HD80 Series Ultrasound Diagnostic System

{0}------------------------------------------------ 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). {1}------------------------------------------------ Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (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 {2}------------------------------------------------ ## 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 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. 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ 510(k) 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., Ltd<br>No. 399 Songling Road, Laoshan District<br>266100, Qingdao, Shandong, P. R. China | | Contact Person: | Yalan Wu<br>Regulatory Affair Manager<br>Qingdao Hisense Medical Equipment Co., Ltd<br>Tel: +86-532-55752797<br>wuyalan@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 CFR<br>892.1570 | | Product Code: | IYN, IYO, ITX | | Device Class: | Class II | | Review Panel: | Radiology | | Submitter/510(k) Holder: | Qingdao Hisense Medical Equipment Co., Ltd | {4}------------------------------------------------ 510(k) Premarket Notification Submission | Clearance: | K213862 (cleared June 8, 2022) | |----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Reference Device:<br>Trade Name: | Resona R9, Resona R9 Exp, Resona R9 Pro,<br>Resona R9S, Nuewa R9, Nuewa R9, Exp,<br>Nuewa R9 Pro, Nuewa R9S, Resona 7,<br>Resona 7CV, Resona 7EXP, Resona 7S,<br>Resona 7OB, Resona 7PRO, Imagyn 7,<br>Resona Y, Resona R9W, Resona R7W,<br>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.,<br>LTD. | | Clearance: | K222928 (cleared Feb 7, 2023) | #### 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. #### Indications for Use: 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, {5}------------------------------------------------ ## 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. 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. ## 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 Ultrasound<br>Diagnostic System | Hisense HD60 Ultrasound<br>Diagnostic System<br>(K213862) | | Indications for<br>use | It is intended for use in<br>abdominal, fetal, pediatric,<br>Small Organ, neonatal and<br>adult cephalic, trans-rectal,<br>trans-vaginal, musculo-<br>skeletal(conventional,<br>superficial), cardiac(adult,<br>pediatric), peripheral vessel,<br>and urology exams. | It is intended for use in<br>abdominal, fetal, pediatric,<br>Small Organ, neonatal and<br>adult cephalic, trans-rectal,<br>trans-vaginal, musculo-<br>skeletal(conventional,<br>superficial), cardiac(adult,<br>pediatric), peripheral vessel,<br>and urology exams. | | User | Qualified and trained<br>physician | Qualified and trained<br>physician | | Environment | Hospital environment | Hospital environment | | Design | Autocorrelation for color<br>processing and FFT for<br>pulse Doppler processing.<br>Supporting Linear, Curve,<br>Phase array and Volume<br>probes. | Autocorrelation for color<br>processing and FFT for<br>pulse Doppler processing.<br>Supporting Linear, Curve,<br>Phase array and Volume<br>probes. | | Patient<br>Contact<br>Materials | Material meet ISO 10993-1<br>and FDA guidance | Material meet ISO 10993-1<br>and FDA guidance | | Mode of<br>operation | 3D/4D Imaging mode, B, M,<br>PW Doppler, CW Doppler,<br>Color Doppler Color M | 3D/4D Imaging mode, B, M,<br>PW Doppler, CW Doppler,<br>Color Doppler Color M | | Description | Subject Device<br>Hisense HD80 Ultrasound<br>Diagnostic System | Predicate Device<br>Hisense HD60 Ultrasound<br>Diagnostic System<br>(K213862) | | | Doppler, Power Doppler,<br>Harmonic Imaging,<br>Combined modes: B/M,<br>B/Color M, B/PWD or CWD,<br>B/Color/PWD or CWD,<br>B/Power/PWD. | Doppler, Power Doppler,<br>Harmonic Imaging,<br>Combined modes: B/M,<br>B/Color M, B/PWD or CWD,<br>B/Color/PWD or CWD,<br>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 Device<br>Hisense HD80 Ultrasound<br>Diagnostic System | Predicate Device<br>Hisense HD60 Ultrasound<br>Diagnostic System<br>(K213862) | | | > Image comparison<br>(dynamic and static<br>images)<br>> DICOM<br>> Teaching System<br>> ECG<br>> Contrast imaging<br>> Automated