(56 days)
The 2MP/3MP LCD Monitor (HMD2C21) is intended to be used in displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners.
The 2MP/3MP LCD Monitor (HMD2C21/HMD3C21) is a display system for medical viewing, with high resolution 1600x1200(HMD2C21)/2048 x 1536(HMD3C21), 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.
This document is a 510(k) summary for the Hisense 2MP/3MP LCD Monitors (HMD2C21/HMD3C21). A 510(k) submission aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it is as safe and effective. This type of submission focuses on comparing the new device's characteristics to a predicate, rather than an independent study to define acceptance criteria and then demonstrate performance against those specific criteria using a test set and ground truth.
Therefore, the requested information cannot be fully provided in the typical format of an AI/ML device study. Instead, I will describe the comparisons made to establish substantial equivalence.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
Instead of formal acceptance criteria and device performance as typically seen in a diagnostic AI study, this document compares the technical specifications and intended use of the proposed devices (Hisense HMD2C21 and HMD3C21) against their predicate devices (BARCO Nio 2MP and Nio 3MP). The "acceptance criteria" here is effectively meeting comparable specifications to the predicate device, thereby demonstrating substantial equivalence.
Table 1: Comparison of Proposed Devices (Hisense HMD3C21/HMD2C21) to Predicate Devices (BARCO Nio 3MP/2MP)
| Feature | "Acceptance Criteria" (Predicate Device Performance) (Nio 3MP) | Proposed Device Performance (HMD3C21) | "Acceptance Criteria" (Predicate Device Performance) (Nio 2MP) | Proposed Device Performance (HMD2C21) | Conclusion on Equivalence |
|---|---|---|---|---|---|
| Intended Use | Displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners. | Same | Displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners. | Same | Substantially Equivalent |
| Panel Size | 21.3" | 21.2" | 21.3" | 21.3" | Substantially Equivalent (difference deemed non-critical) |
| Pixel Pitch | 0.2115 mm | 0.21075 mm | 0.27 mm | 0.27 mm | Substantially Equivalent (proposed device is slightly better) |
| Brightness (typ.) | 800 cd/m² | 900 cd/m² | 800 cd/m² | 770 cd/m² | Substantially Equivalent (difference deemed non-critical) |
| Contrast Ratio (typ.) | 1400:1 | 1400:1 | 1400:1 | 1100:1 | Substantially Equivalent (difference deemed non-critical) |
| Native Resolution | 2048 x 1536 | 2048 x 1536 | 1600 x 1200 | 1600 x 1200 | Substantially Equivalent |
| Power Capacity | <50W | <80W | <50W | <70W | Substantially Equivalent (both comply with IEC standards) |
| Operating Temp. | 0°C ~ 40°C | 0°C ~ 40°C | 0°C ~ 35°C | 0°C ~ 40°C | Substantially Equivalent |
| Operating Humidity | 8% ~ 80% (non-condensing) | 20% ~ 80% | 8% ~ 80% (non-condensing) | 20% ~ 80% | Substantially Equivalent |
| Other (Dimensions, Network Interface, etc.) | Comparable or identical. | Comparable or identical. | Comparable or identical. | Comparable or identical. | Substantially Equivalent |
| Safety Standards | IEC 60601-1, IEC 60601-1-2 | Compliant | IEC 60601-1, IEC 60601-1-2 | Compliant | Substantially Equivalent |
2. Sample Size Used for the Test Set and the Data Provenance
This is an LCD monitor, not an AI/ML diagnostic algorithm that processes medical data. Therefore, there is no "test set" of medical images or patient data, nor is there "data provenance" in the sense of country of origin of patient data or retrospective/prospective studies. The "testing" involves verifying the monitor's physical, electrical, and performance specifications against industry standards and the predicate device's specifications.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. As this is a medical display device, not an AI/ML diagnostic device interpreting images, there is no "ground truth" based on expert consensus on diagnoses. The "truth" lies in the adherence to technical specifications and safety standards.
4. Adjudication Method for the Test Set
Not applicable. There is no test set of patient data requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
Not applicable. This is a medical display device, not an AI diagnostic tool. MRMC studies are used to assess diagnostic performance of algorithms (with or without human readers).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. There is no algorithm in this product for standalone performance evaluation.
7. The Type of Ground Truth Used
Not applicable. The "ground truth" for this device revolves around objective engineering and performance metrics (e.g., brightness levels, resolution, contrast ratio, compliance with electrical safety standards, etc.), not clinical diagnoses or outcomes.
8. The Sample Size for the Training Set
Not applicable. This is a medical display device; there is no AI/ML algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for this device.
