JAZZ SOLO Sensor

K163224 · Jazz Imaging, LLC · MUH · Mar 9, 2017 · Dental

Device Facts

• Record ID: K163224
• Device Name: JAZZ SOLO Sensor
• Applicant: Jazz Imaging, LLC
• Product Code: MUH · Dental
• Decision Date: Mar 9, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1800
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

JAZZ SOLO Digital Sensor is intended for any dental practice that uses Xray 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 the Jazz Solo digital sensor is to be used in a dental practice, an optional software will be necessary.

Device Story

JAZZ SOLO Digital Sensor is a USB-connected dental intra-oral x-ray sensor; utilizes CCD technology with a Cesium Iodide scintillator to convert incident x-rays into digital images. Device is positioned in the patient's mouth similarly to traditional film; captures images for recognition of anatomical structures and dental pathologies. Operated by trained dental professionals in dental practices. Output is a digital image transmitted via USB to a PC; requires separate, third-party image analysis software for optimization, archiving, and printing. Device aids in diagnosis but must be used in conjunction with clinical experience and other diagnostic procedures. Benefits include digital imaging capabilities for dental diagnostics.

Clinical Evidence

Bench testing only. Clinical images were provided as supplemental evidence to demonstrate system functionality, but were not required to establish substantial equivalence given the similarity in detector technology to the predicate.

Technological Characteristics

USB-driven digital sensor; CCD imager with Cesium Iodide scintillator; 1936 x 1460 pixel resolution; 18 μm pixel size. Housing is IPx7 equivalent and ISO 10993 biocompatible. Connectivity via USB 2.0. Power: DC 5V, 350 mA max. Standards: IEC 60601-1 (safety), IEC 60601-1-2 (EMC), IEC 60601-1-6/IEC 62366 (usability), ISO 10993 (biocompatibility).

Indications for Use

Indicated for dental intra-oral radiographic imaging. Intended for use by trained dental professionals on patients of any age receiving intraoral x-ray examinations for diagnostic purposes.

Regulatory Classification

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.

Predicate Devices

• DEXIS Digital Sensor (K090458)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three human profiles facing to the right, with flowing lines extending from the bottom of the profiles.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 9, 2017

Jazz Imaging LLC % W. Edward Johansen Official Correspondent 395 14th Street. NE SALEM OR 97301

Re: K163224 Trade/Device Name: JAZZ SOLO Sensor Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: February 17, 2017 Received: February 21, 2017

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. 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 (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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael O'Hara

For

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

510(k) Number (if known) K163224

Device Name JAZZ SOLO Sensor

Indications for Use (Describe)

The JAZZ SOLO digital sensor is intended to acquire dental intra-oral radiographic images. It can be operated by trained dental professionals for patients receiving intraoral x-ray examinations for diagnostic purposes.

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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## 510(k) Summary

Date Summary Prepared: March 6, 2017 Submitter Information Name: Jazz Imaqing LLC Address: 800 Charcot Ave, Suite 100 San Jose, CA 95131 USA Contact Person: Todd C. Miller Corporate Telephone: [phone] Official Correspondent: W. Edward Johansen Identification of Device 510(k) Number: K163224 Trade Name: JAZZ SOLO Digital Sensor Common Name: Dental digital x-ray sensor Classification Name: Extra-oral source x-ray system Product Code: MUH Class: Il Panel: Radiology Regulation Number: 21 C.F.R. §872.1800 Equivalent legally Marketed Device (Predicate Device) 510(k) Number: K090458 Trade Name: Manufacturer: Sybron Dental Specialties, Inc. Common Name: Dental digital x-ray sensor Classification Name: Extraoral source x-ray system Product Code: MUH Classification: Class II Panel: Radiology Regulation Number: 21 C.F.R. § 872.1800

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#### Device Description

The JAZZ SOLO Digital Sensor, Model 10-001, is a USB-driven digital sensor designed for health care professionals already acquainted with the standard procedures for acquiring dental intra-oral radiographs. Digital xray imaging is an aide for diagnosis and should always be confirmed by the doctor using additional procedures and other diagnostic aides for confirmation.

The JAZZ SOLO Digial Sensor is positioned in the patient's mouth in the same manner as intra-oral film is positioned.

The JAZZ SOLO Digital Sensor has an x-ray imager (CCD) 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 the JAZZ SOLO Digital Sensor through the standard USB port. Image analysis software is not part of the submission. For the Jazz Solo Digital Sensor to be used in a dental practice, an optional image analysis software will be necessary. Only with imaqe analysis software can acquired images be optimized for specific diagnostic tasks, archived as image files and printed out on a suitable printer.

The JAZZ SOLO Digital Sensor captures x-ray images suitable for recognition of normal anatomical structures, dental pathologies and abnormal conditions. Inadequate images may result in mis-diagnosis, subjecting the patient to incorrect or unnecessary dental procedures that would present an unacceptable risk to the patient.

#### Indications for Use

The JAZZ SOLO digital sensor is intended to acquire dental intra-oral radiographic images. It can be operated by trained dental professionals for patients receiving intraoral x-ray examinations for diagnostic purposes.

