The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Intraoperative, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric, 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, Pulsed Wave (PW) Doppler mode, Continuous Wave (CW) Doppler mode, Tissue Doppler Imaging (TDI) mode, Tissue Doppler Wave (TDW) mode, Power Doppler (PD) mode, ElastoScan™ Mode, Multi-Image mode(Dual, Quad), Combined modes, 3D/4D mode

Device Description

The RS85 / RS80 EVO are a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as 2D mode, 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, Tissue Doppler imaging, Tissue Doppler Wave, 3D imaging mode (real-time 4D imaging mode), Elastoscan* Mode, MV-Flow Mode or as a combination of these modes.

The RS85 / RS80 EVO also give the operator the ability to measure anatomical structures and offers analysis packages that provide information that may aid in making a diagnosis by competent health care professionals. the RS85 / RS80 EVO have real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.

AI/ML Overview

This document describes a 510(k) submission for the Samsung Medison RS85 and RS80 EVO Diagnostic Ultrasound Systems. The submission focuses on demonstrating substantial equivalence to previously cleared predicate devices, primarily through non-clinical testing.

Based on the provided text, a significant limitation is that no clinical studies were conducted to support the substantial equivalence of the RS85/RS80 EVO. The acceptance criteria and "device performance" described below are therefore derived from non-clinical tests and comparisons to the predicate device, not from human clinical data related to diagnostic accuracy or improved patient outcomes.

Therefore, the requested information about acceptance criteria and a study proving the device meets them will be based on the provided non-clinical testing and substantial equivalence claims. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was NOT done as no clinical efficacy studies were conducted. Similarly, no standalone (algorithm-only) performance was assessed as this is not an AI-driven diagnostic device beyond what is discussed in the software evaluation context.

Acceptance Criteria and Reported Device Performance (Non-Clinical)

Since no clinical studies were performed, the "acceptance criteria" are based on compliance with regulatory standards and demonstrating comparable performance to the predicate device through non-clinical testing.

Acceptance Criterion (Non-Clinical)	Reported Device Performance
Acoustic Output Compliance	Acoustic power levels are below the applicable FDA limits. Conforms with IEC 60601-2-37:2007 + A1:2015 and NEMA UD 2-2004 (R2009).
Electrical Safety	Conforms with ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012.
Electromagnetic Compatibility (EMC)	Conforms with IEC 60601-1-2: 2014 (4th Edition).
Biocompatibility	Conforms with AAMI / ANSI / ISO 10993-1:2009/(R)2013 for materials found safe for intended use.
Reprocessing (Cleaning/Disinfection)	Effectiveness evaluated as per FDA Guidance: "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" (March 17, 2015, revised June 9, 2017).
Software/Firmware Functionality & Image Quality	All migrated software functionality evaluated using the same test criteria as the predicate 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. Compliance with "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 11, 2005).
Risk Management	Conforms with ISO 14971 Second edition 2007.
Substantial Equivalence (Overall System)	Demonstrated to be substantially equivalent to predicate devices (RS85/RS80 EVO K210959 and V8 K211945) in intended use, imaging capabilities, technological characteristics, safety, and effectiveness based on non-clinical data. This includes having the same clinical intended use, imaging modes, and capabilities (measurements, capturing images, reviewing, reporting).
New Transducer Performance	New transducers (LM2-18, LA2-9S, and migrated CA4-10M) integrated without compromising substantial equivalence. (Implied performance is equivalent to that on the V8 system for CA4-10M and meets general system standards for new ones).

Study Proving Device Meets Acceptance Criteria

The study proving the device meets the acceptance criteria is a non-clinical test program designed to demonstrate compliance with recognized standards and substantial equivalence to a predicate device, rather than a clinical efficacy or performance study on human subjects.

Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not applicable in the traditional sense of patient data. The "test set" consisted of the new RS85/RS80 EVO systems, their components (transducers, software), and their operational characteristics.
- Data Provenance: The data is based on laboratory-based non-clinical testing performed by Samsung Medison Co., Ltd. in the Republic of Korea. The testing is retrospective in the sense that it relies on established standards and comparative analysis against known predicate device performance, not forward-looking clinical trials.
Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts:
- Not applicable. Ground truth for non-clinical testing is established by compliance with published engineering and safety standards (e.g., IEC, ANSI, ISO, NEMA) and comparison to the predicate device's established performance characteristics. No human experts are used to "read" or "adjudicate" test results in the clinical diagnostic sense for this type of submission.
Adjudication Method for the Test Set:
- Not applicable. Non-clinical test results are typically evaluated against pre-defined quantitative thresholds set by the standards or against the established performance of the predicate device. There is no "adjudication" in the sense of multiple human readers resolving discrepancies.
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:
- No MRMC comparative effectiveness study was done. The submission states: "The subject of this premarket submission, RS85 / RS80 EVO, did not require clinical studies to support substantial equivalence." This device is a diagnostic ultrasound system, not explicitly an AI-assisted diagnostic tool as described in the prompt's context for MRMC studies. The software functionality evaluation focuses on maintaining image quality, not on improving human reader performance with AI.
If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No standalone algorithm performance study was done. The device itself is an ultrasound imaging system operated by a human, not a standalone AI algorithm producing diagnostic outputs without human interaction.
The Type of Ground Truth Used:
- For non-clinical testing, the "ground truth" is established by:
  - Engineering Specifications and Performance Benchmarks: Adherence to established limits for acoustic output, electrical safety, EMC, and mechanical performance.
  - Regulatory Standards: Compliance with relevant ISO, IEC, ANSI, AAMI, and NEMA standards.
  - Predicate Device Performance: The established, cleared performance characteristics and functionality of the previously marketed predicate devices (K210959 and K211945).
  - Laboratory-based measurements and tests.
The Sample Size for the Training Set:
- Not applicable. This is not an AI/machine learning submission requiring a training set for model development. The software evaluation focuses on the migration of existing, cleared software functionality.
How the Ground Truth for the Training Set was Established:
- Not applicable, as there was no training set for an AI/ML model.

Summary

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June 17, 2022

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

Re: K221117

Trade/Device Name: RS85 Diagnostic Ultrasound System, RS80 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: April 15, 2022 Received: April 18, 2022

Dear Jee Young Ju:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about 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

Michael D. O'Hara, Ph.D. Deputy Director DHT 8C: Division of Radiological Imaging and Radiation Therapy Devices OHT 8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K221117

Device Name RS85 Diagnostic Ultrasound System RS80 EVO Diagnostic Ultrasound System

Indications for Use (Describe)

The diagnostic ultrasound system and probes are designed to obtain ultrasound images and analyze body fluids.

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

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

Date Prepared April 15, 2022 1.
1. Manufacturer SAMSUNG MEDISON CO., LTD. 3366, Hanseo-ro, Nam-myeon, Hongcheon-gun, Gangwon-do 25108, REPUBLIC OF KOREA
1. Primary Contact Person Jee Young Ju Regulatory Affairs Specialist Phone: +82.2.2194.0861 Fax: +82. 2.2194.0273 Email: jee.ju@samsungmedison.com
1. Secondary Contact Person Ninad Gujar Vice President of Regulatory & Quality Phone: +1.978.564.8632 Fax: +1.978.564.8677 Email: ngujar@neurologica.com
1. Proposed Device

Common Name:	Diagnostic Ultrasound System and Accessories
Trade/Device Name:	RS85 Diagnostic Ultrasound System
	RS80 EVO Diagnostic Ultrasound System
Additional Marketing Name :	RS85 Prestige Diagnostic Ultrasound System
Regulation Name:	Ultrasound pulsed Doppler imaging system
Panel/ Regulatory Class:	Radiology / II
Product Code:	IYN, IYO, ITX
Regulation No.	892.1550, 892.1560, 892.1570

Predicate Device 6.
- RS85 / RS80 EVO Diagnostic Ultrasound System (K210959) Primary -
- V8 Diagnostic Ultrasound System (K211945) Reference -
Device Description 7.

