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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 After finalizing the procedure, the catheter is withdrawn, removed and discarded.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.

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

The guiding catheter is a flexible plastic tube featuring a luer hub, a strain relief, a body, an intermediate tip, and a soft tip. The body and the intermediate tip exist 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 / or therapeutic (interventional) devices within the vascular system. The distal section of the catheter has a variety of preformed shapes (e.g., Judkins Left (abbreviated as JL), Judkins Right (JR), Amplatz (AL), Multipurpose, hockey stick) to facilitate placement of the catheter tip in the desired target vessel. Some catheter models feature two (2) small "inline" 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.

Here's an analysis of the acceptance criteria and study information based on the provided text, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text focuses on the design verification and substantial equivalence of the Convey™ 7F and 8F Guiding Catheters to predicate devices (Convey™ 5F and 6F). It lists various in-vitro performance tests that were conducted to ensure the device conforms to requirements. However, it does not explicitly state quantitative acceptance criteria or numerical performance results for each test. Instead, it implies that the device successfully met the requirements through these tests to establish substantial equivalence.

Therefore, the table below will list the tests performed, as these represent the areas where acceptance would have been determined, but will note the absence of explicit quantitative criteria or reported performance values in the provided document.

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

• Sample Size for Test Set: The document states that "The following in-vitro performance tests... were completed of the 7F & 8F Convey Guiding Catheter." However, it does not specify the number of units tested (sample size) for each of these non-clinical, in-vitro (bench) tests.
• Data Provenance: The tests are described as "non-clinical design verification (bench) tests." The document does not specify the country of origin of the data or whether it was retrospective or prospective, but given it's bench testing for a new device, it would be prospective.

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

This information is not applicable / not provided in the document. The studies described are non-clinical, bench-top performance tests, sterility tests, and biocompatibility tests. These do not typically involve human experts establishing "ground truth" in the way clinical studies or diagnostic AI studies do. The ground truth for these tests would be the established scientific and engineering standards and methods for assessing material properties and device performance.

4. Adjudication Method for the Test Set

This information is not applicable / not provided. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies where multiple human readers interpret data (e.g., medical images) to establish a consensus ground truth. The studies cited are non-clinical, bench 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

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Since the modifications do not have an impact on the indications for use and on the safety and performance of the device, a Clinical Evaluation Study was not regarded for these devices." This indicates no human clinical studies were performed for the 7F and 8F guiding catheters. Furthermore, this device is a physical medical device (catheter), not an AI algorithm, so the concept of human readers improving with AI assistance does not apply.

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

This is not applicable. The device is a physical guiding catheter, not an AI algorithm.

7. The Type of Ground Truth Used

For the non-clinical tests (performance, sterility, biocompatibility), the "ground truth" is based on:

• Established scientific and engineering principles: for physical performance tests (e.g., kink resistance, stiffness, strength, dimensions).
• International standards (e.g., ISO 10993) and USP pharmacopeia tests: for biocompatibility, sterility, and endotoxin testing.
• Manufacturing specifications: for attributes like visual inspection, dimensions, coating properties, etc.

8. The Sample Size for the Training Set

This is not applicable. The device is a physical medical device. It does not use a "training set" in the context of machine learning or AI. The design and validation are based on engineering principles and regulatory standards rather than data training.

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

This is not applicable as there is no training set for a physical medical device in this context.

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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 guiding catheter is a flexible plastic tube featuring a luer hub, a strain relief, a body, an intermediate tip, and a soft tip. The body and the intermediate tip exist of an inner liner (basecoat) and a 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 a guide wire it is brought into position. Subsequently, a guidewire is advanced through its lumen and tracked over by a diagnostic device (angiographic catheter, IVUS-catheter) and/or a therapeutic device (e.g., balloon dilatation catheter, stent and delivery system, embolization device) to the intended location. The distal section of the catheter has a variety of preformed shapes (e.g., Judkins Left (abbreviated as JL), Judkins Right (JR), Amplatz (AL), Multi-purpose, 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. The intravascular guiding catheter is a cardiovascular catheter with GMDN-code 17846 (and ECRI-code 17846) with GMDN definition: A flexible tube with a central lumen used for the percutaneous, transluminal passage and placement of guidewires and diagnostic and therapeutic devices within the vascular system. After the tube is inserted in position, a guidewire is advanced through its lumen and tracked over by a diagnostic / therapeutic device (e.g., balloon dilatation catheter, stent and delivery system, or embolization device) to the intended location. The distal section of the tube can have a variety of preformed shapes (e.g., straight, multi- purpose, hockey stick, renal double curve); This is a single-use device. (Reference www.GMDNagency.org).

The PendraCare Convey™ Guiding Catheter (K120585) obtained 510(k) clearance by demonstrating substantial equivalence to predicate devices, namely the Medtronic Launcher™ Guide Catheter (5F and 6F). The device met its acceptance criteria through a combination of non-clinical design verification tests, biocompatibility testing, and two European clinical post-market surveillance studies.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that the tests were "completed" and their results "provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during the testing." This implicitly indicates that the device met its acceptance criteria for each test.

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

• Sample Size for Test Set: Not explicitly stated for each test. For biocompatibility and in-vitro performance, the sample sizes would be determined by the specific ISO/USP standards. For the clinical studies, the sample size is also not specifically mentioned, only that there were "two European clinical post market surveillance (comparison) studies."
• Data Provenance:
  • Biocompatibility and In-vitro Performance: Laboratory testing.
  • Clinical Studies: Retrospective/Prospective (not specified, but likely retrospective given they are "post market surveillance" studies on existing device types, although comparison studies could be prospective). The country of origin is Europe.

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

• This information is not provided in the given text. For the bench testing and biocompatibility, expert interpretation may be involved in assessing results, but the document does not detail this. For the clinical post-market surveillance studies, the "ground truth" would be clinical outcomes and comparative performance data, which would typically be assessed by medical professionals in a clinical setting, but the number and qualifications of experts are not described.

4. Adjudication Method for the Test Set

• This information is not provided in the given text.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No PendraCare Convey™ Guiding Catheter is a medical device (catheter), not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable to this submission.

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

• No. As stated above, this is a physical medical device, not an algorithm or AI system. Standalone algorithm performance is not applicable.

7. The Type of Ground Truth Used

• For biocompatibility and in-vitro performance tests, the "ground truth" is defined by the specific requirements and benchmarks set forth in the referenced ISO and USP standards. Meeting these standards is considered the ground truth for safety and performance characteristics.
• For the clinical post-market surveillance studies, the "ground truth" would refer to the observed clinical outcomes and performance of the device in comparison to the predicate devices in real-world clinical use. This would generally involve patient data, procedural success rates, and adverse event reporting.

8. The Sample Size for the Training Set

• Not Applicable. This submission is for a physical medical device. There is no machine learning algorithm involved that would require a "training set."

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

• Not Applicable. As no training set is used for this device.

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