(85 days)
Not Found
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 technology in the intended use, device description, or any other section.
No
The device is described as a "diagnostic ultrasound system" intended for obtaining ultrasound images and analyzing body fluids to aid in clinical diagnosis, not for treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The diagnostic ultrasound system and probes are designed to obtain ultrasound images and analyze body fluids." Additionally, the "Device Description" calls it a "diagnostic ultrasound system" and mentions it offers "analysis packages that provide information that may aid in making a diagnosis."
No
The device is described as a "diagnostic ultrasound system and probes" and a "general purpose, mobile, software controlled, diagnostic ultrasound system." This explicitly indicates the presence of hardware components (the system and probes) in addition to the software control.
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. They are used to examine these samples outside of the body.
- Device Function: The description clearly states that this is a diagnostic ultrasound system. Ultrasound uses sound waves to create images of internal body structures. This is an in vivo (within the living body) imaging technique, not an in vitro test.
- Intended Use: The intended use is to "obtain ultrasound images and analyze body fluids." While it mentions analyzing body fluids, the primary function and the detailed description of the modes of operation and anatomical sites all point to ultrasound imaging. The analysis of body fluids is likely a secondary function or a feature related to the ultrasound imaging (e.g., analyzing fluid accumulation seen in an ultrasound image), rather than a standalone in vitro test on a collected sample.
- Device Description: The description focuses entirely on the ultrasound imaging capabilities and analysis packages that aid in diagnosis based on these images.
Therefore, the core function and intended use of this device are related to in vivo ultrasound imaging, not in vitro diagnostic testing of samples.
N/A
Intended Use / 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, 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
Product codes
IYN, IYO, ITX
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
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.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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.
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, RS85 / RS80 EVO, did not require clinical studies to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
RS85 Diagnostic Ultrasound System (K192903)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
June 24, 3021
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
Samsung Medison Co., LTD. % Scully Kim Regulatory Affairs Specialist 3366, Hanseo-ro, Nam-myeon Hongcheon-gun, Gangwon-do 25108 REPUBLIC OF KOREA
Re: K210959
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: May 25, 2021 Received: May 27, 2021
Dear Scully Kim:
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
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
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Indications for Use
510(k) Number (if known) K210959
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)
| Prescription Use (Part 21 CFR 801 Subpart D) | X |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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SAMSUNG MEDISON CO., LTD.
K210959
RS85 / RS80 EVO Diagnostic Ultrasound System
510(K) Summary:
In accordance with 21 CFR 807.92 the following summary of information is provided:
- Date Prepared March 29, 2021 1.
-
- Manufacturer SAMSUNG MEDISON CO., LTD. 3366, Hanseo-ro, Nam-myeon, Hongcheon-gun, Gangwon-do 25108, REPUBLIC OF KOREA
-
- Primary Contact Person Scully Kim Regulatory Affairs Specialist Phone: +82.2.2.2194.1312 Fax: +82. 2.2194.0273 Email: scully.kim@samsungmedison.com
-
- Secondary Contact Person Ninad Gujar Vice President of Regulatory & Quality Phone: +1.978.564.8632 Fax: +1.978.564.8677 Email: ngujar@neurologica.com
-
- 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
- RS85 Diagnostic Ultrasound System (K192903)
-
- 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 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.
4
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. Technologv
The RS85 / RS80 EVO employ the same fundamental scientific technology as its predicate device.
-
- 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.
- Determination of Substantial Equivalence
-
The systems are all intended for diagnostic ultrasound imaging and fluid flow analysis. ●
-
. The proposed RS85 / RS80 EVO and predicate RS85(K192903) have the same clinical intended use.
-
. The proposed RS85 / RS80 EVO and predicate RS85(K192903) have the same imaging modes and modes of operation.
-
. The proposed RS85 / RS80 EVO added two new transducers (LA4-18A, LA3-22AI).
-
. The proposed RS85 / RS80 EVO and predicate RS85(K192903) have same capability in terms of performing measurements, capturing digital images, reviewing and reporting studies.
-
. The proposed RS85 / RS80 EVO and predicate RS85(K192903) 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. There is an addition of new transducers (LA4-18A, LA3-22AI) compare to previously cleared RS85 (K192903) system.
The material and design changes of MMPT3-7 transducer will be applied to all SAMSUNG
5
MEDISON products after 510(k) clearance.
The material change of Endocavity transducers (EV2-10A, EA2-11AR/EA2-11AV) will be applied to all SAMSUNG MEDISON products after 510(k) clearance.
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 to medical devices | |
| Electrical Safety | 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 | AAMI / ANSI / ISO 10993-1:2009/(R)2013, 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, |
-
|
| Software/Firmware-
driven Functionality | All migrated software functionality was 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.
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. Summary of Clinical Tests
The subject of this premarket submission, RS85 / RS80 EVO, did not require clinical studies to support substantial equivalence.
13. Conclusion
SAMSUNG MEDISON considers the RS85 and RS80 EVO to be as safe, as effective, and performance is substantially equivalent to the predicate device.
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- END of 510(K) Summary