(21 days)
Not Found.
No
The document describes standard X-ray imaging and reconstruction techniques, and explicitly states that AI, DNN, or ML were not found in the description.
No
The device is described as an x-ray device for diagnostic support, image acquisition, and image reconstruction, not for providing therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is "for use in diagnostic support," and the "Device Description" calls it a "diagnostic dental X-ray equipment." Furthermore, it mentions that the images "provide useful diagnostic information" when interpreted by a trained physician.
No
The device description explicitly states that the device includes hardware components such as a column, carriage, rotating unit (containing tube head, sensors, and collimator), upper shelf, and patient head support, in addition to software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The ORTHOPANTOMOGRAPH™ OP 3D is an x-ray device that takes images of the cranio-maxillofacial complex. It uses external energy (x-rays) to create images for diagnostic support.
- No Biological Samples: The description does not mention the device analyzing any biological samples from the patient.
The device is a medical imaging device used for diagnostic purposes, but it operates by generating and detecting x-rays, not by analyzing biological specimens.
N/A
Intended Use / Indications for Use
ORTHOPANTOMOGRAPH™ OP 3D is an x-ray device to take panoramic and 3D images of the cranio-maxillofacial complex for use in diagnostic support.
ORTHOPANTOMOGRAPH™ OP 3D must only be used and operated by dentist and other qualified professionals.
Product codes (comma separated list FDA assigned to the subject device)
OAS
Device Description
ORTHOPANTOMOGRAPH™ OP 3D x-ray unit is a software controlled diagnostic dental X-ray equipment for producing panoramic and 3D images of the cranio-dentomaxillofacial complex of patient head. The ORTHOPANTOMOGRAPH™ OP 3D has panoramic programs (adult, child, TMJ, BW and partial) and 3D (CBCT) programs with different 3D Field of View configurations. The components of the device include column, carriage, rotating unit (containing tube head, sensors and collimator), upper shelf, patient head support and driver software including image reconstruction. Workstation software for viewing the images is not included in this submission.
The proposed device utilizes cone beam X-ray technology, which generates conical x-ray beams that rotate around the patient's head and incident upon the receptor that generate sufficiently contrasted images. Quality of the images depends on the level and amount of X-ray energy delivered to the tissue. When interpreted by a trained physician, these images provide useful diagnostic information.
Mentions image processing
Yes, "driver software including image reconstruction." and "The reconstruction of 3D images from 2D image data in the proposed device is made using the same reconstruction techniques as in the predicate device."
Mentions AI, DNN, or ML
Not Found.
Input Imaging Modality
X-ray
Anatomical Site
cranio-maxillofacial complex, cranio-dentomaxillofacial complex, teeth, jaw and TMJ areas of head.
Indicated Patient Age Range
Not Found. (Mentions "adult" and "child" panoramic programs, but no specific age ranges)
Intended User / Care Setting
dentist 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)
Non-Clinical Performance Data: Internal design verification and validation were performed. Electrical, mechanical, safety, performance, and EMC testing were conducted according to relevant IEC standards by a 3rd party test house, and the device passed all tests. Biocompatibility evaluation was conducted on patient contacting accessory parts and found to be in conformance with ISO 10993-1. Bench test images acquired using ORTHOPANTOMOGRAPH™ OP 3D were reviewed by qualified clinicians and found to be of acceptable quality for the proposed Intended Use.
Clinical Performance Data: No clinical images were utilized for this submission. Clinical data was not needed to support substantial equivalence.
Key Results: The device successfully passed all non-clinical design verification and validation tests, and bench test images were deemed acceptable by qualified clinicians.
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.
ORTHOPANTOMOGRAPH™ OP300, K133544
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.
Not Found.
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.
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(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 features an abstract design of three stylized human profiles facing right, stacked vertically and slightly overlapping. The profiles are rendered in black and have a flowing, wave-like quality. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 7, 2017
PaloDEx Group Oy % Terho Turkumaki QA&RA Manager Nahkelantie 160 FI-04300 Tuusula FINLAND
Re: K170813
Trade/Device Name: ORTHOPANTOMOGRAPH™ OP 3D Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: OAS Dated: March 10, 2017 Received: March 17, 2017
Dear Terho Turkumaki:
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 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
Indications for Use
510(k) Number (if known) K170813
Device Name ORTHOPANTOMOGRAPH™ OP 3D
Indications for Use (Describe)
ORTHOPANTOMOGRAPH™ OP 3D is an x-ray device to take panoramic and 3D images of the cranio-maxillofacial complex for use in diagnostic support.
