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-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.

V5 Diagnostic Ultrasound System; cV5 Diagnostic Ultrasound System; V4 Diagnostic Ultrasound System; cV4 Diagnostic Ultrasound System:

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-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric, Thoracic, Trans-esophageal (Cardiac), Peripheral vessel and Dermatology. 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, MV-Flow Mode.

Device Description

■ V8/cV8, V7/cV7, V6/cV6
The V8/cV8, V7/cV7, V6/cV6 Diagnostic Ultrasound Systems are general purpose, mobile, software controlled, diagnostic ultrasound systems. 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/cV8, V7/cV7, V6/cV6 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/cV8, V7/cV7, V6/cV6 have real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.

■ V5/cV5, V4/cV4
The V5/cV5, V4/cV4 Diagnostic Ultrasound Systems are general purpose, mobile, software controlled, diagnostic ultrasound systems. 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 V5/cV5, V4/cV4 diagnostic ultrasound systems also give the 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 V5/cV5, V4/cV4 diagnostic ultrasound systems have a real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.

AI/ML Overview

The provided FDA 510(k) clearance letter describes the Samsung Medison Ultrasound Systems (V8/cV8, V7/cV7, V6/cV6, V5/cV5, V4/cV4) and their AI-powered features: BiometryAssist, ViewAssist, HeartAssist (fetus), and EzNerveMeasure of NerveTrack.

Below is a breakdown of the acceptance criteria and study details for each AI feature, based on the provided text.

BiometryAssist

1. Table of Acceptance Criteria and Reported Device Performance

Feature Area	Acceptance Criteria (Threshold)	Reported Device Performance
Segmentation	Average Dice-score ≥ 0.8	Average Dice-score = 0.869
Size Measurement (Circumference)	Error Rate ≤ 8%	Error Rate = 8% or less
Size Measurement (Distance)	Error Rate ≤ 4%	Error Rate = 4% or less
Size Measurement (NT)	Error Rate ≤ 1mm	Error Rate = 1mm or less

2. Sample Size for Test Set and Data Provenance

Individual Patients: 52 (17 from South Korea, 35 from the US)
Images: 320 static images
Data Provenance: Mix of retrospective and prospective data collection from hospitals in South Korea and the United States.

3. Number of Experts and Qualifications for Ground Truth

Number of Experts: 3 (one obstetrician, two sonographers) + 1 senior obstetrician for supervision.
Qualifications:
- One obstetrician with over 20 years of experience in fetal cardiology.
- Two sonographers, each with more than 10 years of experience.
- One senior obstetrician with over 25 years of clinical experience (supervised and corrected annotations).

4. Adjudication Method for Test Set

Expert reviewers manually performed view classification and measurements following the same protocol as used during actual device operation. The entire process was supervised by a senior obstetrician who reviewed and corrected all annotations to ensure consistency and accuracy. This implies an expert consensus-based adjudication, likely 3+1 or similar, though not explicitly stated as a formal (X+Y) method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not explicitly mentioned. The study focuses on standalone algorithm performance against expert ground truth.

6. Standalone Performance (Algorithm Only)

Yes, performance metrics (Dice-score, error rates) are reported for the algorithm's output compared to established ground truth.

7. Type of Ground Truth Used

Expert Consensus: Ground truth was established by expert reviewers manually classifying views and performing measurements, supervised and corrected by a senior obstetrician. This closely reflects the clinical use environment.

8. Sample Size for Training Set

Not specified. The document only states that data used for training, tuning, and validation were completely separated.

9. How Ground Truth for Training Set Was Established

All images used for training and tuning were first classified into the correct ultrasound views by three participating experts. Following view classification, the corresponding anatomical structures were manually annotated for each image.

