(51 days)
The ultrasound diagnostic 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.
The RS80 EVO 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, Tissue Doppler imaging, Tissue Doppler Wave, 3D imaging mode (real-time 4D imaging mode), Elastoscan Mode or as a combination of these modes. The RS80 EVO also gives 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 RS80 EVO has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.
Here's a summary of the acceptance criteria and the study information for the Samsung Medison RS80 EVO Diagnostic Ultrasound System (K192030), based on the provided FDA 510(k) summary.
Acceptance Criteria and Device Performance (Based on Substantial Equivalence to Predicate)
The submission for the RS80 EVO Diagnostic Ultrasound System relies on demonstrating substantial equivalence to a predicate device (RS85 Diagnostic Ultrasound System, K191115) rather than providing specific performance metrics against pre-defined acceptance criteria. The acceptance criteria essentially infer that the new device performs at least as safely and effectively as the predicate device across all listed functionalities and clinical applications.
| Acceptance Criterion (Inferred from Predicate Equivalence) | Reported Device Performance (RS80 EVO) |
|---|---|
| Clinical Applications: Equivalent range of diagnostic applications as the predicate. | The exact same list of clinical applications as the predicate (RS85, K191115): Fetal/Obstetrics, Abdominal, Gynecology, Intraoperative, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-esoph. (non-Cardiac), Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric, Trans-esophageal (Cardiac), Peripheral vessel. |
| Scanhead Types: Support for equivalent probe types. | Supports the same scanhead types as predicate: Linear Array, Curved Linear Array, Endocavity, Phased Array, Static Probes. |
| Scanhead Frequency: Equivalent frequency range. | 1.0 ~ 20.0 MHz (Same as predicate). |
| Acoustic Output Display & FDA Limits: Compliance with display features and limits. | Display Feature for Higher Output (Track3), MI Output Display, TI Output Display (Same as predicate). |
| Modes of Operation: Equivalent imaging modes. | Supports the same modes of operation as predicate: B-mode, M-mode, Pulsed wave (PW) Doppler, Continuous wave (CW) Doppler, Color Doppler, Power Amplitude Doppler, Tissue Harmonic Imaging, 3D/4D imaging mode, Combined modes. |
| Transmit/Receive Channels: Equivalent hardware capabilities. | 192 transmit and 192 receive channels (Same as predicate). |
| System Characteristics: Similar physical and display specifications. | Mobile cart, 23 inch LCD Monitor (LED Backlight unit) or 23.8 inch LCD Monitor (LED Backlight unit), 256 gray shades, 100-240VAC, 1100VA, 50/60Hz. (Note: Monitor size has a slight variation, but deemed equivalent). |
| Product Safety Certification: Compliance with relevant safety standards. | IEC 60601-1, UL 60601-1, CSA C22.2 No.601.1, IEC 60601-2-37 (Same as predicate). |
| EMC Compliance: Compliance with electromagnetic compatibility standards. | IEC 60601-1-2 (Same as predicate). |
| Acoustic Output Display Standard: Adherence to display standards. | Track 3 (Same as predicate). |
| Biocompatibility Compliance: Materials biocompatibility. | ISO10993-1 (Same as predicate). |
| Software Functionality: Equivalent software features and performance. | All listed software functionalities (Q Scan, ClearVision, MultiVision, Panoramic, Needle Mate, Auto IMT+, Strain+, Stress Echo, Elastoscan, E-Thyroid, E-Breast, E-Strain, S-Shearwave, S-Detect for Breast, S-Detect for Thyroid, HQ Vision, S-Fusion, Clear Track, Virtual Track, S-3D Arterial, ADVR, 3D Imaging, 3D Imaging presentation, 3D Cine/4D Cine, 3D Rendering MPR, 3D XI MSV/Oblique View, Volume CT, 3D MagiCut, Volume Calculation, XI STIC, HDVI, RealisticVue, NaturalVue, CEUS+, MV-Flow, S-Shearwave Imaging, SonoSync) are stated to be evaluated using the same test criteria as the predicate to ensure no compromise in image quality. (Predicate listed CrystalVue, which is not listed here, but the rest are identical). |
| Transducers: Support for equivalent transducers/probes. | The same detailed list of transducers as the predicate device. |
| Biopsy Guides: Support for equivalent biopsy guides. | The same detailed list of biopsy guides as the predicate device. |
| Accessories: Support for equivalent accessories. | The same detailed list of accessories as the predicate device (with the addition of "defibrillation proof" for ECG). |
Study Information:
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Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: The submission explicitly states: "The subject of this premarket submission, RS80 EVO, did not require clinical studies to support substantial equivalence." This implies that no specific "test set" of patient data was used for a clinical study comparing the RS80 EVO directly against a gold standard or the predicate for performance metrics. Instead, the substantial equivalence relies on non-clinical testing and comparison of technological characteristics to the predicate device.
- Data Provenance: Not applicable, as no clinical study was conducted using patient data for performance evaluation in this submission.
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Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
- Not applicable, as no clinical study with a test set requiring ground truth establishment was conducted for this submission.
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Adjudication Method for the Test Set:
- Not applicable, as no clinical study with a test set requiring adjudication was conducted for this submission.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, a MRMC comparative effectiveness study was not done. The submission explicitly states no clinical studies were required to support substantial equivalence.
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Standalone (Algorithm Only Without Human-in-the-Loop) Performance Study:
- While the device includes various software functionalities (e.g., S-Detect, S-Shearwave Imaging, etc.), the submission does not describe a standalone performance study where these algorithms were evaluated independently of human operation against specific performance metrics. The evaluation was primarily focused on ensuring that "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." This suggests a comparative engineering or validation approach rather than a standalone clinical performance study of the algorithms.
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Type of Ground Truth Used:
- Not applicable for performance evaluation against a specific ground truth, as no clinical studies were performed. The "ground truth" for the substantial equivalence determination is the performance and safety profile of the predicate device (RS85). For non-clinical validation (e.g., electrical safety, EMC), appropriate engineering and testing standards (IEC, ANSI, ISO, NEMA) serve as the "ground truth" or acceptance criteria.
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Sample Size for the Training Set:
- Not applicable. As this is a 510(k) submission based on substantial equivalence to a predicate ultrasound system, the focus is on the device's technical specifications, safety, and functional equivalence, not on the training of a new AI/ML algorithm that would require a distinct training dataset. The software functionalities listed are features that were evaluated for their migration to the new system, implying they existed and were cleared in the predicate or follow established medical image processing principles.
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How the Ground Truth for the Training Set Was Established:
- Not applicable, as no specific training set for a new AI/ML algorithm is described in this submission.
§ 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.