i-CAT FLX V series / KaVo 3D eXam+ V series
Device Facts
| Record ID | K162085 |
|---|---|
| Device Name | i-CAT FLX V series / KaVo 3D eXam+ V series |
| Applicant | Imaging Sciences International |
| Product Code | OAS · Radiology |
| Decision Date | Nov 10, 2016 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1750 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
Devices of the i-CAT family consist of an x-ray system that uses a cone beam with a rotational sequence, providing two dimensional images and three dimensional volume reconstructions of the head area, which includes ENT and maxillofacial areas (such as TM Joint studies, mandible & maxilla for implant planning, sinuses, airway), for use in planning and diagnostic support in adult and pediatric care. Devices of the i-CAT family comprise a package of software modules capable of handling 2D and 3D data. This includes 3D reconstruction, storage, retrieval, viewing, and processing of 2D and 3D-image data.
Device Story
Cone Beam Volumetric Tomography (CBCT) and panoramic dental imaging system; utilizes X-ray source on motorized gantry and amorphous silicon detector to capture 2D/3D head/neck images. System includes electric seat for patient positioning; operates in CBCT or panoramic modes. Software (SmartScan STUDIO) performs image acquisition, quality assurance, calibration, and reconstruction using modified Feldkamp algorithm. Clinicians use touchscreen interface to select protocols (Standard, QuickScan, QuickScan+); radiation dose (DAP) displayed on screen. Post-processing software (e.g., TxSTUDIO) enables viewing, simulation, and planning for implants, orthodontics, and surgery. System provides diagnostic images for physician interpretation; aids in clinical decision-making for maxillofacial/ENT procedures.
Clinical Evidence
Clinical images acquired using the device were reviewed by qualified clinicians and deemed to be of acceptable clinical effectiveness for the proposed indications. No formal clinical trial data (e.g., sensitivity/specificity metrics) provided; reliance on bench testing and clinical image review.
Technological Characteristics
CBCT system; high-frequency constant potential generator; stationary anode tungsten X-ray tube (120 kVp, 3-7 mA). Amorphous silicon detector with CsI conversion screen (1536x1920 matrix, 127 µm pixel pitch). 360° orbital rotation. Intel-based PC workstation. Connectivity via DICOM. Biocompatibility per ISO 10993-5/10. Electrical safety per IEC 60601-1, 60601-1-2, 60601-1-3, 60601-1-6, 60601-2-63, 62366.
Indications for Use
Indicated for 2D and 3D dental/maxillofacial/ENT imaging (TMJ, implant planning, sinuses, airway) in adult and pediatric patients for diagnostic support and treatment planning.
Regulatory Classification
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.
Predicate Devices
Reference Devices
- TxSTUDIO (K123519)
Submission Summary (Full Text)
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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 and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 10, 2016
Imaging Sciences International % Ms. Ruth Pui Regulatory Affairs Manager 1910 North Penn Road HATFIELD PA 19440
Re: K162085
Trade/Device Name: i-CAT FLX V series / KaVo 3D eXam+ V series Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: OAS Dated: October 25, 2016 Received: October 26, 2016
Dear Ms. Pui:
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)
# K162085
Device Name
Cone Beam 3D and 2D Panoramic Dental Imaging System (i-CAT FLX V series/ KaVo 3D eXam+ V series)
#### Indications for Use (Describe)
Devices of the i-CAT family consist of an x-ray system that uses a cone beam with a rotational sequence, providing two dimensional images and three dimensional volume reconstructions of the head area, which includes ENT and maxillofacial areas (such as TM Joint studies, mandible & maxilla for implant planning, sinuses, airway), for use in planning and diagnostic support in adult and pediatric care.
Devices of the i-CAT family comprise a package of software modules capable of handling 2D and 3D data. This includes 3D reconstruction, storage, retrieval, viewing, and processing of 2D and 3D-image data.
