(13 days)
The Siemens Acuson X300 ultrasound imaging system is intended for the following applications: General Radiology, Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Neonatal/Adult Cephalic, Cardiac, Transesophageal, Pelvic, Transcranial, OB/GYN, Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications. The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used 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 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 and Soundstar Ultrsound Catheter are 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 SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal Intraoperative, Intraoperative, 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 Acuson Acunav and Soundstar Ultrsound Catheter are intended for intra-cardiac and intraluminal 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 Diagnostic Ultrasound Systems are multi-purpose mobile, software controlled diagnostic ultrasound systems with 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.
Here's a summary of the acceptance criteria and study information based on the provided text, focusing on the request details:
Acceptance Criteria and Device Performance
The document describes the Siemens SC2000/X300 Diagnostic Ultrasound System and its various transducers. The acceptance criteria essentially focus on demonstrating substantial equivalence to previously cleared devices. The "reported device performance" is implicitly that the device performs equivalently to the predicate devices and meets safety and performance standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria / Standard Demonstrated | Reported Device Performance (as implied by the document) |
|---|---|---|
| Substantial Equivalence | Equivalence in Intended Use | Demonstrated against K132654 (SC2000), K121699 (X300), K123001 (X700), K141846 (X700), K140318 (SSe8F), K071234 (AN8F) |
| Equivalence in Technological Characteristics | Demonstrated against predicate devices | |
| Device Safety | Hardware Safety - EN60601-1 Certified | Conforms |
| Acoustic Thermal Safety - IEC 60601-2-37 Certified | Conforms | |
| Medical device software - Software Life Cycle Process - IEC 62304 | Conforms | |
| UL 60601-1, Safety Requirements for Medical Equipment | Complies | |
| CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment | Complies | |
| AIUM/NEMA UD-3 | Complies | |
| AIUM/NEMA UD-2 | Complies | |
| 93/42/EEC Medical Devices Directive | Complies | |
| EN/IEC 60601-1, EN/IEC 60601-1-1, EN/IEC 60601-1-2, EN/IEC 62304, EN/IEC 62366, EN/IEC 60601-2-18, EN/IEC 60601-2-25 | Complies | |
| Biocompatibility | ISO 10993-1 Biocompatibility | Cleared patient contact materials, electrical and mechanical safety are unchanged. |
| Cleaning & Disinfection | Cleaning and disinfection effectiveness | Evaluated and found to conform |
| Quality System | 21 CFR 820 Quality System Regulation & ISO 13485:2003 | Conforms |
2. Sample size used for the test set and the data provenance
The document explicitly states: "Since the modified devices use the same technology and principles as existing devices, clinical data is not required." This indicates that no clinical test set with human patients was used specifically for this 510(k) submission. The evaluation was based on nonclinical tests and comparison to predicate devices. Therefore, there is no sample size, country of origin, or information on retrospective/prospective data for a clinical test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
As there was no clinical test set for this 510(k) submission, there is no mention of experts used to establish ground truth for a test set. The review focused on engineering and performance standards, and comparison to previously cleared devices.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable, as no clinical test set was used.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The document describes a diagnostic ultrasound system and its transducers, not an AI-assisted diagnostic tool. No MRMC study or AI performance evaluation is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a diagnostic ultrasound system, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the nonclinical tests conducted, the "ground truth" would be established by the specifications and performance metrics outlined in the various referenced safety and performance standards (e.g., UL 60601-1, IEC 60601-2-37, etc.). For the substantial equivalence claim, the ground truth is the performance and safety profiles of the predicate devices.
8. The sample size for the training set
Not applicable, as this is a traditional diagnostic ultrasound system, not an AI/ML-based device requiring a training set.
9. How the ground truth for the training set was established
Not applicable, as no training set was used.
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.