(14 days)
No
The summary does not mention AI, ML, or related terms, and the device description focuses on hardware and standard digital imaging components.
No
The device is described as an x-ray imager for diagnostic purposes, not for therapeutic treatment.
Yes
The device performs "radiographic x-ray examinations," which are a form of medical imaging used for diagnosis. Additionally, the device is explicitly stated to comply with "US Performance Standard for Diagnostic X-Ray Systems: 21 CFR 1020.30".
No
The device description explicitly details a physical, ultra-light weight mobile x-ray unit (105 kg) with hardware components like a generator, battery tray, and the ability to operate on uneven ground. It also mentions using FDA cleared digital image capture panels, which are hardware. The performance studies section also details testing of "Systems covering all generator/panel combinations," further indicating a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "perform radiographic x-ray examinations on pediatric and adult patient treatment areas." This describes an imaging device used on the patient, not a device used to examine specimens from the patient in vitro (outside the body).
- Device Description: The description details a mobile x-ray imager, focusing on its physical characteristics and capabilities for generating x-ray images. This aligns with an in vivo imaging device.
- Input Imaging Modality: The input is "Radiographic x-ray," which is an in vivo imaging technique.
- Performance Studies: The performance studies described focus on system functionality, software validation, cybersecurity, and compliance with standards related to x-ray equipment and medical electrical equipment. There is no mention of studies related to analyzing biological samples or diagnostic tests performed on specimens.
- Predicate and Reference Devices: The listed predicate and reference devices are all related to digital x-ray imaging systems and components, further supporting that this is an in vivo imaging device.
IVD devices are used to examine specimens such as blood, urine, or tissue to diagnose diseases or other conditions. This device is clearly designed for generating images of the inside of a patient's body using x-rays.
N/A
Intended Use / Indications for Use
The device is designed to perform radiographic x-ray examinations on pediatric and adult patient treatment areas.
Product codes
IZL, MQB
Device Description
The Rover product concept was developed under a contract from the Australian Department of Defense to fulfil a need for a full performance digital medical x-ray imager, light enough to be used in deployed medical facilities. Key Design Features:
- Full trauma imaging capability 40-110kV, 0.2-20mAs;
- Ultra-light weight at 105 kg;
- Ground Clearance allows for 75mm step up;
- Operation on uneven ground;
- Spare battery tray swap out in under a minute;
The unit uses FDA cleared digital image capture panels and software made by FujiFilm OR Varex.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
Not Found
Indicated Patient Age Range
pediatric and adult patients
Intended User / Care Setting
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
Clinical testing was not required to establish substantial equivalence because all digital x-ray receptor panels have had previous FDA clearance.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
K142003, K192932, K170451, K161459
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1720 Mobile x-ray system.
(a)
Identification. A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. 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/0 description: The image shows 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath in a smaller font.
May 21, 2021
Micro-X Limited % Mr. Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Ct NAPLES FL 34114
Re: K211423
Trade/Device Name: ROVER Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: Class II Product Code: IZL, MQB Dated: May 6, 2021 Received: May 7, 2021
Dear Mr. Kamm:
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
1
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 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 mediation-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
2
Indications for Use
510(k) Number (if known) K211423
Device Name ROVER
Indications for Use (Describe)
The device is designed to perform radiographic x-ray examinations on pediatric and adult patient treatment areas.
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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510(k) Summary: 510(k) Number K211423
Image /page/3/Picture/1 description: The image shows the logo for MICRO-X. The word "MICRO" is in a dark gray color, and the "-X" is in a light green color. The font is sans-serif and the letters are all capitalized.
Limited A14 6 MAB Eastern Promenade, Tonsley (Clovelly Park), South Australia 5042 Phone: +61 8 7099 3966 Email: admin@micro-x.com Date: May 18, 2021 Prepared by: Derek Rogers, Quality and Regulatory Manager
1) Identification of the Device:
Trade/Device Name: Rover Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: II Product Codes: IZL, MQB. Common/Usual Name: Digital Mobile Diagnostic X-Ray System
2) Equivalent legally marketed device: K201488, Micro-X Limited
Trade/Device Name: Rover Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: II Product Codes: IZL, MQB. Common/Usual Name: Digital Mobile Diagnostic X-Ray System
3) Reference devices: We employ these cleared devices without modification:
a) For Model MXU-RV01:
i) Fujifilm FDR D-EVO II & III Series: K142003; K192932 Regulation Number: 21 CFR 892. 1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB ii) FDX Console (DR-ID300CL) Software K170451, K192932 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ
b) For Model MXU-RV19:
Nexus DR Digital X-Ray Imaging System K161459. (Supports digital panels 4336W and 4343W) Regulation Number: 21 CFR 892. 1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB
4
-
- Indications for Use: The device is designed to perform radiographic x-ray examinations on pediatric and adult patients, in all patient treatment areas.
