(294 days)
No
The summary describes a standard digital X-ray imaging system and its components. There is no mention of AI, ML, or any advanced image processing techniques that would suggest the use of such technologies. The performance testing focuses on image quality and dosimetric performance compared to a predicate device, not on the performance of any AI/ML algorithms.
No
The device is an x-ray imaging system intended to produce diagnostic images, not to provide therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states, "It provides diagnostic details of the dento-maxillofacial, sinus and TMJ for adult and pediatric patients." This clearly indicates its role in diagnosis.
No
The device description explicitly lists hardware components such as digital x-ray equipment, a detector, and an X-ray generator, in addition to imaging software. This indicates it is a hardware and software system, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The described device is an X-ray imaging system. It produces images of anatomical structures (dento-maxillofacial, sinus, TMJ, carpal) using X-rays. It does not perform tests on biological samples.
- Intended Use: The intended use is to produce diagnostic images for visual interpretation by healthcare professionals. This is a core function of medical imaging devices, not IVDs.
Therefore, the device falls under the category of medical imaging equipment, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The unit is intended to produce panoramic or cephalometric digital x-ray images. It provides diagnostic details of the dento-maxillofacial, sinus and TMJ for adult and pediatric patients. The system also utilizes carpal images for orthodontic treatment. The device is to be operated by physicians, dentists, and x-ray technicians.
Product codes
MUH
Device Description
The device is an advanced 2-in-1 digital X-ray imaging system that incorporates PANO and CEPH (Optional) imaging capabilities into a single system and acquires 2D diagnostic image data in conventional panoramic and cephalometric modes.
The device is not intended for CBCT imaging.
VistaPano S is identified as panoramic-only models for VistaPano S Ceph.
ProVecta S-Pan Ceph and ProVecta S-Pan are alternative model for VistaPano S Ceph and VistaPano S respectively.
The subject device has different model names designated for different US distributors:
- -VistaPano S Ceph, VistaPano S: DÜRR DENTAL
- ProVecta S-Pan Ceph, ProVecta S-Pan: AIR TECHNIQUES
Key components of the device
-
- VistaPano S Ceph 2.0 (Model: VistaPano S Ceph), VistaPano S 2.0 (Model: VistaPano S) digital x-ray equipment (Alternate: ProVecta S-Pan Ceph 2.0 (Model: ProVecta S-Pan Ceph), ProVecta S-Pan 2.0 (Model: ProVecta S-Pan))
-
- SSXI detector: Xmaru1501CF-PLUS, Xmaru2602CF
-
- X-ray generator
-
- PC system
-
- Imaging software
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
digital x-ray images
Anatomical Site
dento-maxillofacial, sinus and TMJ
Indicated Patient Age Range
adult and pediatric patients
Intended User / Care Setting
physicians, dentists, and x-ray technicians.
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
Bench testing according to FDA Guidance "Format for Traditional and Abbreviated 510(k)s, Performance Testing – Bench" were performed. Image evaluation according to IEC 61223-3-4 were also performed.
Clinical images obtained from the subject and predicate devices are evaluated and compared and demonstrate that the general image quality of the subject device is equivalent or better than the predicate device.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The sponsor tested the subject device in a laboratory. The same test protocol was used to test the performance of the subject and the predicate device for comparison. The sponsor certifies that adequate design and development controls (according to 21 CFR 820.30) were in place for manufacturing the subject device.
The image quality performance of non-binning mode has been evaluated in terms of the measured line pair resolution and contrast data using phantoms. As a result, the HD mode (non-binning mode) of the subject device performed better or equivalent in line pair resolution than the predicate device.
Clinical images obtained from the subject and predicate devices are evaluated and compared and demonstrate that the general image quality of the subject device is equivalent or better than the predicate device.
Clinical and non-clinical evaluation results of the subject device provide further evidence in addition to the laboratory performance data to show that the complete system works as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.1800 Extraoral source x-ray system.
