(119 days)
Not Found
No
The summary describes a large monitor system for displaying and arranging video feeds, with no mention of AI, ML, or advanced image processing beyond basic display functions.
No.
The device is a monitor system intended to display video output from other medical instruments, not to provide therapy itself.
No
The device is a monitor system that displays video output from other instruments; it does not perform any diagnostic analysis itself.
No
The device description explicitly states that the system consists of a 55" TFT color LCD Monitor and optionally other hardware components, indicating it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to integrate and display video output from instruments used in a medical procedure laboratory. It's a display system for visual information, not a device that performs tests on biological samples (in vitro).
- Device Description: The description focuses on the monitor and its ability to display and arrange images from various video sources. It doesn't mention any components or functions related to analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, reagents, calibrators, controls, or any other elements typically associated with in vitro diagnostics.
The device is a display system for medical imaging or video feeds, not a diagnostic test performed outside the body on biological samples.
N/A
Intended Use / Indications for Use
The Essence 55SP Large Monitor System (Essence 55SP) 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.
Product codes
DXJ
Device Description
The system consists of the following components:
- A 55" TFT color LCD Monitor: HL5501SP
- Video wall controller (AVS-540) (optional)
- Optical graphic extension module-fibres detachable (M1-201SA-TR) (optional)
- . A common PC (optional)
- Cables (optional) .
The Essence 55SP 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. DVI lines mean the assemblies consisting of DVI cable and related connectors; DP means the assembly consisting of DP cable and related connectors.
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.
The difference between the Essence 55SP and the legally marketed device Essence 55S is additional glass. Essence 55S is without glass and Essence 55SP with glass, so Essence 55SP is named with the letter "P".
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health care professionals / medical procedure laboratory
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The following tests were successfully performed to validate the Essence 55SP Large Monitor System.
- Display bench tests
- Display validation tests
- System tests
The test results showed that the Essence 55SP Large Monitor System is with display characteristics equivalent to those of the predicate device, Essence 55S Large Monitor System except some items, each of which was determined that it would not affect observer's performance.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2450 Medical cathode-ray tube display.
(a)
Identification. A medical cathode-ray tube display is a device designed primarily to display selected biological signals. This device often incorporates special display features unique to a specific biological signal.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
August 27, 2020
Shenyang Torch-Bigtide Digital Technology Co., Ltd. Fu Ailing Document Engineer No. 18-6B, Yaoyang Road, Huishan Economic Development Area, Shenbei New District Shenyang, Liaoning 110164 China
Re: K201162
Trade/Device Name: Essence 55SP Large Monitor System Regulation Number: 21 CFR 870.2450 Regulation Name: Medical Cathode-Ray Tube Display Regulatory Class: Class II Product Code: DXJ Dated: July 22, 2020 Received: July 29, 2020
Dear Ms. Fu Ailing:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for
Jennifer Shih Assistant Director DHT2A: Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K201162
Device Name Essence 55SP Large Monitor System
Indications for Use (Describe)
The Essence 55SP Large Monitor System (Essence 55SP) 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):
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------ |
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007_510 (k) Summary
4
510(k) Summary
[As required by 21 CFR 807.92]
1. Date Prepared [21 CFR807.92 (a) (1)]
April 15, 2020
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 55SP Large Monitor System (Essence 55SP |
|---|---|
| Common Name: | Essence 55SP 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)]
The identified predicate within this submission is as follow:
Shenyang Torch-Bigtide Digital Technology Co., Ltd., Essence 55S Large Monitor System has been cleared by FDA through 510(k) No. K172969 (Decision Date - February 6, 2018).
5
5. Description of the Device [21 CFR 807.92(a) (4)]
The system consists of the following components:
- A 55" TFT color LCD Monitor: HL5501SP ●
- Video wall controller (AVS-540) (optional) ●
- Optical graphic extension module-fibres detachable (M1-201SA-TR) (optional) ●
- . A common PC (optional)
- Cables (optional) .
The Essence 55SP 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. DVI lines mean the assemblies consisting of DVI cable and related connectors; DP means the assembly consisting of DP cable and related connectors.
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.