-
- Description of the Device: The Rover product concept was developed under a contract from the Australian Department of Defense to fulfil a need for a full performance digital medical x-ray imager, light enough to be used in deployed medical facilities. Key Design Features:
- Full trauma imaging capability 40-110kV, 0.2-20mAs;
- Ultra-light weight at 105 kg;
- Ground Clearance allows for 75mm step up;
- Operation on uneven ground;
- Spare battery tray swap out in under a minute;
The unit uses FDA cleared digital image capture panels and software made by FujiFilm OR Varex.
| Characteristic | Rover, K201488 | Rover, K21__________
(Two models: MXU-RV01, MXU-RV19) | |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use: | The device is designed to perform
radiographic x-ray examinations on pediatric
and adult patients, in all patient treatment
areas. | The device is designed to perform radiographic
x-ray examinations on pediatric and adult
patients, in all patient treatment areas. SAME | |
| Configuration | Battery Operated Mobile System with digital
x-ray panel and image acquisition computer | SAME | |
| Generator | Maximum 4.8 kW @ 104 msec and 7.7 kW @
13 msec; 40 - 110 kV; 0.2 – 20.0 mAs
30-70 mA | Maximum 4.8 kW @ 104 msec and 7.7 kW @
13 msec; 40 – 110 kV; 0.2 – 20.0 mAs;
30-70 mA SAME | |
| | | Model MXU-RV01 | Model MXU-RV19 |
| Digital X-ray
Panel
Supplied | Fujifilm FDR D-EVO Series, all FDA cleared
K142003; K192932; 24x30cm, 14" x 17" and
17" x 17" sizes (CSL & GOS) Equivalent. | Fujifilm FDR D-EVO
Series, all FDA cleared
K142003; K192932;
24x30cm, 14" x 17" and
17" x 17" sizes (CSL &
GOS) (SAME). | Varex PaxScan
Series, all
FDA cleared
K161459,
Panel models
4336W and. 4343W
14" x 17", 17" x 17"
Equivalent. |
| Software | The Fuji FDX Console Advance DR-ID 300CL
Software cleared in K192932 | The Fuji FDX Console
Advance DR-ID 300CL
Software cleared in
K192932 (SAME) | Varex Nexus DR
Software, FDA
cleared in
K161459.
Equivalent. |
| Panel
Interface | Ethernet or Wi-Fi wireless | SAME | Wifi wireless only |
6) Substantial Equivalence Chart
5
| Characteristic | Rover, K201488 | Rover, K21______
(Two models: MXU-RV01, MXU-RV19) | |
|-------------------------------|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|
| Wi-Fi access point | D-Link DAP 2553 dual-band 2.4Ghz/5Ghz | D-Link DAP2610 2.4GHz or Lancom LW-600 dualband 2.4Ghz/5Ghz | Lancom LW-600 dualband 2.4Ghz/5Ghz |
| Operating System | Windows 10 | Windows 10 | Windows 10 |
| Meets US Performance Standard | YES 21 CFR 1020.30 | SAME | |
| Power Source | AC Line or Battery | SAME but the system has the additional optional feature of having a swap-out battery tray to allow for extended use while not connected to AC line for charging. | |
| Photo | Image: Rover K201488 | Image: Rover K21 | |
-
- The technological characteristics, including design, materials, composition, and energy source, are substantially the same, so there are no issues impacting safety and effectiveness. Safety and Effectiveness, comparison to predicate device. The results of bench testing indicate that the new devices are as safe and effective as the predicate devices. Proper system operation is fully verified upon installation. We verified that the modified combination of components worked properly and produced diagnostic quality images as good as our predicate generator/panel combination.
-
- Summary of non-clinical testing: Systems covering all generator/panel combinations were assembled and tested and found to be operating properly. Software was validated according to the FDA Guidance: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document issued on: May 11, 2005. Because the system uses Wi-Fi and Ethernet, we observed the recommendations contained in the FDA Guidance Document: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices Guidance for Industry and Food and Druq Administration Staff Document Issued on: October 2, 2014. The digital panel software employed was already reviewed by FDA. The Rover Battery Mobile X-Ray Units have been tested to be in compliance with the following Standards:
6
US Performance Standard for Diagnostic X-Ray Systems: 21 CFR 1020.30
IEC 60601-1:2005, COR1:2006, COR2:2007, AMD1:2012– Medical Electrical Equipment, Part 1: General requirements for basic safety and essential performance.
IEC60601-1-2:2014 Medical electrical equipment Collateral Standard: Electromagnetic compatibility Requirements and tests.
IEC 60601-1-3:2008 (Second Edition) + A1:2013 for use in conjunction with IEC 60601-1:2005 (Third Edition) + A1:2012
IEC 60601-1-6:2010 (Third Edition) + A1:2013 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
IEC 60601-2-28:2017 for use in conjunction with 60601-1:2005, COR1:2006, COR2:2007, AMD1:2012 (or IEC 60601-1: 2012 reprint) Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis.
IEC 60601-2-54:2009, AMD1:2015 for use in conjunction with IEC 60601-1:2005, AMD1:2012 Particular Requirements For The Basic Safety And Essential Performance Of X-Ray Equipment for Radiography and Radioscopy.
-
- Summary of clinical testing: Clinical testing was not required to establish substantial equivalence because all digital x-ray receptor panels have had previous FDA clearance.
-
- Conclusion: After analyzing bench and our risk assessments, it is the conclusion of Micro-X that the modified Rover Digital Diagnostic Mobile X-Ray Systems are as safe and effective as the predicate device, have few technological differences, and has the same indications for use, thus rendering it substantially equivalent to the predicate device.