| oral radiography | reduced radiation | |
| images. The DEXIS | exposure compared to | |
| Platinum sensor and | analog procedures. | |
| GENDEX GXS-700 | Furthermore, available | |
| sensors shall be | software image | |
| operated by healthcare | enhancement tools | |
| professionals, who are | may enhance | |
| educated and | sensitivity and | |
| | | |
| | competent to perform
the acquisition of
dental intra-oral
radiographs. The
DEXIS Platinum
sensor and GENDEX
GXS-700 sensors 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. | consequently reduce
errors introduced by
subjective analysis.
Clio Prime or Clio
Pedo can perform and
achieve the same type
of two-dimensional
images as
conventional
(traditional) film sizes
0, 1 and 2. However
cannot be used to, or
as a substitution for
extraoral or other types
of dental x-ray. When
using Clio Prime or
Clio Pedo and software
as a diagnostic aide,
clinical experience and
a combination of other
diagnostic aides
should be used to form
a diagnosis and should
not be solely relied
upon for diagnosis. |
| Cable Length | 2.8 meters
2.9 meters
2.9 meters | 1.9 meters and 2.9
meters
1.9 meters and 2.9
meters |
| Product Code | MUH | MUH |
| Number of Sensors | 3 | 2 |
| Sensor Exterior Size | 38.95 mm x 29.75 mm
37 mm x 25 mm
42 mm x 31 mm | 36.31 mm x 24.49 mm
41.76 mm x 30.42 mm |
| Sensor Imaging Size | 32.99 mm x 25.82 mm
30.01 mm x 20.00 mm
35.57 mm x 25.82 mm
image area with four
clipped corners | 30.26 mm x 20.32 mm
36.08 mm x 26.25 mm
image area with four
clipped corners |
8
9
10
11
| Overall Imaging Area | 820 mm2
600.2 mm2
918.4 mm2 | 615.0 mm2
947.1 mm2 |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| Pixel Size | 19.5 µm | 19.5 µm |
| Imager Resolution | 1692 by 1324 pixels
(2.25M pixels)
1026 x 1539 pixels
(1.58M pixels)
1324 x 1842 pixels
(2.44M pixels) | 1539 x 1042 pixels
(1.60M Pixels)
1842 x 1342 pixels
(2.47M pixels) |
| X-Ray Resolution | 20+ visible lp/mm | 20+ visible lp/mm |
| Dynamic Range | 16,384:1 | 16,384:1 |
| Technology | CMOS | CMOS |
| Scintillator Technology | Cesium lodide | Cesium lodide |
| Interface to PC | USB 2.0, Type A Plug | USB 2.0, Type Plug |
| Operating System | Microsoft Windows XP©
Microsoft and Windows Vista© | Microsoft Windows 7 and 10 |
| Sterilization | Not suitable for
sterilization | Not suitable for
sterilization |
| Power Consumption | 1.4 Watts Max | 0.8 Watts Max |
| Electrical Rating | DC 5V, 350 mA max | DC 5V, 350 mA max |
| Housing | IP68 Biocompatible | IPx8 Equivalent ISO
10993 biocompatible |
| Extraoral source | x-ray system | x-ray system |
| MTF | 40% at 6.6 lp/mm | 39% at 6.6 lp/mm |
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XI. Comparison of Safety and Effectiveness of the Predicate Devices. DEXIS Platinum Sensor and GENDEX GXS-700 Sensors to Safety and Effectiveness of Clio Prime and Clio Pedo
Using the above Comparison Table, Clio Prime and Clio Pedo can be compared to the predicate devices, DEXIS Platinum sensor and GENDEX GXS-700 sensors, with respect to intended use, indications of use, environment of use, limitations of technical performance and technological characteristics and provides more detailed information reqarding the basisfor the determination of substantial equivalence.
