Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a standard diagnostic ultrasound system with various imaging modes and analysis packages, but there is no mention of AI or ML capabilities.

Therapeutic

No
The device is explicitly described as a "Diagnostic Ultrasound System" intended for "diagnostic ultrasound imaging and fluid analysis of the human body," and its function is to "acquire ultrasound data and to display the data" for "clinical diagnosis." It states it "offers analysis packages that provide information that is used to make a diagnosis." There is no mention of treating or alleviating any condition.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states, "The Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body." Also, the "Device Description" states that it "is a general purpose, mobile, software controlled, diagnostic ultrasound system."

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "Diagnostic Ultrasound System" and mentions transducers, which are hardware components essential for acquiring ultrasound data. While it is software-controlled, it is not solely software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Function: The description clearly states that the device is a "Diagnostic Ultrasound System." Ultrasound imaging is a non-invasive technique that uses sound waves to create images of internal body structures. It does not involve testing samples taken from the body.
Intended Use: The intended use is for "diagnostic ultrasound imaging and fluid analysis of the human body," and lists various anatomical sites for imaging. This aligns with the function of an ultrasound system, not an IVD.

Therefore, the HS70A Diagnostic Ultrasound System is a medical imaging device, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.

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, Trans-esophageal(Cardiac) and Peripheral vessel.

The Diagnostic Ultrasound System is intended for use by, or by the order of, and under the supervision of, a licensed physician 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.

Product codes

IYN, IYO, ITX

Device Description

The HS70A 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, 3D imaging mode (real-time 4D imaging mode), Elastoscan Mode or as a combination of these modes. The HS70A 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 HS70A has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Fetal/Obstetrics, Abdominal, Gynecology, Intra-operative, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Sketal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric, Trans-esophageal(Cardiac) and Peripheral vessel.

Indicated Patient Age Range

Neonatal Cephalic, Adult Cephalic, Pediatric, Adult

Intended User / Care Setting

The Diagnostic Ultrasound System is intended for use by, or by the order of, and under the supervision of, a licensed physician 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.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The subject of this premarket submission, HS70A, is not required clinical studies to support substantial equivalence.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K173713, K192319

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

0

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text on the right. The symbol on the left is a stylized depiction of the Department of Health & Human Services logo. The text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.

Samsung Medison Co., Ltd. % Ji Yea Lee Regulatory Affairs Specialist 3366, Hanseo-ro, Nam-myeon Hongcheon-gun, Gangwon-do 25108 REPUBLIC OF KOREA

Re: K200699

Trade/Device Name: HS70A 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 13, 2020 Received: March 17, 2020

Dear Ji Yea Lee:

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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

May 7, 2020

1

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 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.

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K200699

Device Name HS70A Diagnostic Ultrasound System

Indications for Use (Describe)

The Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.

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, Trans-esophageal(Cardiac) and Peripheral vessel.

The Diagnostic Ultrasound System is intended for use by, or by the order of, and under the supervision of, a licensed physician 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.

Type of Use (Select one or both, as applicable)	Remediation Use (Part 21 CFR 201.3 Labeling) Over-The-Counter Use (OTC)	Remediation Use (Part 21 CFR 201.3 Labeling)	Over-The-Counter Use (OTC)
Remediation Use (Part 21 CFR 201.3 Labeling)
Over-The-Counter Use (OTC)

| > Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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3

510(k) Premarket Notification - Traditional

Image /page/3/Picture/2 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white, bold letters. The background is a blue, rounded oval shape.

5. 510(K) Summarv: K200699

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

Date Prepared March 13, 2020 1.
1. Manufacturer SAMSUNG MEDISON CO., LTD. 3366, Hanseo-ro, Nam-myeon, Hongcheon-gun, Gangwon-do 25108, Republic of Korea

3. Contact Person

Primary contact Ji Yea Lee Regulatory Affairs Specialist Phone: +82.2.2194.1594 Fax: +82.31.8017.9576 Email: iivea722.lee@samsungmedison.com

Secondary Contact Ninad Gujar Director of Regulatory & Quality Phone: +1.978.564.8632 Fax: +1.978.564.8677 Email: ngujar@neurologica.com

4. Proposed Device

Common/Usual Name: Diagnostic Ultrasound System and Accessories
Proprietary Name: HS70A Diagnostic Ultrasound System
Regulation Name: Ultrasound pulsed Doppler imaging system
Panel/ Requlatory Class: Radiology / II
Product Code: IYN, IYO, ITX
Regulation : 21 CFR 892.1550, 892.1560, 892.1570
1. Predicate Device: HS70A Diagnostic Ultrasound System (K173713) Second Predicate Device:

HERA W9/HERA W10 Diagnostic Ultrasound System (K192319)

Device Description 6.

