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

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 automatically displayed.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

Validation Type	Definition	Acceptance Criteria	Reported Device Performance (Average)	Standard Deviation	95% Confidence Interval
Accuracy (%)	(Number of correctly detected frames / Total frames with nerve) * 100	≥ 80%	91.7%	5.6	89.5 to 93.9%
Speed (FPS)	1000 / Average latency time of each frame (msec)	≥ 2 FPS	7.93 FPS	1.11	7.04 to 8.82 FPS

Study Details

Sample Size and Data Provenance for Test Set:
- Number of Subjects: 18 (13 females, 5 males)
- Number of Images: 2,146 (1,168 from females, 978 from males)
- Country of Origin: All Koreans
- Data Provenance: The text does not explicitly state if the data was retrospective or prospective, but it describes the process of "collecting scan data" and the involvement of experts in establishing ground truth, suggesting it was acquired for the purpose of this validation.
Number of Experts and Qualifications for Ground Truth:
- Number of Experts: 15 experts (Ten anesthesiologists and five sonographers).
- Qualifications: All experts had "more than 10 years of experience."
Adjudication Method for Test Set:
- One anesthesiologist who scanned the ultrasound directly drew the initial ground truth of the nerve location.
- "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." This indicates an iterative consensus-based adjudication.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- The provided document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study to assess how human readers improve with AI vs. without AI assistance. The study focuses solely on the performance of the AI algorithm (NerveTrack) itself.
Standalone Performance (Algorithm Only):
- Yes, a standalone performance study was done. The "Acceptance Criteria" and "Summary Performance data" tables explicitly relate to the performance of the NerveTrack AI algorithm (Accuracy and Speed). The study evaluates the algorithm's ability to detect nerves independently.
Type of Ground Truth Used:
- Expert Consensus: The ground truth was established by a panel of experienced anesthesiologists and sonographers who directly drew and reviewed the nerve locations.
Sample Size for Training Set:
- The document states: "The training data used for the training of the NerveTrack algorithm is independent of the data used to test the NerveTrack algorithm." However, it does not specify the sample size of the training set.
How Ground Truth for Training Set Was Established:
- The document explicitly states that the training data and test data are independent. However, it does not provide details on how the ground truth for the training set was established. It can be inferred that a similar expert-driven annotation process likely took place for the training data, but it is not explicitly stated in the provided text.

Summary

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June 29, 2022

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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. 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

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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

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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.

Type of Use (Select one or both, as applicable)
	X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

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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.
1. Manufacturer SAMSUNG MEDISON CO., LTD. 3366, Hanseo-ro, Nam-myeon, Hongcheon-gun, Gangwon-do, Republic of Korea
1. 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 -
1. Device Description

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automatically displayed.

1. 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.

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.
1. 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

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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. .
1. 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,C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medicalelectrical equipment - Part 1: General requirements for basic safetyand essential performance (IEC 60601-1:2005, MOD)
IEC 60601-1-2	IEC60601-1-2: 2014(4th Edition) , Medical electrical equipment -Part 1-2: General requirements for basic safety and essentialperformance - EMC
IEC 60601-2-37	IEC 60601-2-37 Edition 2.0 2007, Medical electrical equipment -Part 2-37: Particular requirements for the basic safety and essentialperformance of ultrasonic medical diagnostic and monitoringequipment
ISO10993-1	AAMI / ANSI / ISO 10993-1:2009/(R)2013, Biological evaluation ofmedical devices - Part 1: Evaluation and testing within a riskmanagement process
ISO14971	ISO 14971:2007, Medical devices - Application of risk managementto medical devices
NEMA UD 2-2004	NEMA UD 2-2004 (R2009) Acoustic Output Measurement Standardfor 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
-----------------	------------	---------------------

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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.

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The training data used for the training of the NerveTrack algorithm is independent of the data used to test the NerveTrack algorithm.

1. 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 -

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
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.(b)
Classification. Class II.