(24 days)
The 2MP/3MP LCD Monitor (HMD2G21) is intended to be used in displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners.
The 5MP LCD Monitor (HMD5G21) is intended to be used in displaying digital images for review and analysis by trained medical practitioners, including digital mammography.
The 2MP/3MP/5MP LCD Monitor (HMD2G21/HMD3G21) is a display system for medical viewing, with high resolution 1600x1200(HMD2G21)/2048 x 1536(HMD3G21)/ 2560 x 2048(HMD5G21), built-in brightness stabilization circuit, front sensor and ambient light sensor, stable brightness and persistent calibration can be guaranteed. The display can support both landscape and portrait mode. The antiglare screen can prevent display from reflection under highlight conditions, make the image and display clearer.
The document describes a 510(k) premarket notification for several Hisense LCD monitor models (HMD2G21, HMD3G21, HMD5G21). The submission aims to demonstrate substantial equivalence to legally marketed predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by compliance with IEC 60601-1 and IEC 60601-1-2 standards, and by demonstrating performance comparable to or better than the predicate devices. The study detailed below focuses on comparing the Hisense monitors' specifications to those of their respective predicate devices.
Here's a consolidated table comparing the proposed Hisense devices (HMD2G21, HMD3G21, HMD5G21) with their identified predicate devices (BARCO Nio 2MP, Nio 3MP, Nio 5MP) based on the provided "General Comparison" tables.
| Feature | Acceptance Criteria (Predicate Device Performance) | Hisense HMD2G21 Performance | Hisense HMD3G21 Performance | Hisense HMD5G21 Performance |
|---|---|---|---|---|
| Intended Use | Displaying and viewing digital images (excluding digital mammography for 2MP/3MP; including digital mammography for 5MP) for review and analysis by trained medical practitioners. | Same as predicate | Same as predicate | Same as predicate |
| Panel Size & Type | 21.3", TFT LCD display (2MP, 5MP); 21.3", TFT LCD display (3MP) | 21.3", TFT LCD display | 21.2", IPS-NEO, antiglare | 21.3", IPS-NEO, antiglare |
| Pixel Pitch | 0.27 mm (2MP); 0.2115 mm (3MP); 0.165 mm (5MP) | 0.27 mm | 0.21075 mm | 0.165 mm |
| Native Resolutions | 1600x1200 (2MP); 2048x1536 (3MP); 2560x2048 (5MP) | 1600x1200 | 2048x1536 | 2560x2048 |
| Brightness | 1650 cd/m2 (2MP); 800 cd/m2 (3MP); 700 cd/m2 (5MP) | 1900 cd/m2 | 1700 cd/m2 | 1200 cd/m2 |
| Contrast Ratio | 850:1 (2MP); 1700:1 (3MP); 800:1 (5MP) | 1400:1 | 1400:1 | 1200:1 |
| Network Interface | USB (1 Up, 2 Downstream) | USB (1 Up, 2 Downstream) | USB (1 Up, 2 Downstream) | USB (1 Up, 2 Downstream) |
| Active Display Size (HxV) | 432mm x 324mm (2MP); 433mm x 325mm (3MP); 422mm x 338mm (5MP) | 432.0mm x 324.0mm | 431.6mm x 323.7mm | 422.4mm x 337.9mm |
| Operating Temp. | 0°C ~ 35°C (2MP); 0°C ~ 40°C (3MP, 5MP) | 0°C ~ 40°C | 0°C ~ 40°C | 0°C ~ 40°C |
| Transport/Storage Temp. | -20°C ~ 60°C | -20°C ~ 60°C | -20°C ~ 60°C | -20°C ~ 60°C |
| Operating Humidity | 8% ~ 80% (non-condensing) | 20% ~ 80% | 20% ~ 80% | 20% ~ 80% |
| Transport/Storage Humidity | 5% ~ 85% (2MP); 5% ~ 95% (3MP, 5MP) | 10% ~ 90% | 10% ~ 90% | 10% ~ 90% |
| Power Capacity | <70W (2MP); ≤40W (3MP); 61W (5MP) | ≤60W | ≤60W | <80W |
| Input Voltage | 100 | DC24V/2.2A (2MP/3MP); DC24V/3A (5MP) | DC24V/2.5A | DC24V/3A |
| Usability | Button operation, LED indicator | Button operation, LED indicator | Button operation, LED indicator | Button operation, LED indicator |
| Mode of Operation | Continuous operation | Continuous operation | Continuous operation | Continuous operation |
| Biocompatibility | No direct/indirect patient contact, no evaluation needed. | No direct/indirect patient contact, no evaluation needed. | No direct/indirect patient contact, no evaluation needed. | No direct/indirect patient contact, no evaluation needed. |
| Sterility | Not needed | Not needed | Not needed | Not needed |
| Electrical & Mechanical Safety & Thermal Safety | Complying with IEC 60601-1 | Complying with IEC 60601-1 | Complying with IEC 60601-1 | Complying with IEC 60601-1 |
