ORTHOSCAN MOBILE DI MINI C-ARM

K113708 · Orthoscan, Inc. · OXO · Jan 5, 2012 · Radiology

Device Facts

• Record ID: K113708
• Device Name: ORTHOSCAN MOBILE DI MINI C-ARM
• Applicant: Orthoscan, Inc.
• Product Code: OXO · Radiology
• Decision Date: Jan 5, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1650
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The OrthoScan Mobile DI Mini C-Arm is designed to provide the physician with general fluoroscopic visualization of the patient including, but not limited to, surgical orthopedic procedures and critical and emergency care procedures in hospital, emergency care, critical care, or physician office environments.

Device Story

Mobile mini C-arm fluoroscopic imaging system; provides real-time visualization for surgical, orthopedic, and emergency procedures. Operates by capturing X-ray images of patient anatomy; processes signals for display on integrated monitor. Used by physicians in hospitals, critical care units, and physician offices. Facilitates intraoperative guidance and diagnostic visualization; assists in clinical decision-making during procedures. Benefits include portable, high-resolution imaging for minimally invasive interventions.

Clinical Evidence

Bench testing only.

Technological Characteristics

Mobile mini C-arm fluoroscopic X-ray system. Class II device (21 CFR 892.1650). Product codes: OXO, JAA. System includes X-ray generator, image intensifier, and display monitor. Designed for portability in clinical environments.

Indications for Use

Indicated for general fluoroscopic visualization of patients undergoing surgical orthopedic procedures, critical care, or emergency care in hospital, critical care, or physician office settings.

Regulatory Classification

Identification

An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. 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). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic 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. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Submission Summary (Full Text)

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Public Health Service

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

OrthoScan, Inc. % Mr. William Sammons Technical Reviewer & Primary Contact Intertek Testing Services NA, Inc. 2307 E Aurora Road, Unit B7 TWINSBURG OH 44087

AUG 20 2013

Re: K113708

Trade/Device Name: OrthoScan Mobile DI Mini C-Arm Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OXO and JAA Dated: December 14, 2011 Received: December 16, 2011

Dear Mr. Sammons:

This letter corrects our substantially equivalent letter of January 5, 2012.

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. Iisting 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 (OS) 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/cdrl/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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510(k) Number (if known): _ K11 3708

Device Name: _QrthoScan Mobile DI Mini C-Arm

Indications for Use:

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The OrthoScan Mobile DI Mini C-Arm is designed to provide the physician with general fluoroscopic visualization of the patient including, but not limited to, surgical orthopedic procedures and critical and emergency care procedures in hospital, emergency care, critical care, or physician office environments.

Prescription Use X (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 OF NEEDED)

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

Mary S. Potts

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K113708

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