The difference between the Essence 55SP and the legally marketed device Essence 55S is additional glass. Essence 55S is without glass and Essence 55SP with glass, so Essence 55SP is named with the letter "P".
6. Intended Use [21 CFR 807.92(a)(5)]
- Indications for Use:
The Essence 55SP Large Monitor System (Essence 55SP) 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.
7. Technological Characteristics [21 CFR 807.92(a)(6)]
The Essence 55SP Large Monitor System (Essence 55SP) uses a color LCD panel employing In-Plane Switching (IPS) technology to allow wide viewing angles. It is used in landscape mode.
6
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 55SP Large Monitor System (Essence 55SP) 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" |
| (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) | 178°, 178° |
| Brightness (Typ.) | 540 cd/m² |
| Recommended Brightness for Calibration | 400 cd/m² |
| Brightness Uniformity | DIN V 6868-57 |
| Contrast Ratio (Typ.) | 1400:1 |
| Response Time (Typ.) | 18 ms |
| Scanning Frequency (H, V) | 131.3 KHz, 59.5 – 60.5 Hz |
| Dot Clock | 277 MHz |
| Input Terminals | DVI-D (dual link) x 2; |
| DisplayPort x 2; | |
| DVI single link (HDMI) x 2 | |
| Power Requirements | 100-240 VAC, 50/60 Hz, 3.2 - 1.2A |
| Power Consumption / Save Mode | 300 W / Less than 40 W |
| Power Management | DVI DMPM |
| Sensor | Backlight |
| Sensor x 3 | |
| Net Weight | 49.5 +/- 2 Kg |
| Hole Spacing | VESA standard |
| 400 x 400 mm | |
| Degree of Protection | IP20 |
| Operating Temperature | 5℃ - 40℃ |
| Storage Temperature | -20℃ - 70℃ |
| Operating Humidity | 20% to 80% rel. H., non condensing |
| Storage Humidity | 10% to 95% rel. H., non condensing |
| Operating Pressure | 700 hPa - 1060 hPa |
| Storage Pressure | 700 hPa - 1060 hPa |
| Certifications and Standards* | CE: 93/42/EEC: Medical Device |
| Directive | |
| Test Report CE Declaration | |
| CCC Certificate | |
| BIS Certificate - INDIA | |
| CB-Test Certificate: IEC | |
| 60601-1:2005 + A1:2012 (Ed. 3.1) | |
| CB-Test Report: IEC 60601-1:2005 |
- A1:2012 (Ed. 3.1)
NRTL Certificate (US/C):
ANSI/AAMI
ES60601-1:2005/(R2012) +
CAN/CSA C22.2-60601-1-14 |
| Supplied Accessories | AC power cord |
| Optional accessories | Video wall controller (AVS-540)Optical graphic extension module-fibres detachable (M1-201SA-TR)A common PCCablesCD (user's manual) |
| Warranty | Three years |
| Order No. | HL5501SP |
| Dimmensions (Unit:mm) | 1287.2 x 761.2 x 86.3 mm |
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8
8. Substantial Equivalence [21 CFR 807.92(b) (1) and 807.92]
8.1 Intended uses:
| ID | Comparison
Item | Proposed Device
Essence 55SP Large Monitor
System | Predicate Device
Essence 55S Large Monitor
System |
|----|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | Indications
for Use | The Essence 55SP Large
Monitor System (Essence 55SP)
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. | 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. |
Table 1 Intended Use Comparison
8.2 Comparison table
| Table 2 General Comparison | |
|---|---|
| ID | Comparison
Item | Proposed Device
Essence 55SP
Large Monitor
System | Predicate Device
Essence 55S
Large Monitor
System | Explanation
of
Difference |
|------|----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| 2 | Display Performance/Specifications | | | |
| 2.1 | Cabinet Color | Black Grey | Black Grey | - |
| 2.2 | Panel Type | TFT Color LCD
Panel (IPS) | TFT Color LCD
Panel (IPS) | - |
| 2.3 | Panel Size | 139.7 cm / 55"
(1, 397 mm
