Search Results

This product is intended to facilitate the placement and exchange of diagnostic and therapeutic devices during intravascular procedures. This device is intended for peripheral vascular use only.

The ASAHI Gladius Mongo18 PV ES is a steerable guide wire with a maximum diameter of 0.018 inches (0.45mm) and available in 190cm. 235cm and 300cm length. The distal end of the coil part is available straight and is made soft to easily bend with the vessel curve, or available pre shaped. The guide wire is constructed from a stainless-steel core wire with platinum-nickel coil. The coil is soldered to the core wire. The coil assembly consists of an inner coil and an outer coil, and the coil assembly is soldered to the core wire. The solder of distal end is Au-Sn and other solder is Ag-Sn. The distal end of the quide wire has a radiopaque tip to achieve visibility. For the models covered by this submission, a hydrophilic coating is applied to the quide wire along the distal structure. The proximal section of the guide wire is coated with PTFE. The purpose of these surface coatings is to provide lubricity when guide wire is passed through percutaneous catheters. The basic structure, construction, and coating of the ASAHI Gladius Mongo18 PV ES are unchanged from that previously described in the predicate ASAHI Gladius (K150445).

This document describes the premarket notification (510(k)) for the ASAHI Gladius Mongo18 PV ES, a catheter guide wire for peripheral vascular use. The submission argues for substantial equivalence to a predicate device (ASAHI Gladius, K150445) and several reference devices.

Here's a breakdown of the acceptance criteria and study details based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the ASAHI Gladius Mongo18 PV ES "met all acceptance criteria and performed similarly to the predicate device" in bench testing. However, it does not explicitly list the quantitative acceptance criteria for each test. Instead, it lists the types of tests performed.

2. Sample Size and Data Provenance for Test Set

• Sample Size for Test Set: The document does not specify the exact sample size for the non-clinical bench tests (e.g., how many guidewires were tested for tensile strength).
• Data Provenance: The studies were bench tests conducted following FDA guidance. The manufacturing company is ASAHI INTECC CO., LTD., located at 3-100 Akatsuki-cho, Seto-shi, Aichi 489-0071 Japan, implying the testing likely occurred in or under the purview of the company's R&D facilities. This is a pre-market, prospective evaluation of the device's physical and mechanical properties.

3. Number of Experts and Qualifications for Test Set Ground Truth

This submission is for a medical device (guide wire) and primarily relies on non-clinical bench testing rather than interpretation of diagnostic images or patient outcomes. Therefore, the concept of "ground truth" established by human experts in the way it applies to AI/software performance (e.g., radiologists for imaging studies) is not applicable here. The "ground truth" for these tests is the objective physical and mechanical properties measured on the device itself against established engineering specifications and performance criteria derived from the predicate device and FDA guidance.

4. Adjudication Method for Test Set

As the "ground truth" is established through objective bench testing measurements against pre-defined criteria, an adjudication method (like 2+1, 3+1 for human disagreements) is not applicable. The results are quantitative measurements.

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

• Was it done? No. This is a physical medical device (guidewire), not a diagnostic imaging AI or software. Therefore, an MRMC study involving human readers with and without AI assistance is not applicable.
• Effect Size: Not applicable.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Was it done? This question typically applies to AI algorithms. For this physical medical device, the "standalone" performance refers to the device's inherent physical and mechanical properties as measured in bench tests, independent of its use by a human operator for the specific tests mentioned. The non-clinical bench testing effectively represents this "standalone" performance against established engineering criteria.

7. Type of Ground Truth Used

The ground truth for the non-clinical testing was based on objective engineering specifications, physical and mechanical measurements, and performance criteria derived from the predicate device's validated performance and FDA guidance documents.

8. Sample Size for the Training Set

• Sample Size: This device did not undergo a "training" process in the sense of a machine learning algorithm. The "training" for such a device would be its design, manufacturing processes, and quality control. There isn't a "training set" of data in the AI sense for this device.

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

• Not Applicable. As mentioned above, there is no "training set" for this type of device in the context of an FDA 510(k) submission for substantial equivalence based on bench testing. The design and manufacturing processes are validated to produce devices meeting pre-defined specifications.

Ask a specific question about this device

The Bandit guidewire is intended for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and peripheral vasculature.

