(153 days)
No
The document describes standard digital x-ray imaging and image management software without mentioning AI or ML capabilities for image analysis or diagnosis.
No.
The device is used to capture x-ray images for diagnostic purposes, not for treating diseases or conditions.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "to assist in the diagnosing of diseases of the teeth, jaw and oral structures" and is for "dental diagnostic purposes."
No
The device description explicitly states it is comprised of two components: an intraoral detector (hardware) and an Image Management Software package.
Based on the provided information, the QuickRay HD device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples from the human body. The core function of an IVD is to examine specimens like blood, urine, tissue, etc., to provide information about a person's health.
- QuickRay HD is an imaging device. Its purpose is to capture radiographic images of the teeth, jaw, and oral structures using X-rays. It does not analyze any biological samples.
- The intended use is for radiographic examination and diagnosis. The device assists in diagnosis by providing visual information (X-ray images), not by analyzing biological markers or substances.
Therefore, the QuickRay HD falls under the category of a medical imaging device, specifically a digital intraoral X-ray sensor, rather than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
MUH
Device Description
The subject QuickRay HD are intraoral digital x-ray systems comprised of two components: (1) an intraoral detector which connects to a PC via a USB port; and (2) an Image Mangement Software package. The subject devices comes in two sizes: Size 1 is 600mm² and Size 2 is 884mm². QuickRay HD, Size 1 is also known as factory code S11684-12; QuickRay HD, Size 2 is also known as factory code S116845-12. The type of x-ray systems that integrate with the QuickRay HD sensor are wall-mounted xray 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. This device and software cannot act as an x-ray generator controller. All control of x-ray generation is done by controls built into the generator itself. There is no connection between the subject device and the x-ray generator. The subject device does not control the generator, it is a receiver. X-ray Vision, software by Apteryx (K983111) cleared on November 16. 1998, is supported on Windows SP. Vista. 7. 8. 8.1 and 10. Absolute minimum requirements for PC hardware for the sensor and software combination would be a Pentium 4 or better processor. At least 1 GB of RAM, 200MB of hard drive space for the software, plus additional space for the user database (recommended 40GB minimum), a USB 2.0 or 3.0 and a 100MB wired Ethernet connection is needed if networked. The Xray Vision software by Apteryx is a Windows based image management database/software primarily used by dentists to acquire, enhance, store, communicate, print, recall and display digital images.
Mentions image processing
Yes
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 / Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical images were examined by Dr. Parham, a qualified practitioner in Ormond Beach, FL and found to be diagnostically relevant and reliable.
Biocompatible testing for the subject is not warranted because there are no direct or indirect patient-contacting components in the subject device. It is covered with a single-use protective barrier prior to each use just like the Opteo predicate.
EMC and electrical safety testing data reports for the subject device are provided in this petition.
The QuickRay HD sensor conforms to electrical and safety standard IEC 60601-1 Medical Electrical Equipment, Part I: General requirements for basic safety and essential performance).
The QuickRay HD sensor conforms to electrical and safety standard IEC 60601-1-2 (Medical Electrical Equipment, Part 1-2: General requirements for basic safety and essential 3271performance - collateral standard: Electromagnetic compatibility).
QuickRay HD electronics contains firmware along with a driver both provided by Hamamatsu. Additionally, QuickRay HD uses image management software provided by Apteryx Company; therefore, only firmware and driver documentation for the subject device are included in this petition.
Bench tests were performed in conformance with IEC 6220-1 (Medical Electrical Equipment - Characteristics of Digital X-ray Imaging Devices-Part 1: Determination of the Detective Quantum Efficiency and IEC 60529 (Degrees of Protection Provided by Enclosures-IP Codes).
