Search Results

The Guiding Catheter is designed to provide a pathway through which therapeutic and diagnostic devices are introduced. The Guiding Catheter is intended to be used in the coronary or peripheral vascular system.

The Hydrophilic Guiding Catheter consists of a reinforced body with a hub and strain relief at the proximal end and an intermediate and soft tip at the distal end. The distal part of the catheter features a specific tip shape. A part of the catheter body features a hydrophilic coating. The (distal part of the) catheter body is provided either with or without "in-line" side holes.

The guiding catheter is a flexible plastic tube featuring a luer hub, strain relief, a body, an intermediate tip, and a soft tip. The body and the intermediate tip consist of an inner liner (basecoat) and an outer jacket (topcoat) reinforced with a tightly wound stainless steel braid wire in between the layers. The central lumen of the catheter is used for the percutaneous, transluminal passage and placement of guidewires, diagnostic and therapeutic devices within the vascular system. After the catheter is inserted through the skin using a dilator, a sheath (introducer) and guide wire is brought into position. Subsequently, a guidewire is advanced through its lumen and tracked over by a diagnostic device and/or a therapeutic devices to the intended location. The distal section of the catheters has a variety of preformed shapes (e.g. Judkins Left (abbreviated as JL), Judkins Right (JR), Amplatz (AL), Multi-purpose (MP), hockey stick) to facilitate placement of the catheter tip in the desired target vessel. Some catheter models feature two (2) small "in-line" side holes in the intermediate tip section to maintain perfusion of the target vessel. This device is a single-use device (i.e., single patient, single procedure, single purpose use). After finalizing the procedure, the catheter is withdrawn, removed and discarded.

This document is an FDA 510(k) clearance letter for a medical device, specifically a "Primum Hydrophilic Guiding Catheter." It is NOT about a software-based AI/ML device, and therefore does not contain the information requested in your prompt regarding acceptance criteria, study details, human reader studies, or ground truth for AI models.

The device discussed is a physical catheter, and its acceptance criteria and proof of performance are based on bench testing (biocompatibility, physical properties tests) and comparison to a "predicate" device (another catheter already on the market) that is essentially the same product under a different trade name.

Therefore, I cannot provide the information requested in your prompt related to AI/ML device evaluation, as the provided text describes a traditional medical device clearance.

Ask a specific question about this device

Zimmon® Pancreatic Stents/Stent sets (SPSOF, SPSOS, ZEPDF, ZPSOF, ZPSOS); Geenen® Pancreatic Stents/ Stent Sets (GEPD, GPDS, GPSO, GPSOS); Geenen® Sof-Flex® Pancreatic Stent (GPSO-SF. GPSOS-SF); Endoscopic pancreatic stent placement is used for pancreatic drainage that could be caused by pancreatitis, stricture, pancreatic cancer, anatomic anomalies of the pancreas, pancreatic fluid collection, pancreatic stones, disrupted duct, fistula/pancreatic leak. Pancreatic stents are also used prophylactically for prevention of post-ERCP pancreatitis.

Johlin® Pancreatic Wedge Stent and Introducer Set (JPWS): Endoscopic pancreatic stent placement for pancreatic drainage of obstructed ducts that could be caused by pancreatitis, stricture, pancreatic cancer, anatomic anomalies of the pancreas, pancreatic fluid collection, pancreatic stones, and disrupted duct.

Pushing Catheter and Guiding Catheter (GC, PC): These devices are indicated for use with biliary and pancreatic stents for the following indications. For endoscopic biliary stent placement for biliary drainage of obstructed ducts that could be caused by common bile duct stones, malignant biliary obstruction and benign or malignant strictures. For endoscopic pancreatic stent placement for pancreatic duct drainage that could be caused by pancreatitis, stricture, pancreatic cancer, anatomic anomalies of the pancreatic fluid collection, pancreatic stones, disrupted duct, fistula / pancreatic leak. Pancreatic stents are also used prophylactically for prevention of post-ERCP pancreatitis.

The intended use of all Cook pancreatic stents and sets is to drain pancreatic ducts. A variety of stents in different sizes are available across the device range to accommodate various patient anatomies, the size and location of the obstruction and physician preference. They are offered in French sizes of between 3Fr and 11.5Fr, and in labelled lengths of between 2cm and 25cm.The subject devices and their components can be supplied as stent only, introducer only (guiding or pushing catheter) or as stent sets combining stent and introducers/introducer systems.