The HS70A 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, 3D imaging mode (real-time 4D imaging mode), Elastoscan Mode or as a combination of these modes. The HS70A 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 HS70A has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.

7. Indications for Use

The Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound

4

510(k) Premarket Notification - Traditional

Image /page/4/Picture/2 description: The image shows the Samsung logo. The logo consists of the word "SAMSUNG" in white, set against a blue oval background. The font is sans-serif and bold, and the letters are evenly spaced. The oval is tilted slightly to the right.

imaging and fluid analysis of the human body.

The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Intra-operative, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Sketal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric, Trans-esophageal(Cardiac) and Peripheral vessel.

The Diagnostic Ultrasound System is intended for use by, or by the order of, and under the supervision of, a licensed physician 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.

8. Technology

The HS70A employs the same fundamental scientific technology as its predicate devices.

9. Determination of Substantial Equivalence

The proposed HS70A is similar to the predicate device with regards to intended use, imaging capabilities, technological characteristics and safety and effectiveness. A comparison of the proposed device to the currently marketed predicates is provided in the table below.

HS70A	Addition of V2.02	Remarks
Clinical application	- No addition
Operation of modes	- No addition
Applied transducers	- EV2-10A	Transducer 510(k) Clearance EV2-10A K192319
SW Features	- Addition of predicate S/W features:
: IOTA-ADNEX, BiometryAssist, 5D Heart, CrystalVue Flow

Improvement of cleared S/W functions:
: Measurement, Setup&Preferences, Utility, DICOM, 5D Follicle, Sonoview | SW Features 510(k) clearance IOTA-ADNEX K192319 BiometryAssist K192319 5D Heart K192319 CrystalVue Flow K192319 | | | | | | | | | | |
| HW Features | - 23.8 inch Monitor | | | | | | | | | | | |

5

510(k) Premarket Notification – Traditional

Image /page/5/Picture/2 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white, bold letters. The word is placed inside a blue, oval-shaped background.

| | HS70A
(Under Review) | HS70A
(K173713) | HERA W9/HERA W10
(K192319) | Note |
|--------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|
| Device name | The subject device | Primary Predicate | Second Predicate | |
| Manufacturer | SAMSUNG MEDISON. | SAMSUNG MEDISON. | SAMSUNG MEDISON. | |
| Regulation No. | 892.1550
892.1560
892.1570 | 892.1550
892.1560
892.1570 | 892.1550
892.1560
892.1570 | |
| Product Code | IYN, IYO, ITX | IYN, IYO, ITX | IYN, IYO, ITX | Same to predicate |
| Intended Use | The Diagnostic Ultrasound
System and transducers are
intended for diagnostic
ultrasound imaging and fluid
analysis of the human body. | The Diagnostic Ultrasound
System and transducers are
intended for diagnostic
ultrasound imaging and fluid
analysis of the human body. | The Diagnostic Ultrasound
System and transducers are
intended for diagnostic
ultrasound imaging and fluid
analysis of the human body. | |
| clinical Application | - Fetal/Obstetrics | - Fetal/Obstetrics | Fetal/Obstetrics | Same to predicate |
| | - Abdominal | - Abdominal | Abdominal | Same to predicate |
| | - Gynecology | - Gynecology | Gynecology | Same to predicate |
| | - Intra-operative | - Intra-operative | | Same to predicate |
| | - Pediatric | - Pediatric | Pediatric | Same to predicate |
| | - Small Organ | - Small Organ | Small Organ | Same to predicate |
| | - Neonatal Cephalic | - Neonatal Cephalic | Neonatal Cephalic | Same to predicate |
| | - Adult Cephalic | - Adult Cephalic | Adult Cephalic | Same to predicate |
| | - Trans-rectal | - Trans-rectal | Trans-rectal | Same to predicate |
| | - Trans-vaginal | - Trans-vaginal | Trans-vaginal | Same to predicate |
| | - Trans-esophageal
(Cardiac) | - Trans-esophageal
(Cardiac) | | Same to predicate |
| | - Muscular-Skeletal
(Conventional, Superficial) | - Muscular-Skeletal
(Conventional, Superficial) | Muscular-Skeletal
(Conventional, Superficial) | Same to predicate |
| | - Urology | - Urology | Urology | Same to predicate |
| | - Cardiac Adult | - Cardiac Adult | Cardiac Adult | Same to predicate |
| | - Cardiac Pediatric | - Cardiac Pediatric | Cardiac Pediatric | Same to predicate |
| | - Peripheral vessel | - Peripheral vessel | Peripheral vessel | Same to predicate |
| Scanhead Types | - Linear Array | - Linear Array | Linear Array | Same to predicate |
| Device name | HS70A
(Under Review) | HS70A
(K173713) | HERA W9/HERA W10
(K192319) | Note |
| | The subject device | Primary Predicate | Second Predicate | |
| | - Curved Linear Array | - Curved Linear Array | Curved Linear Array | Same to predicate |
| | - Endocavity | - Endocavity | Endocavity | Same to predicate |
| | - Phased Array | - Phased Array | Phased Array | Same to predicate |
| | - Static Probes | - Static Probes | Static Probes | Same to predicate |
| Scanhead
Frequency | 1.0 ~ 20.0 MHz | 1.0 ~ 20.0 MHz | 1.0 ~ 20.0 MHz | Same to predicate |
| Acoustic Output
Display & FDA
Limits | - Display Feature for Higher
Output-Track3

