MEDICATECH, MODEL DDR MAK-800, DDT MAK-1000 FS, DDR MAK-1100 FA

K080582 · Medicatech USA · KPR · May 15, 2008 · Radiology

Device Facts

• Record ID: K080582
• Device Name: MEDICATECH, MODEL DDR MAK-800, DDT MAK-1000 FS, DDR MAK-1100 FA
• Applicant: Medicatech USA
• Product Code: KPR · Radiology
• Decision Date: May 15, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

DDR Digital X-Ray Systems are 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.

Device Story

DDR Digital X-Ray Systems (MAK-800, MAK-1000 FS, MAK-1100 FA) are stationary diagnostic X-ray units. Systems capture radiographic images using a digital flat panel detector (DRTech). MAK-800 is a standalone panel upgrade; MAK-1000 FS includes a straight tube stand; MAK-1100 FA features a C-arm for lateral positioning. Operated by physicians or technicians in hospitals, emergency rooms, and imaging centers. X-ray tube and detector alignment is maintained via mechanical design. Digital images are captured and displayed on a software-driven touch panel LCD console. Output assists clinicians in diagnostic assessment of skeletal and soft tissue structures. Benefits include rapid digital image acquisition and flexible positioning for diverse patient populations, including those with physical restrictions.

Clinical Evidence

Bench testing only. No clinical data provided. Safety and effectiveness established through comparison of technical specifications, user interface, and performance standards against cleared predicate devices.

Technological Characteristics

Stationary X-ray system; digital flat panel detector (17"x17" or 14"x17"); pixel pitch 139 or 160 microns; software-driven touch panel LCD interface; remote control unit; manual or automatic collimator; C-arm or straight tube stand configurations.

Indications for Use

Indicated for adult and pediatric patients requiring diagnostic radiographic imaging of the skull, spine, chest, abdomen, and extremities. Patient may be positioned sitting, standing, or lying (prone/supine).

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 X PLUS LP PLUS Universal Radiographic Systems (K062335)
• DRtech Digital Panel (K080064)
• Sedecal URS LP X-Ray Units with Digital Detector (K042876)

Reference Devices

• CANON CXDI-50G (K031447)

Submission Summary (Full Text)

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KO80582

EXHIBIT 2 510(k) Summary K08 MedicaTech USA 50 Maxwell Irvine , CA , 92618 Toll Free : [phone] Phone : [phone] : [phone] FAX February 25, 2008 Contact: Ashraf Stefan . CEO

MAY 15 2008

- 1. Identification of the Device: Proprietary-Trade Name: DDR MAK-800; the Model # DDR MAK-1000 FS, and the Model DDR MAK-1100 FA Classification Name: Stationary X-ray system, Product Codes Product Code 90 KPR and MQB Common/Usual Name: General purpose diagnostic X-ray Unit.
- 2. Equivalent legally marketed devices: This notification is for a MODIFIED device. This device COMBINES two 510(k) cleared devices, the SEDECAL X PLUS LP PLUS Universal Radiographic Systems K062335 AND a version of the DRtech Digital Panel, K080064. This combination is functionally identical to a SEDECAL cleared device, Sedecal URS LP X-Ray Units with Digital Detector, K.042876..
- 3. Indications for Use (intended use) DDR Digital X-Ray Systems are 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.
- 4. Description of the Devices: The DDR MAK-800 is the digital panel available alone for upgrading current systems. The DDR MAK-1000 FS is a complete system with a straight tube stand/detector combination. The DDR MAK-1100FA is a complete system with a "C-arm" shaped tube stand/detector combination which permits lateral positioning. These systems have been designed as a direct digital imaging system for use in hospital emergency rooms, imaging centers and all general radiology applications. The C-arm design maintains constant alignment between the x-ray tube and image receptor, regardless of C-arm tilt positions or image receptor angle. Its extraordinary flexibility makes the system ideal for all patients in standing, sitting or laying position, including those who are disabled or physically restricted. The DDR MAK-1100 digital flat panel detector provides advanced technology to capture radiographic images in a digital format almost instantly. The nearly 17 x 17 inch imaging area allows for the capture of chest and abdominal images without having to rotate the detector unit.
- 5. Safety and Effectiveness, comparison to predicate device. The results of bench, user, and standards testing indicates that the new device is as safe and effective as the predicate devices.

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## 6. Substantial Equivalence Chart

| Characteristic | Sedecal URS X-<br>Ray Units with<br>Digital Detector<br>K042876 | SEDECAL X<br>PLUS LP PLUS<br>Universal<br>Radiographic<br>Systems K062335 | DDR MAK-800;<br>the Model # DDR<br>MAK-1000 FS, and<br>the Model DDR<br>MAK-1100 FA<br>(This Submission):<br><br>Combines two<br>cleared devices:<br>K062335 AND<br>K080064 |
|--------------------|---------------------------------------------------------------------------------------|---------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: | General purpose<br>diagnostic X-ray unit | SAME | SAME |
| User Interface | Depends on Control<br>Console option<br>chosen. Mainly<br>dedicated touch<br>controls | Software Driven<br>Touch Panel LCD, +<br>IR remote control unit | Software Driven<br>Touch Panel LCD, +<br>remote control unit +<br>remote console |
| Maximum output | Depends on model of<br>generator chosen.<br>Models available from<br>30 kW to 64 kW | SAME as original<br>units. | SAME |
| Image Acquisition | Digital: CANON<br>CXDI-50G.<br>K031447 | Film | Digital: DRTech<br>Portable Digital<br>Radiographic Detector<br>K080064 |
| Digital Panel Size | Up to 14" x 17" active<br>area | N/A | 17" x 17" or 14" x<br>17" |
| Digital Resolution | 160 x 160 microns<br>pixel pitch, with<br>approximately 6<br>million pixels | N/A | 139 x 139 OR 160 x<br>160 micron pixel<br>pitch, either 6.8 or 7.8<br>million pixels. |
| Method of Control | Dedicated push button<br>Controls | Software Driven<br>Touch Panel LCD,<br>+IR remote control<br>unit | Software Driven<br>Touch Panel LCD,<br>+IR remote control<br>unit and control room<br>interface box. |
| Collimator | Manual R302/A | Manual R302/A and<br>Automatic available | SAME |

#### 7. Conclusion

After analyzing bench, user, and standards testing data, it is the conclusion of Medicatech USA that the DDR MAK-800; the Model # DDR MAK-1000 FS, and the Model DDR MAK-1100 FA Radiographic Systems with Digital Detectors are as safe and effective as the predicate devices, have few technological differences, and have no new indications for use, thus rendering them substantially equivalent to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medicatech USA % Mr. Daniel Kamm, P.E. Principal Consultant Kamm & Associates PO Box 7007 DEERFIELD IL 60015

MAY 15 2008

Re: K080582

Trade/Device Name: Models # DDR MAK-800, DDR MAK-1000 FS, and DDR MAK-1100 FA Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR and MOB Dated: February 27, 2008 Received: March 27, 2008

### 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to Iogal] marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this lettoo.

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 24/1276-3474. For questions regarding the reporting of device adverse events (Medical Device Leportion (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You max 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/cdrb/industry/support/index.html

Sincerely yours,

Nancy Brogdon
Nancy C. Brogdon

Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known):
K080582

Device Name: Model # DDR MAK-800; the Model # DDR MAK-1000 FS, and the Model DDR MAK-1100 FA.

Indications For Use:

Indications for Use: The DDR Digital X-Ray Systems are 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.

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

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Hogue Martinez

(Division Sian-C Division of Reproductive, Abdominal and Radiological Devices 510(k) Number