(15 days)
Not Found
No
The device is a film cassette, a passive component used to hold film and screens during traditional x-ray procedures. The description and intended use do not mention any computational or software components, let alone AI/ML.
No.
The device is used to hold radiographic film during diagnostic x-ray procedures, which are investigative, not therapeutic.
No
The device, Agfa Film Cassettes, is described as holding radiographic film for x-ray procedures, providing a lightproof enclosure, and is used to facilitate diagnostic imaging. It is a tool for image acquisition, not a device that directly performs diagnosis or interprets medical information to identify a condition or disease.
No
The device description clearly states it is a physical film cassette, which is a hardware component used in traditional x-ray procedures.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used "during diagnostic x-ray procedures to hold a radiographic film...". This describes a physical component used in an imaging process, not a test performed on a biological sample outside the body.
- Device Description: The description details physical characteristics of film cassettes, which are mechanical devices for holding film and screens.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process that would be performed in vitro (in glass, or outside the living organism).
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or treatment. This device is a component of an imaging system used to capture an image of the inside of the body.
N/A
Intended Use / Indications for Use
The Agfa Film Cassettes are indicated 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 lightproof enclosure for direct exposure of radiographic film.
Product codes
90 IXA
Device Description
There are three product lines of Agfa Film Cassettes covered by the present 510(k): (1) The Mamoray Mammography Cassettes, (2) the metal-bodied CAWO Cassettes, and (3) the ABS Plastic Curix and Lightweight Cassettes. The present submission describes the currently marketed products by cassette type and shows that they are substantially equivalent to cassettes currently marketed in the U.S.
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)
Not Found
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
KOZ3020
SEP 2 6 2002
510(k) Summary
Agfa Film Cassettes
Common/Classification Name: Radiographic Film Cassette, 21 CFR 892.1850
Agfa Corporation 10 South Academy Street Greenville, SC 29602-9048
Contact: Jeff Jedlicka, Prepared: August 21, 2002
INTRODUCTION A.
There are three product lines of Agfa Film Cassettes covered by the present 510(k): (1) The Mamoray Mammography Cassettes, (2) the metal-bodied CAWO Cassettes, and (3) the ABS Plastic Curix and Lightweight Cassettes. The present submission describes the currently marketed products by cassette type and shows that they are substantially equivalent to cassettes currently marketed in the U.S.
B. PREDICATE DEVICES
The Agfa Mamoray Mammography Cassettes are substantially equivalent to the Agfa Mammography Cassettes, which were cleared for marketing by FDA on March 21, 1979 as K790273. The Agfa Metal-Bodied CAWO Cassette is substantially equivalent to the Kodak X-Omat Cassette, which was cleared for marketing by FDA on March 1, 1989 as K890750. The Plastic Curix and Lightweight Cassettes are also substantially equivalent to the Kodak X-Omat Cassette.
C. INTENDED USE
The Agfa Film Cassettes are indicated 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 lightproof enclosure for direct exposure of radiographic film.
SUBSTANTIAL EQUIVALENCE SUMMARY D.
The Agfa Film Cassettes have the same indications for use statement compared to those of the legally marketed predicate devices. The Agfa Film Cassettes have the same technological characteristics as the predicate devices. This premarket notification will describe the
1
characteristics of the Agfa Film Cassettes in sufficient detail to assure substantial equivalence.
TECHNOLOGICAL CHARACTERISTICS E.
The technological characteristics of the Agfa Film Cassettes are the same as those of the predicate devices.
F. STANDARDS
The Agfa Film Cassettes are designed and manufactured to meet the requirements of ANSI/NAPM 1.49-1995, DIN 6832, Parts 2 and 3; and IEC 406.
CONCLUSIONS G.
This pre-market submission has demonstrated Substantial Equivalence as defined and understood in the Federal Food Drug and Cosmetic Act and various guidance documents issued by the Center for Devices and Radiological Health.
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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized design featuring three wavy lines that resemble a human figure or a symbol representing health and well-being.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 6 2002
Agfa Corporation c/o R. Kent Donohue Underwriters Laboratories, Inc. 6 12 Laboratory Drive P.O. Box 13995 RESEARCH TRIANGLE PARK NC 27709-3995
Re: K023020
Trade/Device Name: Agfa Film Cassette Regulation Number: 21 CFR §892.1850 Regulation Name: Radiographic film cassette Regulatory Class: II Product Code: 90 IXA Dated: September 10, 2002 Received: September 11, 2002
Dear Mr. Donohue:
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 (see 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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Pape 2
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 contact the Office 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 Office of Compliance at (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.
Sincercly 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): K1023620
Device Name:
Indications For Use:
The Agfa Film Cassettes are indicated 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 lightproof enclosure for direct exposure of radiographic film.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use ___________
Juil A. begeron
(Division Sign-Off) Division of Reproductive, Al and Radiological Device 510(k) Number