V8/H8 Diagnostic Ultrasound System, V7/H7 Diagnostic Ultrasound System, V6/H6 Diagnostic Ultrasound System

{0}------------------------------------------------ October 3, 2023 Image /page/0/Picture/1 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath. Samsung Medison Co., Ltd. % Jee Young Ju Regulatory Affairs Specialist 3366, Hanseo-ro, Nam-myeon Hongcheon-gun, Gangwon-do 25108 REPUBLIC OF KOREA ### Re: K231772 Trade/Device Name: V8/H8 Diagnostic Ultrasound System, V7/H7 Diagnostic Ultrasound System, V6/H6 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: September 19, 2023 Received: September 19, 2023 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 (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, # Yanna S. Kang -S 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 510(k) Number (if known) K231772 #### Device Name V8 / H8 Diagnostic Ultrasound System V7 / H7 Diagnostic Ultrasound System V6 / H6 Diagnostic Ultrasound System #### Indications for Use (Describe) The diagnostic ultrasound system and transducers are designed to obtain ultrasound images and analyze body fluids. The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Intra-operative, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric, Thoracic, Trans-esophageal (Cardiac) 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 mode(Dual, Quad), 3D/4D mode | Type of Use (Select one or both, as applicable) | | |---------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------| | <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | ### 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 ### K231772 ### 510(K) Summary: In accordance with 21 CFR 807.92, the following summary of information is provided: - Date Prepared June 14, 2023 1. - 2. Manufacturer SAMSUNG MEDISON CO., LTD. 3366, Hanseo-ro, Nam-myeon, Hongcheon-gun, Gangwon-do, Republic of Korea - 3. Primary Contact Person Ju, Jee-Young Regulatory Affairs Specialist Phone: +82.2.2194.0861 Fax: +82. 2.2194.0273 Email: jee.ju(@samsungmedison.com - Secondary Contact Person 4. Ninad Gujar Vice President Phone: +1.978.564.8632 Fax: +1.978.564.8677 Email: ngujar@neurologica.com - 5. Proposed Device - - Common/Usual Name : Diagnostic Ultrasound System and Accessories - - -Proprietary Name : V8 / H8 Diagnostic Ultrasound System - V7 / H7 Diagnostic Ultrasound System - V6 / H6 Diagnostic Ultrasound System - Regulation Name : Ultrasonic pulsed doppler imaging system - Regulatory Class : Class II - - -Product Code : IYN, IYO, ITX - Regulation Number : 21 CFR 892.1550, 892.1560, 892.1570 - - Predicate Devices 6. - V8 / V7 Diagnostic Ultrasound System (K223387) Primary - - RS85 / RS80 EVO Diagnostic Ultrasound System (K221117) Reference - - HS40 Diagnostic Ultrasound System (K221599) Reference - - ScanNav Anatomy Peripheral Nerve Block (DEN220024) Reference - - 7. Device Description The V8 / V7 / V6 / H8 / H7 / H6 are a general purpose, mobile, software controlled, diagnostic ultrasound system. Their function is to acquire ultrasound data and to display the data as 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 mode(Dual, Quad), 3D/4D mode. The V8 / V7 / V6 / H8 / H7 / H6 also give the {4}------------------------------------------------ operator the ability to measure anatomical structures and offer analysis packages that provide information that is used to make a diagnosis by competent health care professionals. The V8 / V7 / V6 / H8 / H7 / H6 have a real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed. - Intended Use 8. The V8 / V7 / V6 / H8 / H7 / H6 diagnostic ultrasound system and transducers are designed to obtain ultrasound images and analyze body fluids. The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Intra-operative, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric, Thoracic, Trans-esophageal (Cardiac) 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 mode(Dual, Quad), 3D/4D mode. - 9. Technological Comparison to Predicate Devices The V8 / V7 / V6 / H8 / H7 / H6 employ the same fundamental scientific technology as its predicate devices V8 / V7 (K223387), RS85/ RS80 EVO(K221117), HS40(K221599) and ScanNav Anatomy Peripheral Nerve Block (DEN220024). - 10. Determination of Substantial Equivalence Comparison to Predicate: The V8 / V7 / V6 / H8 / H7 / H6 are substantially equivalent to the predicate devices with regard to intended use, imaging capabilities, technological characteristics and safety and effectiveness. - The systems are all intended for diagnostic ultrasound imaging and fluid flow ● analysis. - The proposed V8 / V7 / V6 / H8 / H7 / H6 and the primary predicate V8 / V7 (K223387) have the same clinical intended use. - . The proposed V8 / V7 / V6 / H8 / H7 / H6 and