Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The document does not mention AI, ML, or related terms, and the described "semi-automated functions" do not inherently indicate AI/ML.

Therapeutic

No
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for diagnostic ultrasound imaging." There is no mention of therapeutic use.

Diagnostic

Yes
The "Intended Use / Indications for Use" states that the system is "intended for diagnostic ultrasound imaging." Additionally, the "Device Description" mentions that the system is "intended for clinical diagnostic imaging applications" and is a "color diagnostic ultrasound system."

SaMD (Software as a Medical Device)

No

The device description explicitly states it consists of a mobile console with keyboard control panel, power supply module, color LED monitor, and optional probes, indicating it includes significant hardware components beyond just software.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health.
Device Function: The XBit Series Digital Color Doppler Ultrasound System is an imaging device that uses ultrasound waves to create images of structures within the body. It does not analyze specimens taken from the body.
Intended Use: The intended use clearly states it's for "diagnostic ultrasound imaging" of various anatomical sites. This is a form of in vivo (within the living body) diagnostic imaging.

Therefore, based on the provided information, the XBit Series Digital Color Doppler Ultrasound System is a diagnostic imaging device, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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), Musculo-skeletal (Conventional , Superficial) , Peripheral Vascular, Transesophageal, Trans-rectal, Trans-vaginal, OB/GYN and Urology.

Product codes (comma separated list FDA assigned to the subject device)

IYN, IYO, ITX

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.

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.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

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, Urology

Indicated Patient Age Range

Adult, Pediatric, Neonatal, Fetal

Intended User / Care Setting

Qualified clinician / Hospitals, clinics

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

No clinical testing was required.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K180974

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K171233, K141846

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
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.(b)
Classification. Class II.

Summary

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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

1

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 (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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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)	X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
-------------------------------------------------	--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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510(k) Summary

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
Industrial Park, Xinwu District, Wuxi, Jiangsu, China 214142
Contact:	Mr. Liu Qifei
Tel:	+86-510-85310019
Fax:	+86-510-85310021
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
device | Reference
device | Reference
device | Submission
Device | |
|------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 | Remark |
| Indications for
Use | Fetal
Abdominal
Pediatric
Small Organ
(breast,
thyroid ,testes)
Neonatal
Cephalic ,Adult
Cephalic
Trans-rectal
Trans-vaginal
Musculo-skeletal
( Conventional,
Superficial)
Cardiac(adult ,p
ediatric)
Peripheral
Vascular
OB/GYN,Urology
Trans-esophage
al | Fetal
Abdominal
Intra-operative(a
bdominal,
thoracic, and
vascular)
Pediatric
Small
organ(breast,
thyroid ,testes)
Neonatal
Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Musculo-skeleta
I(conventional,
superficial),
Cardiac adult
Cardiac
pediatric
Trans-esoph.
(cardiac),
Peripheral
vessel
urology | Cardiac (Adult,
Pediatric)
Transesphageal
(Cardiac)
Intracardiac
Cerebrovascular
Peripheral
Vessel
Abdominal
Renal
Fetal
Abdominal
Intra-operative
Pediatric
Small Organ
Neonatal
Cepahalic
Adult Cephalic
Orthopedics
Musculo-skeleta

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7

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9

10

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Comparison Analysis

SE Analysis 1:

Operation Controls, compared with the predicate device--Acuson x700 Diagnostic Ultrasound System, the subject device employs the same operation controls design and has some differences in analyzed object.

The synqo® Auto Follicle measurement option of predicate device is an automated measurement tecnique that enables fast and acurate assessment of multiple follicles. Follicles measurement methods supported Distance, 2Dist + Avg, -- 3Dist + Avg, -- 2Dist Avg,-- 3Dist Avg,-- Area,-- Volume,-- Circumference.

Auto Follicle Detection of subject device can automatically identify, trace, and calculate the area and circumference of the follicle after the user moves the square ROI to the follicle area. It is operated in a semi-automated fashion since the output value of area and circumference can be modified.

But both of them can get area and circumference of follicle. so the SE is not affected.

SE Analysis 2:

Operation Controls, compared with the predicate device, the subject device employs the same operation controls design and has some differences in navigation device and navigation bracket. But both of them can make real-time ultrasound image match with CT/MR image. Both of them can improve the diagnostic efficiency. so the SE is not affected.

SE Analysis 3:

Operation Controls, compared with the predicate device, the subject device employs the same operation controls design and has some differences in angle acquisition. subject device recognizes the vessel angle automatically. The predicate reference device recognizes the vessel angle by user control. But both of them can get point velocity and meet clinical requirements. so the SE is not affected.

SE Analysis 4:

Operation Controls, the sonobeam function is a type of image optimization technology. SonoBeam is an improved version of Q-beam as a multi-beam blood flow high frame rate function which is based on traditional dual beamformer principle. Compared with Q-beam, SonoBeam multi-beamformer can improve the processing speed, and then increase the frame rate of image display and reduce noise. But both of them can improve image quality. so the SE is not affected.

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9. Substantially Equivalent Conclusion:

In accordance with the Act. 21 CFR Part 807 and based on the information provided in this premarket notification, CHISON Medical Technologies Co., Ltd. concludes that the XBit Series Digital Color Doppler Ultrasound System is substantially equivalent to the predicate devices with regard to safety and effectiveness.