RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIR

K161345 · Sedecal., Sa. · IZL · Jul 6, 2016 · Radiology

Device Facts

• Record ID: K161345
• Device Name: RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIR
• Applicant: Sedecal., Sa.
• Product Code: IZL · Radiology
• Decision Date: Jul 6, 2016
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1720
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.

Device Story

Mobile X-ray system for bedside, emergency, orthopedics, and operating theater use. Operated by qualified doctors or technicians. System uses high-frequency generator to produce X-ray exposures; digital image acquisition via wireless Canon CXDI panels. Features include battery/line operation, motorized drive, and telescoping tubestand (FLEXPLUS model). Includes Distributed Antenna System (DAS) with 4 sector antennas to improve wireless detector sensitivity/range. Incorporates secondary PC board for 'Enhanced Work Flow' to run third-party client software (RIS, QC, PACS). Output is digital radiographic image displayed for clinical review. Facilitates rapid diagnostic imaging in acute care settings.

Clinical Evidence

No clinical data. Bench testing only. Performance verified via laboratory testing to DHHS radiation standards, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-54, and FCC parts 15/18. Sample images verified by a Board Certified Radiologist.

Technological Characteristics

Mobile X-ray system; high-frequency generator; battery or AC line powered. Wireless digital panels (Canon CXDI series). Distributed Antenna System (DAS) for Wi-Fi. Telescoping tubestand. Connectivity: Ethernet, Wi-Fi 802.11b/g. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-54, 21 CFR 1020.30, FCC Part 15/18. Software: Canon CXDI-NE control software plus secondary PC environment for third-party integration.

Indications for Use

Indicated for adult and pediatric patients requiring diagnostic radiographic imaging of the skull, spine, chest, abdomen, and extremities. Contraindicated for mammography.

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

• Sedecal Mobile Digital Diagnostic X-Ray Systems (K101517)

Reference Devices

• Canon CXDI 401C Wireless (K133693)
• Canon CXDI 701C Wireless (K131106)
• Canon CXDI 801C Wireless (K131106)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 6, 2016

SEDECAL SA % Daniel Kamm, P.E. Principal Engineer Kamm & Associates 8870 Ravello Court NAPLES FL 34114

Re: K161345

Trade/Device Name: RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIR Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: II Product Code: IZL, MOB Dated: June 28, 2016 Received: June 30, 2016

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. 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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael O'Hara

For

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) K161345

Device Name

RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIR

#### Indications for Use (Describe)

Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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# 510(k) Summary 510(k) Number K161345 SEDECAL SA C/ Pelaya, 9 - 13, Pol. Ind. Río de Janeiro 28110 Algete, Madrid, España (Spain) Tel.- [phone] Fax.- [phone] Date Prepared: June 28, 2016 Contact: Mª Luisa Gómez de Agüero, Quality and Regulatory Manager

## 1. Identification of the Device:

Trade/Device Name: RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIR Regulation Number: 21CFR892.1720 Regulation Name: Mobile X-Ray System Regulatory Class: II Product Code: IZL and MQB Common/Usual Name: Digital Mobile Diagnostic X-Ray System

## 2. Equivalent legally marketed device: K101517

Trade/Device Name: Sedecal Mobile Digital Diagnostic X-Ray Systems (various models) Regulation Number: 21CFR892.1720 Regulation Name: Mobile X-Ray System Regulatory Class: II Product Code: IZL and MQB Common/Usual Name: Digital Mobile Diagnostic X-Ray System

- 3. Indications for Use (intended use) Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.
- 4. Description of the Device: RadPRO® Mobile 40kW and RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIR are mobile x-ray units that covers all the specific needs of any radiographic examination at the patient's bed, first aid, and emergency, orthopedics, pediatric, and operating theater. These battery or line operated units combine stand-alone for exposures with battery assisted motor drive for the greatest ease in imaging. Five different models of digital image acquisition panels are offered: Canon CXDI 401C Wireless, Canon CXDI 701C Wireless, Canon CXDI 801C Wireless. All of the Canon panels and the associated software have been cleared by FDA, (K131106 and K133693) so integration with the mobile system was straightforward. The device complies with the US Federal Safety Performance Standard and is UL listed. The key differences between the modified device and the predicate device are as follows:
- 4.1. The FLEXPLUS version has a telescoping Tubestand which enhances visibility while transporting the unit.
- 4.2. We are offering updated versions of the Canon Digital X-Ray Panels, as listed above and shown in the comparison table below.

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- 4.3. We have added a second personal computer board which permits "Enhanced Work Flow" capability. The second, independent computer is configured to run a second, independent software system, (to be supplied by the user) to allow a user to toggle to a Work Flow environment for ease-of-use in mobile X-ray systems. This second computer is configured to be a "slave" to the X-ray system software, including both Canon CXDI and Sedecal Integration software (e.g., the second computer is turned on and off by the X-ray System's power status). The second computer and its Windows environment is specified with sufficient computing requirements to enable third-party client software to be installed that could include RIS, QC and PACS communications.
- 4.4. We have added what we call a "DAS", a distributed antenna system that enhances the detectability of the accompanying detectors, both in range and sensitivity, also increasing the overall wireless sensitivity by utilizing 4 sector antennas.
- 4.5. We have updated the User Manual to reflect the changes made to the device.
- 5. Safety and Effectiveness, comparison to predicate device. Bench, test laboratory results, and clinical image comparisons indicate that the new device is as safe and effective as the predicate devices. All digital panels have previous FDA clearance and are provided unmodified.

