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, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric 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, 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 HS30 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, Freehand 3D, Elastoscan Mode or as a combination of these modes. The HS30 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 HS30 has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.

AI/ML Overview

This document describes the Samsung Medison Co., LTD's HS30 Diagnostic Ultrasound System, which is a general purpose ultrasound system for various clinical applications. The document focuses on showing substantial equivalence to previously cleared predicate devices (HS30 Diagnostic Ultrasound System K182632 and HS40 Diagnostic Ultrasound System K200339).

Here's an analysis based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

For this device, the "acceptance criteria" are demonstrating substantial equivalence to the predicate devices in terms of intended use, imaging capabilities, technological characteristics, safety, and effectiveness. The reported device performance is presented as being conformant to various applicable medical device safety standards.

Acceptance Criteria	Reported Device Performance
Intended Use consistency with predicate devices	Consistent with predicate devices (Fetal/Obstetrics, Abdominal, Gynecology, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric and Peripheral vessel applications).
Imaging Capabilities consistency (Modes of Operation, Scanhead Types, Scanhead Frequency, Features)	Largely consistent or expanded upon predicate devices. The HS30 (under review) explicitly lists "3D/4D mode" as a mode of operation, which was listed for the HS40 but not the primary HS30 predicate. Some transducer types and biopsy guides vary slightly but are generally comparable.
Technological Characteristics (Acoustic Output Display, System Characteristics) consistency	Consistent with predicate devices (e.g., MI/TI output display, mobile cart, LED monitor, 256 gray shades, power requirements).
Safety & Effectiveness Demonstrated by Compliance to Standards	Conforms with applicable medical device safety standards including IEC 60601-1 (general safety), IEC 60601-1-2 (EMC), IEC 60601-2-37 (ultrasonic diagnostic equipment safety), ISO 10993-1 (biocompatibility), ISO 14971 (risk management), and NEMA UD 2-2004 (acoustic output measurement).

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states: "The subject of this premarket submission, HS30 is not required clinical studies to support substantial equivalence."

Therefore, no test set, sample size, or data provenance information from clinical studies is provided for the device for the purpose of this 510(k) submission. The evaluation was non-clinical, focusing on compliance with standards and comparison to predicate devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

As no clinical studies were required, there is no mention of experts establishing a ground truth for a test set. The assessment relied on non-clinical evaluations and technical comparisons.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set was used for this submission.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This submission does not involve an AI-assisted diagnostic device or MRMC studies. The device is a diagnostic ultrasound system.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is a hardware and software diagnostic ultrasound system, not a standalone algorithm.

7. The Type of Ground Truth Used

For this 510(k) submission, the "ground truth" for proving substantial equivalence was primarily:

Compliance with recognized industry standards: IEC and ISO standards for safety, electromagnetic compatibility, acoustic output, and biocompatibility.
Comparison to legally marketed predicate devices: The functional specifications and intended uses of the HS30 (under review) were compared directly to already cleared HS30 (K182632) and HS40 (K200339) systems.

8. The Sample Size for the Training Set

Not applicable. Since no clinical studies were required for this submission, there is no mention of a training set for an algorithm development.

9. How the Ground Truth for the Training Set was Established

Not applicable, as no training set was identified in this submission.

Summary

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October 30, 2020

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

Re: K202556

Trade/Device Name: HS30 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: August 31, 2020 Received: September 3, 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

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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 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 (OS) 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,

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

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Indications for Use

510(k) Number (if known) K202556

Device Name HS30 Diagnostic Ultrasound System

Indications for Use (Describe)

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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510(k) Premarket Notification - Traditional

5. 510(K) Summarv: K202556

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

Date Prepared August 31, 2020 1.
1. Manufacturer SAMSUNG MEDISON CO., LTD. 3366, Hanseo-ro, Nam-myeon, Hongcheon-gun, Gangwon-do 25108, REPUBLIC OF KOREA
1. Primary Contact Person Ji Yea Lee Requlatory Affairs Specialist Phone: +82.2.2.2194.1594 Fax: +82.31.8017.9573 Email: jiyea722.lee@samsungmedison.com
1. Secondary Contact Person 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: HS30 Diagnostic Ultrasound System -
- Common Name: Diagnostic Ultrasound System ।
- Classification Names: system, imaqing, pulsed doppler, ultrasonic ।
- । Product Code: IYN, IYO, ITX
- -Regulation: 21 CFR 892.1550, 892.1560, 892.1570

6. Predicates

HS30 Diagnostic Ultrasound System (K182632) Primary -
HS40 Diagnostic Ultrasound System (K200339) -
1. Device Description

1. Intended Use
  The diagnostic ultrasound system and probes are designed to obtain ultrasound images

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510(k) Premarket Notification – Traditional

and analyze body fluids.

