Search Results

The NeoWire Guidewire is intended to facilitate the introduction and placement of catheters and interventional devices within the coronary and/or peripheral vasculature. Models with Stiff tips (> 9g) are intended for peripheral use only. Models with Floppy, Soft, and Medium tips (≤ 9g) are intended for peripheral or coronary use. The guidewire is not intended for use in the cerebral vasculature.

NeoWire is a steerable guidewire constructed of a nitinol alloy core with a coiled segment on the distal end. The core wire is either PTFE coated or uncoated and the wire may also contain silicone or hydrophilic lubricious coatings. This distal end of the wire can be shapeable and is radiopaque.

The provided text describes a 510(k) premarket notification for a medical device called "NeoWire PTA/PTCA Guidewire." This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than performing a clinical study with acceptance criteria in the way one might for a diagnostic AI device.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set size) are not applicable to the type of submission described in this document.

Here's an analysis based on the provided text, focusing on how the device meets the criteria for substantial equivalence rather than acceptance criteria for a novel clinical performance claim:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are based on demonstrating that the NeoWire Guidewire is as safe and effective as its predicate devices. This is achieved by showing similar technological characteristics and performing a battery of non-clinical tests. The "performance" reported is that the device meets these specifications.

Study Proving Acceptance Criteria:

The study that proves the device meets the acceptance criteria is a non-clinical performance testing study comparing the NeoWire Guidewire to predicate devices and assessing compliance with recognized standards. This is explicitly stated in "Section 5.6 Technological Characteristics" and "Section 5.7 Summary of Non-Clinical Testing."

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

• Sample Size for Test Set: The document does not specify a numerical sample size for each test. It states "To ascertain similarity, the following performance testing was conducted on both the proposed device and the predicate devices" and "competetive devices were tested along with the proposed device in each test." This implies a comparative bench study using physical device samples.
• Data Provenance: The data is generated from bench testing conducted by NeoMetrics, Inc., following FDA Guidance and ISO standards. This is not patient-derived data, so "country of origin" or "retrospective/prospective" in a clinical sense are not applicable.

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

N/A. This is not a clinical study involving expert interpretation or ground truth establishment in that manner. The "ground truth" for these tests comes from established engineering principles, reference materials, and the defined performance characteristics of the predicate devices and relevant standards.

4. Adjudication Method for the Test Set

N/A. There is no adjudication method described as it's not a clinical or interpretive study. Performance is assessed against quantitative engineering specifications and comparison to predicate devices.

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

N/A. No MRMC study was done, as this is a physical medical device (guidewire) and not an AI or diagnostic imaging system that would involve human readers.

6. Standalone Performance Study (Algorithm Only)

N/A. Not applicable, as this is a physical medical device, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" for the non-clinical tests is derived from:

• Established engineering specifications and performance benchmarks defined by FDA guidance documents (e.g., "FDA Coronary and Cerebrovascular Guidewire Guidance January 1995").
• International ISO standards (e.g., ISO 11070, ISO 10993 series).
• ASTM standards (e.g., ASTM F 1929-98, ASTM F 88-09, ASTM Guideline F-756-00).
• NeoMetrics' internal test methods (e.g., TM-3010, TM-3002).
• The performance characteristics of the legally marketed predicate devices, against which the NeoWire is compared to demonstrate substantial equivalence.

8. Sample Size for the Training Set

N/A. This is not an AI/machine learning device; therefore, there is no "training set."

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

N/A. Not applicable.

Ask a specific question about this device

The VascuPuncture PICC Guidewire is indicated for percutaneous entry of peripheral vessels using the Seldinger Technique. VascuPuncture Guidewires are not indicated for use in the coronary or cerebral vasculature.

The VascuPuncture™ PICC Guidewires are guidewires constructed of stainless steel and nickel titanium alloy with a lubricious coating. Devices are available in diameters of 0.014 to 0.018 inches and in lengths ranging from 45 to 135 cm.

The provided document is a 510(k) summary for the VascuPuncture™ PICC Guidewire, which is a medical device. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria in the manner one would see for a novel AI/software medical device.

Therefore, much of the requested information cannot be extracted directly from this document. However, I will fill in what can be inferred or stated based on the nature of a 510(k) submission for a guidewire.

Here's the breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device (guidewire), acceptance criteria and performance are typically related to physical and functional characteristics demonstrating equivalence to existing, legally marketed predicate devices. The document explicitly states:

"Functional and performance characteristics are demonstrated through equivalence with the predicate device and testing of representative device samples."

