(16 days)
The KODAK DirectView DR 7500 System is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions.
Not Found
The provided FDA 510(k) clearance letter (K051258) for the "Kodak DirectView DR 7500 System" does not contain the detailed information required to answer your specific questions about acceptance criteria and study design.
This document is a regulatory clearance letter acknowledging that the device is substantially equivalent to a predicate device. It confirms that the FDA has reviewed the manufacturer's premarket notification and determined that the device can be marketed.
Why the information is not present:
- 510(k)s focus on substantial equivalence: The primary purpose of a 510(k) submission is to demonstrate that a new device is as safe and effective as a legally marketed predicate device, not necessarily to prove its absolute performance against specific metrics in a detailed clinical study for novel devices.
- Detailed study data is often proprietary: Even if a study was conducted, the detailed methodology, acceptance criteria, specific performance metrics, and a full breakdown of the study population are typically found in the full 510(k) submission document itself, which is not usually made public in its entirety as part of the clearance letter. The clearance letter summarizes the FDA's decision.
- The device is an X-ray system: This device is a "Stationary x-ray system" used for generating x-rays. While image quality is crucial, the "performance" here likely refers to technical specifications, dose output, and image acquisition capabilities, rather than a diagnostic AI algorithm's performance metrics like sensitivity/specificity for disease detection.
Therefore, I cannot provide the requested information from the given text.
To find the details you're looking for, you would typically need to:
- Access the full 510(k) submission: Sometimes these are available through Freedom of Information Act (FOIA) requests, or summaries might be present in publicly accessible FDA databases if the manufacturer chose to make more information public.
- Review supporting documentation from the manufacturer: The manufacturer (Eastman Kodak Company, in this case) would have these details in their internal documentation or perhaps in published technical specifications for the device.
Based only on the provided document, here's what I can infer but not directly answer:
- Device Name: Kodak DirectView DR 7500 System
- Intended Use/Indications: "The KODAK DirectView DR 7500 System is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions." This means it's for general diagnostic radiography.
- Regulatory Class: Class II
- Product Codes: KPR (System, X-Ray, Stationary) and MQB (Radiographic System, Digital)
Without the actual study report or further sections from the 510(k) submission that discuss performance data, I cannot populate the table or answer the specific questions about acceptance criteria, sample sizes, ground truth establishment, or clinical study design.
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Ms. Christine E. Ehmann Manager, Regulatory Affairs Eastman Kodak Company 343 State Street ROCHESTER NY 14650
AUG 2 0 2013
Re: K051258
Trade/Device Name: Kodak Direct View DR 7500 System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR and MQB Dated: May 13, 2005 Received: May 18. 2005
Dear Ms. Ehmann:
This letter corrects our substantially equivalent letter of June 1, 2005.
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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed nredicate 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Kodak DirectView DR 7500 System
ATTACHMENT I 510(k): Eastman Kodak Company
Statement of Intended Use
510(k) Number (if known): KOS1258
Device Name: Kodak DirectView DR 7500 System
Intended Use and Indications for Use:
The KODAK DirectView DR 7500 System is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions.
Concurrence of CDRH, Office of Device Evaluation
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Prescription Use (per 21 CFR 801.109) OR
Over-the counter use
Rata Pease
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K051258
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.