(14 days)
The L217TG Color display is intended to be used for displaying and viewing of digital image diagnosis by trained physicians. To guarantee the display performance as specified, it must only be used for in Conjunction with NEC approved display cards. The L217TG cannot be used for a life-support system. This device must not be used in digital mammography. This unit is designed for exclusive interconnection with IEC60601-1 certified equipment.
Medical Display, L217TG is a 21.3" Color LCD monitor that displays image for medical use. I It provides 2 mega pixel (1600*1200) resolution with adjustable gamma gray scale for more precise diagnose use in CT, MRI, HIS, and PACS.
The provided text describes a 510(k) premarket notification for a medical display device, the NEC MD212 MC 21.3" Diagnostic Imaging LCD monitor (Model L217TG). The document focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a study proving the device meets those criteria in a typical clinical performance study sense.
Here's an analysis based on the provided text, addressing your questions where possible:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or a dedicated performance study for the device's diagnostic capabilities. Instead, it relies on demonstrating substantial equivalence to a predicate device (MDC2130-2HC 21.3" 2MP Color LCD Monitor by CHILIN Technology Co., Ltd.) based on shared design, performance, and safety characteristics.
The "performance" referred to is about the characteristics of the monitor itself, not a clinical diagnostic performance.
| Characteristic | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (L217TG) |
|---|---|---|
| Resolution | 2 mega pixel (1600x1200) (from predicate: K063579 is also 2MP) | 2 mega pixel (1600x1200) |
| Display Type | Color LCD monitor | Color LCD monitor |
| Intended Use | Displaying digital image diagnosis by trained physicians (excluding mammography, not for life-support) | Displaying digital image diagnosis by trained physicians (excluding mammography, not for life-support) |
| Gamma/Grayscale | Adjustable gamma gray scale for precise diagnostic use | Adjustable gamma gray scale for more precise diagnose use |
| Safety | EN60601-1-2 (radiation safety), UL60601-1 (electrical safety), Mechanical safety, Human factors compliance | Same as predicate (EN60601-1-2, UL60601-1, mechanical safety, human factors) |
| Interconnection | IEC60601-1 certified equipment | Exclusive interconnection with IEC60601-1 certified equipment |
| Compatibility | Consistent with predicate for environment and other devices | Same compatibility with environment and other devices |
2. Sample Size Used for the Test Set and Data Provenance
This document does not describe a "test set" in the context of clinical performance evaluation with patient data. The evaluation is for an imaging display device, not an AI algorithm or a diagnostic test directly analyzing patient images. Therefore, questions regarding data provenance and retrospective/prospective studies are not applicable in this context. The "test" would involve technical specifications and safety compliance for the monitor itself.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
Not applicable. This is a technical device submission, not a study evaluating diagnostic performance against a ground truth established by experts.
4. Adjudication Method for the Test Set
Not applicable for the reasons stated above.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI Improvement
No. This document pertains to a medical display device, not an AI system. Therefore, an MRMC study and AI-related effect sizes are not applicable.
6. If a Standalone (Algorithm Only) Performance Study Was Done
No. This is a medical display device, not an algorithm.
7. The Type of Ground Truth Used
Not applicable. The "ground truth" for a medical display device would be its technical specifications and compliance with safety standards, not a diagnostic outcome.
8. The Sample Size for the Training Set
Not applicable. This is not an AI algorithm or a device that "learns" from a training set of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable for the reasons stated above.
Summary of the Study/Evaluation Process for K083907:
The "study" in this context is a substantial equivalence determination process. The manufacturer (NEC Display Solutions Ltd.) compared their new device, the L217TG medical display, to an already legally marketed predicate device (MDC2130-2HC by CHILIN Technology Co., Ltd. K063579).
The key argument for acceptance (or substantial equivalence) is presented in section 7 ("CONCLUSION"):
- Comparison Basis: The two devices have the "same target population of trained practitioner in hospital."
- Shared Characteristics: They share "the same design, same performance and is the same in radiation safety (EN60601-1-2), mechanical safety, electrical safety (UL60601-1) and human factors." They also use "similar material" and have "same compatibility with environment and other device."
