(23 days)
No
The description focuses on the hardware (sensor technology, connectivity) and basic software interpretation for image generation. There is no mention of AI/ML terms, advanced image analysis, or performance metrics typically associated with AI/ML algorithms.
No
This device is for diagnostic purposes, specifically for capturing x-ray images of dental structures, and does not provide therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended to be used by dentists and other qualified professionals for providing diagnostic x-ray radiographs of dentition, jaws and other oral structures." The generation of diagnostic images directly aligns with the definition of a diagnostic device.
No
The device description explicitly states "The ODI HD Dental Sensors are electronic medical device intra-oral radiographic images" and details hardware components like a scintillating device, CMOS technology, and USB connectivity. While software is mentioned for image interpretation, the core device is a physical sensor.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide diagnostic x-ray radiographs of dentition, jaws, and other oral structures. This is a form of in vivo imaging, where the device interacts with the patient's body to produce an image.
- Device Description: The description clearly states it's an "intra-oral radiographic image" device and an "indirect light converting digital x-ray detector." It receives X-rays that have passed through the patient's body.
- 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. This device does not analyze biological samples.
The device is a medical imaging device used for diagnostic purposes, but it operates in vivo rather than in vitro.
N/A
Intended Use / Indications for Use
ODI HD Dental Sensor is intended to be used by dentists and other qualified professionals for providing diagnostic x-ray radiographs of dentition, jaws and other oral structures.
Product codes
MUH
Device Description
The ODI HD Dental Sensors are electronic medical device intra-oral radiographic images. The sensor can be operated by Radiologists, Dental Assistants and other healthcare professionals, who are both trained and competent to take Dental X-ray radiographs. Intra-oral positioning of the sensor is accomplished by the use of dedicated intra-oral positioning devices that facilitate the accurate alignment of the sensor may also be aligned with the assistance of the patient. The ODI HD Dental Sensors is an indirect light converting digital x-ray detector. A scintillating device composed of Cesium lodide (Csl) converts incident x-rays into visible light that is optically coupled to a light detection imager based on CMOS technology. The ODI HD Dental Sensors allow for automatic detection of such incident x-rays in order to generate data. Software interprets this data into images used for dental applications. The ODI HD Dental Sensors support USB 2.0 direct connectivity to personal computers and or laptops with dedicated electronics and a sensor software driver. The subject device does not control the generator, it is only a receiver. The X-ray system and the software used are not a part of this submission.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
dentition, jaws and other oral structures.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dentists and other qualified professionals
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)
The following Performance testing has been performed on the Subject Device in accordance with appropriate FDA guidance documents and relevant standards, to support the determination of substantial equivalence. The test data showed that the Subject device is safe and effective for its intended use.
- Electrical and safety requirements established in AAMI ES 60601-1:2005/(R) 2012 .
- Electromagnetic compatibility requirements in IEC 60601-1-2 Edition 3-2007 .
- IEC 62220-1:2015 – Determination of the Detective Quantum Efficiency Detectors used in Radiographic Imaging
- IEC 60529:2001 - Degrees of Protection Provided by Enclosures (IP Code)
- The Subject Device is also in compliance with FDA guidance for the submission of 510(k)s for Solid State X-ray Imaging Devices
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.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.1800 Extraoral source x-ray system.
(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.
0
Image /page/0/Picture/0 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 the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath in a smaller font.
CND Global Technologies, Inc. % Ms. Lisa Jager Regulatory Affairs Consultant Regulatory Science Solutions LLC 11576 W. M179 Hwy MIDDLEVILLE MI 49333
March 1, 2019
Re: K190234
Trade/Device Name: ODI HD Dental Sensor Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: Class II Product Code: MUH Dated: February 1, 2019 Received: February 6, 2019
Dear Ms. Jager:
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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,
Michael D. 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
2
4. Indications for Use Statement
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
Device Name ODI HD Dental Sensor
Indications for Use (Describe)
ODI HD Dental Sensor is intended to be used by dentists and other qualified professionals for providing diagnostic x-ray radiographs of dentition, jaws and other oral structures.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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FORM FDA 3881 (7/17)
3
K190234
510(k) Summary
| Submitted By: | CND Global Technologies, Inc.
