SonoMax Series Digital Color Doppler Ultrasound System

K233697 · CHISON Medical Technologies Co., Ltd. · IYN · Aug 9, 2024 · Radiology

Device Facts

• Record ID: K233697
• Device Name: SonoMax Series Digital Color Doppler Ultrasound System
• Applicant: CHISON Medical Technologies Co., Ltd.
• Product Code: IYN · Radiology
• Decision Date: Aug 9, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The SonoMax Series Digital Color Doppler Ultrasound System is intended for diagnostic ultrasound imaging in B(2D/3D/4D), B/M, M, B+CFM, B+CPA(PD), B+DPD, B+PW, B+CW, B+CFM+D(PW)/CW, B+CPA(PD)+D(PW)/CW, TDI and Fusion Harmonic Imaging modes. The device is a general-purpose ultrasonic imaging instrument intended for use by appropriately-trained qualified healthcare professionals for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, thyroid, testes), Neonatal Cephalic, Cardiac (adult, pediatric), Musculoskeletal (Conventional, Superficial), Peripheral Vascular, Trans-esophageal, Trans-vaginal, OB/GYN and Urology, which is intended to be used in a hospital or medical clinic.

Device Story

Mobile, software-controlled color Doppler ultrasound system; acquires ultrasound echo data via linear, convex, and phased array probes; processes signals using autocorrelation (color) and FFT (Doppler); displays images in various modes including B(2D/3D/4D), M, CFM, PW, CW, and TDI. Used by trained healthcare professionals in hospitals/clinics for diagnostic imaging. Output viewed on integrated color LCD monitor; assists clinicians in anatomical evaluation and physiological measurement. Benefits include non-invasive diagnostic visualization of internal structures and blood flow.

Clinical Evidence

No clinical testing was required. Substantial equivalence is supported by bench testing, including electrical, mechanical, thermal, and electromagnetic compatibility safety, biocompatibility (ISO 10993), and acoustic output measurements.

Technological Characteristics

Mobile console with color LCD, keyboard, and 5 probe ports. Supports linear, convex, and phased array probes. Imaging modes: B, M, CFM, PW, CW, TDI, Fusion Harmonic. Connectivity: image file archive. Safety standards: ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-37. Biocompatibility: ISO 10993-1. Software-controlled.

Indications for Use

Indicated for diagnostic ultrasound imaging in patients requiring evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, thyroid, testes), Neonatal Cephalic, Adult Cephalic, Cardiac (adult, pediatric), Musculoskeletal (Conventional, Superficial), Peripheral Vascular, Trans-esophageal, Trans-rectal, Trans-vaginal, OB/GYN, and Urology. Intended for use by trained healthcare professionals in hospitals or clinics.

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

• XBit 90 Digital Color Doppler Ultrasound System (K200780)

Submission Summary (Full Text)

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

August 9, 2024

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and 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. Yingying Chen Official Correspondent No.3 Changjiang South Road, Xinwu District Wuxi. Jiangsu 214028 CHINA

## Re: K233697

Trade/Device Name: SonoMax Series Digital Color Doppler 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: July 5, 2024 Received: July 8, 2024

## Dear Yingying Chen:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

# Yanna S. Kang -S

Yanna Kang, Ph.D. Assistant Director Mammography and Ultrasound Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

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

# Indications for Use

510(k) Number (if known) K233697

#### Device Name

SonoMax Series Digital Color Doppler Ultrasound System

Indications for Use (Describe)

The SonoMax Series Digital Color Doppler Ultrasound System is intended for diagnostic ultrasound imaging in B(2D/3D/4D), B/M, M, B+CFM, B+CPA(PD), B+DPD, B+PW, B+CW, B+CFM+D(PW)/CW, B+CPA(PD)+D(PW)/CW, TDI and Fusion Harmonic Imaging modes. The device is a general-purpose ultrasonic imaging instrument intended for use by appropriately-trained qualified healthcare professionals for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, thyroid, testes), Neonatal Cephalic, Cardiac (adult, pediatric), Musculoskeletal (Conventional, Superficial), Peripheral Vascular, Trans-esophageal, Trans-vaginal, OB/GYN and Urology, which is intended to be used in a hospital or medical clinic.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