However, specific quantitative acceptance criteria (e.g., tensile strength > X, lubricity

Ask a specific question about this device

The VascuPuncture PICC Guidewire is indicated for percutaneous entry of peripheral vessies using the Seldinger technique. VascuPuncture Guidewires are not indicated for use in the coronary or cerebral vasculature.

The VascuPuncture™ PICC Guidewires are guidewires constructed of stainless steel and nickel titanium alloy with a lubricious coating. Devices are available in diameters of 0.014 and 0.018 inches and in lengths ranging from 45 to 145 cm.

The provided text describes a 510(k) premarket notification for the VascuPuncture™ PICC Guidewire with Hydro-Silk Coating. This is a medical device submission seeking clearance to market a new device by demonstrating its substantial equivalence to a legally marketed predicate device.

The study presented here is a substantial equivalence comparison, not a clinical study designed to test diagnostic or treatment efficacy. Therefore, many of the typical acceptance criteria and study design elements found in a clinical study (like multi-reader multi-case studies, ground truth establishment for a test set of patient data, training set information, etc.) are not applicable in this context.

Here's the breakdown based on the provided document:

1. Table of Acceptance Criteria and the Reported Device Performance

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

For a 510(k) submission like this, the "test set" typically refers to the physical devices manufactured and subjected to bench testing or material characterization. It does not refer to patient-level data.

• Sample Size for Bench/Performance Testing: The document states "testing of representative device samples." The exact number is not specified in the provided text.
• Data Provenance: The data comes from internal testing conducted by NeoMetrics, Inc. The location of the testing is not specified, but it would have been performed by the manufacturer or a contract laboratory. This is retrospective in the sense that the test results are generated for the purpose of the submission after product development. It is not patient data, so "country of origin of the data" in a clinical sense is not applicable.

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

Not applicable for this type of submission. "Ground truth" in the context of patient data adjudicated by experts is not relevant here. The "ground truth" for demonstrating substantial equivalence rests on objective engineering and scientific testing to prove that the device performs as intended and is safe, similar to the predicate. The FDA (specifically the Division of Cardiovascular Devices) evaluates the submitted data to determine if substantial equivalence has been met.

4. Adjudication Method for the Test Set

Not applicable in the sense of expert adjudication of clinical outcomes or images. The "adjudication" for this submission is the FDA's review process, where their experts evaluate the provided test data and comparisons to the predicate to determine substantial equivalence.

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

No, a MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating diagnostic devices where human readers interpret patient data (e.g., radiology images). This submission is for a guidewire, a physical interventional device, and the clearance is based on substantial equivalence to an existing device, not on comparative clinical effectiveness with or without AI assistance.

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

Not applicable. This submission is for a physical medical device (a guidewire), not a software algorithm or AI.

7. The Type of Ground Truth Used

The "ground truth" for this submission is based on:

• Objective Engineering Standards and Bench Test Results: Performance characteristics (e.g., lubricity, tensile strength, kink resistance, coating integrity) are measured against established engineering standards and specifications.
• Biocompatibility Testing Results: Data from tests conducted according to recognized standards (e.g., ISO 10993 series) to confirm the new material's safety in contact with the body.
• Comparison to the Predicate Device: The established performance and safety profile of the legally marketed predicate device (VascuPuncture PICC Guidewire, K031652) serves as the primary benchmark.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of machine learning or AI algorithms for this type of physical device submission.

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

Not applicable. As a mechanical device, there is no training set for an algorithm described in this submission.

Ask a specific question about this device

The NeoMetrics Selectiva SB Guidewire is intended to facilitate the placement of devices for diagnostic and interventional procedures.

NOTE: These guidewires are not intended for PTCA use.

The Selectiva SB Guidewires are constructed of a nickel-titanium alloy with a PTFE polymer jacket. Devices are available in a diameter of 0.035 inches and in lengths ranging from 40 to 300 cm.

The provided text is a 510(k) summary for a medical device called the "Selectiva SB Guidewire." This is a regulatory filing for a medical device, and as such, it focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed clinical study demonstrating device performance against specific acceptance criteria for an AI or software-based device.

Therefore, the information requested about acceptance criteria, detailed study design, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies, is largely not applicable or present in this document. This document describes a physical medical device (a guidewire), not an AI or software-based medical device.

