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510(k) Data Aggregation
(231 days)
The ASAHI FUBUKI 043 and ASAHI FUBUKI Guide Catheters are intended to be used to guide interventional devices for neurovascular therapy to a lesion or a procedural site for a percutaneous intravascular in the neurovasculature. This catheter is also intended to be used for injection of contrast media. Do not use this cather other than for use in the neurovasculature.
ASAHI FUBUKI 043 and ASAHI FUBUKI Guide Catheters consists of a guide catheter, available in the following sizes: ASAHI FUBUKI 043 (4.2 Fr), ASAHI FUBUKI 6Fr (6 Fr), ASAHI FUBUKI 7Fr (7 Fr), ASAHI FUBUKI 8Fr (8 Fr). The ASAHI FUBUKI Neurovascular Guide Catheter Dilator Kit consists of a Catheter and Dilator components, available in the following sizes: ASAHI FUBUKI Dilator Kit 4Fr (Catheter 6 Fr, Dilator Shaft 1.75 mm), ASAHI FUBUKI Dilator Kit 5Fr (Catheter 7 Fr, Dilator Shaft 2.00 mm), ASAHI FUBUKI Dilator Kit 6Fr (Catheter 8 Fr, Dilator Shaft 2.21 mm). The catheter consists of three main sections including a tube, a protector section, and a connector. The proximal part of the tube is covered by the protector and the connector is bonded to the proximal end of the tube. A soft tip is bonded to the distal end of the catheter. The inner lumen of the tube (excluding the connector portion) is lined with PTFE to facilitate movement of the guide wire and other devices. The tube is made of polymer resin and is reinforced by a stainless steel and tungsten braid wire. The outer surface of the tube is partially coated with a hydrophilic polymer.
The provided document discusses a 510(k) premarket notification for the "ASAHI FUBUKI 043 and ASAHI FUBUKI Guide Catheters." This is a regulatory submission to demonstrate that the new device is substantially equivalent to legally marketed predicate devices, not a study designed to prove the device meets acceptance criteria in the context of an AI/ML medical device.
The document describes non-clinical testing performed on the device to establish substantial equivalence to predicate devices, but it does not contain information regarding acceptance criteria for an AI/ML device, nor does it detail a study proving an AI/ML device meets such criteria.
Specifically, the document does not include:
- A table of acceptance criteria and reported device performance for an AI/ML device.
- Sample sizes for a test set or data provenance for an AI/ML model.
- The number or qualifications of experts used to establish ground truth for an AI/ML test set.
- Adjudication methods for an AI/ML test set.
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study or related effect sizes for AI assistance.
- Details about a standalone (algorithm-only) performance study for an AI/ML device.
- The type of ground truth used for an AI/ML model (e.g., pathology, outcomes data).
- The sample size for a training set (relevant for AI/ML).
- How ground truth for a training set was established (relevant for AI/ML).
Instead, the document focuses on non-clinical laboratory testing to compare the new catheter device to existing predicate devices. The tests performed are related to the physical and mechanical properties of the catheter, as listed under "NON CLINICAL TESTING / PERFORMANCE DATA":
- Corrosion resistance
- Force at break
- Liquid leakage under pressure
- Air leakage into hub assembly during aspiration
- Leak and damage under high static pressure
- Radio-detectability
- Kink resistance
- Appearance/Dimensions
- Biocompatibility
The conclusion drawn is that the new catheter device is "substantially equivalent" to the predicate devices based on shared intended use, technological characteristics (components, design, materials, sterilization, shelf life, operating principles), and performance data demonstrating it functions as intended with a similar safety and effectiveness profile.
Therefore, I cannot provide the requested information as it pertains to AI/ML device acceptance criteria and study details because the provided text describes a 510(k) submission for a physical medical device (catheter), not an AI/ML-driven device.
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(309 days)
ASAHI ZenyteEX Guiding Catheter is intended for use in coronary or peripheral vascular applications and is designed to provide a pathway through which medical instruments, such as balloon catheters, guide wires or other therapeutic devices may be introduced. This device is not intended for use in the cerebral vasculature.
The ASAHI ZenyteEX Guiding Catheter is intended for use in coronary or peripheral vascular applications and is designed to provide a pathway through which medical instruments, such as balloon catheters, guide wires or other therapeutic devices may be introduced. The Catheter consists of a tube, which is to be inserted into vasculature, a proximal hub/connector, and strain relief/protector for the joint portion of the first 2 sections. The tube body section consists of soft tip, soft tube and shaft. The tube body itself is constructed of a polyamide elastomer. The shaft is reinforced by stainless steel braid, and it consists of two layers. The distal portion of the tube is made soft in order to easily bend.
The provided text is a 510(k) summary for a medical device called the ASAHI ZenyteEX Guiding Catheter. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a study with specific acceptance criteria and performance metrics in the way that would typically be done for a novel AI/software device.
Therefore, much of the requested information (such as sample sizes for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance for an algorithm, and ground truth establishment for a training set) is not applicable to this type of device submission as described in the provided document.
However, I can extract the relevant information regarding acceptance criteria and the type of study performed to show the device meets these criteria.
Acceptance Criteria and Device Performance for ASAHI ZenyteEX Guiding Catheter
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Tests Performed | Reported Device Performance |
|---|---|---|
| Biocompatibility | Compatibility with patient contact (materials) | "All components that come in direct contact with the patient have a long history of use in medical devices and are proven to be biocompatible for use in the vasculature. Furthermore, this submission contains biocompatibility testing conducted on the subject device." (Implies successful completion.) |
| Technical/Dimensional | Dimensional specifications equivalence to predicate devices | "The dimensional specifications are equivalent to those listed for the currently cleared predicate devices." |
| Material Composition | Use of same materials as predicate devices | "The ASAHI ZenyteEX Guiding Catheter is made of the same materials that have been used in other predicate devices that are labeled for the similar indications." |
| Functional Performance | Mechanical and Functional Bench Testing | "This 510(k) notice also includes mechanical and functional bench testing that demonstrates that the ASAHI ZenyteEX Guiding Catheter performs as intended." (Implies successful performance.) |
| Substantial Equivalence | Equivalence to specified predicate devices for same indication for use | "The ASAHI ZenyteEX Guiding Catheter characteristics are substantially equivalent to the specified predicate devices and other currently marketed devices for the same indication for use." |
| Intended Use | Ability to provide a pathway for medical instruments | "Bench testing demonstrates that the device functions as intended." (Supports the intended use.) |
2. Sample Sizes Used for the Test Set and Data Provenance
Not applicable. This is a physical medical device (guiding catheter), not a software or AI device requiring a "test set" of data. The "testing" refers to physical and material testing. The document does not specify sample sizes (e.g., number of catheters tested) for the mechanical, functional, or biocompatibility bench tests. Data provenance is also not applicable in the context of data for an AI/software device; the provenance here would be the manufacturing site (Japan).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. As this is a physical device, there is no "ground truth" in the context of expert review of data. Performance is evaluated via engineering, material, and biocompatibility testing.
4. Adjudication Method for the Test Set
Not applicable. There is no "adjudication method" as would be used for diagnostic output from an AI/software device. Performance is determined by meeting pre-defined physical and chemical specifications.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a physical medical device, not an AI/software diagnostic aid.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
Not applicable in the context of expert consensus, pathology, or outcomes data. For a physical device like this, the "ground truth" for performance is established through adherence to engineering specifications, material properties, and regulatory standards demonstrated via bench testing.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI/software device that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. This is a physical medical device, not an AI/software device that requires a training set.
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