(208 days)
No
The description focuses on the hardware (CMOS sensor, scintillator, enclosure) and basic image capture/transfer functionality. There is no mention of AI, ML, or advanced image processing beyond simple transfer for diagnostic evaluation by a dentist.
No.
The device is designed for capturing radiographic images for diagnostic purposes, not for providing therapy or treatment.
Yes
The Device Description states that the device transfers the image to an imaging software program on the PC "for diagnostic evaluation." Additionally, the Intended Use / Indications for Use section states the device "should be used under the direction of a licensed Dentist when it is deemed necessary to perform a radiographic series of a patient for diagnostic purposes."
No
The device description clearly details a physical sensor (CMOS photodiode array, scintillator screen, thermoplastic enclosure) that captures the radiographic images. While it includes imaging software, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Z-Ray digital radiography system captures radiographic images of teeth and surrounding structures within the oral cavity. It does not analyze samples taken from the body.
- Intended Use: The intended use is for capturing images for diagnostic purposes, but the diagnosis is made by a licensed dentist based on the visual information in the image, not through the analysis of a biological sample.
- Device Description: The description details a sensor that converts x-rays to visible light and transfers the image. This is a medical imaging device, not a diagnostic test performed on a sample.
Therefore, the Z-Ray digital radiography system falls under the category of a medical imaging device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Z-Ray digital radiography system was designed for the sole purpose of capturing radiographic images of teeth and the surrounding structures limited to the oral cavity. This device should be used under the direction of a licensed Dentist when it is deemed necessary to perform a radiographic series of a patient for diagnostic purposes.
Product codes
MUH
Device Description
The Zuma Dental Z-ray x-ray image sensor is a fully integrated CMOS photodiode array specifically designed for dental radiography. The sensor is available in two image sizes that correspond to a #2 size and a #1 size dental film. Each consists of a matrix of silicon photodiodes on 22.5 um centers. An integrated scintillator screen converts x-ray photons to visible light sensed by the silicon photodiodes.
A rugged thermoplastic enclosure, with rounded corners for patient comfort, protects the sensor from everyday handling and cleaning.
The CMOS sensor connects directly to a USB/PC connection without the need for an intermediate electrical interface. Zuma Z-Ray works with standard dental extra-oral x-ray sources without connection to the x-ray source. Zuma Z-Ray captures an image automatically upon sensing the external x-ray source and after completion of the x-ray procedure, transfers the image to an imaging software program on the PC for diagnostic evaluation.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
Oral cavity, teeth and the surrounding structures
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Licensed Dentist
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)
Summary of Non-Clinical Tests and Evaluations Performed:
Electrical, mechanical and performance safety testing and evaluations were conducted in accordance with ANSI/UL 60601-1 Standard for Safety, Medical Electrical Equipment, Part 1 and, IEC 60601-1-2, Medical Electrical Equipment - Part 1 - 2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests. All test results were satisfactory.
Non-Clinical considerations were conducted in accordance with FDA Guidance "Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices, Section VI". All test results were satisfactory.
Summary of Bench Test:
In-vitro bench testing was conducted according to FDA Guidance "Format for Traditional and Abbreviated 510(k)s, Section 18, Performance Testing - Bench". Results of the bench testing confirmed substantial equivalence in performance between the Zuma Z-Ray System and the predicate device Schick CDR (K072134) included in the test protocol for comparison evaluation. The qualified examiners concluded and certified that the diagnostic images produced by the Z-Ray System are equivalent to those produced by the predicate device.
The Zuma Z-Ray System was also tested at varying external x-ray source exposure parameters and found to continually produce diagnostic quality images as concluded by the examiners.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.1800 Extraoral source x-ray system.
(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.
