XBit Series Digital Color Doppler Ultrasound System

K200780 · CHISON Medical Technologies Co., Ltd. · IYN · Aug 5, 2020 · Radiology

Device Facts

• Record ID: K200780
• Device Name: XBit Series Digital Color Doppler Ultrasound System
• Applicant: CHISON Medical Technologies Co., Ltd.
• Product Code: IYN · Radiology
• Decision Date: Aug 5, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The XBit 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 a qualified clinician for evaluation of Fetal ,Abdominal,Pediatric,Small Organ (breast, thyroid,testes ), Neonatal Cephalic , Adult Cephalic, Cardiac (adult , pediatric), Musculo-skeletal (Conventional , Superficial) , Peripheral Vascular, Transesophageal, Trans-rectal, Trans-vaginal, OB/GYN and Urology.

Device Story

Mobile, software-controlled digital color Doppler ultrasound system; acquires ultrasound echo data via linear, convex, phased array, or volume probes. Transforms inputs using autocorrelation (color) and FFT (PW/CW Doppler) processing; displays images in B, M, CFM, Power Doppler, TDI, and 3D/4D modes. Used in hospitals/clinics by qualified clinicians. Features semi-automated functions (Auto Follicle, SonoBeam, SonoColor, SonoFusion) requiring user modification. Healthcare providers use real-time images and automated measurements to evaluate anatomy and fluid flow; aids clinical decision-making by providing diagnostic visualization of structures and blood flow; benefits patients through non-invasive diagnostic imaging.

Clinical Evidence

No clinical testing was required. Substantial equivalence is supported by 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

Mobile console with LED monitor, keyboard, and multiple probe ports. Supports linear, convex, phased, and volume arrays. Imaging modes: B, M, PW/CW Doppler, CFM, Power Doppler, TDI, 3D/4D. Connectivity: DICOM/standard image archiving. Software-controlled signal processing using autocorrelation and FFT. Safety standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-1.

Indications for Use

Indicated for diagnostic ultrasound imaging in fetal, abdominal, pediatric, small organ (breast, thyroid, testes), neonatal/adult cephalic, cardiac (adult/pediatric), musculoskeletal (conventional/superficial), peripheral vascular, transesophageal, trans-rectal, trans-vaginal, OB/GYN, and urology applications.

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

• CBit 9 Digital Color Doppler Ultrasound System (K180974)

Reference Devices

• Resona 7 Diagnostic Ultrasound System (K171233)
• Acuson x700 Diagnostic Ultrasound System (K141846)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains 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. % Liu Qifei Regulatory Affairs Manager No. 228, Changjiang East Road, Block 51 and 53 Phase 5, Shuofang Industrial Park Xinwu District, Wuxi, Jiangsu 214142 CHINA

August 5, 2020

### Re: K200780

Trade/Device Name: XBit 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: June 6, 2020 Received: June 6, 2020

#### Dear Liu Qifei:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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 (QS) 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 (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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known) K200780

Device Name

XBit Series Digital Color Doppler Ultrasound System

#### Indications for Use (Describe)

The XBit 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 a qualified clinician for evaluation of Fetal ,Abdominal,Pediatric,Small Organ (breast, thyroid,testes ), Neonatal Cephalic , Adult Cephalic, Cardiac (adult , pediatric), Musculo-skeletal (Conventional , Superficial) , Peripheral Vascular, Transesophageal, Trans-rectal, Trans-vaginal, OB/GYN and Urology.

| Type of Use (Select one or both, as applicable) | <span> <span style="padding-right: 10px;"> <span style="border: 1px solid black; padding: 2px;"><b>X</b></span> Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> <span style="border: 1px solid black; padding: 2px;"></span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </span> |
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# 510(k) Summary

# K200780

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: | March 12th, 2020 |

#### 2. Device :

Trade Name: XBit Series Digital Color Doppler 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 | CBit 9 Digital Color Doppler Ultrasound System | IYN, IYO, ITX | K180974 |
| 2.Reference device | Resona 7 Diagnostic Ultrasound System | IYN, IYO, ITX | K171233 |
| 3.Reference device | Acuson x700 Diagnostic Ultrasound System | IYN, IYO, ITX, OBJ | K141846 |

### 4. Device Description:

The XBit Series Digital Color 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 LED monitor and optional probes.

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This system is a mobile, general purpose, software controlled, color diagnostic ultrasound system. Its basic function is to acquire ultrasound echo data and to display the image B-Mode (including Fusion Harmonic Imaging), M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Power Doppler Mode, Directional Power Doppler Mode, TDI Mode or a combination of these modes, Elastography, contrast imaging, 3D/4D.

