(42 days)
CL-S200 (CL-S200xxxxx) and CL-S300 (CL-S300xxxxx) are intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners or certified personnel. It is not meant to be used in digital mammography.
CL-S200 : 1600 x 1200 (landscape), 1200 x 1600 (portrait)
CL-S300 : 2048 x 1536 (landscape), 1536 x 2048 (portrait)
DVI (digital interface) and DisplayPort (digital interface)
The provided text describes the acceptance criteria and performance of medical LCD monitors (CL-S200 and CL-S300) for displaying and viewing medical images. It's a 510(k) summary for these devices, asserting their substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and whether the document describes a study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The document provides a "Technical Specification" section that lists acceptance criteria (referred to as [SPEC]) and then compares the new devices (CL-S200xxxxx, CL-S300xxxxx) against a predicate device (CCL214/[K161895](https://510k.innolitics.com/search/K161895)) in a "Substantial Equivalence Comparison" table. This comparison implicitly shows the reported device performance.
| Acceptance Criterion (Technical Specification) | CL-S200 Reported Performance (Implicitly through comparison to predicate) | CL-S300 Reported Performance (Implicitly through comparison to predicate) | Interpretation of "Meeting" Criteria |
|---|---|---|---|
| 1. Angular Dependencies: More than angle of 20° LR'δ ,θ ≥ 175, kδ ,θ ≤ 30% based on AAPM-TG18 4.4. | Viewing Angle: CR>10:1 Horizontal: Typ.178 Vertical: Typ.178 (Same as predicate) | Viewing Angle: CR>10:1 Horizontal: Typ.178 Vertical: Typ.178 (Same as predicate) | The document states they share "the same technical characteristics," strongly implying they meet this, but no numerical performance is given against the specific criteria of LR'δ, θ, and kδ, θ. The typical viewing angle is provided, which is related but not directly the same metric as the AAPM-TG18 angular dependency spec. |
| 2. Luminance Response: Less than 10% based on AAPM-TG18 4.3. | Not explicitly stated in performance tables. | Not explicitly stated in performance tables. | The document states "Substantial Equivalence: CL-S200 and CL-S300 share the same technical characteristics... as our predicate device CCL214". It's implied this criterion is met by equivalence, but no direct performance data is given. |
| 3. Luminance Uniformity: Less than 30% based on AAPM-TG18 4.4.4 | Uniformity correction System (Same as predicate) | Uniformity correction System (Same as predicate) | The presence of a "Uniformity correction System" suggests the capability to meet this, but no specific performance percentage is provided. |
| 4. Reflection: Based on AAPM-TG18 4.2. | Not explicitly stated in performance tables. | Not explicitly stated in performance tables. | Implied by substantial equivalence, but no direct performance data provided. |
| 5. Chromaticity: Δ (u' , v' ) ≤ 0.01 measured at 80% Lmax based on AAPM-TG18 4.8.4 | Not explicitly stated in performance tables. | Not explicitly stated in performance tables. | Implied by substantial equivalence, but no direct performance data provided. |
| 6. Chromaticity Measurement of 5%, 50%, 95% Level | Not explicitly stated in performance tables. | Not explicitly stated in performance tables. | This is a measurement procedure, not a performance criterion, but no results are given. |
| 7. Artifacts: · phase/clock issues flicker · miscellaneous including ringing, ghosting, image sticking [SPEC] By visible check, no flicker, ringing, ghosting and image sticking. | Not explicitly stated in performance tables. | Not explicitly stated in performance tables. | Implied by substantial equivalence, but no direct performance data provided. |
| 8. Pixel Defects / Fault: [SPEC] Class II or more. ISO13406-2 | Not explicitly stated in performance tables. | Not explicitly stated in performance tables. | Implied by substantial equivalence, but no direct performance data provided. |
| 9. Power On Luminance Drift: [SPEC] ΔLmax≤±10% within 60 seconds. | Not explicitly stated in performance tables. | Not explicitly stated in performance tables. | Implied by substantial equivalence, but no direct performance data provided. |
Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed results from a new comprehensive performance study. The "performance" listed (e.g., Maximum Luminance, Contrast Ratio) are device specifications and comparisons to the predicate, not explicitly "reported device performance" from a dedicated study proving they meet each [SPEC] criterion with actual measured values. The assertion that they "share the same technical characteristics" is the primary argument for meeting the criteria.
2. Sample Size Used for the Test Set and the Data Provenance
This document describes medical display monitors, not an AI or diagnostic algorithm, so there is no "test set" of images or patient data in the typical sense. The performance criteria relate to the physical and optical properties of the display.
