HM70 EVO Diagnostic Ultrasound System

K233112 · Samsung Medison Co., Ltd. · IYN · Dec 21, 2023 · Radiology

Device Facts

• Record ID: K233112
• Device Name: HM70 EVO Diagnostic Ultrasound System
• Applicant: Samsung Medison Co., Ltd.
• Product Code: IYN · Radiology
• Decision Date: Dec 21, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: AI/ML, Pediatric

Intended Use

The diagnostic ultrasound system and probes are designed to obtain ultrasound images and analyze body fluids. The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric, Trans-esophageal (Cardiac), Peripheral vessel, Lung 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 (includes emergency room), private practices, clinics and similar care environment for clinical diagnosis of patients.

Device Story

HM70 EVO is a mobile, software-controlled diagnostic ultrasound system. It acquires ultrasound data via transducers to generate 2D, M-mode, Doppler (Color, Power, PW, CW, Tissue), 3D/4D, and ElastoScan images. Operated by trained healthcare professionals in hospitals, clinics, and private practices. The system includes AI-based software features (NerveTrack, UterineAssist) to assist in anatomical feature detection and measurement. Output is displayed in real-time for clinical diagnosis; clinicians use these measurements and images to inform diagnostic decisions. Benefits include enhanced visualization and automated analysis of anatomical structures, potentially improving diagnostic efficiency and accuracy.

Clinical Evidence

Bench testing only. No clinical studies were required. Performance of AI features was validated using retrospective and prospective datasets. UterineAssist (n=600 images) achieved 96% dice-score for uterus and 92% for endometrium; feature point errors ≤5.8mm (uterus) and ≤4.3mm (endometrium); measurement errors ≤2.0mm. NerveTrack accuracy was 91.5% (95% CI: 88.35-94.65%) with a processing speed of 3.71 FPS. Testing confirmed robustness across BMI subgroups.

Technological Characteristics

Mobile ultrasound system; 2D, M-mode, Doppler, 3D/4D, and ElastoScan modes. Materials evaluated per ISO 10993-1. Connectivity includes digital image capture and reporting. Software includes AI-based algorithms for segmentation and measurement. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, and NEMA UD 2-2004. Power supplied via AC or portable power pack (MEPP).

Indications for Use

Indicated for patients requiring diagnostic ultrasound imaging and body fluid analysis across various clinical applications including fetal/obstetrics, abdominal, gynecology, pediatric, small organ, neonatal/adult cephalic, trans-rectal, musculoskeletal, urology, cardiac, peripheral vessel, lung, and dermatology. No specific age or gender contraindications provided.

Regulatory Classification

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.

Predicate Devices

• HM70 EVO Diagnostic Ultrasound System (K220269)
• V8 Diagnostic Ultrasound System (K223387)
• FUJIFILM SonoSite Vevo MD Imaging System (K190476)

Submission Summary (Full Text)

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December 21, 2023

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a larger font size than the full name. The full name of the agency is "U.S. Food & Drug Administration".

Samsung Medison CO., LTD. % So-Yeon Jang Regulatory Affairs Specialist 3366. Hanseo-ro. Nam-myeon Hongcheon-gun, Gangwon-do 25108 SOUTH KOREA

### Re: K233112

Trade/Device Name: HM70 EVO 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 27, 2023 Received: September 27, 2023

### Dear So-Yeon Jang:

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).

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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 ([e-mail]) or phone [phone] 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

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### Indications for Use

510(k) Number (if known) K233112

#### Device Name

HM70 EVO 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, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric, Trans-esophageal (Cardiac), Peripheral vessel, Lung 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 (includes emergency room), 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 style="font-family: sans-serif;"> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span style="font-family: sans-serif;"> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
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510(k) Premarket Notification - Traditional