16 Branch Avenue
Cumberland, RI 02864
319-333-6767 |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Lisa Jager
Regulatory Affairs Consultant
11576 W. M179 Hwy
Middleville, MI 49333
regulatorysciencesolutions@gmail.com
616-802-2364 |
| Date of Summary
Preparation | January 30, 2019 |
| Trade Name | ODI HD Dental Sensors |
| Submission Number | K190234 |
| Common Name | Intraoral Digital x-ray Sensors |
| Classification Name | Extraoral source x-ray system |
| Classification | Class II per 21 CFR 872.1800 |
| Product Code | MUH |
| Classification Panel | Dental |
Predicate Device Information
| Submitted By: | Masterlink LLC |
|---|---|
| Trade Name | Apex Dental Sensors |
| Submission Number | K163282 |
| Common Name | Intraoral Digital x-ray Sensors |
| Classification Name | Extraoral source x-ray system |
| Classification | Class II per 21 CFR 872.1800 |
| Product Code | MUH |
| Classification Panel | Dental |
Device Description
The ODI HD Dental Sensors are electronic medical device intra-oral radiographic images. The sensor can be operated by Radiologists, Dental Assistants and other healthcare professionals, who are both trained and competent to take Dental X-ray radiographs. Intra-oral positioning of the sensor is accomplished by the use of dedicated intra-oral positioning devices that facilitate the accurate alignment of the sensor may also be aligned with the assistance of the patient. The ODI HD Dental Sensors is an indirect light converting digital x-ray detector. A scintillating device composed of Cesium lodide (Csl) converts incident x-rays into visible light that is optically coupled to a light detection imager based on CMOS technology. The ODI HD Dental Sensors allow for automatic detection of such incident x-rays in order to generate data. Software interprets this data into images used for dental applications. The ODI HD Dental Sensors support USB 2.0 direct connectivity to personal computers and or laptops with dedicated electronics and a sensor software driver. The subject device does not control the generator, it is only a receiver. The X-ray system and the software used are not a part of this submission.
The following hardware and software requirements need to be taken into account to ensure successful integration of ODI HD Dental Sensors with the X-ray systems.
4
Hardware requirements:
The type of x-ray systems that integrate with the Apex Dental Sensors are wall-mounted x-ray generators (both AC and DC) with a tube current between 1 and 15 mA inclusive, and with a tube voltage between 50 and 100 kV inclusive, with in-built controls to set exposure parameters. Generators allow variable mA/K/ to be selected, all will control the exposure time.
The subject device is only a receiver, and not a controller. The subject device and the software cannot act as the controller of an x-ray generators are controlled by built-in controllers and are not part of the subject device.
Premium Plus Disposable Barrier Sleeve (K163447) - Premium Plus Disposable Barrier Sleeve is intended to be used as a disposable barrier sleeve for ODI HD Dental Sensors. The Premium Plus Disposable Barrier Sleeve is non-sterile and intended for single patient use only.
Software requirements:
The Apteryx XrayVision software needs assistance from a TWAIN driver to recognize X-ray images. The recommended requirements for PC hardware for the sensor and software combination would be:
- . Processor: Intel core i5-250m 2.5GHz or Higher
- . Memory: 4G or higher
- Hard disk: Above 20G, 60G recommended
- Interface: USB 2.0 ●
- Display: Resolution 1024 × 758 (15") or above .
- Operating System: .
- O Microsoft Windows 10(64/32 bit)
- o Microsoft Windows 8.1(64-bit)
- Microsoft Windows 8(64-bit) O
- Windows 7 SP1 32 and 64-bit o
- . The computer connected to system shall be in accordance with IEC 60950-1:2005
Indications for Use
ODI HD Dental Sensor is intended to be used by dentists and other qualified professionals for providing diagnostic xray radiographs of dentition, jaws and other oral structures.
