RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound System

K221117 · Samsung Medison Co., Ltd. · IYN · Jun 17, 2022 · Radiology

Device Facts

• Record ID: K221117
• Device Name: RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound System
• Applicant: Samsung Medison Co., Ltd.
• Product Code: IYN · Radiology
• Decision Date: Jun 17, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: 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, 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.

Device Story

General-purpose, mobile, software-controlled diagnostic ultrasound system; acquires ultrasound data via various transducers; displays images in 2D, M-mode, Color/Power/Spectral Doppler, Harmonic, Tissue Doppler, 3D/4D, and Elastoscan modes. Used in hospitals and clinics by trained healthcare professionals. System provides real-time acoustic output indices (mechanical/thermal). Operator uses system to acquire images, perform anatomical measurements, and utilize analysis packages to aid clinical diagnosis. Benefits include non-invasive visualization of internal structures and fluid flow analysis to support diagnostic decision-making.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including acoustic output measurement, biocompatibility, cleaning/disinfection validation, and electrical/mechanical safety testing per recognized standards.

Technological Characteristics

Mobile ultrasound system; software-controlled; supports multiple imaging modes (2D, Doppler, 3D/4D, Elastoscan). Materials evaluated for biocompatibility per ISO 10993-1. Complies with IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), and IEC 60601-2-37 (ultrasound safety). Acoustic output levels below FDA limits. Optional 14-inch touch monitor. Transducers include LM2-18, LA2-9S, and CA4-10M.

Indications for Use

Indicated for fetal/obstetrics, abdominal, gynecological, intraoperative, pediatric, small organ, neonatal/adult cephalic, trans-rectal, trans-vaginal, musculoskeletal, urological, cardiac (adult/pediatric/trans-esophageal), and peripheral vessel imaging in patients requiring diagnostic ultrasound.

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

• RS85 / RS80 EVO Diagnostic Ultrasound System (K210959)

Reference Devices

• V8 Diagnostic Ultrasound System (K211945)

Submission Summary (Full Text)

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June 17, 2022

Image /page/0/Picture/1 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. The FDA logo is on the right, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. The logos are placed side by side.

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

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

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

| <span style="font-family: DejaVu Sans, sans-serif">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family: DejaVu Sans, sans-serif">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |
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|----------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|

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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.
- 2. Manufacturer SAMSUNG MEDISON CO., LTD. 3366, Hanseo-ro, Nam-myeon, Hongcheon-gun, Gangwon-do 25108, REPUBLIC OF KOREA
- 3. Primary Contact Person Jee Young Ju Regulatory Affairs Specialist Phone: [phone] Fax: [phone] Email: [e-mail]
- 4. Secondary Contact Person Ninad Gujar Vice President of Regulatory & Quality Phone: [phone] Fax: [phone] Email: [e-mail]
- 5. 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.

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.

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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.

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

#### 9. Technology

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

- 10. 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).

- 11. 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 management<br>to medical devices |
| Electrical Safety | ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and<br>A2:2010/(R)2012<br>Medical Electrical Equipment - Part 1: General Requirements for basic safety and<br>essential performance. |
| Electromagnetic<br>Compatibility | IEC60601-1-2: 2014(4th Edition) Medical Electrical Equipment -- Part 1-2:<br>General Requirements For Basic Safety And Essential Performance -- Collateral<br>Standard: Electromagnetic Disturbances -- Requirements And Tests |
| Biocompatibility | AAMI / ANSI / ISO 10993-1:2009/(R)2013, Biological evaluation of medical<br>devices - Part 1: Evaluation and testing within a risk management process |
| Reprocessing<br>Medical Devices | FDA Guidance: Reprocessing Medical Devices in Health Care Settings: Validation<br>Methods and Labeling issued on March 17, 2015, revised June 9, 2017. |
| Software/Firmware-<br>driven<br>Functionality | All migrated software functionality was evaluated using the same test criteria as<br>the predicate for all applicable imaging modes to ensure that migration into a new<br>system design did not compromise image quality with respect to the intended use<br>of each feature.<br>Guidance for the Content of Premarket Submissions for Software Contained in<br>Medical Devices issued on May 11, 2005 |
| Ultrasound Safety | Marketing Clearance of Diagnostic Ultrasound Systems and Transducers issued<br>June 27, 2019<br>IEC60601-2-37:2007 + A1:2015, Particular requirements for the safety of<br>ultrasonic medical diagnostic and monitoring equipment<br>NEMA UD 2-2004 (R2009)<br>Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment<br>Revision 3 |

### 12. Summary of Clinical Tests

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

- 13. 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 -