The stent sets can contain one or several of the following stent placement components; a flap protector, a guiding catheter, a pushing catheter or a dedicated introducer system. The flap protector is provided with stents that have duodenal flap-type anti-migration features, and is used to collapse the flap(s) on the device as it is introduced into the working channel of the endoscope. The function of the guiding catheter is to guide the pancreatic stent as part of its introduction to its intended location. The guiding catheter also has a Hub that allows for contrast injection. The function of the Pushing Catheter is to advance the stent, over a pre-positioned wire guide or Guiding Catheter, to its intended location within the anatomy, and to maintain the position of the Stent as it being deployed. The stents are polymeric and some of the stents have radiopaque bands. The stent designs include anti-migrational features such as duodenal pigtails, duodenal bends and ductal and duodenal flaps. To facilitate stent insertion and removal the stent ends are tapered or buffed. Side-ports on the pancreatic stents assist in drainage. All stents are deployed endoscopically over a guide wire in the same manner under fluoroscopic and endoscopic monitoring.

These Cook pancreatic stents and sets are all for professional use and are provided sterile. They are all intended for short-term use and have an indicated indwell of up to 3 months.

The provided document (K233079) describes the Cook Ireland Ltd. Zimmon and Geenen Pancreatic Stents/Stent sets, Johlin Pancreatic Wedge Stent and Introducer Set, and Pushing and Guiding Catheters. This submission is for medical devices, not an AI/ML powered device, therefore, the information requested in the prompt related to acceptance criteria and studies that prove the device meets these criteria is not applicable in the context of AI/ML performance.

Specifically, the document focuses on demonstrating substantial equivalence to a predicate device (Pancreatic Stents & Sets cleared under K172057) through comparisons of technological characteristics and non-clinical performance data. There is no mention of acceptance criteria related to AI/ML device performance metrics like sensitivity, specificity, or AUC, nor any studies involving test sets, ground truth established by experts, or human reader performance with or without AI assistance.

The performance data mentioned in the document are:

• Biocompatibility evaluation: Conducted in accordance with ISO 10993-1: 2018 and FDA's biocompatibility guidance.
• Performance testing: Included simulated use, dimensional and visual testing, tensile strength testing, MRI conditional testing, radiopacity, flow rate, and shelf-life testing.

These tests aim to ensure the physical and material integrity, safety, and functionality of the pancreatic stents and catheters.

Therefore, I cannot provide the requested information in the format of the table or answer the specific questions related to AI/ML acceptance criteria and studies based on the provided text.

Ask a specific question about this device

The TriSalus TriGuide Guiding Catheter is designed to provide a pathway through which therapeutic devices are introduced. The TriSalus TriGuide is intended to be used in the peripheral vascular system.

The TriSalus TriGuideTM Guiding Catheter provides a pathway to introduce and facilitate the advancement of devices into the peripheral vascular system. Its principle of operation is therefore to provide a patent pathway for compatible accessories as described within its labeling.

TriSalus TriGuideTM Guiding Catheter is a single-lumen, braided, fixed-length 5F catheter with a soft distal tip and a proximal Luer-Lock hub and strain relief. The TriSalus TriGuide Catheter has a three-layer construction, consisting of a PTFE inner liner, stainless steel braid mid-layer, and an extruded Pebax polymer outer shaft jacket. The Pebax extruded polymer is filled with barium suffate (BaSO4) as a radiopacifier, to provide visibility of the TriSalus TriGuideTM Guiding Catheter under fluoroscopy.

The TriSalus TriGuideTM Guiding Catheter are 65 cm in length in three pre-shaped tip designs including Axis, Sim 1, and Cobra to accommodate access and positioning in a range of peripheral vascular anatomies. The distal tip is rounded for atraumatic vessel tracking.

The provided text is a 510(k) summary for the TriSalus TriGuide™ Guiding Catheter, which is a medical device and not an AI/ML-enabled device. Therefore, the information requested in the prompt, which is typically relevant to the performance and validation of AI/ML software as a medical device, is not applicable to this submission.

Specifically, the document focuses on demonstrating substantial equivalence to a predicate device through comparisons of indications for use, design, dimensions, materials, packaging, labeling, sterilization, and mechanical performance via bench and animal testing. It does not involve any AI/ML components, and thus "acceptance criteria" in this context refers to engineering specifications and performance benchmarks for a physical device, not AI model metrics.

Therefore, I cannot provide the requested information about acceptance criteria for an AI model, sample sizes for test sets (in the context of AI validation), expert qualifications for ground truth establishment, adjudication methods, MRMC studies, standalone algorithm performance, types of ground truth for AI, or training set details. These concepts do not apply to the TriSalus TriGuide™ Guiding Catheter as described in this FDA submission.

Ask a specific question about this device

The Guiding Catheter is indicated to provide a pathway through which therapeutic devices are introduced. The catheter is intended to be used in the peripheral vascular system.

