PRESTODR PORTABLE

K100400 · Cmt Medical Technologies, Ltd. · IZL · Apr 22, 2010 · Radiology

Device Facts

• Record ID: K100400
• Device Name: PRESTODR PORTABLE
• Applicant: Cmt Medical Technologies, Ltd.
• Product Code: IZL · Radiology
• Decision Date: Apr 22, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1720
• Device Class: Class 2

Intended Use

The PrestoDR Portable ™, is intended for use in general radiographic examinations, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography. PrestoDR Portable ™ allows imaging of the skull, chest, shoulders, spine, abdomen, and extremities.

Device Story

PrestoDR Portable is a digital radiography system utilizing an integrated portable flat panel digital detector (FPD). It functions as a modification of the SMARTRAD system, incorporating updated hardware and software components to integrate the wireless FPD. The device captures X-ray signals to produce digital radiographic images. It is intended for use in clinical settings for general radiographic examinations. Healthcare providers use the system to acquire and view images to assist in clinical decision-making for diagnostic purposes. The system benefits patients by providing digital imaging capabilities for various anatomical regions, replacing conventional screen-film systems.

Clinical Evidence

Bench testing only. The device was verified and validated in accordance with 21 CFR 820.30 regulations. No clinical data was required or provided to support the substantial equivalence determination.

Technological Characteristics

Digital radiography system featuring an integrated portable flat panel digital detector (FPD). Utilizes object-oriented software for connectivity and image processing. Operates as a mobile X-ray system. Technical specifications and materials are consistent with the predicate SMARTRAD system, with updated components for improved cost-effectiveness and performance.

Indications for Use

Indicated for general radiographic examinations of skull, chest, shoulders, spine, abdomen, and extremities in patients requiring diagnostic imaging where conventional screen-film systems are used. Excludes fluoroscopy, angiography, and mammography. Prescription use only.

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

• SMARTRAD (K003438)
• WIRELESS PORTABLE DETECTOR FD-W17 (K090625)

Submission Summary (Full Text)

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# 510(k) Summary of Safety and Effectivencss (in accordance to 21 CFR 807.87(h))

Device Name

Proprietary Device Name: PrestoDR Portable

## Establishment Name and Registration Number of Submitter

APR 2 2 2010

Name: CMT Medical Technologies Ltd. Registration: 8030112 Submission contact: Shlomi Dines Hacarmel St. Bld 7/2, POB. 111, Industrial Park, Yoqneam Ilit 20692, ISRAEL, Tel:[phone] [phone], Fax:[phone],

Device Classification

Product Code: MOB Regulation Number: 892.1650 Common Name: Solid state X-Ray imager Classification Name: Image intensified fluoroscopic x-ray system Regulatory class: Class II

Reason for 510(k) Submission Special 510(k) Submission

Identification of Legally Marketed Equivalent Devices K003438 SMARTRAD K090625 WIRELESS PORTABLE DETECTOR FD-W17

#### Device Description

The PrestoDR Portable is a Digital Radiography system, featuring an integrated portable flat panel digital detector (FPD) K090625 WIRELESS PORTABLE DETECTOR FD-W17, Philips Medical Systems North America CO (this is the 510(k) for the wireless portable flat panel detector) and CMT's proprietary technology, which incorporates state of the art object-oriented software and connectivity. The legally marketed SMARTRAD K003438 has been modified: To integrate the portable flat panel digital detector (FPD) K090625, improve its cost effectiveness, aging technologies and components (hardware and software) have been redesigned. The device major functions and principle of operation were not changed.

#### Indications for use

The PrestoDR Portable, is intended for use in general radiographic examinations, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography. PrestoDR Portable allows imaging of the skull, chest, shoulders, spine, abdomen, and extremities.

### Safety & Effectiveness

The device has been designed verified and validated complying with 21CFR 820.30 regulations. Tests data demonstrate that the PrestoDR Portable meets the required specifications. No adverse affects have been detected.

#### Substantial Equivalency

It is CMT opinion that the PrestoDR Portable is substantially equivalent in terms of safety and effectiveness to the predicate device.

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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Mr. Shlomi Dines Director of Quality & Regulatory Affairs CMT Medical Technologies, Ltd. Hacarmel St., Bld. 7/2. POB. 111 Industrial Park, Yoqneam Ilit 20692 ISRAEL

AUG 2 3 2013

Re: K100400 Trade/Device Name: PrestoIDR Portable Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: II Product Code: IZL and MQB Dated: April 9, 2010 Received: April 13, 2010

Dear Mr. Dines:

This letter corrects our substantially equivalent letter of April 22, 2010.

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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 a legally 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known):

Device Name: PrestoDR: Portable

Indications For Use: The PrestoDR Portable ™, is intended for use in general radiographic examinations, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography. PrestoDR Portable ™ allows imaging of the skull, chest, shoulders, spine, abdomen, and extremities.

Prescription Use: YES (Part 21 CFR 801 Subpart D)

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AND/OR

. . .

Over-the-Counter Use: NO (Part 21 CFR B01 Subpart C)

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Concurrence of CDRH; Office of Device Evaluation (ODE)

Robert Bookerf
(Division Sign-Off)

Division of Rediological Dev Office of In Vitro Diagnostic Device Evalu tion and Safety