Type of Use (Select one or both, as applicable)
| <div> <span> <b> </b> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <b> </b> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |
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# 510(k) Summary for i-CAT FLX V Series / KaVo 3D eXam+ V Series
series
| 1. Submitter Information: |
|----------------------------------------|
| Imaging Sciences International, |
| also dba DEXIS, Gendex Dental Systems |
| 1910 North Penn Road, |
| Hatfield, PA 19440 |
| Phone: 215-997-5666; Fax: 215-997-5665 |
| Contact Person: | Ruth Pui |
|-------------------|----------------------------|
| Title: | Regulatory Affairs Manager |
| Direct Phone No.: | (267) 954-1479 |
| Date Prepared: | October 25, 2016 |
|----------------|------------------|
|----------------|------------------|
| 2. Device Name: | |
|----------------------|--------------------------------------|
| Proprietary Name: | i-CAT FLX V series / KaVo 3D eXam+ V |
| Common Name: | X-ray, Tomography, Computed, Dental |
| Classification Name: | Computed tomography x-ray system |
| CFR Number: | 892.1750 |
| Device Class: | II |
| Product Code: | OAS |
| 3. Predicate Devices: | |
|-----------------------|-------------------------------------|
| Proprietary Name: | GALILEOS family |
| 510(k) Number | K123070 |
| Common Name: | X-ray, Tomography, Computed, Dental |
| Classification Name: | Computed tomography x-ray system |
| CFR Number: | 892.1750 |
| Device Class: | II |
| Product Code: | OAS |
| Proprietary Name: | i-CAT FLX |
|----------------------|-------------------------------------|
| 510(k) Number | K133620 |
| Common Name: | X-ray, Tomography, Computed, Dental |
| Classification Name: | Computed tomography x-ray system |
| CFR Number: | 892.1750 |
| Device Class: | II |
| Product Code: | OAS |
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## 4. Description of Device:
i-CAT FLX V series / KaVo 3D eXam+ V series manufactured by Imaging Sciences International, is a Cone Beam Volumetric Tomography and Panoramic X-ray dental imaging system that consists of a scanner and a software package for image reconstruction. The two models, i-CAT FLX / KaVo 3D eXam+, are of identical design in the i-CAT Scanner family. The components of the system include the main affixed unit, the overhead, the gantry, the tube head, the X-ray source assembly and collimator, the receptor panel, and software package for image reconstruction. The system is an open design that allows patients to sit upright during a procedure. An electric powered seat is built into the scanner for proper patient positioning. The V series refer to 3 different fieldof-view configurations (V8, V10, V17) available on each model based on licensing of the acquisition software.
The software package includes a device specific software package (SmartScan STUDIO) that is required to operate the i-CAT FLX System through a visual touchscreen interface and a post-processing imaging software. The modules within the device specific software perform the Image Acquisition, Quality Assurance, Device Calibration, and Image Reconstruction and Processing functionalities of the device. The software utilizes a modified Feldkamp algorithm for reconstruction. There is a basic DICOM viewer component (with limited image viewing capabilities) for the operator to ensure that the data collection and image processing are correct. Also provided with the device is a postprocessing imaging software, such as TxSTUDIO marketed under K123519. It is a volumetric imaging software designed specifically for dental clinicians, intended for use as a planning and simulation software in the placement of dental implants, orthodontics and surgical treatment. The imaging software reads DICOM data from dental CT machines, such as devices in the i-CAT family.
Cone Beam Volumetric Tomography is a medical imaging technique that uses X-rays to obtain cross-sectional images of the head or neck. The proposed device is a CBCT dental system with 2 modes of operation: panoramic and CBCT. The X-ray 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. The scanner has the ability to capture data for 3D skull reconstruction for the following procedures:
- CBCT mode:
- o Implants
- TM Joints O
- Reconstructed Panoramic o
- Reconstructed Cephalometrics O
- o Airway / Sinus, etc.
- Nerve Canal o
- · Panoramic mode:
- o PAN Conventional Digital Panoramic Feature
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In addition, the user can choose to scan using the Standard protocol, the QuickScan protocol, or the QuickScan+ protocol. The user can choose to reduce the radiation exposure to patients by lowering the exposure time (from Standard to QuickScan), or by lowering all the loading factors (from Standard to QuickScan+). The radiation dose level, in the form of DAP value, is readily displayed on the protocol selection screen of the user interface so the user may make an informed choice.
- 5. Indications for Use:
Devices of the i-CAT family consist of an x-ray system that uses a cone beam with a rotational sequence, providing two dimensional images and three dimensional volume reconstructions of the head area, which includes ENT and maxillofacial areas (such as TM Joint studies, mandible & maxilla for implant planning, sinuses, airway), for use in planning and diagnostic support in adult and pediatric care.
Devices of the i-CAT family comprise a package of software modules capable of handling 2D and 3D data. This includes 3D reconstruction, storage, retrieval, viewing, and processing of 2D and 3D-image data.
