TRIMAX RADIOGRAPHIC CASSETTE

K980722 · Imation Corp. · IXA · Mar 23, 1998 · Radiology

Device Facts

• Record ID: K980722
• Device Name: TRIMAX RADIOGRAPHIC CASSETTE
• Applicant: Imation Corp.
• Product Code: IXA · Radiology
• Decision Date: Mar 23, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1850
• Device Class: Class 2

Intended Use

Imation Trimax Cassettes are intended for use during diagnostic x-ray procedures to hold a radiographic film in close contact with an x-ray intensifying screen and to provide a light-proof enclosure for direct exposure of radiographic film.

Device Story

Imation Trimax Cassettes are radiographic film cassettes used in diagnostic x-ray procedures. The device functions as a light-tight enclosure that holds radiographic film in intimate contact with an x-ray intensifying screen during exposure. The assembly includes a patient-oriented surface transparent to x-ray energy, a compressible backplate to ensure film-screen contact, a latching mechanism for film handling, and lead shielding to block stray x-ray energy. The C-1 series includes a window for film marking, while the C-2 series is windowless. The device is used by radiology personnel in clinical settings to facilitate the capture of diagnostic images.

Clinical Evidence

Bench testing only. No clinical data provided. Safety and effectiveness are supported by conformance to voluntary design standards: ANSI PH. 1.49(1995), IEC 406(1996), and DIN 6832(1992).

Technological Characteristics

Radiographic film cassette; light-tight chamber; compressible backplate; latching mechanism; x-ray transparent patient-facing surface; lead shielding. Conforms to ANSI PH. 1.49(1995), IEC 406(1996), and DIN 6832(1992).

Indications for Use

Indicated for use during diagnostic x-ray procedures to hold radiographic film in close contact with an x-ray intensifying screen and provide a light-proof enclosure for film exposure.

Regulatory Classification

Identification

A radiographic film cassette is a device intended for use during diagnostic x-ray procedures to hold a radiographic film in close contact with an x-ray intensifying screen and to provide a light-proof enclosure for direct exposure of radiographic film.

Special Controls

*Classification.* Class II (special controls). The device 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

• DuPont/Sterling Intensifying Screens and Cassettes

Submission Summary (Full Text)

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K780722

Image /page/0/Picture/1 description: The image shows a logo with the word "IMATION" in bold, sans-serif font. Above the word is a graphic of a hand holding a wand, with stars and dots emanating from the wand. Below the word "510(k) Summary" is written in a smaller font. The phrase "Borne of 3M Innovation" is written in a smaller font to the right of the word "Summary".

February 13, 1998

Imation Corp. 1 Imation Place Oakdale MN 55128-3414 Contact: Stephen G. Slavens 1 Imation Place Bldg 235-2B-23 Oakdale MN 55144-3414 Phone: [phone] FAX:

MAR 2 3 1998

Imation Corp. I Imation Place Oakdale, MN 55128-3414 612 704 4000 phone [phone] fax

# Device:

Imation Trimax™ Cassette Trade name: Common name: Radiographic Film Cassette Classification name: Radiographic Film Cassette - IXA 21 CFR 892.1850 - Class II

## Predicate device:

DuPont/Sterling Intensifying Screens and Cassettes.

### Description and Intended Use of Device:

Imation Trimax Cassettes are intended for use during diagnostic x-ray procedures to hold radiographic film in close contact with an x-ray intensifying screen and to provide a light-proof enclosure for direct exposure of radiographic film. The cassettes are in a family of film sizes. The Trimax C-1 series contain a window that permits writing by a radiographic film marking system. The Trimax C-2 series is windowless.

#### Technological Characteristics:

Radiologic cassettes are comprised of a light-tight chamber for preventing radiologic film exposure, a compressible backplate material to assure intimate film screen contact, a latching mechanism for removal and replacement of radiographic film, a patientoriented surface transparent to x-ray energy, lead shielding to prevent unwanted exposure to stray x-ray energy and suitable support structure for durability of the assembly.

# Performance Data:

Voluntary standards used in the design of the subject device(s) are: ANSI standard PH. 1.49(1995) IEC 406(1996) DIN 6832(1992)

Imation believes the subject device is safe and effective based on comparison to the predicate device and by conformance to the above design standards.

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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 the department's name encircling a stylized symbol. The symbol is a graphic representation of a human figure, with three abstract profiles facing right. The profiles are stacked on top of each other, creating a sense of depth and unity.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Stephen Slavens Regulatory Affairs Imation Corporation 1 Imation Place Oakdale, Minnsota 55128 Re:

K980722 Imation Trimax™ Cassettes Dated: February 13, 1998 Received: February 24, 1998 Regulatory class: II 21 CFR 892.1850/Procode: 90 IXA

MAR 2 3 1998

Dear Mr. Slavens:

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 (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 (2) 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 vitro 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/cdrh/dsmaldsmam.html".

Sincerely yours,

William Yin

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

Enclosure

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# ATTACHMENT 2

Statement of Indications for Use:

510(K) Number (if known):

Device Name: 3M Trimax™ Radiographic Cassette

Indications for Use:

Imation Trimax Cassettes are intended for use during diagnostic x-ray procedures to hold a radiographic film in close contact with an x-ray intensifying screen and to provide a light-proof enclosure for direct exposure of radiographic film.

| Concurrence of CDRH, Office of Device Evaluation (ODE) |
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| Prescription Use<br>(Per 21 CFR 801.109) | OR | Over-the- Counter Use |
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Alvin G. Seymore

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