The HD60 Series Ultrasound Diagnostic System is a general-purpose ultrasound system. It is intended for use by, or under the direction of a qualified and trained physician for ultrasound imaging, measurement, display and analysis of the human body and fluid. The device is intended for use in a hospital environment.

The systems support the following clinical applications:

The HD60 series Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ, neonatal and adult cephalic, trans-rectal, musculo-skeletal (conventional, superficial), cardiac (adult, peripheral vessel, and urology exams.

Modes of operation include: 3D/4D Imaging mode, B, M, PW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Combined modes: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/ Power/PWD.

Device Description

The HD60 Series consists of a mobile console with a height-adjustable control panel, color LCD touch panel, LCD display monitor and optional image storage and printing device. It includes a variety of electronic array transducers operating in linear, curved, sector/phase array, and real time 3D transducer. HD60 series is a Track 3 diagnostic ultrasound system. The system includes electronics for transmit and receive of ultrasound data, ultrasound signal processing, software computing, hardware for image storage, hard copy printing, and network access to the facility through LAN.

AI/ML Overview

The provided text is a 510(k) Premarket Notification Submission for the Hisense HD60 Series Ultrasound Diagnostic System. It does not describe a study that proves the device meets specific acceptance criteria for AI/ML performance. Instead, it details the substantial equivalence of the HD60 Series to a predicate device (Mindray DC-80 Ultrasound Diagnostic System, K192152) based on general ultrasound system performance and safety standards.

Therefore, I cannot create a table of acceptance criteria and reported device performance related to AI/ML, nor can I describe study details like sample size, ground truth establishment, expert adjudication, or MRMC studies for AI/ML performance, as this information is not present in the provided document.

The document focuses on:

Intended Use and Indications for Use: General purpose ultrasound imaging, measurement, display, and analysis for various clinical applications (fetal, abdominal, pediatric, etc.).
Comparison to Predicate Device: Highlighting similarities in fundamental scientific technology, patient contact materials, modes of operation, and basic measurements.
Differences: Noting the HD60 Series omitting intra-operative and trans-esophageal applications, and introducing a "Teaching System" feature.
Non-clinical Tests: Compliance with various safety, biocompatibility, and electromagnetic standards relevant to general medical electrical equipment and ultrasound devices (e.g., AAMI/ANSI ES60601-1, IEC 60601-2-37, ISO 10993).
Clinical Tests: Stating that no clinical studies were required to support substantial equivalence.

In summary, the provided text does not contain the information required to answer your specific questions about AI/ML acceptance criteria and performance studies, as the device described is a general ultrasound diagnostic system and not explicitly an AI/ML-driven device with such specific performance metrics detailed.

Summary

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June 8, 2022

Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left, featuring a stylized human figure. To the right of the HHS logo is the FDA logo, with the letters "FDA" in a blue square and the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Qingdao Hisense Medical Equipment Co., Ltd % Yalan Wu Regulatory Affair Manager No. 399 Songling Road, Laoshan District Qingdao, Shandong 266100 P. R. CHINA

Re: K213862

Trade/Device Name: HD60 Series Ultrasound Diagnostic System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: April 29, 2022 Received: May 10, 2022

Dear Yalan Wu:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For

Michael D. O'Hara, Ph.D. Deputy Director DHT 8C: Division of Radiological Imaging and Radiation Therapy Devices OHT 8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K213862

Device Name

HD60 Series Ultrasound diagnostic System

Indications for Use (Describe)

The systems support the following clinical applications:

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Premarket Notification Submission

510(k) Summary

(K213862)

In accordance with 21 CFR 807.92 the following summary of information is provided:

Date Prepared:	Nov 26, 2021
Manufacturer:	Qingdao Hisense Medical Equipment Co., LtdNo. 399 Songling Road, Laoshan District266100, Qingdao, Shandong, P. R. China
Contact Person:	Yalan WuRegulatory Affair ManangerQingdao Hisense Medical Equipment Co., LtdTel: +86-532-55752797

wuyalan@Hisense.com

ldentification of the Device:

Proprietary/Trade Name:	HD60 Series Ultrasound Diagnostic System
Classification Name:	Ultrasound Diagnostic System
Regulatory Number:	21 CFR 892.1550, 21 CFR 892.1560, 21 CFR 892.1570
Product Code:	IYN,IYO,ITX
Device Class:	Class II
Review Panel:	Radiology

Identification of the Legally Marketed Predicate Device:

Trade Name:	DC-80/DC-80PRO/DC-80EXP/DC-80S/DC-85/DC-86/DC-86S/DC-89/DC-TV/DC-TQ
Classification Name:	Ultrasound Diagnostic System
Regulatory Number:	21 CFR 892.1550, 1560, 1570
Product Code:	IYN, ITX, IYO, LLZ
Device Class:	Class II
Review Panel:	Radiology
Submitter/510(k) Holder:	Shenzhen Mindray Bio-medical ElectronicsCo., LTD.
Clearance:	K192152 (cleared December 13, 2019)

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Reference Device:
Trade Name:	DC-70/DC-70T/DC-70 Pro/DC-70 Exp
Classification Name:	Ultrasound Diagnostic System
Regulatory Number:	21 CFR 892.1550, 1560, 1570
Product Code:	IYN, ITX, IYO, LLZ
Device Class:	Class II
Review Panel:	Radiology
Submitter/510(k) Holder:	Shenzhen Mindray Bio-medical ElectronicsCo., LTD.
Clearance:	K150204 (cleared April 10, 2015)

Device Description:

Indications for Use:

The systems support the following clinical applications:

The HD60 series Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ, neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), cardiac (adult, pediatric), peripheral vessel, and urology exams.

Modes of operation include: 3D/4D Imaging mode, B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Harmonic Imaging, Combined modes: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

Comparison with Predicate Device:

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510(k) Premarket Notification Submission

The HD60 series Ultrasound Diagnostic System and its predicate device, the DC-80/DC-80PRO/DC-80EXP/DC-80S/DC-85/DC-86/DC-86S/DC-89/DC-TV/ DC-TQ Ultrasound Diagnostic System (K192152), have the same intended use, and similar physical characteristics.