Technological Characteristics
The ODI HD Dental Sensors (Subject Device) makes use of a Predicate Device, Apex Dental Sensors (K163282). The detectors in the ODI HD Dental Sensors are the detectors in the predicate device. The subject device and the predicate device are identical and sourced from the same supplier Hamamatsu. The model numbers of the ODI HD Dental Sensors are:
S11684-12 is Size #1 S11685-12 is Size #2
| Attribute | Subject Device-
ODI HD Dental Sensors | Predicate Device-
Apex Dental Sensors (K163282) | Equivalence | Difference and
Justification |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| General | | | | |
| Manufacturer | CND Global Technologies Inc. | Masterlink LLC | | |
| Classification and
Product Code | Class II
21 CFR 872.1800
MUH | Class II
21 CFR 872.1800
MUH | Equivalent | No difference |
| Common Name | Intraoral Digital X-ray Sensors | Intraoral Digital X-ray Sensors | Equivalent | No difference |
| Classification Name | Extraoral source X-ray System | Extraoral source X-ray System | Equivalent | No difference |
| Classification Panel | Dental | Dental | Equivalent | No difference |
| Intended Use | Providing diagnostic x-ray radiographs of
dentition, jaws and other oral structures. | Radiographic examination
to assist with diagnosis of
diseases of the teeth, jaw,
and oral structure. | Equivalent | No difference |
| Indications for Use | ODI HD Dental Sensors is intended to be used by
dentists and other qualified professionals for
providing diagnostic x-ray radiographs of
dentition, jaws and other oral structures. | The Apex Dental Sensors is
intended to be used for a
radiographic examination by
a dental professional to assist
in the diagnosing of diseases
of the teeth, jaw and oral
structures. | Equivalent | No difference |
| Number of Sensors | 2 | 2 | Equivalent | No difference |
| Cable Length | 2m | 2m | Equivalent | No difference |
| Pixel Size | 20 x 20 µm | 20 x 20 µm | Equivalent | No difference |
| Resolution | 20 Lp/mm typ
(S11684-12) | 20 Lp/mm typ
(S11684-12) | Equivalent | No difference |
| Technology | CMOS chip +optical fiber
plate + Csl scintillator | CMOS chip +optical fiber plate +
Csl Scintillator | Equivalent | No difference |
| Matrix dimensions
(mm²) | Sensor Active Area:
600mm² (Size 1)
884mm² (Size 2) | Sensor Active Area:
600mm² (Size 1)
884mm² (Size 2) | Equivalent | No difference |
| Principles of
Operation | X-ray (radiation) =>
scintillator (convert to
light) => fiber optic
(filtering) => CMOS
(convert to digital)=>
electronics=> PC (capture
& display image) | X-ray (radiation) =>
scintillator (convert to
light) => fiber optic
(filtering) => CMOS
(convert to digital)=>
electronics=> PC (capture
& display image) | Equivalent | No difference |
| | Other Requirements | | | |
| Recommended PC
Requirements | Processor: Intel core i5-250m 2.5GHz or
Higher or above; Memory: Above 4G;
Hard disk: Above 20G, Interface: USB
2.0;
Display: Resolution 1024 × 768 (15") or
above
Operating System: Microsoft Windows
10(64/32 bit)
Microsoft Windows 8.1(64-bit)
Microsoft Windows 8(64-bit)
Windows 7 SP1 32 and 64-bit
The computer connected to
system shall be in accordance with IEC
60950-1:2005. | Processor: Intel 1.2GHz chip or
above; Memory: Above 1G;
Hard disk: Above 40G; Interface:
USB 2.0;
Display: Resolution 1024 ×
758 (15") or above
Operating System: Windows
ХР
The computer connected to
system shall be in accordance
with IEC
60950-1:2005. | Equivalent | The Processor,
Memory, Hard Disk
and Operating
System
requirements for
supporting use of
the subject and
predicate device
differ slightly but are
found to be
equivalent. The
outside supporting
PC requirements do
not impact the
devices intended
use, technical
requirements or
safety requirements.
