(27 days)
Imation Trimax Cassettes are 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.
Imation Trimax 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 radiographic film. The cassettes are in a family of film sizes. The Trimax C-1 series contain a window that permits writing by a radiographic film marking system. The Trimax C-2 series is windowless.
Radiologic cassettes are comprised of a light-tight chamber for preventing radiologic film exposure, a compressible backplate material to assure intimate film screen contact, a latching mechanism for removal and replacement of radiographic film, a patientoriented surface transparent to x-ray energy, lead shielding to prevent unwanted exposure to stray x-ray energy and suitable support structure for durability of the assembly.
The provided text does not contain detailed information regarding specific acceptance criteria, device performance metrics, or study designs with sample sizes, expert qualifications, or ground truth establishment for the Imation Trimax™ Cassette. The submission focuses on substantial equivalence to a predicate device and conformance to voluntary design standards.
Therefore, I cannot populate the table or answer the questions with the requested level of detail regarding performance data.
However, based on the limited information provided, here's what can be inferred:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Conformance to ANSI standard PH. 1.49(1995) | Imation believes the subject device is safe and effective based on comparison to the predicate device and by conformance to this design standard. |
| Conformance to IEC 406(1996) | Imation believes the subject device is safe and effective based on comparison to the predicate device and by conformance to this design standard. |
| Conformance to DIN 6832(1992) | Imation believes the subject device is safe and effective based on comparison to the predicate device and by conformance to this design standard. |
| Substantial Equivalence to predicate device (DuPont/Sterling Intensifying Screens and Cassettes) | Imation believes the subject device is safe and effective based on comparison to the predicate device. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
No information provided. The submission relies on conformance to voluntary standards and comparison to a predicate device, rather than a specific performance study with a test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable, as no specific performance study with a test set requiring expert ground truth is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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
No MRMC study was mentioned. The device is a radiographic film cassette, not an AI-powered system for image interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a physical component, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable, as no specific performance study with a test set requiring ground truth is described. The "ground truth" for the submission is based on the established safety and effectiveness of the predicate device and the adherence to relevant industry standards.
8. The sample size for the training set
Not applicable. This device is a physical product, not an AI model requiring a training set.
9. How the ground truth for the training set was established
Not applicable.
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Image /page/0/Picture/1 description: The image shows a logo with the word "IMATION" in bold, sans-serif font. Above the word is a graphic of a hand holding a wand, with stars and dots emanating from the wand. Below the word "510(k) Summary" is written in a smaller font. The phrase "Borne of 3M Innovation" is written in a smaller font to the right of the word "Summary".
February 13, 1998
Imation Corp. 1 Imation Place Oakdale MN 55128-3414 Contact: Stephen G. Slavens 1 Imation Place Bldg 235-2B-23 Oakdale MN 55144-3414 Phone: 612-704-3536 612-736-3116 FAX:
MAR 2 3 1998
Imation Corp. I Imation Place Oakdale, MN 55128-3414 612 704 4000 phone 800 537 4675 fax
Device:
Imation Trimax™ Cassette Trade name: Common name: Radiographic Film Cassette Classification name: Radiographic Film Cassette - IXA 21 CFR 892.1850 - Class II
Predicate device:
DuPont/Sterling Intensifying Screens and Cassettes.
Description and Intended Use of Device:
Imation Trimax 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 radiographic film. The cassettes are in a family of film sizes. The Trimax C-1 series contain a window that permits writing by a radiographic film marking system. The Trimax C-2 series is windowless.
Technological Characteristics:
Radiologic cassettes are comprised of a light-tight chamber for preventing radiologic film exposure, a compressible backplate material to assure intimate film screen contact, a latching mechanism for removal and replacement of radiographic film, a patientoriented surface transparent to x-ray energy, lead shielding to prevent unwanted exposure to stray x-ray energy and suitable support structure for durability of the assembly.
Performance Data:
Voluntary standards used in the design of the subject device(s) are: ANSI standard PH. 1.49(1995) IEC 406(1996) DIN 6832(1992)
Imation believes the subject device is safe and effective based on comparison to the predicate device and by conformance to the above design standards.
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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a stylized symbol. The symbol is a graphic representation of a human figure, with three abstract profiles facing right. The profiles are stacked on top of each other, creating a sense of depth and unity.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Stephen Slavens Regulatory Affairs Imation Corporation 1 Imation Place Oakdale, Minnsota 55128 Re:
K980722 Imation Trimax™ Cassettes Dated: February 13, 1998 Received: February 24, 1998 Regulatory class: II 21 CFR 892.1850/Procode: 90 IXA
MAR 2 3 1998
Dear Mr. Slavens:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 (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 (OS) for Medical Devices: General regulation (2) CFR Part 820) and that, through periodic QS 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 submission 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 vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 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/dsmaldsmam.html".
Sincerely yours,
William Yin
Lilian Yin, Ph.D. Director, Division of Reproductive Abdominal. Ear. Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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ATTACHMENT 2
Statement of Indications for Use:
510(K) Number (if known):
Device Name: 3M Trimax™ Radiographic Cassette
Indications for Use:
Imation Trimax Cassettes are 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.
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| -------------------------------------------------------- |
| Prescription Use(Per 21 CFR 801.109) | OR | Over-the- Counter Use |
|---|---|---|
| ------------------------------------------ | ---- | ----------------------- |
Alvin G. Seymore
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number
§ 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.