The HD80 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 HD80 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, 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 HD80 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. HD80 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 or Wireless with WIFI adapter module.

AI/ML Overview

The provided text is a 510(k) summary for the Hisense HD80 Series Ultrasound Diagnostic System. It aims to demonstrate substantial equivalence to a predicate device, the Hisense HD60 Series Ultrasound Diagnostic System (K213862), rather than providing detailed acceptance criteria and proof of their meeting by a specific study in the context of an AI/human-in-the-loop diagnostic device.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, performance studies with sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for a diagnostic AI device.

The document primarily focuses on:

Device Description and Intended Use: General purpose ultrasound system for various clinical applications.
Comparison to Predicate Device: Highlighting similarities in intended use, physical characteristics, modes of operation, and basic functions.
Differences and Justification: Discussing minor differences (e.g., new functions like Ribbon flow imaging, 3D PW, SCV, and the addition of WIFI and battery) and explaining why these do not affect substantial equivalence or raise new safety/effectiveness concerns.
Non-clinical Testing: Listing various safety and performance standards the device complies with (e.g., electrical safety, EMC, biocompatibility, usability, software life cycle).
Absence of Clinical Studies: Explicitly stating that clinical studies were not required for this 510(k) submission.

**In summary, there is no information in the provided text to fulfill your request for: **

A table of acceptance criteria and reported device performance: This document does not present such a table because it's a 510(k) summary for an ultrasound system, not an AI diagnostic device with specific performance metrics like sensitivity or specificity.
Sample sizes used for the test set and data provenance: No test set data or provenance is mentioned.
Number of experts used to establish ground truth and their qualifications: Not applicable as no diagnostic AI performance study is described.
Adjudication method for the test set: Not applicable.
MRMC comparative effectiveness study and effect size: Not applicable.
Standalone performance study: Not applicable.
Type of ground truth used: Not applicable.
Sample size for the training set: Not applicable.
How ground truth for the training set was established: Not applicable.

The document states: "The subject of this premarket submission, did not require clinical studies to support substantial equivalence." This means the submission relies on demonstrating that the HD80 Series is similar enough to a previously cleared device (HD60 Series) that no new safety or effectiveness questions are raised, and therefore, specific performance studies (like those for an AI diagnostic algorithm) were not necessary for its clearance.

Summary

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May 16, 2024

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services seal on the left and the FDA acronym and name on the right. The seal is a stylized depiction of an eagle and a caduceus, while the FDA acronym and name are written in blue, with the word "Administration" appearing below the acronym and name.

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

Re: K233841

Trade/Device Name: HD80 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 16, 2024 Received: April 16, 2024

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 (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).

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Marjan Nabili -S for

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

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

Submission Number (if known)

K233841

Device Name

HD80 Series Ultrasound Diagnostic System

Indications for Use (Describe)

The systems support the following clinical applications:

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

< | 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

K233841

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

Date Prepared:	Nov 30, 2023
Manufacturer:	Qingdao Hisense Medical Equipment Co., LtdNo. 399 Songling Road, Laoshan District266100, Qingdao, Shandong, P. R. China
Contact Person:	Yalan WuRegulatory Affair ManagerQingdao Hisense Medical Equipment Co., LtdTel: +86-532-55752797wuyalan@Hisense.com

ldentification of the Device:

Proprietary/Trade Name:	HD80 Series Ultrasound Diagnostic System
Classification Name:	Ultrasound Diagnostic System
Regulation Name:	Ultrasonic Pulsed Doppler Imaging 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

Primary Predicate Device:

Proprietary/Trade Name:	HD60 Series Ultrasound Diagnostic System
Classification Name:	Ultrasound Diagnostic System
Regulation Name:	Ultrasonic Pulsed Doppler Imaging System
Regulatory Number:	21 CFR 892.1550, 21 CFR 892.1560, 21 CFR892.1570
Product Code:	IYN, IYO, ITX
Device Class:	Class II
Review Panel:	Radiology
Submitter/510(k) Holder:	Qingdao Hisense Medical Equipment Co., Ltd

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510(k) Premarket Notification Submission

