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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

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The "PivotTM" Steerable Microcatheter is intended to be used to access tortuous vasculature for sub-selective controlled infusion or delivery of diagnostic, embolic, and therapeutic agents into the distal, peripheral, coronary, and neurovasculature, and for guide wire exchange/support during diagnostic or interventional procedures.

The "PivotTM" Steerable Microcatheter is a 1.9F/2.4F (nominal distal/proximal) tubular device, ~150 cm in length, with a lumen to be used for delivery of contrast, drugs, or embolics. The lumen is constructed from a polymeric material and has an inside diameter of 0.017". The device is coated on the outer diameter with a lubricious coating over the distal segment of the device. Two radiopaque markers are positioned at the distal tip of the device to aid visualization under fluoroscopy. The proximal end of the device has a standard luer adapter for attachment of accessories and can be used to flush the lumen. The subject device has the ability to access distal, tortuous vasculature over a guide wire, deliver embolics and agents, and has the ability to be steered like a guide wire as needed.

The "Pivot™" Steerable Microcatheter was evaluated against several performance criteria, demonstrating its safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document does not specify a separate "test set" in the context of clinical trials or data for algorithm performance. The performance evaluation was based on bench testing and simulated conditions, which typically do not involve human subjects or a distinct "test set" in the way an AI/ML device would. Therefore, sample sizes for a test set and data provenance (e.g., country of origin, retrospective/prospective) are not applicable in this context.

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

Given that the evaluation was based on bench testing and simulated conditions of a physical device, there were no "experts" establishing ground truth in the context of interpreting medical images or clinical data. The acceptance criteria were based on engineering and performance standards (ISO 10555-1 and specific mechanical tests).

4. Adjudication Method for the Test Set

As the evaluation was based on bench testing and simulated conditions, an adjudication method for a test set (e.g., 2+1, 3+1) is not applicable. The assessment was likely based on standardized testing protocols and objective measurements.

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

No, an MRMC comparative effectiveness study was not done. The device is a physical microcatheter, and the evaluation was based on its physical and mechanical performance, not on improving human reader performance with AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable. The "Pivot™" Steerable Microcatheter is a physical medical device, not an algorithm or AI model. Therefore, "standalone algorithm performance" is not relevant to its evaluation.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance was established through objective measurements against predefined engineering standards and specifications. This includes:

• Compliance with ISO 10555-1.
• Results from physical tests such as dimensional inspection, hub integrity, flow rate, burst strength, tensile strength, guidewire compatibility, performance under simulated conditions, torsional strength, torqueability, and corrosion resistance.

8. The Sample Size for the Training Set

This question is not applicable. The "Pivot™" Steerable Microcatheter is a physical device, not an AI/ML model, so there is no "training set" in the context of machine learning.

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

This question is not applicable, as there is no training set for a physical microcatheter.

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The PVS "Pivot™" Steerable Delivery System® Microcatheter is intended to be used to access tortuous vasculature for sub-selective controlled infusion or delivery of diagnostic, embolic, and therapeutic agents into the distal, peripheral, coronary, and neurovasculature, and for guide wire exchange/support during diagnostic or interventional procedures.

The PVS "Pivot™" Steerable Delivery System® Microcatheter is a 1.9F/2.4F (nominal distal/proximal) tubular device, ~150 cm in length, with a lumen to be used for delivery of contrast, drugs, or embolics. The lumen is constructed from a polymeric material and has an inside diameter of 0.0165". The device is coated on the outer diameter with a lubricious coating over the distal segment of the device. Two radiopaque markers are positioned at the distal tip of the device to aid visualization under fluoroscopy. The proximal end of the device has a standard luer adapter for attachment of accessories and can be used to flush the lumen. The subject device has the ability to access distal, tortuous vasculature over a guide wire, deliver embolics and agents, and has the ability to be steered like a guide wire as needed.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the PVS "Pivot™" Steerable Delivery System® Microcatheter:

Acceptance Criteria and Device Performance

The submission does not explicitly list quantitative "acceptance criteria" in the format of a requirement and a corresponding measured value for the individual performance tests. Instead, it states that the tests "yielded acceptable results" or were "verified in accordance with" standards. The acceptance criteria for this device are implicitly tied to demonstrating substantial equivalence to predicate devices and meeting established industry standards.

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The PVS 1700 Steerable Delivery System®-10 Microcatheter is intended to be used to access tortuous vasculature for sub-selective controlled infusion or delivery of diagnostic, embolic, and therapeutic agents into the distal, peripheral, coronary, and neurovasculature, and for guide wire exchange/support during diagnostic or interventional procedures.

The PVS 1700 Steerable Delivery System®-10 is a 1.9F/2.4F (nominal distal/proximal) tubular device, 155 cm in length, with a lumen to be used for delivery of contrast, drugs, or embolics. The lumen is constructed from a polymeric material and has an inside diameter of 0.0165". The device is coated on the outer diameter with a lubricious coating over the distal segment of the device. Two radiopaque markers are positioned at the distal tip of the device to aid visualization under fluoroscopy. The proximal end of the device has a standard luer adapter for attachment of accessories and can be used to flush the lumen. The subject device has the ability to access distal, tortuous vasculature over a guide wire, deliver embolics and agents, and has the ability to be steered like a guide wire as needed.

The provided document is a 510(k) summary for a medical device (PVS 1700 Steerable Delivery System®-10 Microcatheter), which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed clinical study results for novel acceptance criteria.

Therefore, many of the requested details about specific acceptance criteria from a clinical study, sample size, expert ground truth establishment, and MRMC studies are not applicable or available in this type of regulatory submission. The device is primarily evaluated through bench testing and comparison to existing, cleared devices.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail manner for each test, nor does it provide detailed performance numbers in a table. Instead, it generally states that tests "yielded acceptable results" or "confirmed biocompatibility."

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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

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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).

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The PVS 1500 SDS is intended to be used to access tortuous vasculature for infusion of diagnostic, embolic, and therapeutic agents into the distal, peripheral, coronary, and neurovasculature, and for guide wire exchange/support during diagnostic Or interventional procedures.

The PVS 1500 SDS is intended for use in accessing distal peripheral, coronary, and neurovasculature for selective, controlled, regional delivery of diagnostic, embolic, and therapeutic agents into selected vessels.

The PVS 1500 SDS is a 2.4 F tubular device, 155 cm in length, with a lumen to be used for delivery of contrast, drugs, or embolics. The lumen is constructed from a polyment material and has an inside diameter of 0.021". The device is coated on the outer diameter with a lubricious coating over the distal segment of the device. Two radiopaque markers are positioned 31 mm apart at the distal tip of the device to aid visualization under fluoroscopy. The proximal end of the device has a standard luer adapter for attachment of accessories and can be used to flush the 1500 SDS. The subject device has the ability to access distal, tortuous vasculature over a guide wire, deliver embolics and agents, and has the ability to be steered like a guide wire as needed.

The provided text describes a medical device, the PVS 1500 SDS (an infusion catheter), and its testing to demonstrate substantial equivalence to predicate devices, rather than a study evaluating an AI/ML powered device. Therefore, many of the requested categories for AI/ML device studies are not applicable.

Here's an analysis based on the provided text:

Acceptance Criteria and Device Performance for PVS 1500 SDS

The study primarily focused on demonstrating the PVS 1500 SDS's substantial equivalence to existing predicate devices by meeting established performance standards for infusion catheters.

Table of Acceptance Criteria and Reported Device Performance

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