Who is the manufacturer of HERA W9, HERA W10 Diagnostic Ultrasound System?

Samsung Medison Co., Ltd. filed the 510(k) submission for HERA W9, HERA W10 Diagnostic Ultrasound System (K211824).

What is the FDA product code for HERA W9, HERA W10 Diagnostic Ultrasound System?

IYN. It is classified under 21 CFR 892.1550 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for HERA W9, HERA W10 Diagnostic Ultrasound System?

510(k) clearance (submission type: Traditional).

Does HERA W9, HERA W10 Diagnostic Ultrasound System use AI or machine learning?

Yes. HERA W9, HERA W10 Diagnostic Ultrasound System (K211824) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

What are the predicate devices for HERA W9, HERA W10 Diagnostic Ultrasound System?

HERA W9, HERA W10 Diagnostic Ultrasound System (K192319); RS85 Diagnostic Ultrasound System (K192903).

Who can help prepare an FDA 510(k) submission like HERA W9, HERA W10 Diagnostic Ultrasound System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Can an AI/ML device like HERA W9, HERA W10 Diagnostic Ultrasound System get a guaranteed FDA 510(k) clearance?

Yes. Innolitics offers a guaranteed FDA 510(k) clearance engagement for AI/ML Software as a Medical Device — combining engineering and regulatory execution under one agreement with a guaranteed clearance outcome. Eligibility: the device must be an AI/ML Software as a Medical Device (SaMD), and its performance must meet the criteria Innolitics determines during an initial regulatory strategy engagement to be necessary for FDA clearance. See https://innolitics.com/services/end-to-end-samd/ or contact https://innolitics.com/contact.

HERA W9, HERA W10 Diagnostic Ultrasound System

K211824 · Samsung Medison Co., Ltd. · IYN · Sep 9, 2021 · Radiology

Device Facts

Record ID	K211824
Device Name	HERA W9, HERA W10 Diagnostic Ultrasound System
Applicant	Samsung Medison Co., Ltd.
Product Code	IYN · Radiology
Decision Date	Sep 9, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1550
Device Class	Class 2
Attributes	AI/ML, Pediatric

AI Performance

Output	Algorithm	Acceptance	Observed	Dev DS	Dev Readers	Test DS	Test Readers
Fetal biometric measurements	Deep learning based algorithm	—	—	—	—	—	—
Fetal heart scanning view classification	Deep learning based algorithm	—	—	—	—	—	—
Anatomical view classification and annotation	Deep learning based algorithm	—	—	—	—	—	—

Indications for Use

The diagnostic ultrasound system and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body. The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric and Peripheral vessel. It is intended for use by, or by the order of, and under the supervision of, an appropriately trained healthcare professional who is qualified for direct use of medical devices. It can be used in hospitals, clinics and similar care environment for clinical diagnosis of patients.

Device Story

HERA W9/W10 are mobile, software-controlled diagnostic ultrasound systems. They acquire ultrasound data via various transducers and display images in modes including 2D, M-mode, Doppler (Color, Power, PW, CW, Tissue), 3D/4D, and Elastoscan+. The system enables anatomical measurements and analysis for clinical diagnosis. Operators (physicians/sonographers) use the system in hospitals/clinics to visualize internal structures. New AI-based features (HeartAssist, ViewAssist, updated BiometryAssist) and Slice A functionality automate view classification, annotation, and measurement proposal to improve efficiency. Output is displayed on a monitor for real-time clinical decision-making. The system includes safety indices (mechanical/thermal) displayed automatically.

Clinical Evidence

No clinical studies were required to support substantial equivalence. Evidence consists of bench testing, including acoustic output measurement, biocompatibility, thermal/electromagnetic/mechanical safety, and software verification/validation. Performance testing confirmed that new AI-based features (HeartAssist, ViewAssist, Slice A) and the updated BiometryAssist met predefined accuracy and performance criteria.