No differences are
noted for Display
and Computer IEC
requirements. |
| Connection to Imaging
Practice PC | USB 2.0 Interface | USB 2.0 Interface | Equivalent | No difference |
| Software-Image
Management | Apteryx XrayVision | Apteryx XrayVision | Equivalent | No difference |
| Sensor Board | All control electronics
directly integrated on
CMOS sensor chip | All control electronics
directly integrated on
CMOS sensor chip | Equivalent | No difference |
| Sensor input voltage
and current | USB2.0 (5V, 4.25min) | USB2.0 (5V, 4.25min) | Equivalent | No difference |
| Operating
Temperature | 0°C~+35°C | 0°C~+35°C | Equivalent | No difference |
| Electrical Safety | | | | |
| Standards of
Conformity | IEC 60601-1 (Electrical)
IEC 60601-1-2 (EMC)
IEC 62220-1 (Performance)
IEC 60529 (Performance) | IEC 60601-1-1 (Electrical)
IEC 60601-1-2 (EMC)
62220-1 (Performance)
IEC 61326-1 (EMC)
IEC 60601-2-65 (Electrical) | Equivalent | Cited standards
differ slightly,
however the devices
are still found to be
equivalent as the
main Electrical, EMC
and Performance
standards cited are
the same. |
5
6
Similarities
- . The ODI HD Dental Sensors and Predicate Device both are available in two sizes
- The interface to PC of both ODI HD Dental Sensors and the Predicate is USB ●
- Both ODI HD Dental Sensors and the Predicate Sensor use CMOS technology, the pixel size for both sensors is 20 x ● 20 um
- . The Sensor Active Area for ODI HD Dental Sensors and Predicate Device is the same i.e., 600mm2 (Size 1) and 884mm2 (Size 2)
- The principles of operation of ODI HD Dental Sensors and Predicate Device is the same, i.e., X-ray (radiation)=> . scintillator (convert to light) => fiber optic (filtering) => CMOS (convert to idigital)=> electronics=> PC (capture & display image)
- . The Software-Image Management of ODI HD Dental Sensors and Predicate Device is the same, i.e., Apteryx XrayVision which has been cleared by the FDA under (K983111)
- Both ODI HD Dental Sensors and Predicate Device have all control electronics directly integrated on CMOS sensor chip .
- The sensor input voltage is 5V in both ODI HD Dental Sensors and Predicate Device ●
- The operating temperature of ODI HD Dental Sensors and Predicate Device is also comparable, i.e., 0°C~+35°C ●
- The ODI HD Dental Sensors and the Predicate Device are tested per IEC 60601-1-2 for Electrical Safety ● and Electromagnetic compatibility
- . The recommended PC requirements in ODI HD Dental Sensors and the Predicate Device is also comparable. The processor that is recommended for ODI HD Dental Sensors is Intel core i5-250m 2.5GHz or Higher, whereas the processor for the Predicate Device is Intel 1.2GHz chip or above
- The ODI HD Dental Sensors and the Predicate Device have the same sensor resolution ●
- The ODI HD Dental Sensors and the Predicate have the same cable lengths. The sensor cable length in ODI HD Dental . Sensors is 2m and in Predicate Device is also 2m.
- . The interface for ODI HD Dental Sensors requires USB 2.0, and the Predicate Device also utilizes USB 2.0.
Performance Data
The following Performance testing has been performed on the Subject Device in accordance with appropriate FDA guidance documents and relevant standards, to support the determination of substantial equivalence. The test data showed that the Subject device is safe and effective for its intended use.
- Electrical and safety requirements established in AAMI ES 60601-1:2005/(R) 2012 .
- Electromagnetic compatibility requirements in IEC 60601-1-2 Edition 3-2007 .
- . IEC 62220-1:2015 – Determination of the Detective Quantum Efficiency Detectors used in Radiographic Imaging
- . IEC 60529:2001 - Degrees of Protection Provided by Enclosures (IP Code)
- The Subject Device is also in compliance with FDA guidance for the submission of 510(k)s for Solid ● State X-ray Imaging Devices
Clinical Performance
Clinical data is not needed to characterize performance and establish substantial equivalence. The non-clinical test data characterizes all performance aspects of the device based on well-established scientific and engineering principles. Clinical testing has not been conducted on the ODI HD Dental Sensors.
Conclusion
The ODI HD Dental Sensors are substantially equivalent to the Predicate, and do not raise any new or different questions of safety or effectiveness. The subject and the predicate devices are identical; the only difference exists in the trade names (for marketing purposes).