Search Results

PCI Guide Wires are intended to facilitate the placement of balloon dilatation catheters during percutaneous coronary intervention (PCI) and percutaneous transluminal angioplasty (PTA).

The PCI Guide Wires are not intended for use in the neurovasculature.

The basic structure of the MINAMO blue / viola consists of a hybrid stainless steel and nitinol (Ni-Ti) core wire, with a stainless steel distal inner rope coil. Surrounding the inner rope coil and the distal core wire is a radiopaque platinum nickel / stainless steel outer coil. The outer and inner coils are soldered to the tapered core wire. A similar coil design is used with other ASAHI guide wires, such as the predicate MINAMO (K190176). In addition, coatings are applied on the surface of the product. The coil portion is coated with a silicone and hydrophilic coating. The proximal side of the core wire is coated with PFA, silicone and PTFE.

The nominal outer diameter of the MINAMO is 0.36 mm. The devices are available in three lengths: 190 cm, 235 cm and 300 cm.

The MINAMO blue / viola radiopaque distal tip enables the user to view the position of the tip under X-ray fluoroscopy.

All sizes are available with a straight, pre-shape, and J-shape design.

The provided text focuses on the 510(k) premarket notification for the MINAMO blue and MINAMO viola guide wires. It describes the device, compares it to predicate and reference devices, and outlines the non-clinical and biocompatibility testing performed to demonstrate substantial equivalence.

However, the text does not contain the specific information requested regarding acceptance criteria and a study proving the device meets these criteria in the context of an AI/ML-enabled medical device.

The document states that the MINAMO blue and MINAMO viola are catheter guide wires, which are physical medical devices, not AI/ML-enabled software devices. Therefore, the questions related to:

• AI/ML performance metrics (e.g., Sensitivity, Specificity, AUC)
• Sample sizes for test sets in an AI/ML context
• Number of experts for ground truth establishment
• Adjudication methods
• Multi-Reader Multi-Case (MRMC) comparative effectiveness studies
• Standalone AI performance
• Training set sample sizes and ground truth establishment for training data

are not applicable to the submitted document as it describes a traditional medical device (guide wire) and not an AI/ML product.

The document focuses on demonstrating the substantial equivalence of the guide wires to previously cleared predicate devices through:

• Indications for Use: Same as the predicate.
• Technological Characteristics: Similar materials, design, operating principle, and sterilization.
• Non-Clinical Testing/Performance Data: Bench tests following FDA guidance, demonstrating performance similar to predicate devices and meeting acceptance criteria for physical and mechanical properties (e.g., tensile strength, torque strength, tip flexibility, coating integrity, lubricity, corrosion resistance, kink resistance, radiopacity, dimensional verification, simulated use).
• Biocompatibility: In accordance with ISO 10993.

Based on the provided text, here's what can be extracted and what cannot:

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

The document states: "The in vitro bench tests demonstrated that the MINAMO blue and MINAMO viola met all acceptance criteria and performed similarly to the predicate devices."
However, the specific numerical acceptance criteria and the quantified reported device performance values are NOT provided in the document. It only lists the types of tests performed.

Types of Performance Tests (Implied Acceptance Criteria for these properties):

• Tensile Strength
• Torque Strength
• Torqueability
• Tip Flexibility
• Coating Integrity
• Lubricity
• Visual Inspection
• Corrosion Resistance
• Kink Resistance
• Radiopacity
• Dimensional Verification
• Simulated use in a clinically relevant mode
• Coating Integrity/Particulate Evaluation in a clinically relevant mode

Biocompatibility Tests (Implied Acceptance Criteria: Non-cytotoxic, Non-sensitizer, Non-irritant, Non-toxic, Non-pyrogenic, Non-hemolytic, Not an activator, Thromboresistant):

For all other points (2-9), the information is NOT applicable to this document as it does not describe an AI/ML-enabled device or an AI/ML study.

2. Sample sized used for the test set and the data provenance: Not applicable (not an AI/ML study). The document refers to "bench testing" and "in vitro" tests, implying physical samples of the guide wire.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable (not an AI/ML study requiring expert review of 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 (not an AI/ML study).
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 concensus, pathology, outcomes data, etc): For the physical device, the "ground truth" would be established by standardized testing protocols and measurements of physical properties. For biocompatibility, it's based on ISO 10993 standards and the biological responses observed in the tests (e.g., no cellular reactivity, no delayed dermal contact sensitization).
8. The sample size for the training set: Not applicable (no AI model).
9. How the ground truth for the training set was established: Not applicable (no AI model).

Ask a specific question about this device

PCI Guide Wires are intended to facilitate the placement of balloon dilatation catheters during percutaneous coronary intervention (PCI) and percutaneous transluminal angioplasty (PTA).

The PCI Guide Wires are not intended for use in the neurovasculature.

The MINAMO consists of a hybrid NiTi and stainless-steel core wire and a coil assembly on the distal end of the device. The coil assembly is soldered to the NiTi portion of the core. In addition, coatings are applied on the surface of the MINAMO. The proximal portion is coated with PTFE. The distal section is coated with hydrophilic coating, with the distal tip coated with silicone. The MINAMO is available in both 190cm and 300cm lengths and with different tip shapes.

The MINAMO is a coronary guide wire. The 510(k) summary provides details about non-clinical testing performed to demonstrate substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that "The in vitro bench tests demonstrated that the MINAMO met all acceptance criteria and performed similarly to the predicate devices." Specific numerical acceptance criteria values and reported device performance values are generally not detailed in 510(k) summaries for non-clinical tests. This is a common practice, as the focus is on demonstrating that the device meets established performance thresholds and is comparable to previously cleared devices.

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 refers to "non-clinical laboratory testing." For medical devices, these tests are typically performed in a laboratory setting, and the provenance is the company's internal R&D or a contract testing lab. These are all retrospective tests conducted on manufactured device samples. There is no information regarding country of origin for the data for non-clinical bench testing, but the applicant's headquarters are in Japan.

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

This information is not applicable to the non-clinical bench testing described. These tests do not involve human interpretation or the establishment of ground truth by clinical experts in the same way an AI diagnostic device would. Performance is measured against physical and chemical specifications.

4. Adjudication Method:

This information is not applicable. Adjudication methods are typically used in clinical studies or studies involving human readers, which is not the nature of the reported performance data.

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

An MRMC study was not done. The device is a physical medical instrument (guide wire), not an AI diagnostic tool.

6. Standalone Performance Study:

A standalone performance study was not done in the context of an AI algorithm. The reported tests are for the physical properties and performance of the guide wire itself. The document describes "non-clinical laboratory testing" which inherently is a standalone evaluation of the device against predefined specifications.

7. Type of Ground Truth Used:

The "ground truth" for the non-clinical tests is established by:

• Engineering Specifications: Predetermined physical and chemical properties that an equivalent guide wire must possess (e.g., specific tensile strength, flexibility parameters, corrosion resistance).
• International Standards: Adherence to relevant ISO standards (e.g., for biocompatibility, sterility) or equivalent national standards.
• Predicate Device Performance: Demonstrating comparable performance to legally marketed predicate devices through comparative bench testing.

8. Sample Size for the Training Set:

This information is not applicable. The MINAMO is a physical medical device, not an AI or machine learning algorithm that requires a training set.

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

This information is not applicable, as there is no training set for a physical guide wire.

Ask a specific question about this device