Essence 55S Large Monitor System

{0}------------------------------------------------ February 6, 2018 Shenyang Torch-Bigtide Digital Technology Co., Ltd. Fu Ailing Document Engineer NO. 18-6B, Yaoyang Road, Huishan Economic Development Area Shenbei New District 110164 Shenyang, CN Re: K172969 Trade/Device Name: Essence 55S Large Monitor System Regulation Number: 21 CFR 870.2450 Regulation Name: Medical cathode-ray tube display Regulatory Class: Class II Product Code: DXJ Dated: December 12, 2017 Received: December 20, 2017 Dear Fu Ailing: This letter corrects our substantially equivalent letter of January 26, 2018. We have reviewed vour 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 {1}------------------------------------------------ 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. 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, Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### Indications for Use 510(k) Number (if known) K172969 Device Name Essence 55S Large Monitor System Indications for Use (Describe) The Essence 55S Large Monitor System (Essence 55S) is intended to be used by health care professionals to integrate the video output from various commercially-available instruments commonly used in a medical procedure laboratory into a single video display. Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D) #### 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}------------------------------------------------ # 510(k) Summary [As required by 21 CFR 807.92] ## 1. Date Prepared [21 CFR807.92 (a) (1)] August 9, 2017 #### 2. Submitter's Information [21 CFR807.92 (a) (1)] | | Name of Sponsor: Shenyang Torch-Bigtide Digital Technology Co., Ltd. | |----------------------------|------------------------------------------------------------------------| | | Address: No. 18-6B, Yaoyang Road, Huishan Economic Development Area, | | | Shenbei New District, 110164 Shenyang, China | | Contact Name: Fu Ailing | | | | Telephone No.: +86-24-88087606 | | | Fax No.: +86-24-88087629 | | | Email Address: btfda@bigtide.com | # 3. Trade Name, Common Name, Classification [21 CFR807.92 (a) (2)] Trade Name/Model: Essence 55S Large Monitor System Common Name: Essence 55S Large Monitor System Classification Name: Display, Cathode-Ray, Tube, Medical Regulation Number: 21 CFR 870.2450 Product code: DXJ Classification Panel: Cardiovascular Device Class: II #### 4. Identification of Predicate Device(s) [21 CFR 807.92(a) (3)] {4}------------------------------------------------ The identified predicates within this submission are as follows: Eizo GmbH Siemensallee 84, D-76187 Karlsruhe, Germany, RadiForce Large Monitor System has been cleared by FDA through 510(k) No. K112645 (Decision Date -September 22, 2011). ## 5. Description of the Device [21 CFR 807.92(a) (4)] The system consists of the following components: - . A 55" TFT color LCD Monitor: HL5501S - Video wall controller (AVS-540) (optional) ● - . Optical graphic extension module-fibres detachable (M1-201SA-TR) (optional) - . A common PC (optional) - . Cables (optional) The Essence 55S Large Monitor System is a large color LCD monitor for viewing images derived from several video sources on a single display and to rearrange these images to the situational requirements of the user. Thanks to the advantages of the large widescreen monitor, the data can be collected from the video sources using the optional video wall controller AVS-540 and fed into the large display via the DVI lines and / or DP. The optical graphic extension module M1-201SA-TR can be used to convert / transmit the video signal, and the common PC can be taken as a video device. ## 6. Intended Use [21 CFR 807.92(a)(5)] The Essence 55S Large Monitor System (Essence 55S) is intended to be used by health care professionals to integrate the video output from various commercially -available instruments commonly used in a medical procedure laboratory into a single video display. {5}------------------------------------------------ ## 7. Technological Characteristics [21 CFR 807.92(a)(6)] The Essence 55S Large Monitor System (Essence 55S) uses a color LCD panel employing In-Plane Switching (IPS) technology to allow wide viewing angles. It is used in landscape mode. When the various video sources from medical and other devices are being collected. they are being fed into the large Display via the corresponding lines and / or DP. The optional optical graphic extension module