The Bandit guidewire is a 0.014" diameter stainless steel core guidewire with a 0.008" diameter tapered distal tip. It is available in 200 cm and 300 cm lengths. The 200 cm length is compatible with a guidewire extension. The distal portion of the guidewire includes a radiopaque coil and is covered with a polymer jacket and hydrophilic coating. The proximal portion has a PTFE coating.

The provided text is a 510(k) summary for the Bandit guidewire, which is a medical device. This document describes the device, its intended use, and how it was determined to be substantially equivalent to a predicate device.

Crucially, this document describes a medical device (a guidewire), not a software or AI-powered medical device. Therefore, many of the requested categories in your prompt (such as sample size for test/training sets, number of experts, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable to this type of device and study. The "acceptance criteria" here refer to standard engineering and biocompatibility tests for a physical device, not performance metrics of a diagnostic or AI algorithm.

Here's a breakdown of the information that is available, and why other parts are not:

1. Table of Acceptance Criteria and Reported Device Performance

The study that proves the device meets the acceptance criteria:

The study refers to a series of bench performance tests and biocompatibility tests. This is a pre-clinical study (laboratory-based testing), not a clinical trial involving human subjects for performance evaluation in the context of AI.

The document states: "The technological differences between the subject and predicate device have been evaluated through bench tests to provide evidence that the Bandit guidewire is substantially equivalent to the predicate device. The device design was verified through the following tests: [list of bench tests]. The results of the verification tests met the specified acceptance criteria and did not raise different questions of safety and effectiveness."

For biocompatibility, it states: "The biocompatibility evaluation for the Bandit guidewire was conducted in accordance with the International Standard ISO 10993-1... The battery of tests included the following: [list of biocompatibility tests]. Passing results from biomaterial tests demonstrate that the Bandit guidewire is non-cytotoxic, non-sensitizing, non-irritating, non-systemically toxic, non-pyrogenic, non-hemolytic, not an activator of the complement system, and thromboresistant."

Information Not Applicable or Not Provided for this Device Type:

• 2. Sample sized used for the test set and the data provenance: Not applicable. These were laboratory bench and biocompatibility tests on physical device samples, not studies on "test sets" of data.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical guidewire is established through engineering and biological testing standards and measurements, not expert consensus on medical images or patient data.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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 or diagnostic tool.
• 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for this device, in the spirit of your question, is established by engineering specifications and international standards (e.g., ISO 10993-1) for physical performance and biological safety.
• 8. The sample size for the training set: Not applicable.
• 9. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device

ASAHI PTCA Guide Wires are intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The ASAHI PTCA Guide Wires are not to be used in the neurovasculature.

The ASAHI® PTCA Guide Wire ASAHI SION black consists of a core wire and a coil assembly. The coil assembly consists of an inner coil, safety wire, and an outer coil, soldered to the core wire. The distal portion of the coil is radiopaque so as to easily confirm its position under radioscopy. In addition, coatings are applied on the surface of the ASAHI® PTCA Guide Wire ASAHI SION black. The coil and distal portion of the quide wire are coated with polyurethane and then covered with hydrophilic coating. The proximal portion of the guide wire is coated with PTFE. The ASAHI® PTCA Guide Wire ASAHI SION black is available in various lengths and tip shapes. The shorter length device is designed for use with a commercially available ASAHI INTECC extension wire.

This document describes the premarket notification for the ASAHI® PTCA Guide Wire ASAHI SION black. It does not contain information about an AI/ML powered device, therefore no information regarding acceptance criteria or a study that proves the device meets acceptance criteria related to AI/ML device performance can be extracted.

The document discusses non-clinical laboratory testing performed on the guide wire to demonstrate substantial equivalence to predicate devices, but this is for a physical medical device, not a software or AI-based one. The types of tests conducted are standard for guide wires (e.g., tensile strength, torqueability, tip flexibility, etc.) and the conclusion is that the device met all acceptance criteria and performed similarly to predicate devices.

Ask a specific question about this device

ASAHI PTCA Guide Wires are intended to facilitate the placement of balloon dilation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA).

The ASAHI PTCA Guide Wires are not to be used in the neurovasculature.

As a basic structure, the Fielder XT-A, Fielder XT-R, consists of a taper core wire and 2 types coils (a tapered outer coil and an inner rope coil). The taper core wire and the coils are soldered together. The coil is radiopaque so as to easily confirm its position under radioscopy.

