Search Results

The Route 92 Medical Sheath System is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.

The Route 92 Medical Sheath System is comprised of a Sheath, a Dilator, a Navigating Catheter, and an RHV (rotating hemostasis valve). The Sheath is a single-lumen, variable stiffness catheter with a radiopaque marker on the distal end. The inner lumen of the catheter is compatible with 8F or smaller catheters. The Dilator may be placed within the Sheath to facilitate percutaneous introduction of the Sheath into a femoral artery. The Dilator has a radiopaque marker at the distal tip. The Navigating Catheter is a single-lumen, variable stiffness catheter with a radiopaque marker at the distal tip. The Navigating Catheter is compatible with the Sheath and has a shaped distal end to facilitate placement. All of the catheters are coated with hydrophilic coating.

The provided text describes the 510(k) summary for the Route 92 Medical Sheath System, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting a de novo study to establish new acceptance criteria and prove its performance. Therefore, the information requested about acceptance criteria and a study proving the device meets those specific acceptance criteria (as would be applied to a novel device or AI software) is not directly present in the provided document.

Instead, the document details non-clinical testing to demonstrate the device's safety and performance against established standards and equivalence to a predicate device. The "acceptance criteria" here are implicitly the "PASS" results for each test, indicating conformity to pre-determined specifications or regulatory requirements.

Here's an attempt to answer your questions based on the provided text, while acknowledging the focus on substantial equivalence:

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

Since this is a 510(k) submission, the acceptance criteria are not explicitly defined numerical targets specific to a new AI model's performance but rather general standards and successful completion of tests demonstrating safety and equivalence.

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

The document generally states "All samples met the pre-determined acceptance criteria" for performance tests and provides results for biocompatibility tests (e.g., "All animals treated had were clinically normal" for acute systemic toxicity). It does not specify precise sample sizes for each non-clinical test.

• Sample Size: Not explicitly stated for most tests, often referred to as "all samples" or "animals" depending on the test type.
• Data Provenance: Not applicable in the context of these non-clinical, lab-based tests on device components/products. The tests are designed to evaluate the physical and biological characteristics of the device itself, not data from human subjects or retrospective/prospective studies in the clinical sense.

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 is not applicable. The tests conducted are non-clinical, laboratory-based evaluations of device properties (e.g., tensile strength, biocompatibility, dimensions). They do not involve expert interpretation of data or images to establish a "ground truth" as would be required for an AI-powered diagnostic device.

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

This is not applicable for non-clinical, laboratory-based testing of device characteristics. Adjudication methods are typically used in clinical studies or for establishing ground truth in diagnostic accuracy studies involving human interpretation.

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

No. The provided document is for a "Percutaneous Catheter" device, which is a physical medical instrument, not an AI software. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant and was not conducted.

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

No. This is a physical medical device, not an algorithm or AI.

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

This is not applicable as the tests are non-clinical hardware evaluations. The "ground truth" broadly refers to the established scientific and engineering principles, international standards (e.g., ISO), and pre-determined specifications against which the device's performance is measured.

8. The sample size for the training set

This is not applicable as the device is a physical medical instrument and no AI/machine learning model was trained.

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

This is not applicable as there is no training set for an AI/machine learning model.

Ask a specific question about this device

The SelectFlex 072 Neurovascular Access System is indicated for the introduction of interventional devices into the peripheral and neurovasculature.

The SelectFlex 072 Neurovascular Access System is a sterile, single-use intravascular catheter used to facilitate access target vasculature during interventional procedures. The system is composed of a the SelectFlex 072 Catheter, a 3cc Inflation Syringe, and a 7Fr Peel Away Introducer. The 072 SelectFlex Catheter has a usable length of 105cm. The SelectFlex 072 Catheter has variable stiffness along its length and has a dual mode stiffness mechanism on the distal portion of the catheter that is activated by the user allowing the device to transition between tracking and support modes. The distal end of the SelectFlex 072 Catheter has a hydrophilic coating.

This document, a 510(k) summary for the SelectFlex 072 Neurovascular Access System, describes various performance tests conducted to demonstrate the device's suitability for its intended use, rather than a clinical study evaluating an AI algorithm's performance.

Therefore, many of the requested fields regarding AI algorithm evaluation are not applicable (N/A) in this context. The document focuses on demonstrating substantial equivalence to a predicate device through physical and biological performance testing.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria for each test in a table, but rather indicates that all samples "met the pre-determined acceptance criteria" or "passed" the tests. The acceptance criteria are implicitly defined by the referenced ISO/ASTM standards and internal product specifications.

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

The document does not specify the exact sample sizes used for each individual performance test (e.g., how many catheters were tested for flex fatigue). It generally states "All samples met the pre-determined acceptance criteria," implying that a sufficient number of samples were tested per the relevant standards.

• Sample Size for Test Set: Not explicitly stated for each test, but implied to be adequate for standard compliance.
• Data Provenance: Not specified. This typically refers to data like patient images or clinical records, which are not relevant to these engineering and biocompatibility tests. The tests themselves are laboratory-based.

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

• Number of Experts: For the "Simulated Use/Usability" test, it states "a usability assessment with multiple physicians." The exact number or qualifications are not provided beyond "physicians."
• Qualifications of Experts: "Multiple physicians" for usability assessment. For other tests, "ground truth" is established by adherence to recognized international standards (e.g., ISO, ASTM, USP) and internal product specifications, carried out by qualified testing personnel, but not "experts" in the sense of clinical specialists interpreting results.

