Rover

K201488 · Micro-X , Ltd. · IZL · Jul 17, 2020 · Radiology

Device Facts

• Record ID: K201488
• Device Name: Rover
• Applicant: Micro-X , Ltd.
• Product Code: IZL · Radiology
• Decision Date: Jul 17, 2020
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 892.1720
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The device is designed to perform radiographic x-ray examinations on pediatric and adult patients, in all patient treatment areas.

Device Story

The Rover is a mobile digital x-ray system designed for use in deployed medical facilities and clinical environments. It captures radiographic images using FDA-cleared digital x-ray panels (Fujifilm FDR D-EVO series) and the Fuji FDX Console Advance DR-ID 300CL software. The system features a lightweight design (105 kg), high ground clearance for uneven terrain, and a swappable battery tray for continuous operation. It operates at 40-110kV and 0.2-20mAs. The device is operated by healthcare professionals to perform trauma and general diagnostic imaging. Output consists of digital radiographic images displayed on the console for clinical review, aiding in diagnostic decision-making. The system provides portability for point-of-care imaging, benefiting patients in remote or mobile medical settings.

Clinical Evidence

No clinical data. Substantial equivalence established via bench testing and verification of component integration. System performance verified against US federal performance standards (21 CFR 1020.30/31) and IEC safety/EMC standards.

Technological Characteristics

Mobile digital x-ray system; 40-110kV, 0.2-20mAs generator; 105 kg weight; swappable battery tray; Wi-Fi/Ethernet connectivity. Uses Fujifilm FDR D-EVO digital panels. Software: Fuji FDX Console Advance DR-ID 300CL (Windows 10). Complies with IEC 60601-1, 60601-1-2, 60601-1-3, 60601-1-6, 60601-2-28, and 60601-2-54.

Indications for Use

Indicated for radiographic x-ray examinations on pediatric and adult patients in all patient treatment areas.

Regulatory Classification

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.

Predicate Devices

• DRX-Revolution Nano Mobile X-ray System (K173924)

Reference Devices

• Fujifilm FDR D-EVO Series (K142003, K192932)
• Fuji FDX Console Advance DR-ID 300CL Software (K192932)
• Carestream DRX Family (K153142, K183245, K183474)

Submission Summary (Full Text)

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July 17, 2020

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food & 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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Micro-X Ltd. % Mr. Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Ct NAPLES FL 34114

Re: K201488

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: June 1, 2020 Received: June 4, 2020

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 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 (QS) 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

For

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) K201488

Device Name Rover

Indications for Use (Describe)

The device is designed to perform radiographic x-ray examinations on pediatric and adult patients treatment areas.

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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### 510(k) Summary: 510(k) Number K201488

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 modern.

## Limited A14 6 MAB Eastern Promenade, Tonsley (Clovelly Park), South Australia 5042 Phone: [phone] Email: [e-mail] Date: July 14, 2020 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: K173924,

Trade/Device Name: DRX-Revolution Nano Mobile X-ray System 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:

- Fujifilm FDR D-EVO Series: K142003; K192932 i) Regulation Number: 21 CFR 892. 1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB
- ii) The Fuji FDX Console Advance DR-ID 300CL Software cleared in K192932 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ
- 4) Indications for Use: The device is designed to perform radiographic x-ray examinations on pediatric and adult patients, in all patient treatment areas.
- 5) 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:

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- 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.

| Characteristic | DRX-Revolution Nano Mobile X-ray System<br>K173924 | Rover, K201488 |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>Use: | The device is designed to perform<br>radiographic x-ray examinations on pediatric<br>and adult patients, in all patient treatment<br>areas. | The device is designed to perform radiographic<br>x-ray examinations on pediatric and adult<br>patients, in all patient treatment areas. SAME |
| Configuration | Battery Operated Mobile System with digital<br>x-ray panel and image acquisition computer | SAME |
| Generator | Maximum 4.8 kW @ 104 msec and 7.7 kW<br>@ 13 msec<br>40 – 110 kV<br>0.2 – 20.0 mAs<br>30 – 70 mA | Maximum 4.8 kW @ 104 msec and 7.7 kW @<br>13 msec of power<br>40 – 110 kV<br>0.2 - 20.0 mAs<br>30 – 70 mA<br>SAME |
| Photos | DRX-Revolution Nano Mobile<br>Image: DRX-Revolution Nano Mobile | Rover<br>Image: Rover<br>Very similar appearance and functionality |
| Digital X-ray<br>Panel Supplied | Carestream DRX Family: K153142; K183245;<br>K183474. 14" x 17" and 17" x 17" sizes. | Fujifilm FDR D-EVO Series, all FDA cleared<br>K142003; K192932; 24x30cm, 14" x 17" and 17"<br>x 17" sizes (CSL & GOS) Equivalent. |
| Software | Carestream DirectView | The Fuji FDX Console Advance DR-ID 300CL<br>Software cleared in K192932 |
| Panel Interface | Ethernet or Wi-Fi wireless | SAME |
| Characteristic | DRX-Revolution Nano Mobile X-ray System<br>K173924 | Rover, K201488 |
| Operating<br>System | Windows 7 | Windows 10 |
| Meets US<br>Performance<br>Standard | Meets all applicable requirements of<br>21 CFR 1020.30 and 21CFR 1020.31 | SAME |
| Power Source | AC Line or Battery | SAME but the system has the additional feature<br>of having a swap-out battery tray so the system<br>does not have to limit use while plugged in to<br>an AC line for charging. |

## 6) Substantial Equivalence Chart

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- 7) 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.
- 8) 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 Drug Administration Staff Document Issued on: October 2, 2014. The digital panel software employed was already reviewed by FDA. Labeling was developed and information provided in accordance with this FDA Guidance Document: Pediatric Information for X-ray Imaging Device Premarket Notifications, Guidance for Industry and Food and Drug Administration Staff, November 2017. Labeling also includes reference to the Image Gently website (http://www.imageqently.org/). Because the device contains wireless technology, we consulted Radio Frequency Wireless Technology in Medical Devices - Guidance for Industry and FDA Staff, AUGUST 2013 and we incorporated those recommendations into our labeling.

The Rover Battery Mobile X-Ray Units have been tested to be in compliance with the following Standards:

US Performance Standard for Diagnostic X-Ray Systems: 21 CFR 1020.30 AND 21 CFR 1020.31.

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

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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, 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.

- 9) 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.
- 10) Conclusion: After analyzing bench and non-clinical tests, it is the conclusion of Micro-X that the new 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.