| EMC Evaluation | Complying with IEC 60601-1-2 | Complying with IEC 60601-1-2 | Complying with IEC 60601-1-2 | Complying with IEC 60601-1-2 |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a clinical study in terms of patient data or image sets. It is a technical comparison (bench testing) between the proposed devices and predicate devices. Therefore, there is no "test set" in the context of clinical images or patient data. The "sample size" implicitly refers to the three models of proposed devices (HMD2G21, HMD3G21, HMD5G21) being compared against their respective predicate models (BARCO Nio 2MP, Nio 3MP, Nio 5MP).
The data provenance is from the manufacturer's (Qingdao Hisense Medical Equipment Co., Ltd.) specifications and the specifications of the predicate devices. This type of comparison is typically based on published technical specifications and internal testing, not retrospective or prospective clinical data. The country of origin for the proposed device manufacturer is China.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is not a clinical study involving experts to establish ground truth for image interpretation. The "ground truth" for this submission are the technical specifications and performance characteristics of the predicate devices and the relevant IEC safety standards.
4. Adjudication Method for the Test Set
Not applicable. There was no clinical test set requiring adjudication.
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 submission is for medical display monitors, not an AI or CAD (Computer-Aided Detection/Diagnosis) software. The study is a technical comparison of display performance, not an evaluation of human reader performance with or without AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an algorithm or AI product.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" used for this submission is based on:
- Technical Specifications: Published specifications of the predicate devices (BARCO Nio 2MP, Nio 3MP, Nio 5MP) and the proposed Hisense devices.
- Regulatory Standards: Compliance with established medical device safety and performance standards, specifically IEC 60601-1 (Electrical, Mechanical & Thermal safety) and IEC 60601-1-2 (Electromagnetic Compatibility - EMC).
- Intended Use Statements: Formal declarations of intended use, which must be comparable to the predicate.
8. The Sample Size for the Training Set
Not applicable. There is no AI or machine learning component, so no training set is relevant.
9. How the Ground Truth for the Training Set Was Established
Not applicable. See point 8.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure in profile, with three overlapping faces suggesting a sense of community and support. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure, emphasizing the organization's name and national affiliation.
March 3, 2016
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Qingdao Hisense Medical Equipment Co.,Ltd. % Mr. Liu Zhitang Regulatory Manager Software outsourcing center 3rd floor north wing No.169 Songling Road, Laoshan Qing dao, Shan dong 266101 CHINA
Re: K160347
Trade/Device Name: Hisense LCD monitor models HMD2G21/HMD3G21/HMD5G21 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: PGY Dated: February 2, 2016 Received: February 8, 2016
Dear Mr. Zhitang:
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 (reporting of medical device-related adverse events) (21 CFR 803); 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.
{1}------------------------------------------------
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Michael D.'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
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Indications for Use
510(k) Number (if known)
Device Name
Hisense LDC monitor models HMD2G21/HMD3G21/HMD5G21
Indications for Use (Describe)
The 2MP/3MP LCD Monitor (HMD2G21) is intended to be used in displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners.