(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 25, 2024
VATECH Co., Ltd % Dave Kim RA Consultant Mtech Group LLC 7505 Fannin St. Suite 610 HOUSTON, TX 77054
Re: K240040
Trade/Device Name: VistaPano S Ceph 2.0 (VistaPano S Ceph) VistaPano S 2.0 (VistaPano S) ProVecta S-Pan Ceph 2.0 (ProVecta S-Pan Ceph) ProVecta S-Pan 2.0 (ProVecta S-Pan) Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral Source X-Ray System Regulatory Class: Class II Product Code: MUH Dated: September 24, 2024 Received: September 25, 2024
Dear Dave Kim:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the
2
Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Lu Jiang
Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
Device Name
VistaPano S Ceph 2.0 (VistaPano S Ceph);
VistaPano S 2.0 (VistaPano S):
ProVecta S-Pan Ceph 2.0 (ProVecta S-Pan Ceph);
ProVecta S-Pan 2.0 (ProVecta S-Pan)
Indications for Use (Describe)
The unit is intended to produce panoramic or cephalometric digital x-ray images. It provides diagnostic details of the dento-maxillofacial, sinus and TMJ for adult and pediatric patients. The system also utilizes carpal images for orthodontic treatment. The device is to be operated by physicians, dentists, and x-ray technicians.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
510(k) Summary K240040
1. 510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
2. Date 510K Summary prepared: September 24, 2024
3. Administrative Information
| Official Correspondent: | Mtech Group LLC
7505 Fannin St. Suite 610, Houston, TX 77054
Tel: +713-467-2607
Contact person: Mr. Dave Kim (davekim@mtechgroupllc.com) |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Submitter: | VATECH Co., Ltd.
Address: 13, Samsung 1-ro 2-gil, Hwaseong-si, Gyeonggi-do, 18449, Korea
Tel: +82-31-379-9492
Fax: +82-31-379-9400
Contact person: Daniel Kim / Manager (daniel.kim@vatech.com) |
4. Device Information
| Type of 510(k) Submission: | Traditional |
|---|---|
| Trade or Proprietary Name: | VistaPano S Ceph 2.0 (VistaPano S Ceph) |
| VistaPano S 2.0 (VistaPano S) | |
| ProVecta S-Pan Ceph 2.0 (ProVecta S-Pan Ceph) | |
| ProVecta S-Pan 2.0 (ProVecta S-Pan) | |
| Common or Usual Name: | Digital X-ray Imaging System |
| Regulation Classification: | Extraoral source x-ray system (21 CFR 872.1800) |
| Product Code: | MUH |
| Class of Device: | Class II |
| Panel: | Radiology |
5. Predicate Device Information
| Manufacturer: | VATECH Co., Ltd. |
|---|---|
| Predicate device: | PaX-i Plus/PaX-i Insight (Model: PCH-30CS) / K170731 |
| Common or Usual Name: | Digital X-ray Imaging System |
| Regulation Classification: | Extraoral source x-ray system (21 CFR 872.1800) |
| Product Code: | MUH |
| Class of Device: | Class II |
| Panel: | Radiology |
5
6. Reference Device Information
| Manufacturer: | VATECH Co., Ltd. |
|---|---|
| Reference device: | Green X 12 (Model: PHT-75CHS) / K231796 |
| Common or Usual Name: | Digital X-ray Imaging System |
| Regulation Classification: | Computed tomography x-ray system (21 CFR 892.1750) |
| Product Code: | OAS |
| Class of Device: | Class II |
| Panel: | Radiology |
7. Device Description
The device is an advanced 2-in-1 digital X-ray imaging system that incorporates PANO and CEPH (Optional) imaging capabilities into a single system and acquires 2D diagnostic image data in conventional panoramic and cephalometric modes.
The device is not intended for CBCT imaging.
VistaPano S is identified as panoramic-only models for VistaPano S Ceph.
ProVecta S-Pan Ceph and ProVecta S-Pan are alternative model for VistaPano S Ceph and VistaPano S respectively.