Description	Subject DeviceHisense HD60 UltrasoundDiagnostic System	Predicate DeviceMindray DC80 UltrasoundDiagnostic System(K192152)
Indications foruse	It is intended for use inabdominal, fetal, pediatric,Small Organ, neonatal andadult cephalic, trans-rectal,trans-vaginal,musculo-skeletal(conventional, superficial), cardiac(adult,pediatric), peripheral vessel,and urology exams.	It is intended for use inabdominal, fetal,intra-operative(abdominal,thoracic, and vascular),pediatric, SmallOrgan(breast, thyroid,testes), neonatal and adultcephalic, trans-rectal,trans-vaginal,musculo-skeletal(conventional, superficial), cardiac(adult,pediatric),trans-esoph.(Cardiac),peripheral vessel, andurology exams.
User	Qualified and trainedphysician	Qualified and trainedphysician
Environment	Hospital environment	Hospital environment
Design	Autocorrelation for colorprocessing and FFT for pulseDoppler processing.Supporting Linear, Curve,Phase array and Volumeprobes.	Autocorrelation for colorprocessing and FFT for pulseDoppler processing.Supporting Linear, Curve,Phase array and Volumeprobes.
PatientContactMaterials	Material meet ISO 10993-1and FDA guidance	Material meet ISO 10993-1and FDA guidance
Modeofoperation	3D/4D Imaging mode, B, M,PW Doppler, CW Doppler,Color Doppler, Color MDoppler, Power Doppler,Harmonic Imaging, Combined	3D/4D Imaging mode, B, M,PW Doppler, CW Doppler,Color Doppler, Color MDoppler, Power Doppler,Harmonic Imaging, Combined
Description	Subject DeviceHisense HD60 UltrasoundDiagnostic System	Predicate DeviceMindray DC80 UltrasoundDiagnostic System(K192152)
	modes: B/M, B/Color M,B/PWD or CWD,B/Color/PWD or CWD,B/Power/PWD.	modes: B/M, B/Color M,B/PWD or CWD,B/Color/PWD or CWD,B/Power/PWD.
Functions	> Spatial compoundimaging	> iBeam
	> Frequency compoundimaging	> Frequency compoundimaging
	> One-Click Optimization> Speckle reductionimaging (SRI)	> iTouch (Auto ImageOptimization)
		> iClear imageenhancement
	> PDI (power Dopplerimaging), DPDI(directional powerDoppler imaging), andTDI (tissue Dopplerimaging)	> PDI (power Dopplerimaging), DPDI(directional powerDoppler imaging), andTDI (tissue Dopplerimaging)
	> Angle deflection of lineararray probes	> Deflection scanning bylinear array probes
	> High-pulse repetitionfrequency	> HPRF
	> Puncture guidance andpuncture enhancement,with real-timedouble-screencomparison	> Puncture guidance
	> Tissue-specific imaging> Extended imaging> TVI (Tissue Dopplerimaging, TDI)> Curve Anatomical MMode> Strain rate imaging	> Tissue-specific imaging> ExFOV (Extended FOV)> Tissue Doppler imaging,TDI (TVI)> Free Xros CM> Strain rate analysis
	> Elastography (Elasticityimaging)	> Elastography (Elasticityimaging)
Description	Subject Device	Predicate Device
	Hisense HD60 Ultrasound	Mindray DC80 Ultrasound
	Diagnostic System	Diagnostic System
		(K192152)
	> High-resolution blood flow	> High-resolution blood flow
	> Image comparison(dynamic and staticimages)	> Image comparison(dynamic and staticimages)
	> DICOM	> DICOM
	> Teaching System
	> ECG	> ECG
Measurements	Basic measurement:Distance, Area,CircumferenceVolume, Velocity, Time	Basic measurement:Distance, Area,CircumferenceVolume, Velocity, Time
	Measurement kits:	Measurement kits:
	Routine measurement	Routine measurement
	Abdominal measurement kit	Abdominal measurement kit
	Gynecological measurementkit	Gynecological measurementkit
	Obstetric measurement kit	Obstetric measurement kit
	Urological measurement kit	Urological measurement kit
	Small part measurement kit	Small part measurement kit
	Vascular measurement kit	Vascular measurement kit
	Cardiac measurement kit	Cardiac measurement kit
	Pediatric measurement kit	Pediatric measurement kit
	Emergency measurement kit	Emergency measurement kit
	Automatic measurement ofintima-media thickness (IMT)	Automatic measurement ofintima-media thickness (IMT)
	Automatic spectrum envelopemeasurement	Automatic spectrum envelopemeasurement
TransducerTypes	Convex arrayPhased arrayLinear arrayMicro convex arrayVolume	Convex arrayPhased arrayLinear arrayMicro convex arrayVolume
AcousticOutput withinFDAguidelines	Track 3;Ispta.3 ≤ 720mW/cm2MI ≤ 1.9	Track 3;Ispta.3 ≤ 720mW/cm2MI ≤ 1.9
Description	Subject Device	Predicate Device
	Hisense HD60 UltrasoundDiagnostic System	Mindray DC80 UltrasoundDiagnostic System(K192152)
	$TI \le 6.0$	$TI \le 6.0$
general safetyandeffectivenessinformation	ANSI/AAMI ES60601-1IEC60601-2-37IEC60601-1-2ISO 10993-1	ANSI/AAMI ES60601-1IEC60601-2-37IEC60601-1-2ISO 10993-1
Labeling	Conforms to 21 CFR Part 801	Conforms to 21 CFR Part 801
Accessories	foot switchECG cable and LeadwireB/W Printer	Foot switchECGB/W Printer

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510(k) Premarket Notification Submission

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510(k) Premarket Notification Submission

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510(k) Premarket Notification Submission

Technology:

The HD60 Series employs the same fundamental scientific technology as its predicated device.

Determination of substantial equivalence:

The Proposed HD60 Series system are substantially equivalent to the predicate the DC-80/DC-80PRO/DC-80EXP/DC-80S/DC-85/DC-86/DC-86S/ DC-89/DC-TV/DC-TQ Ultrasound Diagnostic System (K192152) with regards to intended use, indication for use, image capabilities, technological characteristics, image mode, and safety effectiveness.