The Guiding Catheter is a single-use percutaneous catheter intended to be used in the peripheral vascular system to provide a pathway through which therapeutic devices are introduced. The Guiding Catheter is available in a variety of curves to accommodate various anatomies. The Guiding Catheter is comprised of a braid-reinforced catheter shaft terminating in an atraumatic, radiopaque tip. The device includes a proximal hub with luer fitting for fluid infusion and/or aspiration as well as strain relief. The catheter is a single use disposable device. The Guiding Catheter has an inner diameter of 6F, an outer diameter of 7F, and is compatible with an 0.035" guidewire.

This document describes a 510(k) premarket notification for a medical device called a "Guiding Catheter." It aims to demonstrate substantial equivalence to a predicate device, the Medtronic Launcher Guide Catheter (K022764).

Here's an analysis of the provided text in relation to acceptance criteria and the study that proves the device meets them:

I. Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are not explicitly stated as quantitative targets in the typical "acceptance criteria" table format (e.g., sensitivity > X%, specificity > Y%). Instead, the document focuses on demonstrating that the Guiding Catheter is substantially equivalent to a legally marketed predicate device. This means the device must perform comparably to the predicate device and raise no new questions of safety or effectiveness.

The document presents a comparison of technological characteristics as the primary "performance" data, indicating how the proposed device aligns with the predicate.

Here's a table summarizing the characteristics presented and the conclusion of equivalence:

II. Study Proving Device Meets Acceptance Criteria

The study described is the 510(k) premarket notification process, which involves demonstrating substantial equivalence through a combination of comparative analysis and various performance tests.

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

   • The document mentions "Bench testing, including dimensional evaluation, tensile testing, torque testing, kink resistance testing, packaging testing, tip joint fatigue testing, burst proof testing, high pressure dynamic testing, particulate testing." It states, "All testing was performed on test units representative of finished devices."
   • It also lists "Simulated Use testing" and "In Vivo Testing."
   • Sample Size: The exact sample sizes for each type of testing (bench, simulated use, in vivo) are not specified in the provided text. It only indicates "test units representative of finished devices."
   • Data Provenance: The document does not explicitly state the country of origin for the data or whether it was retrospective or prospective. Given it's a premarket notification for a new device, the testing would typically be prospective, conducted by the manufacturer or a contract research organization.

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

   • This section is not applicable in the context of this 510(k) submission. The "ground truth" here isn't based on expert interpretations of medical images (as would be the case for an AI/CADe device). Instead, the "ground truth" is adherence to engineering specifications and performance comparable to a predicate device, verified through various physical and mechanical tests.

3. Adjudication Method for the Test Set:

   • Not applicable. There's no human "adjudication" in the sense of consensus reading for medical images. The "adjudication" is achieved through standardized testing protocols (e.g., ASTM, ISO) and comparison of quantitative results to predefined engineering standards or the performance of the predicate device.

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

   • No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI/CADe devices where human readers' performance with and without AI assistance is evaluated. This submission is for a physical medical device (catheter) and relies on bench and in-vivo performance testing, not human reading performance.

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

   • Not applicable. This pertains to AI/CADe algorithms. The device here is a physical Guiding Catheter.

6. The Type of Ground Truth Used:

   • For the Guiding Catheter, the "ground truth" is established through:
     • Engineering Specifications/Standards: The device must meet specific physical and mechanical properties (dimensions, tensile strength, torque, kink resistance, burst pressure, etc.).
     • Predicate Device Performance: The device's performance characteristics are compared against those of the legally marketed predicate device to demonstrate substantial equivalence.
     • Biological Compatibility Standards: Adherence to ISO 10993-1 for biocompatibility using in vitro and in vivo models.
     • Simulated Use and In Vivo Testing: Direct measurement of the device's functional performance in environments mimicking its intended use.

7. The Sample Size for the Training Set:

   • Not applicable. There is no "training set" in the context of this device's development and testing as described. Training sets are relevant for machine learning algorithms.

8. How the Ground Truth for the Training Set was Established:

   • Not applicable. As there is no training set mentioned, the establishment of ground truth for it is irrelevant to this submission.

In summary, the document demonstrates that the Guiding Catheter meets "acceptance criteria" by proving its substantial equivalence to a predicate device through a comprehensive set of bench tests, simulated use tests, and in vivo tests, all performed on representative finished devices, and ensuring compliance with relevant biocompatibility standards. The framework of this 510(k) submission is to show that the new device is as safe and effective as a previously cleared device, rather than to demonstrate a specific quantitative improvement over a baseline or human performance.