The 5MP LCD Monitor (HMD5G21) is intended to be used in displaying digital images for review and analysis by trained medical practitioners, including 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) |
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510(k) Summary
[As required by 21 CFR 807.92]
1. Date Prepared [21 CFR807.92 (a) (1)]
Jan 8", 2016
2. Submitter's Information [21 CFR807.92 (a) (1)]
| Name of Sponsor: | Qingdao Hisense Medical Equipment Co., Ltd. |
|---|---|
| Address: | Software outsourcing center 3rd floor north wing, No.169Songling Road, Laoshan Dist. 266101, Qingdao, China |
| Contact Name: | Liu Zhitang |
| Telephone No .: | +86 ( 0 ) 532-55753811 |
3. Trade Name, Common Name, Classification [21 CFR807.92 (a) (2)]
| Trade Name: | Hisense LCD monitor models HMD2G21/ HMD3G21/HMD5G21 | |||
|---|---|---|---|---|
| Common Name: | Display system, medical image workstation, and others | |||
| Classification: | 892.2050 system, image processing, radiological | |||
| Product code: | PGY | |||
| Classification Panel: | Radiology | |||
| Device Class: | II |
4. Identification of Predicate Device(s) [21 CFR 807.92(a) (3)]
The identified predicates within this submission are as follows: BARCO N.V., Nio 2MP(MDNG-2121) has been cleared by FDA through 510(k) No. K091172, BARCO N.V., Nio 3MP(MDCG-3221) has been cleared by FDA through 510(k) No . K131246 BARCO N.V., Nio 5MP(MDNG-5121) has been cleared by FDA through 510(k) No . K062131
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5. Description of the Device [21 CFR 807.92(a) (4)]
The 2MP/3MP/5MP LCD Monitor (HMD2G21/HMD3G21) is a display system for medical viewing, with high resolution 1600x1200(HMD2G21)/2048 x 1536(HMD3G21)/ 2560 x 2048(HMD5G21), built-in brightness stabilization circuit, front sensor and ambient light sensor, stable brightness and persistent calibration can be guaranteed. The display can support both landscape and portrait mode. The antiglare screen can prevent display from reflection under highlight conditions, make the image and display clearer.
6. Intended Use [21 CFR 807.92(a)(5)]
The 2MP/3MP LCD Monitor (HMD2G21/HMD3G21) are intended to be used in displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners.
The 5MP LCD Monitor (HMD5G21) is intended to be used in displaying and viewing digital images for review and analysis by trained medical practitioners, including digital mammography.
7. Technological Characteristics [21 CFR 807.92(a)(6)]
| Panel | 21.3", a-Si TFT LCD, antiglare |
|---|---|
| Brightness (typ.) | 1900 cd/m² |
| CR (typ.) | 1400:1 |
| Viewing angle | R/L 176° , U/D 176° Typ. (CR > 10) |
| Pixel Pitch | 0.27 mm |
| Native resolution | 1600 x 1200 |
| Display area | 432.0mm(H)x324.0mm (V) |
| Compatible video signals | 640 x 480@60Hz(progressive)1024 x 768@60Hz(progressive)1600x1200@60Hz (progressive) |
| Aspect ratio | 4:3 |
| Screen size | 21.3" real diagonal |
| Power | DC24V/2.2A |
| Power consumption | Max. 60 W |
| Input signals | DVI-D, Display Port |
The HMD2G21
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| Digital input | LVDS (single) |
|---|---|
| Plug and play | VESA DDC 2B |
| Dimension | 384.0mm (W) x 492.0mm (H) x70.0mm (D) (without Stand) |
| 384.0 mm (W) x 637.5 mm (H) x 273.5mm (D) (with Stand) | |
| Weight | 5.5kg (without Stand) |
| 9.9kg (with Stand) | |
| Operatingtemperature andhumidity: | Temperature: 0°C ~ 40°C |
| Humidity: 20% ~80% | |
| Storagetemperature andhumidity: | Temperature: -20°C ~ 60°C |
| Humidity:10% ~90% | |
The HMD3G21
