(99 days)
No
The description focuses on the hardware (sensor technology) and basic software for image interpretation. There is no mention of AI, ML, or advanced image processing techniques that would suggest the use of these technologies. The performance studies listed are standard electrical, safety, and imaging performance tests, not studies related to AI/ML algorithm validation.
No
Explanation: The device is an x-ray sensor used for acquiring images to assist in diagnosis, not for treating diseases or improving health outcomes.
Yes
The 'Intended Use / Indications for Use' explicitly states that the device is intended "to assist in the diagnosing of diseases of the teeth, jaw and oral structures."
No
The device description explicitly states it is an "electronic medical device" and describes hardware components like a sensor, 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, the Apex Dental Sensors is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for the diagnosis, treatment, or prevention of disease.
- Apex Dental Sensors Function: The Apex Dental Sensors is an imaging device that acquires radiographic images of the teeth, jaw, and oral structures using X-rays. It does not analyze biological specimens.
- Intended Use: The intended use is for radiographic examination to assist in diagnosing diseases of the teeth, jaw, and oral structures, which is a function of medical imaging, not in vitro diagnostics.
- Device Description: The description clearly outlines its function as an electronic medical device for acquiring intra-oral radiographic images using X-ray technology.
Therefore, the Apex Dental Sensors falls under the category of a medical imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
MUH
Device Description
The Apex Dental Sensors is an electronic medical device used to acquire 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 x-ray beam. The sensor may also be aligned with the assistance of the patient. The Apex Dental Sensors is an indirect light converting digital x-ray detector. A scintillating device composed of Cesium Iodide (CsI) converts incident x-rays into visible light that is optically coupled to a light detection imager based on CMOS technology. The Apex 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 Apex 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 types of x-ray systems that would 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/kV 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. The Apteryx Xray Vision software needs assistance from a TWAIN driver to recognise X-ray images.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
teeth, jaw, and oral structures
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Dental professional, Radiologists, Dental Assistants and other healthcare 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.
- The Subject Device was tested to conform to the electrical and safety requirements established in AAMI ES 60601-1:2005/(R) 2012 and the electromagnetic compatibility requirements in IEC 60601-1-2 - Edition 3-2007
- The Subject Device was also tested to conform to IEC 6220-1:2003 - Determination of the Detective Quantum Efficiency Detectors used in Radiographic Imaging
- The Subject Device is in compliance with IEC 60601-2-65:2012 – Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment
- The Subject Device is also in compliance with FDA guidance document - 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)
Reference Device(s)
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.
0
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized design featuring three profiles facing to the right, with flowing lines above them. The design is simple and monochromatic.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 28, 2017
Masterlink LLC % Parul Chansoria Regulatory Consultant Elexes 6494 Tralee Village Drive DUBLIN CA 94568
Re: K163282
Trade/Device Name: Apex Dental Sensors Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: February 6, 2017 Received: February 6, 2017
Dear Parul Chansoria:
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.
1
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" (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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D'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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K163282
Device Name Apex Dental Sensors
Indications for Use (Describe)
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.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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) (Signature)
3
This 510(k) Summary has been created per the requirements of the Safe Medical Device Act (SMDA) of 1990, and the content is provided in conformance with 21 CFR Part 807.92.
Submitter's Information
| Table 1 : Submitter's Information | |
|---|---|
| Submitter's Name: | Tom Birney, CEO |
| Masterlink, LLC. | |
| Address: | 24654 N. Lake Pleasant Parkway |
| Suite 103-501 Peoria, AZ 85383 | |
| Contact Person: | Ms. Parul Chansoria |
| Founder, Elexes | |
| Phone: | 650-528-2445 |
| Fax: | ---------- |
| Email: | parul@elexes.com |
| Date of Summary | |
| Preparation: | 11-11-2016 |
Device Information
| Table 2 : Device Information | |
|---|---|
| Trade Name: | Apex Dental Sensors |
| Common Name: | Intraoral Digital x-ray Sensors |
| Classification | |
| Name: | Extraoral source x-ray system |
| Classification | |
| Number: | Class II per 21 CFR 872.1800 |
| Product Code: | MUH |
| Classification | |
| Panel: | Dental |
Predicate Device Information
QuickRay HD Intraoral Sensor (K151926)
Device Description
The Apex Dental Sensors is an electronic medical device used to acquire 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
4
positioning of the sensor is accomplished by the use of dedicated intra-oral positioning devices that facilitate the accurate alignment of the x-ray beam. The sensor may also be aligned with the assistance of the patient. The Apex Dental Sensors is an indirect light converting digital x-ray detector. A scintillating device composed of Cesium Iodide (Csl) converts incident x-rays into visible light that is optically coupled to a light detection imager based on CMOS technology. The Apex 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 Apex 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.
