The ME and CCL Series Medical Displays are intended for use with Picture Archiving Communication Systems (PACS) for medical imaging applications by physicians.

Device Description

The ME and CCL Series Medical Displays are displays for medical use. ME Series are monochrome LCD displays consists of the following models. ME181L (Model No. MDL1809A), ME201L (Model No. MDL2006A), ME203L (Model No. MDL2004A). CCL Series are color LCD displays consists of the following models. CCL182 (Model No. CDL1808A), CCL202 (Model No. CDL2005A), CCL314 (Model No. CDL2103A).

AI/ML Overview

This 510(k) summary for the Totoku Electric Co., Ltd. Flat Panel Displays, ME Series and CCL Series, primarily focuses on demonstrating substantial equivalence to a predicate device and compliance with regulatory standards. It does not contain information about the acceptance criteria or a study proving the device meets those criteria in the way medical AI or diagnostic software devices typically would.

Here's a breakdown of why the requested information cannot be found in the provided text:

Device Type: The device is a medical display, not an AI algorithm or a diagnostic software. Its performance is typically assessed by meeting technical specifications (e.g., resolution, luminance, color accuracy) and compliance with safety and EMC standards, rather than clinical performance metrics like sensitivity, specificity, or AUC.
Regulatory Pathway: A 510(k) for a display device emphasizes "substantial equivalence" to a predicate device and compliance with established standards (like UL, CSA, IEC, FCC, VCCI, MDD/CE). This is different from the rigorous clinical efficacy studies often required for novel diagnostic devices.

Therefore, for your specific requests, based only on the provided text:

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria (Implied): Compliance with various safety and EMC standards (UL2601-1, CSA No. 601-1, IEC60601-1 for medical safety; IEC60601-1-2, FCC-B/A, VCCI-B/A for EMC; UL1950, CSA No.950, LVD/CE(EN60950) for IT safety; EN55022, EN55024 for EMC). Substantial equivalence to the Totoku ME311L predicate device (K012099) in terms of principal characteristics (which are not detailed in this excerpt but referred to in Appendix 1).
- Reported Device Performance: The document states, "All ME Series are complies with following standards," and "All CCL Series are complies with following standards." This implies the devices successfully met the requirements of these standards. No specific performance numbers (e.g., specific luminance readings, contrast ratios) are provided in this summary, but rather a statement of compliance.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable or not provided. This information is typically for diagnostic algorithms tested on patient data, not for display hardware.
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 or not provided. Ground truth is not established for a display device in the clinical performance sense.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable or not provided.
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 device is a display, not an AI or diagnostic tool that assists human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to a display device. The "ground truth" for a display would relate to its technical specifications and performance characteristics, which are verified against engineering standards and measurement tools, not clinical "ground truth."
The sample size for the training set: Not applicable. This is hardware; it does not involve training data.
How the ground truth for the training set was established: Not applicable.

In summary, the provided 510(k) submission for a medical display device focuses on regulatory compliance and substantial equivalence rather than clinical performance metrics measured in studies with patient data and expert ground truth, which are typically associated with diagnostic software or AI algorithms.

Summary

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510(k) Summary

as required by 807.92

KU21738

Company Identification 1.

Totoku Electric Co., Ltd. 300 Oya, Ueda-shi, Nagano-ken, 386-0192, JAPAN 011-81-268-34-5484 Tel: Fax: 011-82-268-34-5565

Official Correspondent 2.

Mikio Hasegawa (Mr.) General Manager Product Development Dept.

Date of Submission 3.

May 24, 2002

Device Trade Name 4.

Flat Panel Displays, ME Series and CCL Series

Common Name 5.

Monitor, display, workstation, and others

Classification 6.

Medical displays were classified in Class II per 21 CFR 890.2050

Predicate Device 7.

Totoku ME311L 3Mega Pixel Diagnostic Display, manufactured by Totoku Electric Co., Ltd. (K012099). Comparison of the principal characteristics of the one device which is pertinent to clinical performance is shown in Appendix 1.

Description of Device 8.

The ME and CCL Series Medical Displays are displays for medical use.

Intended Use 9.

The ME and CCL Series Medical Displays are intended for use with Picture Archiving Communication Systems (PACS) for medical imaging applications by physicians.

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10. Explanation of ME Series and CCL Series

ME Series are monochrome LCD displays consists of the following models.

ME181L (Model No. MDL1809A)

ME201L (Model No. MDL2006A)

ME203L (Model No. MDL2004A)

CCL Series are color LCD displays consists of the following models.

CCL182 (Model No. CDL1808A)

CCL202 (Model No. CDL2005A)

CCL314 (Model No. CDL2103A)

Comparison of specifications are shown in Appendix 2.

11. Compliance standards

All ME Series are complies with following standards.

Medical Safety: UL2601-1, CSA No. 601-1, IEC60601-1 MDD/CE (EN60601-1)

EMC: MDD/CE (EN60601-1-2), IEC60601-1-2, FCC-B and VCCI-B for ME181L (MDL1809A) and ME201L (MDL2006A). MDD/CE (EN60601-1-2), IEC60601-1-2, FCC-A and VCCI-A for ME203L (MDL2004A)
All CCL Series are complies with following standards.

ITESafety: UL1950, CSA No.950, LVD/CE(EN60950)

EMC/CE (EN55022, EN55024), FCC-B and VCCI-B EMC: for CCL182 (CDL1808A) and CCL202 (CDL2005A). EMC/CE (EN55022, EN55024),FCC-A and VCCI-A for CCL314 (CDL2103A).

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle. Inside the circle is an abstract image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 9 2002

Mr. Mikio Hasegawa General Manager Totoku Electric Co., Ltd. Product Development Dept. MM Company 300 Oya, Ueda-Shi, Nagano 386-0192 JAPAN

Re: K021738

Trade/Device Name: Medical Flat Panel Displays, ME and CCL Series Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II

Product Code: 90 LLZ Dated: May 24, 2002 Received: May 28, 2002

Dear Mr. Hasegawa:

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. Iisting 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); 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,

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This letter will allow you to begin marketing your device as described in your 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:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

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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510(k) Number (If known): Not known

K.021738

Flat Panel Display, ME and CCL Series Device Name:

Indications for Use:

The ME and CCL Series Medical Displays are intended for use with Picture Archiving Communication Systems (PACS) for medical imaging application by physicians.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation

David A. Seymon

(Division Sign-Off) Division of Reproductive. and Radiological Device 510(k) Number

Prescription Use V

OR Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 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).