### K233112

### 510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided:

- Date Prepared September 27, 2023 1.
- 2. Manufacturer SAMSUNG MEDISON CO., LTD. 3366, Hanseo-ro, Nam-myeon, Hongcheon-gun, Gangwon-do 25108, REPUBLIC OF KOREA
- Primary Contact Person 3. So-Yeon Jang Regulatory Affairs Specialist Phone: [phone] Fax: [phone] Email: sy24.jang(@samsungmedison.com
- Secondary Contact Person 4. Ninad Gujar Vice President Phone: [phone] Fax: [phone] Email: [e-mail]
- 5. Proposed Device
- Proprietary Name: HM70 EVO Diagnostic Ultrasound System
- Common Name: System, Imaging, Pulsed Doppler, Ultrasonic System, Imaging, Pulsed Echo, Ultrasonic Transducer, Ultrasonic, Diagnostic
- Classification: 21 CFR 892.1550 Ultrasonic pulsed doppler imaging system 21 CFR 892.1560 Ultrasonic pulsed echo imaging system 21 CFR 892.1570 Diagnostic ultrasonic transducer
- Product Code(s): IYN, IYO, ITX
- Predicate Device 6.
- HM70 EVO Diagnostic Ultrasound System (K220269) Primary V8 Diagnostic Ultrasound System (K223387) FUJIFILM SonoSite Vevo MD Imaging System (K190476)
- 7. Device Description

The HM70 EVO is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as 2D mode. M mode, Color Doppler imaging, Power Doppler imaging (including Directional Power Doppler mode; S-Flow), PW Spectral Doppler mode, CW Spectral Doppler mode, Harmonic imaging(S-Harmonic), Tissue Doppler imaging, Tissue Doppler Wave, Panoramic Imaging,

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510(k) Premarket Notification - Traditional

Freehand 3D, 3D imaging mode (real-time 4D imaging mode), Elastoscan Mode or as a combination of these modes. The HM70 EVO also gives 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 HM70 EVO has real time acoustic output display with two basic indices, a mechanical index and a thermal index. which are both automatically displayed.

- 8. Indications for Use
The diagnostic ultrasound system and probes are designed to obtain ultrasound images and analyze body fluids.

The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric, Transesophageal (Cardiac), Peripheral vessel, Lung 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 (includes emergency room), 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. Technology
The HM70 EVO employs the same fundamental scientific technology as its predicate devices.

- 10. Determination of Substantial Equivalence
Comparison to Predicates: The HM70 EVO is 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 HM70 EVO and the predicates HM70 EVO (K220269), V8 (K223387) and VEVO MD Imaging system (K190476) have the same intended use.
- . The proposed HM70 EVO has added a clinical application for dermatology.
- The proposed HM70 EVO has added a new transducer L3-22, and another transducer . LA3-22AI migrated from the predicate V8 (K223387). Biocompatibility test has been conducted for the new transducer, and image performance tests have been conducted for both.

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510(k) Premarket Notification - Traditional

- . The proposed HM70 EVO has added SW functions NerveTrack and UterineAssist based on AI technology, previously cleared in V8 (K223387).
- The proposed HM70 EVO has added a MEPP (Minimal Extended Power Pack) as an ● additional portable power supply.
- . The proposed HM70 EVO has added a new type of Gel Warmer as an accessory.
- 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.
- The proposed HM70 EVO and the predicates HM70 EVO (K220269), V8 (K223387) ● and VEVO MD Imaging system (K190476) have similar capability in terms of performing measurements, capturing digital images, reviewing and reporting studies.
- The proposed HM70 EVO and predicates have been designed in compliance with . approved electrical and physical safety standards.

### 11. Summary of Non-Clinical Test

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 HM70 EVO and its applications comply with the following FDA-recognized standards.

| Reference No. | Title |
|----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 60601-1 | ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012,<br>C1:2009/(R)2012 and A2:2010 /(R)2012 Medical Electrical<br>Equipment - Part 1: General Requirements for basic safety and<br>essential performance. |
| IEC 60601-1-2 | IEC60601-1-2: 2020(4.1 Edition), Medical electrical equipment -<br>Part 1-2: General requirements for basic safety and essential<br>performance - EMC |
| IEC 60601-2-18 | IEC 60601-2-18: Edition 3.0 2009-08<br>Medical electrical equipment - Part 2-18: Particular requirements for<br>the basic safety and essential performance of endoscopic equipment |
| IEC 60601-2-37 | IEC60601-2-37:2007 + A1:2015, Particular requirements for the<br>safety of ultrasonic medical diagnostic and monitoring equipment |
| ISO10993-1 | ISO 10993-1:2018, Biological evaluation of medical devices -- Part<br>1: Evaluation and testing within a risk management process. |
| ISO14971 | ISO 14971:2019, Medical devices - Application of risk management<br>to medical devices |
| NEMA UD 2-2004 | NEMA UD 2-2004 (R2009)<br>Acoustic Output Measurement Standard for Diagnostic Ultrasound<br>Equipment Revision 3 |