However, I can extract the relevant information regarding the "study" that proves the device meets the (implied) acceptance criteria of substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a physical guidewire and not an AI/software device, there aren't quantitative "acceptance criteria" in the same way one would have for an AI's performance metrics (e.g., sensitivity, specificity). Instead, the acceptance is based on demonstrating substantial equivalence to predicate devices. The performance is assessed through bench testing comparing the functional and performance characteristics to the predicate.

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

• Sample Size for Test Set: Not explicitly stated. The document refers to "Representative samples of the device" used for bench testing. This typically implies a statistically relevant but undisclosed number of devices were tested to characterize their mechanical and performance properties.
• Data Provenance: The data is generated from bench testing conducted by the manufacturer (NeoMetrics, Inc.). This is a prospective data generation process from newly manufactured devices. The concept of "country of origin of the data" is not applicable as it's not clinical data.

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

• This is not applicable. The "ground truth" for a physical guidewire's performance in bench testing would be defined by engineering specifications and objective measurements (e.g., force required to buckle, torque response, lubricity measurements). It would not involve expert consensus in the way clinical image interpretation or diagnosis would.
• The comparison is to existing predicate devices, which were previously cleared based on their own performance data and established safety and effectiveness.

4. Adjudication Method for the Test Set

• Not applicable. This is not a clinical study involving human interpretation of data where adjudication would be necessary. Bench testing results are typically objective measurements against predefined engineering specifications.

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 submission, not an AI or software device. Therefore, no MRMC study, human readers, or AI assistance is involved.

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

• Not applicable. This is a physical medical device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• The "ground truth" in this context refers to established engineering specifications, performance standards, and the known performance characteristics of the predicate devices. It is based on objective physical measurements and comparisons rather than expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

• Not applicable. This is a physical device, not an AI/ML model that requires a training set. The design and manufacturing process are informed by engineering principles and experience, but there isn't a "training set" in the computational sense.

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

• Not applicable, as there is no "training set." The design and development of the device would be based on engineering principles, materials science, and knowledge gained from predicate devices, rather than a data-driven "ground truth" for training.

In summary, the provided document is a 510(k) premarket notification for a physical medical device. Its "study" consists of bench testing to demonstrate substantial equivalence to predicate devices, not clinical trials or AI performance evaluations.

Ask a specific question about this device

The VascuPuncture PICC Guidewire is intended for percutaneous entry of peripheral vessels using the Seldinger Technique. VascuPuncture Guidewires are not intended for use in the coronary or cerebral vasculature.

The VascuPuncture PICC Guidewires are guidewires constructed of stainless steel and nickel titanium alloy with a lubricious coating. Devices are available in diameters of 0.014 and 0.018 inches and in lengths ranging from 45 to 145 cm.

The provided text describes a 510(k) submission for the VascuPuncture PICC Guidewire, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed acceptance criteria and a study demonstrating performance against those criteria in the same way a clinical trial for a new drug or novel device might.

Based on the provided text, the specific information requested in your prompt is not present for the following reasons:

• No detailed acceptance criteria or performance metrics are explicitly stated in the provided text. The submission aims to show substantial equivalence, implying that the device performs similarly to predicate devices rather than meeting a specific set of quantitative criteria.
• The "study" refers to bench testing, not a clinical trial with human subjects. Clinical studies, sample sizes for test/training sets, expert involvement, and ground truth establishment are not described.
• The document explicitly states "Functional and Safety Testing: Representative samples of the device underwent bench testing to demonstrate appropriate functional and performance characteristics compared to the predicate device." This indicates bench testing (in-vitro) was performed, not an in-vivo study involving human subjects or clinical data in the manner typically associated with the questions asked.

Therefore, I cannot provide a table of acceptance criteria and reported device performance using the information given, nor can I answer the questions regarding sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details because this type of information is simply not included in this 510(k) summary.

The conclusion of the 510(k) summary states: "The VascuPuncture PICC Guidewire modified as proposed in this submission, is substantially equivalent to the predicate devices. This conclusion is based upon the similarity in design, principles of operation, materials, and performance and of the modified device compared to the originally, cleared device."

This heavily implies that the "acceptance criteria" were met by demonstrating that the device's functional and safety characteristics (as evaluated through bench testing) were comparable to the predicate devices, thereby ensuring it met the same safety and effectiveness standards.

Ask a specific question about this device

THE NEOMETRICS VASCUPUNCTURE ACCESS WIRE IS IN DICATED FOR PERCUTANEOUS VASCULAR ENTRY USING THE SELDINGER TECHNIQUE,

This guidewire has a 0.0175" diameter and is available in lengths of 45-120 cm. It features gradual diameter changes in the distal section to facilitate vascular insertion and compatibility with various introducers and catheters. A variety of distal tapers impart different tip flexibilities.