X Prescription Use (Part 21 CFR 801 Subpart D)

| 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}------------------------------------------------

# 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.3 Changjiang South Road, Xinwu District, Wuxi, 214028 Jiangsu,<br>P.R. China |
| Contact : | Mrs. Chen Yingying |
| Tel: | [phone] |
| Fax: | [phone] |
| Date Prepared: | November 10th, 2023 |

#### 2. Device :

Trade Name: SonoMax Series Digital Color Doppler Ultrasound System(SonoMax 1/ SonoMax 2/ SonoMax 3/ SonoMax 5/ SonoMax 6/SonoMax 7/SonoMax 7 Super/ SonoMax 7 EXP/ SonoMax 8/ SonoMax 8 Super/ SonoMax 8 EXP/SonoMax 9/ SonoMax 9 Super/ SonoMax 9 EXP/SonoMax 10/ SonoMax 11/ SonoMax 22)

Common Name: Diagnostic Ultrasound System with Transducers

Classfication: Requlatory Class: II Review Category: Tier II

| Classification Name | 21 CFR<br>Section | Product Code |
|------------------------------------------|-------------------|--------------|
| Ultrasonic Pulsed Doppler Imaging System | 892.1550 | 90-IYN |
| Ultrasonic Pulsed Echo Imaging System | 892.1560 | 90-IYO |
| Diagnostic Ultrasound Transducer | 892.1570 | 90-ITX |

#### 3. Predicate Device(s):

| Device | Model | Product Code | 510(k)Number |
|------------------|----------------------------------------------------|---------------|--------------|
| Predicate device | XBit 90 Digital Color<br>Doppler Ultrasound System | IYN, IYO, ITX | K200780 |

# 4. Device Description:

The SonoMax Series Digital Doppler Ultrasound System is an integrated preprogrammed color doppler ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications.

This system is a Track 3 device that employs a wide array of probes that include linear array, convex array and phased array.This system consists of a mobile console with keyboard control panel, power supply module, color LCD monitor and optional probes. This system is a mobile, general purpose, software controlled, color diagnostic ultrasound system. Its basic function is to acquire ultrasound echo data

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

CHISON Medical Technologies Co., Ltd. SonoMax Series Digital Color Doppler Ultrasound System and to display the image in B(2D/3D/4D), B/M, M, B+CFM, B+CPA(PD), B+DPD, B+PW, B+CW, B+CFM+D(PW)/CW, B+CPA(PD)+D(PW)/CW, TDI, Fusion Harmonic lmaging modes or a combination of these mode.

# 5. Indications for Use:

The SonoMax Series Digital Color Doppler Ultrasound System is intended for diagnostic ultrasound imaging in B(2D/3D/4D), B/M, M, B+CFM, B+CPA(PD), B+DPD, B+PW, B+CW, B+CFM+D(PW)/CW, B+CPA(PD)+D(PW)/CW, TDI and Fusion Harmonic Imaging modes. The device is a general-purpose ultrasonic imaging instrument intended for use by appropriately-trained qualified healthcare professionals for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, thyroid, testes), Neonatal Cephalic, Adult Cephalic, Cardiac (adult, pediatric), Musculo-skeletal (Conventional, Superficial), Peripheral Vascular, Trans-esophageal, Trans-rectal, Trans-vaginal, OB/GYN and Urology, which is intended to be used in a hospital or medical clinic.

# 6. Summary of Non-Clinical Tests:

The SonoMax Series Digital Color Doppler 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.

ANSI AAMI ES60601-1:2015 Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance.