the primary predicate V8 / V7 (K223387) have the same imaging modes and modes of operation. - The proposed V8 / V7 / V6 / H8 / H7 / H6 have added the NerveTrack segmentation function that can be used for pre-injection only and cannot be used as a guide for needling based on similar indication for use of ScanNav Anatomy Peripheral Block (DEN220024) previously cleared. - . The proposed V8/V7/V6 / H8 / H7 / H6 have included two new transducers L3-22 and LA2-16S. V6/H6 has included an additional transducer CA1-7AD migrated {5}------------------------------------------------ from the predicate HS40 (K221599), and V8/H8 has included an additional transducer LM2-18 migrated from the predicate RS85 / RS80 EVO (K221117). Biocompatibility test has been conducted for the new transducers, and image performance tests have been conducted for the new and migrated transducers. - . The proposed V8 / V7 / V6 / H8 / H7 / H6 have added two new biopsy guides with already cleared components. - . The proposed V8 / V7 / V6 / H8 / H7 / H6 and primary predicate V8 / V7 (K223387) have the same capability in terms of performing measurements, capturing digital images, reviewing and reporting studies. - The proposed V8 / V7 / V6 / H8 / H7 / H6 and primary predicate V8 / V7 (K223387) . have been designed in compliance with approved electrical and physical safety standards. - The system is manufactured with materials which have been evaluated and found . to be safe for the intended use of the device. - . The system has acoustic power levels which are below the applicable FDA limits. - 11. Summary of Non-Clinical Testing The device has been evaluated for acoustic output, biocompatibility, software function, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic and mechanical safety, and has been found to conform with applicable FDA guidances and medical device safety standards. The V8 / V7 / V6 / H8 / H7 / H6 and its applications comply with the following FDA-recognized standards. | Reference No. | Title | |----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | IEC 60601-1 | AAMI ANSI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012<br>and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment -<br>Part 1: General requirements for basic safety and essential performance<br>(IEC 60601-1:2005, MOD) | | IEC 60601-1-2 | IEC60601-1-2: 2020-09(4.1 Edition) , Medical electrical equipment - Part<br>1-2: General requirements for basic safety and essential performance -<br>EMC | | IEC 60601-2-37 | IEC 60601-2-37 Edition 2.0 2007, Medical electrical equipment - Part 2-<br>37: Particular requirements for the basic safety and essential performance<br>of ultrasonic medical diagnostic and monitoring equipment | | ISO10993-1 | AAMI / ANSI / ISO 10993-1:2009/(R)2013, Biological evaluation of<br>medical devices – Part 1: Evaluation and testing within a risk management<br>process | | ISO14971 | ISO 14971:2019, Medical devices - Application of risk management to<br>medical devices | | NEMA UD 2-2004 | NEMA UD 2-2004 (R2009) Acoustic Output Measurement Standard for<br>Diagnostic Ultrasound Equipment Revision 3 | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the word "SAMSUNG" in large, bold, blue letters. The letters are evenly spaced and appear to be a sans-serif font. The background is plain white, which makes the blue letters stand out. ### [ The Summary of Testing for AI based NerveTrack ] These are the details on validation of the AI algorithm used for all the new and improved AI-based features that includes expansion of the use of NerveTrack feature and the information about the dataset the device was tested on. ### Acceptance Criteria: | Validation Type | Definition | Acceptance Criteria | |-----------------|---------------------------------------------------------------------------------------------------------------------------|---------------------| | Accuracy (%) | $ \frac{\text{Number of correctly detected frames}}{\text{Total number of frames with nerve}} × 100 $ | ≥ 80% | | Speed (FPS) | $ \frac{1000}{\text{Average latency time of each frame (msec)}} $ | ≥ 2 FPS | Summary Performance data, Standard Deviations & Confidence Intervals: | Validation Type | Average | Standard Deviation | 95% CI | |-----------------|---------|--------------------|--------------| | Accuracy (%) | 90.3 | 4.8 | 88.6 to 92.0 | | Speed (FPS) | 3.61 | 0.25 | 3.43 to 3.78 | Testing Data Information: | | Females | Males | Total | |--------------------|-------------|-------|---------| | Number of Subjects | 13 | 5 | 18 | | Number of Images | 1,168 | 978 | 2,146 | | Age range | 32~68 | 22~50 | 22~68 | | Average age | 45.7 | 35.0 | 42.7 | | BMI range | 16~27.1 | 31.5 | 16~31.5 | | Average BMI | 20.5 | 