ViewAssist

1. Table of Acceptance Criteria and Reported Device Performance

Feature Area	Acceptance Criteria (Threshold)	Reported Device Performance
View Recognition (Sensitivity)	Not explicitly stated (thresholds 75.9%, 88.2% defined)	Achieved sensitivity = 93.97%
View Recognition (Specificity)	Not explicitly stated (thresholds 75.9%, 88.2% defined)	Achieved specificity = 99.62%
Segmentation	Average Dice-score ≥ 0.8	Average Dice-score = 0.863

2. Sample Size for Test Set and Data Provenance

Individual Patients: 102 (42 from South Korea, 60 from the US)
Images: 680 static images
Data Provenance: Mix of retrospective and prospective data collection from hospitals in South Korea and the United States.

3. Number of Experts and Qualifications for Ground Truth

Number of Experts: 3 (one obstetrician, two sonographers) + 1 senior obstetrician for supervision.
Qualifications:
- One obstetrician with over 20 years of experience in fetal cardiology.
- Two sonographers, each with more than 10 years of experience.
- One senior obstetrician with over 25 years of clinical experience (supervised and corrected annotations).

4. Adjudication Method for Test Set

Expert reviewers manually performed view classification and measurements following the same protocol as used during actual device operation. The entire process was supervised by a senior obstetrician who reviewed and corrected all annotations to ensure consistency and accuracy. This implies an expert consensus-based adjudication, likely 3+1 or similar.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not explicitly mentioned. The study focuses on standalone algorithm performance against expert ground truth.

6. Standalone Performance (Algorithm Only)

Yes, performance metrics (sensitivity, specificity, Dice-score) are reported for the algorithm's output compared to established ground truth.

7. Type of Ground Truth Used

Expert Consensus: Ground truth was established by expert reviewers manually classifying views and performing measurements, supervised and corrected by a senior obstetrician. This closely reflects the clinical use environment.

8. Sample Size for Training Set

Not specified. The document only states that data used for training, tuning, and validation were completely separated.

9. How Ground Truth for Training Set Was Established

All images used for training and tuning were first classified into the correct ultrasound views by three participating experts. Following view classification, the corresponding anatomical structures were manually annotated for each image.

HeartAssist (fetus)

1. Table of Acceptance Criteria and Reported Device Performance

Feature Area	Acceptance Criteria (Threshold)	Reported Device Performance
View Recognition (Sensitivity)	Not explicitly stated (thresholds 75.9%, 88.2% defined)	Achieved sensitivity = 94.29%
View Recognition (Specificity)	Not explicitly stated (thresholds 75.9%, 88.2% defined)	Achieved specificity = 99.62%
Segmentation	Average Dice-score ≥ 0.8	Average Dice-score = 0.865
Size Measurement (Area)	Error Rate ≤ 8%	Error Rate = 8% or less
Size Measurement (Angle)	Error Rate ≤ 4%	Error Rate = 4% or less
Size Measurement (Circumference)	Error Rate ≤ 11%	Error Rate = 11% or less
Size Measurement (Diameter)	Error Rate ≤ 11%	Error Rate = 11% or less

2. Sample Size for Test Set and Data Provenance

Individual Patients: 70 (26 from South Korea, 44 from the US)
Images: 280 static images
Data Provenance: Mix of retrospective and prospective data collection from hospitals in South Korea and the United States.

3. Number of Experts and Qualifications for Ground Truth

Number of Experts: 3 (one obstetrician, two sonographers) + 1 senior obstetrician for supervision.
Qualifications:
- One obstetrician with over 20 years of experience in fetal cardiology.
- Two sonographers, each with more than 10 years of experience.
- One senior obstetrician with over 25 years of clinical experience (supervised and corrected annotations).

4. Adjudication Method for Test Set

Expert reviewers manually performed view classification and measurements following the same protocol as used during actual device operation. The entire process was supervised by a senior obstetrician who reviewed and corrected all annotations to ensure consistency and accuracy. This implies an expert consensus-based adjudication, likely 3+1 or similar.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not explicitly mentioned. The study focuses on standalone algorithm performance against expert ground truth.

6. Standalone Performance (Algorithm Only)

Yes, performance metrics (sensitivity, specificity, Dice-score, error rates) are reported for the algorithm's output compared to established ground truth.

7. Type of Ground Truth Used

Expert Consensus: Ground truth was established by expert reviewers manually classifying views and performing measurements, supervised and corrected by a senior obstetrician. This closely reflects the clinical use environment.

