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 Description

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. Radiographic cassettes are composed of: a light tight chamber for preventing radiographic film exposure, a compressible backplate material to assure intimate film-screen contact, a latching mechanism for removal and replacement of radiographic film, a patient oriented surface transparent to x-ray energy, lead shielding to prevent unwanted exposure to x-rays assembled in a robust support structure to assure durability.

AI/ML Overview

The provided text describes a 510(k) Premarket Notification for Ferrania S.p.A. LifeRay™ Cassettes. This document focuses on demonstrating substantial equivalence to a predicate device rather than a study proving performance against specific acceptance criteria for a novel AI or medical device with complex performance metrics.

Therefore, many of the requested elements (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable or not provided in the context of this type of submission for a radiographic film cassette.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Conformity to ANSI PH1.49 - 1995	Ferrania LifeRay™ Cassettes conform to ANSI PH1.49 - 1995.
Conformity to ISO/FDIS 4090: 2000	Ferrania LifeRay™ Cassettes conform to ISO/FDIS 4090: 2000.
Safety and Effectiveness (as compared to predicate device)	"Ferrania S.p.A. concluded that the LifeRay™ Cassettes are safe, effective and perform as well as the predicate device."
Functionality: Light-tight enclosure	Designed with a light-tight chamber for preventing radiographic film exposure.
Functionality: Intimate film-screen contact	Designed with a compressible backplate material to assure intimate film-screen contact.
Functionality: Latching mechanism	Designed with a latching mechanism for removal and replacement of radiographic film.
Functionality: X-ray transparent patient oriented surface	Designed with a patient oriented surface transparent to x-ray energy.
Functionality: Lead shielding	Designed with lead shielding to prevent unwanted exposure to x-rays.
Durability	Assembled in a robust support structure to assure durability.
Compatibility (KW Cassette only): Data writing system	The LifeRay™ KW Cassettes contain a window compatible with Kodak system, that permits data writing by a radiographic film marking system.

2. Sample size used for the test set and the data provenance

Not Applicable / Not Provided. This 510(k) submission relies on conformity to voluntary standards and comparison to a predicate device, not on a clinical test set with patient data for performance evaluation in the way a diagnostic algorithm would.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable / Not Provided. Ground truth in the context of expert review is not relevant for this device.

4. Adjudication method for the test set

Not Applicable / Not Provided.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable. This is a physical radiographic cassette, not an AI or software device that would assist human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not Applicable. This is a physical radiographic cassette, not an algorithm.

7. The type of ground truth used

The "ground truth" for this device's performance is its compliance with established voluntary industry standards (ANSI PH1.49 - 1995 and ISO/FDIS 4090: 2000) and its functional equivalence to the predicate device (TRIMAX RADIOGRAPHIC CASSETTE, K980722). These standards inherently define the acceptable physical and performance characteristics of such a device.

8. The sample size for the training set

Not Applicable / Not Provided. This is not a machine learning or AI device that would have a training set.

9. How the ground truth for the training set was established

Not Applicable / Not Provided.

Summary

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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 +39 0195224055 (phone) +39 0195224546 (fax)

Device:

Trade name:	LifeRay™ WL CassetteLifeRay™ 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:K980722), IMATION Corp., 1 Imation Place, Oakdale, MN55128

Description and Intended Use of Device

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: pmannella@ferraniait.com -

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 (301) 594-4639. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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:

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over the Counter Use -------

Nancy C Brigdon
(Division Sign Off)

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

Regulation Number and Section

§ 892.1850 Radiographic film cassette.

(a)
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.(b)
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.