LIFERAY WL CASSETTE, LIFERAY KW CASSETTE

K012373 · Ferrania S.P.A. · IXA · Aug 9, 2001 · Radiology

Device Facts

• Record ID: K012373
• Device Name: LIFERAY WL CASSETTE, LIFERAY KW CASSETTE
• Applicant: Ferrania S.P.A.
• Product Code: IXA · Radiology
• Decision Date: Aug 9, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1850
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

Ferrania LifeRay™ Cassettes are intended for use during diagnostic X-ray procedures to provide a light-proof enclosure for direct exposure of radiographic film and to hold this radiographic film in close contact with an X-ray intensifying screen.

Device Story

LifeRay™ Cassettes (WL and KW models) are radiographic film cassettes used in diagnostic X-ray procedures. The device functions as a light-proof enclosure that holds radiographic film in intimate contact with an X-ray intensifying screen to facilitate film exposure. The KW model includes a window compatible with Kodak systems for data marking. The device is used in clinical radiology settings by healthcare professionals. It consists of a support structure, a patient-facing X-ray transparent surface, a compressible backplate for film-screen contact, a latching mechanism, and lead shielding. The device ensures proper image capture by maintaining film-screen contact and preventing light exposure.

Clinical Evidence

Bench testing only. The device conforms to voluntary standards ANSI PH1.49-1995 and ISO/FDIS 4090:2000 to demonstrate safety and effectiveness.

Technological Characteristics

Radiographic film cassette consisting of a light-tight chamber, compressible backplate, latching mechanism, X-ray transparent patient-facing surface, and lead shielding. Conforms to ANSI PH1.49-1995 and ISO/FDIS 4090:2000. KW model features a data-writing window.

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. No specific patient population or contraindications defined.

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

• TRIMAX RADIOGRAPHIC CASSETTE (K980722)

Submission Summary (Full Text)

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## AUG - 9 2001

#### 510(k) PREMARKET NOTIFICATION FOR FERRANIA S.p.A. LifeRay™ Cassettes

# Section 9 - SUMMARY OF SAFETY AND EFFECTIVENESS

# 510(k) Summary

Ferrania, March 30, 2001

Contact: Ing. Mannella Paolo Ferrania S.p.A. Regulatory Manager Viale della Libertà 57 Viale della Libertà 57 17014 Ferrania 17014 Ferrania Savona (Italy) Savona - Italy [phone] (phone) [phone] (fax)

Device:

| Trade name: | LifeRay™ WL Cassette<br>LifeRay™ KW Cassette |
|----------------------|----------------------------------------------------------------------------------------------------------------|
| Common Name: | Radiographic film cassette |
| Classification Name: | Radiographic film cassette (per 21 CFR 892.1850) |
| Predicate Device: | TRIMAX RADIOGRAPHIC CASSETTE (510(k) number:<br>K980722), IMATION Corp., 1 Imation Place, Oakdale, MN<br>55128 |

### Description and Intended Use of Device

Ferrania LifeRay™ 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 this film. The Cassettes are in a family of film sizes. The LifeRay™ KW Cassettes contain a window compatible with Kodak system, that permits data writing by a radiographic film marking system. The LifeRay™ WL Cassette is windowless.

### Technological Characteristics

Radiographic cassettes are composed of:

- a light tight chamber for preventing radiographic film exposure, 피
- a compressible backplate material to assure intimate film-screen contact, .
- a latching mechanism for removal and replacement of radiographic film, 트
- 1 a patient oriented surface transparent to x-ray energy,
- 1 lead shielding to prevent unwanted exposure to x-rays

RA-
Class

Section 9 - Page 1 of 2

E-mail: [e-mail] -

SK7

2001-04-13

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#### 510(k) PREMARKET NOTIFICATION FOR FERRANIA S.p.A. LifeRay™ Cassettes

### Section 9 - SUMMARY OF SAFETY AND EFFECTIVENESS

assembled in a robust support structure to assure durability.

#### Performance data

Voluntary standards to which the Ferrania LifeRay™ Cassettes conform are: ANSI PH1.49 - 1995 ISO/FDIS 4090: 2000.

### Conclusion

Based on the analysis of the comparison made between the LifeRay™ Cassettes and the predicate device, Ferrania S.p.A. concluded that the LifeRay™ Cassettes are safe, effective and perform as well as the predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 9 2001

Ferrania S.P.A. % Ms. Chantel Carson Underwriters Laboratories 333 Pfingsten Road NORTHBROOK IL 60062-2096 Re: K012373

LifeRay™ WL and KW Series Cassettes (Radiographic film cassette) Dated: July 23, 2001 Received: July 26, 2001 Regulatory Class: II 21 CFR 892.1850/Procode: 90 IXA

Dear Ms. Carson:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the w unero released your booken of 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). 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 (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 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 yitro 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" (21CFR 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/dsma/dsmamain.html".

Sincerely vours

Nancy C. Bogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure (s)

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## Statement of Indications for Use

510(k) Number (if known) _____________________________________________________________________________________________________________________________________________________

#### LifeRay™ WL Cassette Device Name: LifeRay™ KW Cassette

Indications for Use:

Ferrania LifeRay™ Cassettes are intended for use during diagnostic X-ray procedures to provide a light-proof enclosure for direct exposure of radiographic film and to hold this radiographic film in close contact with an X-ray intensifying screen.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OR

Over the Counter Use -------

Nancy C Brigdon
(Division Sign Off)

Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K02373