can be used as an optional part of the system to convert / transmit the video signal, and the optional PC can be taken as a video device. The Essence 55S Large Monitor System (Essence 55S) may be provided in different housing colors and with different logos. The cosmetic differences do not affect the function and performance of the system. | Panel Type | TFT Color LCD Panel (IPS) | | |----------------------------------------|--------------------------------------------------------------------------|--| | Panel Size | 139.7 cm / 55"<br>(1, 397 mm diagonal) | | | Display Size (H x V) | 1209.6 mm x 680.4 mm | | | Pixel Pitch | 0.315 x 0.315 mm | | | Native Resolution | 3840 x 2160 pixels | | | Display Colors | 1.07 billion colors | | | Viewing Angle (H,V) | 1780, 1780 | | | Brightness (Typ.) | 560 cd/m² | | | Recommended Brightness for Calibration | 400 cd/m² | | | Brightness Uniformity | DIN V 6868-57 | | | Contrast Ratio (Typ.) | 1400:1 | | | Response Time (Typ.) | 6.5 ms (Midtone) | | | Scanning Frequency (H, V) | 131.3 KHz, 59.5 – 60.5 Hz | | | Dot Clock | 257.4 MHz | | | Input Terminals | DVI-D (dual link) x 2;<br>DisplayPort x 2;<br>DVI single link (HDMI) x 2 | | | Power Requirements | 100-240 VAC, 50/60 Hz, 3.2 -1.2 A | | | Power Consumption / Save Mode | 300 W / Less than 40 W | | | Power Management | DVI DMPM | | K172969 Page 8-3 {6}------------------------------------------------ | Sensor | Backlight<br>Sensor x 3 | |-------------------------------|--------------------------------------------------------------------------------------------------------------------------| | Net Weight | 38 +/- 1 Kg | | Hole Spacing | VESA standard<br>400 x 400 mm | | Degree of Protection | IP20 | | Operating Temperature | 0°C- 40°C (+32 to + 104 °F) | | Storage Temperature | -20°C- 60°C (+4 to +140 °F) | | Operating Humidity | 15% to 85% rel. H., non condensing | | Storage Humidity | 10% to 90% rel. H., non condensing | | Operating Pressure | 700 hPa - 1060 hPa | | Storage Pressure | 700 hPa - 1060 hPa | | Certifications and Standards* | CE(Medical Device Directive),<br>EN60601-1, ANSI/AAMI<br>ES60601-1, CSA C22.2 No. 601-1,<br>FCC-B, RoHS, China RoHS, CCC | | Supplied Accessories | AC power cord, CD (user's manual) | | Optional accessories | Video wall controller (AVS-540)Optical graphic extension module-fibres detachable (M1-201SA-TR)A common PCCables | | Warranty | Three years | | Order No. | HL5501S | | Dimmensions (Unit:mm) | 1287.2 x 761 x 85.6 mm | ## 8. Substantial Equivalence [21 CFR 807.92(b) (1) and 807.92] #### 8.1 Intended uses: | ID | Comparison<br>ltem | Proposed Device<br>Essence 55S Large Monitor<br>System | Predicate Device<br>RadiForce Large Monitor<br>System | |----|--------------------|-------------------------------------------------------------|-------------------------------------------------------| | | | The Essence 55S Large Monitor The RadiForce Large Monitor | | | | Intended Use | System (Essence 55S) is | System is intended to be used | | | | intended to be used by health | by health care professionals to | | Table 1 Intended Use Comparison | |----------------------------------| | | {7}------------------------------------------------ | care professionals to integrate<br>the video output from various<br>commercially-available<br>instruments commonly used in a<br>medical procedure laboratory<br>into a single video display. | integrate the video output from<br>various commercially available<br>instruments commonly used in<br>a medical procedure laboratory<br>into a single video display. | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------| |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------| #### 8.2 Comparison table | ID | Comparison<br>ltem | Proposed Device<br>Essence 55S Large<br>Monitor System | Predicate Device<br>RadiForce Large<br>Monitor System | Explanation of<br>Difference | | | |------|----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|--|--| | 2 | Display Performance/Specifications | | | | | | | 2.1 | Cabinet Color | Black Grev | Anthracite Gray | Different<br>design<br>scheme | | | | 2.2 | Panel Type | TFT Color LCD<br>Panel (IPS) | TFT Color LCD<br>Panel (MVA) | Different<br>screen | | | | 2.3 | Panel Size | 139.7 cm / 55"<br>(1, 397 mm<br>diagonal) | 143 cm / 56.2"<br>(1, 430 mm<br>diagonal) | Different<br>screen | | | | 2.4 | Display Size (H x<br>V) | 1209.6 mm x 680.4<br>mm | 1244 x 700 mm | Different<br>screen | | | | 2.5 | Pixel