- Sample Size: Not applicable in the context of image data. The "sample size" would refer to the number of monitors tested. The document does not specify the number of monitors tested for these technical specifications.
- Data Provenance: Not applicable to image data. The technical specifications are inherent to the monitor design and manufacturing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. Ground truth for display monitor performance is established by objective physical measurements (e.g., luminance meters, colorimeters, spectroradiometers) according to specified standards like AAPM-TG18 and ISO13406-2, not by expert consensus on medical images.
4. Adjudication Method for the Test Set
Not applicable. There is no human interpretation of a test set requiring adjudication for these medical display monitors.
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 document is about medical display monitors, not an AI or diagnostic algorithm that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This document is about medical display monitors, which are passive display devices, not standalone algorithms.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the "acceptance criteria" (technical specifications) of these monitors is based on objective physical measurements using specialized equipment and established industry standards (e.g., AAPM-TG18, ISO13406-2) for display performance.
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.
In Summary:
The provided document details a 510(k) submission for medical display monitors. Its primary goal is to demonstrate "substantial equivalence" to existing legally marketed predicate devices, not to present a comprehensive, independent study proving performance against each specific acceptance criterion with detailed, quantitative results from a large test set (which would be typical for an AI algorithm). The implicit proof of meeting acceptance criteria comes from the assertion that the new devices "share the same technical characteristics, application, and intended use" as the predicate device, and by listing their general specifications. The "acceptance criteria" are technical specifications related to display quality, and "proof" comes from internal testing and compliance with display standards, rather than clinical studies with patient data and expert ground truth.
{0}------------------------------------------------
December 14, 2017
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
JVC KENWOOD Corporation % Masafumi Yugami Manager 3-12, Moriya-cho, Kanagawa-ku Yokohama. Kanagawa 221-0022 JAPAN
Re: K173434
Trade/Device Name: 2MP Color LCD Monitor CL-S200, 3MP Color LCD Monitor CL-S300 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: PGY Dated: November 17, 2017 Received: November 20, 2017
Dear Masafumi Yugami:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 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.
{1}------------------------------------------------
Page 2 - Masafumi Yugami
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice
(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. O'Hara For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K173434
Device Name 2MP Color LCD Monitor CL-S200 3MP Color LCD Monitor CL-S300
Indications for Use (Describe)
CL-S200 (CL-S200xxxxx) and CL-S300 (CL-S300xxxxx) are intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners or certified personnel. It is not meant to be used in digital mammography.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| -------------------------------------------------------------------------------------- |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|
| ----------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
JVCKENWOOD
510(k) SUMMARY
| Submitted Information: | JVC KENWOOD Corporation3-12, Moriya-cho, Kanagawa-ku,Yokohama-shi, Kanagawa, 221-0022 Japan | |
