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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).

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This product is designed to direct a catheter to the desired anatomical location in the peripheral vasculature during diagnostic or interventional procedures.

The CROSSLEAD Penetration Peripheral Guide Wire (hereafter "CROSSLEAD Penetration") is steerable guide wire with a maximum diameter of 0.014" (0.36 mm) and 0.018" (0.46 mm) and available in 200 cm, 235 cm and 300 cm length. The guide wire is constructed from a stainless steel core wire with a Pt-Ni-Au alloy coil. The coil is soldered to the core wire with Au-Sn solder. The coil has radio - detectability to achieve visibility and can be made to bend with the vessel curve. A hydrophilic coating is applied to the distal portion of the guide wire. A hydrophobic coating is applied to proximal portion. The basic structure, construction, and coating of the CROSSLEAD Penetration are similar to that previously described in the predicate ASAHI Peripheral Guide Wire ASAHI Astato XS 40 (K153443) (hereafter "ASAHI Astato XS 40") and reference CROSSLEAD Peripheral Guide Wire (K213315) (hereafter "CROSSLEAD").and ASAHI Peripheral Guide Wire ASAHI Halberd (K150445) (hereafter "ASAHI Halberd")..

The provided document describes the FDA's 510(k) clearance for the CROSSLEAD Penetration Peripheral Guide Wire. This is a medical device, not an AI/ML powered device, so many of the requested fields are not applicable. However, I can extract information related to its non-clinical testing and acceptance criteria as provided.

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

The document states that the CROSSLEAD Penetration met all acceptance criteria in its bench testing. Specific acceptance criteria are not detailed in the summary, but the categories of tests performed are listed. The reported performance is generally stated as "performed similarly to the predicate devices" and "functions as intended."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document describes non-clinical bench testing and biocompatibility testing. It generally refers to "bench testing" and "in vitro bench tests." There is no mention of a "test set" in the context of patient data, as this is a device clearance for a physical medical guide wire, not a diagnostic or prognostic algorithm. Therefore, information on sample size for a test set or data provenance (country of origin, retrospective/prospective) is not applicable or provided in this document.

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)

Not applicable. This is a physical medical device. "Ground truth" in the context of expert consensus on data is not relevant here. The "ground truth" for the performance of the device is established by meeting specified physical and biological performance criteria during bench and biological compatibility testing, per established international standards (e.g., ISO 10993).

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

Not applicable. This is a physical medical device, not an AI/ML algorithm requiring adjudication of a test set based on expert opinion.

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/ML device, and therefore no MRMC study or AI assistance assessment was conducted.

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 AI/ML algorithm.

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

The "ground truth" for this medical device is established through compliance with recognized performance standards and validated test methods for physical characteristics and biocompatibility. This includes:

• Compliance with FDA guidance document: "Coronary, Peripheral, and Neurovascular Guidewires - Performance Tests and Recommended Labeling, 15JUN2018."
• Compliance with ISO 10993 series for biocompatibility: This involves specific laboratory tests with predefined acceptance criteria. For example, for cytotoxicity, the ground truth is established by observing no signs of cellular reactivity (Grade 0) for controls. For sensitization, no evidence of delayed dermal contact sensitization in guinea pigs. For pyrogenicity, no increase in rectal temperature by more than 0.5 degrees Celsius.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/ML algorithm 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/ML algorithm.

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