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K 133206
Page 1 of 5
000018
510k Number: To be determir
MAY 1-3 2014
Section 5
Premarket Notification 510(k) Summary
This summary of 510(k) safety and effectiveness information is submitted in accordance with requirements of 21 CFR Part 807 and FDA Guidance Document "Format for Traditional and Abbreviated 510(K)s"
Submitters Name and Address:
Zuma Dental, LLC 2775 San Nicolo Lane League City, TX 77573 Contact Person: Ekram Khan Tel: (973) 703-4437
Device Name:
- · Trade Name Z-Ray Intra-Oral Digital Radiography System
- · Common Name Digital Dental X-ray System
- · Classification Name Extra-oral source x-ray system
Regulatory Classification:
Class II, per 21 CFR 872.1800 Product Code: MUH
Devices for Which Substantial Equivalence is claimed:
Device Description:
The Zuma Dental Z-ray x-ray image sensor is a fully integrated CMOS photodiode array specifically designed for dental radiography. The sensor is available in two image sizes that correspond to a #2 size and a #1 size dental film. Each consists of a matrix of silicon photodiodes on 22.5 um centers. An integrated scintillator screen converts x-ray photons to visible light sensed by the silicon photodiodes.
1
Image /page/1/Picture/2 description: The image shows the logo for Zuma Dental. The word "zuma" is written in large, bold, black letters. Below the word "zuma" is the word "DENTAL" written in smaller, black letters.
Device Description cont :
A rugged thermoplastic enclosure, with rounded corners for patient comfort, protects the sensor from everyday handling and cleaning.
The CMOS sensor connects directly to a USB/PC connection without the need for an intermediate electrical interface. Zuma Z-Ray works with standard dental extra-oral x-ray sources without connection to the x-ray source. Zuma Z-Ray captures an image automatically upon sensing the external x-ray source and after completion of the x-ray procedure, transfers the image to an imaging software program on the PC for diagnostic evaluation.
Intended/Indications for Use:
The Z-Ray digital radiography system was designed for the sole purpose of capturing radiographic images of teeth and the surrounding structures limited to the oral cavity. This device should be used under the direction of a licensed Dentist when it is deemed necessary to perform a radiographic series of a patient for diagnostic purposes.
Statement of Substantial Equivalence:
The technological characteristics of the Zuma Dental Z-Ray System is essentially the same as the referenced predicate devices with respect to intended use, design, materials and operating characteristics. Minor technological differences do not raise any new questions regarding the safety or effectiveness of the device.
Comparison Table:
The following table compares the technological characteristics between the Zuma Z-Ray System and the referenced predicate devices, Schick Computed Oral Radiography System (K072134) and the Dexis Sensor (K090458).
2
510k Number: To be determined
Image /page/2/Picture/3 description: The image shows the logo for Zuma Dental. The word "zuma" is in large, bold, black letters on the top line. Below that, the word "DENTAL" is in smaller, black letters with a sans-serif font. The logo is simple and modern.
Comparison to Predicate Devices:
| Parameter | Z-Ray
510k #: TBD | Schick CDR System
(K072134) | Dexis Sensor
(K090458) |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The Z-Ray digital
radiography system was
designed for the sole
purpose of capturing
radiographic images of
teeth and the surrounding
structures limited to the
oral cavity. This device
should be used under the
direction of a licensed
Dentist when it is deemed
necessary to perform a
radiographic series of a
patient for diagnostic
purposes. | The Computed Oral
Radiology System is
intended for intra-oral x-ray
examinations and indicated
for dental patients. It
produces instant, digital
intra-oral x-ray images of a
patient's mouth while
reducing the necessary x-
ray dosage. | The Dexis sensor is a
USB-driven digital sensor
which is intended to
acquire dental intra-oral
radiology images. The
Dexis sensor shall be
operated by healthcare
professionals who are
educated and competent
to perform the acquisition
of dental intra-oral
radiographs. The Dexis
sensor can be used either
in combination with
special positioning devices
to facilitate positioning and
alignment with the x-ray
beam or it may also be
positioned by hand with
the assistance of a
patient. |
| Number of Sensors | 2 | 3 | 1 |
| Sensor size (mm)
Active Area | 32.6 x 20.5mm
36 x 27mm | 31 x 22mm
37 x 24mm
43 x 30mm | 30 x 39mm |
| Sensor Technology | CMOS | CMOS | CMOS |
| System Technology | Computed Direct
Radiography | Computed Direct
Radiography | Computed Direct
Radiography |
| Interface to PC | USB | USB | USB |
| Data Box
Connection to PC | Standard USB Cable | Standard USB Cable | Standard USB Cable |
| Power Supply | Powered through USB
connection | Powered through USB
connection | Powered through USB
connection |
| Dynamic Range | 4096:1 | 4096:1 | 16,384:1 |
| Image Capture S/W
Req'd | Yes | Yes | Yes |
| Sensor Cable
Length (m) | 2.0m | 2.0m | 2.8m |
3
Image /page/3/Picture/2 description: The image shows the logo for Zuma Dental. The word "zuma" is in large, bold, black letters on the top line. Underneath, the word "DENTAL" is in smaller, black letters.
