SonoEye P1/ SonoEye P1-G/ SonoEye V1/ SonoEye V1-G/ SonoEye G1/ SonoEye G1-G Digital Color Doppler Palm Ultrasound System
Device Facts
| Record ID | K201965 |
|---|---|
| Device Name | SonoEye P1/ SonoEye P1-G/ SonoEye V1/ SonoEye V1-G/ SonoEye G1/ SonoEye G1-G Digital Color Doppler Palm Ultrasound System |
| Applicant | CHISON Medical Technologies Co., Ltd. |
| Product Code | IYN · Radiology |
| Decision Date | Mar 2, 2021 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
The Digital Color Doppler Palm Ultrasound System is intended for diagnostic ultrasound imaging in B (2D), B/M, Color Doppler, Combined(B+Color), Pulsed Wave and Fusion Harmonic Imaging modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Pediatrics, Small Organ, Musculoskeletal, Peripheral Vessel, Carotid. The Digital Color Doppler Palm Ultrasound System is intended for use in environments where is provided by healthcare professionals.
Device Story
Mobile, software-controlled diagnostic ultrasound system for point-of-care use. System consists of a linear array USB transducer connected to a commercial off-the-shelf (COTS) Android mobile device running CHISON ultrasound application software. Acquires ultrasound data and displays in B (2D), B/M, Color Doppler, Combined (B+Color), Pulsed Wave, and Fusion Harmonic Imaging modes. Healthcare professionals operate the system to perform diagnostic imaging and fluid flow analysis. Output is displayed on the mobile device screen for clinical assessment. Benefits include portability and diagnostic utility in clinical settings.
Clinical Evidence
No clinical testing was required. Device safety and performance were established through non-clinical bench testing, including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), acoustic output (IEC 60601-2-37), and biocompatibility (ISO 10993-1).
Technological Characteristics
Portable ultrasound system using linear array USB transducers. Powered by COTS Android mobile devices (e.g., Samsung Galaxy A70s, Huawei MatePad Pro) via USB 2.0. Transducers are Type BF isolated applied parts. Complies with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-37. Software-controlled; moderate level of concern.
Indications for Use
Indicated for diagnostic ultrasound imaging and fluid flow analysis in pediatrics, small organ, musculoskeletal, peripheral vessel, and carotid applications. Intended for use by healthcare professionals.
Regulatory Classification
Identification
An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
Predicate Devices
- Lumify Diagnostic Ultrasound System (K192226)
Reference Devices
Submission Summary (Full Text)
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March 2, 2021 CHISON Medical Technologies Co., Ltd. % Qifei Liu Regulatory Affairs Manager No.228, Changjiang East Road, Block 51 and 53, Phase 5, Shuofang Industrial Park, Xinwu District, Wuxi. Jiangsu 214142 CHINA
Re: K201965
Trade/Device Name: SonoEye P1/ SonoEye V1/ SonoEye V1/ SonoEye V1-G/ SonoEye G1/ SonoEye G1-G Digital Color Doppler Palm Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: January 13, 2021 Received: January 27, 2021
Dear Qifei Liu:
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
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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
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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### Indications for Use
510(k) Number (if known) K201965
Device Name
SonoEye P1-G/ SonoEye V1 /SonoEye V1-G/ SonoEye G1/ SonoEye G1-G Digital Color Doppler Palm Ultrasound System
#### Indications for Use (Describe)
The Digital Color Doppler Palm Ultrasound System is intended for diagnostic ultrasound imaging in B (2D), B/M, Color Doppler, Combined(B+Color), Pulsed Wave and Fusion Harmonic Imaging modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Pediatrics, Small Organ, Musculoskeletal, Peripheral Vessel, Carotid.
The Digital Color Doppler Palm Ultrasound System is intended for use in environments where is provided by healthcare professionals.
| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|
| <span style="text-decoration: underline;"><b> Prescription Use (Part 21 CFR 801 Subpart D) </b></span> | <span style="text-decoration: overline;"><b> Over-The-Counter Use (21 CFR 801 Subpart C) </b></span> |
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### K201965
# 510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
### 1. Submitter:
| Submitter: | CHISON Medical Technologies Co., Ltd. |
|----------------|----------------------------------------------------------------------------------------------------------------------------------|
| Address: | No.228, Changjiang East Road, Block 51 and 53, Phase 5, Shuofang<br>Industrial Park, Xinwu District, Wuxi, Jiangsu, China 214142 |
| Contact: | Mr. Liu Qifei |
| Tel: | +86-510-85310019 |
| Fax: | +86-510-85310021 |
| Date Prepared: | July 3, 2020 |
### 2. Device :
Trade Name: SonoEye P1/ SonoEye P1-G/ SonoEye V1/ SonoEye V1-G/ SonoEye G1/ SonoEye G1-G Digital Color Doppler Palm Ultrasound System
Common Name: Diagnostic Ultrasound System
Classification: Regulatory Class: II Review Category: Tier II
| Classfication Name | 21 CFR Section | Product Code |
|------------------------------------------|----------------|--------------|
| Ultrasonic pulsed doppler imaging system | 892.1550 | 90-IYN |
| Ultrasonic pulsed echo imaging system | 892.1560 | 90-IYO |
| Diagnostic ultrasonic transducer | 892.1570 | 90-ITX |
### 3. Predicate Device(s):
| Device | Model | Product Code | 510(k)Number |
|-------------------------|-------------------------------------------|--------------|--------------|
| 1.Main predicate device | Lumify<br>Diagnostic<br>Ultrasound System | IYN,IYO,ITX | K192226 |
| 2.Reference device | Clarius Ultrasound System | IYN,ITX,IYO | K192107 |
| 3.Reference device | TE7 Diagnostic Ultrasound<br>System | IYN,ITX,IYO | K160381 |
### 4. Device Description:
The SonoEye P1/ SonoEye P1-G/ SonoEye V1-G/ SonoEye V1-G/ SonoEye G1/ SonoEye G1-G Digital Color Doppler Palm Ultrasound System is a mobile, general purpose, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data in various modes of operation. The Digital Color Doppler Palm Ultrasound System is a portable system facilitating point of care ultrasound
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### applications.
The Digital Color Doppler Palm Ultrasound System includes:
- A commercial off-the-shelf (COTS) Android mobile device .
- . CHISON Ultrasound software is running as an app (Android) on the COTS device
- . The SonoEye P1, SonoEye V1, SonoEye G1, SonoEye P1-G, SonoEye V1-G, SonoEye G1-G Linear array USB transducer.
## 5. The requirement of commercial off-the-shelf (COTS) devices
All models need to comply with IEC55032, IEC60950-1, among which we have selected typical models to do verification testing with SonoEye on ANSI/AAMI ES60601-1 and IEC60601-1-2, such as Samsung Galaxy A70s or Huawei MatePad Pro.
. Electrical Safety
> The transducer and software, along with a representative device, have been verified as compliant with IEC 60601-1. The transducers meet Type BF isolated applied part requirements. When the transducer and software are used in conjunction with a device(COTS devices) compliant with IEC 60950-1, the system meets IEC 60601-1 requirements for Class II equipment.
- Electromagnetic Compatibility The transducer and representative Android device are classified as Group 1, Class A equipment in accordance with international standard CISPR 11 for radiated and conducted electromagnetic disturbances. When the transducer and software are used in conjunction with a device(COTS devices) compliant with IEC 55032, the system meets IEC 60601-1-2 requirements for Group1,Class A equipment.
- Android devices' output current and voltage The representative Android devices' output current is 1.5A and voltage is 5V. A COTS device connected to our transducer and should meet the current and voltage range, the output current is greater than or equal to 1.5A, and the output voltage is 5V±5%.
- Full compliance with USB 2.0 standard The representative Android devices are full compliance with USB 2.0 standard. A COTS device connected to our transducer and system should meet the USB 2.0 standard.
- · Representative Android devices Representative Android devices are Samsung Galaxy A70s and Huawei MatePad Pro.The configuration is as follows. Samsung Galaxy A70s:
·CPU frequency 2.0GHz (big quad core), 1.7GHz (small quad core),Octa-core
·RAM capacity 8GB
- ·ROM capacity 128GB
·Main screen resolution 2400x1080 pixels
•WLAN function Dual-band WIFI, IEEE 802.11 a/b/g/n/ac (support 2.4G and 5GHz)
•Operating System: Android 9
- ·Support Bluetooth 5.0
•Huawei MatePad Pro:
•CPU frequency 2 x Cortex-A76 Based 2.86 GHz+ 2 x Cortex-A76 Based 2.09 GHz+ 4 x
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Cortex-A55 1.86 GHz,Octa-core
- •RAM capacity 8GB
- ·ROM capacity 128GB
- •Main screen resolution 2560x1600 pixels
·WiFi function supports dual frequency (2.4GHz+5GHz)
·Bluetooth function supports Bluetooth 5.1 module
•Operating System: Android 9
### 6. Indications for Use:
The Digital Color Doppler Palm Ultrasound System is intended for diagnostic ultrasound imaging in B (2D), B/M,Color Doppler,Combined(B+Color), Pulsed Wave and Fusion Harmonic Imaging modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Pediatrics, Small Organ, Musculoskeletal, Peripheral Vessel, Carotid.