Clearance:	K213862 (cleared June 8, 2022)
Reference Device:Trade Name:	Resona R9, Resona R9 Exp, Resona R9 Pro,Resona R9S, Nuewa R9, Nuewa R9, Exp,Nuewa R9 Pro, Nuewa R9S, Resona 7,Resona 7CV, Resona 7EXP, Resona 7S,Resona 7OB, Resona 7PRO, Imagyn 7,Resona Y, Resona R9W, Resona R7W,Nuewa R9W, Nuewa R7W
Classification Name:	Ultrasound Diagnostic System
Regulation Name:	Ultrasonic Pulsed Doppler Imaging System
Regulatory Number:	21 CFR 892.1550, 1560, 1570
Product Code:	IYN, IYO, ITX
Device Class:	Class II
Review Panel:	Radiology
Submitter/510(k) Holder:	Shenzhen Mindray Bio-medical Electronics Co.,LTD.
Clearance:	K222928 (cleared Feb 7, 2023)

Device Description:

Indications for Use:

The systems support the following clinical applications:

The HD80 series Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal,

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510(k) Premarket Notification Submission

abdominal, pediatric, small organ, neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), cardiac (adult, pediatric), peripheral vessel, and urology exams.

Comparison with Predicate Device:

The HD80 series Ultrasound Diagnostic System and its predicate device, the HD60 series Ultrasound Diagnostic System (K213862), have the same intended use, and similar physical characteristics.

Description	Subject Device	Predicate Device
	Hisense HD80 UltrasoundDiagnostic System	Hisense HD60 UltrasoundDiagnostic System(K213862)
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, pediatric,Small Organ, neonatal andadult cephalic, trans-rectal,trans-vaginal, musculo-skeletal(conventional,superficial), cardiac(adult,pediatric), peripheral vessel,and urology exams.
User	Qualified and trainedphysician	Qualified and trainedphysician
Environment	Hospital environment	Hospital environment
Design	Autocorrelation for colorprocessing and FFT forpulse Doppler processing.Supporting Linear, Curve,Phase array and Volumeprobes.	Autocorrelation for colorprocessing and FFT forpulse Doppler processing.Supporting Linear, Curve,Phase array and Volumeprobes.
PatientContactMaterials	Material meet ISO 10993-1and FDA guidance	Material meet ISO 10993-1and FDA guidance
Mode ofoperation	3D/4D Imaging mode, B, M,PW Doppler, CW Doppler,Color Doppler Color M	3D/4D Imaging mode, B, M,PW Doppler, CW Doppler,Color Doppler Color M
Description	Subject DeviceHisense HD80 UltrasoundDiagnostic System	Predicate DeviceHisense HD60 UltrasoundDiagnostic System(K213862)
	Doppler, Power Doppler,Harmonic Imaging,Combined modes: B/M,B/Color M, B/PWD or CWD,B/Color/PWD or CWD,B/Power/PWD.	Doppler, Power Doppler,Harmonic Imaging,Combined modes: B/M,B/Color M, B/PWD or CWD,B/Color/PWD or CWD,B/Power/PWD.
Functions	Spatial compound imaging	Spatial compound imaging
	Frequency compound imaging	Frequency compound imaging
	One-Click Optimization	One-Click Optimization
	Speckle reduction imaging (SRI)	Speckle reduction imaging (SRI)
	PDI (power Doppler imaging), DPDI (directional power Doppler imaging), and TDI (tissue Doppler imaging)	PDI (power Doppler imaging), DPDI (directional power Doppler imaging), and TDI (tissue Doppler imaging)
	Angle deflection of linear array probes	Angle deflection of linear array probes
	High-pulse repetition frequency	High-pulse repetition frequency
	Puncture guidance and puncture enhancement, with real-time double-screen comparison	Puncture guidance and puncture enhancement, with real-time double-screen comparison
	Tissue-specific imaging	Tissue-specific imaging
	Extended imaging	Extended imaging
	TVI (Tissue Doppler imaging, TDI)	TVI (Tissue Doppler imaging, TDI)
	Curve Anatomical M Mode	Curve Anatomical M Mode
	Strain rate imaging	Strain rate imaging
	Elastography (C-Elasto)	Elastography (C-Elasto)
	High-resolution blood flow	High-resolution blood flow
Description	Subject DeviceHisense HD80 UltrasoundDiagnostic System	Predicate DeviceHisense HD60 UltrasoundDiagnostic System(K213862)
	> Image comparison(dynamic and staticimages)> DICOM> Teaching System> ECG> Contrast imaging> Automated workflow (Hi-Step)> Lithotripsy guide (Middleline)> Voice comment> Ribbon flow imaging (RFlow)> 3D spectral Dopplerimaging (3D PW )> Spectral color velocity(SCV) imaging	> Image comparison(dynamic and staticimages)> DICOM> Teaching System> ECG> Contrast imaging> Automated workflow (Hi-Step)> Lithotripsy guide (Middleline)> Voice comment
Measurements	Basic measurement:Distance, Area,CircumferenceVolume, Velocity, TimeMeasurement kits:Routine measurementAbdominal measurement kitGynecological measurementkitObstetric measurement kitUrological measurement kitSmall part measurement kitVascular measurement kitCardiac measurement kitPediatric measurement kit	Basic measurement:Distance, Area,CircumferenceVolume, Velocity, TimeMeasurement kits:Routine measurementAbdominal measurement kitGynecological measurementkitObstetric measurement kitUrological measurement kitSmall part measurement kitVascular measurement kitCardiac measurement kitPediatric measurement kit
Description	Subject Device	Predicate Device
	Hisense HD80 UltrasoundDiagnostic System	Hisense HD60 UltrasoundDiagnostic System(K213862)
	Emergency measurementkitAutomatic measurement ofintima-media thickness(IMT)Automatic spectrumenvelope measurementThorax Measurement	Emergency measurementkitAutomatic measurement ofintima-media thickness(IMT)Automatic spectrumenvelope measurementThorax Measurement
	TransducerTypes	Convex arrayPhased arrayLinear arrayMicro convex arrayVolume
	AcousticOutput withinFDAguidelines	Track 3;$Ispta.3 \le 720$mW/cm²$MI \le 1.9$$TI \le 6.0$
	general safetyandeffectivenessinformation	ANSI/AAMI ES60601-1IEC60601-2-37IEC60601-1-2ISO 10993-1
	Labeling	Conforms to 21 CFR Part801
	Accessories	foot switchECG cable and LeadwireB/W PrinterWIFI moduleBattery