IEC 60601-1-2: 2014 Medical Electrical Equipment - Part 1-2: General Requirements For Safety - Collateral Standard: Electromagnetic Compatibility -- Requirements and Tests.

IEC 60601-2-37:2015 Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment.

Output Indices on Diagnostic Ultrasound Equipment

ISO 10993-1:2018 Biological Evaluation of Medical Devices -- Part 1: Evaluation And Testing Within A Risk Management Process

The following quality assurance measures are applied to the development of the system:

Risk Management

Requirement review and Design reviews

Testing on unit level (Module verification)

Integration testing (system verification)

Performance testing (Verification)

Safety testing (Verification)

The biocompatibility was evaluated and meets the ISO10993 series standard and FDA quidance.

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

# 7. Clinical Test:

No clinical testing was required.

Software Documentation for a Basic Documentation Level, per the FDA guidance document,"Guidance for Content of Premarket Submissions for Device Software Functions Document issued on June 14, 2023", is also included as part of this submission.

# 8. Determination of Substantially Equivalent:

| Items | Predicate Device | Submission Device | Remark |
|--------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|
| Items | XBit 90 Digital Color Doppler<br>Ultrasound System<br>(K200780) | SonoMax Series Digital Color<br>Doppler Ultrasound System | Remark |
| Indications<br>for Use | Fetal<br>Abdominal<br>Pediatric<br>Small Organ (breast,<br>thyroid ,testes)<br>Neonatal Cephalic<br>Adult Cephalic<br>Trans-rectal<br>Trans-vaginal<br>Musculo-skeletal( Conventional,<br>Superficial)<br>Cardiac(adult ,pediatric)<br>Peripheral Vascular<br>OB/GYN, Urology<br>Trans-esophageal | Fetal<br>Abdominal<br>Pediatric<br>Small Organ (breast,<br>thyroid ,testes)<br>Neonatal Cephalic<br>Adult Cephalic<br>Trans-rectal<br>Trans-vaginal<br>Musculo-skeletal( Conventional,<br>Superficial)<br>Cardiac(adult ,pediatric)<br>Peripheral Vascular<br>OB/GYN, Urology<br>Trans-esophageal | Same |
| Design | Autocorrelation for color<br>processing and FFT for pulse<br>and CW Doppler processing.<br>Supporting Linear, Curve ,<br>Phase array and Volume probes .<br>Cine play back capability<br>Image file archive | Autocorrelation for color<br>processing and FFT for pulse<br>and CW Doppler processing.<br>Supporting Linear, Curve and<br>Phase array probes.<br>Cine play back capability<br>Image file archive | Same |
| | TGC 8 slider | TGC 10 slider | SE<br>Analysis I |
| | Depth Range: 0-45 cm | Depth Range:0- 45 cm | Same |
| Operating<br>Controls<br>Items | 256 shades of gray | 256 shades of gray | Same |
| Operating<br>Controls<br>Items | B Dynamic range control: 20-<br>180dB | B Dynamic range control: 20-<br>180dB | Same |
| Operating<br>Controls<br>Items | Gain:0-255, 1/step | Gain:0-255,1/step | Same |
| Operating<br>Controls<br>Items | Focal Number: adjustable | Focal Number: adjustable | Same |
| Operating<br>Controls<br>Items | Focus position: adjustable | Focus position: adjustable | Same |
| | | | |
| B steer: available on linear<br>transducers | B steer: available on linear<br>transducers | Same | |
| B Persistence: 7 steps | B Persistence: 7 steps | Same | |
| ROI size/position: adjustable | ROI size/position: adjustable | Same | |
