Search Results

The PVS 1600 Synchro® 0.010" Neuro Guidewire series of products is intended for neurovascular use. It can be used to selectively introduce and position catheters and other interventional devices within the neurovasculature. This device should be used only by physicians trained in percutaneous, intravascular techniques and procedures.

The PVS 1600 is a member of the Synchro® Neuro Guidewire family of products having a 0.010" outside diameter, being a sterile, single use/disposable product, with a shapeable tip which is used to gain intravascular access to and facilitate the positioning and exchange of interventional devices in small diameter, tortuous vasculature for neuro diagnostic and interventional procedures. The guidewire can be torqued to facilitate navigation through the vasculature. A torque device, (Merit Medical Systems (K936032)) is supplied with the wire to facilitate deployment & positioning. A guidewire introducer (B. Braun (K760389)) is also supplied and may be used to aid introduction of the guidewire into the catheter hub and/or hemostasis valve and to gently shape the guidewire's distal flexible tip, if desired, according to standard practice. Neither the guidewire introducer or the torque device are intended to enter the body. The product is projected to be provided in a 180cm - 300cm length range, with 200cm being nominal. The Nitinol tip length is projected to be presented in a 35cm - 65cm range, with 55cm being nominal. A traditional range of flexibility profiles shall also be provided, ranging from standard (stiff) to flex (soft). The device is coated on the outer diameter with a lubricious coating over the distal segment of the device. The marker coil is platinum wire at the distal tip of the device to aid visualization under fluoroscopy. The subject device has the ability to access distal, tortuous vasculature, with steerability and torque transmission properties.

The provided document describes the PVS 1600 Synchro® 0.010" Neuro Guidewire and its demonstration of substantial equivalence to predicate devices, rather than a study with specific acceptance criteria and detailed performance metrics as would typically be presented for a new or significantly modified device under a comprehensive clinical trial.

However, based on the information provided, I can extract the relevant details regarding the safety and performance tests conducted to support its substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not specify quantitative acceptance criteria with corresponding performance statistics in a tabular format as one would expect from a controlled study with predefined thresholds. Instead, it states that "Subject product testing has yielded acceptable safety & performance outcomes" and that tests "also yielded acceptable results." The criteria are implied to be met if the PVS 1600 Synchro® 0.010" Neuro Guidewire is comparable to its predicate devices and conforms to relevant standards.

Therefore, the table below provides the performance tests conducted and the general outcome stated in the document. The "Acceptance Criteria" are inferred from the context of demonstrating substantial equivalence to predicate devices and adherence to relevant standards (ISO 10993-1, ISO 11070:1998).

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

• Sample Size: The document does not specify numerical sample sizes for the performance tests conducted. It refers to "Performance testing of materials" and "Subject product testing."
• Data Provenance: The document does not provide details about the country of origin of the data or whether the tests were retrospective or prospective. These appear to be laboratory-based engineering performance tests rather than clinical studies on patient data.

3. Number of Experts and Qualifications for Ground Truth Establishment (Test Set):

Not applicable. The document describes engineering and materials performance tests, not clinical studies involving expert interpretation or ground truth establishment based on human review.

4. Adjudication Method (Test Set):

Not applicable, as no adjudication by experts for ground truth is mentioned. The tests appear to be objective measurements against engineering standards and comparison to predicate devices.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done. The document describes a 510(k) submission for substantial equivalence based on technological characteristics and performance testing, not a clinical trial evaluating human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study:

Not applicable. The device is a physical medical instrument (guidewire), not an AI algorithm or software device that would perform a standalone analysis. The performance studies focus on the physical and material properties of the guidewire.

7. Type of Ground Truth Used:

For the performance tests, the "ground truth" is implied to be:

• Compliance with established international standards (ISO 10993-1 for biocompatibility, ISO 11070:1998 for catheter introducers).
• Comparative performance against existing legally marketed predicate devices, demonstrating similar safety and efficacy profiles.
• Objective measurements of physical and mechanical properties.

8. Sample Size for the Training Set:

Not applicable. The guidewire is a physical device, not an AI, machine learning, or software device that requires a training set.

9. How the Ground Truth for the Training Set was Established:

Not applicable. There is no training set mentioned or implied as this is not an AI/ML device.

Ask a specific question about this device