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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.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 16, 2015
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 P.R. CHINA
Re: K152030
Trade/Device Name: Hisense 2MP/3MP LCD Monitor (HMD2C21/HMD3C21) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: PGY Dated: July 7, 2015 Received: July 22, 2015
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.
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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/Resourcesfor You/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,
Robert Ochs
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) K152030
Device Name
Hisense 2MP/3MP LCD Monitor (HMD2C21/HMD3C21)
Indications for Use (Describe)
The 2MP/3MP LCD Monitor (HMD2C21) is intended to be used in displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| ☒ Residential Use (Rentals of 30+ Consecutive Days) |
|---|
| ☐ Care/Elderly Services Use (Rentals of 30+ Consecutive Days) |
X | 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)]
Jul 8th, 2015
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 HMD2C21/ HMD3C21 |
|---|---|
| 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., Coronis 3MP (MDCG-3221) has been cleared by FDA through 510(k) No.K131246 (Decision Date --May 24, 2013), BARCO N.V., Nio 2MP (MDNC-2221) has been cleared by FDA through 510(k) No
510(k) Summary
K133663 (Decision Date -03/25/2014)
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5. Description of the Device [21 CFR 807.92(a) (4)]
The 2MP/3MP LCD Monitor (HMD2C21/HMD3C21) is a display system for medical viewing, with high resolution 1600x1200(HMD2C21)/2048 x 1536(HMD3C21), 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 (HMD2C21/HMD3C21) is intended to be used in displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners.
7. Technological Characteristics [21 CFR 807.92(a)(6)]
| The HMD3C21 | |
|---|---|
| Panel | 21.2", TFT color LCD screen, antiglare |
| Brightness (typ.) | 900 cd/m² |
| CR (typ.) | 1400:1 |
| Viewing angle | R/L 176°, U/D 176° Typ. (CR > 10) |
| Pixel Pitch | 0.21075 mm |
| Native resolution | 2048 x 1536 |
| Display area | 431.6mm(H)x323.7mm (V) |
| Compatible video signals | 640 x 480@60Hz(progressive)2048x1536@60Hz (progressive) |
| Horizontal resolution | 2048 x 1536 |
| Aspect ratio | 4:3 |
| Screen size | 21.2" real diagonal |
| Power | DC24V/3.5A |
| Power consumption | Max. 80 W |
| Input signals | DVI-D, Display Port |
| Digital input | TMDS (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 |
The HMD3C21
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| Stand ) | |
|---|---|
| Weight | 6.1kg (without Stand )10.4kg (with Stand ) |
| Operatingtemperature andhumidity: | Temperature: 0°C ~ 40°CHumidity: 20% ~80% |
| Storagetemperature andhumidity: | Temperature: -20°C ~ 60°CHumidity: 10% ~90% |
The HMD2C21
| The HMD2C21 | |
|---|---|
| Panel | 21.3", TFT color LCD screen, antiglare |
| Brightness (typ.) | 770 cd/m² |
| CR (typ.) | 1100:1 |
| 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)1600 x 1200@60Hz (progressive) |
| Horizontal resolution | 1600 x 1200 |
| Aspect ratio | 4:3 |
| Screen size | 21.3" real diagonal |
| Power | DC24V/3.0A |
| Power consumption | Max. 70 W |
| Input signals | DVI-D, Display Port |
| Digital input | TMDS (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 | 6.1kg (without Stand) |
| 10.4kg (with Stand) | |
| Operatingtemperature andhumidity: | Temperature: 0°C ~ 40°C |
| Humidity: 20% ~80% | |
| Storagetemperature andhumidity: | Temperature: -20°C ~ 60°C |
| Humidity: 10% ~90% |
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8. Substantial Equivalence [21 CFR 807.92(b) (1) and 807.92]
8.1 Intended uses:
| ID | Comparison Item | Proposed Device3MP LCD Monitor(HMD3C21) | Predicate DeviceNio 3MP(MDNC-3221) |
|---|---|---|---|
| 1 | Intended Use | The HMD3C21 is intended to be used in displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners. | "The Nio 3MP (MDNC-3221)" is intended to be used as a tool in displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners. |
Table 1 Intended Use Comparison of HMD3C21
Table 2 Intended Use Comparison of HMD2C21
| ID | Comparison Item | Proposed Device2MP LCD Monitor(HMD2C21) | Predicate DeviceNio 2MP(MDNC-2221) |
|---|---|---|---|
| 1 | Intended Use | The HMD2C21 is intended to be used in displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners. | "The Nio 2MP (MDNC-2221)" is intended to be used in displaying and viewing digital images for review by trained medical practitioners. These devices must not be used in primary image diagnosis in mammography. |
8.2 Comparison table
Table 3 General Comparison about HMD3C21 and Nio 3MP