The Digital Color Doppler Palm Ultrasound System is intended for use in environments where healthcare is provided by healthcare professionals.
## 7. Summary of Non-Clinical Tests:
The Digital Color Doppler Palm Ultrasound System has been evaluated for electrical, mechanical, thermal and electromagnetic compatibility safety, biocompatibility and acoustic output.
The device has been found to conform to applicable medical device safety standards in regards to thermal, mechanical and electrical safety as well as biocompatibility.
The product fulfils the requirement of:
ANSI/AAMI ES60601-1:2005Medical Electrical Equipment -Part1:General Requirements for Safetv
IEC 60601-1-2: 2014 Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility -- Requirements and Tests IEC 60601-2-37: 2007 Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
ISO 10993-1:2009 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process
The device has been found to conform to applicable FDA medical device guidance documents titled as followings:
- Marketing Clearance of Diagnostic Ultrasound Systems and Transducers (Document ● issued on: June 27, 2019)
- Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document issued on: May 11, 2005)
- Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (Document Issued on: October 2, 2014)
- Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" (Document issued on: June 16, 2016)
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### 8. Clinical Test:
No clinical testing was required.
Software Documentation for a Moderate Level of Concern, per the FDA guidance document,"Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document issued on May 11, 2005", is also included as part of this submission.
## 9. Comparison to Predicate Device:
| | Main predicate<br>device | Reference<br>device | Reference device | Submission<br>Device | |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|
| Items | Lumify<br>Diagnostic<br>Ultrasound<br>System | Clarius<br>Ultrasound<br>System | TE7 Diagnostic<br>Ultrasound<br>System | Digital<br>Color<br>Doppler<br>Palm<br>Ultrasound<br>System | Remark |
| Indication<br>s for Use | Fetal/Obstetric,<br>Abdominal,<br>Pediatric,<br>Cephalic,<br>Urology,<br>Gynecological,<br>Cardiac Fetal<br>Echo, Small<br>Organ,<br>Musculoskeletal<br>,<br>Peripheral<br>Vessel, Carotid,<br>Cardiac. | ophthalmic,<br>fetal,<br>abdominal,<br>intraoperative<br>(non-neurologi<br>cal), pediatric,<br>small organ,<br>cephalic<br>(adult),<br>trans-rectal,<br>transvaginal,<br>musculo-skelet<br>al<br>(conventional,<br>superficial),<br>urology,<br>gynecology,<br>cardiac (adult,<br>pediatric),<br>peripheral<br>vessel, carotid,<br>and procedural<br>guidance of<br>needles into<br>the body. | fetal, abdominal,<br>Intra-operative(abd<br>ominal, thoracic,<br>and vascular),<br>Pediatric ,small<br>organ(breast,<br>thyroid, testes),<br>neonatal and adult<br>cephalic,<br>trans-esoph.<br>(Cardiac),<br>trans-rectal,<br>trans-vaginal,<br>musculo-skeletal<br>(conventional,<br>superficial),<br>urology, Peripheral<br>vessel, Adult and<br>Pediatric cardiac | Pediatrics, Small<br>Organ,<br>Musculoskeletal,<br>Peripheral<br>Vessel, Carotid | Same |
| Design | Autocorrelation<br>for color<br>processing and<br>FFT for pulse<br>Doppler<br>processing.<br>Supporting<br>Linear, Curve,<br>Phase array<br>and Volume<br>probes. | Autocorrelatio<br>n for color<br>processing<br>and FFT for<br>pulse Doppler<br>processing.<br>Supporting<br>Linear, Phase<br>array, Micro<br>convex array,<br>Endocavity | Autocorrelation for<br>color processing<br>and FFT for pulse<br>Doppler<br>processing.<br>Supporting Linear,<br>convex and<br>phased array.<br>Cine play back<br>capability<br>Image file archive | Autocorrelation<br>for color<br>processing and<br>FFT for pulse<br>Doppler<br>processing.<br>Supporting<br>Linear probe.<br>Cine play back<br>capability<br>Image file | Same |
| Items | Main predicate<br>device | Reference<br>device | Reference device | Submission<br>Device | Remark |
