(15 days)
The S2000™ ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
The system also provides the ability to measure anatomical structures {fetal, abdominal, intraoperative, intraoperative neurological, pediatric, small organ, neonatal cephalic, adult cephalic, cardiac, trans-esophageal, transvaginal, peripheral vessel, musculoskeletal (conventional), musculo-skeletal (superficial) and neonatal cardiac} and calculation packages that provide information that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular system. This feature should be utilized according to the "ASE Consensus Statement; Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Association of Echocardiography; Carotid Intima-Media Thickness Task Force, Endorsed by the Society for Vascular Imaging".
The Acuson Acunav Ultrsound Catheter is intended for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology, as well as visualization of other devices in the heart of adult and pediatric patients.
The S2000™ Ultrasound System is a multi-purpose mobile, software controlled diagnostic ultrasound system with and 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, or Harmonic Imaging and 3D/4D Imaging on a Flat Panel Display.
The Siemens Acuson S2000 Ultrasound System (K111674) is a diagnostic ultrasound system. As a 510(k) submission, the device demonstrates substantial equivalence to predicate devices, meaning it does not require new clinical studies to prove safety and effectiveness. Therefore, the information typically requested regarding acceptance criteria and separate efficacy studies is not applicable in the same way as it would be for a novel device.
The submission primarily focuses on demonstrating that the modified Acuson S2000 Ultrasound System has equivalent technological characteristics and intended uses to existing cleared devices (Acuson Antares and other S2000 systems).
Here's a breakdown of the relevant information from the provided text:
1. Acceptance Criteria and Reported Device Performance
Since this is a 510(k) submission for substantial equivalence based on
existing technology, the "acceptance criteria" are primarily met through comparisons to predicate devices and adherence to recognized safety and performance standards. There isn't a specific "device performance" section with metrics in the format of a clinical trial. Instead, performance is implied to be equivalent to the predicate devices.
The table below summarizes characteristics and their equivalence to predicate devices:
| Feature / Characteristic | Acuson S2000 (New Device) | Acuson Antares (Predicate K# 063803) |
|---|---|---|
| Indications for Use: | ||
| Fetal | √ | √ |
| Abdominal | √ | √ |
| Intraoperative abdominal and vascular | √ | √ |
| Intraoperative neurological | - | - |
| Pediatric | √ | √ |
| Small Organ | √ | √ |
| Neonatal cephalic | √ | √ |
| Adult Cephalic | √ | √ |
| Cardiac | √ | √ |
| Trans-esophageal | √ | √ |
| Transrectal | √ | √ |
| Transvaginal | √ | √ |
| Peripheral vessel | √ | √ |
| Laparoscopic | - | - |
| Musculo-skeletal (conventional) | √ | √ |
| Musculo-skeletal (superficial) | √ | √ |
| Center Frequencies Supported: | ||
| 2.0 MHz | √ | √ |
| 3.0 MHz | √ | √ |
| 3.2 MHz | √ | √ |
| 3.3 MHz | √ | √ |
| 4.2 MHz | √ | √ |
| 4.4 MHz | √ | √ |
| 4.8 MHz | √ | - |
| 5.0 MHz | √ | √ |
| 5.2 MHz | √ | √ |
| 6.0 MHz | √ | √ |
| 6.5 MHz | √ | √ |
| 6.9 MHz | √ | √ |
| 9.5 MHz | √ | √ |
| 10.0 MHz | √ | - |
| Modes: | ||
| B | √ | √ |
| Parallel processing in B mode | √ | √ |
| M | √ | √ |
| PWD (Pulsed Wave Doppler) | √ | √ |
| CWD (Continuous Wave Doppler) | √ | √ |
| D (Color Doppler) | √ | √ |
| Amplitude Doppler | √ | √ |
| Combined (BMDC) | √ | √ |
| Output Display Standard (Track 3) | √ | √ |
| Patient Contact Materials | Tested to ISO 10993-1 | Tested to ISO 10993-1 |
| UL 60601-1 Certified | √ | √ |
Key Acceptance Criteria (as per 510(k) process):
- Substantial Equivalence: The primary acceptance criterion for a 510(k) is demonstrating substantial equivalence to a legally marketed predicate device in terms of intended use, technological characteristics, and safety and effectiveness.
- Adherence to Standards: Compliance with recognized national and international safety and performance standards (e.g., UL 60601-1, IEC 60601-2-37, ISO 10993-1, AIUM/NEMA UD-3, AIUM/NEMA UD-2).
- Biocompatibility: Patient contact materials meet ISO 10993-1.
- Safety: Evaluation for acoustic output, thermal, electrical, electromagnetic, and mechanical safety.
- Cleaning and Disinfection: Effectiveness demonstrated.
2. Sample Size Used for the Test Set and Data Provenance
The provided document states: "Since the S2000 uses the same technology and principles as existing devices, clinical data is not required." This indicates that no specific clinical test set data was generated or used for this 510(k) submission to demonstrate new performance or efficacy. The substantial equivalence argument relies on the established performance and safety of the predicate devices and the technical verification of the modified device. Therefore, information on sample size, data provenance (country of origin, retrospective/prospective) for a test set, expert ground truthing, or adjudication methods is not directly applicable to this type of submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable (see point 2).
4. Adjudication Method for the Test Set
Not applicable (see point 2).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not performed or presented as part of this 510(k) submission. The submission is not designed to prove improvement with or without AI assistance, as it's a re-clearance/modification of an existing diagnostic ultrasound system based on substantial equivalence.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not performed or presented. This device is a diagnostic ultrasound system operated by a human clinician, not a standalone AI algorithm.
7. Type of Ground Truth Used
Not applicable, as no new clinical studies were conducted for efficacy. The "ground truth" for the predicate devices would have been established through methodologies typical for diagnostic ultrasound validation at the time of their original clearance (e.g., correlation with clinical outcomes, expert interpretation, pathology, or other imaging modalities), but this is not detailed for this specific submission.
8. Sample Size for the Training Set
Not applicable. There is no mention of a "training set" in the context of an AI/ML algorithm. This submission describes a hardware and software system, not an AI model requiring a training set in the modern sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable (see point 8).
In summary: The K111674 submission for the Siemens Acuson S2000 Ultrasound System demonstrates substantial equivalence to predicate devices. This means that extensive new clinical acceptance criteria studies, including test sets, ground truth establishment by experts, or AI-specific performance metrics (like MRMC or standalone performance), were not required or presented. The primary "study" is the comparison against technical specifications and intended uses of already cleared devices, and adherence to relevant safety and performance standards.
§ 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.