(60 days)
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
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.
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.
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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.
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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.
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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.
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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.
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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.
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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.
- For non-clinical testing, the "ground truth" is established by:
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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.
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How the Ground Truth for the Training Set was Established:
- Not applicable, as there was no training set for an AI/ML model.
§ 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.