Ask a specific question about this device

The Balloon Guiding Catheter is intended to assist intravascular catheterization and guidance of an intravascular catheter into a selected vessel in the neuro or peripheral vascular system. The balloon can provide temporary vascular occlusion during angiography.

The proposed device, Balloon Guiding Catheter, is a braid-reinforced, variable stiffness catheter designed for use in facilitating the guidance of an intravascular catheter into a target vessel in the neuro or peripheral vascular system. A radiopaque marker is included on the distal end for angiographic visualization. A compliant balloon is mounted on the distal end to provide temporary vascular occlusion during angiographic procedures. The proposed device is divided into the S and S+ types with different effective lengths, the difference between S type is the size of the catheter.

The provided document is a 510(k) summary for a medical device called a "Balloon Guiding Catheter." It describes the device, its intended use, a comparison to a predicate device, and the non-clinical testing performed to establish substantial equivalence.

Here's an analysis of the acceptance criteria and study information, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not specify the exact sample sizes used for each individual non-clinical test. It generally states that "Non-clinical tests were conducted to verify that the proposed device met all design specifications."

• Sample Size: Not explicitly stated for each test.
• Data Provenance: The tests are non-clinical (benchtop and in vitro/in vivo biocompatibility). The document does not specify country of origin for the data; however, the manufacturer is Shanghai Heartcare Medical Technology Co., Ltd. in China, implying testing was likely conducted or commissioned by them. The studies are retrospective in the sense that they are conducted on finished or pilot-production devices to demonstrate performance against specifications.

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

Not applicable. This device is a physical medical instrument, not an AI/software device requiring expert consensus for ground truth on a dataset. The "ground truth" for the non-clinical tests is established by objective measurements against established engineering specifications and recognized international standards (e.g., ISO, ASTM, USP).

4. Adjudication Method for the Test Set:

Not applicable. As described above, this is not a study requiring human adjudication of results in the traditional sense of medical image or clinical outcome 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:

Not applicable. This is not an AI/software device. No MRMC study was performed.

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

Not applicable. This is not an AI/software device. No standalone algorithm performance study was performed.

7. The Type of Ground Truth Used:

The "ground truth" for this device's acceptance criteria are based on:

• Engineering Specifications: Defined dimensional tolerances, mechanical properties (tensile strength, burst pressure, kink resistance), and functional performance (balloon expansion, torque, anti-collapse).
• International Standards: Adherence to ISO (e.g., ISO 10993 for biocompatibility, ISO 11135 for sterilization, ISO 594 for connectors, ISO 10555-1 for leakage), ASTM (e.g., for seal strength, dye penetration, hemolysis), and USP (for pyrogen and endotoxin testing) standards.
• Benchtop Test Results: Objective measurements and observations from physical testing in controlled laboratory environments.
• Biological Test Results: In vitro and in vivo testing (on study animals, e.g., for systemic toxicity, thromboresistance) according to ISO standards.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/software device. There is no "training set."

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

Not applicable. This is not an AI/software device.

Ask a specific question about this device

In conjunction with the Selectra accessory kit, Selectra guiding catheters are used to facilitate lead implantation in the heart chambers or in the coronary veins via the coronary sinus.

BIOTRONIK's Selectra lead introducer system is a combination of quiding catheters and implantation accessories used to facilitate access to the heart for suitable leads and catheters. The Selectra lead introducer system consists of several individually available guiding catheters with various different curve shapes and the Selectra accessory kit.

The catheters are available as inner (5F) and outer (7F) catheters which jointly form a telescopic system, and facilitate implantation of leads into the heart. The Selectra catheters are compatible with one another as well as the Selectra Accessory Kit.

The provided text describes a 510(k) premarket notification for the BIOTRONIK Selectra 3D Outer Guiding Catheters (K193474). This device is a percutaneous catheter used to facilitate lead implantation in the heart. The submission asserts substantial equivalence to a predicate device (BIOTRONIK's Selectra 7F Guiding Outer Catheters, K192996).

Crucially, the provided document explicitly states that "No clinical testing was deemed necessary or completed in the premarket notification submission for a determination of substantial equivalence." This means that the device's acceptance criteria and proven performance are based on non-clinical data.

Therefore, for aspects related to clinical performance, a multi-reader multi-case (MRMC) study, or human-in-the-loop performance, the information is not available in the given text. The "acceptance criteria" and "study proving the device meets the acceptance criteria" in this context refer to engineering and biocompatibility testing, not clinical effectiveness or human interpretability.