Auto Follicle, SonoBeam, SonoColor, and SonoFusion, these four features are all semi-automated functions, they need to be modified during processing.

### 5. Indications for Use:

The XBit 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 a qualified clinician for evaluation of Fetal,Abdominal,Pediatric,Small Organ (breast, thyroid,testes ), Neonatal Cephalic ,Adult Cephalic,Cardiac (adult , pediatric),Musculoskeletal (Conventional, Superficial), Peripheral Vascular,Transesophageal,Trans-rectal, Trans-vaginal, OB/GYN and Urology.

### 6. Summary of Non-Clinical Tests:

The XBit 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.

IEC 60601-1: 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 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)

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- 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)
## 7. 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.

#### 8. Comparison to Predicate Device:

#### Table 1 Substantial Equivalence Comparison

| | Main predicate<br>device | Reference<br>device | Reference<br>device | Submission<br>Device | |
|------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Items | CBit 9 Digital<br>Color Doppler<br>Ultrasound<br>System<br>K180974 | Resona 7<br>Diagnostic<br>Ultrasound<br>System<br>K171233 | Acuson x700<br>Diagnostic<br>Ultrasound<br>System<br>K141846 | XBit Series<br>Digital Color<br>Doppler<br>Ultrasound<br>System | Remark |
| Indications for<br>Use | Fetal<br>Abdominal<br>Pediatric<br>Small Organ<br>(breast,<br>thyroid ,testes)<br>Neonatal<br>Cephalic ,Adult<br>Cephalic<br>Trans-rectal<br>Trans-vaginal<br>Musculo-skeletal<br>( Conventional,<br>Superficial)<br>Cardiac(adult ,p<br>ediatric)<br>Peripheral<br>Vascular<br>OB/GYN,Urology<br>Trans-esophage<br>al | Fetal<br>Abdominal<br>Intra-operative(a<br>bdominal,<br>thoracic, and<br>vascular)<br>Pediatric<br>Small<br>organ(breast,<br>thyroid ,testes)<br>Neonatal<br>Cephalic<br>Adult Cephalic<br>Trans-rectal<br>Trans-vaginal<br>Musculo-skeleta<br>I(conventional,<br>superficial),<br>Cardiac adult<br>Cardiac<br>pediatric<br>Trans-esoph.<br>(cardiac),<br>Peripheral<br>vessel<br>urology | Cardiac (Adult,<br>Pediatric)<br>Transesphageal<br>(Cardiac)<br>Intracardiac<br>Cerebrovascular<br>Peripheral<br>Vessel<br>Abdominal<br>Renal<br>Fetal<br>Abdominal<br>Intra-operative<br>Pediatric<br>Small Organ<br>Neonatal<br>Cepahalic<br>Adult Cephalic<br>Orthopedics<br>Musculo-skeleta<br> <br>Conventional<br>Musculo-skeleta<br>I Superficial<br>Pelvic<br>Obstetrical<br>Gynecological<br>Urological | Fetal<br>Abdominal<br>Pediatric<br>Small Organ<br>(breast,<br>thyroid ,testes)<br>Neonatal<br>Cephalic ,Adult<br>Cephalic<br>Trans-rectal<br>Trans-vaginal<br>Musculo-skeleta<br>I( Conventional,<br>Superficial)<br>Cardiac(adult ,p<br>ediatric)<br>Peripheral<br>Vascular<br>OB/GYN,Urology<br>Trans-esophage<br>al | Same |
| Items | Main predicate device | Reference device | Reference device | Submission Device | Remark |
| | CBit 9 Digital Color Doppler Ultrasound System K180974 | Resona 7 Diagnostic Ultrasound System K171233 | Acuson x700 Diagnostic Ultrasound System K141846 | XBit Series Digital Color Doppler Ultrasound System | |
| Design | Autocorrelation for color processing and FFT for pulse and CW Doppler processing. Supporting Linear, Curve, Phase array and Volume probes . Cine play back capability Image file archive | Transmit ultrasonic energy into patients, then perform post processing of received echoes to generate onscreen display of anatomic structures and fluid flow within the body. | The ACUSON X700 ultrasound system features a sophisticated imaging engine migrated from our premium imaging products as well as technology to bolster compatibility across systems. | Autocorrelation for color processing and FFT for pulse and CW Doppler processing. Supporting Linear, Curve, Phase array and Volume probes . Cine play back capability Image file archive | Same |
