(99 days)
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.
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 (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.
The provided document is a 510(k) premarket notification for a medical device called "Apex Dental Sensors". The purpose of this notification is to demonstrate substantial equivalence to a legally marketed predicate device, QuickRay HD Intraoral Sensor (K151926).
The document does not describe a study involving patient data, expert evaluation, or MRMC comparative effectiveness to establish the device's performance in a clinical context or against specific acceptance criteria related to diagnostic accuracy. Instead, the performance data presented focuses on engineering and safety standards to show that the new device performs equivalently to its predicate.
Therefore, many of the requested items (sample size, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable or cannot be extracted from this specific 510(k) summary.
Here's a breakdown based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria provided are primarily based on equivalence to the predicate device and conformity to various engineering and safety standards. There are no clinical performance acceptance criteria (e.g., sensitivity, specificity for detecting a specific disease) reported in this document.
| Parameter | Acceptance Criteria (Equivalent to Predicate / Standard Conformance) | Reported Device Performance |
|---|---|---|
| General | ||
| Intended Use | Equivalent to Predicate | Radiographic examination to assist with diagnosis of diseases of the teeth, jaw, and oral structure |
| Indications for Use | Equivalent to Predicate | 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. |
| Classification (Class, Panel) | Equivalent to Predicate | Class II, Dental Panel |
| Common Name | Equivalent to Predicate | Intraoral Digital x-ray Sensor |
| Product Code | Equivalent to Predicate | MUH |
| Regulation Number | Equivalent to Predicate | 21 CFR 872.1800 |
| Classification Name | Equivalent to Predicate | Extraoral source x-ray System |
| Key Features | ||
| Number of Sensors | Equivalent to Predicate | 2 |
| Cable Length | Equivalent to Predicate | 2m |
| Pixel Size | Equivalent to Predicate | 20 x 20μm |
| Resolution | Equivalent to Predicate | 20 Lp/mm typ (S11684-12) |
| Technology | Equivalent to Predicate | CMOS chip +optical fiber plate + CsI scintillator |
| Matrix dimensions (Active Area) | Equivalent to Predicate | 600mm² (Size 1), 884mm² (Size 2) |
| Principles of Operation | Equivalent to Predicate | X-ray (radiation) => scintillator (convert to light) => fiber optic (filtering) => CMOS (convert to digital) => electronics => PC (capture & display image) |
| Software-Image Management | Equivalent to Predicate (Apteryx XrayVision) | Apteryx XrayVision |
| Sensor Board | Equivalent to Predicate (control electronics integrated on CMOS chip) | All control electronics directly integrated on CMOS sensor chip |
| Sensor Input Voltage | Equivalent to Predicate (5V) | USB2.0 (5V, 4.25min) |
| Operating Temperature | Equivalent to Predicate (0°C to 35°C) | 0°C ~ +35°C |
| Other Requirements / Standards | ||
| Recommended PC Requirements | Comparable to Predicate | Processor: Intel 1.2GHz or above, Memory: 1G+, Hard disk: 40G+, Interface: USB 2.0, Display: 1024x758+, OS: Windows XP, IEC 60950-1:2005 compliant PC. |
| Connection to Imaging PC | Equivalent to Predicate (USB 2.0) | USB 2.0 Interface |
| Electrical Safety | Conformance to IEC 60601-1-1 | Conforms to AAMI ES 60601-1:2005/(R) 2012 |
| EMC | Conformance to IEC 60601-1-2 | Conforms to IEC 60601-1-2 - Edition 3-2007, IEC 61326-1 |
| Performance Imaging | Conformance to IEC 6220-1 | Conforms to IEC 6220-1:2003 (Determination of DQE) |
| Dental X-ray Equipment | Conformance to IEC 60601-2-65 | Conforms to IEC 60601-2-65:2012 |
| FDA Guidance | Conformance to Solid State X-ray Imaging Devices guidance | In compliance with FDA guidance document (Solid State X-ray Imaging Devices) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document describes a premarket notification based on technical and performance equivalence to a predicate device and adherence to industry standards, not a clinical study with a test set of patient data. Therefore, this information is not applicable and not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable, as no clinical test set requiring expert ground truth establishment is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical test set is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is an intraoral digital x-ray sensor, a hardware component for image acquisition, not an AI-powered diagnostic software. Therefore, an MRMC study related to AI assistance for human readers is not relevant or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a hardware sensor, not an algorithm, so standalone AI performance is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as no clinical study requiring ground truth is described. The "ground truth" in this context is the predicate device's established performance and the requirements of various engineering and safety standards.