| Panel | 21.2", IPS-NEO, antiglare |
|---|---|
| Brightness (typ.) | 1700 cd/m² |
| CR (typ.) | 1400:1 |
| Viewing angle | R/L 176° , U/D 176°Typ. (CR > 10) |
| Pixel Pitch | 0.21075 mm |
| Native resolution | 2048x1536 |
| Display area | (H)431.6x(V)323.7(mm) |
| Compatible videosignals | 640 x 480@60Hz(progressive)2048x1536@60Hz (progressive) |
| Aspect ratio | 4:3 |
| Screen size | 21.2" real diagonal |
| Power | DC24V/2.2A |
| Power consumption | Max. 60 W |
| Input signals | DVI-D, Display Port |
| Digital input | LVDS (single) |
| Plug and play | VESA DDC 2B |
| Dimension | 384.0mm (W) x 492.0mm (H) x 70.0mm (D) (withoutStand) |
| 384.0 mm (W) x 637.5 mm (H) x 273.5mm (D) (withStand) | |
| Weight | 6.1kg (without Stand) |
| 10.4kg (with Stand) | |
| Operatingtemperature andhumidity: | Temperature: 0°C ~ 40°CHumidity: 20% ~80% |
| Storage | Temperature: -20°C ~ 60°C |
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| temperature andhumidity: | Humidity: 10% ~ 90% |
|---|---|
| ------------------------------ | --------------------- |
The HMD5G21
| Panel | 21.3", IPS-NEO, antiglare |
|---|---|
| Brightness (typ.) | 1200 cd/m² |
| CR (typ.) | 1200:1 |
| Viewing angle | R/L 176° , U/D 176° Typ. (CR > 50) |
| Pixel Pitch | 0.165 mm |
| Native resolution | 2560 x 2048 |
| Display area | 422.4mm(H)x337.9mm (V) |
| Compatible video signals | 640 x 480@60Hz(progressive)1024 x 768@60Hz(progressive)2560 x 2048@60Hz (progressive) |
| Aspect ratio | 5:4 |
| Screen size | 21.3" real diagonal |
| Power | DC24V/3A |
| Power consumption | Max. 72 W |
| Input signals | DVI-D, Display Port |
| Digital input | LVDS (double) |
| Plug and play | VESA DDC 2B |
| Dimension | 392.0mm (W) x 498.0mm (H) x83.0mm (D) (without Stand)392.0 mm (W) x 632.0 mm (H) x 273.5mm (D) (with Stand) |
| Weight | 8.5kg (without Stand)12.8kg (with Stand) |
| Operating temperature and humidity: | Temperature: 0°C ~ 40°CHumidity: 20%~80% |
| Storage temperature and humidity: | Temperature: -20°C ~ 60°CHumidity: 10% ~90% |
8. Substantial Equivalence [21 CFR 807.92(b) (1) and 807.92]
8.1 Intended uses:
Table 1 Intended Use Comparison of HMD2G21
| ID | Comparison Item | Proposed Device2MP LCD Monitor (HMD2G21) | Predicate DeviceNio 2MP(MDNG-2121) |
|---|---|---|---|
| ---- | ----------------- | ---------------------------------------------- | ---------------------------------------- |
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| 1 | IntendedUse | The HISENSE 2MP LCDMonitor (HMD2G21) is intendedto be used in displaying andviewing digital images (excludingdigital mammography) for reviewand analysis by trained medicalpractitioners. | The Nio 2MP(MDNG-2121)is intended to be used indisplaying and viewing digitalimages for review by trainedmedical practitioners. Thesedevices must not be used inprimary image diagnosis inmammography. |
|---|---|---|---|
| --- | ----------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
Table 2 Intended Use Comparison of HMD3G21
| ID | ComparisonItem | Proposed Device3MP LCD Monitor (HMD3G21) | Predicate DeviceNio 3MP(MDCG-3221) |
|---|---|---|---|
| 1 | IntendedUse | The HISENSE 3MP LCDMonitor ( HMD3G21) is intendedto be used in displaying andviewing digital images (excludingdigital mammography) for reviewand analysis by trained medicalpractitioners. | The Nio 3MP(MDCG-3221) isintended to be used in displayingand viewing digital images forreview by trained medicalpractitioners. These devicesmust not be used in primaryimage diagnosis inmammography. |
Table 3 Intended Use Comparison of HMD5G21