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510(k) Premarket Notification - Traditional

| IEC 62304 | ANSI AAMI IEC 62304:2006/A1:2016 |
|-----------|--------------------------------------------------------------------|
| | Medical device software - Software life cycle processes [Including |
| | Amendment 1 (2016)] |

#### [ The Summary of Testing for UterineAssist]

- Summary test statistics or other test results including acceptance criteria or other information supporting the appropriateness of the characterized performance.
We tested on three areas : image segmentation, feature points extraction and size measurement.

- □ Segmentation test
- ் A deep learning based segmentation algorithm was validated using 450 sagittal uterus images and 150 transverse uterus images collected at three hospitals.
- ் The average dice-score of uterus is 96%
- · The average dice-score of endometrium is 92%
- □ Feature points extraction test
- · We acquired, in addition, 45 sagittal and 41 transverse plane images of uterus collected at three hospitals.
- · The errors of uterus feature points are 5.8 mm or less
- · The errors of endometrium feature points are 4.3 mm or less
- □ Size measurement test
- · We use same data set of Feature points extraction test
- · The errors of Measurements performance are 2.0 mm or less
- Demographic distribution:
- □ Gender : Female
- □ Age : Reproductive age, specific age not collected
- □ Ethnicity/Country : All Koreans
- Information about clinical subgroups and confounders present in the dataset:
- | | We divided the sagittal uterus images, depending on the shape of the endometrium, into 4 phases : early proliferative, peri-ovulatory, secretory, and post-menopause.
- | | During testing, a differentiation is made between good image quality and challenging image quality data set.

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510(k) Premarket Notification - Traditional

■ Information about equipment and protocols used to collect images

- | | We acquired the data set with 4 SAMSUNG MEDISON's ultrasound systems and probes in order to secure diversity of the data set: Mix of data from retrospective data collection and prospective data collection in clinical practice
- Information about how the reference standard was derived from the dataset (i.e. the "truthing" process) :
- □ Segmentation of the ground truth was generated by three participating OB/GYN experts with more than 10 years' experience.
- □ The set of images (uterus and endometrium) were divided into 3 subsets and the three participating OB/GYN experts each drew the ground truths for one of the subsets.
- □ The ground truths drawn by an expert were cross-checked by the other two experts. Any images that do not meet the inclusion/exclusion criteria were excluded from the set of images.
- Description of how the independence of test data from training data was ensured:
- [ ] Data used for test/training validation purpose are completely separated from the ones during training process and there is no overlap between the two.

[ The validation for expansion of the detection nerve of NerveTrack based on AI ]

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.

| Validation Type | Definition | Acceptance Criteria |
|-----------------|----------------------------------------------------------------------------------------------------------|---------------------|
| 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 |

Acceptance Criteria:

Summary Performance data, Standard Deviations & Confidence Intervals:

| Validation Type | Average | Standard Deviation | 95% CI |
|-----------------|---------|--------------------|----------------|
| Accuracy (%) | 91.50 | 5.08 | 88.35 to 94.65 |
| Speed (FPS) | 3.71 | 0.06 | 3.65 to 3.78 |

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510(k) Premarket Notification - Traditional

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 the detected nerve was 3.31 cm from skin. When we calculate the relationship between BMI and the maximum depth of nerves, it shows a 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 exist.

| | 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 | | |

Testing Data Information on BMI:

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 perpendicular to the skin, obtained by sliding the probe in both the proximal and distal directions.

Ten anesthesiologists and five sonographers with more than 10 years of experience participated to establish the ground truth (GT) for the location of 10 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.

- 12. Summary of Clinical Tests
The subject of this premarket submission, HM70 EVO, is not required clinical studies to support substantial equivalence.

- 13. 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.

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510(k) Premarket Notification – Traditional

considers the HM70 EVO to be as safe, as effective, and performance is substantially equivalent to the primary predicate device (K220269) that is currently marketed for the same intended use.

- END of 510(k) Summary -