8. The sample size for the training set
Not applicable. This is a hardware device; thus, there is no AI model requiring a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for an AI model.
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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.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (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
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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)
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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, CEOMasterlink, LLC. |
| Address: | 24654 N. Lake Pleasant ParkwaySuite 103-501 Peoria, AZ 85383 |
| Contact Person: | Ms. Parul ChansoriaFounder, Elexes |
| Phone: | 650-528-2445 |
| Fax: | ---------- |
| Email: | parul@elexes.com |
| Date of SummaryPreparation: | 11-11-2016 |
Device Information
| Table 2 : Device Information | |
|---|---|
| Trade Name: | Apex Dental Sensors |
| Common Name: | Intraoral Digital x-ray Sensors |
| ClassificationName: | Extraoral source x-ray system |
| ClassificationNumber: | Class II per 21 CFR 872.1800 |
| Product Code: | MUH |
| ClassificationPanel: | 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
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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
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- 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 (SubjectDevice) Apex DentalSensors | QuickRay HDIntraoral Sensor(Predicate Device)K151926 | Equivalence |
| General | |||
| Manufacturer | Masterlink LLC | DenterpriseInternational, Inc. | Equivalent |
| Intended Use | Radiographic examinationto assist with diagnosis ofdiseases of the teeth, jaw,and oral structure | Radiographicexamination to assistwith diagnosis ofdiseases of the teeth,jaw, and oralstructure | Equivalent |
| Indication for Use | The Apex Dental Sensors isintended to be used for aradiographic examination bya dental professional to assistin the diagnosing of diseasesof the teeth, jaw and oralstructures. | QuickRay HD isused for aradiographicexamination by adental professional toassist in thediagnosing ofdiseases of the teeth,jaw and oralstructures | Equivalent |
| Class | II | II | Equivalent |
| Common Name | Intraoral Digital x-raySensor | 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 tolight) => fiber optic(filtering) => CMOS(convert to digital)=>electronics=> PC (capture& display image) | X-ray (radiation) =>scintillator (convertto light) => fiberoptic (filtering) =>CMOS (convert todigital)=>electronics=> PC(capture & displayimage) | Equivalent |
| Other Requirements | |||
| Recommended PC Requirements | Processor: Intel 1.2GHzchip or above;Memory: Above 1G ;Hard disk: Above 40G;Interface: USB 2.0;Display: Resolution 1024 ×758 (15") or aboveOperating System:Windows XPThe computer connected tosystem shall be inaccordance with IEC60950-1:2005. | Pentium 4 or betterprocessor. At least 1GB RAM, 200MB ofhard drive space forthe software, plusadditional space forthe user database(recommended 40GBminimum), USB 2.0or 3.0 and 100MBwired Ethernetconnection is neededif networked. | Equivalent |
| Table 3: Substantial Equivalence Table for Apex Dental Sensors | |||
| Parameter | Proposed Device (SubjectDevice) Apex DentalSensors | QuickRay HDIntraoral Sensor(Predicate Device)K151926 | Equivalence |
| Connection toImaging Practice PC | USB 2.0 Interface | USB 2.0 High-Speed | Equivalent |
| Software-ImageManagement | Apteryx XrayVision | ApteryxXrayVision | Equivalent |
| Sensor Board | All control electronicsdirectly integrated onCMOS sensor chip | All controlelectronics directlyintegrated on CMOSsensor chip | Equivalent |
| Sensor input voltageand current | USB2.0 (5V, 4.25min) | 5V (via USBconnection); 0.15AMax | Equivalent |
| OperatingTemperature | 0°C~+35°C | 0 °C to 35 °C | Equivalent |
| Electrical Safety | |||
| Standards ofConformity | 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); IEC60601-1-2 (EMC)62220-1(Performance) 60529(IP Code) | Equivalent |
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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 ●
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(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).
§ 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.