(22 days)
Not Found
No
The document describes a digital x-ray sensor and associated software for image acquisition and basic processing. There is no mention of AI, ML, or advanced image analysis features that would typically indicate the use of such technologies. The focus is on the sensor hardware and basic image display/enhancement.
No.
The device is a digital sensor for acquiring dental intraoral radiography images, used for diagnostic purposes, not for providing therapy or treatment.
Yes
The JAZZ Solo sensor is explicitly stated to be intended for "intraoral diagnostic purposes" and "acquires dental intraoral radiography images" which are used in "diagnostic tasks." It is also referred to as a "diagnostic imaging device" and a "suitable diagnostic method."
No
The device description explicitly states that the JAZZ Solo sensor is a "USB-driven digital sensor" with an "x-ray imager (CMOS)" that creates a digital image. This indicates the device includes hardware components beyond just software. While it requires software to operate fully, it is not a software-only medical device.
Based on the provided text, the JAZZ Solo sensor is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- JAZZ Solo Sensor Function: The JAZZ Solo sensor is a digital x-ray sensor used to capture images of the inside of a patient's mouth. It works by detecting x-rays that pass through the patient's tissues.
- No Specimen Analysis: The device does not analyze any biological specimens from the patient. It directly captures an image based on the interaction of x-rays with the patient's anatomy.
Therefore, the JAZZ Solo sensor falls under the category of a medical imaging device, specifically for dental radiography, rather than an IVD.
N/A
Intended Use / Indications for Use
JAZZ Solo sensor is 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 that can be displayed, enhanced, printed, and saved.
Product codes (comma separated list FDA assigned to the subject device)
MUH
Device Description
The JAZZ Solo sensor, Model 10-002, is a USB-driven digital sensor 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 procedures and other diagnostic aides for confirmation.
The JAZZ Solo sensor design uses advanced ergonomic principles with four beveled corners, a moderate profile and a rounded casing providing enhanced comfort for patients. The JAZZ Solo sensor is positioned in the patient's mouth in the same manner as intra-oral film is positioned.
The JAZZ Solo sensor has an x-ray imager (CMOS) 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 sensor through the standard USB port. Image analysis software is not part of the submission. For the JAZZ Solo sensor 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. The software of the JAZZ Solo sensor being used is unchanged from the predicate JAZZ SOLO Sensor. Firmware for the JAZZ Solo sensor, which controls basic imager function and readout, has been simplified from the predicate JAZZ SOLO Sensor.
The JAZZ Solo sensor captures x-ray images suitable for recognition of normal anatomical structures, dental pathologies, and abnormal conditions.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray
Anatomical Site
intraoral
Indicated Patient Age Range
patients of any age
Intended User / Care Setting
trained dental professionals / 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 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.
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.
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December 10, 2021
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Jazz Imaging LLC dba Jazz Imaging % Mr. W. Edward Johansen Official Correspondent W. Edward Johansen 1239 Stanford Street. #205 SANTA MONICA CA 90404
Re: K213637
Trade/Device Name: JAZZ Solo sensor Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: Class II Product Code: MUH Dated: November 16, 2021 Received: November 18, 2021
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 and Part 809); 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
1
Part 820); 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 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.
. 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)
K213637
Device Name JAZZ Solo sensor
Indications for Use (Describe)
JAZZ Solo sensor is 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 that can be displayed, enhanced, printed, and saved.
| 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 - K213637
Date Summary Prepared: December 6, 2021
A. Submitter Information
Name: Jazz Imaging LLC dba JAZZ Imaging
Address: 770 Charcot Avenue, San Jose, CA 95131 USA
Contact Person: Todd C. Miller
Corporate Telephone: (567) 234-5299
Official Correspondent: W. Edward Johansen
B. Identification of Device
510(k) Number: K213637 Trade Name: JAZZ Solo sensor Common Name: Dental digital x-ray sensor
Classification Name: Extraoral source x-ray system Product Code: MUH Class: Il
Panel: Radiology
Regulation Number: 21 C.F.R. §872.1800
C. Equivalent Legally Marketed Device (Predicate Device) 510(k) Number: K163224 Trade Name: JAZZ SOLO Sensor Manufacturer: Jazz Imaging LLC dba JAZZ Imaging Common Name: Dental digital x-ray sensor Classification Name: Extraoral source x-ray system Product Code: MUH Classification: Panel: Radiology Regulation Number: 21 C.F.R. § 872.1800
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D. Device Description
The JAZZ Solo sensor, Model 10-002, is a USB-driven digital sensor 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 procedures and other diagnostic aides for confirmation.
The JAZZ Solo sensor design uses advanced ergonomic principles with four beveled corners, a moderate profile and a rounded casing providing enhanced comfort for patients. The JAZZ Solo sensor is positioned in the patient's mouth in the same manner as intra-oral film is positioned.