## Intended Use

JAZZ SOLO Digital Sensor is intended for any dental practice that uses Xray 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 the Jazz Solo digital sensor is to be used in a dental practice, an optional software will be necessary.

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# Comparison Table

| Descriptive Information | DEXIS Digital Sensor | JAZZ SOLO Digital Sensor |
|-------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K090458 | K163224 |
| Indication for Use | The DEXIS Digital<br>Sensor is a USB-driven<br>digital sensor which is<br>intended to acquire<br>dental intra-oral<br>radiography images.<br>The DEXIS Sensor shall trained dental<br>be operated by<br>healthcare,<br>professionals, who are<br>educated and<br>competent to perform<br>the acquisition of<br>dental intra-oral<br>radiographs. The DEXIS<br>Digital Sensor can be<br>used either in<br>combination with special<br>positioning devices to<br>facilitate positioning and<br>alignment with the x-<br>ray beam or it may<br>also be positioned by<br>hand with the<br>assistance of the<br>patient. | The JAZZ SOLO digital<br>sensor is intended to<br>acquire dental intra-oral<br>radiographic images. It<br>can be operated by<br>trained dental<br>professionals for<br>patients receiving<br>intraoral x-ray<br>examinations for<br>diagnostic purposes |
| Intended Use | The DEXIS Digital<br>Sensor is an indirect<br>converting x-ray<br>detector, e.g. incident<br>x-rays are converted<br>by a scintillating<br>material | The JAZZ SOLO<br>Digital Sensor is a<br>USB-driven digital<br>sensor which is<br>intended to acquire<br>dental intraoral<br>radiography images. |
| into (visible) light, this | The JAZZ SOLO | |
| light is coupled | Digital Sensor shall be | |
| optically to a light | operated by healthcare | |
| detection imager | professionals, who are | |
| based on CMOS | educated and | |
| technology. The | competent to perform | |
| design of the sensor | the acquisition of | |
| assembly supports the | dental intraoral | |
| automatic detection of | radiographs. The JAZZ | |
| the incident x-rays to | SOLO Digital Sensor | |
| generate digital images | can be used either in | |
| for dental intra-oral | combination with the | |
| applications. The | provided JAZZ | |
| DEXIS Digital Sensor | IMAGING positioners, | |
| supports USB 2.0 and | other universal | |
| USB 1.1 connectivity to | positioning devices | |
| personal computers | manufactured to | |
| using a dedicated | facilitate the | |
| electronic assembly | positioning and | |
| and a sensor software | alignment with an x-ray | |
| driver. | beam or it may also be | |
| The DEXIS Digital | positioned by hand | |
| Sensor is a USB-<br>driven digital sensor | with the assistance of | |
| which is intended to | the patient. The JAZZ | |
| acquire dental intra-<br>oral radiography<br>images. | SOLO Digital Sensor | |
| The DEXIS Digital | can be used with | |
| Sensor shall be | patients of any age, | |
| operated by healthcare | providing the correct | |
| professionals, who are | positioning of the | |
| educated and | sensor in the patient | |
| competent to perform | mouth can be realized. | |
| the acquisition of<br>dental intra-oral<br>radiographs. The | JAZZ SOLO Digital | |
| DEXIS digital sensor | Sensor is a suitable | |
| can be used either in | diagnostic method and | |
| combination with | may offer reduced | |
| | radiation exposure | |
| | compared to analog<br>procedures. | |
| special positionip.g<br>devices to facilitate | | |
| positioning and<br>alignment with the x-<br>ray beam or it may<br>also be positioned by<br>hand with the<br>assistance of the<br>patient. | The JAZZ SOLO Digital<br>Sensor can perform and<br>achieve the same type<br>of two dimensional<br>images as conventional<br>(traditional) film sizes 0,<br>1 and 2. However the<br>JAZZ SOLO Digital<br>Sensor cannot be used<br>to, or as a substitution<br>for extraoral or other<br>types of dental x-ray.<br>When using the JAZZ<br>SOLO Digital Sensor<br>as a diagnostic aide,<br>clinical experience and<br>a combination of other<br>diagnostic aides should<br>be used to form a<br>diagnosis and should<br>not be solely relied<br>upon for diagnosis. | |

