(21 days)
The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN (useful for visualization of the ovaries, follicles, uterus and other pelvic structures), 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, pediatric, small organ, neonatal cephalic, adult cephalic, cardiac, trans-esophageal, transrectal, transvaginal, peripheral vessel, musculo-skeletal (conventional), musculo-skeletal (superficial) and neonatal cardiac} 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 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 Ultrasound 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 ultrasound systems are multi-purpose mobile, software controlled diagnostic ultrasound svstems with and on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms. The function is to acquire primary or secondary harmonic ultrasound echo data and display it in B-Mode, M-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.
Siemens Medical Solutions USA, Inc. has demonstrated the substantial equivalence of their ACUSON S1000, S2000, S3000 Diagnostic Ultrasound Systems to previously cleared predicate devices (K162243). This submission (K163635) indicates that clinical studies were not required given the devices' consistent technology and principles with existing, cleared devices.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as numerical performance metrics in the provided document. Instead, the submission relies on demonstrating substantial equivalence to a previously cleared device (K162243) based on identical indications for use and technological characteristics. The "reported device performance" is the confirmation that all features and applications are consistent with the predicate device.
| Feature/Characteristic | Acceptance Criteria (based on predicate K162243) | Reported Device Performance (This Submission) |
|---|---|---|
| Indications for Use (all listed) | Identified in K162243 | Achieved (all indicated applications are √) |
| Center Frequencies Supported (all listed) | Identified in K162243 | Achieved (all listed frequencies are √) |
| Modes (all listed) | Identified in K162243 | Achieved (all listed modes are √) |
| Features (all listed) | Identified in K162243 | Achieved (all listed features are √) |
| Patient Contact Materials | Tested to ISO 10993-1 | Tested to ISO 10993-1 |
| UL 60601-1 Certified | Certified | Certified |
| Acoustic Output | Conforms with AIUM/NEMA UD-3, UD-2, IEC 62359 | Conforms with relevant standards |
| Biocompatibility | Conforms with ISO 10993-1 | Conforms with ISO 10993-1 |
| Cleaning and Disinfection Effectiveness | Conforms with applicable standards | Conforms with applicable standards |
| Thermal, Electrical, Electromagnetic Safety | Conforms with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18, IEC 60601-2-37 | Conforms with relevant standards |
| Mechanical Safety | Conforms with applicable standards | Conforms with applicable standards |
| Software Testing | Performed to verify software release | Performed |
| Quality System | Conforms with 21 CFR 820 Quality System Regulation and ISO 13485:2003 quality standards | Conforms with regulations and standards |
2. Sample Size for the Test Set and Data Provenance
The document explicitly states that "clinical studies were not required to support substantial equivalence" because the S1000, S2000, S3000 systems in this submission use the same technology and principles as existing devices. Therefore, there is no test set of patient data and consequently no specific sample size or data provenance (country of origin, retrospective/prospective) mentioned for performance testing, as clinical performance was not re-evaluated for this submission. The evaluation focused on non-clinical tests and technological equivalence.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Since no clinical test set was used for performance evaluation, there were no experts used to establish ground truth for a test set. The evaluation was based on demonstrating equivalence to a previously cleared device (K162243) and adherence to technical standards.
4. Adjudication Method for the Test Set
As there was no clinical test set involving human interpretation for performance evaluation, no adjudication method was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission explicitly states that clinical studies were not required. The product is an ultrasound system and not an AI-assisted diagnostic tool that would typically undergo such a study to evaluate human reader improvement.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This submission is for an ultrasound diagnostic system, which is a medical imaging device operated by human users. It is not an AI-algorithm intended for standalone diagnostic performance. Therefore, a standalone performance study in the context of an algorithm's diagnostic accuracy was not done. The non-clinical tests focused on device safety and operability.
7. The Type of Ground Truth Used
For the purpose of this 510(k) submission, the "ground truth" essentially refers to the established safety and effectiveness of the predicate device (K162243) and adherence to recognized medical device safety and quality standards. These standards (e.g., ISO, IEC, AIUM/NEMA) represent a consensus on best practices and performance requirements for diagnostic ultrasound equipment.
8. The Sample Size for the Training Set
This submission is for a medical device (ultrasound system), not a machine learning algorithm that requires a "training set" of data in the conventional sense. Therefore, there is no training set sample size described. The development process would have involved engineering design, testing, and validation against specifications and standards.
9. How the Ground Truth for the Training Set Was Established
As noted above, there is no training set. The "ground truth" for the device's design and validation was established through compliance with established industry and regulatory standards for medical devices, as well as the proven performance and safety of its predicate device, K162243.
§ 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.