Safety and Effectiveness Information:
Summary of Non-Clinical Tests and Evaluations Performed:
Electrical, mechanical and performance safety testing and evaluations were conducted in accordance with ANSI/UL 60601-1 Standard for Safety, Medical Electrical Equipment, Part 1 and, IEC 60601-1-2, Medical Electrical Equipment - Part 1 - 2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests. All test results were satisfactory.
Non-Clinical considerations were conducted in accordance with FDA Guidance "Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices, Section VI". All test results were satisfactory.
The software of the Zuma Z-Ray System has been validated according to FDA "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and applicable requirements contained in the guidance document.
Summary of Bench Test:
In-vitro bench testing was conducted according to FDA Guidance "Format for Traditional and Abbreviated 510(k)s, Section 18, Performance Testing - Bench". Results of the bench testing confirmed substantial equivalence in performance between the Zuma Z-Ray System and the predicate device Schick CDR (K072134) included in the test protocol for comparison evaluation. The qualified examiners concluded and certified that the diagnostic images produced by the Z-Ray System are equivalent to those produced by the predicate device.
The Zuma Z-Ray System was also tested at varying external x-ray source exposure parameters and found to continually produce diagnostic quality images as concluded by the examiners.
4
510k Number: To be determin
Image /page/4/Picture/7 description: The image shows the logo for Zuma Dental. The word "zuma" is written in large, bold, sans-serif letters. Below "zuma" is the word "DENTAL" in a smaller, sans-serif font. There is a horizontal line below the word "DENTAL".
Conclusion:
Based on analyzing the device characteristics, bench-test, safety and non-clinical testing to applicable standards, it is the conclusion of Zuma Dental, LLC that the Z-Ray Digital Imaging System is as safe and effective as the referenced predicate devices. The Z-Ray system has minimal technological differences compared to the legally marketed predicate devices and is safe and effective for its intended use as well as substantially equivalent to the predicate devices.
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three wavy lines representing the department's mission to promote health, well-being, and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 13, 2014
Zuma Dental, LLC % Albert Rego, Ph.D. Regulatory Consultant 27001 La Paz Road, Suite 312 MISSION VIEJO CA 92691
Re: K133206
Trade/Device Name: Z-Ray Intra-Oral Digital Radiography System Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: April 12, 2014 Received: April 16, 2014
Dear Dr. Rego:
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 cnactment date of the Medical Device Amendments, or 10 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 notc: CDRH docs not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not mislcading.
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.
6
Page 2-Dr. Rego
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 (800) 638 2041 or (301) 796-7100 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" (21CFR 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/McdicalDevices/Safetv/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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Smh. 7)
for
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
7
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
510(k) Number (if known) K133206
Device Name
Zuma Dental Z-Ray Intra-Oral Digital Radiography System
Indications for Use (Describe)
The Z-Ray digital radiography system was designed for the sole purpose of capturing radiographic images of teeth and the surrounding structures limited to the oral cavity. This device should be used under the direction of a licensed Dentist when it is deemed necessary to perform a radiographic series of a palient 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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signalure)
FORM FDA 3881 (9/13)