(51 days)
The Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.
The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Intra-operative, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric, Trans-esophageal(Cardiac) and Peripheral vessel.
The Diagnostic Ultrasound System is intended for use by, or by the order of, and under the supervision of, a licensed physician 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.
The HS70A 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(S-Harmonic), Tissue Doppler imaging, Tissue Doppler Wave, 3D imaging mode (real-time 4D imaging mode), Elastoscan Mode or as a combination of these modes. The HS70A also gives the operator the ability to measure anatomical structures and offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals. The HS70A has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.
This document is a 510(k) Premarket Notification for the Samsung Medison HS70A Diagnostic Ultrasound System. It aims to demonstrate substantial equivalence to previously cleared predicate devices.
Summary of Acceptance Criteria and Device Performance:
The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing specific quantitative acceptance criteria or a dedicated study with performance metrics against those criteria for the new device features. Instead, it states that the device was evaluated against existing standards and guidance, and that migrated software functionality was tested to ensure image quality was not compromised.
The comparison table in the document indicates that the HS70A (Under Review) is largely "Same to predicate" for various features, including:
- Intended Use and Clinical Applications: Identical to predicate devices (Fetal/Obstetrics, Abdominal, Gynecology, etc.).
- Fundamental Technology: Employs the same as predicate devices.
- Operating Modes: Identical (B-mode, M-mode, PW Doppler, CW Doppler, Color Doppler, Power Amplitude Doppler, S-Harmonic, 3D imaging, ElastoScan, Combined modes).
- Scanhead Types and Frequency: Identical.
- Acoustic Output Display & FDA Limits: Identical.
- Transmit/Receive Channels: Identical (192).
- System Characteristics: Mostly identical, with an addition of a 23.8-inch monitor option (predicate had 23-inch).
- Product Safety Certification: Conforms to IEC 60601-1, CSA C22.2 No.601.1, IEC 60601-2-37.
- EMC Compliance: Conforms to IEC60601-1-2: 2014(4th Edition).
- Acoustic Output Display Standard: Track 3.
- Biocompatibility Compliance: Conforms to ISO10993-1.
- Software Functionality: Many features are "Same to predicate" (e.g., Q Scan, ClearVision, MultiVision, Auto IMT+, Strain+, S-Detect for Breast/Thyroid, 3D Imaging features, HDVI, RealisticVue, CEUS+, 5D NT, 5D LB, 5D CNS, ElastoScan, E-Thyroid, E-Breast, ArterialAnalysis).
New Features and their Predicate Clearance:
The document highlights the addition of new software features and one new transducer, which are cleared based on their presence in the second predicate device (HERA W9/W10, K192319), indicating that these features themselves have undergone prior FDA review and clearance.
| Feature | Reference in Document | Predicate Clearance |
|---|---|---|
| IOTA-ADNEX | K192319 | Same (Refer to SE analysis 1) |
| BiometryAssist | K192319 | Same (Refer to SE analysis 2) |
| CrystalVueFlow | K192319 | SE (Refer to SE analysis 3) |
| 5D Heart | K192319 | SE (Refer to SE analysis 4) |
| EV2-10A Transducer | K192319 | Same (Refer to SE analysis 5) |
This implies that the acceptance criteria for these specific features were met in their previous 510(k) clearances.
Details of the Study (as described in the document):
The document explicitly states: "The subject of this premarket submission, HS70A, is not required clinical studies to support substantial equivalence."
Instead, the submission relies on:
- Non-Clinical Tests: Evaluation for acoustic output, biocompatibility, cleaning and disinfection effectiveness, and thermal, electrical, electromagnetic, and mechanical safety, conforming with applicable medical device safety standards (e.g., ISO 14971, ANSI AAMI ES60601-1, IEC60601-1-2, ISO 10993-1, IEC60601-2-37, NEMA UD 2-2004).
- Software Functionality Evaluation: "All migrated software functionality was evaluated using the same test criteria as the predicates 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." This evaluation followed the "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices issued on May 11, 2005."
Based on the provided text, the following information is not available or not applicable:
- Sample Size Used for the Test Set and Data Provenance: Not specified for performance of new features or overall substantial equivalence, as clinical studies were not required. The non-clinical evaluations likely used test equipment and phantom data.
- Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts: Not applicable, as expert-driven ground truth for performance studies is not described.
- Adjudication Method: Not applicable.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not done.
- Standalone (algorithm only without human-in-the-loop performance) Study: Not explicitly described in terms of separate performance metrics, but the software functionality evaluation would implicitly be a standalone test for the algorithm's output.
- Type of Ground Truth Used: For non-clinical tests, physical measurements and engineering specifications would serve as ground truth (e.g., Acoustic Output, EMC, Electrical Safety). For the software functionality evaluation, the "same test criteria as the predicates" implies comparison against established performance levels or outputs of the predicate versions.
- Sample Size for the Training Set: Not applicable, as the submission focuses on substantial equivalence based on existing technology and non-clinical testing, not on developing a new AI/ML model that requires a distinct training set. The software is largely inherited or based on previously cleared modules.
- How the Ground Truth for the Training Set Was Established: Not applicable.
§ 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.