- Intended Use: Both devices have the "same intended use."
- Evidence: A "Comparison table of the principal characteristics of two devices is shown in the Section 3, table 3.3" (though Section 3 itself is not provided in your input, the summary implies the comparison was successful).
Therefore, the device meets its "acceptance criteria" by demonstrating that its technical specifications, safety profile, and intended use are functionally identical or very similar to a legally marketed predicate device, as required for a 510(k) clearance.
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K0r3907
510(K) Summary of Safety and Effectiveness
As required by 807.92
DEVICE ESTABLISHMENT AND CONTACT PERSON 1.
Mr. Shuichi Kino Manager NEC Display Solutions Ltd. 4-13-23 Shibaura, Minato-ku, Tokyo, 108-0023 Japan Ph: +81-465-85-2376
COMPANY REISTRATION NUMBER 2.
3003623028
DATE SUMMARY PREPARED 3.
24 October 2008
DEVICE NAME 4.
| Trade Name: | MD212 MC 21.3" Diagnostic Imaging LCD monitor |
|---|---|
| Model Name: | L217TG |
| Common Name: | Color LCD Monitor, Color Diagnostic Display, etc. |
| Classification Name: | System, Image Processing, Radiological (CLASS II CFR 892.2050) |
4. PREDICATE DEVICE
MDC2130-2HC 21.3" 2MP Color LCD Monitor by CHILIN Technology Co., Ltd. (K063579).
DEVICE DESCRIPTION ડ.
Medical Display, L217TG is a 21.3" Color LCD monitor that displays image for medical use. I It provides 2 mega pixel (1600*1200) resolution with adjustable gamma gray scale for more precise diagnose use in CT, MRI, HIS, and PACS.
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б. INTENDRD USE OF DEVICE
The L217TG color display is intended to be used for displaying of digital image diagnosis by trained physicians.
To guarantee the display performance as specified, it must only be used for in conjunction with NEC approved display cards.
The L217TG cannot be used for a life-support system.
This device must not be used in digital mammography.
This unit is designed for exclusive interconnection with IEC60601-1 certified equipment.
7. CONCLUSION
These two devices have the same target population of trained practitioner in hospital; it shares the same design, same performance and is the same in radiation safety (EN60601-1-2), mechanical safety, electrical safety (UL60601-1) and human factors. It use similar material, and have same compatibility with environment and other device. Comparison table of the principal characteristics of two devices is shown in the Section 3, table 3.3. These two devices also have the same intended use; Therefore we concluded that it is substantially equivalent to MDC2130-2HC by Chi Lin Technology Co., Ltd. (K063579).
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AN 1 3 2009
NEC Display Solutions Ltd. % Mr. Marc M. Mouser Manager/FDA Office Coordinator Underwriters Laboratories, Inc. 2600 N.W. Lake Road CAMAS WA 98607
Re: K083907
Trade/Device Name: Medical Display, L217TG Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: December 12, 2008 Received: December 30, 2008
Dear Mr. Mouser:
We have reviewed your Section 510(k) premarket notification of intent to market the device for use at tod in the 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, its ing 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 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 . In audi
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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 electionic 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 os 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 892.xxx | (Radiology) | (240) 276-0120 |
| Other | (240) 276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRF s Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464 You may obtain other general information on your responsibilities under the Act from the Division of Small Manufactures, 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 yours,
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
510(k) Number (if known):
Device Name: Medical Display, L217TG
Indications For USe: The L217TG Color display is intended to be used for displaying and viewing of digital image diagnosis by trained physicians.
To guarantee the display performance as specified, it must only be used for in Conjunction with NEC approved display cards.
The L217TG cannot be used for a life-support system.
This device must not be used in digital mammography.
This unit is designed for exclusive interconnection with IEC60601-1 certified equipment.
| Prescription Use | X |
|---|---|
| (Part 21 CFR 801 Subpart D) |
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Tommy McWhirter
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 083907 510(k) Number
iii .
§ 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).