MI Output Display
TI Output Display | - Display Feature for Higher
Output-Track3
MI Output Display
TI Output Display | - Display Feature for Higher
Output-Track3
MI Output Display
TI Output Display | Same to predicate |
| Modes of Operation | - B-mode | - B-mode | B-mode | Same to predicate |
| | - M-mode | - M-mode | M-mode | Same to predicate |
| | - Pulsed wave (PW)
Doppler | - Pulsed wave (PW) Doppler | Pulsed wave (PW) Doppler | Same to predicate |
| | - Continuous wave (CW)
Doppler | - Continuous wave (CW)
Doppler | Continuous wave (CW)
Doppler | Same to predicate |
| | - Color Doppler | - Color Doppler | Color Doppler | Same to predicate |
| | - Power Amplitude Doppler | - Power Amplitude Doppler | Power Amplitude Doppler | Same to predicate |
| | - Pulse Inversion Harmonic
Imaging (S-Harmonic) | - Pulse Inversion Harmonic
Imaging (S-Harmonic) | Pulse Inversion Harmonic
Imaging (S-Harmonic) | Same to predicate |
| | - 3D imaging mode | - 3D imaging mode | 3D imaging mode | Same to predicate |
| | - ElastoScan Mode | - ElastoScan Mode | ElastoScan Mode | Same to predicate |
| | - Combined modes | - Combined modes | Combined modes | Same to predicate |
| #Transmit Channels | 192 | 192 | 192 | Same to predicate |
| #Receive Channels | 192 | 192 | 192 | Same to predicate |
| System | - Beamformer 192 | - Beamformer 192 | Beamformer 192 | Same to predicate |
| Characteristics | - Mobile cart | - Mobile cart | Mobile cart | Same to predicate |
| | - LCD Monitor (LED
Backlight unit): | - LCD Monitor (LED
Backlight unit): | LCD Monitor (LED
Backlight unit): | Same to predicate |
| Device name | HS70A
(Under Review)
The subject device | HS70A
(K173713)
Primary Predicate | HERA W9/HERA W10
(K192319)
Second Predicate | Note |
| | 23inch, 23.8inch | 23inch | 23inch | |
| | - 256 gray shades on
monitor | - 256 gray shades on
monitor | 256 gray shades on monitor | Same to predicate |
| | - 100-240VAC, 1100VA,
50/60Hz | - 100-240VAC, 1100VA,
50/60Hz | 100-240VAC, 1100VA,
50/60Hz | Same to predicate |
| Product Safety
Certification | - IEC 60601-1 | - IEC 60601-1 | IEC 60601-1 | Same to predicate |
| | - CSA C22.2 No.601.1 | - CSA C22.2 No.601.1 | CSA C22.2 No.601.1 | Same to predicate |
| | - IEC 60601-2-37 | - IEC 60601-2-37 | IEC 60601-2-37 | Same to predicate |
| EMC Compliance | - IEC 60601-1-2 | - IEC 60601-1-2 | IEC 60601-1-2 | Same to predicate |
| Acoustic Output
Display Standard | - Track 3 | - Track 3 | Track 3 | Same to predicate |
| Biocompatibility
Compliance | - ISO10993-1 | - ISO10993-1 | ISO10993-1 | Same to predicate |
| Software
Functionality | - Q Scan | - Q Scan | - Q Scan | Same to predicate |
| | - ClearVision | - ClearVision | - ClearVision | Same to predicate |
| | - MultiVision | - MultiVision | - MultiVision | Same to predicate |
| | - Panoramic | - Panoramic | - Panoramic | Same to predicate |
| | - Needle Mate+ | - Needle Mate | - Needle Mate+ | Same to predicate |
| | - Auto IMT+ | - Auto IMT+ | - Auto IMT+ | Same to predicate |
| | - Strain+ | - Strain+ | | Same to predicate |