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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 HD80 Series employs the same fundamental scientific technology as its predicated device.

Determination of substantial equivalence:

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The Proposed HD80 Series system are substantially equivalent to the predicate HD60 Series Ultrasound Diagnostic System (K213862) 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 HD80 Series and its predicate device.

Comparison Analysis

Note 1: Patient Contact Materials.

The Patient Contact Materials of 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 Substantially Equivalent in safety and effectiveness, and no new risk is raised, so the SE is not affected.

Note 2: Functions.

(1) New added function is equivalent as reference device Ribbon flow imaging (R Flow) is a new function compare with predicate device. The feature is equivalent as Resona R9 Ultrasonic pulsed doppler imaging system (K222928) manufactured by Mindray. The SE is not affected. (2) New added functions which is not support on predicated/reference device There are two functions of 3D PW (3DSpectral) and SCV(Spectral Color Velocity) which are not support on predicated/reference device. The performance of them meets the requirements. These new functions have no impact on safety or effectiveness.

The two new added functions of the HD80 series are features that are used to characterize blood flow measurements.

Note 3: WIFI and battery

Adding WIFI module, and the device support wireless function to connect LAN. The device with WIFI module was verified on safety/EMC, software and cybersecurity, The SE is not affected.

The Li-Battery was added and the system with battery was verified on safety/EMC and performance, The SE is not affected.

Summary of Non-clinical test:

HD80 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 HD80 Series complies with voluntary standards: 1. ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 &

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510(k) Premarket Notification Submission

A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) [Including Amendment 2 (2021)]

1. IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
1. IEC/TR 60601-4-2 Edition 1.0 2016-05 Medical electrical equipment Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems
1. IEC 60601-2-37 Edition 2.1 2015 Medical electrical equipment Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
1. IEC62359, Ultrasonics-Field characterization- Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields, 2017.
1. ISO10993-1 Fifth edition 2018-08 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
1. ISO 10993-5 Third edition 2009-06-01 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
1. ISO 10993-10 Fourth edition 2021-11 Biological evaluation of medical devices - Part 10: Tests for skin sensitization
1. ISO10993-23 First edition 2021-01 Biological evaluation devices - Part 23: Tests for irritation
1. ISO14971 Third Edition 2019-12 Medical devices - Application of risk management to medical devices
1. NEMAPS 3.1 3.20 2022d Digital Ilmaging and Communications in Medicine (DICOM) Set.
1. IEC60601-1-6 Edition 3.2 2020-07 CONSOLIDATED VERSION Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
1. IEC62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION Medical devices - Part 1: Application of usability engineering to medical devices
1. IEC62304 Edition 1.1 2015-06 CONSOLIDATED VERSION Medical device software - Software life cycle processes
15.ISTA3B 2017 Packaged-Products for Less-Than-Truckload (LTL) Shipment
1. IEC 62133-2:2017+AMD1:2021 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems

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Summary of Clinical Tests:

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

Conclusion:

Hisense Considers the HD80 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.