V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System

{0}------------------------------------------------ June 29, 2022 Image /page/0/Picture/1 description: The image shows 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. % Jee Ju Regulatory Affairs Specialist 3366. Hanseo-ro. Nam-myeon Hongcheon-gun, Gangwon-do 25108 REPUBLIC OF KOREA #### Re: K220975 Trade/Device Name: V8 Diagnostic Ultrasound System, V7 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: March 31, 2022 Received: April 4, 2022 #### Dear Jee 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). 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. 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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 {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 medical devices and radiation-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 Michael D. O'Hara, Ph.D. Deputy Director DHT 8C: Division of Radiological Imaging and Radiation Therapy Devices OHT 8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K220975 #### Device Name V8 Diagnostic Ultrasound System V7 Diagnostic Ultrasound System #### Indications for Use (Describe) The diagnostic ultrasound system and probes 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-raginal, 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) | | |-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------| | | <span>X Prescription Use (Part 21 CFR 801 Subpart D)</span> <span>Over-The-Counter Use (21 CFR 801 Subpart C)</span> | ### 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 Traditional 510(k) K220975 # 510(K) Summary: In accordance with 21 CFR 807.92 the following summary of information is provided: - Date Prepared -March 31, 2022 1. - 2. Manufacturer SAMSUNG MEDISON CO., LTD. 3366, Hanseo-ro, Nam-myeon, Hongcheon-gun, Gangwon-do, Republic of Korea - 3. Primary Contact Person Jee Young Ju 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 - Proposed Device 5. - - - Common/Usual Name : Diagnostic Ultrasound System and Accessories - - Proprietary Name : V8 Diagnostic Ultrasound System - V7 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 Diagnostic Ultrasound System (K211945) Primary - - HS50 / HS60 Diagnostic Ultrasound System (K210068) Reference - - 7. Device Description The V8 / V7 are a general purpose, mobile, software controlled, diagnostic ultrasound system. Its 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 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 V8 / V7 have real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both {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 frame. automatically displayed. - 8. Intended Use The V8 / V7 diagnostic ultrasound system and probes 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. - Technological Comparison to Predicate Devices 9. The V8 / V7 employs the same fundamental scientific technology as its predicate devices V8 (K211945) system and HS50 / 60 (K210068) System. - 10. Determination of Substantial Equivalence Comparison to Predicate: The V8 / V7 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 and predicates V8 (K211945) and HS50 / 60 (K210068) are the same clinical intended use. - The proposed V8 / V7 and predicates V8 (K211945) and HS50 / 60 (K210068) . have the same imaging modes and modes of operation. - . The proposed V8 / V7 have expanded the detection nerve type (Elbow : MN, UN, RN / Neck&Shoulder : ISBP, SCBP, AxBP) of NerveTrack based on AI in the previously cleared V8 (K211945). - The proposed V7 has included three new transducers CA1-7SD, EA2-11ARD and . EA2-11AVD. Also, CV1-8AD has been migrated from the predicate HS50 / /60(K210068). the biocompatibility has been conducted for new transducers and the image performance test have been conducted for new and migrated transducers. - The proposed V8 / V7 and predicates V8 (K211945) and HS50 / 60 (K210068) have same capability in terms of performing measurements, capturing digital {5}------------------------------------------------ Image /page/5/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 white, providing a clear contrast to the blue text. images, reviewing and reporting studies. - The proposed V8 / V7 and predicates V8 (K211945) and HS50 / 60 (K210068) have been designed in compliance with approved electrical and physical safety standard. - 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 guidance and medical device safety standards. The V8 / V7 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,<br>C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical<br>electrical equipment - Part 1: General requirements for basic safety<br>and essential performance (IEC 60601-1:2005, MOD) | | IEC 60601-1-2 | IEC60601-1-2: 2014(4th Edition) , Medical electrical equipment -<br>Part 1-2: General requirements for basic safety and essential<br>performance - EMC | | IEC 60601-2-37 | IEC 60601-2-37 Edition 2.0 2007, Medical electrical equipment -<br>Part 2-37: Particular requirements for the basic safety and essential<br>performance of ultrasonic medical diagnostic and monitoring<br>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<br>management process | | ISO14971 | ISO 14971:2007, Medical devices - Application of risk management<br>to medical devices | | NEMA UD 2-<br>2004 | NEMA UD 2-2004 (R2009) Acoustic Output Measurement Standard<br>for Diagnostic Ultrasound Equipment Revision 3 | [ The validation for expansion of the detection nerve of NerveTrack based on AI ] This is the details on validation of the AI algorithm used for all the new and improved AIbased 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 | |-----------------|------------|---------------------| |-----------------|------------|---------------------| {6}------------------------------------------------ | Accuracy (%) | $\frac{\text{Number of correctly detected frames}}{\text{Total number of frames with nerve}} \times 100$ | ≥ 80% | |--------------|----------------------------------------------------------------------------------------------------------|---------| | Speed (FPS) | $\frac{1000}{\text{Average latency time of each frame (msec)}}$ | ≥ 2 FPS | Summary Performance data, Standard Deviations & Confidence Intervals: | Validation Type | Average | Standard Deviation | 95% CI | |-----------------|---------|--------------------|--------------| | Accuracy (%) | 91.7 | 5.6 | 89.5 to 93.9 | | Speed (FPS) | 7.93 | 1.11 | 7.04 to 8.82 | 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 are 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 detected nerve was at 3.31 cm from skin. When we calculate the relationship between BMI and the maximum depth of nerves, it shows the low correlation and no significant difference of NerveTrack performance according to the patient's BMI information. So, we believe that our model is robust even if the cases with various BMI information. When collecting scan data, the speed of the probe varies from about 1cm to 5cm per second. the orientation of the probe was short-axis imaging and was perpendicular to the skin, obtained by sliding the probe 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 8 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. {7}------------------------------------------------ Image /page/7/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 training data used for the training of the NerveTrack algorithm is independent of the data used to test the NerveTrack algorithm. - 12. Summary of Clinical Tests The proposed device V8 / V7 Ultrasound System did not require clinical studies to demonstrate substantial equivalence. #### 13. Conclusion Since the predicate devices and 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 Ultrasound System should perform as intended in the specified use conditions. Therefore, SAMSUNG MEDISON CO., LTD. concludes that the performance of the subject device is as safe and effective, and is therefore substantially equivalent, to the primary predicate device that is currently marketed for the same intended use. END of 510(k) Summary -