The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric 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.

1. Technology
  The HS30 employs the same fundamental scientific technology as the predicates.
1. Determination of Substantial Equivalence
  The HS30 is substantially equivalent to the predicate devices with regard to intended use, imaging capabilities, technological characteristics and safety and effectiveness.

Feature	HS30(Under Review)	HS30(K182632)Primary	HS40(K200339)
Indication forUse	- Fetal/Obstetrics- Abdominal- Gynecology- Pediatric- Small Organ- Neonatal Cephalic- Adult Cephalic- Trans-rectal- Trans-vaginal- Musculo-skel.(Conventional)- Musculo-skel.(Superficial)- Urology- Cardiac Adult- Cardiac Pediatric- Peripheral vessel	- Fetal/Obstetrics- Abdominal- Gynecology- Pediatric- Small Organ- Neonatal Cephalic- Adult Cephalic- Trans-rectal- Trans-vaginal- Musculo-skel.(Conventional)- Musculo-skel.(Superficial)- Urology- Cardiac Adult- Cardiac Pediatric- Peripheral vessel	- Fetal/Obstetrics- Abdominal- Gynecology- Pediatric- Small Organ- Neonatal Cephalic- Adult Cephalic- Trans-rectal- Trans-vaginal- Musculo-skel.(Conventional)- Musculo-skel.(Superficial)- Urology- Cardiac Adult- Cardiac Pediatric- Peripheral vessel
ScanheadTypes:	- Linear Array- Curved Linear Array- Endocavity- Phased Array- Static Probes	- Linear Array- Curved Linear Array- Endocavity- Phased Array- Static Probes	- Linear Array- Curved Linear Array- Endocavity- Phased Array- Static Probes
Scanhead Frequency	1.0 ~ 20.0 MHz	1.0 ~ 20.0 MHz	1.0 ~ 20.0 MHz
Feature	HS30(Under Review)	HS30(K182632)Primary	HS40(K200339)
AcousticOutput Display& FDA Limits:	- Display Feature forHigher Output-Track3- MI Output Display- TI Output Display	- Display Feature forHigher Output-Track3- MI Output Display- TI Output Display	- Display Feature forHigher Output-Track3- MI Output Display- TI Output Display
Modes ofOperation:	- 2D Mode- Color Doppler Mode- Power Doppler (PD)mode- M mode- Pulsed Wave (PW)Doppler mode- Continuous Wave(CW) Doppler mode- Tissue DopplerImaging (TDI) mode- Tissue Doppler Wave(TDW) mode- ElastoScan Mode- Combined modes- Multi-Image mode(Dual, Quad)- 3D/4D mode	- 2D Mode- Color Doppler Mode- Power Doppler (PD)mode- M mode- Pulsed Wave (PW)Doppler mode- Continuous Wave(CW) Doppler mode- Tissue DopplerImaging (TDI) mode- Tissue Doppler Wave(TDW) mode- ElastoScan Mode- Combined modes- Multi-Image mode(Dual, Quad)	- 2D Mode- Color Doppler Mode- Power Doppler (PD)mode- M mode- Pulsed Wave (PW)Doppler mode- Continuous Wave(CW) Doppler mode- Tissue DopplerImaging (TDI) mode- Tissue Doppler Wave(TDW) mode- ElastoScan Mode- Combined modes- Multi-Image mode(Dual, Quad)- 3D/4D mode
510(k) Track	Track 3	Track 3	Track 3
SystemCharacteristics:	- Mobile cart- LED Monitor- 256 gray shades onmonitor- 100-120V, 60 Hz;- 200-240V, 50 Hz	- Mobile cart- LED Monitor- 256 gray shades onmonitor- 100-120V, 60 Hz;- 200-240V, 50 Hz	- Mobile cart- LED Monitor- 256 gray shades onmonitor- 100-120V, 60 Hz;- 200-240V, 50 Hz
Product SafetyCertification	- IEC 60601-1- IEC60601-2-37	- IEC 60601-1- IEC60601-2-37	- IEC 60601-1- IEC60601-2-37
EMCCompliance	IEC60601-1-2	IEC60601-1-2	IEC60601-1-2
Functionality	- DICOM- Quick Scan (QScan)- ClearVision- MultiVision- Auto IMT+- Elastoscan- Panoramic- Needle Mate+- Strain +- EzExam+- 3D Imaging(Freehand 3D)- 3D Rendering (MPR)	- DICOM- Quick Scan (QScan)- ClearVision- MultiVision- Auto IMT+- Elastoscan- Panoramic- Needle Mate+- Strain +- EzExam+- 3D Imaging(Freehand 3D)- 3D Rendering (MPR)	- DICOM- Quick Scan (QScan)- ClearVision- MultiVision- Auto IMT+- Elastoscan- Panoramic- Needle Mate+- Strain +- EzExam+- 3D Imaging(Freehand 3D)- 3D Rendering (MPR)
Feature	HS30(Under Review)	HS30(K182632)Primary	HS40(K200339)
	3D MagiCut3D XI(MSV, ObliqueView, XI VOCAL)XI STIC2D NTBiometryAssistLaborAssist	3D MagiCut	3D MagiCut3D XI (MSV, ObliqueView, XI VOCAL)XI STIC2D NTBiometryAssistLaborAssist
Transducers	[Linear array]	[Linear array]	[Linear array]
	-LN5-12-L5-12/50	-LN5-12-L5-12/50	-LA3-16AD-LN5-12-L5-12/50-L4-7-LS6-15
	[Curved array]-CF4-9-C2-8-C2-5-CA2-6BM	[Curved array]-CF4-9-C2-8-C2-5	[Curved array]CA2-8AD-CF4-9-C2-8-C2-5-CA2-6BM
	[Endo Cavity]-EVN4-9-ER4-9	[Endo Cavity]-EVN4-9-ER4-9	[Endo Cavity]-EVN4-9-ER4-9
	[Phased array]-PN2-4-SP3-8	[Phased array]PN2-4	[Phased array]-PN2-4-SP3-8
	[3D]-VN4-8-EV2-10A		[3D]-VN4-8-V5-9-EV2-10A
	[CW]DP2B	[CW]DP2B	[CW]DP2B-DP8B
Biopsy Guides	BP-KIT-024	BP-KIT-024	- BP-KIT-024- BP-KIT-029
	- BP-KIT-035 [BP-KIT-035-NG]- BP-KIT-040 [BP-KIT-040-NG]- BP-KIT-045 [BP-KIT-045-NG]- BP-KIT-047 [BP-KIT-047-NG]- BP-KIT-049 [BP-KIT-049-NG]- BP-KIT-061- BP-KIT-085- BP-KIT-086	- BP-KIT-035 [BP-KIT-035-NG]- BP-KIT-040 [BP-KIT-040-NG]- BP-KIT-045 [BP-KIT-045-NG]- BP-KIT-047 [BP-KIT-047-NG]- BP-KIT-061	- BP-KIT-054 [BP-KIT-054-NG]- BP-KIT-055 [BP-KIT-055-NG]- BP-KIT-049 [BP-KIT-049-NG]- BP-KIT-060- BP-KIT-061- BP-KIT-068 [BP-KIT-068-NG]- BP-KIT-043- BP-KIT-085- BP-KIT-086
Feature	HS30(Under Review)	HS30(K182632)Primary	HS40(K200339)
optionaldevices	- Digital B/W VideoPrinter- Digital Color VideoPrinter- USB PrinterDVD recorder (DVR)	- Digital B/W VideoPrinter- Digital Color VideoPrinter- USB PrinterDVD recorder (DVR)	- Digital B/W VideoPrinter- Digital Color VideoPrinter- USB PrinterDVD recorder (DVR)
Accessories	- Foot Switch- ECGGel Warmer	- Foot Switch- ECGGel Warmer	- Foot Switch- ECGGel Warmer