ORTHOPANTOMOGRAPH™ OP 3D must only be used and operated by dentist and other qualified professionals.
| 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) |
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3
510(k) SUMMARY for ORTHOPANTOMOGRAPH™ OP 3D
Submitter Information:
Palodex Group Oy Nahkelantie 160 FI-04300 Tuusula Finland
| Contact Person: | Terho Turkumäki |
|---|---|
| Telephone Number: +358 10 270 2000 | |
| Fax Number: | +358 50 320 9113 |
Date Prepared: March 10, 2017
Device Name:
| Proprietary Name: | ORTHOPANTOMOGRAPH™ OP 3D |
|---|---|
| Common Name: | X-ray, Tomography, Computed, Dental |
| Classification Name: | Computed tomography x-ray system |
| CFR Number: | 892.1750 |
| Device Class: | II |
| Product Code: | OAS |
Predicate Device:
| Proprietary Name: | ORTHOPANTOMOGRAPH™ OP300 |
|---|---|
| 510(k) Number | K133544 |
| Common Name: | X-ray, Tomography, Computed, Dental |
| Classification Name: Computed tomography x-ray system | |
| CFR Number: | 892.1750 |
| Device Class: | |
| Product Code: | OAS |
Description of Device
ORTHOPANTOMOGRAPH™ OP 3D x-ray unit is a software controlled diagnostic dental X-ray equipment for producing panoramic and 3D images of the cranio-dentomaxillofacial complex of patient head. The ORTHOPANTOMOGRAPH™ OP 3D has panoramic programs (adult, child, TMJ, BW and partial) and 3D (CBCT) programs with different 3D Field of View configurations. The components of the device include column, carriage, rotating unit (containing tube head, sensors and collimator), upper shelf, patient head support and driver software including image reconstruction. Workstation software for viewing the images is not included in this submission.
The proposed device utilizes cone beam X-ray technology, which generates conical x-ray beams that rotate around the patient's head and incident upon the receptor that generate sufficiently contrasted images. Quality of the images depends on the level and amount of X-ray energy delivered to the tissue. When interpreted by a trained physician, these images provide useful diagnostic information.
4
The following quidances were followed when preparing this 510k submission:
-Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, May 11, 2005
-Guidance for Industry and FDA Staff: Premarket Assessment of Pediatric Medical Devices, March 24, 2014
-Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices, September 1, 2016 -Guidance for Industry and Food and Drug Administration Staff: Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices, July 11, 2016. -Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf Software Use in Medical Devices, September 9, 1999
-Guidance for the Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, October 2, 2014"
-FDA Guidance "Use of International Standard ISO 10993-1, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a Risk management process".
Description of Substantial Equivalence
| | Concept | Proposed device
(ORTHOPANTOMOGRAPH™ OP
3D) | Predicate device
(ORTHOPANTOMOGRAPH™
OP300, K133544) |
|----|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1. | Indications for Use/
Intended Use | ORTHOPANTOMOGRAPH™ OP 3D
is an x-ray device to take panoramic
and 3D images of the cranio-
maxillofacial complex for use in
diagnostic support.
ORTHOPANTOMOGRAPH™ OP 3D
must only be used and operated by
dentist and other qualified
professionals | The OP300 dental panoramic,
cephalometric and cone beam
computed tomography x-ray device is
intended for dental radiographic
examination of teeth, jaw and TMJ
areas by producing conventional 2D
x-ray images as well as x-ray
projection images of an examined
volume for the reconstruction of a 3D
view. The device is operated and
used by qualified healthcare
professionals. |
| 2. | Imaging modes | Panoramic, TMJ, 3D (CBCT) | Panoramic, TMJ, 3D (CBCT),
Cephalometric (optional) |
| 3. | Focal spot | 0.5mm | 0.5mm |
| 4. | Image detector(s) | CMOS Flat Panel | CMOS Flat Panel +CMOS detector
(Pan/ceph) |
| 5. | 3D imaging technique | Reconstruction from 2D images | Reconstruction from 2D images |
| 6. | 3D's Field Of View | 5 x 5
6 x 9
9 x 11
9 x 14 (optional) | 5 x 5
6 x 8
8 x 8
8 x 15
13 x 15 (optional) |
| 7. | 3D's total viewing
angle | 360 | 360 |
5
| 8. | 3D's effective
exposure time | 1.7 - 20 sec | 1.2 - 12.5 |
|-----|---------------------------------------------|-----------------------------------------------|-----------------------------------------------|
| 9. | 3D Reconstruction
Time | 1-3 min | 1-3 min |
| 10. | Patient's Position | Standing and wheelchair | Standing and wheelchair |
| 11. | System footprint
(includes the operator) | H167-247cm x D77-100cm x 130 cm | H161-241cm x D139cm x W97-193
cm |
| 12. | Weight | App. 100 kg | App. Pan/3D 205 kg
Ceph 240 kg |
| 13 | Classification | OAS | OAS |
| 14 | 3D resolution | Low , standard, high, endo | Low , standard, high, endo |
| 15 | 2D imaging programs | Adult Pan, Child Pan, TMJ, BW, Partial
Pan | Adult Pan, Child Pan, TMJ, BW,
Partial Pan |
| 16 | CMOS flat panel size | 147.3mm x 113.7 mm
(1488x1148 pixels) | 124.8mm x 124.8mm
(1248x1248 pixels) |
| 17 | CMOS flat panel pixel
size | 99um x 99um | 100um x 100um |
| 18 | System MTF @10%,
FOV 5x5 High Res | 2.2 lp/mm @125µm voxel | 2.25 lp/mm @125µm voxel |
Indications for Use
ORTHOPANTOMOGRAPH™ OP 3D is an x-ray device to take panoramic and 3D images of the cranio-maxillofacial complex for use in diagnostic support.