| Color Wall Filter settings: 8 steps | Color Wall Filter settings: 8 steps | Same | |
| Color Baseline:16 steps | Color Baseline: 16 steps | Same | |
| Color Maps: 21 maps | Color Maps: 21 maps | Same | |
| PW sweeping speed: 6 steps | PW sweeping speed: 6 steps | Same | |
| Color Invert: on/off | Color Invert: on/off | Same | |
| PW Wall Filter: 7 steps | PW Wall Filter: 7 steps | Same | |
| PW sample volume: 0.5-30mm<br>(PW only) | PW sample volume: 0.5-30mm<br>(PW only) | Same | |
| PW angle correction:<br>89~89degrees,1/ste | PW angle correction:89~<br>89degrees, 1/step | Same | |
| Baseline: 8steps | Baseline: 8steps | Same | |
| Cine control:step, play backward,<br>play continuously | Cine control:step, play backward,<br>play continuously | Same | |
| Doppler Auto Trace | Doppler Auto Trace | Same | |
| Freeze control:Toggling freeze<br>key | Freeze control: Toggling freeze<br>key | Same | |
| Safety<br>Compliance | ANSI AAMI ES60601-1<br>IEC 60601-1-2<br>ISO 10993-1<br>ISO 10993-5<br>ISO 10993-10<br>ISO 10993-23<br>IEC 60601-2-37 | ANSI AAMI ES60601-1<br>IEC 60601-1-2<br>ISO 10993-1<br>ISO 10993-5<br>ISO 10993-10<br>ISO 10993-23<br>IEC 60601-2-37 | Same |
| | Operation<br>Mode | B Mode | B Mode |
| FHI | | FHI | Same |
| B/M Mode | B/M Mode | Same | |
| M Mode | M Mode | Same | |
| Dual mode | Dual mode | Same | |
| Quad mode | Quad mode | Same | |
| CFM mode | CFM mode | Same | |
| CPA mode | CPA mode | Same | |
| DPD mode | DPD mode | Same | |
| PW mode | PW mode | Same | |
| CW mode | CW mode | Same | |
| B/BC mode | B/BC mode | Same | |
| 2D Steer | 2D Steer | Same | |
| Triplex | Triplex | Same | |
| Quadplex | Quadplex | Same | |
| Free Steer M | Free Steer M | Same | |
| HPRF Mode | HPRF Mode | Same | |
| TDI | TDI | Same | |
| Color M Mode | Color M Mode | Same | |
| TSS | TSS | Same | |
| Curved Panoramic | Curved Panoramic | Same | |
| Sono Contrast | Sono Contrast | Same | |
| SoundFlow | SoundFlow | Same | |
| SonoVector | SonoVector | Same | |
| Auto TGC | Auto TGC | Same | |
| LGC | LGC | Same | |
| HD 3D | HD 3D | Same | |
| Stress Echo | Stress Echo | Same | |
| Strain and Strain Rate | Strain and Strain Rate | Same | |
| Trapezoidal Imaging | Trapezoidal Imaging | Same | |
| Compound | Compound | Same | |
| SRA | SRA | Same | |
| ECG | ECG | Same | |
| Human Bodymark | Human Bodymark | Same | |
| Auto IMT | Auto IMT | Same | |
| Free NT | Free NT | Same | |
| Biopsy | Biopsy | Same | |
| Super Needle | Super Needle | Same | |
| general measurement package | general measurement package | Same | |
| OB measurement package | OB measurement package | Same | |
| GYN measurement package | GYN measurement package | Same | |
| URO measurement package | URO measurement package | Same | |
| cardiac measurement package | cardiac measurement package | Same | |
| vascular measurement package | vascular measurement package | Same | |
| | | | |
| | small parts measurement<br>package | small parts measurement<br>package | Same |
| | Pediatric measurement package | Pediatric measurement package | Same |
| | TCD measurement package | TCD measurement package | Same |
| | 4D software package | 4D software package | Same |
| | Virtual HD | Virtual HD | Same |
| | SonoFusion | SonoFusion | Same |
| | Helpfunction | SonoHelp | Same |
| | Q-image | Q-image | Same |
| | Q-flow | Q-flow | Same |
| | Q-beam | Q-beam | Same |
| | SonoColor | SonoColor | Same |
| | Elastography | Elastography…