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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.

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The Sequoia platform 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, 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 system is a multi-purpose diagnostic ultrasound system with accessories and proprietary software, and is substantially equivalent to our current product that is already cleared for USA distribution under the following 510(k) PreMarket Notification number: K051139 (May 13, 2005) cleared as ACUSON Sequoia™ Diagnostic Ultrasound . System. The Sequoia Diagnostic Ultrasound System has been designed to conform to the following product safety standards: UL 2601-1, Safety Requirements for Medical Equipment . CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment . AIUM/NEMA UD-2, 1998, Acoustic Output Measurement Standard for Diagnostic . Ultrasound AIUM/NEMA UD-3, 1998, Standard for Real Time Display of Thermal and . Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment 93/42/EEC Medical Device Directive . Safety and EMC Requirements for Medical Equipment . . EN 60601-1 · EN 60601-1-1 EN 60601-1-2 . ISO 10993 Biocompatibility . The system's acoustic output is in accordance with ALARA principle (as low as . reasonably achievable)

The provided document is a 510(k) Pre-Market Notification for the ACUSON Sequoia™ Ultrasound System. It primarily outlines the substantial equivalence to a previously cleared device (K051139) and lists the intended uses for various transducers. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

The document details the intended uses for a wide range of transducers and clinical applications, stating that these uses were "P=previously cleared by the FDA" under various earlier 510(k) notifications. This indicates that the current submission relies on the prior clearances for its claimed performance.

Therefore, since no new performance study is described in this document, the requested information cannot be provided based on the input text.

Here's a breakdown of why each section cannot be addressed based on the provided text:

1. Table of acceptance criteria and reported device performance: Not available. The document is a 510(k) submission primarily establishing substantial equivalence to a predicate device and listing intended uses for transducers already cleared. It does not present new performance data or acceptance criteria in the context of a new study.
2. Sample size used for the test set and data provenance: No new test set is described. The document refers to "previously cleared" applications, implying that any testing was conducted for earlier submissions.
3. Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable, as no new test set with ground truth establishment is described.
4. Adjudication method for the test set: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study, including effect size: Not applicable. The document does not describe any MRMC study or AI assistance.
6. Standalone (algorithm only without human-in-the-loop performance) study: Not applicable. This document pertains to an ultrasound system, not an AI algorithm.
7. Type of ground truth used: Not applicable, as no new ground truth establishment is described.
8. Sample size for the training set: Not applicable, as no AI algorithm or training set is mentioned.
9. How the ground truth for the training set was established: Not applicable.

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