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.

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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Clio Prime and Clio Pedo devices:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on establishing substantial equivalence to predicate devices rather than defining specific numerical acceptance criteria. The key performance metric explicitly compared is the Modulation Transfer Function (MTF).

Acceptance Criteria (Implied)	Reported Device Performance (Clio Prime / Clio Pedo)
X-Ray Resolution: 20+ visible lp/mm (matching predicate)	20+ visible lp/mm
Dynamic Range: 16,384:1 (matching predicate)	16,384:1
Technology: CMOS (matching predicate)	CMOS
Scintillator Technology: Cesium Iodide (matching predicate)	Cesium Iodide
MTF at 6.6 lp/mm: Similar to predicate (DEXIS Platinum and GENDEX GXS-700)	39% at 6.6 lp/mm (Predicate: 40% at 6.6 lp/mm)
Biocompatibility: Meets ISO 10993 requirements for Cytotoxicity, Sensitization, and Irritation for limited exposure and mucosal contact	Deemed "not warranted" as devices are covered with single-use protective barriers that meet ISO 10993.
Safety and Effectiveness: Conformance to relevant standards (ISO 14971, ANSI AMI ES 60601-1, IEC 62304, IEC 60529, IEC 60601-1-2, EN 60601-1-2, ISO 10993-1)	Performance testing in accordance with listed standards.
Operating System Compatibility: Microsoft Windows 7 and 10	Microsoft Windows 7 and 10
Power Consumption: 0.8 Watts Max	0.8 Watts Max
Electrical Rating: DC 5V, 350 mA max	DC 5V, 350 mA max
Housing: IPx8 Equivalent ISO 10993 biocompatible	IPx8 Equivalent ISO 10993 biocompatible

2. Sample Size Used for the Test Set and Data Provenance:

Test Set Sample Size: Not explicitly stated as a number of distinct cases or patients. The clinical study involved providing "clinical images," but the quantity is not specified.
Data Provenance: Not explicitly stated. The document refers to a "clinical study performance testing," but does not mention the country of origin, nor whether it was retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

Number of Experts: Not specified.
Qualifications of Experts: Not specified. The document only states that "Clio Prime or Clio Pedo shall be operated by healthcare professionals who are educated and competent to perform the acquisition of dental intraoral radiographs." It does not mention who evaluated the clinical images for ground truth.

4. Adjudication Method for the Test Set:

Adjudication Method: Not specified.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Improvement with AI vs. Without AI Assistance:

MRMC Study: No MRMC study was described. The device is a digital intraoral x-ray sensor, not an AI-assisted diagnostic tool. Its performance was compared against predicate sensors.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

A standalone performance characterization of the sensor itself was conducted through bench testing, specifically the MTF comparison. However, the device is explicitly intended to be used by trained healthcare professionals, and "Image analysis software is not part of the submission." Therefore, a standalone "algorithm only" performance (in the context of automated diagnosis) is not applicable or described for this device. The closest is the physical sensor performance.

7. The Type of Ground Truth Used:

The document implies a combination of:
- "Clinical images" from a clinical study, suggesting a comparison of image quality or diagnostic utility against a clinical gold standard (though not explicitly defined).
- Bench testing data (e.g., MTF), which relies on standardized physical measurements and engineering specifications as ground truth.
- Comparison to predicate devices: The primary method for establishing "substantial equivalence" is direct comparison of parameters and performance with an already cleared device.

8. The Sample Size for the Training Set:

Not applicable/Not provided. The document describes a medical device (digital x-ray sensor), not a machine learning or AI model that requires a distinct training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable/Not provided, as there is no mention of a training set for a machine learning model.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K202664

Device Name

Clio Prime and Clio Pedo

Indications for Use (Describe)

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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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: info@namecheap.com

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

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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

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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.

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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.