Here's a breakdown based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a detailed table with specific numerical acceptance criteria and corresponding reported performance for each test. Instead, it broadly states that the modified devices were tested against "the same test methods and acceptance criteria for the predicate devices" and that they "meet the same functional acceptance criteria."

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

• Sample Size for Test Set: Not specified in terms of number of devices or test samples. The document states "the following tests were conducted."
• Data Provenance: Not explicitly stated, but given it's a submission to the U.S. FDA by BIOTRONIK, Inc. (Lake Oswego, Oregon), it's highly likely the testing was conducted in the US or in compliance with US standards. The data is retrospective in the sense that it's reported after the completion of the tests.

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

• Applicability: Not applicable given that no clinical studies involving human interpretation or subjective 'ground truth' were performed. The testing described is engineering and laboratory-based.

4. Adjudication Method for the Test Set

• Applicability: Not applicable for the same reason as #3. Adjudication methods are relevant for studies involving human assessment where consensus or arbitration is needed to establish ground truth.

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

• Answer: No. The document explicitly states: "No clinical testing was deemed necessary or completed in the premarket notification submission for a determination of substantial equivalence." Therefore, an MRMC study related to human reader improvement with AI assistance was not performed.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Answer: No. This device is a physical medical device (catheter), not an AI algorithm. "Standalone performance" in the context of AI refers to the algorithm's performance independent of a human. This concept does not apply to this device.

7. The Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" for this device's performance is established by engineering specifications, material science standards, and biocompatibility requirements. For example, a "functional test" for catheter flexibility would have a predefined acceptable range of force or deflection, which serves as the "ground truth" for that test. Similarly, sterility testing has specific pass/fail criteria based on absence of microbial growth.

8. The Sample Size for the Training Set

• Applicability: Not applicable. This is not an AI/machine learning device. There is no concept of a "training set" for physical medical devices in this context.

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

• Applicability: Not applicable for the same reason as #8.

Ask a specific question about this device

"Intended for the intravascular introductional devices into the peripheral, including pulmonary, vasculature."

Lumax® Guiding Catheters are conduits introduced, either singly or as a coaxial pair, into a vein or artery and tracked over a wire guide to the site of a vascular lesion where interventional devices can be delivered through the guiding catheter's internal lumen for treatment. The Lumax® Guiding Catheters may include either a single guiding catheter or a coaxial catheter pair (composed of an outer guiding catheter and an inner coaxial catheter). The single guiding catheters are available in a 7.0 French outer diameter in lengths of 80 or 90 cm. They are manufactured with a multilayered braided nylon shaft, bonded Luer hub, and radiopaque tip. The guiding catheters are designed with a multipurpose (MPA) distal curve configuration. The coaxial catheter pair comprises an outer guiding catheter matched to an inner coaxial catheter. The guiding catheter component is available in an outer diameter of 8.0 French and a length of 80 cm. The inner coaxial catheter is manufactured from radiopaque braided nylon tubing and has an outer diameter of 6.0 French and a length of 100 cm. For lubricity, the distal 40 cm of the inner catheter is treated with hydrophilic coating. The Lumax® Guiding Catheters are supplied as packaged, sterile devices, intended for single-patient use.

The provided text describes the Lumax® Guiding Catheters and their acceptance criteria through various performance tests. However, it does not include a study that proves the device meets acceptance criteria for an AI/CADe device, as this device is a physical medical catheter, not a software or AI-based diagnostic tool.

Therefore, many of the requested categories for AI/CADe studies will not be applicable or present in this document.

Here's the information extracted from the document regarding the acceptance criteria and performance of the Lumax® Guiding Catheters:

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

2. Sample sized 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 document. The document describes laboratory performance testing, not a clinical trial with a "test set" and "data provenance" in the context of an AI/CADe study.

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 applicable and not provided. The testing described is performance testing of a physical device against engineering and safety standards, not an evaluation requiring expert interpretation of results to establish ground truth.

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

This is not applicable and not provided.

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 is not applicable and not provided, as this is a medical device (catheter) and not an AI or CADe system.

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

This is not applicable and not provided, as this is a medical device (catheter) and not an AI or CADe system.

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

The "ground truth" for this device's performance testing is based on established engineering standards (e.g., ISO, BS EN ISO) and pre-determined acceptance criteria for physical and mechanical properties, as well as biocompatibility.

8. The sample size for the training set

This is not applicable and not provided. This document describes the performance testing of a manufactured medical device, not the training of an AI model.

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

This is not applicable and not provided. There is no concept of a "training set" or "ground truth" establishment for training in the context of this device's regulatory submission.

Ask a specific question about this device

The Medtronic Guiding Catheter is designed to provide a pathway through which therapeutic devices are introduced. The guiding catheter is intended to be used in the coronary or peripheral vascular system.