The coil and distal part of tapered core wire of the products are coated with polyurethane and then covered with hydrophilic polymer. The proximal end of the tapered core wire is coated with PTFE.

The nominal outer diameter of both the Fielder XT-A and Fielder XT-R is 0.36mm. with a distal diameter of 0.26mm. Both the Fielder XT-A and Fielder XT-R are available in 190cm and 300cm, total length. The tip shape is straight.

The provided document does not contain an acceptance criteria table with reported device performance for a medical device. Instead, it is an FDA 510(k) summary for the ASAHI Fielder XT-A and ASAHI Fielder XT-R guide wires, demonstrating substantial equivalence to predicate devices. The document outlines general testing performed but does not provide specific quantitative acceptance criteria or detailed results.

However, based on the information provided, here's a breakdown of what is available regarding testing and equivalence:

1. Table of Acceptance Criteria and Reported Device Performance:

The document explicitly states: "The in vitro bench tests demonstrated that the ASAHI Fielder XT-A and ASAHI Fielder XT-R met acceptance criteria and performed similarly to the predicate devices."

It does not provide a table with specific quantitative acceptance criteria or the numerical results of the device's performance against those criteria. It only lists the types of tests performed.

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

• Sample Size for Test Set: The document does not specify the exact sample size for each bench test performed (Dimensional Verification, Tensile Strength, Torque Strength, Torqueability, Tip Flexibility, Coating Adhesion, Catheter Compatibility, Coating Integrity / Particulate testing).
• Data Provenance: The tests were "Non clinical laboratory testing" performed by "ASAHI INTECC CO.,LTD" (applicant). The company is based in Nagoya, Aichi, Japan, with research facilities and factories in Osaka, Seto, Thailand, and Hanoi, suggesting the testing likely occurred in one of these locations. The data is retrospective for the purpose of this 510(k) submission.

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

This information is not applicable and therefore not provided. The testing described is bench testing of physical device characteristics, not clinical studies requiring expert interpretation of patient data to establish ground truth.

4. Adjudication Method for the Test Set:

This information is not applicable as the testing involves objective physical measurements and comparisons to predicate devices, not subjective interpretations requiring adjudication.

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

No MRMC study was done. The device is a PTCA guide wire, and its performance is evaluated through bench testing and comparison to existing predicate devices, not through a comparative clinical effectiveness study with human readers interpreting imaging.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance):

This question is not applicable. The device is a physical medical device (guide wire), not an algorithm or AI system. Its performance is inherent to the device itself.

7. Type of Ground Truth Used:

The "ground truth" for the bench tests was based on predetermined acceptance criteria for physical and mechanical properties, likely derived from engineering specifications and performance characteristics of functionally equivalent predicate devices. For example, a certain tensile strength or torqueability range would be considered acceptable based on established standards for guide wires.

8. Sample Size for the Training Set:

This information is not applicable. There is no training set mentioned or implied as this is not an AI/ML device.

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

This information is not applicable, as there is no training set.

Ask a specific question about this device

Fighter™, Marvel™, Samurai™, and Samurai™ RC Guidewires:

Boston Scientific Fighter™, Marvel™, and Samurai™ RC Guidewires are intended to facilitate the placement of balloon dilatation catheters or other interventional therapeutic devices during percutaneous transluminal coronary angioplasty (PTCA) or other intravascular interventional procedures. These guidewires are not intended for use in the cerebral vasculature.

Stretch Extension Wire:

Attachment of the Stretch Extension Wire to a Boston Scientific extendable guidewire creates an extended guide wire that can be used to exchange out a percutaneous transluminal coronary angioplasty (PTCA) or percutaneous transluminal angioplasty (PTA) catheter without removing the original guide wire from the exchange is complete, the Stretch Extension Wire can be detached and the original guide wire can be used in a conventional manner.

The Fighter™, Marvel™, Samurai™, and Samurai™ RC Guidewires are designed to facilitate the placement of interventional coronary devices such as dilating balloon catheters, stent delivery systems and other coronary artery diagnostic or therapeutic devices. The guide wires are available in a nominal diameter of 0.014 inches and nominal lengths of 190 cm and 300 cm. The 190 cm quide wires are compatible exclusively with the Stretch Extension Wire which can extend the quide wire length allowing for exchange of Over-The-Wire systems. The guide wires are composed of a stainless steel core wire which tapers at the distal end. The tapered distal end of the quide wire is covered with a proximal stainless steel coil and a distal platinum/nickel radiopaque coil that allows for visualization while using fluoroscopy. The proximal end of the guide wire contains a polytetrafluoroethylene (PTFE) coating and the distal portion of the wire is coated with a hydrophilic coating. All wires are available in a straight tip configuration. The Marvel and Samurai wires are available in an additional J-tip configuration.

