MODEL AMI1200 C-ARM

K022911 · Integrity Practice Management, Inc. · JAA · Dec 2, 2002 · Radiology

Device Facts

• Record ID: K022911
• Device Name: MODEL AMI1200 C-ARM
• Applicant: Integrity Practice Management, Inc.
• Product Code: JAA · Radiology
• Decision Date: Dec 2, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1650
• Device Class: Class 2

Intended Use

The AMI1200 is intended to be used only by licensed practitioners; to produce imaging techniques required, providing the patient with an adequate diagnosis of their presented condition.

Device Story

The AMI1200 is an image-intensified fluoroscopic x-ray system. It functions by capturing x-ray images to assist licensed practitioners in diagnosing patient conditions. The device is operated by clinicians in a clinical setting. It provides visual output to the practitioner, which is used to inform clinical decision-making and patient diagnosis.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on regulatory classification and device description.

Technological Characteristics

Image-intensified fluoroscopic x-ray system; Class II; Product Code JAA; 21 CFR 892.1650.

Indications for Use

Indicated for use by licensed practitioners to produce imaging techniques for the diagnosis of patient conditions.

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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/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 three stripes extending from its head, representing the department's commitment to health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle symbol.

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## DEC 0 2 2002

Mr. Kevin J. Meuret President Integrity Practice Management, Inc, 1104 Enterprise Drive SIOUX FALLS SD 57106

Re: K022911 Trade/Device Name: AMII200 C-Arm Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: 90 JAA Dated: September 17, 2002 Received: September 23, 2002

Dear Mr. Meuret:

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 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.

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.

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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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Snogdon

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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K092911

## Intended Use Statement

The AMI1200 is intended to be used only by licensed practitioners; to produce imaging techniques required, providing the patient with an adequate diagnosis of their presented condition.

*FDA/GORM/OPE/BMO

SEP 23 2 51 PM '02

RECEIVED

Submitted by:

Kevin J. Meuret, President Integrity Practice Management, Inc.

Submitted on September 18, 2002

*Prescription Use*

✓

Colin m Pollard

(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devices 510(k) Number