The subject device has different model names designated for different US distributors:
- -VistaPano S Ceph, VistaPano S: DÜRR DENTAL
- ProVecta S-Pan Ceph, ProVecta S-Pan: AIR TECHNIQUES ।
Key components of the device
-
- VistaPano S Ceph 2.0 (Model: VistaPano S Ceph), VistaPano S 2.0 (Model: VistaPano S) digital x-ray equipment (Alternate: ProVecta S-Pan Ceph 2.0 (Model: ProVecta S-Pan Ceph), ProVecta S-Pan 2.0 (Model: ProVecta S-Pan))
2) SSXI detector: Xmaru1501CF-PLUS, Xmaru2602CF
| Description | ||
|---|---|---|
| Item | PANO | |
| (VistaPano S 2.0 / ProVecta S-Pan 2.0) | CEPH | |
| (VistaPano S Ceph 2.0 / ProVecta S-Pan Ceph 2.0) | ||
| Model | Xmaru1501CF-PLUS | Xmaru2602CF |
| Detector Type | CMOS photodiode array | CMOS photodiode array |
| Pixel Size | 100 μm | 100 μm- Non binning |
| 200 μm -2X2 binning | ||
| Active Area | 151.2 x 6.0 mm | 259 x 15.6 mm |
| Frame Rate | ~287 fps | ~109 fps (Non binning) |
| ~330 fps (2x2 Binning) | ||
| Analogue- | ||
| Digital | ||
| Conversion | 14 bits | 14 bits |
| Converter | Csl:Ti | Csl:Ti |
| Energy Range | 50 ~ 120 kV | 50 ~ 120 kV |
6
| Description | ||
|---|---|---|
| Item | PANO | |
| (VistaPano S 2.0 / ProVecta S-Pan 2.0) | CEPH | |
| (VistaPano S Ceph 2.0 / | ||
| ProVecta S-Pan Ceph 2.0) | ||
| Readout Type | Charge amplifier array | Charge amplifier array |
| Video Output | Optic | Optic |
3) X-ray generator
| Item | Description | |
|---|---|---|
| High Voltage | ||
| Generator | Model | DG-07E22T2 |
| Rated output power | 1.6 kW | |
| Type | Inverter | |
| Normal/Pulse | kV | |
| mA | ||
| Cooling | Thermals protect | |
| Total filtration | Min. 2.5 mm Al | |
| Added filter | 1.5 mm Al | |
| X-ray Tube | Manufacturer | Canon Electron Tubes & Devices |
| Model | D-052SB (Stationary Anode type) | |
| Focal spot size | 0.5 x 0.5 mm | |
| Target Angle | 5 degrees | |
| Inherent Filtration | At least 0.8 mm Al equivalent at 50 kV | |
| Anode Heat Content | 35 kJ | |
| Duty Cycle | 1:60 or more (Exposure time : Interval time) |
Note: The subject device has the same X-ray generator as the reference device (K231796).
4) PC system
| Item | Description |
|---|---|
| Operating System | Windows 10 Professional 64-Bit OS or higher |
| CPU | Intel® Core i5-8500 6C |
| RAM | 16GB (2x8 GB) DDR4-2666 ECC REG APJ or Larger |
| HDD | 1TB SATA 7200 rpm * 2EA |
| Graphics board | GEFORCE RTX1060 Graphics |
| Ethernet interface | Broadcom 5761 Gigabit PCIe NIC |
| Serial Port (RS232) | HP Serial Port Adapter Kit |
| Power Supply | 500W internal power module, up to 90% efficiency, active PFC |
| Slots | 1 ports PCIe 3 x4 |
| 2 ports M.2 PCIe 3 x4 | |
| 1 ports PCIe x1 (x4 open ended connector) | |
| 1 ports PCIe x16 |
- Imaging software
| Item | Description |
|---|---|
| Image Viewing Program | VisionX 3.0 (K213326) |
7
8. Indications for use
The unit is intended to produce panoramic or cephalometric digital x-ray images. It provides diagnostic details of the dento-maxillofacial, sinus and TMJ for adult and pediatric patients. The system also utilizes carpal images for orthodontic treatment. The device is to be operated by physicians, dentists, and x-ray technicians.
