DDRCRUZE (DIGITAL MOBILE DIAGNOSTIC X-RAY SYSTEM)

K131314 · Swissray Medical AG · MQB · Jun 25, 2013 · Radiology

Device Facts

• Record ID: K131314
• Device Name: DDRCRUZE (DIGITAL MOBILE DIAGNOSTIC X-RAY SYSTEM)
• Applicant: Swissray Medical AG
• Product Code: MQB · Radiology
• Decision Date: Jun 25, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

The ddrCruze™ is 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

ddRCruze™ is a fully motorized mobile digital radiography (DR) system; utilizes X-ray generator and wireless digital detector panel to capture diagnostic images. System includes viewing monitor for image review/setup, adjustable positioning, and front-view camera for maneuverability. Operated by qualified doctors or technicians in clinical settings. Device integrates previously cleared components: Sedecal mobile X-ray system and Pixium Portable 3543 EZ detector. Output consists of digital radiographic images for clinical diagnostic decision-making. Benefits include mobile, high-quality diagnostic imaging for patients unable to be transported to fixed radiology suites.

Clinical Evidence

No clinical data. Bench testing only, including electrical safety, electromagnetic compatibility, and system integration testing.

Technological Characteristics

Mobile X-ray system with 20-50 kW generator. Detector: Pixium Portable 3543 EZ (A-Si TFT, CsI scintillator, 148 μm pixel size, 16-bit gray scale). Connectivity: Tethered Ethernet or WiFi. Safety standards: IEC 60601-1, IEC 60601-1-2. Motorized mobility with front-view camera.

Indications for Use

Indicated for adult and pediatric patients for diagnostic radiographic imaging of skull, spine, chest, abdomen, and extremities. Patient may be sitting, standing, or recumbent. Contraindicated for mammography.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Sedecal Mobile Digital Diagnostic X-Ray Systems (K101517)
• PrestoDR Portable (K100400)
• ddRVersa Motion (K123005)

Submission Summary (Full Text)

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### 510(k) Summary

1. Submitter: Swissrav Medical AG . Turbistrasse 25 – 27 CH-6280 Hochdorf, Switzerland Phone [phone] Fax [phone] Date Prepared: February 6, 2013 Contact: Markus Bütler, Quality Manager

# JUN 2 5 2013

- 2. Identification of the Device: ddRCruze™ (Digital Mobile Diagnostic X-Ray System); Recommended classification regulation: 21 CFR 892.1650, 892. 1720 Device class: 11, Panel: Radiology, Product code: MQB and IZL
- 3. Predicate Devices: K101517, Sedecal Mobile Digital Diagnostic X-Ray Systems (various models), manufactured by Sedecal SA (Spain), Software: PrestoDR Portable, K100400, CMT Medical Technologies LTD. The Digital Wi-Fi panel we are using was cleared in our own 510(k): K123005, ddRVersa Motion.
- 4. A description of the device: This represents the combination of the two of the predicate devices: K101517, Sedecal Mobile Digital Diagnostic X-Ray Systems (various models), manufactured by Sedecal SA (Spain), Software: PrestoDR Portable, K100400, CMT Medical Technologies LTD. (Used UNMODIFIED ). ddRCruze™ features a fully motorized mobile DR system, wireless connectivity, diagnostic image quality, viewing monitor for image review and system setup which can be positioned on any side of the system for added convenience. The system has a front-view camera for safe maneuverability.
- Intended for use by a qualified/trained doctor or technician on both 5. Intended use of the device: adult and pediatric subjects for taking diagnostic 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) (SAME as predicate)