| ID | ComparisonItem | Proposed Device5MP LCD Monitor (HMD5G21) | Predicate DeviceNio 5MP(MDNG-5121) |
|---|---|---|---|
| 1 | IntendedUse | The 5MP LCD Display(HMD5G21) is intended to beused in displaying and viewingdigital images for review andanalysis by trained medicalpractitioners, including digitalmammography. | The Nio 5MP(MDNG-5121) isintended to be used as a tool indisplaying and viewing digitalimages for review and analysisby trained medical practitioners,including digital mammography. |
8.2 Comparison table
Table 4 General Comparison about HMD2G21 and Nio 2MP
| ID | ComparisonItem | Proposed DeviceHMD2G21 | Predicate DeviceNio 2MP(MDNG-2121) |
|---|---|---|---|
| 2 | Performance | ||
| 2.1 | Panel Size and Type | 21.3", TFT LCD display | 21.3", TFT LCD display |
| 2.2 | Pixel Pitch | 0.27 mm | 0.27 mm |
| ID | ComparisonItem | Proposed DeviceHMD2G21 | Predicate DeviceNio 2MP(MDNG-2121) |
| 2.3 | Native Resolutions | 1600x1200 | 1600x1200 |
| 2.4 | Brightness | 1900 cd/m2 | 1650 cd/m2 |
| 2.5 | Contrast Ratio | 1400:1 | 850:1 |
| 2.6 | Network Interface | USB(1 Up, 2 Downstream) | USB(1 Up, 2 Downstream) |
| 2.7 | Active Display Size(HxV) | 432.0mm x324.0mm | 432mm x324mm |
| 3 | Physical Specifications | ||
| 3.1 | Dimensions(Wx Hx D) | 384mm (W) x 492mm (H) x70mm (D) (without Stand)384 mm (W) x 517.5-637.5mm (H) x 273.5mm (D) (withStand) | 382x 488 x 114 mm (withoutStand)Portrait:382 x 577 |
| Temperature | |||
| 3.2 | Operating | 0°C ~ 40°C | 0°C ~ 35°C |
| 3.3 | Transport/ Storage | -20°C ~ 60°C | -20°C ~ 60°C |
| Relative humidity | |||
| 3.4 | Operating | 20% ~80% | 8% ~80%(non-condensing) |
| 3.5 | Transport/ Storage | 10% ~90% | 5% ~85% |
| 4 | Power Supply | ||
| 4.1 | PowerCapacity | ≤60W | <70W |
| 4.2 | Input Voltage | DC24V/2.2A | 100~240V |
| 5 | Human factors (operation characteristic) | ||
| 5.1 | Usability | Button operation,LED indicator | Button operation,LED indicator |
| 5.2 | Mode of operation | Continuous operation | Continuous operation |
| 6 | Biocompatibility | ||
| 6.1 | Evaluation | The proposed device does notcontain any components thatcome into direct or indirectcontact with patients, so theevaluation doesn't be needed. | The proposed device doesnot contain any componentsthat come into direct orindirect contact with patients,so the evaluation doesn't beneeded. |
| 7 | Sterility | ||
| 7.1 | Sterilization | The proposed device doesnot need sterilization. | The proposed device doesnot need sterilization. |
| 8 | Electrical & Mechanical safety& Thermal safety | ||
| 8.1 | Type of protectionagainst electric shock | Class I | Class I |
| 8.2 | Degree of protectionagainst harmfulingress of liquid | Ordinary equipment. | Ordinary equipment. |
| 8.3 | Evaluation | The electrical, mechanical andthermal safety evaluation is | The electrical, mechanicaland thermal safety |
| ID | ComparisonItem | Proposed DeviceHMD2G21 | Predicate DeviceNio 2MP(MDNG-2121) |
| requirements of the standardIEC 60601-1. | evaluation is conducted asper the requirements of thestandard IEC 60601-1. | ||
| 9 | Electromagnetic Compatibility | ||
| 9.1 | EMC Evaluation | Complying withIEC 60601-1-2 | Complying withIEC 60601-1-2 |
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Table 5 General Comparison about HMD3G21 and Nio 3MP
| ID | Comparison Item | Proposed DeviceHMD3G21 | Predicate DeviceNio 3MP(MDCG-3221) |
|---|---|---|---|
| 2 | Performance | ||
| 2.1 | Panel Size and Type | 21.3", TFT LCD display | 21.3",TFT LCD display |
| 2.2 | Pixel Pitch | $0.21075$ mm | $0.2115$ mm |
