Search Results

The Site~Rite® 8 Ultrasound System is intended for diagnostic ultrasound imaging of the human body. Specific clinical applications include:

• Pediatric
• Peripheral Vessel and Vascular Access
• Small Organ (breast, thyroid, parathyroid, testicles)
• Musculo-skeletal (conventional and superficial)
• Cardiac (adult and pediatric)

Typical examinations performed using the Site~Rite® 8 Ultrasound System include:
Vascular: Assessment of vessels in the extremities and neck (e.g., jugular, carotid) leading to or coming from the heart, superficial veins in the arms and legs (e.g., basilic, cephalic, brachial, femoral, radial, saphenous), and vessel mapping. Assessment of superficial thoracic vessels (e.g., axillary, innominate, subclavian)
Vascular Access: Guidance for PICC, CVC, dialysis catheter, port, PIV, midline, arterial line placement, access to fistula and grafts, and general vein and artery access
Interventional: Guidance for biopsy and drainage
Superficial: Assessment of breast, thyroid, parathyroid, testicle, lymph nodes, musculoskeletal procedures (e.g., joints, ligaments, tendons), soft tissue structures, and surrounding anatomical structures

Cue™ Needle Tracking System and Pinpoint™ GT Needle Technology are each intended to provide visual needle tracking to assist with ultrasound guided vascular access.

The subject Site-Rite® 8 Ultrasound System with Cue™ Needle Tracking System and Pinpoint™ GT Needle Technology is a portable device that features real-time 2D ultrasound imaging, customized vascular access applications, procedure documentation, vessel measurement tools, and electronic connectivity (if enabled).

The Site~Rite® 8 Ultrasound System has two optional needle guidance technologies available depending on the selected probe.

Both available needle guidance technologies are designed to track and display the location and trajectory of a needle under ultrasound guidance. The technologies consist of software installed on an ultrasound system and sensors incorporated into the ultrasound probes. The sensors detect a passive magnetic field emitted from the needle. The software interprets the data from the sensors and creates a virtual image of the needle on the ultrasound display, providing clinicians with a visual representation of the needle during the insertion process.

Cue™ Needle Tracking System requires the use of a Site-Rite® 8 Ultrasound System with the Cue™ Needle Tracking System software module, Cue™ 20mm Linear Probe, the Cue™ Needle Tracking System Activator and a Cue™ compatible needle. The Cue™ 20mm Linear Probe contains sensors for tracking Cue™ compatible needles (following magnetization by the Cue™ Needle Tracking System Activator). The tracked needle's current position, trajectory, and Intersection Window are displayed over the ultrasound image.

Pinpoint™ GT Needle Technology requires the use of a Site~Rite® 8 Ultrasound System with the Pinpoint™ GT Needle Technology software module, 20mm Pinpoint™ GT Linear Probe and a Pinpoint™ GT Safety Introducer Needle. The 20mm Pinpoint™ GT Linear Probe contains sensors for tracking Pinpoint™ GT Safety Introducer Needles, which contain a permanent magnet within the safety canister of the needle. The tracked needle's current position, trajectory, and point of intersection with the ultrasound plane are displayed over the ultrasound image.

The subject device, SiteRite® 8 Ultrasound System with Cue™ Needle Tracking System and Pinpoint™ GT Needle Technology is bringing forward and amending the currently cleared SiteRite® 8 Ultrasound System with Pinpoint™ GT Needle Technology's functionality (K152554). The subject Site~Rite® 8 Ultrasound System with Cue™ Needle Tracking System and Pinpoint™ GT Needle Technology differs from its predicate device (K152554) primarily because it incorporates an additional needle guidance technology (Cue™ Needle Tracking System) that is similar to the one present in the reference device (K140254). Cue™ Needle Tracking System tracks a qualified needle that has been magnetized using the Cue™ Needle Tracking System Activator. All other previously cleared features of the predicate device are being brought forward.

Site~Rite® 8 Ultrasound System with Cue™ Needle Tracking System and Pinpoint™ GT Needle Technology includes the following components:

• Site~Rite® 8 Ultrasound System Console
• Cue™ 20mm Linear Probe
• 20mm Pinpoint™ GT Probe
• 32mm Linear Probe
• Cue™ Needle Tracking System Activator

Site~Rite® 8 Ultrasound System with Cue™ Needle Tracking System and Pinpoint™ GT Needle Technology is compatible with the following accessories:

• Cue™ Activator mounting arm
• Pinpoint™ GT Needle Guide Kits
• Site~Rite® Needle Guide Kits
• Site~Rite® Probe Cover Kits
• MER Roll Stand
• Optional printers* with mounting hardware
• Kickstand mounting accessory
• Probe holder accessory
• Site~Rite® Keyboard
• USB storage device* (flash/pen drive) with no external power connection
• Silex® Wireless Bridge*

The provided text does not contain detailed information about specific acceptance criteria and the comprehensive study results to demonstrate that the device meets those criteria for the "Site~Rite® 8 Ultrasound System with Cue™ Needle Tracking System and Pinpoint™ GT Needle Technology".