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| Manufacturer | Sybron Dental<br>Specialties, Inc. | Jazz Imaging LLC |
|-------------------------|----------------------------------------------------------------|----------------------------------------------------------------|
| Trade Name | DEXIS Sensor | JAZZ SOLO Digital Sens |
| Classification Name | Extraoral source x-ray<br>system | Extraoral source x-ray<br>system |
| Classification Panel | Radiology | Radiology |
| Product Code | MUH | MUH |
| Regulation Number | 21 C.F.R. § 872.1800 | 21 C.F.R. § 872.1800 |
| Classification | Class II | Class II |
| Common Name | Digital x-ray sensor | Digital x-ray sensor |
| Number of Sensors | 1 | 1 |
| Sensor Exterior Size | 38.95 mm x 29.75 mm | 39.1 mm x 30 mm |
| Sensor Imaging Size | 32.99 mm x 25.82 mm<br>image area with four<br>clipped corners | 34.85 mm x 26.28 mm<br>image area with four<br>clipped corners |
| Overall Imaging Area | 820 mm2 | 873 mm2 |
| Pixel Size | 19.5 μm | 18 μm |
| Imager Resolution | 1692 by 1324 pixels<br>(2.25 M Pixels) | 1936 x 1460 pixels<br>(2.7 M Pixels) |
| X-Ray Resolution | 20+ visible lp/mm | 20+ visible lp/mm |
| Dynamic Range | 16,384:1 | 4096:1 |
| Technology | CMOS | CCD |
| Scintillator Technology | Cesium Iodide | Cesium Iodide |
| Interface to PC | USB 2.0, Type A Plug | USB 2.0, Type A Plug |
| Cable Length | 2.8 m | 72" Nominal. Extension<br>Supplied |
| Operating System | Microsoft Windows<br>XP© Microsoft and<br>Windows Vista© | Windows 7, 8 or 10 (32<br>or 64 Bit) |
| Power Consumption | 1.4 Watts Max | 1.4 Watts Max |
| Sterilization | Not suitable for<br>sterilization | Not suitable for<br>sterilization |
| | | |
| Housing | IP68<br>10993 Biocompatible | IPx7 Equivalent ISO<br>10993 Biocompatible |
| Electrical Rating | DC 5V, 350 mA max | DC 5V, 350 mA max |

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## Comparison of MTF and DQE for the DEXIS Sensor and the JAZZ SOLO Sensor

The DEXIS Digital Sensor operates only within its proprietary software application and its closed software application performs extensive manipulation of images from the DEXIS Digital Sensor for viewing purposes only. Its proprietary software application does not allow raw images to be generated for scientific evaluation of characteristics such as MTF and DQE. Without Dexis cooperation, which we will not get, these measurements are not possible.

JAZZ Imaging believes that by comparing the MTV and DQE of the DEXIS Digital Sensor with the MTF and DQE of the JAZZ SOLO Digital Sensor that they are substantially equivalent to each other.

## Clinical Testing

Clinical images were provided. These clinical images were not necessary to establish substantial equivalence based on the modifications to the device (note that the x-ray detector technology is similar to predicate). These clinical images provide further evidence in addition to the laboratory performance data to show that the complete system works as intended.

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### Meaningful Differences

The DEXIS Digital Sensor is an X-ray image sensor (CMOS). The JAZZ SOLO Digital Sensor is an x-ray image sensor (CCD). JAZZ Imaging has compared the MTV and DQE of the DEXIS Digital Sensor with the MTF and DQE of the JAZZ SOLO Digital Sensor and has determined they are substantially equivalent to each other. The JAZZ SOLO Digital Sensor is not only similar in performance as the DEXIS Digital Sensor, but is also safe and effective based on performance testing in accordance with the following reference standards:

Recognition Number 5-70: ISO 14971:2007/(R)2010 (Corrected 4 October 2007), medical devices - applications of risk management to medical devices.

Recognition Number 19-4: ES60601-1:2005/(R)2012 and A1:2012,

c1:2009/(r)2012 and a2:2010/(r)2012 (consolidated text) medical electrical equipment - part 1: general requirements for basic safety and essential performance (IEC 60601-1:2005, mod).

Recognition Number 19-12: IEC 60601-1-2:2007/(R)2012, medical electrical equipment - part 1-2: general requirements for basic safety and essential performance - collateral standard: electromagnetic compatibility requirements and tests (edition 3).

Recognition Number 5-89: IEC 60601-1-6 Edition 3.1 2013-10, medical electrical equipment - part 1-6: general requirements for basic safety and essential performance - collateral standard: usability.

Recognition Number 2-156: ISO 10993-1:2009/(R)2013, biological evaluation of medical devices - part 1: evaluation and testing within a risk management process (Biocompatibility).

Recognition Number 5-87: IEC 62366 Edition 1.1 2014-01, Medical devices - application of usability engineering to medical devices.

CB TEST CERTIFICATE for IEC 60601-1-6:2010/AMD1:2013, IEC 60601-1:2005/AMD1:2012 and IEC 62366:2007/AMD1:2014

Reference 510(k) DEXIS Digital Sensor: K090458

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## Comparison of Safety and Effectiveness to the Predicate Device

Using the above Comparison Table the JAZZ SOLO Digital Sensor can be compared to the predicate device, DEXIS Digital Sensor, with respect to intended use, indications of use, environment of use, limitations of technical performance and technological characteristics and provides more detailed information regarding the basis for the determination of substantial equivalence.

## Conclusion:

The JAZZ SOLO Digital Sensor is substantially equivalent to a legally marketed device in the United States. The JAZZ SOLO Digital Sensor is substantially equivalent in intended use, indications for use, safety and effectiveness, and technical characteristics to the DEXIS Digital Sensor marketed by Sybron Dental Specialties, Inc. under its cleared 510(k) submission K090458.