| | - Stress Echo | - Stress Echo | | Same to predicate |
| | - E-Strain | - E-Strain | E-Strain | Same to predicate |
| | - S-Shearwave | - S-Shearwave | | Same to predicate |
| | - S-Detect for Breast | - S-Detect for Breast | S-Detect for Breast | Same to predicate |
| Device name | HS70A
(Under Review)
The subject device | HS70A
(K173713)
Primary Predicate | HERA W9/HERA W10
(K192319)
Second Predicate | Note |
| | - S-Detect for Thyroid | - S-Detect for Thyroid | - S-Detect for Thyroid | Same to predicate |
| | - ADVR | - ADVR | - ADVR | Same to predicate |
| | - 3D Imaging (Volume Data
Acquisition) | - 3D Imaging (Volume Data
Acquisition) | - 3D Imaging (Volume Data
Acquisition) | Same to predicate |
| | - 3D Imaging presentation
(3D Cine/4D Cine/5D Cine) | - 3D Imaging presentation
(3D Cine/4D Cine/5D Cine) | - 3D Imaging presentation
(3D Cine/4D Cine/5D Cine) | Same to predicate |
| | -3D Rendering (MPR) | -3D Rendering (MPR) | -3D Rendering (MPR) | Same to predicate |
| | -3D XI (MSV/Oblique View) | -3D XI (MSV/Oblique View) | -3D XI (MSV/Oblique View) | Same to predicate |
| | -3D MXI (Volume Slice,
Mirror View) | -3D MXI (Volume Slice,
Mirror View) | -3D MXI (Volume Slice,
Mirror View) | Same to predicate |
| | - XI Volume CT (Volume
CT) | - XI Volume CT (Volume
CT) | - XI Volume CT (Volume
CT) | Same to predicate |
| | -3D MagiCut | -3D MagiCut | -3D MagiCut | Same to predicate |
| | -Volume Calculation
(VOCAL, XI VOCAL) | -Volume Calculation
(VOCAL, XI VOCAL) | -Volume Calculation
(VOCAL, XI VOCAL) | Same to predicate |
| | - XI STIC | - XI STIC | - XI STIC | Same to predicate |
| | - HDVI | - HDVI | - HDVI | Same to predicate |
| | - RealisticVue | - RealisticVue | - RealisticVue | Same to predicate |
| | - CEUS+ | - CEUS+ | - CEUS+ | Same to predicate |
| | - 5D Follicle | - 5D Follicle | | Same to predicate |
| | - HDVI | - HDVI | | Same to predicate |
| | - 5D NT | - 5D NT | - 5D NT | Same to predicate |
| | - 5D LB | - 5D LB | - 5D LB | Same to predicate |
| | - 5D CNS | - 5D CNS | - 5D CNS | Same to predicate |
| | - Auto NT (Old Name: 2D
NT) | - Auto NT (Old Name: 2D
NT) | - Auto NT (Old Name: 2D
NT) | Same to predicate |
| | - ElastoScan | - ElastoScan | - ElastoScan+ | Same to predicate |
| | - E-Thyroid | - E-Thyroid | - E-Thyroid | Same to predicate |
| | - E-Breast | - E-Breast | - E-Breast | Same to predicate |
| Device name | HS70A
(Under Review)
The subject device | HS70A
(K173713)
Primary Predicate | HERA W9/HERA W10
(K192319)
Second Predicate | Note |
| | - ArterialAnalysis | - ArterialAnalysis | | Same to predicate |
| | - IOTA-ADNEX | | - IOTA-ADNEX | Same; refer to SE
analysis 1 |
| | - BiometryAssist | | - BiometryAssist | Same; refer to SE
analysis 2 |
| | - CrystalVueFlow | | - CrystalVueFlow | SE; refer to SE
analysis 3 |
| | - 5D Heart | | - 5D Heart | SE; refer to SE
analysis 4 |
| Transducer | - CA1-7A | - CA1-7A | - CA1-7A | Same to predicate |
| | - CA2-8A | - CA2-8A | | Same to predicate |
| | - CF4-9 | - CF4-9 | - CF4-9 | Same to predicate |
| | - E3-12A | - E3-12A | - E3-12A | Same to predicate |
