LIFERAY FW MAMMO CASSETTE, LIFERAY KW MAMMO CASETTE

K013229 · Ferrania USA, Inc. · IXA · Oct 12, 2001 · Radiology

Device Facts

• Record ID: K013229
• Device Name: LIFERAY FW MAMMO CASSETTE, LIFERAY KW MAMMO CASETTE
• Applicant: Ferrania USA, Inc.
• Product Code: IXA · Radiology
• Decision Date: Oct 12, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1850
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

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

Device Story

LifeRay™ Mammo Cassettes (FW and KW models) are radiographic film cassettes used in mammography. Device functions as light-proof enclosure for X-ray film; maintains intimate contact between film and X-ray intensifying screen during exposure. KW model includes window compatible with Kodak ID printers; FW model includes window compatible with Ferrania ID printers for patient identification. Used in clinical radiology settings by healthcare professionals. Device ensures proper image capture by protecting film from light and ensuring screen-film contact, facilitating diagnostic mammography procedures.

Clinical Evidence

Bench testing only. Device conforms to ANSI PH1.49 1995 and ISO/FDIS 4090: 2000 standards.

Technological Characteristics

Radiographic film cassette. Components: light-tight chamber, compressible backplate, latching mechanism. Standards: ANSI PH1.49 1995, ISO/FDIS 4090: 2000. Available in two sizes/models (FW/KW) with ID printer windows.

Indications for Use

Indicated for use during mammography diagnostic 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

• Kodak MIN-R 2 CASSETTE (K890361)

Submission Summary (Full Text)

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#### 510(k) PREMARKET NOTIFICATION FOR FERRANIA S.p.A. LifeRayTM Mammo Cassettes

#### Section 9 - SUMMARY OF SAFETY AND EFFECTIVENESS

# OCT 1 2 2001

## 510(k) Summary

KOI 3229

Ferrania, July 27, 2001

Ferrania S.p.A. Viale della Libertà 57 17014 Ferrania Savona (Italy)

Contact: Ing. Mannella Paolo Regulatory Manager Viale della Libertà 57 17014 Ferrania Savona - Italy

> [phone] (phone) [phone] (fax) E-mail: [e-mail]

Device:

| Trade name: | LifeRay™ FW Mammo Cassette<br>LifeRay™ KW Mammo Cassette | |
|----------------------|--------------------------------------------------------------------------------------------------------------|--|
| Common Name: | Radiographic film cassette for mammography | |
| Classification Name: | Radiographic film cassette (per 21 CFR 892.1850) | |
| Medical specialty | Radiology | |
| Product code | IXA | |
| Predicate Device: | Kodak MIN-R 2 CASSETTE (510(k) number: K890361),<br>Kodak Corp., 343 State Street, Rochester, NY 14650 0207. | |

#### Description and Intended Use of Device

Ferrania LifeRay™ Mammo Cassettes are intended for use during mammography diagnostic 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 available in two sizes and two models. The LifeRay™ KW Mammo Cassettes contain a window that is compatible with Kodak ID Printers for marking film with patient identification data. The LifeRay™ FW Mammo Cassettes contain a window that is compatible with Ferrania ID Printers for the same purpose as before.

2001-07-27

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### Section 9 - SUMMARY OF SAFETY AND EFFECTIVENESS

### Technological Characteristics

Both Ferrania LifeRay™ Mammo Cassettes and the predicate device are composed of:

- a light tight chamber for preventing radiographic film exposure, 마
- a compressible backplate material to assure intimate film-screen contact,
- l a latching mechanism for removal and replacement of radiographic film.

#### Performance data

Voluntary standards to which the Ferrania LifeRay™ Mammo Cassettes conform are:

- ANSI PH1.49 19952 ●
- ISO/FDIS 4090: 2000. .

#### Conclusion

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

² CDRH Recognized Consensus Standard

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## OCT 1 2 2001

Ferrania S.P.A. % Ms. Chantel Carson Engineering Team Leader Underwriters Laboratories Inc. 333 Pfingsten Road NORTHBROOK IL 60062-2096 Re: K013229

Trade/Device Name: LifeRay™ FW Mammo Cassette LifeRay™ KW Mammo Cassette Regulation Number: 21 CFR 892.1850 Regulation Name: Radiographic film cassette Regulatory Class: II Product Code: 90 IXA Dated: September 25, 2001 Received: September 27, 2001

Dear Ms. Carson:

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 (sec 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 If you desire 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 Additionally, for question [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. Brogdon

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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# Statement of Indications for Use

510(k) Number (if known) _ KO / 3229

#### LifeRay™ FW Mammo Cassette Device Name: LifeRay™ KW Mammo Cassette

### Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | <div>✓</div> | OR | Over the Counter Use |
|------------------|--------------|----|----------------------|
|------------------|--------------|----|----------------------|

Nancyc brigdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices

| 510(k) Number | K013229 |
|---------------|---------|
|---------------|---------|