(35 days)
The Sequoia ultrasound imaging system is intended for use in the following applications:
General Imaging and Cardiology for Fetal, Abdominal, Intraoperative (abdominal and neurological), Pediatrics, Small Organs (breast, testes, thyroid and penis), Neonatal/Adult Cephalic, Cardiac (adult, pediatric and neonatal), Transesophageal, Transvaginal, Peripheral Vessels, and Musculosceletal (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.
Ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Intraoperative Abdominal, Intraoperative Neurological, Pediatric, Small Organ (breast, testes, thyroid, penis), Neonatal Cephalic, Adult Cephalic, Cardiac, Trans-esophageal, Transrectal, Transvaginal, Peripheral Vessel, Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Neonatal Cardiac, Intra-luminal, Intra-Cardiac.
The Siemens Acuson Sequoia is a multi-purpose diagnostic ultrasound system with accessories and proprietary software.
The provided document is a 510(k) Pre-market Notification for the Siemens ACUSON Sequoia Ultrasound System. It details intended uses and lists various transducers with their cleared applications. However, it does not contain information about specific acceptance criteria or a study proving device performance against those criteria.
The document states in Section E, "Performance Data": "The Sequoia modifications are verified and validated according to the company's design control process." This is a general statement and does not provide details of a study to demonstrate acceptance criteria. The clearance in this 510(k) is based on substantial equivalence to a predicate device (Siemens Acuson Sequoia ultrasound system (K052410)), not on new performance data demonstrating meeting specific acceptance criteria for a novel functionality.
Therefore, many of the requested items cannot be answered from the provided text.
Here's a summary of what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
Not provided in the document. The submission is based on substantial equivalence to a predicate device, not on meeting new quantitative performance criteria described in this document.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable/Not mentioned. No specific test set or data provenance for proving performance against acceptance criteria is described. The document indicates that prior applications for existing transducers were "previously cleared by the FDA under premarket notifications" (e.g., #K052410, #K051139, etc.), implying their performance was established in those earlier submissions.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable/Not mentioned.
4. Adjudication Method for the Test Set
Not applicable/Not mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable/Not mentioned. The submission is for an ultrasound system and transducers, not an AI-assisted diagnostic tool.
6. Standalone (Algorithm Only) Performance Study
Not applicable/Not mentioned.
7. Type of Ground Truth Used
Not applicable/Not mentioned. The document relies on "previously cleared" indications for use from predicate devices.
8. Sample Size for the Training Set
Not applicable/Not mentioned.
9. How the Ground Truth for the Training Set Was Established
Not applicable/Not mentioned.
Additional Information from the Document:
- Acceptance Criteria (General): The device (and its modifications) are verified and validated according to the company's design control process. This implies internal acceptance criteria for design validation, but the specifics are not disclosed in this summary.
- Proof of Meeting Acceptance Criteria: The submission relies on "substantial equivalence" to a predicate device (Siemens Acuson Sequoia ultrasound system (K052410)) for its intended uses and technological characteristics. The performance of individual transducers for specific clinical applications (e.g., Fetal, Abdominal, Cardiac) is indicated by "P=previously cleared by the FDA under premarket notifications" or "N=New Indication" for specific modes (B, M, PWD, CWD, Color Doppler, Power Doppler, Harmonic Imaging). This means the performance for these indications was established in earlier 510(k) submissions, not in this current one.
In essence, this 510(k) is a "Special 510(k)" submission, which is typically used for modifications to a manufacturer's own legally marketed device. The focus is on demonstrating that the changes do not affect the safety and effectiveness of the device as cleared in the predicate, rather than generating new performance data against specific, public-facing acceptance criteria for a novel technology.
§ 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.