Medtronic 6F Taiga Guiding Catheter is an intravascular catheter that is supplied sterile and intended for single use only. The primary function of the 6F Taiga Guiding Catheter is to provide a pathway through which therapeutic devices are introduced. Medtronic 6F Taiga Guiding Catheter has a 6F outer diameter (0.082") and is be available in variety of curves and lengths, identical to the predicate Medtronic Taiga Guide Catheter. The various curves and lengths available, will allow the catheter to accommodate the varying patient vascular system anatomies

The Medtronic 6F Taiga Guiding Catheter is a physical medical device, not an AI/ML device. Therefore, the questions related to AI/ML specific aspects such as human readers, AI assistance, training sets, and ground truth for AI algorithms are not applicable.

Based on the provided text, the acceptance criteria and the study that proves the device meets them are as follows:

1. Table of Acceptance Criteria and Reported Device Performance

The device is a modified version of a legally marketed predicate device (Medtronic 6F Taiga™ Guiding Catheter - K083422). The modification involves a specification related to the soft tip component. Therefore, the acceptance criteria are generally based on demonstrating substantial equivalence to the predicate device through performance/bench testing and biocompatibility testing. The specific acceptance criteria for each test are not explicitly detailed in the provided summaries (e.g., specific thresholds for tensile strength or kink resistance). Instead, the document states that tests were conducted "in accordance to the relevant FDA guidance to demonstrate substantial equivalence."

For the modified soft tip component, two specific tests were performed on the subject device to demonstrate substantial equivalence to the predicate:

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

The document does not explicitly state the sample size (number of units) used for each specific bench test. It mentions that "Performance/Bench Testing" was conducted, and "biocompatibility tests were conducted." The testing is described as non-clinical data. The provenance of the data is from Medtronic Vascular, the manufacturer. The data is retrospective in the sense that it's reported after the tests were conducted for the 510(k) submission.

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

This question is not applicable as the device is a physical medical device and its performance is evaluated through objective bench testing and biocompatibility assessments, not through expert-driven ground truth establishment for an AI/ML algorithm.

4. Adjudication Method for the Test Set

This question is not applicable for the same reasons as point 3. Bench tests have objective measurements and pass/fail criteria, not subjective adjudication by experts.

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 question is not applicable as the device is a physical medical device and not an AI/ML-assisted diagnostic tool.

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

This question is not applicable as the device is a physical medical device and not an AI/ML algorithm.

7. The Type of Ground Truth Used

For a physical device, the "ground truth" for performance is typically defined by:

• Engineering Specifications/Standards: Each bench test will have predefined acceptance limits or ranges derived from engineering design specifications and relevant industry standards (e.g., ISO, ASTM) and FDA guidance for catheters.
• Predicate Device Performance: For substantial equivalence, the performance of the subject device is compared against the established performance characteristics of the predicate device.
• Biocompatibility Standards: Ground truth for biocompatibility is established by international standards like ISO 10993-1, which outlines the requirements for biological evaluation of medical devices.

8. The Sample Size for the Training Set

This question is not applicable as the device is a physical medical device and does not involve AI/ML requiring a training set.

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

This question is not applicable as the device is a physical medical device and does not involve AI/ML requiring a training set or its associated ground truth establishment.

Ask a specific question about this device

The guiding catheter is intended to use for introduction of interventional/diagnostic devices into the coronary or peripheral vascular systems.

The Xcess guiding catheter is available in many different curve shapes and two sizes (5F and 6F). Each device consists of a catheter shaft, soft extension, soft tip, strain relief and luer. The catheter shaft is constructed with 3 layers: an outer layer of radiopaque Nylon/Pebax material, a middle layer of braided stainless steel, and an inner layer of PTFE tubing. The soft extension and soft tip consist of 2 layers: an outer layer of a radiopaque Nylon/Pebax material of differing hardness than the layer in the catheter shaft and an inner layer of PTFE. The strain relief at the proximal end of the catheter prevents kinking during catheter manipulation, and the luer is used to connect with either a hemostasis valve-linked accessory or 3-way connector. The distal ends of the guiding catheters are formed into a variety of shapes required to access differing vasculatures. The guiding catheters are provided with a hydrophilic coating on the catheter body. The guiding catheters are designed to accept a maximum of 0.038" (0.97mm) diameter guide wire.

The provided document is a 510(k) summary for a medical device (Xcess Guiding Catheter), not an AI/ML-enabled medical device. Therefore, the questions related to AI/ML specific acceptance criteria, such as "effect size of how much human readers improve with AI vs without AI assistance," "standalone (i.e., algorithm only) performance," "sample size for the training set," and "how ground truth for the training set was established," are not applicable.