| | - VR5-9 | - VR5-9 | | Same to predicate |
| | - CA2-9A | - CA2-9A | | Same to predicate |
| | - CA3-10A | - CA3-10A | - CA3-10A | Same to predicate |
| | - EA2-11B | - EA2-11B | - EA2-11B | Same to predicate |
| | - L3-12A | - L3-12A | - L3-12A | Same to predicate |
| | - LA3-16A | - LA3-16A | | Same to predicate |
| | - LA3-16AI | - LA3-16AI | | Same to predicate |
| | - LA2-9A | - LA2-9A | - LA2-9A | Same to predicate |
| | - LA4-18B | - LA4-18B | - LA4-18B | Same to predicate |
| | - LM4-15B | - LM4-15B | | Same to predicate |
| | - PE2-4 | - PE2-4 | | Same to predicate |
| | - PA3-8B | - PA3-8B | - PA3-8B | Same to predicate |
| | - P4-12B | - P4-12B | | Same to predicate |
| | - PA1-5A | - PA1-5A | | Same to predicate |
| | - MMPT3-7 | - MMPT3-7 | | Same to predicate |
| | - CV1-8A | - CV1-8A | - CV1-8A | Same to predicate |
| | - V5-9 | - V5-9 | | Same to predicate |
| Device name | HS70A
(Under Review)
The subject device | HS70A
(K173713)
Primary Predicate | HERA W9/HERA W10
(K192319)
Second Predicate | Note |
| | - LV3-14A | - LV3-14A | | Same to predicate |
| | - CW4.0 | - CW4.0 | | Same to predicate |
| | - CW6.0 | - CW6.0 | | Same to predicate |
| | - DP2B | - DP2B | | Same to predicate |
| | - DP8B | - DP8B | | Same to predicate |
| | - EV2-10A | | - EV2-10A | Same; refer to SE
analysis 5 |
| Compatible
Biopsy Guide | - BP-KIT-029 | - BP-KIT-029 | - BP-KIT-029 | 510(k) Exempt |
| | - BP-KIT-030 | - BP-KIT-030 | | 510(k) Exempt |
| | - BP-KIT-041 | - BP-KIT-041 | - BP-KIT-041 | 510(k) Exempt |
| | - BP-KIT-043 | - BP-KIT-043 | - BP-KIT-043 | 510(k) Exempt |
| | - BP-KIT-053 | - BP-KIT-053 | | 510(k) Exempt |
| | - BP-KIT-054 | - BP-KIT-054 | - BP-KIT-054 | 510(k) Exempt |
| | - BP-KIT-055 | - BP-KIT-055 | | 510(k) Exempt |
| | - BP-KIT-057 | - BP-KIT-057 | - BP-KIT-057 | 510(k) Exempt |
| | - BP-KIT-058 | - BP-KIT-058 | - BP-KIT-058 | 510(k) Exempt |
| | - BP-KIT-059 | - BP-KIT-059 | - BP-KIT-059 | 510(k) Exempt |
| | - BP-KIT-060 | - BP-KIT-060 | - BP-KIT-060 | 510(k) Exempt |
| | - BP-KIT-065 | - BP-KIT-065 | - BP-KIT-065 | 510(k) Exempt |
| | - BP-KIT-066 | - BP-KIT-066 | - BP-KIT-066 | 510(k) Exempt |
| | - BP-KIT-068 | - BP-KIT-068 | | 510(k) Exempt |
| | - BP-KIT-069 | - BP-KIT-069 | - BP-KIT-069 | 510(k) Exempt |
| | - BP-KIT-071 | - BP-KIT-071 | - BP-KIT-071 | 510(k) Exempt |
| | - BP-KIT-075 | - BP-KIT-075 | | 510(k) Exempt |
| | - BP-KIT-083 | | | 510(k) Exempt |
| | - BP-KIT-085 | | - BP-KIT-085 | 510(k) Exempt |
| | - BP-KIT-086 | | - BP-KIT-086 | 510(k) Exempt |
| Digital
Storage/Transfer | - Foot Switch
ECG (defibrillation proof) | - Foot Switch
ECG (defibrillation proof) | - Foot Switch
ECG (defibrillation proof) | Same to predicate |
| Device name | HS70A
(Under Review)
The subject device | HS70A
(K173713)
Primary Predicate | HERA W9/HERA W10
(K192319)
Second Predicate | Note |
| Station | - Gel Warmer
Clear Track/ Virtual Track
System Stand
WLAN Card | - Gel Warmer
Clear Track/ Virtual Track
System Stand
WLAN Card | - Gel Warmer
Clear Track/ Virtual Track
System Stand
WLAN Card | |

