Search Results

The NaviCross 0.018" is intended to guide wire during access of the peripheral vasculature, allow for wire exchanges and provide a conduit for the delivery of saline or diagnostic contrast agents.

The NaviCross 0.018" is a single use, ethylene oxide sterilized device that is intended to guide and support a guide wire during access of the peripheral vasculature, allow for wire exchanges and provide a conduit for the delivery of saline or diagnostic contrast agents.

NaviCross 0.018" features a three-layer construction, which consists of a stainless steel mesh braid sandwiched between an outer layer of polyamide and an inner layer of polytetrafluoroethylene. It has a distal tip that is comprised of a polyamide. It also has a hydrophilic coating over the distal 40 cm of the catheter.

The device is offered in effective lengths of 65, 90, 135 and 150 cm.

The provided text describes a 510(k) submission for the NaviCross 0.018" catheter. It details the device's technical specifications, comparison to predicate and reference devices, and non-clinical performance testing. However, it explicitly states that no clinical tests were performed or included in this 510(k) submission.

Therefore, I cannot provide information regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment based on the provided text, as these typically pertain to clinical studies.

The document focuses on demonstrating substantial equivalence through non-clinical performance testing and biocompatibility testing.

Here's a breakdown of what is available in the document regarding non-clinical performance:

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

The document lists various performance tests conducted. While it states that "Performance testing met the predetermined acceptance criteria and is acceptable for clinical use throughout its shelf life," the specific numerical acceptance criteria and the exact reported performance values for each test are not detailed in the provided text. The table (Table 5.4) only lists the Test Items.

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

• Sample Size: The document does not specify exact sample sizes for each non-clinical test. It states that tests were performed on "non-aged and accelerated aged samples."
• Data Provenance: The device manufacturer and sterilization facility are the Ashitaka Factory of Terumo Corporation in Japan (Fujinomiya, Shizuoka 418-0015, Japan). The testing was conducted as part of their 510(k) submission for the US market. The testing is pre-market, laboratory-based performance and biocompatibility testing, not human data.

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

This is not applicable as the testing described is non-clinical performance and biocompatibility testing, not clinical data requiring expert ground truth or interpretation of images/patient outcomes.

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

Not applicable for non-clinical performance testing.

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. No clinical studies, especially MRMC studies comparing human performance with and without AI assistance, were performed or referenced in this document.

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

Not applicable. This device is a medical catheter, not an AI algorithm.

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

For the non-clinical tests, the "ground truth" or reference for acceptance is established by predefined engineering and material science standards (e.g., ISO standards, internal specifications for dimensions, strength, leakage, etc.). It's based on physical and chemical measurements rather than clinical ground truth types.

8. The sample size for the training set:

Not applicable. This device is a physical medical device, not an AI algorithm requiring a training set.

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

Not applicable. No training set for an algorithm is mentioned.

In summary, the provided document details non-clinical performance and biocompatibility testing for a medical device (catheter) to establish substantial equivalence. It explicitly states that no clinical tests were included in this 510(k) submission. Therefore, most of the questions relating to clinical study design, expert involvement, and AI performance are not applicable to the information given.

Ask a specific question about this device

The IMDS NHancer™ Guide Wire Support Catheter with Hydrophilic Coating is a guidewire exchange and infusion device designed for use in the vascular system. The IMDS NHancer™ guidewire support catheter is intended to support a guidewire during access of vasculature and allows for exchange of guidewires and provides a conduit for the delivery of diagnostic contrast agents.

The purpose of the NHancer™ guidewire support catheter is to facilitate the placement of a guide wire through an occluded vessel during Percutane Transluminal Coronary Intervention procedures. The NHancer™ is a single use device, consisting of a shaft, a distal tip and a female luer (hub) on the proximal end. On the shaft are two depth markings applied to indicate the length of the device that is in the body. On the distal tip of the device a radiopaque marker band is applied. The distal part of the shaft is fitted with a hydrophilic coating. On the shaft a torquer is placed. With this component the catheter can be locked on to the guide wire that is in the device. The torquer is initially placed on a strain relief which is located on the proximal end of the shaft, near the female luer (hub).

