(95 days)
The device is intended for use for medical purpose in a hospital, etc., in order to convert X-ray image data to digital signal and to transfer the converted data to printer, filing system, image display device, etc. Flex DR C30 is not intended for use with FFDM systems.
FlexDR C30 is comprised of a reader and an elevator stand that raises and lowers the reader. The reader is an X-ray image reader with a built-in FPD as an X-ray detector. This reader is linked to the exposure liming of the X-ray generator and starts reading of the X-ray image immediately after exposure. The read images are stored inside, and then they are converted one by one to digital data and sent to Medical Image Working Station, CS-3000, 510(k) cleared, K051523. The operator can manually adjust the height of the reader to match the height of the patient by holding the reader elevation handle at the rear of the reader.
This 510(k) submission for the Konica Minolta FlexDR C30, a Solid State X-ray Imager, focuses on its substantial equivalence to previously cleared predicate devices. Therefore, the submission does not contain a detailed study with specific acceptance criteria and performance metrics for the FlexDR C30 itself, as would be expected for a novel device. Instead, the demonstration of substantial equivalence relies on comparing the technological characteristics of the new device to the predicates.
Here's a breakdown of the requested information based on the provided text, highlighting what is present and what is absent:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the given 510(k) summary. Since the submission is for substantial equivalence to predicate devices, a direct study with specific acceptance criteria and detailed performance metrics for the FlexDR C30 itself is not presented. The claim is that its technological characteristics are "basically the same" as the predicates.
2. Sample size used for the test set and the data provenance
This information is not provided as a standalone performance study with a test set was not detailed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided as a standalone performance study with a test set was not detailed.
4. Adjudication method for the test set
This information is not provided as a standalone performance study with a test set was not detailed.
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
There is no mention of an MRMC study or AI assistance in this 510(k) submission. The device is an X-ray imager, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not provided as the device is an imaging hardware system, not an algorithm.
7. The type of ground truth used
This information is not provided as a standalone performance study with a test set was not detailed.
8. The sample size for the training set
This information is not provided. As an imaging hardware device, it would not typically have a "training set" in the context of an AI algorithm.
9. How the ground truth for the training set was established
This information is not provided. As an imaging hardware device, it would not typically have a "training set" in the context of an AI algorithm.
Summary of Device and Equivalence:
The FlexDR C30 is a Solid State X-ray Imager intended for converting X-ray image data to digital signals and transferring them. Its substantial equivalence is claimed to the Konica Minolta Direct Digitizer, Regius Model 370 (K051418), and the Canon Inc. Digital Radiography Model CXDI-40C (K031633). The comparison of principal characteristics is referenced in "Section 4" (which is not provided in the excerpt), and the conclusion states that the FlexDR C30 "has basically the same technological characteristic" as the predicate devices. The submission also indicates compliance with safety and electromagnetic compatibility standards (IEC60601-1 and IEC60601-1-2).
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NOV 1 8 2008
510(k) Summary
as required by 807.92
1. Company Identification
Konica Minolta Medical & Graphic, Inc. No. 1 Sakura-machi, Hino-shi, Tokyo 191-8511, Japan
2. Submitter's Name and Address
Koji Matsushima (Mr.) General Manager Regulation Management Division Quality Assurance Center 2970 Ishikawa-machi, Hachioji-shi, Tokyo 192-8505, Japan Telephone: 81-42-660-9607 Fax: 81-42-660-9588
3. Date of Submission
August 12, 2008
4. Device Trade Name
Digital Radiography, FlexDR C30
5. Common Name
Solld State X-ray Imager (Flat Panel / Digital Imager)
6. Classification
Class II, 21 CFR 892. 1630, Solid State X-ray Imager
7. Product Code 90 MQB
8. Predicate Device
Direct Digitizer, Regius Model 370, K051418 Canon Inc, Digital Radiography Model CXDI-40C, K031633
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9. Description of Device
FlexDR C30 is comprised of a reader and an elevator stand that raises and lowers the reader.
The reader is an X-ray image reader with a built-in FPD as an X-ray detector. This reader is linked to the exposure liming of the X-ray generator and starts reading of the X-ray image immediately after exposure. The read images are stored inside, and then they are converted one by one to digital data and sent to Medical Image Working Station, CS-3000, 510(k) cleared, K051523. The operator can manually adjust the height of the reader to match the height of the patient by holding the reader elevation handle at the rear of the reader.
10. Indications for Use
The device is intended for use for medical purpose in a hospital, etc., in order to convert X-ray image data to digital signal and to fransfer the converted data to printer, filing system, image display device, etc.
11. Substantial Equivalence to Predicate Device
The Digital Radiography, FlexDR C30 is substantially equivalent to our Direct Digitizer, Regius Model 370, K051418 and Canon Inc, Digital Radiography Model CXDI-40C, K031633. Comparison of the principal characteristics is shown in Section 4.
12. Compliance Standard
Safety standard : IEC60601-1 Ed.2(1988)+ A1(1991)+A2(1995) Electromagnetic Compatibility : IEC60601-1-2 Ed.2(2001)+A1(2004)
13. Conclusion
The Digital Radiography, FlexDR C30 has basically the same technological characteristic as the predicate devices which are approved 510(k) number: K051418 and K031633. This 510(k) has demonstrated substantial equivalence as the predicate devices.
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Image /page/2/Picture/0 description: The image shows the logo of the Department of Health & Human Services. The logo includes the department's emblem on the left, which features a stylized human figure. To the right of the emblem, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is displayed in a clear, sans-serif font.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Konica Minolta Medical & Graphic, Inc. % Mr. Russell Munves Official Correspondent Storch, Amini & Munves, P.C. 140 East 45th Street, 25th Floor Two Grand Central Tower NEW YORK NY 10017
AUG 2 3 2013
Re: K082347
Trade/Device Name: Flex DR C30 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: October 20, 2008 Received: October 22, 2008
Dear Mr. Munves:
This letter corrects our substantially equivalent letter of November 18, 2008.
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed 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 conninered pror to thay 2018 11:12 provisions of the Federal Food, Drug, de nees may been recuire approval of a premarket approval approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, merelore, mains 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 11 your device is bluesting 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 that I DA has made a decol regulations administered by other Federal agencies. You must of any irederal statutes and regulations ancluding, 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 pactice medical devioc-reated ad retor vality 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 will anow you to oogin finding of substantial equivalence of your device to a legally marketed predication. * In I Dr intention 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 If you desire specific antile of Jour aver in Viro 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 Tour may 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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Indications for Use
510(k) Number (if known) : K082347
Device Name : Flex DR C30
Indications for Use:
The device is intended for use for medical purpose in a hospital, etc., in order to convert X-ray image data to digital signal and to transfer the converted data to printer, filing system, image display device, etc.
Flex DR C30 is not intended for use with FFDM systems.
Prescription Use AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Division ign-Off Division of Reproductive, A Radiological Devices 510(k) Number
§ 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.