| Characteristic | Predicate Device<br>K101517, Sedecal Mobile Digital<br>Diagnostic X-Ray Systems<br>(various models),. | PrestoDR Portable, K100400,<br>CMT Medical Technologies<br>LTD. | New Device ddRCruze™ |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications | Intended for use by a<br>qualified/trained doctor or<br>technician on both adult and<br>pediatric subjects for taking<br>diagnostic radiographic<br>exposures of the skull, spinal<br>column, chest, abdomen,<br>extremities, and other body<br>parts. Applications can be<br>performed with the patient<br>sitting, standing, or lying in the<br>prone or supine position. (Not<br>for mammography) | The PrestoDR Portable, is<br>intended for use in general<br>radiographic examinations,<br>wherever conventional screen-<br>film systems may be used,<br>excluding fluoroscopy,<br>angiography and<br>mammography. PrestoDR 4143<br>allows imaging of the skull,<br>chest, shoulders, spine,<br>abdomen, and extremities. | 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<br>sitting, standing, or lying in the<br>prone or supine position. (Not<br>for mammography) (SAME) |
| Characteristic | Predicate Device<br>K101517, Sedecal Mobile Digital<br>Diagnostic X-Ray Systems<br>(various models),. | PrestoDR Portable, K100400,<br>' CMT Medical Technologies<br>LTD. | New Device ddRCruze™ |
| Digital Receptor<br>Panel(s) | Pixium PORTABLE 3543pR:<br>Pixium* Csl coupled to TFT matrix<br>a:Si-technology<br>Pixel size 144 μm<br>Matrix size 2372 x 3000 pixels<br>16 bit gray scale | Pixium RAD 4600+ and/or<br>Pixium Portable 3543 (WiFi or<br>Cabled) Pixium© Csl on<br>amorphous silicon technology<br>144 mm 17x14 inch (43.2x34.2<br>cm) 3,000 x 2,372 pixels<br>16 bit gray scale | Pixium Portable 3543 EZ<br>Technology Single A-Si TFT +<br>photodiode plate, Csl Scintillator.<br>Active detector area 43 cm x 43<br>cm, Spatial resolution 3.5 lp/mm<br>Active pixel matrix 2880 x 2880<br>pixels, Pixel size 148 μm<br>16 bit gray scale (Cleared in our<br>own 510(k): K123005, ddRVersa<br>Motion.) |
| Panel Operating<br>Time (battery<br>life) | 2 Hours | Up to 8 hours | Up to 8 hours |
| Panel<br>Communication | Tethered Ethernet or WiFi | Tethered Ethernet or WiFi | Tethered Ethernet or WiFi |
| Generator | 20 kW 32 kW 40 kW 50 kW | Not included | 20 kW 32 kW 40 kW 50 kW |
| Safety | UL Listings and IEC Standards IEC<br>60601-1 and IEC 60601-1-2, US<br>Performance Standards | UL/CSA Listings and IEC<br>Standards IEC 60601-1 and IEC<br>60601-1-2, US Performance<br>Standards | UL/CSA Listings and IEC Standards<br>IEC 60601-1 and IEC 60601-1-2,<br>US Performance Standards |
| Photo | Image: Sedecal Mobile Digital Diagnostic X-Ray Systems | Image: CMT Medical Technologies LTD | Image: New Device ddRCruze |

### Comnarison Table

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- ર્દ . Description of non-clinical tests. The unit has undergone electrical safety and electromagnetic compatibility testing, as well as system integration testing. The technical characteristics of the panel have been measured and included in the bench testing information.
- 7. Description of clinical tests: Not applicable. Both the mobile system and the digital panel, as well as the software has been previously cleared and is provided unmodified.
- 8. Conclusions drawn: The nonclinical tests that demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device identified in paragraph 3, above.

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Image /page/2/Picture/0 description: The image shows a circular seal with text around the perimeter and a symbol in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The symbol in the center is a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0003

June 25, 2013

Swissray Medical AG % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LL.C. 1394 25th Street NW BUFFALO MN 55313

Rc: K131314

Trade/Device Name: ddrCruzeTM Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB, IZL Dated: June 10, 2013 Received: June 11, 2013

Dear Mr. Job:

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 vou, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into cither 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. F.DA 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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Page 2 - Mr. Job

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.ida.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/Safetv/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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Sm.7)

for

Janine M. Morris 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): K131314

Device Name: ddrCruze™

Indications For Use:

The ddrCruze™ is 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}

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE ~ CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)


(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k) K131314

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