The provided text describes the 510(k) submission for the NHancer™ guidewire support catheter. The device is a traditional guidewire support catheter, not an AI/ML device, and therefore the acceptance criteria and study information typically associated with AI/ML device submissions are not directly applicable.

However, I can extract the performance criteria and the study approach used to demonstrate substantial equivalence to a predicate device, which is the regulatory pathway for this type of medical device.

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that the NHancer™ guidewire support catheter met all acceptance criteria. Specific quantitative acceptance criteria are not detailed in the provided text. Instead, the document focuses on demonstrating that the NHancer™ performed similarly or was substantially equivalent to the predicate device, the Spectranetics QuickCross® Support Catheter, for a range of performance characteristics.

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

The document details performance testing for both the NHancer™ and a predicate device. However, it does not specify the sample sizes used for the in-vitro and in-vivo tests. It only states that "Comparison testing was performed on the IMDS NHancer™ guidewire support catheter and the Spectranetics QuickCross Support Catheter" and that various "bench tests were performed on NHancer™ guidewire support catheter."

The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. Given the nature of a 510(k) submission for a physical medical device, these tests would typically be laboratory-based (in-vitro) and animal studies (in-vivo) conducted prospectively for the purpose of demonstrating regulatory compliance.

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

This information is not applicable to this type of device and submission. "Ground truth" established by experts is typically a concept used in the evaluation of AI/ML diagnostic or prognostic devices, where human expert labels are used to train and validate AI algorithms. For a guidewire support catheter, the "ground truth" is determined by objective performance measurements against engineering specifications and predicate device performance, not expert consensus on interpretations.

4. Adjudication Method for the Test Set:

This information is not applicable for the same reasons as point 3. Adjudication methods like "2+1" or "3+1" are used in AI/ML studies to resolve disagreements among human labelers for establishing ground truth.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size of Human Improvement with/without AI Assistance:

This information is not applicable as the NHancer™ is a physical medical device, not an AI/ML diagnostic or prognostic tool. Therefore, there are no "human readers" interpreting data with or without AI assistance, and no MRMC study would be conducted.

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

This information is not applicable as the NHancer™ is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used:

For the NHancer, the "ground truth" is based on:

• Engineering specifications: For various dimensions, material properties, and functional tests (e.g., usable length, outer diameter, pull strength, burst strength, flow rate).
• Performance relative to a predicate device: For clinical performance characteristics like crossability, guidewire friction, torqueability, marker visibility, guidewire exchangeability, and contrast administration. The predicate device's established performance serves as the benchmark.
• International Standards: For biocompatibility (ISO 10993), sterility (ISO 11137, ISO 11737), and non-pyrogenicity (Ph. Eur. Chapter 2.6.14 Method C, USP).

8. The Sample Size for the Training Set:

This information is not applicable. The concept of a "training set" refers to data used to train an AI/ML algorithm. The NHancer™ is a physical device and does not involve AI/ML.

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

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

Ask a specific question about this device

The GlideCross™ Support Catheter is intended to be used for guide wire support during access of the vasculature allowing for exchange of guide wires and provides for the delivery of saline and/or diagnostic contrast agents. The GlideCross™ Support Catheter is indicated for use in the peripheral vasculature.

The GlideCross Support Catheters are single lumen intravascular catheters designed for use in the peripheral vasculature. The catheters provide support to guide wires during access of the vasculature and allow for exchange of guide wires while maintaining vessel access. The GlideCross Support Catheters are available in 9 models compatible with various guide wire sizes and have a lubricous hydrophilic coating on the distal shaft and a female Luer on the proximal end. The catheters have 3 encapsulated radiopaque marker bands evenly spaced along the distal shaft, with the distal band 3 mm from the tip, to aid in positioning of the catheter tip and in estimating distances.

The provided document describes a medical device, the GlideCross Support Catheter, and its clearance through a 510(k) premarket notification. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting new clinical trials to prove efficacy against specific acceptance criteria in a human study. Therefore, the information typically requested for AI/ML device studies (such as MRMC studies, expert ground truth, sample sizes for training/test sets, etc.) is not applicable in this context.