Technological Characteristics

Mobile ultrasound system; software-controlled. Materials evaluated per ISO 10993-1. Standards: ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, NEMA UD 2-2004. Features include 2D, 3D/4D, Doppler, and AI-based analysis. Connectivity includes multiple probe ports. Sterilization/disinfection per manufacturer instructions. Software includes deep learning-based automated measurement and classification algorithms.

Indications for Use

Indicated for diagnostic ultrasound imaging and fluid analysis in patients requiring Fetal/Obstetrics, Abdominal, Gynecology, Pediatric, Small Organ, Neonatal/Adult Cephalic, Trans-rectal, Muscular-Skeletal, Urology, Cardiac, and Peripheral vessel exams. Intended for use by trained healthcare professionals in clinical settings.

Regulatory Classification

Identification

An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

HERA W9, HERA W10 Diagnostic Ultrasound System (K192319)
RS85 Diagnostic Ultrasound System (K192903)

Reference Devices

Voluson SWIFT, Voluson SWIFT+ (K201828)

Submission Summary (Full Text)

{0}------------------------------------------------ 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. Samsung Medison Co., Ltd. % Scully Kim Regulatory Affairs Specialist 3366. Hanseo-ro. Nam-myeon Hongcheon-gun, Gangwon-do 25108 REPUBLIC OF KOREA Re: K211824 Trade/Device Name: HERA W9, HERA W10 Diagnostic 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 11, 2021 Received: June 14, 2021 Dear Scully Kim: 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 September 9, 2021 {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 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 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 {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K211824 Device Name HERA W9, HERA W10 Diagnostic Ultrasound System Indications for Use (Describe) The diagnostic ultrasound system and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body. The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric and Peripheral vessel. It is intended for use by, or by the order of, and under the supervision of, an appropriately trained healthcare professional who is qualified for direct use of medical devices. It can be used in hospitals, clinics and similar care environment for clinical diagnosis of patients. Modes of Operation: 2D mode, Color Doppler mode, Power Doppler (PD) mode, M mode, Pulsed Wave (PW) Doppler mode, Continuous Wave (CW) Doppler mode, Tissue Doppler Imaging (TDI) mode, Tissue Doppler Wave (TDW) mode, ElastoScan+™ Mode, Combined modes, Multi-Image modes (Dual, Quad), 3D/4D modes. Type of Use (*Select one or both, as applicable*) | | <div> <input checked="true" type="checkbox"/>Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <input type="checkbox"/>Over-The-Counter Use (21 CFR 801 Subpart C) </div> | |----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------| |----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------| 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}------------------------------------------------ ## SAMSUNG K211824 ## 510(k) Summary In accordance with 21 CFR 807.92 the following summary of information is provided: - Date Prepared June 11, 2021 1. - Manufacturer 2. SAMSUNG MEDISON CO., LTD. 3366, Hanseo-ro, Nam-myeon, Hongcheon-gun, Gangwon-do 25108, REPUBLIC OF KOREA - 3. Primary Contact Person Scully Kim Regulatory Affairs Specialist Phone: +82.2.2194.1312 Fax: +82. 2.2194.0273 Email: scully.kim(@samsungmedison.com Secondary Contact Person Ninad Gujar Vice President Phone: +1.978.564.8632 Fax: +1.978.564.8677 Email: ngujar@neurologica.com - 4. Proposed Device - Common/Usual Name: Diagnostic Ultrasound System and Accessories । - Proprietary Name: HERA W9, HERA W10 Diagnostic Ultrasound System - Common Name: Diagnostic Ultrasound System - Classification Names: system, imaging, pulsed doppler, ultrasonic i - Product Code: IYN, IYO, ITX - Regulation: 892.1550, 892.1560, 892.1570 - Predicate Device 5. - HERA W9, HERA W10 Diagnostic Ultrasound System (K192319) Primary Predicate - - RS85 Diagnostic