SonoEye P2/ SonoEye V2/ SonoEye G2 Digital Color Doppler Palm Ultrasound System

K201967 · CHISON Medical Technologies Co., Ltd. · IYN · Feb 26, 2021 · Radiology

Device Facts

• Record ID: K201967
• Device Name: SonoEye P2/ SonoEye V2/ SonoEye G2 Digital Color Doppler Palm Ultrasound System
• Applicant: CHISON Medical Technologies Co., Ltd.
• Product Code: IYN · Radiology
• Decision Date: Feb 26, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Intended 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.

Device Story

Mobile, software-controlled diagnostic ultrasound system; consists of a linear array USB transducer and a COTS Android mobile device running the CHISON ultrasound app. Acquires ultrasound data via transducer; processes signals using autocorrelation (color) and FFT (pulse Doppler); displays images in B, B/M, Color Doppler, Combined, Pulsed Wave, and Fusion Harmonic modes. Used in point-of-care settings by healthcare professionals. Output includes real-time ultrasound images, measurements (distance, area, volume, velocity, heart rate), and reports. Enables clinicians to perform diagnostic imaging and fluid flow analysis, facilitating clinical decision-making at the point of care.

Clinical Evidence

No clinical testing was required. The device was evaluated through bench testing, including electrical, mechanical, thermal, and electromagnetic compatibility safety, biocompatibility, and acoustic output verification.

Technological Characteristics

Linear array USB transducer; COTS Android mobile device (e.g., Samsung Galaxy A70s, Huawei MatePad Pro). Imaging modes: B, B/M, Color Doppler, Pulsed Wave, Fusion Harmonic. Connectivity: USB 2.0, Wi-Fi, Bluetooth. Power: 5V DC. Safety: Type BF applied parts, IEC 60601-1, IEC 60601-2-37, IEC 60601-1-2, ISO 10993-1. Software: Android-based app.

Indications for Use

Indicated for diagnostic ultrasound imaging and fluid flow analysis in pediatric, small organ, musculoskeletal, peripheral vessel, and carotid applications. Intended for use by healthcare professionals in clinical environments.

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

• Clarius Ultrasound System (K192107)
• TE7 Diagnostic Ultrasound System (K160381)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

CHISON Medical Technologies Co., Ltd. February 26, 2021 % 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: K201967

Trade/Device Name: SonoEye P2/ SonoEye V2/ SonoEye G2 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

{1}------------------------------------------------

requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); 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 ([e-mail]) or phone [phone] 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

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K201967

Device Name

SonoEye P2/ SonoEye V2/ SonoEye G2 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 healthcare is provided by healthcare professionals.

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| <span style="font-size: 1.2em;">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size: 1.2em;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

K201967

# 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: | [phone] |
| Fax: | [phone] |
| Date Prepared: July 3, 2020 | |

#### 2. Device :

Trade Name: SonoEye P2/ SonoEye V2/ SonoEye G2 Digital Color Doppler Palm Ultrasound System

Common Name: Diagnostic Ultrasound System with Transducers

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 Diagnostic Ultrasound System | IYN,IYO,ITX | K 192226 |
| 2.Reference device | Clarius Ultrasound System | IYN,ITX,IYO | K192107 |
| 3.Reference device | TE7 Diagnostic Ultrasound<br>System | IYN,ITX,IYO | K 160381 |

## 4. Device Description:

The SonoEye P2/ SonoEye V2/ SonoEye G2 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 SonoEye P2/ SonoEye V2/ SonoEye G2 Digital Color Doppler Palm

{4}------------------------------------------------

Ultrasound System is a portable system facilitating point of care ultrasound 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 P2, SonoEye V2, SonoEye G2 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 alb/g/n/ac (support 2.4G and 5GHz) · Operating System: Android 9

- •Support Bluetooth 5.0
•Huawei MatePad Pro:

{5}------------------------------------------------

•CPU frequency 2 x Cortex-A76 Based 2.86 GHz+ 2 x Cortex-A76 Based 2.09 GHz+ 4 x 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 reqards to thermal, mechanical and electrical safety as well as biocompatibility.

The product fulfils the requirement of:

ANSI/AAM ES60601-1:2005Medical Electrical Equipment-Part 1: General Requirements for Safety.

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

{6}------------------------------------------------

issued on: June 16, 2016)

#### 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:

| Table 1 Substantial Equivalence Comparison | | | | | |
|----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|
| Items | Main predicate device | Reference device | Reference device | Submission 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 | |
| Indication<br>s for Use | Fetal/Obstetric,<br>Abdominal,<br>Pediatric,<br>Cephalic,<br>Urology,<br>Gynecological,<br>Cardiac Fetal<br>Echo,<br>Small Organ,<br>Musculoskeletal<br>,<br>Peripheral<br>Vessel,<br>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-skeletal<br>(conventional,<br>superficial),<br>urology,<br>gynecology,<br>cardiac (adult,<br>pediatric),<br>peripheral<br>vessel,<br>carotid, and<br>procedural<br>guidance of<br>needles into<br>the body. | fetal,<br>abdominal,<br>intra-operative(abdo<br>minal,<br>thoracic, and<br>vascular),<br>pediatrics,<br>small organ(breast,<br>thyroid, testes),<br>neonatal and adult<br>cephalic,<br>trans-esoph.(Cardia<br>c), trans-vaginal,<br>musculo-<br>skeletal(convention<br>al, superficial),<br>urology,<br>peripheral vessel,<br>adult and pediatric<br>cardiac,<br>ophthalmic exams | Pediatrics,<br>Small Organ,<br>Musculoskeletal,<br>Peripheral<br>Vessel,<br>Carotid | 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 | |
| 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.<br>Cine play back<br>capability<br>Image file<br>archive | Autocorrelation<br>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<br>probe and<br>Volume probes<br>Cine play back<br>capability<br>Image file<br>archive | Autocorrelation for<br>color processing<br>and FFT for pulse<br>Doppler processing.<br>Supporting Linear,<br>convex and phased<br>array.<br>Cine play back<br>capability<br>Image file archive | Autocorrelation<br>for color<br>processing<br>and FFT for<br>pulse<br>Doppler<br>processing.<br>Supporting<br>Linear probe.<br>Cine play back<br>capability<br>Image file<br>archive | Same |
| | TGC | TGC | TGC | TGC/STC | Same |
| | 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 of<br>gray | Same |
| | Gain | Gain | Gain | Gain:0-255,1/step | Same |
| | Focus | Focus | Focus | Focus: adjustable | Same |
| Operating<br>Controls | 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 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,<br>backward,<br>play<br>play<br>continuously | Same |
| | Freeze control:<br>Toggling freeze<br>key | Freeze control:<br>Toggling<br>freeze key | Freeze control:<br>Toggling freeze key | Freeze control:<br>Toggling<br>freeze<br>key | Same |
| Safety<br>Compliance | IEC60601-1<br>IEC60601-2-37<br>IEC60601-1-2<br>ISO 10993-1 | IEC60601-1<br>IEC 60601-2-37<br>IEC 60601-1-2<br>ISO 10993-1 | IEC60601-1<br>IEC60601-2-37<br>IEC60601-1-2<br>ISO 10993-1 | IEC60601-1<br>IEC60601-2-37<br>IEC60601-1-2<br>ISO 10993-1 | Same |
| Operation<br>Mode | B mode | B mode | B mode | B mode | Same |
| | N/A | PW mode | Pulsed<br>wave | PW mode | 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 | | |
| | M mode | M mode | Doppler mode | B/M mode | Same |
| | 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 | TGC/STC | Same |
| | 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<br>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 | Son…