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Comparison Table

DescriptiveInformation	DEXIS Platinumsensor and GENDEXGXS-700 sensors	Clio Prime and ClioPedo
510(k) Number	K090458	K202664
Manufacturer	Dental ImagingTechnologiesCorporation	Sota Precision Optics,Inc. doing business asSOTA Imaging
Trade Name	DEXIS Platinumsensor and GENDEXGXS-700 sensors	Clio Prime and ClioPedo
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 Platinumsensor or the GENDEXGXS-700 sensors areUSB-driven, digitalintraoral x-ray sensorswhich are intended toacquire dental intraoralradiography images.The DEXIS Platinumsensor or the GENDEXGXS-700 sensors shallbe operated byhealthcareprofessionals who areeducated andcompetent to performthe acquisition of dentalintraoral radiographs.The DEXIS Platinumsensor or the GENDEXGXS-700 sensors canbe used either incombination with	Clio Prime and ClioPedo are USB-driven,digital intraoral x-raysensors which areintended to acquiredental intraoralradiography images.Clio Prime or ClioPedo shall be operatedby healthcareprofessionals who areeducated andcompetent to performthe acquisition ofdental intraoralradiographs. ClioPrime or Clio Pedo canbe used either incombination withspecial positioning
	GXS-700 sensors canbe used either incombination with	devices to facilitatepositioning andalignment with an x-raybeam, or Clio Prime or

	special positioningdevices to facilitatepositioning andalignment with an x-raybeam or the intraoralradiography images.The DEXIS Platinumsensor or the GENDEXGXS-700 sensors shallbe operated byhealthcareprofessionals who areeducated andcompetent to performthe acquisition ofdental intraoralradiographs. TheDEXIS Platinumsensor or the GENDEXGXS-700 sensors canbe used either incombination withspecial positioningdevices to facilitatepositioning andalignment with an x-raybeam, or the DEXISPlatinum sensor or theGENDEX GXS-700sensors can also bepositioned by handwith the assistance ofthe patient.	Clio Pedo can also bepositioned by handwith the assistance ofthe patient.
Intended Use	The DEXIS Platinumsensor and theGENDEX GXS-700sensors are indirectconverting x-raydetectors, e.g.incident x-rays are	Clio Prime and ClioPedo are USB-drivendigital sensors whichare intended toacquire dentalintraoral 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 performthe acquisition ofdental intra-oralradiographs. TheDEXIS Platinumsensor and GENDEXGXS-700 sensors canbe used either incombination withspecial positioningdevices to facilitatepositioning andalignment with the x-ray beam or it mayalso be positioned byhand with theassistance of thepatient.	consequently reduceerrors introduced bysubjective analysis.Clio Prime or ClioPedo can perform andachieve the same typeof two-dimensionalimages asconventional(traditional) film sizes0, 1 and 2. Howevercannot be used to, oras a substitution forextraoral or other typesof dental x-ray. Whenusing Clio Prime orClio Pedo and softwareas a diagnostic aide,clinical experience anda combination of otherdiagnostic aidesshould be used to forma diagnosis and shouldnot be solely reliedupon for diagnosis.
Cable Length	2.8 meters2.9 meters2.9 meters	1.9 meters and 2.9meters1.9 meters and 2.9meters
Product Code	MUH	MUH
Number of Sensors	3	2
Sensor Exterior Size	38.95 mm x 29.75 mm37 mm x 25 mm42 mm x 31 mm	36.31 mm x 24.49 mm41.76 mm x 30.42 mm
Sensor Imaging Size	32.99 mm x 25.82 mm30.01 mm x 20.00 mm35.57 mm x 25.82 mmimage area with fourclipped corners	30.26 mm x 20.32 mm36.08 mm x 26.25 mmimage area with fourclipped corners

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Overall Imaging Area	820 mm2600.2 mm2918.4 mm2	615.0 mm2947.1 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 forsterilization	Not suitable forsterilization
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 ISO10993 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.

Regulation Number and Section

§ 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.