| ID | ComparisonItem | Proposed Device3MP LCD Monitor(HMD3C21) | Predicate DeviceNio 3MP(MDNC-3221) |
|---|---|---|---|
| 2 | Performance | ||
| 2.1 | Panel Size and Type | 21.2", TFT LCD display | 21.3",TFT LCD display |
| 2.2 | Pixel Pitch | 0.21075 mm | 0.2115 mm |
| 2.3 | Available CabinetColors | Red , Green , Blue | Red , Green , Blue |
| ID | Comparison Item | Proposed Device3MP LCD Monitor(HMD3C21) | Predicate DeviceNio 3MP(MDNC-3221) |
| 2.4 | Native Resolutions | 2048 x1536 | 2048 x1536 |
| 2.5 | Brightness | 900 cd/m2 | 800 cd/m2 |
| 2.6 | Contrast Ratio | 1400:1 | 1400:1 |
| 2.7 | Network Interface | USB(1 Up, 2 Downstream) | USB(1 Up, 2 Downstream) |
| 2.8 | Active Display Size | 431.616mm x 323.712mm | 433.2mm x 324.9mm |
| 3 | Physical Specifications | ||
| 3.1 | Dimensions(Wx Hx D) | 384.0mm (W) x 492.0mm(H) x 70.0mm (D) (withoutStand )384.0 mm (W) x517.5-637.5 mm (H) x273.5mm (D) (with Stand) | 375mm x 488mm x 84mm(without Stand)Portrait:375mm x 620 |
| 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 | Power Capacity | <80W | <50W |
| 4.2 | Input Voltage | DC24V/3.5A | 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 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 does notneed sterilization. | The proposed device doesnot need sterilization. |
| 8 | Electrical & Mechanical safety& Thermal safety | ||
| 8.1 | Type of protection | Class I | Class I |
| ID | ComparisonItem | Proposed Device3MP LCD Monitor(HMD3C21) | Predicate DeviceNio 3MP(MDNC-3221) |
| against electricshock | |||
| 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 safety evaluationis conducted as per therequirements of the standardIEC 60601-1. |
| 9 | Electromagnetic Compatibility | ||
| 9.1 | EMC Evaluation | Complying withIEC 60601-1-2 | Complying withIEC 60601-1-2 |
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Table 4 General Comparison about HMD2C21 and Nio 2MP
| ID | ComparisonItem | Proposed Device2MP LCD Monitor(HMD2C21) | Predicate DeviceNio 2MP(MDNC-2221) |
|---|---|---|---|
| 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 |
| 2.3 | Available CabinetColors | Red , Green , Blue | Red , Green , Blue |
| 2.4 | Native Resolutions | 1600×1200 | 1600×1200 |
| 2.5 | Brightness | 770 cd/m2 | 800 cd/m2 |
| 2.6 | Contrast Ratio | 1100:1 | 1400:1 |
| 2.7 | Network Interface | USB(1 Up, 2 Downstream) | USB(1 Up, 2 Downstream) |
| 2.8 | Active Display Size(H x V) | 432.0mm x324.0mm | 433.2mm x324.9mm |
| 3 | Physical Specifications | ||
| 3.1 | Dimensions(W x H x 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 83.2mm(without Stand)Portrait:378mm x 625 |
| Temperature | |||
| ID | ComparisonItem | Proposed Device2MP LCD Monitor(HMD2C21) | Predicate DeviceNio 2MP(MDNC-2221) |
| 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 | Power Capacity | <70W | < 50W |
| 4.2 | Input Voltage | DC24V/3A | 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 does notneed sterilization. | The proposed device doesnot need sterilization. |
| 8 | Electrical & Mechanical safety& Thermal safety | ||
| 8.1 | Type of protectionagainst electricshock | 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 safety evaluationis conducted as per therequirements of the standardIEC 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 system and its predicate do not affect the safety and effectiveness (SE).
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 three items as below, both are the same, so the SE is not affected.
About HDM3C21 and Nio 3MP
-
- Panel Size, The proposed device is 21.2" and the predicate device is 21.3", 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.
-
- 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, they can be considered Substantially Equivalent in safety and effectiveness. So the SE is not affected.
-
- Brightness, The proposed device is 900cd/m2 and the predicate device is 700cd/m2. but the 900 cd/m2 is better than 700cd/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.
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.
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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 HDM2C21 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.
-
- Contrast Ratio, The proposed device is 1100:1 and the predicate device is 1400:1, but the different contrast ratio just affect in terms of the image quality. Therefore, they can be considered Substantially Equivalent in safety and effectiveness. So the SE is not affected.
-
- Brightness, The proposed device is 770cd/m2 and the predicate device is 800cd/m2, but the different brightness just affect in terms of the bright lifetime. 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.
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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, 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).