| | Lumify<br>Diagnostic<br>Ultrasound<br>System | Clarius<br>Ultrasound<br>System | TE7 Diagnostic<br>Ultrasound<br>System | Digital Color<br>Doppler Palm<br>Ultrasound<br>System | |
| | Cine play back<br>capability<br>Image<br>file<br>archive | probe and<br>Volume probes<br>Cine play back<br>capability<br>Image<br>file<br>archive | | archive | |
| | TGC | TGC | TGC | STC | Same |
| Operating<br>Controls | Depth<br>Range:<br>0.003 to >30 cm | Depth Range:<br>5.0 to 10.0cm<br>(Depth depend<br>on probe type) | Depth depend on<br>probe type | Depth<br>Range:<br>1.0 to 9.9cm | SE<br>Analysis<br>1 |
| | 256 shades of<br>gray | 256 in B-Mode | 30-240 in B mode | 256 shades<br>of gray | Same |
| | Gain | Gain | Gain | Gain:0-255,1/step | Same |
| | Focus | Focus | Focus | Focus: adjustable | Same |
| | Color box<br>size/position<br>can be adjust | ROI adjust | ROI adjust | ROI size/position:<br>adjustable | Same |
| | N/A | Baseline | Baseline | Baseline | Same |
| | Cine control:<br>drag scroll bar,<br>press<br>or | Tap the cine<br>capture button<br>to capture the<br>cine as part of<br>the exam. | Cine control | Cine control:<br>step, play<br>backward, play<br>continuously | Same |
| | Freeze control:<br>Toggling freeze<br>key | Freeze control:<br>Toggling<br>freeze key | Freeze control:<br>Toggling freeze<br>key | Freeze control:<br>Toggling freeze<br>key | Same |
| Safety<br>Complian<br>ce | ANSI/AAMI<br>ES60601-1<br>IEC60601-1<br>IEC60601-2-37<br>IEC60601-1-2<br>ISO 10993-1 | ANSI/AAMI<br>ES60601-1<br>IEC60601-1<br>IEC60601-2-37<br>IEC 60601-1-2<br>ISO 10993-1 | ANSI/AAMI<br>ES60601-1<br>IEC60601-1<br>IEC60601-2-37<br>IEC60601-1-2<br>ISO 10993-1 | ANSI/AAMI<br>ES60601-1<br>IEC60601-1<br>IEC60601-2-37<br>IEC60601-1-2<br>ISO 10993-1 | Same |
| | B mode | B mode | B mode | B mode | Same |
| | N/A | PW mode | Pulsed wave<br>Doppler mode | PW mode | Same |
| | M mode | M mode | M mode | B/M mode | Same |
| Operation<br>Mode | Color mode | Color Doppler<br>Mode | Color mode | CFM mode | Same |
| | N/A | N/A | IQ | FHI | Same |
| | Gain | Gain | Gain | Gain | Same |
| | Depth | Depth | Depth | Depth | Same |
| | TGC | TGC | TGC | STC | Same |
| | Main predicate<br>device | Reference<br>device | Reference device | Submission<br>Device | |
| Items | Lumify<br>Diagnostic<br>Ultrasound<br>System | Clarius<br>Ultrasound<br>System | TE7 Diagnostic<br>Ultrasound<br>System | Digital Color<br>Doppler Palm<br>Ultrasound<br>System | Remark |
| | N/A | Spatial<br>Compound | Spatial Compound | Compound | Same |
| | Frequency | Frequency | Frequency | Frequency<br>Scaling | Same |
| | Freeze | Freeze | Freeze | Freeze/Unfreeze | Same |
| | Zoom | Zoom | Zoom | Zoom | Same |
| | 2D distance | 2D distance | distance | B-distance | Same |
| | Circumference | Circumference | Circumference | B-Circumference | Same |
| | Area | Area | Area | B-Area | Same |
| | N/A | Volume | Volume | B-Volume | Same |
| | N/A | Distance | Distance | B/M-Distance | Same |
| | N/A | M-Time | Time | B/M-Time | Same |
| | N/A | M-HR | HR | B/M-HR | Same |
| | N/A | Velocity | Velocity | PW-Velocity | Same |
| | N/A | Time | Time | PW-Time | Same |
| | N/A | Vascular | Vascular | Vessel measure<br>package | Same |
| | N/A | Small Organ | Small part | Small Organ<br>measure<br>package | Same |
| | N/A | Report | Report | General report | Same |
| | N/A | N/A | Vascular Exam<br>Report | Vessel report | Same |
| | N/A | N/A | Small Parts Exam<br>Report | Small Organ<br>report | Same |
| | Language<br>follow system | N/A | Multi-language<br>Interface | Multi-language<br>Interface | Same |
| | Thumbnail | N/A | Thumbnail window | Clipboard | Same |
| | N/A | N/A | iTouch | Instant AIO | Same |
| | Biopsy Guide<br>Line | Biopsy Guide | Biopsy Guide | Biopsy Guide | Same |
| | Reacts Session<br>Views | N/A | N/A | SonoRemote | Same |
| | N/A | N/A | iNeedle | SonoNeedle | Same |
| | N/A | NeedleEnhanc<br>e | iNeedle | SuperNeedle | Same |
| | Save Loop | Save Cine…