diagonal) | 139.7 cm / 55"
(1, 397 mm
diagonal) | - |
| 2.4 | Display Size (H x
V) | 1209.6 mm x 680.4
mm | 1209.6 mm x 680.4
mm | - |
| 2.5 | Pixel Pitch | 0.315 x 0.315 mm | 0.315 x 0.315 mm | - |
| | | | | |
| 2.6 | Native Resolution | 3840 x 2160 pixels | 3840 x 2160 pixels | - |
| 2.7 | Display Colors | 1.07 billion colors | 1.07 billion colors | - |
| 2.8 | Viewing Angle
(H,V) | 178°, 178° | 178°, 178° | - |
| 2.9 | Brightness (Typ.) | 540 cd/m² | 560 cd/m² | The same
screen is
used, but
55SP is with
additional
glass. |
| 2.10 | Recommended
Brightness for
Calibration | 400 cd/m² | 400 cd/m² | - |
| 2.11 | Brightness
Uniformity | DIN V 6868-57 | DIN V 6868-57 | - |
| 2.12 | Contrast Ratio
(Typ.) | 1400:1 | 1400:1 | - |
| 2.13 | Response Time | 6.5 ms (Midtone) | 6.5 ms (Midtone) | - |
| 3 | Video Signal Input | | | |
| 3.1 | Scanning
Frequency (H, V) | 131.3 KHz, 59.5 –
60.5 Hz | 131.3 KHz, 59.5 –
60.5 Hz | - |
| 3.2 | Dot Clock | 277 MHz | 257.4 MHz | EDID is
changed,
which does
not raise any
new issue of
substantial
equivalence. |
| 3.3 | Input Terminals | DVI-D (dual link) x 2;
DisplayPort x 2;
DVI single link
(HDMI) x 2 | DVI-D (dual link) x 2;
DisplayPort x 2;
DVI single link
(HDMI) x 2 | - |
| 4 | | Power Related Specifications | | |
| 4.1 | Power
Requirements | AC 100-240 V, 50 /
60Hz, 3.2 - 1.2A | AC 100-240 V, 50 /
60Hz, 3.2 - 1.2A | - |
| 4.2 | Power
Consumption /
Save Mode | 300 W / Less than 40
W | 300 W / Less than 40
W | - |
| 4.3 | Power
Management | DVI DMPM | DVI DMPM | - |
| 5 | Miscellaneous Features/Specifications | | | |
| 5.1 | Sensor | Backlight
Sensor x 3 | Backlight
Sensor x 3 | - |
| 5.2 | Net Weight | $49.5 + /- 2 Kg$ | $38 + /- 1 Kg$ | The 55SP is with additional glass. |
| 5.3 | Hole Spacing | VESA standard
400 x 400 mm | VESA standard
400 x 400 mm | - |
| 5.4 | Supplied
Accessories | AC power cord, CD
(user' manual) | AC power cord, CD
(user' manual) | - |
| 5.5 | Optional
accessories | Video wall controller
(AVS-540),
Optical graphic
extension
module-fibres
detachable
(M1-201SA-TR),
a common PC,
Cables | Video wall controller
(AVS-540),
Optical graphic
extension
module-fibres
detachable
(M1-201SA-TR),
a common PC,
Cables | - |
| 5.6 | Order No. | HL5501SP | HL5501S | Different coding rule |
| 5.7 | Dimmensions
(Unit:mm) | 1287.2 x 761.2 x
86.3 mm | 1287.2 x 761 x 85.6
mm | The 55SP is with additional glass. |
9
10
It is clear that the technological characteristics differences discussed above do not affect the safety and the effectiveness of the Essence 55SP.
8.3 Performance Testing
The following tests were successfully performed to validate the Essence 55SP Large Monitor System.
- Display bench tests ●
- . Display validation tests
- . System tests
The test results showed that the Essence 55SP Large Monitor System is with display characteristics equivalent to those of the predicate device, Essence 55S 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 55SP.
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9. Conclusion [21 CFR 807.92(b) (3)]
In accordance with the Federal Food, Drug 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 55SP Large Monitor System (Essence 55SP) is totally . same as that of the predicate device.
- . The technological characteristics differences between 55SP Large Monitor System and 55S Large Monitor System do not raise different questions of safety and effectiveness.
- . Demonstrated by the bench tests, the display characteristics of Essence 55SP Large Monitor System are substantially equivalent to those of the predicate device.