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.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized graphic of three human profiles facing right, stacked on top of each other. The profiles are connected and form a single, flowing shape. The graphic is surrounded by a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 14, 2015
Denterprise International, Inc. % Mr. Claude Berthoin Regulatory Executive, Owner 100 East Granada Blvd., Suite 219 ORMOND BEACH FL 32176
Re: K151926
Trade/Device Name: OuickRav HD Intraoral Sensor Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: November 24, 2015 Received: November 30, 2015
Dear Mr. Berthoin:
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,
Robert Oals
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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Indications for Use
510(k) Number (if known)
Device Name QuickRay HD Intraoral Sensor
Indications for Use (Describe)
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.
| 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)
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Image /page/3/Picture/0 description: The image shows the logo for Denterprise International, Inc. The logo features a stylized blue tooth graphic to the left of the word "DENTERPRISE" in gray block letters. Below "DENTERPRISE" is the text "INTERNATIONAL, INC" in smaller gray letters.
100 E. Granada Blvd. Suite 219 Ormond Beach, FL 32176 Ph: 386-672-0450 800-323-2690
510 (k) Summary
Submitter
Denterprise International, Inc. 100 East Granada Blvd., Suite 219 Ormond Beach, FL 32176
Phone: 386-672-045 Fax: 855-235-7902 Contact Person: Claude Berthoin Date Prepared: July 10, 2015
Device Classification
Trade Name: QuickRay HD Common Name: Intraoral Digital X-Ray Sensor Regulation Number: 21 CFR 872.1800 Classification Name: Extraoral Source X-Ray System Product Code: MUH Submission Type: 510(k) Regulatory Class: 2 Medical Specialty: Dental
Predicate Device
The following predicate is a legally marketed, post-amendment device:
510(k) Number: K133271 Clearance Date: April 28, 2014 Actual Trade Name: Opteo Regulation & PC: 872.1800; MUH
Reference Device: 510(k) Number: K150823 August 265, 2015 Clearance Date:
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Actual Trade Name: EDLENi Intra-oral Sensor Regulation & PC:
K150823 was in review when the subject device was submitted in July. This device is identical to the subject device. The K150823 would have been used as the predicate had it been available.
Device Description
The subject QuickRay HD are intraoral digital x-ray systems comprised of two components: (1) an intraoral detector which connects to a PC via a USB port; and (2) an Image Mangement Software package.
The subject devices comes in two sizes: Size 1 is 600mm² and Size 2 is 884mm².
QuickRay HD, Size 1 is also known as factory code S11684-12; QuickRay HD, Size 2 is also known as factory code S116845-12.
Before Denterprise sells this device, our technicians discuss the hardware and software that the dentist has, to make sure that their systems are compatible with the QuickRay HD sensor. Denterprise offers technical support for this device to ensure proper operation and to answer any questions regarding the function of the device. A means to contact Denterprise is provided to all end users and in our user manual.
The type of x-ray systems that integrate with the QuickRay HD sensor are wall-mounted xray 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.
This device and software cannot act as an x-ray generator controller. All control of x-ray generation is done by controls built into the generator itself. There is no connection between the subject device and the x-ray generator. The subject device does not control the generator, it is a receiver.
X-ray Vision, software by Apteryx (K983111) cleared on November 16. 1998, is supported on Windows SP. Vista. 7. 8. 8.1 and 10. Absolute minimum requirements for PC hardware for the sensor and software combination would be a Pentium 4 or better processor. At least 1 GB of RAM, 200MB of hard drive space for the software, plus additional space for the user database (recommended 40GB minimum), a USB 2.0 or 3.0 and a 100MB wired Ethernet connection is needed if networked.
The Xray Vision software by Apteryx is a Windows based image management database/software primarily used by dentists to acquire, enhance, store, communicate, print, recall and display digital images.
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The firmware in the QuickRay HD has already been cleared. The exact same device as the subject is EDLENi Intra-Oral Sensor, K150823. We could not use this device as our predicate because it was in review and cleared August 26, 2015. Our subject device was submitted for review in July 10, 2015. The subject device is identical in firmware/hardware from Hamamatsu, and the software is identical from Aptervx. Hamamatsu is the main subcontractor of this device for Denterprise International, Inc.