Ultrasound System (K192903) Secondary Predicate - - Voluson SWIFT, Voluson SWIFT+ (K201828) Reference - ### Device Description 6. The HERA W9/ HERA W10 are general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as B-mode, M-mode, Pulsed wave (PW) Doppler, Continuous wave (CW) Doppler, Color Doppler, Tissue Doppler Imaging (TDI), Tissue Doppler Wave (TDW), Power Amplitude Doppler, Pulse Inversion Harmonic Imaging (S-Harmonic), Directional Power Doppler (S-Flow), Color M-Mode, 3D Imaging Mode, 4D Imaging Mode, Elastoscan+ Mode, Tissue Harmonic Imaging, MV-Flow Mode or as a combination of these modes. The HERA W9/HERA W10 also give the operator the ability to measure anatomical structures and offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals. The HERA W10 have real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the word "SAMSUNG" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The word is centered and takes up most of the image space. #### 7. Indications for Use The diagnostic ultrasound system and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body. The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric and Peripheral vessel. It is intended for use by, or by the order of, and under the supervision of, an appropriately trained healthcare professional who is qualified for direct use of medical devices. It can be used in hospitals, private practices, clinics and similar care environment for clinical diagnosis of patients. Modes of Operation: 2D mode, Color Doppler mode, Power Doppler (PD) mode, M mode, Pulsed Wave (PW) Doppler mode, Continuous Wave (CW) Doppler mode, Tissue Doppler Imaging (TDI) mode, Tissue Doppler Wave (TDW) mode, ElastoScan+™ Mode, Combined modes, Multi-Image modes (Dual, Quad), 3D/4D modes. - 8. Technology The HERA W9/ HERA W10 employ the same fundamental scientific technology as its predicate device. #### 9. Determination of Substantial Equivalence The proposed HERA W9/ HERA W10 are substantially equivalent to the predicate device with regards to intended use, imaging capabilities, technological characteristics and safety and effectiveness. As compared with the primary predicate device (HERA W9 / HERA W10, K192319), the subject device has changes: addition of new software functions (HeartAssist, Slice A), addition of migrated transducers (LA2-14A, PA1-5A), and improvement of cleared software functions (Changed an algorithm of BiometryAssist to AI version). | Feature | HERA W9 /HERA W10 (Under Review) | HERA W9/HERA W10 (K192319) Primary Predicate | RS85 (K192903) Secondary Predicate | Voluson SWIFT (K201828) Reference | |---------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | SAMSUNG MEDISON CO.,LTD | SAMSUNG MEDISON CO.,LTD | SAMSUNG MEDISON CO.,LTD | GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC | | Intended Use | The HERA W9/ HERA W10 Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body. | The HERA W9/ HERA W10 Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body. | The RS85 Ultrasound Diagnostic System and probes are designed to obtain ultrasound images and analyze body fluids. | The Voluson SWIFT, Voluson SWIFT+ is a general-purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid. | | Functionality | - Q Scan - ClearVision - MultiVision - Panoramic - NeedleMate+ - AutoIMT+ - Elastoscan+ | - Q Scan - ClearVision - MultiVision - Panoramic - NeedleMate+ - AutoIMT+ - Elastoscan+ | - Q Scan - ClearVision - MultiVision - Panoramic - NeedleMate+ - AutoIMT+ - Elastoscan+ | - Q Scan - ClearVision - MultiVision - Panoramic - NeedleMate+ - AutoIMT+ - Elastoscan+ | | Feature | HERA W9 /HERA W10 (Under Review) | HERA W9/HERA W10 (K192319) Primary Predicate | RS85 (K192903) Secondary Predicate | Voluson SWIFT (K201828) Reference | | | E-Thyroid E-Breast E-Strain S-Detect for Breast S-Detect for Thyroid ADVR 3D Imaging (Volume Data Acquisition) 3D Imaging presentation 3D Cine/4D Cine 3D Rendering MPR 3D XI MSV/Oblique View Volume CT 3D MagiCut Volume Calculation (VOCAL, XI VOCAL) XI STIC HDVI RealisticVue CEUS+ HQ-Vision MV-Flow CrystalVue CrystalVue Flow* 5D CNS+ 5D Follicle 5D Heart Color 