ORTHOPANTOMOGRAPH™ OP 3D must only be used and operated by dentist and other qualified professionals.
The proposed ORTHOPANTOMOGRAPH™ OP 3D has similar Intended Use/ Indications for Use as the predicate device ORTHOPANTOMOGRAPH™ OP300. Difference in Intended Use statements is due to the different imaging modes available. The proposed ORTHOPANTOMOGRAPH OP 3D does not have cephalometric imaging. Cranio-maxillofacial complex encompasses the same anatomy than in the predicate device i.e teeth, jaw and TMJ areas of head.
Principle of Operation
The proposed ORTHOPANTOMOGRAPH™ OP 3D shares similar architectural components and principle of operation as the predicate device ORTHOPANTOMOGRAPH™ OP300. Both devices utilize cone beam x-ray technology to acquire volumetric data, which generates conical x-ray beams that rotate around the patient's head and incident upon the receptor that generate sufficiently contrasted images similar to the predicate devices. The reconstruction of 3D images from 2D image data in the proposed device is made using the same reconstruction techniques as in the predicate device. Additionally the interfaces to 2D/3D image viewing software are similar. There is no substantial difference in the functionality for the data acquisition, data/image display nor integration with 2D/3D imaging software of ORTHOPANTOMOGRAPH™ OP 3D, when compared to the predicate device. The proposed and the predicate device utilize the similar format for interfacing with the 2D and/or 3D imaging software.
6
Technological Characteristics
The technical characteristics of the proposed device and predicate device, including imaging technology, available Field of Views, technical resolution and other basic technological characteristics are substantially equivalent to the predicate device ORTHOPANTOMOGRAPH™ OP300. The proposed ORTHOPANTOMOGRAPH™ OP 3D can produce 2D and 3D images of the cranio-maxillofacial areas of equivalent diagnostic quality as the images with the predicate device ORTHOPANTOMOGRAPH OP300 (K133544). Differences in technical characteristics are small and the device performance is equivalent as evidenced through verification and validation testing.
Non-Clinical Performance Data
As part of the design control activities, the ORTHOPANTOMOGRAPH™ OP 3D device has successfully passed internal design verification and validation.
Electrical, mechanical, safety and performance testing according to standards IEC 60601-1: 2005, IEC 60601-1-6:2013, IEC 62366:2014, IEC 60601-2-63:2012, IEC 60601-2-28:2010, and IEC 60601-1-3:2007 were performed, and EMC testing was conducted in accordance with standard IEC 60601-1-2:2014. Testing was completed by 3rd party test house, and the proposed ORTHOPANTOMOGRAPH™ OP 3D has passed all tests.
Biocompatibility evaluation was conducted on patient contacting accessory parts and their material and found to be in conformance with ISO 10993-1.
Software for ORTHOPANTOMOGRAPH™ OP 3D has been categorized as Moderate Level of Concern and documented according to Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
Bench test images acquired using ORTHOPANTOMOGRAPH OP™ 3D was reviewed by qualified clinicians to be of acceptable quality for the proposed Intended Use.
Clinical Performance Data
No clinical images were utilized for this submission. Clinical data was not needed to support substantial equivalence.
Conclusion as to Substantial Equivalence
There are no significant differences between the proposed ORTHOPANTOMOGRAPH™ OP 3D and predicate ORTHOPANTOMOGRAPH™ OP300 (K133544). Minor differences have been shown not to affect the substantial equivalence of the device.
The proposed device does not introduce a fundamentally new scientific technology and the nonclinical tests demonstrate that the device is substantially equivalent with regards to safety and effectiveness. All internal verification and validation has been completed successfully.
In summary, the proposed ORTHOPANTOMOGRAPH™ OP 3D device is substantially equivalent to the predicate ORTHOPANTOMOGRAPH™ OP300 device.