| 2.3 | Native Resolutions | 2048x1536 | 2048x1536 |
| 2.4 | Brightness | 1700 cd/m2 | 800 cd/m2 |
| 2.5 | Contrast Ratio | 1400:1 | 1700:1 |
| 2.6 | Network Interface | USB(1 Up, 2 Downstream) | USB(1 Up, 2 Downstream) |
| 2.7 | Active Display Size(HxV) | 431.6mm x323.7mm | 433mm x325mm |
| 3 | Physical Specifications | ||
| 3.1 | Dimensions(Wx Hx D) | 384mm (W) x 492mm (H) x70mm (D) (without Stand)384 mm (W) x 517.5-637.5mm (H) x 273.5mm (D) (withStand ) | 378mm x 491mm x 84mm(without Stand)Portrait:378mm x 628 |
| Temperature | |||
| 3.2 | Operating | 0°C ~ 40°C | 0°C ~ 40°C |
| 3.3 | Transport/ Storage | -20°C ~ 60°C | -20°C ~ 60°C |
| Relative humidity | |||
| 3.4 | Operating | 20% ~80% | 8% ~80%(non-condensing) |
| 3.5 | Transport/ Storage | 10% ~90% | 5% ~95% |
| 4 | Power Supply | ||
| 4.1 | PowerCapacity | ≤60W | ≤40W |
| 4.2 | Input Voltage | DC24V/2.5A | 100~240v |
| 5 | Human factors (operation characteristic) | ||
| 5.1 | Usability | Button operation,LED indicator | Button operation,LED indicator |
| 5.2 | Mode of operation | Continuous operation | Continuous operation |
| 6 | Biocompatibility | ||
| 6.1 | Evaluation | The proposed device does not | The proposed device does |
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| ID | ComparisonItem | Proposed DeviceHMD3G21 | Predicate DeviceNio 3MP(MDCG-3221) |
|---|---|---|---|
| contain any components thatcome into direct or indirectcontact with patients, so theevaluation doesn't be needed. | not contain any componentsthat come into direct orindirect contact with patients,so the evaluation doesn't beneeded. | ||
| 7 | Sterility | ||
| 7.1 | Sterilization | The proposed device doesnot need sterilization. | The proposed device doesnot need sterilization. |
| 8 | Electrical & Mechanical safety& Thermal safety | ||
| 8.1 | Type of protectionagainst electric shock | Class I | Class I |
| 8.2 | Degree of protectionagainst harmfulingress of liquid | Ordinary equipment. | Ordinary equipment. |
| 8.3 | Evaluation | The electrical, mechanical andthermal safety evaluation isconducted as per therequirements of the standardIEC 60601-1. | The electrical, mechanical andthermal safetyevaluation is conducted asper the requirements of thestandard IEC 60601-1. |
| 9 | Electromagnetic Compatibility | ||
| 9.1 | EMC Evaluation | Complying withIEC 60601-1-2 | Complying withIEC 60601-1-2 |
Table 6 General Comparison about HMD5G21 and Nio 5MP
| ID | ComparisonItem | Proposed DeviceHMD5G21 | Predicate DeviceNio 5MP(MDNG-5121) |
|---|---|---|---|
| 2 | Performance | ||
| 2.1 | Panel Size and Type | 21.3", TFT LCD display | 21.3", TFT LCD display |
| 2.2 | Pixel Pitch | 0.165 mm | 0.165 mm |
| 2.3 | Native Resolutions | 2,560 × 2,048 | 2,560 × 2,048 |
| 2.4 | Brightness | 1200 cd/m2 | 700 cd/m2 |
| 2.5 | Contrast Ratio | 1200:1 | 800:1 |
| 2.6 | Network Interface | USB(1 Up, 2 Downstream) | USB(1 Up, 2 Downstream) |
| 2.8 | Active Display Size(HxV) | 422.4mm x337.9mm | 422mm x338mm |
| 3 | Physical Specifications | ||
| 3.1 | Dimensions(Wx Hx D) | 392mm×498mm×83mm(without Stand)392mm×514-632mm×273.5mm(with Stand) | 408mm x 492mm x 115mm(without Stand)Portrait:408mm x 489 |
| ID | ComparisonItem | Proposed DeviceHMD5G21 | Predicate DeviceNio 5MP(MDNG-5121) |
| x 250mm(with Stand) | |||
| 3 | Temperature | ||
| 3.2 | Operating | 0°C ~ 40°C | 0°C ~ 40°C |
| 3.3 | Transport/ Storage | -20°C ~ 60°C | -20°C ~ 60°C |
| 3 | Relative humidity | ||
| 3.4 | Operating | 20% ~80% | 8% ~80%(non-condensing) |
| 3.5 | Transport/ Storage | 10% ~90% | 5% ~95% |