The following is an overview of the differences between the proposed HD60 Series and its predicate device.

Comparison Analysis

Note 1:

Indication for use:

The Indication for use of subject device does not support intra-operative (abdominal, thoracic, and vascular) and trans-esoph.(Cardiac). As the subject device does not support intra-operative and trans-esoph probe. It is less than Predicate device. They can be considered Substantially Equivalent in safety and effectiveness, and no new risk is raised, so the SE is not affected.

Note 2:

Patient Contact Materials:

The Patient Contact Materials of the probes is equivalent to the predicated device, both the subject and predicated device probe material meet ISO 10993-1 and FDA guidance requirement. They can be considered

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Substantially Equivalent in safety and effectiveness, and no new risk is raised, so the SE is not affected.

Note 3:

Functions:

Teaching System is new functions compare with predicate device. Other functions are same, just name description is minor different for some functions. The teaching feature is same as "iScanhelper" of Diagnostic Ultrasound System model DC-70/DC-70T/DC-70 Pro/DC-70 Exp manufactured by Mindray (K150204 cleared on April 10, 2015). By providing the referential information, such as, displays the standard ultrasonic image, anatomical sketch, scanning approach image and scanning tips, the system helps the doctors to operate the scanning by teaching system. Furthermore, it is a good platform for the self-learning and training of ultrasound scanning technique for doctors. The system also plays a role in the assistant software system in fulfilling training and education. It is verified and meet the requirement. It can be considered Substantially Equivalent in safety and effectiveness, and no new risk is raised, so the SE is not affected.

The teaching system is intended for off line training and not live guidance during real time imaging. The teaching system is for teaching only and should not be used for diagnostic purposes.

Summary of Non-clinical test:

HD60 Series were evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic, and mechanical safety, and have been found to comply with applicable medical device safety standard, The HD60 Series complies with voluntary standards:

1. AAMI/ANSI ES60601-1: Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Essential Performance, 2005/A2:2012
1. IEC 60601-1-2 Medical Electrical Equipment Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic Disturbance - Requirements and tests, 2014
1. IEC 60601-2-37 Medical electrical equipment Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment, Ed2.1, 2015
1. ISO 10993-1 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process, 2018
1. ISO 10993-5 Biological Evaluation of Medical Devices Part 5: Tests for In Vitro Cytotoxicity
1. ISO 10993-10 Biological Evaluation of Medical Devices Part 10: Tests for Irritation and Skin Sensitization

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510(k) Premarket Notification Submission

1. IEC62359, Ultrasonics-Field characterization- Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields, 2017.
1. ISO 14971 Medical Devices Applications of Risk Management to Medical Devices. 2019
1. NEMA PS3.1-3.20. Digital Imaging and Communications in Medicine (DICOM) Set.(radiology), 2016.
10.IEC 60601-1-6 Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance -Collateral standard: Usability
1. IEC 62366 Consolidated Version Medical Devices Application of Usability Engineering to Medical Devices
1. IEC 62304 Medical Device Software Software Life Cycle Processes

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

Risk Management Requirement review and Design reviews Integration testing (system verification) Performance testing (Verification) Safety testing (Verification)

Transducer material and other patient contact materials are biocompatible.

Summary of Clinical Tests:

The subject of this premarket submission, did not require clinical studies to support substantial equivalence.

Conclusion:

Hisense Considers the HD60 Series Ultrasound Diagnostic System to be as safe, as effective, and performance is substantially equivalent to the predicate device.

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.

Indications for Use

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510(k) Summary

(K213862)

wuyalan@Hisense.com

ldentification of the Device:

Identification of the Legally Marketed Predicate Device:

Device Description:

Indications for Use:

Comparison with Predicate Device:

510(k) Premarket Notification Submission

Technology:

Determination of substantial equivalence:

Comparison Analysis

Note 1:

Note 2:

Note 3:

Summary of Non-clinical test:

Summary of Clinical Tests:

Conclusion:

§ 892.1550 Ultrasonic pulsed doppler imaging system.

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