(15 days)
No
The device description and intended use clearly define the device as a passive cassette for holding film and screens during mammography, with no mention of any computational or analytical capabilities that would involve AI/ML.
No.
The device is used for diagnostic imaging (mammography) by holding film and providing a light-proof enclosure; it does not provide therapy.
No
The device is a cassette for holding film during mammography diagnostic procedures, not a diagnostic device itself. It facilitates the diagnostic process but does not perform the diagnosis.
No
The device description clearly outlines physical components like a light tight chamber, backplate material, and a latching mechanism, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The Ferrania LifeRay™ Mammo Cassettes are described as devices used to hold radiographic film and intensifying screens during mammography procedures. Their function is to facilitate the capture of an X-ray image, not to analyze biological specimens.
- Intended Use: The intended use clearly states "for use during mammography diagnostic procedures to hold radiographic film... for direct exposure of this film." This is a function related to image acquisition, not in vitro analysis.
The device is a component used in an imaging process (mammography), which is distinct from in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
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.
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.
Product codes
IXA
Device Description
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Voluntary standards to which the Ferrania LifeRay™ Mammo Cassettes conform are: ANSI PH1.49 19952, ISO/FDIS 4090: 2000. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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 Cassette
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),
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
1
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
2
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.
3
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
4
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 |
|---|---|---|---|
| ------------------ | -------------- | ---- | ---------------------- |
Nancyc brigdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
| 510(k) Number | K013229 |
|---|---|
| --------------- | --------- |