The EDLENi device also has 2 sizes like our subject device. The subject device and the EDLENi device are identical in all aspects of the device. They will have different names only for marketing purposes. The subject and predicate device are similar and the differences do not change the safety and effectiveness of the subject device.
The latest publication of CR Clinicians the November newsletter reports that 70% of all the practices use dental sensors and only 16% use film. This newsletter may be reviewed in section 21 Other.
Indications for Use
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.
Intended Use
Radiographic examination to assist with diagnosis of diseases of the teeth, jaw, and oral structure.
The QuickRay HD dental sensor is intended to replace film and to capture an intraoral x-ray image, when exposed to X-rays, for dental diagnostic purposes.
Comparison of Technological Characteristics with Predicate
The subject QuickRay HD and predicate Opteo are similar dental devices.
Both are comprised of the following two components...
- . Intraoral Detector System... The subject device and predicate device includes an intraoral detector, flexible cord, and direct USB 2.0 plug, as described in subject OuickRay HD and predicate Opteo marketing literature in this petition
- Imaging Software... The subject is using a third party software called Xray Vision . which is manufactured by Apteryx in Akron, Ohio (K983111) cleared November 16, 1998. The predicate uses Owandy proprietary software called QuickView.
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Comparison Table
| | QuickRay HD
(Subject) | Opteo
(Predicate) | Differences |
|----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| 510(k) | Not assigned yet | K133271 (Cleared April
28, 2014) | NA |
| Applicant/Assembler/
Repackager/Relabeler | Denterprise International
(Ormond Beach, FL) | Owandy (Croissy-
Beauvourg, France | NA |
| Manufacturer-Imaging SW
Component | Apteryx (Akron, OH) | Owandy, France | Similar |
| Classification & Product Code | 872.1800; MUH | 872.1800; MUH | None |
| Common name | Intraoral Digital X-Ray
Sensor | Intraoral Digital X-Ray
Sensor | None |
| 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. | None |
| 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) | None |
| Software-Firmware | Firmware combined on
sensor electronic board | Firmware combined on
sensor electronic board | None |
| Software-Image Management | Xray Vision (OTS package
from Apteryx, USA) | Owandy proprietary
(QuickView) third party | None |
| Sensor technology | QuickRay HD: CMOS chip
- optical fiber plate + CSi
scintillator | CMOS chip + optical fiber
plate + CSi scintillator | None |
| Matrix dimensions (mm2) | Active area: 600mm²
(Size 1) 884mm² (Size 2) | Active area: 600mm²
(Size 1); 900mm² (Size 2) | None |
| Matrix dimensions (pixels) | 1000 lines X 1500
columns (Size 1); 1300 X
1700 (Size 2). | 1000 lines X 1500
columns (Size 1); 1300 X
1700 (Size 2). | None |
| Lifespan CMOS | Min. 100,000 cycles | Min. 100,000 cycles | None |
| Resolution | Real ≥ 20pl/mm | Real ≥ 20pl/mm | None |
| Pixel size | 20 X 20μm | 20 X 20μm | None |
| Grey levels | 14 bits | 14 bits | None |
| Sensor board | All control electronics
directly integrated on
CMOS sensor chip | All control electronics
directly integrated on
CMOS sensor chip | None |
| Sensor shell | Specific shape design;
material is ABS and the
flammability is HB if YK-
94 (UL File No. 49895) | Specific shape design;
material is thermoplastic
polyamide (Grilamid
LV3H Black) | None |
| Cable material and design | Cable consists of PVC,
ETFE, copper, plug
connector and sensor
connector, diameter ф3.7
±0.3 and cable length 2
meters. | 4 conductor cable with
polyurethane sheath,
external global diameter
of 3.5mm | None |
| Connection to imaging practice
PC | USB 2.0 High-Speed | USB 2.0 High-Speed | None |
| Operating temperature | 0°C to 35°C | 10°C to 40°C | None |
| Sensor input voltage and current | 5V (via USB connection);
0.15A Max | 5V (via USB connection);
0.15A Max | None |
| Standards of conformity | IEC 60601-1 (Electrical);
IEC 60601-1-2 (EMC)
62220-1 (Performance)
60529 (IP Code) | IEC 60601-1 (Electrical);
IEC 60601-1-2 (EMC) | None |
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Input Calculation software*1 Output
$$DQE = \frac{MTF^2}{\Phi \cdot NMPS}$$
Image /page/7/Figure/3 description: The figure shows a plot of DQE [%] versus Spatial Frequency [cycles/mm]. The x-axis ranges from 0 to 25, while the y-axis ranges from 0.0 to 1.0. The plot shows a curve that starts at approximately 0.45 DQE at 0 cycles/mm and decreases to nearly 0 DQE at 25 cycles/mm.
