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The CV70 ultrasound imaging system is intended for the following applications: Abdominal, Fetal, OB/GYN, Cardiac, Intracardiac, Transesophageal, Intraoperative, Small Parts, Transcranial, Cerebrovascular, Musculoskeletal, Superficial Musculoskeletal, Great Vessel, and Peripheral Vascular applications. The system also provides for the measurement of anatomical structures and for analysis of information that is used for clinical diagnosis purposes.

The CV70 is a general purpose, mobile, software-controlled, diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bioeffect an on-screen display for thermal and re primary or secondary harmonic ultrasound echo data and modiantinin B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, ulsplay it in. D Mode, it would (f Mode, a combination of modes, or Harmonic Imaging, or 3D imaging, on a CRT display.

This document is a 510(k) Premarket Notification summary for the ACUSON CV70™ Cardiovascular System, an ultrasound diagnostic system and its associated transducers. It establishes substantial equivalence to previously cleared predicate devices. Therefore, the document describes the device's intended use and technological comparison, rather than presenting a study proving performance against acceptance criteria for a novel AI/CAD device.

As such, the information required for this request (acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, and MRMC study details) is not applicable in this regulatory submission. This document pertains to the market clearance of a diagnostic ultrasound system based on its substantial equivalence to already approved predicate devices, not on a new performance study proving its diagnostic accuracy.

The key points from the provided document are:

• Device Name: ACUSON CV70™ Cardiovascular System
• Device Type: Diagnostic Ultrasound System with Accessories
• Regulation Numbers: 21 CFR 892.1550 (Ultrasonic pulsed doppler imaging system), 21 CFR 892.1560 (Ultrasonic pulsed echo imaging system), 21 CFR 892.1570 (Diagnostic ultrasound transducer), 21 CFR 870.1200 (Diagnostic intravascular catheter)
• Regulatory Class: II
• Product Codes: 90 IYN, IYO, ITX, and 74 DQO
• Predicate Devices: K042770 (ACUSON CV70™ Cardiovascular System) and K042593 (ACUSON Sequoia™ Diagnostic Ultrasound System). This indicates the device is considered substantially equivalent to existing devices, meaning its safety and effectiveness are established by comparison to these predicates rather than requiring a new clinical performance study as might be the case for a novel AI device.
• Intended Uses: Abdominal, Fetal, OB/GYN, Cardiac, Intracardiac, Transesophageal, Intraoperative, Small Parts, Peripheral, Cerebrovascular, Musculoskeletal, Superficial Musculoskeletal, Great Vessel, and Peripheral Vascular applications. It also provides for measurement of anatomical structures and analysis of information for clinical diagnosis.
• Technological Comparison: The CV70 is deemed "substantially equivalent" to the predicate devices. All systems transmit ultrasonic energy, perform post-processing to generate on-screen displays, and allow specialized measurements and calculations.

In summary, this document is a 510(k) clearance, which relies on demonstrating similarity to existing devices, not on a new performance study with acceptance criteria for diagnostic accuracy.

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Diagnostic imaging or fluid flow analysis of the human body as follows: Abdominal, Intraoperative, Small Parts, Transcranial, OB/GYN, Cardiac, Transesophageal, Pelvic, Neonatal/Adult Cephalic, 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 CV70 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 (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Amplitude Doppler Mode, a combination of modes, or Harmonic Imaging, or 3D imaging, on a CRT display.

The provided document is a 510(k) Pre-Market Notification for the ACUSON CV70™ Cardiovascular System, submitted by Siemens Medical Solutions USA, Inc. in 2004. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving the device meets specific acceptance criteria through a clinical study with performance metrics.

Therefore, the document does not contain the acceptance criteria or a study proving the device meets acceptance criteria in the way typically expected for a new medical device claiming specific performance metrics (e.g., sensitivity, specificity, accuracy).

Instead, the document focuses on:

• Substantial Equivalence: Comparing the ACUSON CV70™ to previously cleared predicate devices (K032111 and K041319) based on intended use, technological characteristics, and safety standards.
• Intended Uses: Listing the clinical applications for which the system, and various transducers, are intended (e.g., Abdominal, Cardiac, Vascular imaging).
• Safety Standards: Demonstrating compliance with various safety and EMC standards (e.g., UL 2601-1, CSA C22.2 No. 601-1, IEC 60601-1, AIUM/NEMA standards for acoustic output, ISO 10993 for biocompatibility).
• Device Description: Describing the system's general function (acquiring and displaying ultrasound echo data in various modes).

Key reasons why the requested information is not present:

• 510(k) Pathway: The 510(k) pathway is primarily about demonstrating substantial equivalence, not about proving clinical effectiveness or performance against pre-defined acceptance criteria through a de novo clinical study. Clinical trials with specified endpoints and performance metrics are more common for PMA (Pre-Market Approval) submissions or sometimes for De Novo classifications, or if there's a significant change in intended use or technology that doesn't fit within an existing predicate.
• Device Type: Diagnostic ultrasound systems are generally well-established technology. The submission is for a "general purpose, mobile, software-controlled, diagnostic ultrasound system." The performance of such systems is often evaluated against established standards and through general validation (e.g., image quality assessment, measurement accuracy), rather than through specific, quantifiable acceptance criteria on a clinical dataset with AI-like metrics (sensitivity, specificity).
• Timing: This submission is from 2004, prior to the widespread adoption of AI/ML in medical devices, which typically requires more rigorous performance validation against ground truth and specific acceptance criteria. The document makes no mention of AI or machine learning components.

Therefore, I cannot populate the table or provide the requested details about acceptance criteria, study sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set ground truth because this information is not included in the provided 510(k) summary.

The tables provided in the document list the intended uses for each transducer and the available imaging modes, explicitly stating whether these indications were "previously cleared by FDA (K032111)" (P) or "added under Appendix E" (E) or are "new indications" (N). This is a demonstration of equivalence, not performance against acceptance criteria.

The "acceptance criteria" in this context refer to compliance with safety standards and substantial equivalence to predicate devices for the stated intended uses. The "study" proving this is the 510(k) submission itself, which details this equivalence and compliance.

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