The JAZZ Solo sensor has an x-ray imager (CMOS) 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 sensor through the standard USB port. Image analysis software is not part of the submission. For the JAZZ Solo sensor 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. The software of the JAZZ Solo sensor being used is unchanged from the predicate JAZZ SOLO Sensor. Firmware for the JAZZ Solo sensor, which controls basic imager function and readout, has been simplified from the predicate JAZZ SOLO Sensor.
The JAZZ Solo sensor captures x-ray images suitable for recognition of normal anatomical structures, dental pathologies, and abnormal conditions. Inadequate images may result in misdiagnosis, subjecting the patient to incorrect or unnecessary dental procedures that would present an unacceptable risk to the patient.
E. Indications for Use
The JAZZ Solo sensor is 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 that can be displayed, enhanced, printed, and saved.
F. Intended Use
The JAZZ Solo sensor is a USB-driven digital sensor which is intended to acquire dental intraoral radiography images. The JAZZ Solo sensor shall be healthcare operated on by educated are and competent to perform the acquisition of dental intraoral
5
radiographs. The JAZZ Solo sensor can be used either in combination with the provided JAZZ IMAGING positioners, other universal positioningdevices manufactured to facilitate the positioning and alignmentwith an x-ray beam, or it may also be positioned by hand with the assistance of the patient. The JAZZ Solo sensor can be used with patients of any age, providing the correct positioning of the sensor in the patient mouth can be realized.
The JAZZ Solo sensor requires a dedicated imaging software package to operate at full potential as a diagnostic imaging device. The imaging software is not included and may need to be purchased separately.
Using a JAZZ Solo sensor is a suitable diagnostic method and may offer reduced radiation exposure compared to analog procedures. Furthermore, available software image enhancement tools may enhance sensitivity and consequently reduce errors introduced by subjective analysis.
When using the JAZZ Solo sensor 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.
G. Comparison of Image Qualities
JAZZ Imaging believes that by comparing the MTF, SNR and usable x-ray Dose range of the JAZZ SOLO Sensor with the JAZZ Solo sensor shows that the Image Quality is substantially better in the new JAZZ Solo Sensor.
H. Performance Testing--Clinical
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.
I. Comparison Table
The following comparison table compares the JAZZ Solo sensor to the predicate JAZZ SOLO Sensor 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 Chart
| Manufacturer | Jazz Imaging LLC | Jazz Imaging LLC |
|---|---|---|
| Trade Name | JAZZ SOLO Sensor | JAZZ Solo sensor |
| Classification Name | Extraoral source x-ray system | Extraoral source x-ray system |
| Label | Label contains Part Number (10-001), Serial Number and all required regulatory identification | Label contains Part Number (10-002), Serial Number and all required regulatory identification |
| 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 | 39.1 mm x 30 mm (not including chamfered corners) | 39.1 mm x 30 mm (not including chamfered corners) |
| Sensor Imaging Size | 34.85 mm x 26.28 mm image area with four clipped corners | 34.9 mm x 26.3 mm (not including chamfered corners) |
| Overall Imaging Area | 873 mm2 | 873 mm2 |
| Pixel Size | 18 μm | 18 μm |
| Imager Resolution | 1936 x 1460 pixels (2.7 M Pixels) | 1936 x 1460 pixels (2.7 M Pixels) |
| X-Ray Resolution | 20+ visible lp/mm | 20+ visible lp/mm |
| Dynamic Range | 4096:1 | 16384:1 |
| Technology | CCD | CMOS |
| Scintillator Technology | Cesium lodide | Cesium lodide |
| Interface to PC | USB 2.0, Type A Plug | USB 2.0, Type A Plug |
| Cable Length | 72" Nominal plus 12" Extension Supplied | 72" Nominal plus 36" Extension Supplied |
| Operating System | Windows 7, 8 or 10 (32 or 64 Bit) | Windows 7, 8 or 10 (32 or 64 Bit) |
| Power Consumption | 1.4 Watts Max | 0.7 Watts Max |
| Sterilization | Not suitable for sterilization | Not suitable for sterilization |
| Housing | IPx7 Equivalent ISO 10993 Biocompatible | IPx7 Equivalent ISO 10993 Biocompatible |
| Electrical Rating | DC 5V, 350 mA max | DC 5V, 350 mA max |
| Descriptive Information | Predicate JAZZ SOLO Sensor | JAZZ Solo sensor |
| Indications for Use | The JAZZ SOLO Sensor is | |
| 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 | ||
| that can be displayed, | ||
| enhanced, printed, and | ||
| saved. | The JAZZ Solo sensor is | |
| 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 | ||
| that can be displayed, | ||
| enhanced, printed, and | ||
| saved. | ||
| Intended Use | The JAZZ SOLO Sensor is | |
| a USB-driven digital | ||
| sensor which is intended | ||
| to acquire dental intraoral | ||
| radiography images. The | ||
| JAZZ SOLO Sensor | ||
| shall be operated by | ||
| healthcare professionals, | ||
| who are educated and | ||
| competent to perform the | ||
| acquisition of dental | ||
| intraoral radiographs. | ||
| The JAZZ SOLO Sensor | ||
| can be used either in | ||
| combination with the | ||
| provided JAZZ IMAGING | ||