This request requires the extraction of very specific information about acceptance criteria and study design, which is not present in the provided text. The document is a 510(k) summary for a medical device (guidewire) and primarily focuses on establishing substantial equivalence to predicate devices, not on detailed performance studies or specific acceptance criteria with reported device performance.

Therefore, I cannot provide the requested table or detailed study information. The text explicitly states: "NeoMetrics Access Wires and predicate devices were subjected to bench and biocompatibility testing to demonstrate equivalency in terms of safety and effectiveness." However, it does not provide:

• A table of acceptance criteria (e.g., minimum tensile strength, maximum friction) or reported device performance against those criteria.
• Details about the sample size for any test set, data provenance, or number/qualifications of experts used to establish ground truth.
• Information on adjudication methods, MRMC studies, standalone algorithm performance, type of ground truth, or training set specifics (as these are typically relevant for AI/software-based devices, not a physical guidewire).

The provided text focuses on the regulatory submission process and the determination of substantial equivalence for a physical medical device.

Ask a specific question about this device

To facilitate the placement of devices for diagnostic and interventional procedures. NOTE: These guidewires are not intended for PTCA use.

The Selective™ Guidewire is used to facilitate the placement of devices for diagnostic and interventional procedures. The shaft of the device is constructed of PES (polyethersulfone) coated Nitinol or stainless steel with a tapered distal end secured to a platinum or stainless steel helical coil. A selection of distal tapers imparts different tip flexibilities. The guidewire is coated with silicone fluid to improve lubricity. The Selectiva™ Guidewire will be offered in diameters of 0.018" - 0.035" and lengths of 60 cm - 260 cm. It will be supplied sterile, intended for one-time use.

The provided text describes a submission for a medical device (Selectiva™ Guidewire) to the FDA, seeking substantial equivalence to a predicate device. This document is a 510(k) Premarket Notification, a process used to demonstrate that a device is at least as safe and effective as a legally marketed predicate device. This type of submission relies on comparisons to an existing device rather than presenting novel clinical study data to establish acceptance criteria and performance against those criteria in the way one might for a new drug or an AI-powered diagnostic tool.

Therefore, many of the requested categories for AI/diagnostic studies are not applicable to this type of device submission. The "acceptance criteria" here are fundamentally about demonstrating equivalence to the predicate device in specific functional and safety aspects.

Here's an attempt to answer the questions based on the provided text, indicating "N/A" (Not Applicable) where the information is not present or relevant to a 510(k) submission for a guidewire, which is not an AI/diagnostic device.

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

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

• Sample Size: Not specified for individual tests. The submission refers to a comparison of "all functional and safety tests."
• Data Provenance: Not specified. The testing was conducted by the submitter (NeoMetrics, Inc.) and potentially independent laboratories. The country of origin of the data is not mentioned, but the submitter is based in Plymouth, MN, USA.
• Retrospective or Prospective: Not explicitly stated, but device testing of this nature is generally prospective for the specific tests performed to support a 510(k).

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)

N/A. This type of information is not relevant to demonstrating substantial equivalence for a physical medical device like a guidewire. Ground truth is established by objective engineering and biocompatibility testing standards, not expert consensus on diagnostic images.

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

N/A. Adjudication methods are typically employed in clinical studies where subjective human interpretation or diagnostic accuracy is being assessed. For physical device performance tests, the results are typically objective measurements or pass/fail criteria against established specifications.

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

N/A. This context relates to AI-powered diagnostic tools. The Selectiva™ Guidewire is a physical device, not an AI or diagnostic tool, and therefore, an MRMC study is not relevant.

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

N/A. This applies to AI algorithms. The Selectiva™ Guidewire is a physical medical device.

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

The "ground truth" for this device's performance is established by:

• Pre-defined engineering specifications and performance standards for functional characteristics (e.g., tensile strength, flexibility, torqueability).
• Biocompatibility testing against ISO standards or equivalent for safety to demonstrate the device is non-toxic and compatible with the human body.
• Characteristics of the predicate device (Lake Region Manufacturing Mandrel Guidewire Assembly K011084) serve as the primary reference for demonstrating "substantial equivalence."

8. The sample size for the training set

N/A. There is no "training set" in the context of a 510(k) submission for a physical guidewire; this term refers to machine learning.

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

N/A. As there is no training set, this question is not applicable.

Ask a specific question about this device