(118 days)
21.3 inch (54cm) Monochrome Digital Mammography 5M pixel LCD Monitor with subpixel driving techniques enabling 15M subpixels to be driven independently, MS53i2 (ML21053) is intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners. It is to be used in digital mammography PACS and modalities including FFDM.
MS53i2 (ML21053) is a 21.3-inch (54 cm) monochrome LCD monitor whose display resolution is 2048 x 2560 (landscape), 2560 x 2048 (portrait) supporting DVI (digital visual interface).
The provided text describes a medical device, a monochrome digital mammography LCD monitor, and its regulatory clearance process through a 510(k) submission. However, it does not contain any information about acceptance criteria, clinical studies, sample sizes, expert qualifications, or ground truth establishment relevant to the performance of the device in a diagnostic context.
The document is a US FDA 510(k) summary and clearance letter, which focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive performance study with specific acceptance criteria as you've requested.
Therefore, I cannot fulfill your request for the specific details about acceptance criteria and study design because that information is not present in the provided text.
The information available is:
- Device Name: 21.3 inch (54 cm) Monochrome Digital Mammography LCD Monitor MS53i2 (ML21053)
- Intended Use: "displaying and viewing medical images for diagnosis by trained medical practitioners. It is to be used in digital mammography PACS and modalities including FFDM."
- Predicate Device: 5M Monochrome Digital Mammography LCD Monitor ME551i2 (MDL2116A) (K061447).
- Reason for Substantial Equivalence: Shares the same characteristics with the predicate device "except for the LCD panel and the power supply."
To answer your questions, details from a performance study demonstrating the diagnostic capabilities of the monitor would be required, which are not included in this regulatory summary.
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(1144
510(k) SUMMARY
SEP 2 6 2011
- Submitter Information: TOTOKU ELECTRIC CO., LTD. 300 Oya, Ueda Nagano 386-0192 Japan
Contact Person: Tsukasa Tashiro, General Manager Email: tasirot@totoku.co.jp Tel: +81.258.24.6611 Fax: +81.258.24.6617
Date Prepared: May 26, 2011
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Device Name: 21.3 inch (54 cm) Monochrome Digital Mammography LCD Monitor MS53i2 (ML21053)
MS53i2, ML21053 Common Name: -
Classification Name: Class II (Part 892 Radiology Devices Sec. 892.2050 Picture Archiving and Communication System)
Predicate Device: 5M Monochrome Digital Mammography LCD Monitor ME551i2 (MDL2116A) (K061447). -
Device Description: MS53i2 (ML21053) is a 21.3-inch (54 cm) monochrome LCD monitor whose display resolution is 2048 x 2560 (landscape), 2560 x 2048 (portrait) supporting DVI (digital visual interface).
- Indended Use: 21.3 inch (54cm) Monochrome Digital Mammography 5M pixel LCD Monitor with sub-pixel driving techniques enabling 15M subpixels to be driven independently, MS53i2 (ML21053) is intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners. It is to be used in digital mammography PACS and modalities including FFDM.
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MS53i2 (ML21053) shares the same characteristics with our Substantial Equivalence: predicate device ME551i2 (K061447) except for the LCD panel and the power supply.
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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird-like figure.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Mr. Tsukasa Tashiro General Manager TOTOKU Electric Co., Ltd 300 Ova, Ude, Nagano 386-0192 JAPAN
SEP 2 6 201
Re: K111496
Trade/Device Name: 21.2 Inch (54cm) Monochrome Digital Mammography LCD Monitor MS53i2 (ML21053) Regulation Number: 21 CFR 892.2050
Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: August 22, 2011 Received: August 24, 2011
Dear Mr. Tashiro:
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 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 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/ReportalProblem/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,
Mary Pastel
Mary S. Pastel, Sc.D. 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: Not Known
Device Name: 21.3 inch (54cm) Monochrome Digital Mammography LCD Monitor MS53i2 (ML21053)
Indications for Use:
21.3 inch (54cm) Monochrome Digital Mammography 5M pixel LCD Monitor with subpixel driving techniques enabling 15M subpixels to be driven independently, MS53i2 (ML21053) is intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners. It is to be used in digital mammography PACS and modalities including FFDM.
Prescription Use AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mary S. Patil
(Division Sign Off)
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K
K111996
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).