(27 days)
PACSmate MMD=4300C/4300CX is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. PACSmate MMD-4300C/4300CX does not support the display of mammography images for diagnosis.
The PACSmate MMD-4300C/4300CX is a 30" monochrome/color LCD display for medical image viewing.4 Mega pixel medical grade LCD monitor with high resolutions.
The provided document describes a 510(k) summary for the PACSmate MMD-4300C/4300CX medical display. This device is a monitor used for displaying medical images, not an AI-powered diagnostic tool. Therefore, many of the requested categories related to AI performance, such as sample sizes for test sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment for AI models, are not applicable to this submission.
The "study that proves the device meets the acceptance criteria" refers to bench testing demonstrating the device's conformance to applicable standards and its substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance |
|---|---|---|
| Operating Specification | Conformance to applicable operating specifications | Meets applicable standards |
| Safety | Conformance to IEC 60601-1 | Conforms to IEC 60601-1 |
| EMC Requirements | Conformance to IEC 60601-1-2 | Conforms to IEC 60601-1-2 |
| Intended Use | Displaying and viewing digital images for diagnosis of X-ray or MRI etc. (excluding mammography) | Same as predicate device |
| Technological Characteristics | Similar to predicate device (COLOR LCD MONITOR, FLEXSCAN MX300W K073340) | Any differences do not raise new questions of safety or effectiveness |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a medical display device, not an AI diagnostic algorithm that processes image data from a test set. The performance evaluation is based on engineering specifications and adherence to standards, not analysis of clinical images.
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. Ground truth for clinical images is not established for this type of device. The assessment is based on technical specifications and safety standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are relevant for evaluating diagnostic accuracy using human readers or AI algorithms on clinical cases, which is not the purpose of this device's submission.
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. An MRMC study was not done as this is a medical display device and does not involve AI assistance for human readers in a diagnostic capacity.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This device is a display monitor and does not involve any standalone algorithm performance.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for this device's performance evaluation is based on engineering specifications, recognized industry standards (IEC 60601-1, IEC 60601-1-2), and comparison to a legally marketed predicate device's characteristics.
8. The sample size for the training set
Not applicable. This device does not use a training set as it is not an AI algorithm.
9. How the ground truth for the training set was established
Not applicable. This device does not use a training set.
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JUL - 7 2009
510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR §807.92
1. Submitter's Name: IEI Technology Corp. Address: No.29,Jhong-Sing Road, Si-Jhih City, Taipei County, 221, Taiwan Phone: +886-2-26902098 EXT: 18853 Fax: +886-2-26902099 Mr. Tom Chen Contact:
2. Device Name :
| Trade Name: | PACSmate |
|---|---|
| Model no.: | MMD-4300C/MMD-4300CX |
| Common Name: | Image display system, medical image workstation, imagemonitor/display, and others |
| Classification name | System, image processing, radiological |
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- DEVICE CLASS
The PACSmate MMD-4300C/4300CX has been classified ક્ષક Regulatory Class: II Panel: Radiology
Product Code: LLZ Regulation Number: 21CFR 892.2050
- The predicate device is the COLOR LCD MONITOR, 4. Predicate Device: FLEXSCAN MX300W (K073340) marketed by EIZO NANAO CORPORATION.
- PACSmate MMD-4300C/4300CX is intended to be used in 5. Intended Use: displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. PACSmate MMD-4300C/4300CX does not support the display of mammography images for diagnosis.
Product: PACSmate MMD-4300C/4300CX Section 4 - 510(k) Summary
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Section 4 – 510(k) Summary
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6. Device Description: The PACSmate MMD-4300C/4300CX is a 30" monochrome/color LCD display for medical image viewing.4 Mega pixel medical grade LCD monitor with high resolutions.
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- Performance In terms of operating specification, Safety & EMC requirements, the device conforms to applicable standards Summary: included IEC 60601-1 and IEC 60601-1-2 requirements.
8. Conclusions:
The PACSmate MMD-4300C/4300CX has the same intended use and similar technological characteristics as the COLOR LCD MONITOR, FLEXSCAN MX300W (K073340) marketed by EIZO NANAO CORPORATION. Moreover, bench testing contained in this submission demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness. Thus, The PACSmate MMD-4300C/4300CX is substantially equivalent to the predicate devices.
Product: PACSmate MMD-4300C/4300CX Section 4 - 510(k) Summary Page 2 of 2
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three lines representing the branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circle around the caduceus.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 7 2009
IEI Technology Corp. % Ms. Jennifer Reich Senior Consultant Harvest Consulting Corp. (USA) 2904 N. Boldt Drive FLAGSTAFF AZ 86001
Re: K091687
Trade/Device Name: PACSmate, Model No .: MMD-4300C/MMD-4300CX Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: June 5, 2009 Received: June 10, 2009
Dear Ms. Reich:
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 of medical
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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours
Shurly M. Morris
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: PACSmate Model No.: MMD-4300C/MMD-4300CX IEI Technology Corp.
Indications For Use:
PACSmate MMD=4300C/4300CX is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. PACSmate MMD-4300C/4300CX does not support the display of mammography images for diagnosis.
Prescription Use V (Parl 21 CFR 801 Subpart D) AND/OR
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 Rign Off
(Division Sign-Off) Division of Reproductive, Abdominal an Radiological Devices 510(k) Number
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§ 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).