Instead, acceptance criteria and performance are demonstrated through engineering testing, material comparisons, and biocompatibility assessments to show that the new device is as safe and effective as its predicate.

Here's an analysis of the provided information, framed to address the spirit of your request where applicable, even if direct answers for AI/ML device studies are not available:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the GlideCross Support Catheter are largely derived from ensuring its specifications and performance are similar to its predicate device (Spectranetics QUICK CROSS CATHETERS, K033678) and that it meets established industry standards for medical devices of its type. The "reported device performance" refers to the results of various engineering and biocompatibility tests.

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

For a traditional medical device (not AI/ML), the "test set" primarily refers to the number of individual devices or components subjected to each specific physical, mechanical, or biological test. The document does not specify exact sample sizes for each test (e.g., how many catheters were tested for trackability or burst pressure). However, it implies that sufficient samples were tested to demonstrate conformity to specifications and substantial equivalence to the predicate.

The data provenance is from Terumo Medical Corporation's in-house testing facilities, likely following established laboratory procedures and standards (e.g., ISO, ASTM, USP) for medical device evaluation. This is a prospective generation of data specifically for this 510(k) submission, comparing the new device's performance against its own pre-approved specifications and in comparison to the predicate device.

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

This concept is not directly applicable to a traditional medical device 510(k) submission concerning physical and mechanical properties. "Ground truth" in this context is established by:

• Engineering specifications and standards: These are the objective benchmarks (e.g., maximum pressure, specific lengths, material properties) that the device must meet.
• Predicate device's performance: The Spectranetics QUICK CROSS CATHETERS (K033678) serves as the established benchmark for "safe and effective" performance through its prior clearance.
• Regulatory standards: ISO, ASTM, and USP standards for biocompatibility and sterilization are the "ground truth" for these aspects.

The expertise lies in the engineers, scientists, and quality assurance personnel who design the tests, conduct them, and interpret the results against these established standards. Their qualifications would typically involve degrees in engineering, materials science, biology, and chemistry, with experience in medical device testing and regulatory affairs. Their 'number' is not specified globally but would involve teams for each testing area.

4. Adjudication Method for the Test Set

Again, this is not applicable in the context of a physical medical device. Adjudication methods like 2+1 or 3+1 are used in clinical studies or expert reviews of data (e.g., imaging reads) to resolve disagreements. For engineering tests, the "adjudication" is inherent in:

• Objective measurements: A tensile strength test yields a numerical result. Either it meets the specification or it doesn't.
• Pre-defined pass/fail criteria: Each test has clear parameters for what constitutes a successful outcome.
• Comparison to predicate: Direct comparison of measurements or observations with the predicate device's characteristics.
• Standard compliance: Meeting the requirements of relevant ISO or ASTM standards.

Any discrepancies or failures would lead to investigation, redesign, or retesting, rather than an "adjudication" in the clinical sense.

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

No, an MRMC comparative effectiveness study was not done. MRMC studies are clinical effectiveness studies typically used for diagnostic devices (like imaging software) to assess how human reader performance changes with or without AI assistance across multiple cases and readers. The GlideCross Support Catheter is an interventional/support device, and its safety and effectiveness are demonstrated through engineering tests, biocompatibility, and comparison to a predicate device, not through human reader studies.

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

No, a standalone (algorithm-only) performance study was not done. This device is a physical medical instrument, not an AI algorithm. Its performance is entirely dependent on the physical properties of the catheter and its interaction with physiological systems and clinicians.

7. The Type of Ground Truth Used

The ground truth used for this device can be categorized as:

• Engineering Specifications/Standards: Detailed quantitative and qualitative requirements for the device's physical and mechanical properties (e.g., dimensions, strength, flexibility, flow rates, coating integrity).
• Predicate Device Performance Profile: The known and accepted performance characteristics of the legally marketed predicate device (Spectranetics QUICK CROSS CATHETERS, K033678). The "substantial equivalence" claim relies on the new device performing similarly.
• International and National Standards: Compliance with recognized standards for biocompatibility (ISO 10993 series, ASTM F756), sterilization (ISO 11135, ISO 10993-7), and endotoxin testing (USP , FDA guidelines). These standards themselves represent established "ground truths" for safety.