XII. Comparison of MTF for the DEXIS Platinum Sensor and the GENDEX GXS-700 Sensor with MTF of Clio Prime and Clio Pedo
Clio Prime and Clio Pedo use components from contract manufacturer BAE Systems Imaging Solutions, a division of BAE Systems Inc., which is also responsible for the manufacture of the DEXIS Platinum sensor and the GENDEX GXS-700 sensors which are the predicate devices. The components used in Clio Prime and Clio Pedo are a combination of identical components and incremental improvements over the components in the DEXIS Platinum sensor and the GENDEX GXS-700 sensors. SOTA lmaging believes that by comparing the MTF of the DEXIS Platinum sensor and the GENDEX GXS-700 sensors with the MTF of Clio Prime and Clio Pedo thev are all substantially equivalent to each other.
XIII. Meaningful Differences
The DEXIS Platinum sensor, the GENDEX GXS-700 sensors, Clio Prime, and Clio Pedo are all CMOS x-ray image sensors. SOTA Imaging has compared the MTF of the DEXIS Platinum sensor and the GENDEX GXS-700 sensors with the MTF of Clio Prime and Clio Pedo and has determined they are substantially equivalent to each other. Clio Prime and Clio Pedo are not only similar in performance as the DEXIS Platinum sensor and the GENDEX GXS-700 sensors, but is also safe and effective based on performance testing in accordance with the following reference standards: ISO 14971; ANSI AMI ES 60601-1; IEC 62304; IEC 60529; IEC 60601-1-2; EN 60601-1-2; and ISO 10993-1.
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XIV. Biocompatibility
BAE Systems Imaging Solutions uses a different SABIC resin than SABIC's ULTEM resin for the sensor housing of the DEXIS Platinum sensor and the housing of the GENDEX GXS-700 sensors. BAE Systems Imaging Solutions uses SABIC's ULTEM resin for the sensor housing of Clio Prime and the housing of Clio Pedo.
Clio Prime and Clio Pedo are intended to be used in the oral cavity by a trained clinician. During a typical full mouth series. Clio Prime or Clio Pedo is repeatedly placed in the oral cavity and removed or repositioned a total of 18 times. The average time of each insertion is less than 1 minute and the total time for a complete set of images is less than 10 minutes. This places Clio Prime and Clio Pedo in the category of "Limited Exposure" defined by Table A.1 of the CDRH Guidance Document dated June 16, 2016. With Mucosal contact the sensor shall meet the following requirements for biocompatibility-Cytotoxicity, Sensitization, and Irritation.
SOTA Imaging recommends that usage of Clio Prime or Clio Pedo requires a hygienic barrier that meets ISO 10993 requirements for biocompatibility. There is foreseeable misuse where a clinician would place the sensor in the oral cavity without a barrier, exposing the sensor housing to the oral cavity.
Biocompatible testing for the subject devices. Clio Prime and Clio Pedo. is not warranted because in the dental clinic there are not direct or indirect patient-contacting components in the subject devices. They are covered with a single-use protective barrier prior to each use just like the predicate devices, the DEXIS Platinum sensor and the two GENDEX GXS-700 sensors.
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XV. Conclusion
On behalf of SOTA Imaging. BAE Systems Imaging Solutions has compared the MTF for the DEXIS Platinum sensor and the GENDEX GXS-700 sensors with the MTF of the Clio Prime and Clio Pedo and has determined that they are substantially equivalent to each other.
Clio Prime and Clio Pedo are substantially equivalent to the legally marketed DEXIS Platinum sensor and the legally marketed GENDEX GXS-700 sensors in the United States. Clio Prime and Clio Pedo are substantially equivalent in intended use, indications for use, safety and effectiveness, and technical characteristics to the DEXIS Platinum sensor and the GENDEX GXS-700 sensors which Dental Imaging Technologies Corporation markets under the cleared 510(k) Premarket Notification No. K090458. Clio Prime and Clio Pedo are not only similar in performance as the DEXIS Platinum sensor and the GENDEX GXS-700 sensors, but are also safe and effective based on performance testing in accordance with the following reference standards: ISO 14971; ANSI AMI ES 60601-1; IEC 62304; IEC 60529; IEC 60601-2; EN 60601-1-2: and ISO 10993-1.