(12 days)
The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal Intraoperative, Intraoperative Neurological, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications. The system also provides the ability to measure anatomical structures and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. The typical examinations performed using the SC2000 Ultrasound System are: Cardiac Imaging Applications and Analysis, Vascular Imaging Applications and Analysis, Superficial Imaging Applications, Intraoperative Imaging Applications, Transcranial Imaging Applications.
The SC2000™ Diagnostic Ultrasound System is a multi-purpose mobile, software controlled diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to acquire primary or secondary harmonic ultrasound echo data and display it in B-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Amplitude Doppler Mode, a combination of modes, 3D Imaging, or Harmonic Imaging and 4D imaging on a Flat Panel Display.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Siemens Acuson SC2000™ Diagnostic Ultrasound System. It's important to note that this document is a 510(k) summary for a modification to an already cleared device, and the focus is on demonstrating substantial equivalence, rather than proving performance from scratch for a novel device.
Acceptance Criteria and Study for Siemens Acuson SC2000™ Diagnostic Ultrasound System (Modification K123622)
This 510(k) submission primarily focuses on demonstrating substantial equivalence of a modified Acuson SC2000™ Diagnostic Ultrasound System to previously cleared predicate devices. Therefore, the "acceptance criteria" and "study" are framed in terms of compliance with regulatory standards and comparison to existing, cleared technology, rather than novel clinical performance endpoints.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Safety - Hardware | Compliance with UL 60601-1 (Safety Requirements for Medical Equipment). | The device is "designed, verified, and validated according to the company's design control process" and "meets all of its specifications." Explicitly states "Hardware Safety - EN60601-1 Certified." |
| Safety - Software | Compliance with EN60601-4 (Software Safety). | "Software Safety - EN60601-4 Certified." |
| Safety - Acoustic Thermal | Compliance with IEC 60601-2-37 (Diagnostic Ultrasound Safety Standards). Compliance with AIUM/NEMA UD-3 (Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment). Compliance with AIUM/NEMA UD-2 (Acoustic Output Measurement Standard for Diagnostic Ultrasound). | "Acoustic Thermal Safety - EN60601-2-37 Certified." "Compliance is verified through independent evaluation with ongoing factory surveillance." |
| Safety - EMC | Compliance with IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2 (EMC Requirements for Medical Equipment). | "Compliance is verified through independent evaluation with ongoing factory surveillance." Explicitly states compliance with IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2. |
| Safety - Biocompatibility | Compliance with ISO 10993-1 (Biocompatibility). For transducers, "Same transducers no new materials" implies continued biocompatibility. | "Biocompatibility - Same transducers no new materials" for all listed transducers. "Biocompatibility" for the Respirometer accessory. |
| Quality System | Compliance with 21 CFR 820 Quality System Regulation and ISO 13485:2003 quality system standards. | "The design and development process of the manufacturer conforms with 21CFR820 Quality System Requlation and ISO 13485:2003 quality system standards." |
| Intended Use | The intended uses for the modified device and its transducers are substantially equivalent to previously cleared devices. | Detailed tables for the main system and each transducer (9L4, V5M TEE, 4V1c, 8V3c, AUX CW2, 4Z1c, AcuNav 8F/10F, ACUSON AcuNav™ V 10F, SoundStar 10F, V7M TEE, 10V4) explicitly indicate "P = Previously Cleared in 510(k)" for specific clinical applications and imaging modes. No "N=new indication" is present for the system itself, only for some transducer tables where 'P' indicates presence in prior 510(k)s. |
| Technological Characteristics | The technological characteristics of the modified device are substantially equivalent to, or improve upon while maintaining safety and effectiveness, those of previously cleared predicate devices. | A comparison table (page 2) lists various hardware, software, transducer, accessories, imaging, and calculation features. All features are marked as present in either the previous SC2000™ (K113179), S2000 (K111674), X300 (K121699), or the current submission, demonstrating consistency or updates within a predicate framework. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable in the traditional sense for this submission. The 510(k) is for a modification to a previously cleared ultrasound system. The primary "test" is demonstrating compliance with recognized standards and comparison to predicate devices.
- Data Provenance: The document does not describe specific clinical test datasets. Instead, it relies on:
- Prior Clearances: K072365, K102017, K113179 (for the SC2000), K111674 (for the S2000), K121699 (for the X300).
- Nonclinical Tests: The submission relies on "extensive safety and performance testing" according to the company's design control process, and verification that the device "meets all of its specifications" (page 4).
- Standards Compliance: This includes documented adherence to various IEC, UL, CSA, AIUM/NEMA, and ISO standards (e.g., IEC 60601-1, ISO 10993-1).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. No new clinical reader studies are described in this 510(k) summary because the device is a modification and relies on substantial equivalence to predicate devices, supported by nonclinical safety and performance testing.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable, as no new clinical test set requiring expert adjudication is presented.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No. The submission explicitly states: "Since the SC2000 uses the same technology and principles as existing devices, clinical data is not required." (page 4)
- Effect Size of Human Readers Improvement with AI vs. without AI Assistance: Not applicable, as no MRMC study or AI assistance feature is mentioned or evaluated in this 510(k) summary.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: Not applicable. This document describes a diagnostic ultrasound system (hardware and software), not a standalone algorithm. The "performance" assessment is based on meeting engineering specifications, safety standards, and equivalence to existing ultrasound technology.
7. The Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" in this context is the established safety, effectiveness, and intended use of the predicate devices and the requirements of recognized regulatory standards. The modified device demonstrates its "ground truth" by showing it adheres to these established benchmarks through nonclinical testing (e.g., electrical safety, acoustic output, EMC, biocompatibility) and direct comparison of features to cleared devices.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This refers to a medical device system, not an AI/machine learning algorithm that requires a training set. The development process involved design, verification, and validation, but not in the sense of training a model on a dataset.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no mention of an AI/machine learning component requiring a training set in this 510(k) summary. The development relies on engineering principles, compliance with medical device standards, and substantial equivalence to predicate devices, which collectively establish its "ground truth" for regulatory clearance.
§ 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.