SONOSITE HAND-CARRIED ULTRASOUND SYSTEM (C2 SERIES)

• K Number: K023957
• Device Name: SONOSITE HAND-CARRIED ULTRASOUND SYSTEM (C2 SERIES)
• Manufacturer: SONOSITE,INC.
• Date Cleared: 2002-12-12 ( 15 days)
• Product Code: IYN , ITX , IYO
• Regulation Number: 892.1550
• Type: Traditional
• Panel: RA
• Reference & Predicate Devices: K014116 , K010374 , K011224

Intended Use

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal - OB/GYN, Abdominal, Intra-operative (Abdominal organs and vascular), Laparoscopic, Pediatric, Small Organ (breast, thyroid, testicles.), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-urethral, Musculo-skel. (Conventional), Musculo-skel. (Superficial), Cardiac Adult, Cardiac Pediatric, Peripheral vessel.

Typical examinations performed using the SonoSite hand-carried ultrasound system (C2 Series) are: Abdominal Imaging Applications, Cardiac Imaging Applications, Cephalic Imaging Applications, Gynecology and Infertility Imaging Applications, Interventional and Intraoperative Imaging Applications, Obstetrical Imaging Applications, Pediatric and Neonatal Imaging Applications, Prostate Imaging Applications, Superficial Imaging Applications, Vascular Imaging Applications.

Device Description

The SonoSite hand-carried ultrasound system, C2 Series is a highly portable, software controlled ultrasound system used to acquire and display highresolution, real-time ultrasound data in 2D, Pulsed Wave (PW) Doppler, Continuous Wave (CW) Doppler, Color Power Doppler, Velocity Color Doppler (VCD) and Directional Color Power Doppler, or in a combination of these modes.

The System has an electrocardiography (ECG) display feature and supports a 3lead ECG cable assembly to collect data for M-mode measurements. The System provides measurement capabilities for anatomical structures and fetal biometry that provide information used for clinical diagnostic purposes. The System has a PW and CW Doppler audio output feature and cine review, image zoom, labeling, biopsy, measurements and calculations, image storage and review, printing, and recording capabilities. The system includes Digital Imaging and Communications (DICOM) to capabilities to provide the acceptance, transfer, display, storage, and digital processing of ultrasound images.

The SonoSite hand-carried ultrasound system (C2 Series) is designed to accept curved or linear transducers of the types and frequency listed in the table below. All actions affecting the performance of the transducer are activated from the main system control panel.

AI/ML Overview

The provided text is a 510(k) Summary of Safety and Effectiveness for the SonoSite hand-carried ultrasound system (C2 Series). This document focuses on demonstrating substantial equivalence to predicate devices and detailing the intended use and technological characteristics. Crucially, it does not include information about clinical studies, acceptance criteria, or performance metrics in the way a clinical validation study would.

Therefore, I cannot extract the information required to populate a table of acceptance criteria and reported device performance or describe a study proving the device meets acceptance criteria as envisioned by your request. The document describes the device's technical specifications and intended uses, and lists applicable standards, but not specific performance metrics against acceptance criteria from a clinical study.

Here's a breakdown of what can be extracted based on the provided text, and what cannot:

What can be extracted:

• Device Description: The SonoSite hand-carried ultrasound system, C2 Series, is a highly portable, software-controlled ultrasound system for acquiring and displaying high-resolution, real-time ultrasound data in various modes (2D, PW Doppler, CW Doppler, Color Power Doppler, Velocity Color Doppler (VCD), Directional Color Power Doppler). It includes ECG display, measurement capabilities, audio output, cine review, image zoom, labeling, biopsy, storage, printing, recording, and DICOM capabilities.
• Intended Use: The system is intended for numerous clinical applications, including Fetal-OB/GYN, Abdominal, Intra-operative, Laparoscopic, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-urethral, Musculoskeletal (Conventional and Superficial), Cardiac Adult, Cardiac Pediatric, and Peripheral Vessel. Specific modes of operation are cleared for each application (B-mode, M-mode, PWD, CWD, Color Doppler, Combined modes, and other specialized modes like Color Power Doppler, Directional Color Power Doppler, 3-D Imaging, and Tissue Harmonic Imaging).
• Technological Characteristics:
  • Operates identically to predicate devices, using piezoelectric material in the transducer to transmit and receive sound waves, converting them to electrical signals for display.
  • Conforms to AIUM/NEMA standards for on-screen display of thermal and mechanical acoustic output indices (ALARA principle).
  • Acoustic output limits:
    • ISPTA(d): 720 mW/cm² (Maximum)
    • TIS/TIB/TIC: 0.1 - 4.0 (Range)
    • Mechanical Index (MI): 1.9 (Maximum)
    • ISPPA(d): 0 - 700 W/cm² (Range)
• Transducers: The submission lists multiple transducers (C11/7-4, C11e/10-5, C15/4-2, C60/5-2, HST/10-5, ICT/7-4, C8/8-5, ICTe/10-5, L25/10-5, L38/10-5, L52/10-5, L52S/10-5, and a 2.0 MHz Dual Element Circular Array) with their frequency ranges and cleared indications for use.
• Regulatory Nature: This is a 510(k) premarket notification, indicating a claim of substantial equivalence to legally marketed predicate devices, not a de novo clearance or PMA requiring extensive de novo clinical studies with predefined acceptance criteria for performance endpoints.

What cannot be extracted (and why):

1. A table of acceptance criteria and the reported device performance: This document explicitly states it is a "Summary Of Safety And Effectiveness" and repeatedly references "substantial equivalence" to predicate devices (K014116, K010374, and Philips Ultrasound HDI® 5000 Ultrasound System). Substantial equivalence primarily relies on demonstrating that the new device has the same intended use and similar technological characteristics as predicate devices, or that differences do not raise new questions of safety or effectiveness. It does not typically involve establishing new, quantitative acceptance criteria for performance (e.g., sensitivity, specificity, accuracy) based on clinical data and then proving the device meets those criteria with a new study. The performance is deemed acceptable because it is similar to already cleared devices.
2. Sample size used for the test set and the data provenance: No new clinical test sets or studies are described in this document for the purpose of establishing performance against acceptance criteria. The clearance is based on comparison to existing, already cleared devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: As no new clinical study measuring performance against ground truth is presented, this information is not available.
4. Adjudication method for the test set: Not applicable, as no new test set is described.
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. This device is a diagnostic ultrasound system, not an AI-assisted diagnostic tool in the sense of a software-only device. There is no mention of such a study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a hardware/software system, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no new clinical study is detailed.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided 510(k) submission is a regulatory document focused on demonstrating equivalence to existing devices through descriptions of technological characteristics and intended uses, rather than a report on a clinical study with predefined acceptance criteria and performance results.

Regulation Number and Section

§ 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.