(141 days)
The MiniCAT 2D is a diagnostic x-ray system for general radiographic x-ray imaging of the head and neck for use in hospitals, clinics, medical imaging centers, and medical practices.
The MiniCAT 2D is a dedicated X-ray imaging device that acquires a 360° rotational X-ray sequence and produces two dimensional views. MiniCAT 2D provide immediate access to images at the patient's point-of-care resulting in faster diagnosis and treatment. The MiniCAT 2D system consists of a high voltage x-ray generator, 360-degree rotational overhead gantry, x-ray tube assembly, x-ray controller, fixed detector panel, and x-ray controls containing a "power distribution unit and operator PC (user interface)."
This document does not contain information about the acceptance criteria and study that proves the device meets the acceptance criteria for a new AI/algorithm feature. Instead, it is a 510(k) summary for a general X-ray system (MiniCAT 2D) seeking substantial equivalence to a predicate device (Carestream DRX-Evolution).
The document details the device description, indications for use, and a comparison of technological characteristics to the predicate device to demonstrate substantial equivalence, rather than providing performance data for a specific algorithm or AI component.
Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details.
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November 20, 2020
Xoran Technologies LLC % Mr. Mark McGarrow VP of Quality and Operations 5210 South State Road ANN ARBOR MI 48108
Re: K201825
Trade/Device Name: MiniCAT 2D Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary X-Ray System Regulatory Class: Class II Product Code: KPR Dated: October 16, 2020 Received: October 19, 2020
Dear Mr. McGarrow:
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. 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 located 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 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 of medical device-related adverse events) (21 CFR 803) for
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devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 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 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.
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K201825
Device Name MiniCAT 2D
Indications for Use (Describe)
The MiniCAT 2D is a diagnostic x-ray system for general radiographic x-ray imaging of the head and neck for use in hospitals, clinics, medical imaging centers, and medical practices.
| 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 Xoran Technologies. The logo is in a light blue color and features a stylized "X" with a square behind it. To the right of the "X" is the word "ORAN" in a sans-serif font. Below "ORAN" is the word "TECHNOLOGIES" in a smaller font size.
510(k) Summary
This 510(k) summary of the Safety and Effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92.
Date Prepared: June 1, 2020
Submitter:
Xoran Technologies LLC 5210 S. State Road Ann Arbor, MI 48108
Contact Person:
Mark McGarrow Vice President of Quality and Operations Phone: 734-418-5125 Email: mark.mcgarrow@xorantech.com
Device Name and Classification:
| Trade Name: | MiniCAT 2D |
|---|---|
| 510(k) number: | K201825 |
| Classification Name: | Stationary X-Ray System |
| Classification Panel: | Radiology |
| Classification Regulation: | 21 CFR 892.1680 |
| Device Class: | Class II |
| Product Code: | KPR |
Predicate Devices:
| Trade Name: | Carestream DRX-Evolution |
|---|---|
| 510(k) number: | K141837 cleared 03/11/2015 |
| Manufacturer: | Carestream Health, Inc. |
| Classification Name: | Stationary X-Ray System |
| Classification Panel: | Radiology |
| Classification Regulation: | 21 CFR 892.1680 |
| Device Class: | Class II |
| Product Code: | KPR |
Device Description:
The MiniCAT 2D is a dedicated X-ray imaging device that acquires a 360° rotational X-ray
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sequence and produces two dimensional views. MiniCAT 2D provide immediate access to images at the patient's point-of-care resulting in faster diagnosis and treatment.
The MiniCAT 2D system consists of a high voltage x-ray generator, 360-degree rotational overhead gantry, x-ray tube assembly, x-ray controller, fixed detector panel, and x-ray controls containing a "power distribution unit and operator PC (user interface)."
Indications for Use:
The MiniCAT 2D is a diagnostic x-ray system for general radiographic x-ray imaging of the head and neck for use in hospitals, clinics, medical imaging centers, and medical practices.
