(70 days)
The MITS DICOM Gateway and Image Manager is a device that captures 2 dimensional images and data or receives images and data from various medical imaging sources ( i.e. ultrasound system, R/F units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data (2 dimensional or 3 dimensional) can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations.
Typical users of this system are trained medical professionals, including physicians, nurses, technicians and computer system professionals.
To support the diagnostic interpretation of mammography studies the full fidelity DICOM image in a non-compressed format. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5Mpixel resolution and meets other technical specifications reviewed and accepted by FDA. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary diagnosis or image interpretation.
MITS DICOM Gateway and Image Manager is a suite of applications designed and produced by MITSMED Medical Instrument Technology CO., Ltd. It is a client-server based software system manages archiving, retrieving and displaying medical images. The DICOM converter application is MITS DICOM Gateway. The server side is MITS Image Manager SERVER. And the client side is MITS Image Manager CLIENT.
The provided text is a 510(k) summary for the MITS DICOM Gateway and Image Manager. It describes the device's administrative information, intended use, technological characteristics, and claim of substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert involvement.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.
The document primarily focuses on:
- Administrative Information: Manufacturer, contact, date prepared, device name, classification, regulation number, product code.
- Device Description: A client-server based software system for archiving, retrieving, and displaying medical images. Functions include DICOM conversion, server management, and client display.
- Intended Use: Capturing, receiving, storing, communicating, processing, and displaying 2D and 3D medical images from various sources. It specifies use by trained medical professionals and requirements for mammography interpretation (non-compressed DICOM, FDA-approved 5Mpixel monitor).
- Technological Characteristics: Software server application, no patient contact, no control over life-sustaining devices, human intervention for interpretation.
- Substantial Equivalence: Claims equivalence to CSIST DICOM Gateway and Image Manager (K012327) based on similar working principles and technologies, with differences attributed to feature design not affecting safety or effectiveness. It references software validation and risk analysis results.
- FDA Determination: A letter from the FDA stating substantial equivalence and outlining regulatory compliance requirements.
To answer your questions about acceptance criteria and performance studies, such information would typically be found in a separate section of a 510(k) submission, often under "Performance Data" or "Clinical Data," which is absent here.
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Image /page/0/Picture/0 description: The image shows the logo for MITS, which is a telecommunications company. The logo consists of the letters "MITS" in a bold, sans-serif font. The letters are arranged horizontally, with the "M" and "I" connected. A circle surrounds the letters, and there is a small line underneath the circle.
2. ADMINISTRATIVE INFORMATION
- 2.1 510(k) Summary of Safety and Effectiveness
(Per 21 CFR 807.92)
General Information Establishment
OCT 3 0 2000
- MITSMED Medical Instrument Technology Co., Ltd. . Manufacturer:
- . Address: ' 4F-6, No. 99, Sec 1, NanKan Rd., Luzhu shiang, Taoyua County, 33858. Taiwan, R.O.C.
Owner Number: 10026488 I Contact Person: E-mail: ceirs.jen@msa.hinet.net Dr. Jen, Ke-Min (official correspondent) 886-3-5208829 (Tel); 886-3-5209783 (Fax) Address: No.58, Fu Chiun Street, Hsin Chu City, 30067, Taiwan, ROC
. Date Prepared: August 12, 2009
Device Information
| ● | Proprietary Name: | MITS DICOM Gateway and Image Manager |
|---|---|---|
| ● | Classification Name: | SYSTEM, IMAGE PROCESSING, RADIOLOGICAL,Class II |
| ● | Regulation Number: | 892.2050 |
| ● | Product Code: | LLZ |
Safety and Effectiveness Information
-
. Predicate Device:
Claim of Substantial Equivalence (SE) is made to CSIST DICOM Gateway and Image Manager, K012327. -
. Device Description:
MITS DICOM Gateway and Image Manager is a suite of applications designed and produced by MITSMED Medical Instrument Technology CO., Ltd. It is a client-server based software system manages archiving, retrieving and displaying medical images. The DICOM converter application is MITS DICOM Gateway. The server side is MITS Image Manager SERVER. And the client side is MITS Image Manager CLIENT,
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Image /page/1/Picture/0 description: The image shows a logo with the letters 'MIT' inside of a circle. The letters are in a bold, sans-serif font. There is a small graphic to the left of the circle, which appears to be a stylized representation of a building or structure. The logo is simple and clean, with a focus on the acronym 'MIT'.
0 Intended Use:
The MITS DICOM Gateway and Image Manager a device that captures 2 D images and data or receives images and data from various medical imaging sources ( i.e. ultrasound system, R/F units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data (2 D or 3 D) can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations.
Typical users of this system are trained medical professionals, including physicians, nurses, technicians and computer system professionals.
To support the diagnostic interpretation of mammography studies, ImageSVR PACS the full fidelity DICOM image in a non-compressed will display format. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5Mpixel resolution and meets other technical specifications reviewed and accepted by FDA. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary diagnosis or image interpretation.
Technological Characteristics .
The MITS DICOM Gateway and Image Manager are a software server application and do not contact the patient, nor does it control any life sustaining devices. A physician, providing ample opportunity for competent human intervention interprets images and information being displayed and printed.
Substantial Equivalence (SE) .
A claim of substantial equivalence is made to CSIST DICOM Gateway and Image Manager, K012327. Both of them have the same working principle and technologies. The differences are due to the feature design aspects, not relating to the safety or Besides, the submission contains the results of software effectiveness aspects. validation that the risks analysis and the potential hazards have been classified Minor. Thus they are substantially equivalent.
Keter Teon
Dr. Jen. Ke-Min official correspondent for MITSMED Medical Instrument Technology Co., Ltd.
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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or body. The logo is in black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
MITSMED Medical Instrument Technology Co., Ltd % Dr. Jen, Ke-Min Official Correspondent ROC Chinese-European Industry Research Society No. 58, Fu Chiun Street, Hsin Chu City, 30067 TATWAN ROC
OCT 3 0 2009
Re: K092581
Trade/Device Name: MITS DICOM Gateway and Image Manager Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: П Product Code: LLZ Dated: October 11, 2009 Received: October 21, 2009
Dear Dr. Jen, Ke-Min:
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); medical device reporting (reporting of medical
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Page 2 -
Enclosure
device-related adverse events) (21 CFR 803), good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Lucian M. Morris
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
K192581 510(k) Number:
Device Name: MITSMED Medical Instrument Technology Co., Ltd. MITS DICOM Gateway and Image Manager
Indications for Use :
-
· The MITS DICOM Gateway and Image Manager is a device that captures 2 dimensional images and data or receives images and data from various medical imaging sources ( i.e. ultrasound system, R/F units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data (2 dimensional or 3 dimensional) can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations.
Typical users of this system are trained medical professionals, including physicians, nurses, technicians and computer system professionals. -
· To support the diagnostic interpretation of mammography studies the full fidelity DICOM image in a non-compressed format. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5Mpixel resolution and meets other technical specifications reviewed and accepted by FDA. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary diagnosis or image interpretation.
Prescription Use V
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device 510(k) Number
Page 1 of 1
§ 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).