5D Limb Vol 5D LB 5D NT 2D NT IOTA-ADNEX BiometryAssist E-Cervix LumiFlow ShadowHDR MPI+* Slice A HeartAssist * ViewAssist | E-Thyroid E-Breast E-Strain S-Detect for Breast S-Detect for Thyroid ADVR 3D Imaging (Volume Data Acquisition) 3D Imaging presentation 3D Cine/4D Cine 3DRendering MPR 3D XI MSV/Oblique View Volume CT 3D MagiCut Volume Calculation (VOCAL, XI VOCAL) XI STIC HDVI RealisticVue CEUS+ HQ-Vision MV-Flow CrystalVue CrystalVue Flow* 5D CNS+ 5D Follicle 5D Heart Color 5D Limb Vol 5D LB 5D NT 2D NT IOTA-ADNEX BiometryAssist E-Cervix LumiFlow ShadowHDR MPI+* | E-Thyroid E-Breast E-Strain S-Detect for Breast S-Detect for Thyroid ADVR 3D Imaging (Volume Data Acquisition) 3D Imaging presentation 3D Cine/4D Cine 3D Rendering MPR 3D XI MSV/Oblique View Volume CT 3D MagiCut Volume Calculation (VOCAL, XI VOCAL) XI STIC HDVI RealisticVue CEUS+ HQ-Vision MV-Flow CrystalVue CrystalVue Flow 2D NT IOTA-ADNEX BiometryAssist LumiFlow ShadowHDR | VCIA SonoLystIR SonoLystIR | | Transducers | L3-12A LA2-9A LA4-18B CA1-7A CA2-9A CA3-10A CF4-9 | L3-12A LA2-9A LA4-18B CA1-7A CA2-9A CA3-10A CF4-9 | L3-12A LA2-9A LA4-18B CA3-10A CF4-9 | Unknown | | Feature | HERA W9 /HERA W10 (Under Review) | HERA W9/HERA W10 (K192319) Primary Predicate | RS85 (K192903) Secondary Predicate | Voluson SWIFT (K201828) Reference | | | EA2-11B | EA2-11B | EA2-11B | | | | VR5-9 | VR5-9 | - | | | | PA4-12B | PA4-12B | PA4-12B | | | | PA3-8B | PA3-8B | PA3-8B | | | | PM1-6A | PM1-6A | PM1-6A | | | | CV1-8A | CV1-8A | CV1-8A | | | | EV3-10B | EV3-10B | EV3-10B | | | | EV2-10A | EV2-10A | EV2-10A | | | | EA2-11AV | EA2-11AV | EA2-11AV | | | | EA2-11AR | EA2-11AR | EA2-11AR | | | | LA2-14A | | LA2-14A | | | | PA1-5A | | PA1-5A | | {5}------------------------------------------------ # SAMSUNG Traditional 510(k) {6}------------------------------------------------ Traditional 510(k) HERA W9/ HERA W10 Diagnostic Ultrasound Systems * Note : SW feature is supported in HERA W10 only. - . The systems are all intended for diagnostic ultrasound imaging and fluid flow analysis. - . The proposed HERA W9/ HERA W10 and predicate HERA W9/ HERA W10 (K192319) have the same clinical intended use. - . The proposed HERA W9/ HERA W10 and predicate HERA W10 (K192319) have the same imaging modes and modes of operation. - The proposed HERA W9/ HERA W10 added two transducers (LA2-14A, PA1-5A) that previously cleared in predicate RS85 (K192903) system. - . The proposed HERA W9/ HERA W10 added new SW features AI based HeartAssist(HERA W10 only), and ViewAssist. It provides similar functionality to SonoLystIR in predicate Voluson SWIFT (K201828). HeartAssist is a deep learning based function that provides classification of ultrasound image into measurement views required for fetal heart scanning and provides measurement results. The feature recognizes views and proposes caliper placements and corresponding measurements allowing users to save time and increase examination efficiency through reducing key-strokes and proposing measurements which can be edited by the user. ViewAssist is a deep learning based function that provides classification of ultrasound image into key scanning views and provides annotations. The feature recognizes views and proposes corresponding anatomy annotations and initiates measurements allowing users to save time and increase examination efficiency through reducing key-strokes and proposing annotations which can be edited by the user. - The proposed HERA W9/ HERA W10 added new SW feature Slice A. It provides similar ● functionality to VCIA in predicate Voluson SWIFT (K201828). - . The proposed HERA W9/ HERA W10 implemented an AI version of BiometryAssist which improved from previously cleared function BiometryAssist in predicate HERA W9/ HERA W10 (K192319). BiometryAssist, a feature based on deep learning technology, is an automatic technology for biometric measurement which can be edited by the user. It enables users to measure the fetal growth parameters with one click while maintaining exam consistency. - . The proposed HERA W9/ HERA W10 and predicate HERA W9/ HERA W10 (K192319) have same capability