Search Results

The Asahi SUOH PTCA Guide Wire is intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The Asahi SUOH PTCA Guide Wire is not to be used in the cerebral blood vessel.

The Asahi SUOH PTCA Guide Wire is A steerable guide wire with a maximum diameter of 0.014 inches (0.36mm) and available in 180 cm and 300 cm length. The extension wire is connected to the end of the guide wire outside the body. The guide wire is constructed from a stainless steel core wire with a platinum-nickel and stainless steel coil. The core wire and coil are soldered. The distal end of the guide wire has a radiopaque tip to achieve visibility, and is available in a straight configuration and can be made to easily bend with the vessel curve. A hydrophilic coating is applied to the distal portion of the guide wire. The proximal section of the guide wire is coated with PTFE.

The provided text does not describe acceptance criteria or a study proving that a device meets acceptance criteria. Instead, it is a 510(k) summary for the Asahi SUOH PTCA Guide Wire, focusing on its substantial equivalence to predicate devices based on technical characteristics and performance data.

Specifically:

• There is no table of acceptance criteria and reported device performance.
• There are no details about sample size, data provenance, number of experts, adjudication methods, or specific study types like MRMC or standalone algorithm performance.
• The text mentions "mechanical and functional bench testing" and a "long history of use in medical devices" for biocompatibility, but it does not provide details about the methodology, results, or specific criteria involved in these evaluations.
• There's no information about training set size or how ground truth was established for a training set, as this type of submission (for a medical device like a guide wire) typically relies on engineering tests and comparison to existing, cleared predicate devices rather than AI/machine learning model validation.

The conclusion of the summary states: "The Asahi SUOH PTCA Guide Wire characteristics are substantially equivalent to the specified predicate devices and other currently marketed devices for the same indication for use." This indicates that the primary "acceptance criterion" demonstrated is substantial equivalence to legally marketed predicate devices, rather than meeting specific performance thresholds through a detailed clinical or AI-centric study.

Ask a specific question about this device

To facilitate the placement of balloon dilatation catheters during perculaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal blood vessel transluminal coronary angloplasty (1 YOA) and poroculared in the cerebral blood vessel.

The Asani PTCA Guide Wiles are stechable gelde is constructed from a 0.014" and available in 150 cm and oo of the guide wire has a radiopaque tip that is stainless steel core wire. The distal end of the guide wire The coating stainless steel core wire. The distar end of the gd with the vessel curve. The coating available straight and is made soft to easily bend with wire guide wire. The available straignt and is thade soll to casily bonion of the wire guide wire. The (Hydrophilie or onlooms) is coated with PTFE.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Asahi PTCA Guide Wire:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, specific quantitative acceptance criteria are not explicitly stated or defined. The submission focuses on demonstrating substantial equivalence to predicate devices. The performance data section broadly states:

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

This information is not provided in the document. The submission references "bench testing" but does not detail the sample sizes of devices or test conditions.

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

This information is not applicable as the document describes a medical device (guide wire), not an algorithm or diagnostic tool that requires expert-established ground truth on a test set (e.g., medical images). The testing appears to be physical or mechanical bench testing.

4. Adjudication Method for the Test Set

This information is not applicable for the same reason as point 3.

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

This information is not applicable. The device is a physical medical instrument (guide wire), not a diagnostic algorithm where human readers assess cases.

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

This information is not applicable. The device is a physical medical instrument, not a software algorithm.

7. The Type of Ground Truth Used

For this device, the "ground truth" would relate to its physical and functional properties meeting specifications. The document states:

• "Biocompatibility": Demonstrated by a "long history of use in medical devices" for its components. This implies a historical record of safe and successful use in similar applications.
• "Functioning as intended": Established through "bench testing." This likely involves engineering specifications and performance metrics for parameters like tensile strength, flexibility, lubricity, etc. However, the specific parameters are not detailed in the summary.
• "Substantial equivalence": Established by comparing its characteristics and materials to previously cleared predicate devices.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical medical instrument, not a machine learning model that requires a training set.

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

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

Summary of the Study and Acceptance:

The submission for the Asahi PTCA Guide Wire (K052339) is a 510(k) premarket notification, which aims to demonstrate that the new device is "substantially equivalent" to legally marketed predicate devices.

The "study" described is primarily focused on bench testing to demonstrate:

• The device's materials are the same as existing predicate devices and have a long history of biocompatible use.
• The device functions as intended.
• The device's characteristics are substantially equivalent to the specified (presumably for the predicate devices) specifications.

The acceptance criteria, while not quantified with specific thresholds, are met by demonstrating this substantial equivalence and satisfactory performance in bench testing, allowing the FDA to conclude that the device is as safe and effective as its predicates. The FDA's acceptance is conveyed in the letter from November 30, 2005, stating that the device is "substantially equivalent."

Ask a specific question about this device

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 cerebral blood vessel.

The Asahi PTCA Guide Wire Fielder is steerable guide wire with a maximum diameter of 0.36mm (0.014 inches) and available in 180 cm and 300 cm length. The wire is constructed from a stainless steel core wire. The core wire and coil are soldered. The distal tip of the guide wire has a radiopaque tip to achieve visibility, and is made flexible to bend easily at the vessel curve. There is polyurethane coating covered with hydrophilic coating applied to the distal section of the guide wire. The proximal section of this guide wire is coated with PTFE.

The provided text describes a 510(k) premarket notification for the Asahi PTCA Guide Wire Fielder. It states that "Bench and biocompatibility testing were conducted according to the recommendations from relevant FDA guidance to demonstrate that the Asahi PTCA Guide Wire Fielder met the acceptance criteria and performed equivalent to the predicate devices." However, it does not provide a table of acceptance criteria or specific reported device performance metrics. It also does not detail the methodology of the study or the provenance of data, only that testing was conducted.