The proposed indications for use above of i-CAT FLX / KaVo 3D eXam+ include specification of airway within the ENT and maxillofacial area. The proposed device has been verified and validated to satisfy the requirements derived from the indications for use.
- 6. Summary of Technological Characteristics:
i-CAT FLX / KaVo 3D eXam+ models share the same architectural components as the predicate devices including:
- An X-ray source on a motorized gantry a.
- b. Collimation of X-ray
- Two-dimensional (2D) X-ray detector (for Panoramic and Cone Beam mode) C.
- A patient positioning and support system to ensure stability of the patient during d. scan.
- A software package which prepares and displays three dimensional (3D) e. reconstructions of the acquired data.
The system architecture of the proposed device is identical to the predicate device, i-CAT FLX (K133620), see comparison table below for details.
| Characteristics | Proposed Device<br>i-CAT FLX / KaVo 3D<br>eXam+<br>V series | Predicate Device<br>GALILEOS Comfort Plus<br>(K123070) | Predicate Device<br>i-CAT FLX<br>(K133620) |
|----------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| Principle of<br>Operation | Cone Beam X-ray | Cone Beam X-ray | Cone Beam X-ray |
| Generator | High Frequency, Constant<br>Potential | N/A | High Frequency, Constant<br>Potential |
| X-ray tube | Stationary anode | Stationary Anode | Stationary anode |
| Characteristics | Proposed Device<br>i-CAT FLX / KaVo 3D<br>eXam+<br>V series | Predicate Device<br>GALILEOS Comfort Plus<br>(K123070) | Predicate Device<br>i-CAT FLX<br>(K133620) |
| Tube Voltage | 120 kV(peak) | 98 kV | 120 kV(peak) |
| Tube Current | 3-7 mA | 3-6 mA | 3-7 mA |
| Scan time | 4 to 40 seconds | 14 seconds | 4 to 40 seconds |
| Exposure | 6-100mAs | 30 mAs | 6-100mAs |
| Target material | Tungsten | Tungsten | Tungsten |
| Minimum<br>Filtration | > 10 mm of Al equivalent at<br>120 kV | 2.8 mm of Al equivalent at 98<br>k V | > 10 mm of Al equivalent at<br>120 kV |
| Focal spot | 0.5 mm | 0.5 mm | 0.5 mm |
| Anode capacity | 30 kHU | 48 kHU | 30 kHU |
| Detector* | | | |
| Type | Amorphous Silicon | Image Intensifier | Amorphous Silicon |
| Conversion Screen | Direct Deposit CsI, DRZ Plus | Not Available | Direct Deposit CsI, DRZ Plus |
| Size | 20 x 25 cm | Not Available | 20 x 25 cm |
| Active Input<br>Window Size | N/A | 215 mm diameter | N/A |
| Camera | N/A | Pixels: 1000^2, FPS: 15-30,<br>Dynamics: 12 bits, (4096<br>brightness values), 63 dB | N/A |
| Total Pixel Area | 19.5 x 24.4 cm | Not Available | 19.5 x 24.4 cm |
| Pixel Matrix | 1536 x 1920 | Not Available | 1536 x 1920 |
| Pixel Pitch | 127 µm² | Not Available | 127 µm² |
| Limiting<br>Resolution | 3.94 lp/mm | Not Available | 3.94 lp/mm |
| MTF | >48% @ 1 lp/mm | Not Available | >48% @ 1 lp/mm |
| DQE | >75% (1x1) | Not Available | >75% (1x1) |
| Energy Range | 40 - 160 kVp | Not Available | 40 - 160 kVp |
| Gantry | | | |
| Resolution angle /<br>Orbital angle | 360° | 204° | 360° |
| Number of<br>projections/ single<br>exposures | 160, 300, 320, 600, 1100 or<br>1200 | 200, 357 | 160, 300, 320, 600, 1100 or<br>1200 |
| Orientation | Vertical | N/A | Vertical |
| Source to Sensor<br>distance | 71.4 cm | 59.0 cm | 71.4 cm |
| Characteristics | Proposed Device<br>i-CAT FLX / KaVo 3D<br>eXam+<br>V series | Predicate Device<br>GALILEOS Comfort Plus<br>(K123070) | Predicate Device<br>i-CAT FLX<br>(K133620) |
| Source to isocenter<br>distance | 49.53 cm | 41.3 cm | 49.53 cm |
| Image Reconstruction | | | |
| Field of view, axial | 17 cm max | 15.4 cm (diameter) spherical<br>imaging volume | 17 cm max |
| Field of view, cross<br>sectional | 23 cm max | | 23 cm max |
| Other | | | |
| Effective Dose<br>(ICRP 2007) | 4-171 µSv (Ludlow) | 28-154µSv (Ludlow) | 4-171 µSv (Ludlow) |
| Workstation | Intel based PC | Intel based PC | Intel based PC |