in terms of performing measurements, capturing digital images, reviewing and reporting studies. {7}------------------------------------------------ ## SAMSUNG - . The proposed HERA W9/ HERA W10 and predicate HERA W9/ HERA W10 (K192319) have been designed in compliance with approved electrical and physical safety standards. - . The systems are manufactured with materials which have been evaluated and found to be safe for the intended use of the device. - . The systems have acoustic power levels which are below the applicable FDA limits. The differences between HERA W9 and HERA W10 in the subject device are as below. | | Difference | HERA W9 | HERA W10 | |-------------------------|-----------------|----------------------------------|------------------| | Software | CrystalVue Flow | Not Supported | Supported | | Software | MPI+ | Not Supported | Supported | | | HeartAssist | Not Supported | Supported | | | Hardware | Internal DVD | Not Included | | Caster size | | 5" | 6" | | Active array probe port | | 3 port (default), 4 port(option) | 4 port | | Main monitor | | 21.5"/23.8" | 21.5"/23" /23.8" | - 10. Summary of Non-Clinical Test The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electromagnetic and mechanical safety, and has been found to conform with applicable medical device safety standards. The HERA W9/ HERA W10 and its applications comply with voluntary standards. | Reference No. | Title | |----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | IEC 60601-1 | ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 Medical Electrical Equipment - Part 1: General Requirements for basic safety and essential performance. | | IEC 60601-1-2 | IEC60601-1-2: 2014(4th Edition), Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - EMC | | IEC 60601-2-37 | IEC60601-2-37:2007 + A1:2015, Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment | | ISO10993-1 | ISO 10993-1, Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process. | | ISO14971 | ISO 14971:2007, Medical devices - Application of risk management to medical devices | | NEMA UD 2-2004 | NEMA UD 2-2004 (R2009) Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment Revision 3 | In addition to conformance to the above harmonized standards, HERA W9 / HERA W10 quality assurance activities include the following: - Risk analysis and mitigation . - . Software verification and validation testing - System verification and validation testing ● - Image quality tests . Below a summary has been provided from testing results that demonstrated that the HERA W9 / HERA W10 systems meet all the image quality criteria. - Two transducers LA2-14A, PA1-5A are migrated from the predicate device RS85 (K192903) to ● this submission. The image performance tests were completed to confirm all requirements were {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the word "SAMSUNG" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The word is centered and takes up most of the image space. met. - . Performance testing was successfully completed for the new software functions (artificial intelligence based features HeartAssist, ViewAssist and Slice A) to show passing results for predefined testing criteria. - . The improved feature of BiometryAssist based on artificial intelligence was validated through performance testing to confirm the measurement accuracy requirements were met. - 11. Summary of Clinical Tests The subject of this premarket submission, HERA W9/ HERA W10, did not require clinical studies to support substantial equivalence. - 12. Conclusion Intended uses and other key features are consistent with traditional clinical practices and FDA guidelines. The design, development and quality process of the manufacturer confirms with 21 CFR 820 and ISO 13485. The device is designed to conform to applicable medical device safety standards and compliance. Therefore, SAMSUNG MEDISON CO., LTD. considers the HERA W9/ HERA W10 to be as safe, as effective, and provide performance substantially equivalent to the primary predicate device(K192319). END of 510(k) Summary

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