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As defined by FDA guidance documents, the intended uses of the SonoSite ultrasound systems referenced herein remain unchanged from previously cleared indications, except for a modification to their labeling to add imaging guidance for peripheral nerve blocks in musculoskeletal and intraoperative imaging applications.

The SonoSite ultrasound systems are intended for use for ultrasound evaluation of fetal - OB/GYN, abdominal, intra-operative (abdominal organs and vascular), laparoscopic, pediatric, small organ (breast, thvroid, testicles), neonatal cephalic, trans-rectal, trans-vaginal, musculoskeletal (conventional and superficial), cardiac (adult and pediatric), and peripheral vessel applications. The TITAN™ Ultrasound System has been additionally cleared for adult cephalic applications. The systems provide imaging for quidance of biopsy and imaging to assist in the placement of needles and catheters in vascular or other anatomical structures.

Included in this 510(k) is an expanded intended use for imaging guidance for peripheral nerve block procedures.

The devices referenced in this Submission are highly portable, software-controlled, diagnostic ultrasound systems with accessories. This Submission does not include any technological or feature changes from the previously cleared SonoSite devices or transducers.

By this Submission, the clinical application for imaging guidance for peripheral nerve block procedures is being added to previously cleared indications for use for each of these systems and to the following transducers:

TITAN™ High-Resolution Ultrasound System with Transducers: C11/8-5 Curved Array (8.0 - 5.0 MHz), L25/10-5 Linear Array (10.0 - 5.0 MHz), L38/10-5 Linear Array (10.0 - 5.0 MHz).
SonoSite® Ultrasound System with Transducers: C11/7-4 Curved Array (7.0 - 4.0 MHz), L38/10-5 Linear Array (10.0 - 5.0 MHz), L25/10-5 Linear Array (10.0 - 5.0 MHz).
iLook™ 25 Ultrasound System with Transducer: L25/10-5 Linear Array (integrated) (10.0 - 5.0 MHz).

The provided text is a 510(k) summary for SonoSite ultrasound systems. It does not describe acceptance criteria or a study proving that a device meets such criteria. Instead, it details the device, its intended uses, and its substantial equivalence to previously cleared devices.

Therefore, I cannot provide the requested information. The document explicitly states: "No additional clinical testing is required, as the specific indication for use adds no significant risk to the general indication for use of the referenced diagnostic ultrasound systems, in accordance with FDA's Guidance for Industry: General/Specific Intended Use document issued November 4, 1998." This indicates that no new performance study was conducted or deemed necessary for this particular 510(k) submission, as it primarily extends existing indications for use.

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