8. Sample Size for Training Set

Not specified. The document only states that data used for training, tuning, and validation were completely separated.

9. How Ground Truth for Training Set Was Established

All images used for training and tuning were first classified into the correct ultrasound views by three participating experts. Following view classification, the corresponding anatomical structures were manually annotated for each image.

EzNerveMeasure of NerveTrack

1. Table of Acceptance Criteria and Reported Device Performance

Feature Area	Acceptance Criteria (Threshold)	Reported Device Performance
Flattening Ratio (FR)	Not explicitly stated	Average error rate = 8.05% (95% CI: [7.64, 8.46]), Std Dev = 0.87
Cross-Sectional Area (CSA)	Not explicitly stated	Average error rate = 13.11% (95% CI: [11.83, 14.38]), Std Dev = 2.73

2. Sample Size for Test Set and Data Provenance

Individual Patients: 20 (10 from South Korea, 10 from the US)
Images: 200 static images (10 static images per patient from a 2D sequence)
Data Provenance: Prospective data collected in clinical practice using Samsung ultrasound systems (RS80A and V8) from South Korea and the United States.

3. Number of Experts and Qualifications for Ground Truth

Number of Experts: 3 anesthesiologists + 1 senior anesthesiologist for resolution.
Qualifications: All three anesthesiologists had over 10 years of experience. The senior anesthesiologist had over 10 years of extensive clinical experience in regional anesthesia and ultrasound-guided procedures.

4. Adjudication Method for Test Set

The ground truth (GT) for median nerve locations was initially drawn by one anesthesiologist performing the ultrasound scans, then verified by the other two anesthesiologists. Disagreements were resolved by a senior anesthesiologist. This is a consensus-based adjudication process, effectively a 3+1 method for resolving disagreements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not explicitly mentioned. The study focuses on standalone algorithm performance against expert ground truth.

6. Standalone Performance (Algorithm Only)

Yes, performance metrics (average error rate, confidence interval, standard deviation) are reported for the algorithm's output compared to established ground truth.

7. Type of Ground Truth Used

Expert Consensus: Ground truth (median nerve locations, FR, CSA measurements) was established by three anesthesiologists, with disagreements resolved by a senior anesthesiologist. A clinical evaluation was also conducted by experienced doctors to assess clinical significance.

8. Sample Size for Training Set

Not specified. The document only states that data used for training, tuning, and validation were completely separated.

9. How Ground Truth for Training Set Was Established

Not explicitly detailed for the training set itself, but it implies a similar expert annotation process as described for validation, with clear separation between data sets.

Summary

FDA 510(k) Clearance Letter - Samsung Medison Ultrasound Systems

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.08.00

Samsung Medison Co., Ltd.
Yujin Kim
Regulatory Affairs Specialist
3366, Hanseo-ro, Nam-myeon
Hongcheon-gun, Gangwon-do 25108
REPUBLIC OF KOREA

Re: K250999

Trade/Device Name: V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System; V5 Diagnostic Ultrasound System; cV5 Diagnostic Ultrasound System; V4 Diagnostic Ultrasound System; cV4 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, LLZ, QIH
Dated: June 17, 2025
Received: June 17, 2025

Dear Yujin 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 (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

July 18, 2025

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K250999 - Yujin Kim
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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).

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 (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-reporting-combination-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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the

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K250999 - Yujin Kim
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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-devices/device-advice-comprehensive-regulatory-assistance/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,

MARJAN NABILI -S for

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

Enclosure

Page 4

FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

510(k) Number (if known): K250999

Device Name: V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System; V5 Diagnostic Ultrasound System; cV5 Diagnostic Ultrasound System; V4 Diagnostic Ultrasound System; cV4 Diagnostic Ultrasound System

Indications for Use (Describe)

V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System:

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.

V5 Diagnostic Ultrasound System; cV5 Diagnostic Ultrasound System; V4 Diagnostic Ultrasound System; cV4 Diagnostic Ultrasound System:

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

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