8
9. Comparison of Technological characteristics with the predicate device
| Subject Device | Predicate Device | |
|---|---|---|
| Device Name | VistaPano S Ceph 2.0 (Model: VistaPano S Ceph) | |
| VistaPano S 2.0 (Model: VistaPano S) | ||
| ProVecta S-Pan Ceph 2.0 (Model: ProVecta S-Pan Ceph) | ||
| ProVecta S-Pan 2.0 (Model: ProVecta S-Pan) | PaX-i Plus / PaX-i Insight | |
| (Model: PCH-30CS) | ||
| Applicant Name | VATECH Co., Ltd. | VATECH Co., Ltd. |
| 510(k) Number | K240040 | K170731 |
| Device Classification Name | System, X-Ray, Extra oral Source, Digital | System, X-Ray, Extra oral Source, Digital |
| Classification Product Code | MUH | MUH |
| Regulation Number | 21 CFR 872.1800 | 21 CFR 872.1800 |
| Indications for Use | The unit is intended to produce panoramic or | |
| cephalometric digital x-ray images. It provides | ||
| diagnostic details of the dento-maxillofacial, sinus | ||
| and TMJ for adult and pediatric patients. The | ||
| system also utilizes carpal images for orthodontic | ||
| treatment. The device is to be operated by | ||
| physicians, dentists, and x-ray technicians. | PCH-30CS is intended to produce panoramic or | |
| cephalometric digital x-ray images. It provides | ||
| diagnostic details of the dento-maxillofacial, sinus | ||
| and TMJ for adult and pediatric patients. The | ||
| system also utilizes carpal images for orthodontic | ||
| treatment. The device is to be operated by | ||
| physicians, dentists, and x-ray technicians. | ||
| Performance Specification | Panoramic, Cephalometric | Panoramic, Cephalometric |
| Input Voltage | AC 200-240 V | AC 100 - 240 V |
| X-Ray source | D-052SB | D-052SB |
| Tube Voltage | 60 - 99 kV | 60 - 99 kV |
| Tube Current | 4 - 16 mA | 4 - 10 mA |
| Focal Spot Size | 0.5 x 0.5 mm | 0.5 x 0.5 mm |
| Exposure Time | Max. 13.5 s | Max. 20.2 s |
| Slice Width | Min. 0.1 mm | Min. 0.1 mm |
| Total Filtration | Min. 2.5 mm Al | Min. 2.5 mm Al |
| Mechanical | Compact design | Compact design |
| Electrical | LDCP logic circuit | LDCP logic circuit |
| Software | DICOM 3.0 Format compatible | DICOM 3.0 Format compatible |
9
VATECH Co., Ltd.
| Subject Device | Predicate Device | |||
|---|---|---|---|---|
| Image Viewing Program | VisionX 3.0 (K213326) | EasyDent (Cleared under K122155) | ||
| EzDent-i (K163533) | ||||
| Anatomical Sites | Maxillofacial | Maxillofacial | ||
| Image Receptor | PANO | Xmaru1501CF-PLUS | Xmaru1501CF-PLUS | |
| Xmaru1404CF-PLUS | ||||
| CEPH | Xmaru2602CF | Xmaru2602CF | ||
| Pixel Resolution | PANO | Xmaru1501CF-PLUS | 5 lp/mm | Xmaru1501CF-PLUS |
| 5 lp/mm | ||||
| Xmaru1404CF-PLUS | ||||
| 5 lp/mm -2x2 binning | ||||
| (detector spec, Not system spec) | ||||
| 2.5 lp/mm -4x4 binning | ||||
| (system spec) | ||||
| CEPH | 5 lp/mm-Non binning | |||
| 2.5 lp/mm -2x2 binning | ||||
| Pixel Size | PANO | Xmaru1501CF-PLUS | 100 μm | Xmaru1501CF-PLUS |
| 100 μm | ||||
| Xmaru1404CF-PLUS | ||||
| 198 μm - 4X4 binning | ||||
| (system spec) | ||||
| CEPH | 100 μm- Non binning | |||
| 200 μm -2X2 binning |
10
10. Performance Data
Summary of Performance Testing
The device described in this 510(k) is similar to the predicate device in terms of indications for use, materials, safety characteristics, X-ray source, and Image Receptor.
The following information further substantial equivalence between the subject device and predicate device:
- a. The fundamental technological characteristics of the subject and predicate device are similar.
- b. The imaging modes are same; PANO and CEPH (Optional).
- c. The same x-ray source.
- d. The same image receptor for PANO imaging mode.
The sponsor tested the subject device in a laboratory. The same test protocol was used to test the performance of the subject and the predicate device for comparison. The sponsor certifies that adequate design and development controls (according to 21 CFR 820.30) were in place for manufacturing the subject device.
The differences between the subject device and the predicate device:
- a. The subject device is equipped with the Xmaru2602CF detector which has been cleared with predicate device and added Non binning mode for system specification.
- b. The materials of the subject device's components such as temple support cushion, chin holder for bite block & comfort bite holder, bite block and comfort bite foam, sanitary vinyl cover are different than the predicate device. The biocompatibility testing for the subject device 's positioning aids has been updated according to the latest ISO 10993-1 standard. The biocompatibility testing results showed that the device's accessory part are biocompatible and safe for its intended use. In addition, ProVect S-Pan Ceph and ProVecta S-Pan products use separate sanitary vinyl covers approved by FDA (K151123).