| Characteristic | Sedecal Easy Moving Digital<br>K101517 | RadPRO® Mobile 40kW; RadPRO® Mobile<br>40kW FLEXPLUS, Model SM-40HF-B-D-VIR<br>K161345 |
|----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: | Intended for use by a<br>qualified/trained doctor or<br>technician on both adult and<br>pediatric subjects for taking<br>diagnostic radiographic exposures<br>of the skull, spinal column, chest,<br>abdomen, extremities, and other<br>body parts. Applications can be<br>performed with the patient sitting,<br>standing, or lying in the prone or<br>supine position. | SAME, adding FDA requested language:<br>Not for mammography. |
| Configuration | Battery or line operated mobile | SAME, now with telescopic tube mount<br>(FLEX PLUS) (see photo below) |
| Performance<br>Standard | 21 CFR 1020.30 | SAME |
| Generator | High frequency made by Sedecal | SAME |
| Generator<br>power level | Four available power levels:<br>20 KW, 32 KW, 40 KW, 50 KW | 40 kW (One power level) |
| Collimator | Ralco R221 DHHS Manual<br>Collimator | SAME |
| Characteristic | Sedecal Easy Moving Digital<br>K101517 | RadPRO® Mobile 40kW; RadPRO® Mobile<br>40kW FLEXPLUS, Model SM-40HF-B-D-VIR<br>K161345 |
| Image<br>acquisition | Trixell 3543pR: (Wireless)<br>Pixel size 144 $ μ $ m/2372 x 3000<br>pixels or<br>Varian 4336R<br>Pixel size 139 $ μ $ m/3072 x 2560<br>pixels | Canon CXDI 401C Wireless (CSI) K133693<br>Pixel size: 125 $ μ $ m 3320 × 3408 pixels<br>Canon CXDI 701C Wireless (CSI) K131106<br>Pixel size: 125 $ μ $ m 2800 × 3408 pixels<br>Canon CXDI 801C Wireless (CSI) K131106<br>Pixel size: 125 $ μ $ m 2800 × 2192 pixels |
| Software | dicomPACS®DXR | Canon control software CXDI-NE |
| Connection | Ethernet or Wireless Wi-Fi | SAME |
| DICOM | YES | YES |
| Workflow | Not applicable | Enhanced Work Flow via second PC. |
| Power Source | AC Line or Rechargeable Battery | SAME |
| Electrical<br>safety and<br>EMC | Electrical Safety per IEC-60601. UL<br>listed; EMC per IEC-60601-1-2;<br>IEC 60601-1-3 Radiation protection<br>in diagnostic X-ray equipment<br>IEC 60601-2-54 Particular<br>Requirements For The Basic Safety<br>And Essential Performance Of X-Ray<br>Equipment for Radiography and<br>Radioscopy | SAME |
| Standards<br>(Other than<br>Electrical and<br>EMC) | Wi-Fi 802.11b/g | Wi-Fi 802.11b/g and:<br>FCC Rules and Regulations 47 CFR Chapter I<br>Part 15 Subpart B; Part 18 Subpart C ICES-<br>003 ISSUE 5 (2012) & ICES-001 ISSUE 4<br>(2014) & ANSI C63.4-2009. |
| Wi-Fi<br>communication<br>with detectors | One single antenna | "DAS" distributed Wi-Fi antenna system |
| Characteristic | Sedecal Easy Moving Digital<br>K101517 | RadPRO® Mobile 40kW; RadPRO® Mobile<br>40kW FLEXPLUS, Model SM-40HF-B-D-VIR<br>K161345 |
| Photos | Image: Sedecal Easy Moving Digital K101517 | Image: RadPRO® Mobile<br><br>Image: RadPRO® Mobile Flex Plus |

## 6. Substantial Equivalence Chart

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- 7. Summary of Laboratory Testing and Bench Testing: Laboratory testing included performance testing to the DHHS Radiation Safety Performance Standard, Electrical Safety per IEC-60601. EMC per IEC-60601-1-2; IEC 60601-1-3 Radiation protection in diagnostic X-ray equipment, IEC 60601-2-54 Particular Requirements For The Basic Safety And Essential Performance Of X-Ray Equipment for Radiography and Radioscopy, and FCC Parts 15 and 18. Software integration testing (enhanced workflow) was documented and a detailed risk analysis was performed. Test images were obtained to confirm total system functionality. Every unit manufactured undergoes thorough performance testing which includes visual and configuration testing, hi-pot testing, hi-pot testing, power supply testing, (batteries, etc.), generator controls (voltage, current, timing), and image acquisition. Additional Wi-Fi testing was done to verify the functionality of internal Wi-Fi antennas. Mechanical testing of the new telescoping Tubestand was performed.

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- 8. Summary of Clinical Testing: Not required because all of the proposed digital panels have prior FDA clearance. Sample images were verified by a Board Certified Radiologist.
- 9. Conclusion After analyzing bench and laboratory testing to applicable standards, it is the conclusion of Sedecal SA that the modified Sedecal Mobile X-Ray Systems are as safe and effective as the predicate devices, have few technological differences, and has no new indications for use, thus rendering them substantially equivalent to the predicate devices.