|---|---|---|
| Contact Person: | Masafumi Yugami, ManagerEmail: yugami.masafumi@jvckenwood.comTel: +81-258-24-6611Fax: +81-258-24-6617 | |
| Date Prepared: | November 1, 2017 | |
| Device Name: | 2MP Color LCD Monitor CL-S2003MP Color LCD Monitor CL-S300 | |
| Common Name: | CL-S200 (CL-S200xxxxx)CL-S300 (CL-S300xxxxx) | |
| Classification Name: | Class II(Part 892 Radiology DevicesSec. 892.2050 Picture Archiving and Communication System) | |
| Predicate Device: | 21.3 inch (54cm) Color LCD Monitor CCL214(CL21214/K161895) | |
| Device Description: | CL-S200 : 1600 x 1200 (landscape), 1200 x 1600 (portrait)CL-S300 : 2048 x 1536 (landscape), 1536 x 2048 (portrait)DVI (digital interface) and DisplayPort (digital interface) | |
| Intended Use: | CL-S200 and CL-S300 are intended to be used in displaying andviewing medical images for diagnosis by trained medicalpractitioners or certified personnel.It is not meant to be used in digital mammography. | |
| Substantial Equivalence: | CL-S200 and CL-S300 share the same technical characteristicsapplication, and intended use as our predicate device CCL214(CL21214 / K161895) |
JVC KENWOOD Corporation
{4}------------------------------------------------
Technical Specification
| 1. Angular Dependencies[SPEC] More than angle of 20° LR'δ ,θ ≥ 175, kδ ,θ ≤ 30% based on AAPM-TG18 4.4. |
|---|
| 2. Luminance Response[SPEC] Less than 10% based on AAPM-TG18 4.3. |
| 3. Luminance Uniformity[SPEC] Less than 30% based on AAPM-TG18 4.4.4 |
| 4. ReflectionBased on AAPM-TG18 4.2. |
| 5. Chromaticity[SPEC] Δ (u' , v' ) ≤ 0.01 measured at 80% Lmax based on AAPM-TG18 4.8.4 |
| 6. Chromaticity Measurement of 5%, 50%, 95% Level |
| 7. Artifacts· phase/clock issues flicker· miscellaneous including ringing, ghosting, image sticking[SPEC] By visible check, no flicker, ringing, ghosting and image sticking. |
| 8. Pixel Defects / Fault[SPEC] Class II or more. ISO13406-2 |
| 9. Power On Luminance Drift[SPEC] ΔLmax≤±10% within 60 seconds.ΔLmax : the deviation between the target maximum luminance and the measured luminance. |
{5}------------------------------------------------
Substantial Equivalence Comparison
<CL-S200 (CL-S200xxxxx)>
| CCL214(CL21214) | CL-S200xXXXX | |
|---|---|---|
| 510(k) Number | K161895 | — |
| Resolution orMatrix Size | 2MP(1200 x 1600) | 2MP(1200 x 1600) |
| Screen Technology | TFT ColorLCD Panel (IPS) | TFT ColorLCD Panel (IPS) |
| Backlighting | LED | LED |
| Maximum Luminance | 500 cd/m2 typ. | 1000 cd/m2 typ. |
| DICOMCalibrated Luminance | 250 cd/m² | 500 cd/m² |
| Viewing Angle | CR>10:1Horizontal: Typ.178Vertical: Typ.178 | CR>10:1Horizontal: Typ.178Vertical: Typ.178 |
| Display Area | Horizontal: 432.0mm,Vertical: 324.0mm | Horizontal: 432.0mm,Vertical: 324.0mm |
| Response Time (typical) | 10%-90%Ton 8ms Typ.Toff 8ms Typ. | 10%-90%Ton 8ms Typ.Toff 8ms Typ. |
| Aspect Ratio | 3:4 | 3:4 |
| Pixel Pitch | Horizontal: 0.270mmVertical: 0.270mm | Horizontal: 0.270mmVertical: 0.270mm |
| Contrast Ratio | 1200:1 | 1800:1 |
| Grayscale Tones | 10-bit (DisplayPort): 1,024from a palette of 65,473 tones8-bit: 256 from a palette of65,473 tones | 10-bit (DisplayPort): 1,024from a palette of 65,473 tones8-bit: 256 from a palette of65,473 tones |
| Non-UniformityCompensation | Uniformity correctionSystem | Uniformity correctionSystem |
| Input Video Signal | DVI-D x1DisplayPort x1 | DVI-D x1DisplayPort x1 |
| USB Ports /Standard | USB: upstream port (x 1),downstream port (x 2)Ver.2.0 | USB: upstream port (x 1),downstream port (x 2)Ver.2.0 |
| Scanning Frequency | DVI74.1KHz, Vertical: 60Hz(Landscape)98.1KHz, Vertical: 60Hz (Portrait)DisplayPort75.0KHz, Vertical: 60Hz (Landscape)99.0KHz, Vertical: 60Hz (Portrait) | DVI74.1KHz, Vertical: 60Hz(Landscape)98.1KHz, Vertical: 60Hz (Portrait)DisplayPort75.0KHz, Vertical: 60Hz (Landscape)99.0KHz, Vertical: 60Hz (Portrait) |