| MFR. | Model | Kv/mA | Adult | Child | ||
|---|---|---|---|---|---|---|
| Anterior | Posterior | Anterior | Posterior | |||
| Progeny | Preva | 65*/*7 | .080-.125 | .125-.200 | .040-.064 | .064-.100 |
| Sirona | Heliodent Plus | 70*/7 | .06-.10 | .10-.16 | .04-.06 | .04-.08 |
| Sirona | Heliodent DS | 60/7 | .80-.12 | .12-.20 | .04-.06 | .04-.10 |
| Gendex | 765DC/Expert DC | 65/7 | .080-.125 | .125-.200 | .040-.063 | .040-.100 |
| Gendex | 770 | 70/7 | 6-7 Pulses | 7-10 Pulses | 4-5 Pulses | 5-7 Pulses |
| PlanMeca | Intra | 66*/8* | .080-.120 | .120-.200 | .040-.080 | .040-.100 |
| Belmont | Belray | 70/7* | .06-.10 | .10-.16 | .04-.06 | .04-.08 |
| Aribex | Normad (Handheld) | 60/2.5 | .34-.40 | .40-.50 | .25-.30 | .30-.36 |
The following are the types of x-ray systems that would integrate with the Apex Dental Sensors.
- Adjustable
The following hardware and software requirements need to be taken into account to ensure successful integration of Apex Dental Sensors with the X-ray systems.
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/kV 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.
Software requirements:
The Apteryx Xray Vision software needs assistance from a TWAIN driver to recognise X-ray images. The recommended requirements for PC hardware for the sensor and software combination would be:
- . Processor: Intel 1.2GHz chip or above
- . Memory: Above 1G
- . Hard disk: Above 40G
5
- Interface: USB 2.0
- Display: Resolution 1024 × 758 (15") or above
- Operating System: Windows XP
- . The computer connected to system shall be in accordance with IEC 60950-1:2005
Indications for Use
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.
Technological Characteristics
The Apex Dental Sensors (Subject Device) makes use of a Predicate Device, QuickRay HD Intraoral Sensor (K151926). The detectors in Apex Dental Sensors are the same as 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 Apex dental sensors are:
- S11684-12 is Size #1 ●
- S11685-12 is Size #2 .
| Table 3: Substantial Equivalence Table for Apex Dental Sensors | |||
|---|---|---|---|
| Parameter | Proposed Device (Subject | ||
| Device) Apex Dental | |||
| Sensors | QuickRay HD | ||
| Intraoral Sensor | |||
| (Predicate Device) | |||
| K151926 | Equivalence | ||
| General | |||
| Manufacturer | Masterlink LLC | Denterprise | |
| International, Inc. | Equivalent | ||
| Intended Use | Radiographic examination | ||
| to assist with diagnosis of | |||
| diseases of the teeth, jaw, | |||
| and oral structure | Radiographic | ||
| examination to assist | |||
| with diagnosis of | |||
| diseases of the teeth, | |||
| jaw, and oral | |||
| structure | Equivalent | ||
| Indication for Use | 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. | QuickRay HD is | ||
| used for a | |||
| radiographic | |||
| examination by a | |||
| dental professional to | |||
| assist in the | |||
| diagnosing of | |||
| diseases of the teeth, | |||
| jaw and oral | |||
| structures | Equivalent | ||
| Class | II | II | Equivalent |
| Common Name | Intraoral Digital x-ray | ||
| Sensor | Intraoral Digital x- | ||
| ray sensor | Equivalent | ||
| Table 3: Substantial Equivalence Table for Apex Dental Sensors | |||
| Parameter | Proposed Device (Subject Device) Apex Dental Sensors | QuickRay HD Intraoral Sensor (Predicate Device) K151926 | Equivalence |
| Product Code | MUH | MUH | Equivalent |
| Classification Panel | Dental | Dental | Equivalent |
| Regulation Number | 21 CFR 872.1800 | 21 CFR 872.1800 | Equivalent |
| Classification Name | Extraoral source x-ray System | Extraoral source x-ray system | Equivalent |
| Key Features | |||
| Number of Sensors | 2 | 2 | Equivalent |
| Cable Length | 2m | 2m | Equivalent |
| Pixel Size | 20 x 20μm | 20 x 20μm | Equivalent |
| Resolution | 20 Lp/mm typ (S11684-12) | >= 20 Lp/mm | Equivalent |
| Technology | CMOS chip +optical fiber plate + CsI scintillator | CMOS chip +optical fiber plate + CsI scintillator | Equivalent |
| Matrix dimensions (mm²) | Sensor Active Area: | ||
| 600mm² (Size 1) | |||
| 884mm² (Size 2) | Sensor Active Area: | ||
| 600mm² (Size 1) | |||
| 884mm² (Size 2) | Equivalent | ||
| 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 | ||
| Other Requirements | |||
| Recommended PC Requirements | 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 XP | |||