The Stretch Extension Wire is composed of a stainless steel core wire coated with PTFE and contains a hypotube that is compatible with the 190 cm Fighter, Marvel, Samurai, and Samurai RC Guidewires.

The provided document is a 510(k) premarket notification for guidewires and an extension wire. It describes the design verification and biocompatibility testing performed to demonstrate substantial equivalence to predicate devices, rather than a study proving a device meets specific acceptance criteria with reported performance metrics. Therefore, most of the requested information regarding acceptance criteria and study particulars cannot be extracted directly from this document in the manner typically associated with clinical performance studies for AI/medical imaging devices.

However, I can extract information about the types of tests performed and the overall conclusion of substantial equivalence.

Here's a breakdown of the information that can and cannot be found in the provided text:

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

This document does not provide a table of acceptance criteria or specific reported device performance metrics in the format requested. It lists various tests performed (e.g., Dimensional Evaluation, Coating Durability, Tensile) but does not provide quantitative acceptance criteria or results. The conclusion states that the tests provide "reasonable assurance that the proposed devices have been designed and tested to assure conformance to the requirements for its intended use" and "no new safety or performance issues were raised."

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. The document describes design verification and biocompatibility testing, not clinical studies with patients. Therefore, terms like "test set" in the context of clinical data are not applicable here.

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. No ground truth establishment by experts is mentioned, as this is a materials/engineering performance evaluation, not expert-based assessment.

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

This information is not applicable. No adjudication method is mentioned as this is a materials/engineering performance evaluation.

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 information is not applicable. This document is for medical devices (guidewires and extension wires), not an AI/imaging device. No MRMC study or AI assistance is mentioned.

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

This information is not applicable. This document is for medical devices (guidewires and extension wires), not an AI/imaging device.

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

This information is not applicable. The "ground truth" in this context would be the pass/fail criteria for the engineering and biocompatibility tests performed.

8. The sample size for the training set

This information is not applicable. No training set is mentioned as this is a medical device performance evaluation, not a machine learning model.

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

This information is not applicable. No training set is mentioned.

Summary of what is available from the document:

This submission details the design verification and biocompatibility testing for Fighter™, Marvel™, Samurai™, Samurai™ RC Guidewires, and the Stretch™ Extension Wire. The purpose of these tests was to demonstrate substantial equivalence to legally marketed predicate devices.

Tests Performed:

The following performance tests were completed:

• Dimensional Evaluation
• Tip Flexibility
• Tensile
• Device Compatibility
• Coating Lubricity
• Master Shipping Carton/Condition
• Label Adhesion and Print Quality
• Sterile Barrier Integrity
• Coating Durability
• Wire Flex
• Combined Load
• Torque Response
• Wire Fracture
• Pouch Seal Strength
• Shelf Carton Condition
• Visual Sterile Barrier Integrity
• Radiodetectability
• Particulate Evaluation
• Corrosion Testing
• Exchange Connect
• Exchange Tensile
• Carrier Tube Assembly
• Withdrawal from Carrier Tube

The following biocompatibility tests were completed:

• Cytotoxicity
• Sensitization
• Intracutaneous Reactivity
• Acute Systemic Injection
• Natural Rubber Latex
• Ames Mutagenicity
• Mouse Lymphoma
• Hemolysis Direct Contact
• Hemolysis Extract Method
• Partial Thromboplastin Time
• In vitro Hemocompatibility
• Materials Mediated Pyrogen
• In Vivo Thrombogenicity
• USP Physicochemical
• Complement Activation C3a and SC5b-9

Conclusion of the Study:

"Based on the indications for use, technological characteristics, safety and performance testing, the Fighter, Marvel, Samurai, and Samurai RC Guide Wires are appropriate for the stated intended uses and are considered to be substantially equivalent to the ChoICE Guide Wire (K143587) and the Stretch Extension Wire is considered to be substantially equivalent to the AddWire Extension Wire (K030617)."

Clinical Testing:

• "Clinical evaluation was not required for this device."

Ask a specific question about this device