6

Image /page/6/Picture/1 description: The image shows the SAMSUNG logo. The logo is in a blue oval shape with the word "SAMSUNG" in white letters. The logo is simple and recognizable.

7

Image /page/7/Picture/1 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white letters on a blue oval background. The logo is tilted slightly to the right.

8

Image /page/8/Picture/1 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white, bold letters. The wordmark is placed inside a blue, oval-shaped background.

9

Image /page/9/Picture/5 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white letters on a blue oval background. The logo is simple and recognizable.

10

Image /page/10/Picture/1 description: The image shows the Samsung logo. The logo consists of the word "SAMSUNG" in a bold, sans-serif font. The word is white and is set against a blue, oval-shaped background. The logo is simple and modern.

11

Image /page/11/Picture/1 description: The image shows the Samsung logo. The logo consists of the word "SAMSUNG" in white, set against a blue oval background. The font is sans-serif and bold, and the logo is tilted slightly.

510(k) Premarket Notification – Traditional

10. Summary of Non-Clinical Test

The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic and mechanical safety, and has been found to conform with applicable medical device safety standards. The HS70A and its applications comply with voluntary standards.

Test	Standards and FDA Guidance
Risk Management	ISO 14971 Second edition 2007 Medical devices - Application of risk management to medical devices
Electrical Safety	The HS70A Ultrasound System with defibrillation-proof ECG electrode was evaluated per the following
standards.
ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012
Medical Electrical Equipment - Part 1: General Requirements for basic safety and essential performance.
Electromagnetic
Compatibility	IEC60601-1-2: 2014(4th Edition) Medical Electrical Equipment -- Part 1-2: General Requirements For
Basic Safety And Essential Performance -- Collateral Standard: Electromagnetic Disturbances --
Requirements And Tests
Biocompatibility	ISO 10993-1 Fourth edition 2009-10-15 Biological evaluation of medical devices - Part 1: Evaluation and
testing within a risk management process.
Reprocessing Medical
Devices	FDA Guidance: Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling
issued on March 17, 2015, revised June 9, 2017.
Software/Firmware-
driven Functionality	All migrated software functionality was evaluated using the same test criteria as the predicates for all
applicable imaging modes to ensure that migration into a new system design did not compromise image
quality with respect to the intended use of each feature.
Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices issued on
May 11, 2005
Ultrasound Safety	Marketing Clearance of Diagnostic Ultrasound Systems and Transducers issued June 27, 2019
	IEC60601-2-37:2007 + A1:2015, Particular requirements for the safety of ultrasonic medical diagnostic and
monitoring equipment
	NEMA UD 2-2004 (R2009)
Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment Revision 3

12

510(k) Premarket Notification – Traditional

Image /page/12/Picture/2 description: The image shows the Samsung logo. The logo is a blue oval with the word "SAMSUNG" in white letters inside. The letters are bold and sans-serif. The logo is simple and recognizable.

1. Summary of Clinical Tests The subject of this premarket submission, HS70A, is not required clinical studies to support substantial equivalence.
1. Conclusion

SAMSUNG MEDISON CO., LTD. considers the HS70A to be as safe, as effective, and performance is substantially equivalent to the predicate devices.

-END of 510(K) Summary