workflow (Hi-<br>Step)<br>> Lithotripsy guide (Middle<br>line)<br>> Voice comment<br>> Ribbon flow imaging (R<br>Flow)<br>> 3D spectral Doppler<br>imaging (3D PW )<br>> Spectral color velocity<br>(SCV) imaging | > Image comparison<br>(dynamic and static<br>images)<br>> DICOM<br>> Teaching System<br>> ECG<br>> Contrast imaging<br>> Automated workflow (Hi-<br>Step)<br>> Lithotripsy guide (Middle<br>line)<br>> Voice comment | | Measurements | Basic measurement:<br>Distance, Area,<br>Circumference<br>Volume, Velocity, Time<br>Measurement kits:<br>Routine measurement<br>Abdominal measurement kit<br>Gynecological measurement<br>kit<br>Obstetric measurement kit<br>Urological measurement kit<br>Small part measurement kit<br>Vascular measurement kit<br>Cardiac measurement kit<br>Pediatric measurement kit | Basic measurement:<br>Distance, Area,<br>Circumference<br>Volume, Velocity, Time<br>Measurement kits:<br>Routine measurement<br>Abdominal measurement kit<br>Gynecological measurement<br>kit<br>Obstetric measurement kit<br>Urological measurement kit<br>Small part measurement kit<br>Vascular measurement kit<br>Cardiac measurement kit<br>Pediatric measurement kit | | Description | Subject Device | Predicate Device | | | Hisense HD80 Ultrasound<br>Diagnostic System | Hisense HD60 Ultrasound<br>Diagnostic System<br>(K213862) | | | Emergency measurement<br>kit<br>Automatic measurement of<br>intima-media thickness<br>(IMT)<br>Automatic spectrum<br>envelope measurement<br>Thorax Measurement | Emergency measurement<br>kit<br>Automatic measurement of<br>intima-media thickness<br>(IMT)<br>Automatic spectrum<br>envelope measurement<br>Thorax Measurement | | | Transducer<br>Types | Convex array<br>Phased array<br>Linear array<br>Micro convex array<br>Volume | | | Acoustic<br>Output within<br>FDA<br>guidelines | Track 3;<br>$Ispta.3 \le 720$<br>mW/cm²<br>$MI \le 1.9$<br>$TI \le 6.0$ | | | general safety<br>and<br>effectiveness<br>information | ANSI/AAMI ES60601-1<br>IEC60601-2-37<br>IEC60601-1-2<br>ISO 10993-1 | | | Labeling | Conforms to 21 CFR Part<br>801 | | | Accessories | foot switch<br>ECG cable and Leadwire<br>B/W Printer<br>WIFI module<br>Battery | {6}------------------------------------------------ 510(k) Premarket Notification Submission {7}------------------------------------------------ 510(k) Premarket Notification Submission {8}------------------------------------------------ 510(k) Premarket Notification Submission ## Technology: The HD80 Series employs the same fundamental scientific technology as its predicated device. ## Determination of substantial equivalence: {9}------------------------------------------------ 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 & {10}------------------------------------------------ 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)] - 2. 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 - 3. 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 - 4. 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 - 5. IEC62359, Ultrasonics-Field characterization- Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields, 2017. - 6. ISO10993-1 Fifth edition 2018-08 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process - 7. ISO 10993-5 Third edition 2009-06-01 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity - 8. ISO 10993-10 Fourth edition 2021-11 Biological evaluation of medical devices - Part 10: Tests for skin sensitization - 9. ISO10993-23 First edition 2021-01 Biological evaluation devices - Part 23: Tests for irritation - 10. ISO14971 Third Edition 2019-12 Medical devices - Application of risk management to medical devices - 11. NEMAPS 3.1 3.20 2022d Digital Ilmaging and Communications in Medicine (DICOM) Set. - 12. 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 - 13. IEC62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION Medical devices - Part 1: Application of usability engineering to medical devices - 14. 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 - 16. 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 {11}------------------------------------------------ ## 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.