| positioners, other universal | ||
| positioning devices | ||
| manufactured to facilitate | ||
| the positioning and | ||
| alignment with an x-ray | The JAZZ Solo sensor is a | |
| USB-driven digital sensor | ||
| which is intended to | ||
| acquire dental intraoral | ||
| radiography images. The | ||
| JAZZ Solo sensor shall be | ||
| operated by healthcare | ||
| professionals, who are | ||
| educated and competent | ||
| to perform the acquisition | ||
| of dental intraoral | ||
| radiographs. The JAZZ | ||
| Solo sensor can be used | ||
| either in combination with | ||
| the provided JAZZ | ||
| IMAGING positioners, | ||
| other universal positioning | ||
| devices manufactured to | ||
| facilitate the positioning | ||
| and alignment with an x- | ||
| ray beam, or it may also | ||
| positioned by hand with | ||
| the assistance of the | ||
| patient. The JAZZ SOLO | ||
| Sensor can be used with | ||
| patients of any age, | ||
| providing the correct | ||
| positioning of the sensor in | ||
| the patient mouth can be | ||
| realized. The JAZZ SOLO | ||
| 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. | the assistance of the | |
| patient. The JAZZ Solo | ||
| sensor can be used with | ||
| patients of any age, | ||
| providing the correct | ||
| positioning of the sensor in | ||
| the patient mouth can be | ||
| realized. The JAZZ Solo | ||
| sensor requires a | ||
| dedicated imaging | ||
| software package to | ||
| operate at full potential as | ||
| a diagnostic imaging | ||
| device. The imaging | ||
| software is not included | ||
| and may need to be | ||
| purchased separately. | ||
| Using a JAZZ SOLO | ||
| Sensor is a suitable | ||
| diagnostic method and may | ||
| offer reduced radiation | ||
| exposure compared to | ||
| analog procedures. | ||
| Furthermore, available | ||
| software image | ||
| enhancement tools may | ||
| enhance sensitivity and | ||
| consequently reduce errors | ||
| introduced by subjective | ||
| analysis. | Using a JAZZ Solo sensor | |
| is a suitable diagnostic | ||
| method and may offer | ||
| reduced radiation | ||
| exposure compared to | ||
| analog procedures. | ||
| Furthermore, available | ||
| software image | ||
| enhancement tools may | ||
| enhance sensitivity and | ||
| consequently reduce | ||
| errors introduced by | ||
| subjective analysis. | ||
| When using the JAZZ | ||
| SOLO Sensor 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. | When using the JAZZ Solo | |
| sensor 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. |
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J. Meaningful Differences
The JAZZ Solo sensor has an x-ray image sensor (CMOS). The predicate JAZZ SOLO Sensor has an x-ray image sensor (CCD). JAZZ Imaging has compared the Image Quality of the Solo sensor with the Image Quality of the predicate JAZZ SOLO Sensor and has determined the Image Quality of the JAZZ Solo Sensor is substantially better. The JAZZ Solo sensor is not only better in performance as the predicate JAZZ SOLO Sensor, but is also safe and effective based on performance testing in accordance with the following reference standards:
FR Recognition Number 19-4: ANSI AAMI 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).
FR Recognition Number 19-8: IEC 60601-1-2 Edition 4.0 2014-02/ IEC60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances - Requirements and tests.
FR 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.
FR Recognition Number 5-114: IEC 62366-1 Edition 1.0 2015-02 Medical devices - Application of usability engineering to medical devices.
FR Recognition Number 2-258: ISO 10993-1 Fifth Edition 2008-08 Biological evaluation of medical devices - part 1: evaluation and testing within a risk management process.
FR Recognition Number 5-40: ISO 14971 Second Edition 2007-03-01/(R)2010 (Corrected 4 October 2007 Medical d devices - Applications of risk management to medical devices.
FR Recognition Number 13-79: IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION Medical device software - Software life cycle processes.
K. Comparison of Safety and Effectiveness to the Predicate Device
Using the above Comparison Table, the JAZZ Solo sensor can be compared to the predicate JAZZ SOLO 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.
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L. Summary of Changes
The USB microprocessor to CMOS of the JAZZ Solo sensor and the USB microprocessor to CCD of the JAZZ SOLO Sensor are identical. The software for the predicate JAZZ SOLO Sensor and the software for the JAZZ Solo sensor are identical. The firmware has been simplified from the firmware of the predicate JAZZ SOLO Sensor. The firmware of the JAZZ Solo sensor controls basic imager function and readout. A single FPGA of the JAZZ Solo sensor controls all CMOS timing, acquisition, readout, and sensor functions.
M. Conclusion
JAZZ Solo sensor image quality is substantially better than the legally marketed predicate JAZZ SOLO Sensor, in the United States. The JAZZ Solo sensor is substantially equivalent in intended use, indications for use, safety and effectiveness, and technical characteristics to the predicate JAZZ SOLO Sensor marketed by Jazz Imaging LLC dba JAZZ Imaging under its cleared 510(k) submission K163224.