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

Not applicable. This is not a clinical study involving interpretation of data by multiple readers. The assessment of performance tests is based on objective measurements against pre-defined criteria in laboratory settings.

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 document pertains to the performance and safety testing of a neurovascular access system, not an AI or imaging diagnostic device. No AI component is mentioned.

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

Not applicable. This is not an AI algorithm.

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

For the performance and biocompatibility tests, the "ground truth" is established by:

• Compliance with international standards: ISO, ASTM, AAMI, USP.
• Adherence to internal product specifications: Dimensional verification.
• Comparison to predicate/reference devices: For tip deflection, flow rate, and device removal forces.
• Usability assessment: By "multiple physicians" in a simulated environment.

No pathology or outcomes data are referenced as this is a pre-market notification for a device and not a clinical trial.

8. The sample size for the training set

Not applicable. This is not an AI algorithm, so there is no training set.

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

Not applicable. There is no AI training set.

Ask a specific question about this device

The R2P (radial to peripheral) SlenGuide is designed for the introduction of interventional and diagnostic devices into the peripheral vasculature of the lower extremities.

The R2P SlenGuide is a single use, ethylene oxide sterilized device that is designed to perform as a guiding catheter for interventional procedures in the peripheral vasculature. It is packaged with a guiding catheter and an inner guide. The guiding catheter features a three-layer construction with a stainless steel mesh, polyamide elastomer, and polytetrafluoroethyelene. The distal end has a hydrophilic coating and a soft-tip visible under fluoroscopy. The inner guide is an accessory device made of polyester elastomer with a flexible distal portion containing tungsten, visible under fluoroscopy.

The provided document describes the R2P SlenGuide, a percutaneous catheter, and its testing to demonstrate substantial equivalence to predicate devices. It does not contain information about a study proving the device meets acceptance criteria in terms of performance metrics like sensitivity, specificity, accuracy, or effect size for AI assistance. Instead, the "acceptance criteria" here refer to meeting standards for safety and performance characteristics through non-clinical testing.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists various non-clinical tests performed and states that "Performance testing met the predetermined acceptance criteria." However, it does not explicitly state the numerical acceptance criteria for each test or the specific reported performance results in a detailed, quantitative table. It only confirms that the criteria were met.

For example, for "Peak tensile force," the test procedure is described (measure peak tensile strength), but the acceptable range (e.g., >X Newtons) and the actual measured value are not provided in this summary. The same applies to other tests.

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

• Test Set Sample Size: The document mentions that performance tests were performed on "non-aged and accelerated aged samples." However, it does not specify the number of samples used for each test.
• Data Provenance: The tests are described as non-clinical performance testing conducted by the manufacturer, Terumo Corporation, or its Ashitaka Factory in Japan. The data is retrospective in the sense that it was collected as part of the device development and regulatory submission process.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable as the document describes non-clinical performance and biocompatibility testing of a physical medical device (a catheter), not an AI/software device that would require expert-established ground truth for a test set.

4. Adjudication Method

This information is not applicable for the same reason as point 3.

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

This information is not applicable as the device is a physical catheter, not an AI system. There is no mention of human readers or AI assistance in this context.

6. Standalone (Algorithm Only) Performance Study

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

7. Type of Ground Truth Used

This information is not applicable as the document describes non-clinical performance and biocompatibility testing of a physical medical device. The "ground truth" for these tests would be the established scientific and engineering principles and the specific requirements outlined in the referenced ISO and ASTM standards, as well as internal standards.

8. Sample Size for the Training Set

This information is not applicable as the device is a physical catheter, not an AI/machine learning device that would require a training set.

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

This information is not applicable for the same reason as point 8.

Summary of Non-Clinical Tests Performed (as a proxy for "study")

The study to demonstrate that the device meets performance requirements involved a series of non-clinical, in-vitro tests based on established international standards (ISO and ASTM) and FDA guidance documents. These tests were categorized into performance testing and biocompatibility testing.

Performance Testing (Guiding Catheter & Inner Guide):

• Standards Referenced: ISO 10555-1:2013, ASTM F640-12, USP , FDA Guidance "Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters."
• Tests Included:
  • Radio-detectability
  • Surface quality
  • Peak tensile force
  • Freedom from leakage
  • Hub performance (for Guiding Catheter)
  • Distal tip appearance
  • Particulate evaluation
  • Torque Strength (for Guiding Catheter)
  • Coating lubricity (for Guiding Catheter)
  • Evaluation of flexibility and kink resistance (for Guiding Catheter)
  • Distal tip flexibility (for Guiding Catheter)
  • Kink condition (for Guiding Catheter)
  • Flexural rigidity
  • Distal tip strength (for Guiding Catheter)
  • Cleanliness
  • Product dimensions

Biocompatibility Testing:

• Standards Referenced: ISO 10993-1, FDA General Program Memorandum #G95-1 (5/1/95), Draft Guidance for Industry and Food and Drug Administration Staff - Use of International Standard ISO-10993.
• Classification: Externally Communicating Device, Circulating Blood, Limited Contact (-6.

In essence, the "study" demonstrating the device meets its "acceptance criteria" here refers to the comprehensive non-clinical testing outlined above, which confirmed adherence to recognized standards for safety, performance, and biocompatibility, thereby supporting the claim of substantial equivalence to predicate devices.

Ask a specific question about this device