(30 days)
RadiForce GX220 and RadiForce GS220 are intended to be used in displaying for diagnosis in CT, DSA or MRI etc., except for a digital mammography system.
RadiForce GX220 and Radiforce GS220 are a 54cm (21,3") Monochrome LCD display for medical image viewing, RadiForce GX220 and RadiForce GS220 display high-definition medical imaging. The model difference between GX220 and GS220 are the built-in swing calibration sensor and the protection panel equipped with GX220 as standard feature.
This document is a 510(k) summary for the EIZO NANAO Monochrome LCD Monitors, RadiForce GX220 and RadiForce GS220, from 2007. It outlines the device's classification, intended use, and technological characteristics compared to a predicate device. However, it does not include detailed information regarding acceptance criteria or a study proving the device meets specific performance metrics in the way a modern AI/ML medical device submission would.
This document describes a medical imaging display monitor, not an AI/ML device. Therefore, the questions related to AI/ML specific criteria (such as ground truth, training sets, MRMC studies, standalone performance with AI, etc.) are not applicable here.
Here's the information that can be extracted from the provided text, primarily regarding the device itself and its comparison to a predicate device for substantial equivalence:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a quantitative performance metric sense for image display quality. Instead, it focuses on substantial equivalence to a predicate device (RadiForce G22, K041597). The "performance" is implicitly tied to meeting the functional requirements expected of a medical display for diagnosis in CT, DSA, or MRI.
| Feature/Characteristic | Predicate Device (RadiForce G22) | New Devices (RadiForce GX220 / GS220) |
|---|---|---|
| Intended Use | Displaying for diagnosis in CT, DSA, or MRI, etc., except for a digital mammography system. | Displaying for diagnosis in CT, DSA, or MRI, etc., except for a digital mammography system. |
| Grayscale Tones | (Not specified, but implies larger) | Smaller |
| Panel Size | 19.6" | 54cm (21.3") |
| Digital Uniformity Equalizer (DUE) | (Not specified, implies not present) | Included (compensates for luminance non-uniformity) |
| Built-in Swing Calibration Sensor | (Not specified, implies not present) | GX220: Standard feature; GS220: Optional photo sensor |
| Protection Panel | (Not specified, implies not present) | GX220: Standard feature |
| Patient Contact | No | No |
| Control Life-Sustaining Device | No | No |
The statement: "Any difference between both devices not affects safety or efficacy" is the primary "acceptance criterion" met through comparison to the predicate device. The changes (smaller grayscale tones, larger panel, DUE, sensor, protection panel) are presented as not negatively impacting safety or efficacy, thus demonstrating substantial equivalence.
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 display monitor, not a data-driven diagnostic device. There is no "test set" of medical images or patient data to evaluate its diagnostic performance in the way an AI/ML algorithm would be tested. The evaluation is on display characteristics and functionality.
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. See point 2.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. See point 2.
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
Not applicable. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a display monitor, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. See point 2.
8. The sample size for the training set
Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
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510(k) Summary as required by 807.92
FEB 1 5 2007
1. Submitter Information
EIZO NANAO CORPORATION 153 Shimokashiwano-cho, Hakusan, Ishikawa-ken, 924-8566, Japan Phone: +81-76-274-2468 Fax: +81-76-274-2484
2. Official Correspondent
Hiroaki Hashimoto (Mr.) Manager of Engineering Management Section
3. Date of Submission
January 9, 2007
4. Device Trade name
Monochrome LCD Monitor, RadiForce GX220 and RadiForce GS220
5. Common/Usual Name
Image display system, medical image worksfation, image monitor/display, and others
6. Classification Number
Medical displays classified in Class II per 21 CFR 892.2050.
7. Predicate Device
: EIZO NANAO CORPORATION Manufacturer Device Name .. Monochrome LCD Monitor Model Name : RadiForce G22 510(k) No. : K041597
8. Description of Device
RadiForce GX220 and Radiforce GS220 are a 54cm (21,3") Monochrome LCD display for medical image viewing, RadiForce GX220 and RadiForce GS220 display high-definition medical imaging. The model difference between GX220 and GS220 are the built-in swing calibration sensor and the protection panel equipped with GX220 as standard feature.
9. Intended Use
RadiForce GX220 and Radiforce GS220 are intended to be used in displaying for diagnosis in CT, DSA, or MRI, etc., except for a digital mammography system.
10. Technological Characteristics
RadiForce GX220 and RadiForce GS220 are substantially equivalent to G22 (K041597). RadiForce GX220 and GS220 employ smaller grayscale tones than that of G22. The panel size became big with 54cm (21.3") from 19.6". Additional product innovations include Digital Uniformity Equalizer (DUE), which enables compensates for luminance non-uniformity. The built-in swing calibration sensor and the Protection Panel are equipped with GX220 as standard feature. Comparison table of the principal characteristics in Attachment 1 shows that new and predicate devices are substantially equivalent in the areas of technical characteristics, general functions. Regarding to upgrade in software, refer to Software Information for RadiCX ver.2.5 used for built-in swing calibration sensor (GX220), or optional photo sensor (GS220). The device does not come into contact with the patient. It does not control any life-sustaining device either. Any difference between both devices not affects safety or efficacy.
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Image /page/1/Picture/0 description: The image shows a circular logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling an emblem. The emblem is a stylized representation of an eagle or bird-like figure, with three curved lines forming its body and wings.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Mr. Hiroaki Hashimoto Manager EIZO NANAO Corporation Engineering Management Section 153 Shimokashiwano-cho Hakusan, Ishikawa-ken 924-8566 JAPAN
FEB 15 2007
Re: K070131
Trade/Device Name: Monochrome LCD Monitor, RadiForce GX220 and RadiForce GS220 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: January 9, 2007 Received: January 16, 2007
Dear Mr. Hishimoto:
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 (Premarket Approval), it may be subject to such 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.
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Protecting and Promoting Public Health
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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); 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.
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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrl/industry/support/index.html.
Sincerely yours,
Nancy Crogdon
Nancy C. Brogdon 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
K070131 510(k) Number (if known): Not known
Monochrome LCD Monitor, RadiForce GX220 and RadiForce GS220 Device Name :
Indications for Use:
RadiForce GX220 and RadiForce GS220 are intended to be used in displaying for diagnosis in CT, DSA or MRI etc., except for a digital mammography system.
Prescription Use
(Part 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)
David A. Sycamore
Division Sign Off
Reproductive, Abdominal, ogical Devic
र्व- I
§ 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).