- c. The solid state X-ray imagers (SSXI), Xmaru1501CF-PLUS and Xmaru2602CF, for the subject device are the same SSXI used for the predicate device, K170731. For the Xmaru2602CF detector, the predicate device as an X-ray system used 2x2 binning only in CEPH mode whereas the subject device uses both 2x2 binning and non-binning in CEPH mode. The subject device provides the user with HD mode (nonbinning) and SD mode (2x2 binning) options when capturing X-ray images in CEPH mode. Based on Non-Clinical Test results of Xmaru2602CF detector for the subject device, the bench testing data shows better performance for the Non binning mode compared to 2x2 binning mode.
In addition, the dosimetric performance of the subject device and the predicate device was compared in terms of DAP. With similar FDD(Focal Spot to Detector Distance), DAP measurement in the PANO mode of each device under the same X-ray exposure conditions (exposure time, tube current) was similar. In CEPH mode, the subject device has two imaging mode options, HD and SD, based on the exposure condition (exposure time, tube voltage, tube current), and the predicate device has also two image options, Normal and The SD mode of the subject device uses the same 2x2 binning mode as the predicate device and the X-ray Fast. exposure conditions (exposure time, tube voltage, tube current) are the same with the Fast mode of the predicate device. The HD mode (non-binning mode) of the subject device requires increased exposure time under the same kVp and mA exposure condition with the Xmaru2602CF detector. Any adjustment of the exposure setting in HD and SD mode of the subject device should consider the patient exposure level to be as low as possible.
11
The image quality performance of non-binning mode has been evaluated in terms of the measured line pair resolution and contrast data using phantoms. As a result, the HD mode (non-binning mode) of the subject device performed better or equivalent in line pair resolution than the predicate device.
Clinical images obtained from the subject and predicate devices are evaluated and compared and demonstrate that the general image quality of the subject device is equivalent or better than the predicate device.
Clinical and non-clinical evaluation results of the subject device provide further evidence in addition to the laboratory performance data to show that the complete system works as intended.
The following FDA guidance has been utilized in the development of the subject device:
- -"Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices"
- -"Pediatric Information for X-ray Imaging Device Premarket Notifications, Guidance for Industry and Food and Drug Administration Staff, November 2017,"
Software Verification and Validation Testing
Software verification and validation were conducted and documented as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern, since a failure or latent flaw in the software would not directly result in serious injury or death to the patient or operator. The following cyber security guidance was applied in the development of the subject device:
-
-"Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions".
The device provides the following image viewing programs; -
। lmage viewing program: VisionX 3.0 (K213326)
Safety, EMC and Performance Data
Electrical, mechanical, environmental safety and performance testing according to standard IEC 60601-1:2005+AMD1:2012+AMD2:2020 (Edition 3.2), IEC 60601-1-3:2008+AMD1:2013+AMD2:2021 (Edition 2.2), IEC 60601-2- 63:2012+AMD1:2017+AMD2:2021 (Edition 1.2) were performed, and EMC testing were conducted in accordance with standard IEC 60601-1-2:2014+AMD1:2020 (Edition 4.1). The manufacturing facility is in conformance with the relevant EPRC standards as specified in 21 CFR 1020.30, 31 and the records are available for review. The device conforms to the provisions of NEMA PS 3.1-3.18, Digital Imaging and Communications in Medicine (DICOM) Set.
Non-clinical consideration in accordance with the FDA guidelines "Guidance for the submissions of 510(k)'s for Solid State X-ray Imaging Devices" was provided.
Bench testing according to FDA Guidance "Format for Traditional and Abbreviated 510(k)s, Performance Testing – Bench" were performed. Image evaluation according to IEC 61223-3-4 were also performed.
All test results were satisfactory.
12
11. Conclusions
The proposed device and the predicate device have same indications for use and demonstrated similar technical characteristics. The applied image receptor for PANO and CEPH mode was previously cleared by the predicate device, PCH-30CS (K170731). The subject device added the HD mode, utilizing the non-binning capability of the Xmaru2602CF detector in CEPH mode. As demonstrated in the subject device performance test, the detector Xmaru2602CF with non-binning mode added to the system specifications performed similarly or better in comparison with the predicate device. Quality assurance procedures are adhered to, and the specifications and functional requirements were met as the test results indicated.
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, VATECH Co., Ltd. concludes that the subject device (VistaPano S Ceph 2.0 (Model: VistaPano S Ceph), VistaPano S 2.0 (Model: VistaPano S), ProVecta S-Pan Ceph 2.0 (Model: ProVecta S-Pan Ceph), ProVecta S-Pan 2.0 (Model: ProVecta S-Pan))is substantially equivalent to the predicate device as described herein.