HERA W10 Diagnostic Ultrasound System, HERA W9 Diagnostic Ultrasound System

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Samsung Medison Co., LTD % Jee Young Ju Regulatory Affairs Specialist 3366, Hanseo-ro, Nam-myeon Hongcheon-gun, Gangwon-do 25108 KOREA April 5, 2022 # Re: K220043 Trade/Device Name: HERA W10 Diagnostic Ultrasound System, HERA W9 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Diagnostic Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN, ITX, IYO Dated: December 30, 2021 Received: January 5, 2022 # Dear Jee Young Ju: 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). 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Sincerely, Jessica Lamb, Ph.D. Assistant Director Mammography Ultrasound and Imaging Software Branch 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) K220043 ### 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, 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. Type of Use (Select one or both, as applicable) | <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | |--------------------------------------------------------------------------------------| | <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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 # 510(k) Summary In accordance with 21 CFR 807.92 the following summary of information is provided: - Date Prepared December 30, 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 Jee Young Ju Regulatory Affairs Specialist Phone: +82.2.2194.0861 Fax: +82. 2.2194.0278 Email: jee.ju@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 - 5. Predicate Device - HERA W9, HERA W10 Diagnostic Ultrasound System (K211824) Primary Predicate - - 6. Device Description 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 (TDD), 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. #### Indications for Use 7. 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. | Feature | HERA W9 /HERA W10<br>(Under Review) | HERA W9/HERA W10 (K211824)<br>Primary Predicate | |---------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | SAMSUNG MEDISON CO.,LTD | SAMSUNG MEDISON CO.,LTD | | Intended Use | The HERA W9/ HERA W10 Diagnostic<br>Ultrasound System and transducers are<br>intended for diagnostic ultrasound imaging<br>and fluid analysis of the human body. | The HERA W9/ HERA W10 Diagnostic<br>Ultrasound System and transducers are<br>intended for diagnostic ultrasound imaging<br>and fluid analysis of the human body. | | Functionality | - Q Scan<br>- ClearVision<br>- MultiVision<br>- Panoramic<br>- NeedleMate+<br>- AutoIMT+<br>- Elastoscan+<br>- E-Thyroid<br>- E-Breast<br>- E-Strain<br>- S-Detect for Breast<br>- S-Detect for Thyroid<br>- ADVR<br>- 3D Imaging<br>(Volume Data Acquisition)<br>- 3D Imaging presentation<br>- 3D Cine/4D Cine<br>- 3D Rendering MPR<br>- 3D XI MSV/Oblique View<br>- Volume CT<br>- 3D MagiCut<br>- Volume Calculation<br>(VOCAL, XI VOCAL)<br>- XI STIC | - Q Scan<br>- ClearVision<br>- MultiVision<br>- Panoramic<br>- NeedleMate+<br>- AutoIMT+<br>- Elastoscan+<br>- E-Thyroid<br>- E-Breast<br>- E-Strain<br>- S-Detect for Breast<br>- S-Detect for Thyroid<br>- ADVR<br>- 3D Imaging<br>(Volume Data Acquisition)<br>- 3D Imaging presentation<br>- 3D Cine/4D Cine<br>- 3DRendering MPR<br>- 3D XI MSV/Oblique View<br>- Volume CT<br>- 3D MagiCut<br>- Volume Calculation<br>(VOCAL, XI VOCAL)<br>- XI STIC | | Feature | HERA W9 /HERA W10<br>(Under Review) | HERA W9/HERA W10 (K211824)<br>Primary Predicate | | | HDVI<br>RealisticVue<br>CEUS+<br>HQ-Vision<br>MV-Flow<br>CrystalVue<br>CrystalVue Flow*<br>5D CNS+<br>5D Follicle<br>5D Heart Color<br>5D Limb Vol<br>5D LB<br>5D NT<br>2D NT<br>IOTA-ADNEX<br>BiometryAssist<br>E-Cervix<br>LumiFlow<br>ShadowHDR<br>MPI+*<br>Slice A<br>HeartAssist *<br>ViewAssist | HDVI<br>RealisticVue<br>CEUS+<br>HQ-Vision<br>MV-Flow<br>CrystalVue<br>CrystalVue Flow*<br>5D CNS+<br>5D Follicle<br>5D Heart Color<br>5D Limb Vol<br>5D LB<br>5D NT<br>2D NT<br>IOTA-ADNEX<br>BiometryAssist<br>E-Cervix<br>LumiFlow<br>ShadowHDR<br>MPI+*<br>Slice A<br>HeartAssist *<br>ViewAssist | | Transducers | L3-12A<br>LA2-9A<br>LA4-18B<br>CA1-7A<br>CA2-9A<br>CA3-10A<br>CF4-9<br>E3-12A<br>EA2-11B<br>VR5-9<br>PA4-12B<br>PA3-8B<br>PM1-6A<br>CV1-8A<br>EV3-10B<br>EV2-10A<br>EA2-11AV<br>EA2-11AR<br>LA2-14A | L3-12A<br>LA2-9A<br>LA4-18B<br>CA1-7A<br>CA2-9A<br>CA3-10A<br>CF4-9<br>E3-12A<br>EA2-11B<br>VR5-9<br>PA4-12B<br>PA3-8B<br>PM1-6A<br>CV1-8A<br>EV3-10B<br>EV2-10A<br>EA2-11AV<br>EA2-11AR<br>LA2-14A | {5}------------------------------------------------ * 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 (K211824) have the same clinical intended use, imaging modes and modes of operation. - The proposed HERA W9/ HERA W10 have expanded the measurement parts of BiometryAssist . (AI version) in the previously cleared HERA W9/ HERA W10 (K211824). - . The proposed HERA W9 HERA W10 have expanded the view recognition and the annotation of ViewAssist (AI version) in the previously cleared HERA W9/ HERA W10 (K211824) {6}------------------------------------------------ # SAMSUNG - . The proposed HERA W9/ HERA W10 have added the 14 inch touch monitor as an option. - The proposed HERA W9/ HERA W10 and predicate HERA W9/ HERA W10(K211824) have ● same capability in terms of performing measurements, capturing digital images, reviewing and reporting studies. - The proposed HERA W9/ HERA W10 and predicate HERA W9/ HERA W10(K211824) 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. | | Difference | HERA W9 | HERA W10 | |----------|-------------------------|----------------------------------|--------------------| | Software | CrystalVue Flow | Not Supported | Supported | | | MPI+ | Not Supported | Supported | | | HeartAssist | Not Supported | Supported | | Hardware | Internal DVD | Not Included | 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" | The differences between HERA W9 and HERA W10 in the subject device are as below. # 10. Summary of Non-Clinical Test The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, 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<br>/(R)2012<br>Medical Electrical Equipment - Part 1: General Requirements for basic safety and<br>essential performance. | | IEC 60601-1-2 | IEC60601-1-2: 2014(4th Edition), Medical electrical equipment - Part 1-2: General<br>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<br>medical diagnostic and monitoring equipment | | ISO10993-1 | ISO 10993-1, Biological evaluation of medical devices -- Part 1: Evaluation and testing<br>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)<br>Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment Revision<br>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 . {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the word "SAMSUNG" in all capital letters. The letters are a dark blue color. The background is white. # 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(K211824). END of 510(k) Summary