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The PV 2000 Synchro®2 Guidewire series of products are intended for general intravascular use, including the neuro and peripheral vasculature. The device can be used to selectively introduce and position catheters and other interventional devices within the peripheral and neurovasculature. This device should be used only by physicians trained in percutaneous, intravascular techniques and procedures.

The PV 2000 is a member of the Synchro® Guidewire family of products having a 0.014" 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 peripheral and neuro diagnostic and interventional procedures. The guidewire can be torqued to facilitate navigation through the vasculature. A torque device, (Merit Medical (K936032)) is supplied with the wire to facilitate deployment & positioning. A guidewire introducer/shaping mandrel (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 nor the torque device are intended to enter the body. The product is projected to be provided in a 100cm - 300cm length range, with 200cm being nominal. The Nitinol tip length is projected to be presented in a 35cm length. A traditional range of flexibility profiles shall also be provided, ranging from support (stiff) to flex (soft). The device is coated on the outer diameter with a lubricious coating over the distal portion 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 text describes safety and performance tests for the PV 2000 Synchro®2 Guidewire to demonstrate substantial equivalence to predicate devices, rather than establishing acceptance criteria or a study proving that a device meets its acceptance criteria. Therefore, most of the requested information cannot be extracted directly from the given content.

However, based on the information provided, here's what can be addressed:

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

The document states that "Performance testing of materials comprising the PV 2000 Synchro®2 Guidewire was conducted in accordance with ISO 11070:1998, Sterile, Single-Use Intravascular Catheter Introducers." It then lists the types of tests performed and their outcomes. While specific numerical acceptance criteria are not explicitly stated, the reported performance is that each test yielded "acceptable safety & performance outcomes" or "acceptable results."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

This information is not provided in the given text. The document mentions "Performance testing of materials" and "tests," but does not specify sample sizes for these tests. The country of origin of data or whether it was retrospective or prospective is also not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This information is not provided in the given text, as the tests described are primarily engineering and material performance tests, not clinical studies requiring expert ground truth assessment.

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

This information is not provided in the given text.

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:

This information is not provided in the given text. The device is a guidewire, a physical medical instrument, not an AI-assisted diagnostic or interventional system that would typically undergo MRMC studies with human readers.

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

This information is not applicable as the device is a physical guidewire, not an algorithm.

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

For the performance and biocompatibility tests, the "ground truth" or reference for acceptance would be:

• Engineering specifications and regulatory standards: For dimensional inspection, fatigue, tensile strength, torsional strength, torqueability, tip flexibility, tip shaping, guidewire compatibility, and performance under simulated conditions.
• ISO 10993-1 and ISO 11070:1998 standards: For biocompatibility and design/material performance.
• Sterilization validation protocols: For EO sterilization adoption tests.

There is no mention of expert consensus, pathology, or outcomes data as "ground truth" for the tests described.

8. The sample size for the training set:

This information is not applicable as the device is not an AI algorithm that requires a training set.

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

This information is not applicable as the device is not an AI algorithm that requires a training set.

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The PV 1900 Synchro® 0.016" Neuro Guidewire series of products is intended for peripheral and neurovascular use. It can be used to selectively introduce and position catheters and other interventional devices within the peripheral and neurovasculature. This device should be used only by physicians trained in percutaneous, intravascular techniques and procedures.

The PV 1900 is a member of the Synchro® Guidewire family of products having a 0.016" 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 peripheral and neuro diagnostic and interventional procedures. The guidewire can be torqued to facilitate navigation through the vasculature. A torque device, (Boston Scientific (K903606)) 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 nor the torque device are intended to enter the body. The product is projected to be provided in a 100cm - 300cm length range with 140-180cm being nominal. The Nitinol tip length is projected to be presented in a 25cm - 35cm range. A traditional range of flexibility profiles shall also be provided ranging from support (stiff) to flex (soft). The device is coated on the outer diameter with a lubricious coating over the distal portion 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.

This is a 510(k) premarket notification for a medical device (a guidewire), not an AI/ML device. Therefore, the typical acceptance criteria and study design for AI/ML performance evaluation are not applicable.

However, I can extract the information relevant to the device's performance given the context of this document.

Summary of Device Performance Information Provided:

Since this is a filing for a traditional medical device (guidewire) and not an AI/ML diagnostic or prognostic system, the requested information (acceptance criteria, sample size, ground truth, experts, MRMC, standalone performance) for AI/ML devices is not directly applicable in the sense of predictive or classification performance metrics.

Instead, the "acceptance criteria" for this device are implicitly tied to demonstrating substantial equivalence to predicate guidewires by meeting various physical and mechanical performance characteristics. The "study" refers to the engineering and biological testing performed on the device.

Here's an attempt to map the requested AI/ML-centric questions to the provided information for this traditional medical device:

1. Table of Acceptance Criteria and Reported Device Performance:

   The document does not explicitly present acceptance criteria in a quantifiable table with corresponding performance values for each criterion as one would for an AI/ML device (e.g., sensitivity >X%, specificity >Y%). Instead, it states that "Performance testing of materials comprising the PV 1900 Synchro® 0.016" Guidewire was conducted in accordance with ISO 11070:1998, Sterile, Single-Use Intravascular Catheter Introducers." and "Subject product testing has yielded acceptable safety & performance outcomes."