Substantial Equivalence:
| ComparableProperties | Predicate Device:DRX-Evolution | MiniCAT 2D | ComparisonResult |
|---|---|---|---|
| Intended Use | The device is apermanently installeddiagnostic x-ray systemfor generalradiographic x-rayimaging includingtomography. Thetomography feature isnot to be used forimaging of pediatricpatients. | The MiniCAT 2D is adiagnostic x-raysystem for generalradiographic x-rayimaging ofthe head and neck foruse in hospitals,clinics, medicalimaging centers, andmedicalpractices. | Equivalent |
| Patient Support | Table: contains Buckywith detector | Chair, max patientweight 350 lbs (159kg), motorizedadjustable height | FunctionallyEquivalent |
| Wall stand | Wall stand containsBucky with detector | No wall stand | Not applicable |
| Overhead | Overhead tube cranewith manual andautomated x-ray tubeassembly movement | Motorized overhead,360 degree rotationof x-ray tube anddetector aroundpatient | FunctionalEquivalent |
| ComparableProperties | Predicate Device:DRX-Evolution | MiniCAT 2D | ComparisonResult |
| Forward/backwards motion for sinus/ear scan positioning | |||
| X-Ray Tube & powersupply | Varian x-ray Tube(RAD-60 with B-130 housing) / Alternate:Toshiba E7254GX with XH-157 Housing | Source-Ray Inc. x-ray tube model SXR-130-15-0.5125 kVp; 0.5 mm focal spot | Equivalent |
| X-Ray generator | Communication Power Industries CMP200DR x-ray generatorAlternative optional generator | Source-Ray Inc., Model XRS-125-7K | Equivalent |
| X-ray controller | Power Distribution Unit (provides power distribution & generator interface):Optional APC 1500 VA UPS | Xoran designed x-ray controller board 20240. Fixed KVp, mA, pulse width settings. Interfaces with XRS-125-7K generator | Equivalent |
| Collimator | Ralco R302 DACS/A | Xoran designed beam limiter board 15006 | FunctionalEquivalent |
| Fixed Detector | Compatible with Carestream DRX-1 Digital Detector, DRX-1C, and DRC 2530C | Varex 2520DX receptor panel | Equivalent |
| Operator Console | PC | PC | Equivalent |
Table 1
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Comparison of Technological Characteristics:
The differences between the subject device and the predicate device, the reason they do not impact the indications of use, or the safe and effective use of MiniCAT 2D are listed below:
- Patient support. MiniCAT 2D intended use is x-ray imaging of the head and neck. Patient position for such exams is sitting position for comfort and ergonomics. MiniCAT 2D chair is designed to accommodate up to 350lbs and 6.5 ft height patients. The MiniCAT 2D chair is functionally equivalent to the predicate device
- · Wall stand and overhead. MiniCAT 2D intended use is x-ray imaging of the head and neck. The overhead contains the x-ray tube and x-ray detector panel. It's motorized to
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rotate 360 degrees around the patient's head. It also has a motorized forward/backward motion optimize positioning for imaging the sinus or ear. MiniCAT 2D does not have a wallstand to image other parts of the anatomy. The MiniCAT 2D overhead is functionally equivalent to the predicate device
- · Collimator: The Beam limiter board 15006 in MiniCAT 2D is designed to collimate the x-ray beam for a fixed detector size and fixed SID. The user cannot modify SID, detector position or detector size in MiniCAT 2D. The collimation is adjusted to the field of view (FOV) by the system depending on the imaging protocol selected by the user. The MiniCAT 2D collimator is functionally equivalent to the predicate device
The rest of the MiniCAT 2D system components are equivalent to the predicate device, and do not affect the safety or effectiveness of the device.
The properties of the subject device (MiniCAT 2D) presented in the comparison table above (see Table 1) and described throughout this submission do not differ significantly from the legally marketed predicate (Carestream DRX Evolution) device with regards to fundamental scientific technology, nor do they reflect a significant change in the indications for use. The differences between the subject device and the legally marketed predicate device have been assessed using Risk Management and through third-party evaluation using FDA-recognized consensus standards. The results of these efforts demonstrate that the device is as safe and effective as the predicate device and does not raise different questions of safety and effectiveness than the predicate.
Performance Testing:
MiniCAT 2D has undergone Verification, SW Validation and Product Validation testing to . demonstrate its safety, effectiveness, and conformance to its user needs intended use, as required by 21 CFR 820.30 Design controls - (f) Design Verification, and (g) Design Validation. In addition, the MiniCAT 2D conforms to IEC standard 60601-2-63 and FDA performance standards, 21 CFR 1020.30 and 21 CFR 1020.31.
. Each Verification or Validation has followed the same process and it has been documented in the manner listed below:
- . The test plan and test instructions were laid out in the Test Protocol and Test Cases documents, where information such as test configurations, test sample sizes and test result evaluation criteria, is established.
- The testing was performed, and the results captured in the Test Results document.
- . The testing was performed on production equivalent units. Verification and SW validation tests were performed by qualified Xoran personnel, familiar with the function and use of MiniCAT 2D, but not directly responsible for its design. Product validation evaluations were performed by qualified physicians, who have anatomical and/or surgical expertise related to MiniCAT 2D's intended use.
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- The evaluation of the results and of the overall verification or validation result was ● discussed in the Test Report document.
- Both the Design Verification and the Product Validation had all identified hazards and . risks tested and successfully mitigated by traceable requirements.
MiniCAT 2D meets all the evaluation criteria for Verification, SW Validation and Product ● Validation tests.
Conclusion:
The MiniCAT 2D is intended for the same use as the DRX-Evolution. It uses components similar to those in the DRX-Evolution (e.g. x-ray tube, collimator, x-ray generator, operator console). It is Xoran Technology, LLC's opinion that the MiniCAT 2D is substantially equivalent to the cleared predicate device, the DRX-Evolution.
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.