8
Image /page/8/Figure/0 description: This image is a plot of the Modulation Transfer Function (MTF) versus spatial frequency. The x-axis represents spatial frequency in cycles per millimeter, ranging from 0 to 25. The y-axis represents the MTF, ranging from 0 to 1. The plot shows a curve that starts at MTF=1 at a spatial frequency of 0 and gradually decreases as the spatial frequency increases, indicating a reduction in image contrast with increasing spatial frequency.
Image /page/8/Figure/1 description: The figure is a plot of NNPS [mm^2] vs Spatial Frequency [cycles/mm]. The y-axis is on a log scale from 1.E-08 to 1.E-04. The x-axis is on a linear scale from 0 to 30. The plot shows a curve that decreases from approximately 1.E-06 at x=0 to approximately 1.E-07 at x=25.
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Performance Data
Clinical images were examined by Dr. Parham, a qualified practitioner in Ormond Beach, FL and found to be diagnostically relevant and reliable.
Biocompatibility
Biocompatible testing for the subject is not warranted because there are no direct or indirect patient-contacting components in the subject device. It is covered with a single-use protective barrier prior to each use just like the Opteo predicate.
Electrical Safety and EMC
EMC and electrical safety testing data reports for the subject device are provided in this petition.
- The QuickRay HD sensor conforms to electrical and safety standard IEC 60601-1 ● (Medical Electrical Equipment, Part I: General requirements for basic safety and essential performance).
- The QuickRay HD sensor conforms to electrical and safety standard IEC 60601-1-2 (Medical Electrical Equipment, Part 1-2: General requirements for basic safety and essential 3271performance - collateral standard: Electromagnetic compatibility).
Software Verification and Validation Testing
QuickRay HD electronics contains firmware along with a driver both provided by Hamamatsu. Additionally, QuickRay HD uses image management software provided by Apteryx Company; therefore, only firmware and driver documentation for the subject device are included in this petition.
Bench Testing
Bench tests were performed in conformance with IEC 6220-1 (Medical Electrical Equipment - Characteristics of Digital X-ray Imaging Devices-Part 1: Determination of the Detective Quantum Efficiency and IEC 60529 (Degrees of Protection Provided by Enclosures-IP Codes).
Conclusions
The subject and the predicate device have the same intended use and the same technological features. QuickRay HD and Opteo share the same principles of operation, sensor technology,
10
use the same USB connection to PC and use similar imaging firmware. The conclusion is that the subject device is as safe and effective as the predicate.
Since the subject device went in for review an identical device has been cleared. The EDLENi with K150823 was cleared August 26, 2015. This device is identical to the subject device. The sensors will only have different brand names for marketing purposes. Again, K150823 and K151926 are identical. Therefore, QuickRay HD warrants a finding of substantial equivalence to both the legally marketed original Opteo and the newly cleared EDLENi sensor and thus clearance for premarket activities in the United States.