This document describes the process of demonstrating substantial equivalence for a physical medical device. The acceptance criteria focus on bench testing performance and biocompatibility in comparison to a predicate device.

Here's an analysis of the provided text in the context of the requested information, while acknowledging the non-AI nature of the device:

Device Name: Xcess Guiding Catheter
Device Type: Percutaneous Catheter (Class II)
Predicate Device: VISTA BRITE TIP Guiding Catheter (K962830)

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "All tests confirmed the products met the pre-defined acceptance criteria." However, it does not provide a quantitative table of the specific acceptance criteria (e.g., maximum force for tensile strength, specific values for torquability) or the specific numerical results of the tests. It only lists the types of tests performed.

Specific Performance Tests Conducted (without quantitative criteria/results):

• Visual and dimension inspection
• Coating integrity and particulate evaluation
• Catheter usability
• Catheter shape retention
• Catheter freedom from leakage
• Catheter torque
• Catheter pressure integrity
• Catheter flexibility and kink
• Catheter joints tensile strength
• Corrosion resistance
• Radio-detectability

Specific Biocompatibility Tests Conducted:

• Cytotoxicity
• Sensitization
• Irritation or Intracutaneous Reactivity
• Acute Systemic Toxicity
• Material-Mediated Pyrogenicity
• Hemocompatibility (Hemolysis, Thrombogenicity, and Complement Activation)

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

• Sample Size: The document does not specify the sample sizes used for any of the performance or biocompatibility tests.
• Data Provenance: The document implies the testing was conducted internally by Curatia Medical Co. (Santa Clara, CA, USA) or its designated testing facilities, as it states, "Curatia Medical has determined that the Xcess Guiding Catheters are substantially equivalent." The data is prospective in the sense that the tests were performed specifically for this 510(k) submission, not gathered retrospectively from existing data. The country of origin for the data is implicitly USA (California).

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

• Not Applicable: For a physical medical device like a guiding catheter, "ground truth" as it would be understood for an AI/ML model (e.g., disease diagnosis) is not established by human experts in the same way. The "ground truth" or acceptance criteria for mechanical and biological performance are established by engineering standards (e.g., ISO 10555-1, ISO 10993 series) and risk analysis, not by expert interpretation of images or clinical cases. Testing against these standards determines performance.

4. Adjudication Method for the Test Set

• Not Applicable: As this is verification testing of a physical device against engineering and biological standards, there is no "adjudication method" involving multiple human readers/experts in the way there would be for, say, an AI diagnostic tool. Test results are objective measurements compared against predefined specifications.

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

• Not Applicable: This type of study is relevant for AI/ML-enabled diagnostic or assistive devices where human reader performance is being evaluated. The Xcess Guiding Catheter is a physical interventional device, not an AI or diagnostic tool.

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

• Not Applicable: This question pertains specifically to AI/ML algorithms. The Xcess Guiding Catheter is a physical device, and therefore does not have an "algorithm-only" mode.

7. The Type of Ground Truth Used

• The "ground truth" for the Xcess Guiding Catheter's performance is based on established international standards (ISO 10555-1 for performance, ISO 10993 series for biocompatibility) and the specific design requirements derived from a risk analysis for a percutaneous catheter. This is a scientific/engineering ground truth based on accepted practices for medical device design and testing, rather than an expert consensus on clinical data, pathology, or outcomes data in the context of an AI model.
• The comparison to the predicate device (VISTA BRITE TIP Guiding Catheters) also serves as a benchmark for substantial equivalence.

8. The Sample Size for the Training Set

• Not Applicable: This question applies to AI/ML algorithms where a "training set" of data is used to develop the model. For a physical medical device, there is no training set in this context. Device design and manufacturing processes are developed and refined through engineering iterations, but not via "training" on a data set.

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

• Not Applicable: As there is no "training set" for a physical device, there is no ground truth established for it.

Ask a specific question about this device

Stents: Zimmon® Pancreatic Stent/Stent Sets, Geenen® Pancreatic Stent/Stent Sets and Johlin® Pancreatic Wedge Stent and Introducer.
This device is used to drain obstructed pancreatic ducts.
Stent Introducers: Guiding Catheter and Pushing Catheter. This device is used for endoscopic pancreatic stent placement.