Therefore, many of the requested details cannot be extracted from the provided text.

Here's a summary of what can be extracted and what cannot:

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

• Cannot be provided. The text states that "bench and biocompatibility testing...met the acceptance criteria and performed equivalent to the predicate devices" but does not explicitly list the criteria or the specific device performance results.

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

• Cannot be provided. The text mentions "bench and biocompatibility testing" but does not specify sample sizes or data provenance (e.g., country of origin, retrospective/prospective).

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

• Cannot be provided. There is no mention of expert involvement in establishing ground truth for any testing described.

4. Adjudication method for the test set

• Cannot be provided. There is no mention of an adjudication method.

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

• Cannot be provided. The device is a PTCA Guide Wire, not an AI or imaging device that would typically involve human reader studies.

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

• Cannot be provided. The device is a medical instrument, not an algorithm.

7. The type of ground truth used

• Cannot be explicitly stated based on the text. For "bench and biocompatibility testing," ground truth would typically be established through standardized methods, specifications, and laboratory measurements. However, the text does not detail how the acceptance criteria for these tests were set or what constitutes "ground truth" for them.

8. The sample size for the training set

• Not applicable. The device is a physical medical instrument, not a machine learning model, so there is no "training set."

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

• Not applicable. As above, there is no "training set" for a physical device.

Summary of available information:

• Study Type: Bench and biocompatibility testing.
• Conclusion: The device "met the acceptance criteria and performed equivalent to the predicate devices." This implies the study aimed to demonstrate substantial equivalence through these tests.
• Predicate Devices: JoWire Neo's PTCA Guide Wire (K022762) and JoWire Asahi PTCA Guide Wire (K031277).
• No new safety or effectiveness issues were raised during the testing.

Ask a specific question about this device

To facilitate the placement of balloon dilatation catheters during perculaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The Asahi PTCA Guide Wires are not to be used in the cerebral blood vessel.

'I'he Asahi PTCA Guide Wire Confianza Pro is steerable guide wire with a maximum 0.014" and available in 180 cm and 300 cm length. The extension wire is diameter of connected to the end of the guide wire outside the body. The wire is constructed from a stainless steel core wire. The core wire and coil are soldered. The distal end of the guide wire has a radiopaque tip that is available straight and is made soft to easily bend with the vessel curve. The coating (hydrophilic and silicone) is applied to the distal portion of the wire guide wire. The proximal section of the guide wire is coated with PTFE.

This is a 510(k) premarket notification for a medical device, which typically relies on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study data with acceptance criteria for device performance in the same way a PMA (Premarket Approval) application would.

Based on the provided text, the device in question is the Asahi PTCA Guide Wire Confianza Pro.

Here's an analysis of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table of
specific, quantifiable acceptance criteria or detailed reported device performance for the Asahi PTCA Guide Wire Confianza Pro.

The document states:
"Bench and biocompatibility testing were conducted according to the recommendations from relevant FDA guidance to demonstrate that the Asahi PTCA Guide Wire Confianza Pro met the acceptance criteria and performed similarly to the predicate devices. No new safety or effectiveness issues were raised during the testing."

This indicates that:

• Acceptance Criteria: Existed, but are not explicitly listed in the provided summary. They were likely derived from relevant FDA guidance for guide wires.
• Reported Device Performance: The device "met the acceptance criteria and performed similarly to the predicate devices." No specific numerical performance metrics are provided. The "bench and biocompatibility testing" would have assessed physical properties (e.g., tensile strength, kink resistance, lubricity) and biological safety (e.g., cytotoxicity, sensitization), aiming to show equivalence to the predicate.

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

This information is not provided in the document. The text only mentions "bench and biocompatibility testing," which are typically laboratory-based tests of the device itself, not clinical tests on patient data. There is no indication of a "test set" of patient data in the context of clinical performance.

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

This information is not applicable/provided. Since no clinical test set with patient data is described, there's no mention of experts establishing ground truth for such a set.

4. Adjudication Method for the Test Set

This information is not applicable/provided. No clinical test set is described.

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

This information is not applicable/provided. The 510(k) summary focuses on substantial equivalence based on bench testing and biocompatibility, not on a clinical MRMC study. There is no mention of human readers or AI assistance.

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

This information is not applicable/provided. This device is a physical medical device (guide wire), not a software algorithm. Therefore, "standalone performance" in the context of an algorithm is irrelevant.

7. Type of Ground Truth Used

This information is not applicable/provided in the context of clinical performance. For the bench testing, the "ground truth" would be established specifications and standards for guide wire performance (e.g., material properties, force measurements, kink resistance thresholds). For biocompatibility, it would be established ISO standards for biological evaluation of medical devices.

8. Sample Size for the Training Set

This information is not applicable/provided. As this is a physical device and not an AI/software product, there is no "training set."

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

This information is not applicable/provided. There is no training set for this type of device.

Overall Summary:

The provided document is a 510(k) summary, which aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. This process primarily relies on comparing technological characteristics, materials, and intended use, supported by bench and biocompatibility testing. It does not typically involve the extensive clinical trials or human-reader studies that would provide the type of detailed performance data and acceptance criteria you've asked for, especially for AI or diagnostic devices. The acceptance criteria and performance data mentioned relate to the physical and biological characteristics of the guide wire itself, assessed in a lab setting, rather than its clinical performance in patients as measured by diagnostic accuracy, for example.

Ask a specific question about this device