| 4 | Power Supply | ||
| 4.1 | PowerCapacity | <80W | 61W |
| 4.2 | Input Voltage | DC24V/3A | 100~250V |
| 5 | Human factors (operation characteristic) | ||
| 5.1 | Usability | Button operation, | Button operation, |
| LED indicator | LED indicator | ||
| 5.2 | Mode of operation | Continuous operation | Continuous operation |
| 6 | Biocompatibility | ||
| 6.1 | Evaluation | The proposed device does notcontain any components thatcome into direct or indirectcontact with patients, so theevaluation doesn't be needed. | The proposed device doesnot contain any componentsthat come into direct orindirect contact with patients,so the evaluation doesn't beneeded. |
| 7 | Sterility | ||
| 7.1 | Sterilization | The proposed device doesnot need sterilization. | The proposed device doesnot need sterilization. |
| 8 | Electrical & Mechanical safety& Thermal safety | ||
| 8.1 | Type ofprotectionagainst electric shock | Class I | Class I |
| 8.2 | Degree of protectionagainst harmfulingress of liquid | Ordinary equipment. | Ordinary equipment. |
| 8.3 | Evaluation | The electrical, mechanical andthermal safety evaluation isconducted as per therequirements of the standardIEC 60601-1. | The electrical, mechanicaland thermal safetyevaluation is conducted asper the requirements of thestandard IEC 60601-1. |
| 9 | Electromagnetic Compatibility | ||
| 9.1 | EMC Evaluation | Complying withIEC 60601-1-2 | Complying withIEC 60601-1-2 |
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8.4 Discussion of Differences:
It is reasonable that there are some differences between our new system and its predicate. All of parameters comply with 21CFR1020.33 and related IEC standards. We did not use any new technology in this system, so those differences between our new
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system and its predicate do not affect the safety and effectiveness (SE).
About HDM2G21 and Nio 2MP
Review of ID 1 - Intended use, both of them are intended to be used in displaying and viewing digital images, excluding digital mammography, for review and analysis by trained medical practitioners. So the SE is not affected.
Review of ID 2 - Performance, except two items as below, both are the same, so the SE is not affected.
1.Brightness, The proposed device is 1900cd/m2 and the predicate device is 1650cd/m2, but the 1900 cd/m2 is better than 1650cd/m2 mm in terms of the bright lifetime. Therefore, they can be considered Substantially Equivalent in safety and effectiveness. So the SE is not affected.
2.Contrast Ratio, The proposed device is 1400:1 and the predicate device is 850:1, but the 1400:1 is better than 850:1 in terms of the Contrast Ratio. Therefore, they can be considered Substantially Equivalent in safety and effectiveness. So the SE is not affected.
Review of ID 3 - Physical Specifications, Dimensions and Relative humidity are comparable, so the SE is not affected
Review of ID 4 - Power Supply, both of them comply with IEC 60601-1 and IEC 60601-1-2. Therefore, they can be considered Substantially Equivalent in safety and effectiveness. So the SE is not affected.
Review of ID 5 - Human factors, both are the same, so the SE is not affected.
Review of ID 6 - Biocompatibility, both are the same, so the SE is not affected.
Review of ID 7 - Sterility, both are the same, so the SE is not affected.
Review of ID 8 - Electrical & Mechanical safety& Thermal safety, both are the same, so the SE is not affected.
Review of ID 9 - EMC, both are the same, so the SE is not affected.