31.5 | 21.5 | | Ethnicity | All Koreans | | | The standalone performance of NerveTrack was evaluated for BMI (Body Mass Index) subgroups, which are potential subject and image confounder. For subgroup analysis, we divided BMI values into four groups according to the CDC (Centers for Disease Control and Prevention) definition for adult overweight & obesity. They are underweight (BMI < 18.5), healthy weight (18.5 ≤ BMI < 25), overweight (25 ≤ BMI < 30), and obesity (BMI ≥ 30). We evaluated the performance for the four groups and observed very good generalizability for BMI, because the average accuracy of all subgroups is included within the confidence interval of the accuracy for the full dataset. The depth range was set 2.5cm to 4.5cm, and the maximum depth of the detected nerve was 3.31 cm from skin. When we calculate the relationship between BMI and the maximum depth of nerves, it illustrates a low correlation and no significant difference of NerveTrack performance according to the patient's BMI information. Therefore, we believe that our model is robust even if the cases with various BMI information exist. {7}------------------------------------------------ When collecting scan data, the speed of the transducer varies approximately from 1cm to 5cm per second. The orientation of the transducer was short-axis imaging and perpendicular to the skin, obtained by sliding the transducer in both the proximal and distal directions. All the nerve data were acquired on Samsung ultrasound devices including V8. Ten anesthesiologists and five sonographers with more than 10 years of experience participated to establish the ground truth (GT) for the location of 12 different kinds of nerves. One anesthesiologist who scanned the ultrasound directly drew the GT of nerve location, and two or more other anesthesiologists and sonographers reviewed and confirmed that it was correct. If there was any mistake during the review, it was revised again. The training data used for the training of the NerveTrack algorithm are independent of the data used to test the NerveTrack algorithm. Contour segmentation for two kinds of nerves (ISBP: interscalene brachial plexus, and AxBP: axillary brachial plexus) and surrounding structures in the body are added to display the boundary of each region. Contours are displayed with different colors: nerve with yellow, bone with blue, blood vessel with red, and muscle with green. | Validation Type | Definition | Acceptance Criteria | |-----------------|-----------------------------------------------------------------------------------------------------------|---------------------| | Accuracy (%) | $\frac{\text{Number of correctly segmented frames}}{\text{Total number of frames with nerve}} \times 100$ | ≥ 80% | | Speed (FPS) | $\frac{1000}{\text{Average latency time of each frame (msec)}}$ | ≥ 2 FPS | Acceptance Criteria for Segmentation: Summary Performance data, Standard Deviations & Confidence Intervals for Segmentation: | Validation Type | Average | Standard Deviation | 95% CI | |-----------------|---------|--------------------|--------------| | Accuracy (%) | 98.69 | 0.64 | 96.31 to 100 | | Speed (FPS) | 3.62 | 0.36 | 3.49 to 3.75 | #### Testing Data Information for Segmentation: | | Females | Males | Total | |--------------------|-------------|-------|-------| | Number of Subjects | 8 | 3 | 11 | | Number of Images | 3,041 | 795 | 3,836 | | Age range | 38~71 | 32~51 | 32~71 | | Average age | 45.1 | 39.7 | 43.6 | | Ethnicity | All Koreans | | | The accuracy was measured by comparing the segmented outputs of NerveTrack and ground truth made by anesthesiologists. Measurement using the test images was repeated three times, and the average values were calculated. - 12. Summary of Clinical Tests {8}------------------------------------------------ Image /page/8/Picture/0 description: The image contains the word "SAMSUNG" in all capital letters. The word is written in a bold, sans-serif font. The color of the text is blue, and the background is white. The proposed device V8 / V7 / V6 / H8 / H7 / H6 Ultrasound System did not require clinical studies to demonstrate substantial equivalence. ### 13. Conclusion Since the predicate devices and the subject device have a similar intended use and key technological features, the non-clinical data support the safety of the device and demonstrate that the V8 / V7 / V6 / H8 / H7 / H6 Ultrasound System should perform as intended in the specified use conditions. Therefore, SAMSUNG MEDISON CO., LTD. considers the subject device to be as safe, as effective, and performance is substantially equivalent to the primary predicate device that is currently marketed for the same intended use. ### - END of 510(k) Summary