| | TGC 8 slider | TGC 8 slider | TGO: 8 controls | TGC 8 slider | Same |
| | Depth Range: 0 to 45 cm | Depth Range: 1.5 to 40 cm | Depth Range: 1 to 30 cm | Depth Range: 0 to 45 cm | Same |
| | 256 shades of gray | NA | NA | 256 shades of gray | Same |
| | B Dynamic range control: 20-280dB | B Dynamic range control: 30-260dB | B Dynamic range selection: 30-90dB | B Dynamic range control: 20-280dB | Same |
| | Gain:0-255,1/step | Gain:0-100,1/step | Gain:-30-+30,1/step | Gain:0-255,1/step | Same |
| | Focal Number: adjustable | No physical focus to adjust | Focal Number: adjustable | Focal Number: adjustable | Same |
| | Focus position: adjustable | No physical focus to adjust | Focus position: adjustable | Focus position: adjustable | Same |
| Operating Controls | B steer: available on linear transducers | B steer: available on linear transducers | B steer: available on linear transducers | B steer: available on linear transducers | Same |
| | B Persistence: 7 steps | B Persistence: 7 steps | B Persistence:5 levels | B Persistence: 7 steps | Same |
| | ROI size/position: adjustable | ROI size/position: adjustable | ROI size/position: adjustable | ROI size/position: adjustable | Same |
| | Color Wall Filter settings:8 steps | Color Wall Filter settings:8 steps | Wall filter : 4 selections | Color Wall Filter settings:8 steps | Same |
| | Color Baseline: 16 steps Color Maps: 21 maps Color Invert: | Color Baseline: 16 steps Color Maps: 21 maps Color Invert: | Color Baseline: 9 steps Color maps: 16 maps Color | Color Baseline: 16 steps Color Maps: 21 maps Color Invert: | Same |
| | Main predicate device | Reference device | Reference device | Submission Device | Remark |
| Items | CBit 9 Digital Color Doppler Ultrasound System K180974 | Resona 7 Diagnostic Ultrasound System K171233 | Acuson x700 Diagnostic Ultrasound System K141846 | XBit Series Digital Color Doppler Ultrasound System | |
| | on/off | on/off | invert :on/off | on/off | |
| | PW sweeping speed: 6 steps | PW sweeping speed: 6 steps | Sweep speed: 8 selections | PW sweeping speed: 6 steps | Same |
| | PW Wall Filter: 7 steps | PW Wall Filter: 8 or 9 steps | Wall filter: 25 – 3906 Hz, 8 steps | PW Wall Filter: 7 steps | Same |
| | PW sample volume:<br>0.5-30mm (PW only) | PW sample volume:<br>0.5-30mm (PW only) | Gate size: 0.2 - 20 mm | PW sample volume:<br>0.5-30mm (PW only) | Same |
| | PW angle correction:-89~8 9degrees, 1/step | PW angle correction:-89~8 9degrees, 1/step | Angle correction: 0 – 89° in 1° increments | PW angle correction:-89~8 9degrees, 1/step | Same |
| | Baseline: 8steps | Baseline: 9steps | Baseline shift: 17 levels | Baseline: 8steps | Same |
| | Cine control: step, play backward, play continuously | Cine control: step, play backward, play continuously | Cine control: step, play backward, play continuously | Cine control: step, play backward, play continuously | Same |
| | Doppler Auto Trace | Doppler Auto Trace | Autotrace Function | Doppler Auto Trace | Same |
| | Freeze control:Toggling freeze key | Freeze control:Toggling freeze key | Freeze control:Toggling freeze key | Freeze control:Toggling freeze key | Same |
| Safety Compliance | IEC60601-1<br>IEC60601-1-2<br>ISO 10993-1<br>ISO 10993-5<br>ISO 10993-10<br>IEC 60601-2-37 | IEC60601-1<br>IEC60601-1-2<br>ISO 10993-1<br>ISO 9001<br>ISO 13485<br>IEC 60601-2-37 | EN/IEC 60601-1<br>EN/IEC 60601-1-1<br>EN/IEC 60601-1-2<br>EN/IEC 62304<br>EN/IEC 62366<br>EN/IEC 60601-2-18<br>EN/IEC 60601-2-25 | IEC60601-1<br>IEC60601-1-2<br>ISO 10993-1<br>ISO 10993-5<br>ISO 10993-10<br>IEC 60601-2-37 | Same |
| Operation Mode | B mode | B mode | B mode | B mode | Same |
| | B/M mode | B/M mode | B/M mode | B/M mode | Same |
| | M mode | M mode | M mode | M mode | Same |
| | Dual mode | Dual mode | Dual mode | Dual mode | Same…