About HDM3G21 and Nio 3MP
Review of ID 1 - Intended use, both of them are intended to be used in displaying and viewing digital images, excluding digital mammography, for review and analysis by trained medical practitioners. So the SE is not affected.
Review of ID 2 - Performance, except four items as below, both are the same, so the SE is not affected.
1.Pixel Pitch, The proposed device is 0.21075 mm and the predicate device is 0.2115 mm, but the 0.21075 mm is better than 0.2115 mm in terms of the image quality. Therefore,
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they can be considered Substantially Equivalent in safety and effectiveness. So the SE is not affected.
2.Brightness, The proposed device is 1700cd/m2 and the predicate device is 800cd/m2, but the 1700 cd/m2 is better than 800cd/m2 in terms of the bright lifetime. Therefore, they can be considered Substantially Equivalent in safety and effectiveness. So the SE is not affected.
3.Contrast Ratio, The proposed device is 1400:1 and the predicate device is 1700:1, but the Contrast Ratio are comparable, Therefore, they can be considered Substantially Equivalent in safety and effectiveness. So the SE is not affected.
4.Active Display Size, The proposed device is 431.6mm x323.7mm and the predicate device is 433mm x325mm, the different of the effective display area due to the different size of the pixel pitch, and the smaller the better in terms of the image quality. Therefore, they can be considered Substantially Equivalent in safety and effectiveness. So the SE is not affected.
Review of ID 3 - Physical Specifications, Dimensions and Relative humidity are comparable, so the SE is not affected
Review of ID 4 - Power Supply, both of them comply with IEC 60601-1 and IEC 60601-1-2. Therefore, they can be considered Substantially Equivalent in safety and effectiveness. So the SE is not affected.
Review of ID 5 - Human factors, both are the same, so the SE is not affected.
Review of ID 6 - Biocompatibility, both are the same, so the SE is not affected.
Review of ID 7 - Sterility, both are the same, so the SE is not affected.
Review of ID 8 - Electrical & Mechanical safety& Thermal safety, both are the same, so the SE is not affected.
Review of ID 9 - EMC, both are the same, so the SE is not affected.
About HDM5G21 and Nio 5MP
Review of ID 1 - Intended use, both of them are intended to be used in displaying and viewing digital imaqes, including digital mammography, for review and analysis by trained medical practitioners. So the SE is not affected.
Review of ID 2 - Performance, except one item as below, both are the same, so the SE is not affected.
1.Brightness, The proposed device is 1200cd/m2 and the predicate device is 700cd/m2, but the different brightness just affect in terms of the bright lifetime. They can be considered Substantially Equivalent in safety and effectiveness. So the SE is not affected.
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2.Contrast Ratio, The proposed device is 1200:1 and the predicate device is 800:1, and the higher the better in terms of the image quality. Therefore, they can be considered Substantially Equivalent in safety and effectiveness. So the SE is not affected.
3.Active Display Size, The proposed device is 422.4mm x337.9mm and the predicate device is 422mm x338mm, the different of the effective display area due to the different size of the pixel pitch. Therefore, they can be considered Substantially Equivalent in safety and effectiveness. So the SE is not affected.
Review of ID 3 - Physical Specifications, Dimensions and Relative humidity are comparable, so the SE is not affected
Review of ID 4 - Power Supply, both of them comply with IEC 60601-1 and IEC 60601-1-2. Therefore, they can be considered Substantially Equivalent in safety and effectiveness. So the SE is not affected.
Review of ID 5 - Human factors, both are the same, so the SE is not affected.
Review of ID 6 - Biocompatibility, both are the same, so the SE is not affected.
Review of ID 7 - Sterility, both are the same, so the SE is not affected.
Review of ID 8 - Electrical & Mechanical safety& Thermal safety, both are the same, so the SE is not affected.
Review of ID 9 - EMC, both are the same, so the SE is not affected.
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, Qingdao Hisense Medical Equipment Co., Ltd. concludes that :
The subject device has same intended use, similar product design, same performance effectiveness, performance safety as the predicate device. The differences above between the subject device and predicate device do not affect the basic design principle, usage, effectiveness and safety of the subject device. And no new risk is raised regarding to effectiveness and safety.
§ 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).