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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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The SiteRite IV Ultrasound System with associated probes and accessories provide ultrasound imaging of vascular structures, various organs, and structures of the body. Ultrasound guidance for placement of needles and catheters in these structures or organs may also be performed. The ultrasound guidance may occur either intraoperatively or percutaneously. The SiteRite IV Ultrasound System is not intended for ophthalmic applications.

The Site-Rite IV pulsed echo ultrasound system is a lightweight, lowoutput, portable, real-time, B-mode, ultrasound scanner designed primarily to assist clinicians in gaining vascular access to major veins, arteries and organs. It is a unique scanner that offers high resolution imaging to the depth of 18 cm. Site-Rite is portable and thus easy to use at the bedside and in a variety of clinical settings: intensive care units, emergency rooms, operating rooms, angiography suites, catheterization laboratories, etc. The Site-Rite IV ultrasound scanner can be operated on battery or AC power. It utilizes only proprietary probes manufactured and currently marketed by Dymax, with frequencies ranging from 3.5 MHz to 9.0 MHz. Image depth depends on the choice of probe and ranges from a minimum of 0.5 cm with the 9.0 MHz probe to a maximum of 18 cm with the 3.5 MHz probe. The disposable items, supplied in sterile packs, are currently marketed products.

The provided 510(k) summary for the Site~Rite IV Ultrasound Scanner (K032135) does not contain acceptance criteria or detailed study results directly proving the device meets specific performance acceptance criteria.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices (SiteRite 3 Ultrasound Scanner K993624 and Dymax SiteRite II Ultrasound System K862127). The core argument is that the Site~Rite IV has identical indications for use and similar technological characteristics, with updates primarily for manufacturability and reliability, and that these differences do not raise new questions of safety and effectiveness.

Here's an breakdown of the information available, and what is explicitly not included based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Not explicitly provided within this document.

The document states: "Performance data are presented in the 510(k) and these data demonstrate equivalence." However, the summary itself does not contain a table of specific acceptance criteria (e.g., image resolution targets, penetration depth targets) or quantitative performance metrics for the Site~Rite IV or its predicates. The "performance data" mentioned would be in a separate, more detailed section of the 510(k) submission, not summarized here.

The document does mention the following capabilities:

• Imaging Depth: "high resolution imaging to the depth of 18 cm."
• Depth Range (by probe):
  • 9.0 MHz probe: minimum 0.5 cm
  • 3.5 MHz probe: maximum 18 cm

These are descriptive capabilities, not acceptance criteria with specific thresholds.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable/provided for a specific "test set" demonstrating acceptance criteria.

The submission relies on equivalence to predicate devices and general standards. It mentions: "Clinical studies carried out using the SiteRite 2 device, which uses the same transducers and image processing algorithms, has shown the usefulness of the SiteRite for needle placement in a number of different vascular and non-vascular applications. These studies are summarized and reports are included in the 510(k)."

• Sample Size: Not specified.
• Data Provenance: "Clinical studies carried out using the Site~Rite 2 device" - implying these were conducted prior to this submission and likely involved human subjects for clinical usefulness. The country of origin and whether they were retrospective or prospective are not mentioned in this summary.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Not applicable/provided.

Since there's no specific "test set" for the SiteRite IV's de novo performance assessment, there's no mention of experts establishing ground truth for such a test. The reliance is on the predicate device's established performance and the SiteRite IV's equivalent characteristics.

4. Adjudication Method for the Test Set

Not applicable/provided.

Again, without a specified "test set" for performance evaluation, adjudication methods are not discussed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, there is no mention of an MRMC comparative effectiveness study.

The submission does not discuss human readers, AI, or improvements with AI assistance. This device is an ultrasound scanner, not an AI-powered diagnostic tool in the sense of the examples typically related to MRMC studies.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable/provided.

This device is an imaging system for clinical use with a human operator, not a standalone algorithm.

7. The Type of Ground Truth Used

Not explicitly stated for the Site~Rite IV.

For the predicate Site~Rite 2 device, the "clinical studies" likely established "usefulness" in needle placement based on medical outcomes or expert observation during procedures ("clinical utility"). This would generally fall under outcomes data or expert observation/clinical assessment from the real-world use of the device for its intended purpose.

8. The Sample Size for the Training Set

Not applicable/provided.

This is a traditional medical imaging device, not a machine learning or AI-based system that would typically have a "training set" in the context of algorithm development.

9. How the Ground Truth for the Training Set Was Established

Not applicable/provided.

As above, this concept does not apply to the type of device and submission described.

Summary of Device Performance and Equivalence Argument:

The SiteRite IV Ultrasound Scanner demonstrates its "performance" and meets regulatory requirements by demonstrating substantial equivalence to its predicate devices (SiteRite 3 and Site~Rite II).