Pitch | 0.315 x 0.315 mm | 0.324 x 0.324 mm | Different<br>screen | | | | 2.6 | Native Resolution | 3840 x 2160 pixels | 3840 x 2160 (16:9<br>aspect ration) | - | | | | 2.7 | Display Colors | 1.07 billion colors | 16.77 million colors | Different<br>screen | | | | 2.8 | Viewing Angle<br>(H,V) | 178% 178º | 176º, 176º | Different<br>screen | | | | 2.9 | Brightness (Typ.) | 560 cd/m² | 450 cd/m² | Different<br>screen | | | | 2.10 | Recommended<br>Brightness for<br>Calibration | 400 cd/m² | 300 cd/m² | Different<br>screen | | | | 2.11 | Brightness<br>Uniformity | DIN V 6868-57 | DIN V 6868-57 | - | | | | 2.12 | Contrast Ratio<br>(Typ.) | 1400:1 | 1200:1 | Different<br>screen | | | | 2.13 | Response Time<br>(Typ.) | 6.5 ms (Midtone) | 6.5 ms (Midtone) | - | | | | 3 | Video Signal Input | | | | | | | 3.1 | Scanning<br>Frequency (H, V) | 131.3 KHz, 59.5 –<br>60.5 Hz | 131.3 KHz,<br>59.7-60.3 Hz | - | | | | 3.2 | Dot Clock | 257.4 MHz | 257 MHz | — | | | | 3.3 | Input Terminals | DVI-D (dual link) x 2;<br>DisplayPort x 2;<br>DVI single link<br>(HDMI) x 2 | DVI-D (dual link) x 2 | Different<br>design<br>scheme | | | | 4 | Power Related Specifications | | | | | | | 4.1 | Power<br>Requirements | AC 100-240 V, 50 /<br>60Hz, 3.2 - 1.2A | AC 100 - 120 V, 200<br>- 240 V: 50 / 60 Hz | Different<br>design<br>scheme | | | | 4.2 | Power<br>Consumption /<br>Save Mode | 300 W / Less than 40<br>W | 500 W / Less than 41<br>W | Different<br>design<br>scheme | | | | 4.3 | Power<br>Management | DVI DMPM | DVI DMPM | - | | | | 5 | Miscellaneous Features/Specifications | | | | | | | 5.1 | Sensor | Backlight<br>Sensor x 3 | Backlight Sensor x 2 | Different<br>design<br>scheme | | | | 5.2 | Net Weight | 38 + / - 1 Kg | 48.2 + / - 1.8 kg | Different<br>design<br>scheme | | | | 5.3 | Hole Spacing | VESA standard<br>400 x 400 mm | VESA standard<br>400 x 400 mm | - | | | | 5.4 | Supplied<br>Accessories | AC power cord, CD<br>(user' manual) | AC power cord, dual<br>link signal cable<br>(DVI-D ~ DVI-D),<br>Utility Disk (user's<br>manual) | Determined by<br>customers'<br>requirements | | | | 5.5 | Optional<br>accessories | Video wall controller<br>(AVS-540),<br>Optical graphic<br>extension<br>module-fibres<br>detachable<br>(M1-201SA-TR),<br>a common PC, | Large Monitor<br>Manager LMM56800<br>/LMM0802, cable<br>DVI~HDMI, adapter<br>DVI~HDMI, Analog<br>~DVI converter<br>PDC0100, DVI<br>Transmission Link | Determined by<br>customers'<br>requirements | | | #### Table 2 General Comparison {8}------------------------------------------------ {9}------------------------------------------------ | | | Cables | TDL3600-QL (Quad<br>Link) | | |-----|-------------------------|---------------------------|--------------------------------------------|----------------------------------------------------------------------| | 5.6 | Order No. | HL5501S | 6GF6200-8AA01<br>(LS560W without<br>Stand) | Different<br>coding rule | | 5.7 | Dimensions<br>(Unit:mm) | 1287.2 x 761 x 85.6<br>mm | 1319 x 776 x 146<br>mm | Different<br>housing<br>design due to<br>the different<br>panel size | It is clear that the technological characteristics differences discussed above do not affect the safety and the effectiveness of the Essence 55S. #### 8.3 Performance Testing The following tests were successfully performed to validate the Essence 55S Large Monitor System. - Display bench tests ● - . Display validation tests - . System tests The test results showed that the Essence 55S Large Monitor System is with display characteristics equivalent to those of the predicate device, RadiForce Large Monitor System except some items, each of which was determined that it would not affect observer's performance. No animal or clinical testing is needed for the Essence 55S. ## 9. Conclusion [21 CFR 807.92(b) (3)] In accordance with the Federal Food, Druq and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, Shenyang Torch-Bigtide Digital Technology Co., Ltd. concludes that: - The intended use of Essence 55S Large Monitor System (Essence 55S) is totally ● same as that of the predicate device. - The technological characteristics differences between 55S Large Monitor System . and RadiForce Large Monitor System do not affect the safety and effectiveness, no new risk is raised. - Demonstrated by the bench tests, the display characteristics of Essence 55S {10}------------------------------------------------ Large Monitor System are equivalent to those of the predicate device.