The document focuses on establishing substantial equivalence to a predicate device (K152554) and a reference device (K140254) by comparing intended use, indications for use, and technological characteristics. While it lists various nonclinical tests and references guidance documents and standards, it does not provide specific performance metrics or thresholds for acceptance criteria, nor does it detail the results of these tests in a quantifiable manner to show how the device met them.

Here's a breakdown of what can be extracted and what is missing:

1. A table of acceptance criteria and the reported device performance

The document lists "Design Requirements and Corresponding Nonclinical Tests" but does not explicitly state acceptance criteria in terms of numerical thresholds or performance targets. It also does not present numerical or descriptive results of how the device performed against these unstated criteria.

• Design Requirements (from the document):

  • User needs
  • Physical characteristics
  • Electrical, electronic, and radiation characteristics
  • Thermal characteristics
  • Mechanical characteristics
  • Operating environment
  • Labeling characteristics
  • Equipment and device interfaces and mounting
  • Minimum requirements for computing platform
  • Usability requirements
  • Operating requirements
  • Software requirements
  • Dimensional Characteristics
  • Chemical characteristics
  • Biological and biocompatibility characteristics
  • Packaging characteristics

• Corresponding Nonclinical Tests (from the document):

  • Site-Rite® 8 Ultrasound System Software Verification
  • Cue™ Needle Tracking System Accuracy
  • Site-Rite® 8 Ultrasound System Image Verification
  • SiteRite® 8 vs. SiteRite® 6 Image Comparison
  • Site-Rite® 8 Ultrasound System and Needle Guide Accuracy Test Report
  • Site-Rite® 8 Ultrasound System Electrical Safety and EMC - IEC 60601-1 Edition 3.1
  • Site~Rite® 8 Operational Temperature and Humidity Testing
  • Site-Rite® 8 Mechanical Testing
  • Site~Rite® 8 Response Time Verification
  • Cue™ VAD Library Information Verification
  • Admin Tool Verification
  • Site-Rite® 8 Shared Requirements Verification
  • Site-Rite® 8 Verification and Validation Rationale
  • Site~Rite® 8 Cleaning Solution Compatibility Verification
  • Site~Rite® 8 Biocompatibility Assessment
  • Cue™ Activator Ship Test Verification
  • Ultrasound Probe Ship Test Verification

Reported Device Performance: The document states:
"Testing verifying the performance requirements of the subject device software when connected to a Cue™ 20mm Linear Probe was conducted and is included in this Abbreviated premarket notification, the results of which support substantial equivalence."
However, the actual results of these tests are not provided in this excerpt. We know that "Cue™ Needle Tracking System Accuracy" was tested, among others, suggesting a focus on the accuracy of needle tracking, but no specific accuracy values or acceptance thresholds are given.

2. Sample size used for the test set and the data provenance

• Sample Size: This information is not provided in the document.
• Data Provenance: This information is not provided in the document. The studies listed are generally non-clinical in nature (e.g., software verification, electrical safety, mechanical testing).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided. Given that the studies listed are non-clinical, the concept of "experts establishing ground truth for a test set" in a clinical context isn't directly applicable here. If "expert" refers to engineers or technicians verifying software or hardware performance, their number and qualifications are not mentioned.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not provided.

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

• The document explicitly states: "No human clinical data was provided to support substantial equivalence."
• Therefore, an MRMC study was not performed and no effect size can be reported. The device is not described as having "AI assistance" for human readers in the traditional sense, but rather "visual needle tracking to assist with ultrasound guided vascular access."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• The non-clinical tests listed include "Cue™ Needle Tracking System Accuracy" and "Site-Rite® 8 Ultrasound System and Needle Guide Accuracy Test Report". These sound like standalone performance tests of the system's needle tracking capabilities. However, the details of these tests (e.g., what metrics were measured, the test setup, the results) are not provided.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• For the non-clinical performance tests mentioned (e.g., accuracy of needle tracking), the "ground truth" would likely be established through precise mechanical or optical measurements in a controlled laboratory setting. However, the specific methodology for establishing this ground truth is not described in the provided text.

8. The sample size for the training set

This information is not provided. The document does not describe any machine learning or AI components that would typically require a "training set." The needle tracking technologies (Cue™ and Pinpoint™ GT) are based on detecting magnetic fields from needles, which is a physics-based approach rather than a data-driven machine learning approach requiring a training set.

9. How the ground truth for the training set was established

This information is not applicable/provided for the reasons stated in point 8.

Ask a specific question about this device