PATHFINDER MOBILE C ARM

K981131 · Acoma Medical Imaging, Inc. · OXO · Jun 26, 1998 · Radiology

Device Facts

• Record ID: K981131
• Device Name: PATHFINDER MOBILE C ARM
• Applicant: Acoma Medical Imaging, Inc.
• Product Code: OXO · Radiology
• Decision Date: Jun 26, 1998
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 892.1650
• Device Class: Class 2

Intended Use

The Pathfinder Mobile C-Arm is intended to be used for routine radiography and follow-up x-rays after studies such as (e.g. gastrointestinal studies, chest, bone, hip pnnings, and pacemaker implants).

Device Story

Pathfinder Mobile C-Arm is a mobile X-ray imaging system; used in clinical settings for routine radiography and post-procedural follow-up (e.g., GI studies, chest, bone, hip pinnings, pacemaker implants). Device generates X-ray images for physician review to assist in clinical decision-making and patient monitoring. Operated by trained healthcare professionals (physicians, technicians). System provides real-time or static imaging capabilities to support surgical or diagnostic procedures.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Mobile C-arm X-ray system; class II device (21 CFR 892.1650); intended for routine radiography and follow-up imaging.

Indications for Use

Indicated for patients requiring routine radiography and follow-up x-rays for gastrointestinal studies, chest, bone, hip pinnings, and pacemaker implants.

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 9200 Corporate Boulevard Rockville MD 20850

## JUN 26 1998

Jim Lambrecht Official Correspondent Program Director Acoma Medical Imaging Inc. 150 Chaddick Drive Wheeling, Illinois 60090

Re:

K981131 Pathfinder Mobil C-Arm Dated: March 25, 1998 Received: March 30, 1998 Regulatory class: II 21 CFR 892.1650/Procode: 90 JAA

Dear Mr. Lambrecht:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 Part 801 and additionally 809.10 for in vitn diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrb/dsmaldsmam.html".

Sincerely yours,

Lillian Yin, Ph.D.

Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal. Ear. Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page__________________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known): K981131

Device Name: Pathfinder Mobile C-Arm

Indications for use:

The Pathfinder Mobile C-Arm is intended to be used for routine radiography and follow-up x-rays after studies such as (e.g. gastrointestinal studies, chest, bone, hip pnnings, and pacemaker implants).

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David An. Segmen

(Division Sign-Off) Division of Reproductive, Abdominal, El and Radiological Devi 510(k) Number

Prescription Use_X (Per 21 CFR 801.109)

:

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)