| Electrical<br>requirements | 100VAC, 115VAC, 200VAC or<br>230VAC 50/60 Hz (Factory<br>Set) | 200 V - 240 V, 50/60 Hz | 100VAC, 115VAC, 200VAC<br>or 230VAC 50/60 Hz (Factory<br>Set) |
| Patient Positioning | Seated | Standing or seated | Seated |
| Patient Positioning<br>Accessories | Chin rest, chin cup, bite block,<br>head rest, head strap, head<br>holder, booster seat, foot stool | Chin rest, bite block, forehead<br>support and head fixation<br>device | Chin rest, chin cup, bite block.<br>head rest, head strap, head<br>holder, booster seat, foot stool |
| Laser indication of<br>scanned area | Yes | Yes | Yes |
| Exposure<br>parameters for<br>determining<br>leakage radiation | 7mA / 120 kV | 6mA / 98 kV | 7mA / 120 kV |
| Continuing<br>current for<br>leakage radiation<br>measurements | 0.5 mA (at 130 kVp) | 0.14 mA | 0.5 mA (at 130 kVp) |
| Performance-<br>related<br>Conformance<br>Standards | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-1-3<br>IEC 60601-1-6<br>IEC 60601-2-63<br>IEC 62366 | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-1-3<br>IEC 60601-2-63 | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-1-3<br>IEC 60601-1-6<br>IEC 60601-2-63<br>IEC 62366 |
Comnarison Table:
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*Receptor panels utilized in the proposed device has been previously cleared as a component of the device in K 133620.
As evidenced through the Design Verification and Validation, the proposed device can produce volumetric and panoramic images of the maxillofacial (including ENT) areas in the head, and they are of equivalent diagnostic quality as the predicate devices. The minor technological difference in the shape of image volumes does not affect imaging of the intended anatomical structures.
Based upon an analysis of the technological differences, and the substantiation through design verification and validation, ISI determines that the proposed i-CAT FLX / KaVo 3D eXam+ is substantially equivalent to the predicate devices, GALILEOS Comfort Plus (K123070) and i-CAT FLX (K133620), and does not raise any new concerns.
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## 7. Non-Clinical Performance Data:
Performance bench testing was conducted as part of design control to ensure the substantial equivalence of i-CAT FLX/KaVo 3D eXam+ to the predicate devices. The substantial equivalence for the proposed indications for use is substantiated through verification and validation testing on two dimensional images and three dimensional volume reconstructions of the head area, which includes ENT and maxillofacial areas, for use in planning and diagnostic support in adult and pediatric care. The verification and validation activities for the software package also supports the substantial equivalence of the proposed device. Biocompatibility evaluation was conducted on patient contacting accessory parts and found to be in conformance with ISO 10993-5:2009 and ISO 10993-10:2010. EMC and Electrical Safety testing were performed by Intertek Testing Services and found to meet all the requirements in standards IEC 60601-1: 2005 (R)2012 (AAMI ES60601-1:2005/(R)2012), IEC 60601-1-6:2010, IEC 62366:2007/(R)2013, IEC 60601-2-63:2012, IEC 60601-1-3:2008, IEC 60601-1-2:2007, and IEC 60825-1:2007.
## 8. Clinical Performance Data:
Clinical images acquired using i-CAT FLX/KaVo 3D eXam+ were reviewed by qualified clinicians to be of acceptable clinical effectiveness for the proposed indications for use.
## 9. Conclusion as to Substantial Equivalence:
Based on the substantial equivalence comparison of intended use, design, technological characteristics, performance, labeling, biocompatibility, standards, and other characteristics, the minor differences between i-CAT FLX/KaVo 3D eXam+, and the predicate devices, GALILEOS Comfort Plus (K123070) and i-CAT FLX (K133620), do not raise new concerns for the proposed indications of use. Imaging Sciences International concludes that the proposed device is substantially equivalent to the predicate devices.