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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, Intraoperative, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric, Trans-esophageal(Cardiac) and Peripheral vessel.

9. Technology

The RS85 / RS80 EVO employ the same fundamental scientific technology as its predicate devices.

1. Determination of Substantial Equivalence
  Comparison to Predicate: The RS85 / RS80 EVO are substantially equivalent to the predicate device 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 RS85 / RS80 EVO and predicates RS85 / RS80 EVO (K210959) have the same . clinical intended use.
. The proposed RS85 / RS80 EVO and predicates RS85 / RS80 EVO (K210959) have the same imaging modes and modes of operation.
The proposed RS85 / RS80 EVO have added new two transducers (LM2-18, LA2-9S) and one transducer(CA4-10M) has been migrated from the predicate V8(K211945).
. The proposed RS85 / RS80 EVO have added the 14-inch touch monitor as an option.
The proposed RS85 / RS80 EVO and predicates RS85 / RS80 EVO (K210959) have same . capability in terms of performing measurements, capturing digital images, reviewing and reporting studies.
. The proposed RS85 / RS80 EVO and predicates RS85 / RS80 EVO (K210959) have been designed in compliance with approved electrical and physical safety standards
. The systems are manufactured with materials which have been evaluated and found to be safe for the intended use of the device.
The systems have acoustic power levels which are below the applicable FDA limits. ●

RS85 and RS80 EVO are the same systems that provide only different option configurations. as compared with previously cleared RS85 / RS80 EVO (K210959) system, they have added new two

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transducers (LM2-18, LA2-9S) and one transducer(CA4-10M) has been migrated from the predicate V8(K211945).

1. Summary of Non-Clinical Test
  The proposed devices have 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 RS85 / RS80 EVO and its applications comply with voluntary standards.

Test	Standards and FDA Guidance
Risk Management	ISO 14971 Second edition 2007 Medical devices - Application of risk managementto medical devices
Electrical Safety	ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 andA2:2010/(R)2012Medical Electrical Equipment - Part 1: General Requirements for basic safety andessential performance.
ElectromagneticCompatibility	IEC60601-1-2: 2014(4th Edition) Medical Electrical Equipment -- Part 1-2:General Requirements For Basic Safety And Essential Performance -- CollateralStandard: Electromagnetic Disturbances -- Requirements And Tests
Biocompatibility	AAMI / ANSI / ISO 10993-1:2009/(R)2013, Biological evaluation of medicaldevices - Part 1: Evaluation and testing within a risk management process
ReprocessingMedical Devices	FDA Guidance: Reprocessing Medical Devices in Health Care Settings: ValidationMethods and Labeling issued on March 17, 2015, revised June 9, 2017.
Software/Firmware-drivenFunctionality	All migrated software functionality was evaluated using the same test criteria asthe predicate for all applicable imaging modes to ensure that migration into a newsystem design did not compromise image quality with respect to the intended useof each feature.Guidance for the Content of Premarket Submissions for Software Contained inMedical Devices issued on May 11, 2005
Ultrasound Safety	Marketing Clearance of Diagnostic Ultrasound Systems and Transducers issuedJune 27, 2019IEC60601-2-37:2007 + A1:2015, Particular requirements for the safety ofultrasonic medical diagnostic and monitoring equipmentNEMA UD 2-2004 (R2009)Acoustic Output Measurement Standard for Diagnostic Ultrasound EquipmentRevision 3

12. Summary of Clinical Tests

The subject of this premarket submission, RS85 / RS80 EVO, did not require clinical studies to support substantial equivalence.

1. Conclusion
  Since the predicate devices and subject device have a similar intended use and key technological features, the non-clinical data support the safety of the device and demonstrate that the RS85 and RS80 EVO Ultrasound System should perform as intended in the specified use conditions. Therefore, SAMSUNG MEDISON CO., LTD. concludes that the performance of the subject device is as safe and effective, and is therefore substantially equivalent, to the primary predicate device that is currently marketed for the same intended use.
END of 510(K) Summary -

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.