   The performance aspects tested and the general outcome are listed.

   Acceptance Criteria (Implicit)	Reported Device Performance
   Compliance with ISO 10993-1 for Biocompatibility (for external communicating, blood contact, short duration <24 hours device)	Biocompatibility verified; materials test results confirmed biocompatibility.
   Compliance with ISO 11070:1998 for Performance Testing (dimensional, fatigue, tip flexibility, tip shaping, tensile strength, guidewire compatibility, performance under simulated conditions)	Acceptable safety & performance outcomes.
   Torsional Strength (Specific test)	Acceptable results.
   Torqueability (Specific test)	Acceptable results.
   EO Sterilization (Specific test)	Acceptable results.
   Substantial equivalence in design, materials, sterilization, principles of operation, and indications for use to cited predicates	Demonstrated through testing and comparison, leading to FDA's determination of substantial equivalence (K050964). No new questions raised regarding safety or efficacy compared to the predicate PVS 1300 Synchro® 0.014" Guidewire, and similarity in basal design, dimensions, generic materials & construction, and hydrophilic coating to competitive predicates.

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

   • Sample Size: Not explicitly stated in terms of a "test set" like in an AI/ML study. Performance testing involved various physical and mechanical tests on the guidewire. The number of guidewires or samples used for each specific test (e.g., fatigue, tensile strength) is not detailed.
   • Data Provenance: Not applicable in the context of human data. The tests were laboratory and engineering tests on the materials and finished guidewire device.

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

   • Not applicable as "ground truth" in the AI/ML sense (e.g., expert labels on medical images) is not relevant here. Performance was assessed through objective physical and mechanical tests following established standards. While engineers and quality control personnel would have interpreted test results, their role is not "ground truth establishment" in this context.

4. Adjudication method for the test set:

   • Not applicable. Performance was assessed against pre-defined engineering and biocompatibility standards, not through expert adjudication of an output.

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 is a physical medical device (guidewire), not an AI system intended to assist human readers (e.g., radiologists).

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

   • Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

   • "Ground truth" here is the adherence to established international standards (ISO 10993-1 for biocompatibility, ISO 11070:1998 for catheter introducers, and other specific engineering tests for torsional strength, torqueability, sterilization). The product's physical and biological properties were measured against these objective standards.

8. The sample size for the training set:

   • Not applicable. This is a physical medical device, not an AI/ML algorithm that requires training data.

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

   • Not applicable. As above, no training set for an AI/ML algorithm.

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The PVS 1300 Synchro® 0.014" & 1600 Synchro® 0.010" Neuro Guidewire series of products are intended for general intravascular use, which includes peripheral and neurovascular use. The device can be used to selectively introduce and position catheters and other interventional devices within the peripheral & neurovasculature. The device should be used only by physicians trained in percutaneous, intravascular techniques and procedures.

products having a 0.014" & 0.010" outside diameter respectively, being sterile, single use/disposable products, with 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 peripheral, 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 products are 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 25cm - 65cm range, with 35-45cm being nominal. A traditional range of flexibility profiles shall also be provided, ranging from support (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 text describes a 510(k) submission for guidewires, which are physical medical devices, not software or AI-powered devices. Therefore, the questions related to AI/algorithm performance metrics, expert reviews, ground truth, and training sets are not applicable to this document. The submission focuses on demonstrating substantial equivalence to predicate guidewires through material properties and performance testing.

Here's the relevant information that can be extracted from the provided text, structured to best fit your request:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The study conducted was a series of "Safety and Performance Tests" on the materials comprising the PVS 1300 Synchro® 0.014" & PVS 1600 Synchro® 0.010" guidewires. These tests were performed in accordance with ISO 11070:1998, Sterile, Single-Use Intravascular Catheter Introducers.

2. Sample Size for the Test Set and Data Provenance

The document does not specify the exact sample sizes used for each individual performance test (e.g., how many guidewires were tested for tensile strength or fatigue). It generally states "Subject product testing has yielded acceptable safety & performance outcomes."

The data provenance is from laboratory testing of the manufactured guidewires by Precision Vascular. It is prospective in the sense that these tests were conducted specifically for this 510(k) submission to demonstrate the device's performance. The country of origin of the data is not explicitly stated, but the manufacturer is based in West Valley City, UT, USA, suggesting the testing was likely conducted in the USA or by a contracted lab.

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

This question is not applicable. The "ground truth" for a physical medical device like a guidewire is its adherence to predefined engineering specifications and performance standards through physical testing, not expert interpretation of data.

4. Adjudication Method for the Test Set

This question is not applicable, as there was no expert review or "ground truth" establishment in the context of interpretation that would require an adjudication method. The results are from objective physical tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

This question is not applicable. This is a physical medical device, not an AI or imaging device that would involve human readers.

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

This question is not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by engineering and material specifications and internationally recognized standards (e.g., ISO 10993-1, ISO 11070:1998). The performance tests directly assess whether the device meets these objective, quantifiable standards.

8. The Sample Size for the Training Set

This question is not applicable. There is no algorithm or AI model being "trained" for this device.

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

This question is not applicable.

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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.

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