8. The Sample Size for the Training Set

No "training set" in the context of machine learning was used. This device is a physical product, not an AI/ML model. Therefore, the concept of a training set is not applicable. The design and manufacturing processes are refined through engineering development and quality control, not iterative training on data.

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

Since there was no "training set" for an AI/ML model, this question is not applicable. For physical device development, the "ground truth" (i.e., desired performance and specifications) for the design phase is established through:

• Clinical needs assessment: Understanding the requirements for guide wire support and delivery in peripheral vasculature.
• Benchmarking against existing products: Analyzing the predicate device (Spectranetics QUICK CROSS CATHETERS) and other similar devices to inform design goals.
• Material science: Selecting materials with known properties suitable for the intended use.
• Engineering principles: Applying principles of mechanical engineering and fluid dynamics to design the catheter.
• Regulatory requirements: Ensuring the design inherently meets relevant safety and performance standards.

Ask a specific question about this device

Terumo Support Catheters are intended to guide and support a guidewire during access of the vasculature, allow for wire exchanges and provide a conduit for the delivery of saline or diagnostic contrast agents.

The Terumo Support Catheter is a three-layer construction comprised of a stainless steel braid sandwiched between two layers of polyester elastomer. The polyester elastomer contains tungsten for visibility and contrast under fluoroscopy in the distal portion of the catheter. The most distal tip contains no braid and the tip is available in either straight or curved shapes. The device has three radiopaque markers, the distal one is embedded in the tip wall while the more proximal two are swaged to the outer surface of the catheter. There is a hydrophilic coating on the distal portion of the catheter to enhance lubricity.

The provided text describes a 510(k) premarket notification for the Terumo Support Catheter, which aims to demonstrate substantial equivalence to predicate devices. This type of submission does not typically involve the rigorous clinical trials or complex statistical analyses that would be found in a PMA (Premarket Approval) application for novel, high-risk devices. Therefore, many of the requested elements regarding acceptance criteria, sample sizes, expert ground truth establishment, MRMC studies, and standalone performance for AI/ML devices are not applicable.

The "acceptance criteria" for a 510(k) device primarily revolve around demonstrating that the new device is as safe and effective as a legally marketed predicate device, and does not raise any new questions of safety or effectiveness. This is achieved through a combination of design, materials, specifications, and performance testing, often comparing the new device directly to the predicate.

Here's an attempt to extract and present the information based on the provided document, addressing the requested points where possible, and noting when information is not applicable to this type of submission.

Acceptance Criteria and Device Performance for Terumo Support Catheter

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission like this, "acceptance criteria" are generally framed as demonstrating substantial equivalence to predicate devices across various attributes. The performance tests conducted are to ensure the new device meets specifications comparable to or better than the predicates. The text states:

"The Terumo Support Catheter met all performance specifications."

While specific numerical acceptance criteria for each test (e.g., minimum force at break, maximum allowable leakage) are not explicitly detailed in the provided summary, the overarching acceptance criterion is successful completion of all listed performance tests, demonstrating substantial equivalence to the predicate devices. The reported device performance is that it met all specifications.

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

The document does not specify the exact sample sizes (e.g., number of catheters tested) for each performance or biocompatibility test. It indicates that "Testing was performed on nonaged and aged Terumo Support Catheters vs the Spectranetics QUICK CROSS CATHETERS and the Spectranetics QUICK CROSS EXTREME SUPPORT CATHETERS." This implies a comparison study, but the specific N for each test article is not disclosed.

The "data provenance" mentioned in the context of AI/ML (country of origin, retrospective/prospective) is not applicable here as this is a physical medical device. The data comes from in vitro (laboratory) and in vivo (Thrombogenicity Study in Dogs) testing of device prototypes.

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

This section is not applicable. The evaluations are based on objective physical, chemical, and biological tests, not expert interpretation of diagnostic images or patient outcomes. The "ground truth" for parameters like "force at break" is a direct measurement, not an expert consensus.