| Dot Clock | 162 MHz | 162 MHz |
| Rated | AC100-240V, 50/60Hz1.4 – 0.7A | AC100-240V, 50/60Hz2.2-1.1A |
| Luminance Calibration | Software: FCALCalibration Sensor (Optional): i1 Display (X-Rite) | Software: FCALCalibration Sensor (Optional): i1 Display (X-Rite) |
| Sensor | Built-in Front Sensor | Built-in Front Sensor |
| Sensor | Built-in Ambient Light Sensor | Built-in Ambient Light Sensor |
| None | Built-in Human presence sensor | |
| Safety Standards | ANSI/AAMI ES60601-1,CAN/CSA C22.2 No.60601-1,FCC (Class B), MDD/CE,VCCI-B (Class B) | ANSI/AAMI ES60601-1,CAN/CSA C22.2 No.60601-1,FCC (Class B), MDD/CE,VCCI-B (Class B) |
| Dimensionsw/o Stand(W x H x D) | Net: 11.1kg474(w) x 468.4 - 529.9(H) x 220(D) mm (Landscape)367(w) x 524.9 - 586.4(H) x 220(D) mm (Portrait)Packed: 14.0kg470(w) x 670(H) x 34(D) mm | Net: 9.2kg493(w) x 451.3-546.3(H) x 196.5(D) mm (Landscape)361.5(w) x 517-612(H) x 196.5(D) mm(Portrait)Packed: 12.0kg585(w) x 580(H) x 285(D) mm |
| CCL214(CL21214) | CL-S300xxxXXX | |
| 510(k) Number | K161895 | — |
| Resolution or Matrix Size | 2MP(1200 x 1600) | 3MP(1536 x 2048) |
| Screen Technology | TFT ColorLCD Panel (IPS) | TFT ColorLCD Panel (IPS) |
| Backlighting | LED | LED |
| Maximum Luminance | 500 cd/m2 typ. | 1000 cd/m2 typ. |
| DICOMCalibrated Luminance | 250 cd/m² | 500 cd/m² |
| Viewing Angle | CR>10:1Horizontal: Typ.178Vertical: Typ.178 | CR>10:1Horizontal: Typ.178Vertical: Typ.178 |
| Display Area | Horizontal: 432.0mm,Vertical: 324.0mm | Horizontal: 433.15mm,Vertical: 324.86mm |
| Response Time (typical) | 10% - 90%Ton 8ms Typ.Toff 8ms Typ. | 10% - 90%Ton 15ms Typ.Toff 15ms Typ. |
| Aspect Ratio | 3:4 | 3:4 |
| Pixel Pitch | Horizontal: 0.270mmVertical: 0.270mm | Horizontal: 0.2115mmVertical: 0.2115mm |
| Contrast Ratio | 1200:1 | 1500:1 |
| GrayscaleTones | 10-bit (DisplayPort): 1,024from a palette of 65,473 tones8-bit: 256 from a palette of65,473 tones | 10-bit (DisplayPort): 1,024from a palette of 65,473 tones8-bit: 256 from a palette of65,473 tones |
| Non-UniformityCompensation | Uniformity correctionSystem | Uniformity correctionSystem |
| Input Video Signal | DVI-D x1DisplayPort x1 | DVI-D x1DisplayPort x1 |
| USB Ports /Standard | USB: upstream port (x 1),downstream port (x 2)Ver.2.0 | USB: upstream port (x 1),downstream port (x 2)Ver.2.0 |
| Scanning Frequency | DVI74.1KHz, Vertical: 60Hz(Landscape)98.1KHz, Vertical: 60Hz (Portrait)DisplayPort75.0KHz, Vertical: 60Hz (Landscape)99.0KHz, Vertical: 60Hz (Portrait) | DVI (Dual Link)93.1KHz, Vertical: 60Hz(Landscape)123.9KHz, Vertical: 60Hz(Portrait)DisplayPort94.77KHz, Vertical: 59.98Hz(Landscape)126.33KHz, Vertical: 59.96Hz |
| (Portrait) | ||
| Dot Clock | 162 MHz | 216 MHz |
| Rated | AC100-240V, 50/60Hz1.4 - 0.7A | AC100-240V, 50/60Hz2.2-1.1A |
| Luminance Calibration | Software: FCALCalibration Sensor (Optional): i1 Display (X-Rite) | Software: FCALCalibration Sensor (Optional): i1 Display (X-Rite) |
| Sensor | Built-in Front SensorBuilt-in Ambient Light SensorNone | Built-in Front SensorBuilt-in Ambient Light SensorBuilt-in Human presence sensor |
| Safety Standards | ANSI/AAMI ES60601-1,CAN/CSA C22.2 No.60601-1,FCC (Class B), MDD/CE,VCCI-B (Class B) | ANSI/AAMI ES60601-1,CAN/CSA C22.2 No.60601-1,FCC (Class B), MDD/CE,VCCI-B (Class B) |
| Dimensionsw/o Stand(W x H x D) | Net: 11.1kg474(w) x 468.4 - 529.9(H) x 220(D) mm (Landscape)367(w) x 524.9 - 586.4(H) x 220(D) mm (Portrait)Packed: 14.0kg470(w) x 670(H) x 34(D) mm | Net: 10.3kg493(w) x 451.3-546.3(H) x 196.5(D) mm (Landscape)361.5(w) x 517-612(H) x 196.5(D) mm (Portrait)Packed: 13.0kg585(w) x 580(H) x 285(D) mm |
{6}------------------------------------------------
{7}------------------------------------------------
<CL-S300 (CL-S300xxxxx)>
{8}------------------------------------------------
§ 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).