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.

Both Ferrania LifeRay™ Mammo Cassettes and the predicate device 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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for Ferrania S.p.A. LifeRay™ Mammo Cassettes. However, it does not contain information about acceptance criteria, device performance metrics, or a formal study proving the device meets specific criteria.

The submission states that the device is "substantially equivalent" to a predicate device (Kodak MIN-R 2 CASSETTE) based on technological characteristics and adherence to voluntary standards. This type of submission relies on demonstrating that the new device is as safe and effective as a legally marketed device, rather than proving performance against specific quantitative acceptance criteria through a dedicated performance study with human readers or standalone algorithm performance.

Here's an analysis of the requested information based on the provided text, highlighting what is present and what is absent:

Description of Acceptance Criteria and Study to Prove Device Meets Criteria

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not Explicitly Stated	The device "performs as well as the predicate device" (Kodak MIN-R 2 CASSETTE). This is a qualitative comparison rather than specific quantitative performance metrics.

Conformity to ANSI PH1.49 1995² (Radiographic Film Cassettes)	Yes, the device conforms to this standard.
Conformity to ISO/FDIS 4090: 2000 (Non-screen-type Medical Radiographic Films)	Yes, the device conforms to this standard.

Explanation: The document does not define specific quantitative acceptance criteria such as sensitivity, specificity, or image quality metrics. Instead, the "acceptance" is based on substantial equivalence to a predicate device and conformity to relevant industry standards. The reported performance is a qualitative statement of equivalence.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not applicable. No test set of radiographic images or patient data is mentioned. The assessment relies on a comparison of device characteristics and adherence to standards, not a clinical performance study.
Data Provenance: Not applicable. No clinical data or test data is mentioned.

Explanation: This 510(k) summary is for a radiographic film cassette, not an imaging algorithm or a device that produces diagnosable images itself. Therefore, a "test set" of images or patient data with an established ground truth is not relevant to this submission. The device's performance is intrinsically linked to its physical characteristics and ability to hold film and screens properly, as assessed against standards and a predicate device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Number of Experts: Not applicable. No "ground truth" was established for a test set as there was no study comparing diagnostic outcomes.
Qualifications of Experts: Not applicable.

Explanation: As no clinical performance study involving diagnostic interpretation was conducted for the cassette itself, there were no experts used to establish a ground truth.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. No test set requiring expert adjudication was used.

Explanation: Without a clinical or image-based test set, adjudication methods are irrelevant here.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study: No, an MRMC comparative effectiveness study was not done.
Effect Size: Not applicable.

Explanation: An MRMC study is typically performed for AI or imaging devices where human interpretation is involved. This device is a passive film cassette, and its effectiveness is not measured by its ability to assist human readers in interpretation.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Standalone Study: No, a standalone performance study was not done as this is not an algorithm or an AI device.

Explanation: This device is a physical component (a cassette) for mammography, not an algorithm. Therefore, a standalone algorithm performance study is not relevant.

7. Type of Ground Truth Used

Type of Ground Truth: Not applicable. No "ground truth" (such as expert consensus, pathology, or outcomes data) was used in the context of a clinical performance study for this device. The "ground truth" for the submission is based on engineering specifications, material characteristics, and conformity to voluntary standards for film cassettes.

Explanation: The "safety and effectiveness" conclusion for this device is based on its engineering design, materials, and its ability to meet published industry standards for film cassettes (e.g., maintaining light-tightness and intimate film-screen contact), as well as its substantial equivalence to an existing predicate device. This does not involve clinical diagnostic ground truth.

8. Sample Size for the Training Set

Sample Size: Not applicable. There is no mention of a training set as this is not an AI/ML device.

Explanation: As this is not an AI/ML device, the concept of a "training set" for an algorithm is not relevant.

9. How the Ground Truth for the Training Set Was Established

Ground Truth Establishment: Not applicable.

Explanation: Since there was no training set, there was no ground truth established for one.

Summary of this 510(k) Submission:

This 510(k) submission for the Ferrania LifeRay™ Mammo Cassettes is a "substantial equivalence" filing. It demonstrates safety and effectiveness by:

Technological Comparison: Highlighting that its components and function are similar to the predicate device (Kodak MIN-R 2 CASSETTE).
Standards Conformance: Stating that the device conforms to relevant voluntary industry standards (ANSI PH1.49 1995 and ISO/FDIS 4090: 2000) for radiographic film cassettes.

Crucially, this type of submission does not involve clinical performance studies with patient data, human readers, or AI algorithms that would require the establishment of ground truth or the measurement of diagnostic performance metrics like sensitivity and specificity. The "acceptance criteria" are implied by the standards and the features of the predicate device, with the "study" being the engineering assessment and comparison presented in the submission.

Summary

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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

+39 0195224055 (phone) +39 0195224546 (fax) E-mail: pmannella@ferraniait.com

Device:

Trade name:	LifeRay™ FW Mammo CassetteLifeRay™ 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),Kodak Corp., 343 State Street, Rochester, NY 14650 0207.

Description and Intended Use of Device

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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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The logo is black and white and appears to be of low resolution.

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	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, for question (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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	✓	OR	Over the Counter Use
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Nancyc brigdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices

510(k) Number	K013229
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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.