The intended use of all Cook pancreatic stents is to drain obstructed pancreatic ducts. A variety of stents in different sizes are available across the device range to accommodate various patient anatomies, the size and location of the obstruction and physician preference. They are offered in French sizes of between 3Fr and 11.5Fr, and in labelled lengths of between 2cm and 25cm.The subject devices and their components can be supplied as stent only, introducer only (guiding or pushing catheter) or as stent sets combining stent and introducers/introducer systems.
The stent sets can contain one or several of the following stent placement components; a flap protector, a guiding catheter, a pushing catheter or a dedicated introducer system. The flap protector is provided with stents that have duodenal flap-type anti-migration features, and is used to collapse the flap(s) on the device as it is introduced into the working channel of the endoscope. The function of the guiding catheter is to guide the pancreatic stent as part of its introduction to its intended location. The guiding catheter also has a Hub that allows for contrast injection. The function of the Pushing Catheter is to advance the stent, over a prepositioned wire guide or Guiding Catheter, to its intended location within the anatomy, and to maintain the position of the Stent as it being deployed. The stents are polymeric and some of the stents have radiopaque bands. The stent designs include anti-migrational features such as duodenal pigtails, duodenal bends and ductal and duodenal flaps. To facilitate stent insertion and removal the stent ends are tapered or buffed. Side-ports on the pancreatic stents assist in drainage. All stents are deployed endoscopically over a guide wire in the same manner under fluoroscopic and endoscopic monitoring.
These Cook pancreatic stents are all for professional use and are provided sterile. They are all intended for short-term use and have an indicated indwell of up to 3 months.

This document is a 510(k) summary for the Zimmon® Pancreatic Stent/Stent sets, Geenen® Pancreatic Stent Sets, Johlin® Pancreatic Wedge Stent and Introducer, Guiding Catheter, and Pushing Catheter. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a specific study proving device performance against those criteria in the way a clinical trial might.

Therefore, much of the requested information regarding acceptance criteria for device performance (e.g., sensitivity, specificity, accuracy), sample sizes for test sets, expert ground truth, MRMC studies, standalone performance, and training set details, is not present in this regulatory submission for a Class II medical device.

Here's what can be extracted and what cannot:

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

The document does not provide a table of acceptance criteria for diagnostic or clinical performance (e.g., sensitivity, specificity) because these are drainage stents, not diagnostic AI devices. Instead, it details performance testing conducted to ensure safety and effectiveness of the device itself.

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

• Sample Size for Test Set: Not applicable in the context of device performance in a clinical diagnostic sense. The document refers to engineering and biocompatibility testing, not clinical trials with patient data test sets. The sample sizes for the various engineering tests (e.g., tensile, flow rate) are not specified.
• Data Provenance: Not applicable for this type of submission. The tests are described as engineering and biocompatibility evaluations performed according to Cook Ireland's design control system, implying lab-based testing rather than clinical data from specific countries.

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)

Not applicable. This device is a physical medical stent, not an AI or diagnostic algorithm that relies on expert interpretation for ground truth. Ground truth for engineering tests is based on objective measurements against specifications.

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

Not applicable. Adjudication methods are typically for subjective assessments (e.g., image interpretation in diagnostic studies with AI). This document describes objective engineering and biocompatibility tests.

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 not an AI-assisted diagnostic device. It's a pancreatic stent.

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 non-clinical testing described, the "ground truth" would be established by:

• Biocompatibility: Adherence to established international standards (ISO 10993-1).
• Engineering Tests (Simulated use, dimensional, flow rate, tensile, radiopacity, MRI, shelf life): Objective measurements against pre-defined engineering specifications and performance requirements established internally by Cook Ireland Ltd. during their design control process.

8. The sample size for the training set

Not applicable. This refers to an AI training set, which is not relevant to this medical stent.

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

Not applicable. This refers to an AI training set, which is not relevant to this medical stent.

Summary of Device Performance and Substantial Equivalence:

The core of this 510(k) submission is to demonstrate substantial equivalence to predicate devices (Cook Zimmon Endoscopic Pancreatic Stent K900923 and Wilson-Cook Pancreatic Wedge Stent K990130).

The "study" referenced in the document is the non-clinical performance data collected through various engineering and biocompatibility tests:

• Biocompatibility: Evaluated according to ISO 10993-1.
• Physical/Mechanical Testing: Included simulated use, dimensional and visual verification, flow rate, tensile strength, radiopacity, MRI compatibility, and shelf-life testing. These tests were performed as per Cook Ireland's design control system.

Conclusion from the document: The non-clinical data collected supports the safety and effectiveness of the subject device (the various pancreatic stents and introducers) and demonstrates that they perform as intended in the specified use conditions. This data is used to support the claim of substantial equivalence to the predicate devices. The "acceptance criteria" for these tests would be internal engineering specifications that the device must meet to function safely and effectively and to be considered similar to the predicate.

Ask a specific question about this device