4. Adjudication Method for the Test Set

This section is not applicable, as there's no subjective interpretation requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. This is typically relevant for diagnostic imaging AI tools, not for a physical medical device like a catheter seeking 510(k) clearance based on substantial equivalence.

6. If a Standalone Performance Study (Algorithm only without human-in-the-loop performance) was done

This section is not applicable. This is not an algorithm or AI device. The performance tests evaluate the physical device itself.

7. The Type of Ground Truth Used

The "ground truth" for the performance tests (e.g., force at break, burst pressure, flow rate, dimensions) is established through direct physical measurements and standardized test methods. For biocompatibility, the ground truth is determined by the results of specific biological assays (e.g., cytotoxicity, hemolysis, pyrogenicity) against established safety thresholds as per ISO-10993. For sterilization, the ground truth is the demonstration of sterility to a specific SAL (Sterility Assurance Level) through validated processes in accordance with relevant ISO standards.

8. The Sample Size for the Training Set

This section is not applicable. There is no AI/ML model being "trained" for this device. The development process involves design, prototyping, testing, and refinement, but not in the sense of a machine learning training set.

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

This section is not applicable, as there is no training set in the context of this device's development or regulatory submission.

Ask a specific question about this device

The Skyway Support Catheter is to be used in conjunction with steerable guidewires in order to access discrete regions of the coronary and peripheral arterial vasculature and to facilitate placement of guidewires and other interventional devices.

The Skyway Support Catheters are 3F O.D. catheters that taper to a 1.9F tip and are compatible with a 0.014" standard guide wires. The Skyway catheters have a working length of 130-135cm and contains positioning markers at 95 and 105cm which provide a visual indication of the relative positions of Skyway and the end of a standard 105cm guide catheter. A single radiopaque markerband at tip of the catheter provide for a radiographic means of locating the tip position. The softer, distal end of the catheter is coated with a hydrophilic coating to assist passage through the guide catheter and vessels while the proximal end of the catheter contains a strain relief and a standard luer hub. The catheters are provided in both an over-the-wire (OTW) and rapid exchange (RX) versions. The RX version has a uniquely designed RX port to facilitate exchange of short guidewires. A 120cm stiffening mandrel is included with the Skyway RX version to provide support and pushability.

The provided document is a 510(k) premarket notification for the Skyway™ Support Catheter. It indicates that no clinical evaluations of this product have been conducted. Therefore, it is impossible to provide the requested information about acceptance criteria and a study proving the device meets them, as such a study was not performed.

The submission relies on non-clinical testing and substantial equivalence to predicate devices (Lumend Percutaneous Catheter and Quick-Cross Catheter) to establish safety and effectiveness.

Here's a breakdown of why the requested information cannot be provided based on the given text:

1. A table of acceptance criteria and the reported device performance: Not available. The document states, "Testing conducted included assessments of the design verification of the Skyway Support Catheter along with biocompatibility assessments. The results of this battery of tests confirmed the suitability of the Skyway Support Catheter for its intended use." However, specific acceptance criteria or performance metrics are not listed.

2. Sample size used for the test set and the data provenance: Not available. No clinical test set was used. "Non-clinical testing" is mentioned, which typically refers to bench or animal studies, but no details on sample size or data provenance are provided for these.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical test set was used.

4. Adjudication method: Not applicable, as no clinical test set was used.

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 medical device (catheter), not an AI-powered diagnostic tool. No MRMC study was conducted.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device, not an algorithm.

7. The type of ground truth used: For non-clinical testing, ground truth would be established through engineering specifications, material analyses, and established testing protocols. Specific types (e.g., pathology, outcomes data) are not mentioned as they relate to clinical studies, which were not performed.

8. The sample size for the training set: Not applicable. This refers to AI/machine learning models, which are not relevant to this device submission.

9. How the ground truth for the training set was established: Not applicable.

In summary, this 510(k) submission demonstrates substantial equivalence primarily through non-clinical testing (design verification and biocompatibility) and comparison to predicate devices, rather than through a clinical study with defined acceptance criteria and performance data as would be typically required for a novel device or AI software.

Ask a specific question about this device