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SAMSUNG

510(k) Premarket Notification – Traditional

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510(k) Premarket Notification – Traditional

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510(k) Premarket Notification - Traditional

11. Summary of Non-Clinical Test

The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electromagnetic and mechanical safety, and has been found to conform with applicable medical device safety standards. The HS30 and its applications comply with voluntary standards.

Reference No.	Title
IEC 60601-1	ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012,C1:2009/(R)2012 and A2:2010 /(R)2012Medical Electrical Equipment - Part 1: General Requirements forbasic safety and essential performance.
IEC 60601-1-2	IEC60601-1-2: 2014(4th Edition), Medical electrical equipment - Part1-2: General requirements for basic safety and essentialperformance - EMC
IEC 60601-2-37	IEC60601-2-37:2007 + A1:2015, Particular requirements for thesafety of ultrasonic medical diagnostic and monitoring equipment
ISO10993-1	ISO 10993-1, Biological evaluation of medical devices -- Part 1:Evaluation and testing within a risk management 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 Standard for Diagnostic UltrasoundEquipment Revision 3

1. Summary of Clinical Tests
  The subject of this premarket submission, HS30 is not required clinical studies to support substantial equivalence.
1. 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. considers the HS30 to be as safe, as effective, and performance is substantially equivalent to the predicate devices.

END of 510(K) Summary i

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.