(9 days)
Ultrasound imaging or fluid flow analysis of the human body as follows: General Imaging and Cardiology for Fetal, Abdominal, Intraoperative (abdominal and neurological), Pediatrics, Small Organs (breast, testes, thyroid, penis and prostate), Neonatal/Adult Cephalic, Cardiac (adult, pediatric, and neonatal), Trans-esophageal, Transrectal, Transvaginal, Peripheral Vessel, and Musculo-sceletal (superficial and conventional) applications, and intended uses as defined in the FDA guidance document. 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 Sequoia with Real Time 3D Imaging is substantially equivalent to the predicates listed herein. The Sequoia is a general purpose, mobile, software-controlled, diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bioeffect mechanisms. Its function is to acquire primary or secondary harmonic ultrasound echo data and display it in B-Mode, M-Mode, Pulsed (PWD) Doppler Mode, Continuous (CWD) Doppler Mode, Color Doppler Mode, Power (Amplitude) Doppler Mode, a combination of these modes, Harmonic Imaging, 3D imaging, or Clarify VE imaging, and Real Time 3D Imaging.
The provided document is a 510(k) summary for the Siemens Medical Solutions USA, Inc. ACUSON® Sequoia Diagnostic Ultrasound System. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive clinical study data and performance metrics with acceptance criteria in the way a novel device might. Therefore, many of the requested details about acceptance criteria, clinical study design, and ground truth establishment are not explicitly present in this summary.
Based on the provided text, here's a breakdown of what can be inferred and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't present specific acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy) for a given clinical task. Instead, the acceptance criterion for regulatory clearance appears to be substantial equivalence to predicate devices. The device performance is generally described within the context of its capabilities and modes, mirroring those of its predicates.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices (K041319, K022303, K041552) | "The Sequoia with Real Time 3D Imaging is substantially equivalent to the predicates listed herein." |
| "The Sequoia functions in the same manner as other diagnostic ultrasound systems, in that they transmit ultrasonic energy into the body via a transducer. In the body, acoustic impedance of different tissues reflect different amounts of ultrasound energy back to the transducer, where post processing of received echoes is performed to generate two-dimensional or three-dimensional on-screen images of anatomic structures and fluid flow within the body." | |
| Conformance to Product Safety Standards | The Sequoia Diagnostic Ultrasound System has been designed to conform to: |
- UL 60601-1, CSA C22.2 No. 60601-1
- NEMA UD-2, NEMA UD-3
- 93/42/EEC Medical Device Directive
- EN 60601-1, EN 60601-1-1, EN 60601-1-2
- ISO 10993 Biocompatibility |
| Acoustic Output within ALARA Principle | "The system's acoustic output is in accordance with ALARA principle (as low as reasonably achievable)" |
| Intended Uses are Equivalent or Similar to Predicates | The Sequoia platform is intended for use in the specified applications: General Imaging and Cardiology for Fetal, Abdominal, etc. (pages 6 and 7 list "new indications" (N) or "previously cleared" (P) modes for specific applications, suggesting a direct comparison to existing cleared functionalities). |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not describe a clinical "test set" in the context of performance evaluation for a specific clinical task. This 510(k) is for a diagnostic ultrasound system, not an AI/CADe device, and therefore the evaluation focuses on hardware and software functionality, safety, and acoustic output, not diagnostic accuracy based on patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
Not applicable. As noted above, there's no mention of a clinical test set requiring expert ground truth for diagnostic accuracy in this submission.
4. Adjudication Method for the Test Set:
Not applicable for the reasons stated above.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC study is mentioned. The submission is for a diagnostic ultrasound system, not an AI-assisted interpretation tool for which such a study would typically be conducted.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Not applicable. This is a diagnostic imaging system, not an AI algorithm.
7. Type of Ground Truth Used:
Ground truth, in the sense of a clinical diagnostic reference standard, is not described in this document. The assessment revolves around adherence to standards, safety, specification conformance, and equivalence to predicate devices. The "ground truth" for acoustic output, for instance, would be measurements against established NEMA standards.
8. Sample Size for the Training Set:
Not applicable. This is not an AI/machine learning device that would require a training set of patient data.
9. How the Ground Truth for the Training Set Was Established:
Not applicable.
Summary of Device and Approval:
The Siemens Medical Solutions USA, Inc. ACUSON® Sequoia Diagnostic Ultrasound System is a general-purpose, mobile, software-controlled, diagnostic ultrasound system. Its function is to acquire and display ultrasound echo data in various modes (B-Mode, M-Mode, Pulsed Doppler, Continuous Doppler, Color Doppler, Power Doppler, Harmonic Imaging, 3D imaging, Real Time 3D Imaging) for a wide range of clinical applications (Fetal, Abdominal, Cardiac, Small Organs, Peripheral Vessel, etc.).
The device received 510(k) clearance (K051135) by demonstrating substantial equivalence to previously cleared predicate devices (K041319, K022303, K041552). This means the FDA determined that the new device is as safe and effective as existing legally marketed devices, sharing similar technological characteristics and intended uses. The clearance was conditional on the submission of a special report detailing complete information, including acoustic output measurements based on production line devices, as requested in Appendix G of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers."
§ 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.