• Identical Indications for Use: The SiteRite IV has the same intended uses as the SiteRite 3.
• Technological Characteristics: Similar to predicates, with updates for manufacturability and reliability, particularly a digital design (like SiteRite 3) compared to the analog SiteRite II.
• Transducers: Unchanged from currently marketed products. The submission lists 3.5 MHz, 5.0 MHz, 7.5 MHz, and 9.0 MHz probes, each with various B-mode clinical applications (Abdominal, Intraoperative, Small Organ, Neonatal Cephalic, Adult Cephalic, Peripheral Vascular, Conventional Musculo-skeletal, and Pediatric for some).
• Testing: Electrical safety, electromagnetic emissions, and acoustic output testing were performed, and the results demonstrate equivalence with predicate devices and meet FDA guidance recommendations.
• Clinical Studies (Predicate Device): Usefulness for needle placement was shown with the SiteRite 2 device, which uses the same transducers and image processing algorithms as the SiteRite IV. This supports the clinical utility and performance of the underlying imaging technology.

In essence, the "study that proves the device meets the acceptance criteria" in this case is the demonstration of substantial equivalence through comparative analysis with predicate devices and adherence to relevant FDA guidance and safety standards, rather than a de-novo study with specific quantitative acceptance criteria for image quality or diagnostic accuracy for the Site~Rite IV itself.

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The Inceptio Medical Technologies, L.C. PunctSURE® Ultrasound Vascular Imaging System and associated PunctSURE® Vascular Imaging Procedure Kit are indicated for real-time imaging of selected blood vessels and nearby anatomic structures before and during percutaneous procedures, ultrasonic guidance for needle placement and vessel catheterization in a sterile environment, and Doppler confirmation of directional blood flow.

The Inceptio Medical Technologies, L.C. PunctSURE® Ultrasound Vascular Imaging System with associated transducer and accessories is designed and manufactured to provide hands-free ultrasound vascular imaging (simultaneous transverse and longitudinal views) for percutaneous vascular punctures (needle placement and vessel catheterization). The PunctSURE® System consists of three major subsystems: (1) the Transducer and Cable, (2) the Dual Image Monitor, and (3) the Sterile Vascular Imaging Procedure Kit. The sterile, single use, and disposable PunctSURE® Vascular Imaging Procedure Kit contains products used for the diagnostic procedure (magnetic laminate, acoustic coupling gel, sheath, snap ring, transducer cover, gauze sponges, and cotton swabs).

The provided text describes the 510(k) summary for the Inceptio Medical Technologies, L.C. PunctSURE® Ultrasound Vascular Imaging System. However, it does not contain specific acceptance criteria or a detailed study proving the device meets acceptance criteria in terms of performance metrics like sensitivity, specificity, accuracy, or any comparative effectiveness with human readers.

Here's the breakdown of what is available in the provided text:

Acceptance Criteria and Reported Device Performance

The document describes the device's technological and operational characteristics in comparison to a predicate device (Site~Rite 3). The "performance testing" section primarily references compliance with FDA guidance and various safety and electromagnetic compatibility standards, rather than clinical performance metrics.

Note on Acceptance Criteria: The document primarily uses the predicate device (Site~Rite 3) for establishing substantial equivalence. Thus, the "acceptance criteria" are largely implied by meeting or demonstrating similar functionality/safety as the predicate, along with compliance to recognized standards. There are no explicit quantitative performance metrics (e.g., sensitivity, specificity) stated as acceptance criteria in this summary.

Study Details

The provided text does not include information about a clinical study with a test set, ground truth, or expert review that would typically prove device performance in terms of diagnostic accuracy or effectiveness. The "Performance Testing" section states:

"The PunctSURE® Ultrasound Vascular Imaging System and associated PunctSURE® Vascular Imaging Procedure Kit were tested according to and demonstrated in compliance with requirements set forth in FDA Guidance "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" (1997) including the following, FDA-recognized, voluntary standards... In addition, verification and validation testing demonstrates that the System fulfills performance specifications."

This indicates that internal verification and validation were performed to ensure the system meets its own specifications and complies with regulatory standards, which are largely related to safety, electrical, and electromagnetic compatibility. It does not describe a clinical performance study as typically understood in the context of diagnostic accuracy.

Therefore, the following information is not available in the provided text:

• Sample size used for the test set and the data provenance: Not mentioned. The testing described is compliance-focused, not clinical performance-focused with a test set of patient data.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned as there's no described clinical performance study with a ground truth.
• Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not mentioned.
• 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 mentioned. This device is an ultrasound imaging system from 2002, and the concept of "AI assistance" in this context is likely not applicable.
• If a standalone (i.e., algorithm only without human-in-the loop performance) was done: Not mentioned. The device is described as an imaging system intended for real-time human-in-the-loop use.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned.
• The sample size for the training set: Not mentioned.
• How the ground truth for the training set was established: Not mentioned.

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