| The computer connected to | |||
| system shall be in | |||
| accordance with IEC | |||
| 60950-1:2005. | Pentium 4 or better | ||
| processor. At least 1 | |||
| GB RAM, 200MB of | |||
| hard drive space for | |||
| the software, plus | |||
| additional space for | |||
| the user database | |||
| (recommended 40GB | |||
| minimum), USB 2.0 | |||
| or 3.0 and 100MB | |||
| wired Ethernet | |||
| connection is needed | |||
| if networked. | Equivalent | ||
| Table 3: Substantial Equivalence Table for Apex Dental Sensors | |||
| Parameter | Proposed Device (Subject | ||
| Device) Apex Dental | |||
| Sensors | QuickRay HD | ||
| Intraoral Sensor | |||
| (Predicate Device) | |||
| K151926 | Equivalence | ||
| Connection to | |||
| Imaging Practice PC | USB 2.0 Interface | USB 2.0 High-Speed | Equivalent |
| Software-Image | |||
| Management | Apteryx XrayVision | Apteryx | |
| XrayVision | Equivalent | ||
| Sensor Board | All control electronics | ||
| directly integrated on | |||
| CMOS sensor chip | All control | ||
| electronics directly | |||
| integrated on CMOS | |||
| sensor chip | Equivalent | ||
| Sensor input voltage | |||
| and current | USB2.0 (5V, 4.25min) | 5V (via USB | |
| connection); 0.15A | |||
| Max | Equivalent | ||
| Operating | |||
| Temperature | 0°C~+35°C | 0 °C to 35 °C | Equivalent |
| Electrical Safety | |||
| Standards of | |||
| Conformity | IEC 60601-1-1 (Electrical) | ||
| IEC 60601-1-2 (EMC) | |||
| 62220-1 (Performance) | |||
| IEC 61326-1 (EMC) | |||
| IEC 60601-2-65 | |||
| (Electrical) | IEC 60601-1 | ||
| (Electrical); IEC | |||
| 60601-1-2 (EMC) | |||
| 62220-1 | |||
| (Performance) 60529 | |||
| (IP Code) | Equivalent |
6
7
Similarities
- . The Apex Dental Sensors and Predicate Device both are available in two sizes
- The interface to PC of both Apex Dental Sensors and the Predicate is USB
- . Both Apex Dental Sensors and the Predicate Sensor use CMOS technology, the pixel size for both sensors is 20 x 20um
- The Sensor Active Area for Apex Dental Sensors and Predicate Device is the same i.e., 600mm² ●
8
(Size 1) and 884mm² (Size 2)
- . The principles of operation of Apex Dental Sensors and Predicate Device is the same, i.e., X-ray (radiation)=> scintillator (convert to light) => fiber optic (filtering) => CMOS (convert to digital)=> electronics=> PC (capture & display image)
- The Software-Image Management of Apex Dental Sensors and Predicate Device is the same, i.e., Apteryx XrayVision which has been cleared by the FDA under (K983111)
- Both Apex Dental Sensors and Predicate Device have all control electronics directly integrated on CMOS sensor chip
- . The sensor input voltage is 5V in both Apex Dental Sensors and Predicate Device
- . The operating temperature of Apex Dental Sensors and Predicate Device is also comparable, i.e., 0°C~+35°C
- . The Apex Dental Sensors and the Predicate Device are tested per IEC 60601-1-1 and 60601-1-2 for Electrical Safety and Electromagnetic compatibility
- . The recommended PC requirements in Apex Dental Sensors and the Predicate Device is also comparable. The processor that is recommended for Apex Dental Sensors is Intel 1.2GHz chip or above whereas the processor for the Predicate Device is Pentium 4 or better.
- The Apex Dental Sensors and the Predicate Device have the same sensor resolution.
- The Apex Dental Sensors and the Predicate have the same cable lengths. The sensor cable length in Apex Dental Sensors is 2m and in Predicate Device is also 2m.
- . The interface for Apex 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.
- . The Subject Device was tested to conform to the electrical and safety requirements established in AAMI ES 60601-1:2005/(R) 2012 and the electromagnetic compatibility requirements in IEC 60601-1-2 - Edition 3-2007
- . The Subject Device was also tested to conform to IEC 6220-1:2003 - Determination of the Detective Quantum Efficiency Detectors used in Radiographic Imaging
- . The Subject Device is in compliance with IEC 60601-2-65:2012 – Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment
- . The Subject Device is also in compliance with FDA guidance document - Guidance for the submission of 510(k)s for Solid State X-ray Imaging Devices
Conclusion
The Apex Dental Sensors is substantially equivalent to the Predicate, and does 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).