Search Results
Found 1 results
510(k) Data Aggregation
(74 days)
The Cook MicroWire Wire Guide is indicated for use in facilitating delivery of percutaneous catheters into the cardiovascular system.
The Cook MicroWire Wire Guide is manufactured using a nitinol mandril with a PTFE coating and a stainless steel and palladium distal tip. The maximum outside diameter is 0.0142-inch and will be available in 135, 190 and 300 cm lengths. It will be supplied sterile, intended for one-time use.
The provided text describes a Special 510(k) Premarket Notification for the Cook MicroWire Wire Guide. This type of regulatory submission is for medical devices and focuses on demonstrating substantial equivalence to a predicate device, rather than providing extensive clinical trial data or detailed performance metrics against specific quantitative acceptance criteria in the same way modern AI/software as a medical device (SaMD) submissions might.
Therefore, many of the requested categories for acceptance criteria and study details are not applicable or directly available in this document. The submission focuses on physical and material properties and safety, reflecting the nature of a hardware device.
Here's an analysis based on the provided text, highlighting what is available and what is not:
Acceptance Criteria and Device Performance for Cook MicroWire Wire Guide
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Not explicitly stated as quantitative thresholds in the document, but implied successful completion) | Reported Device Performance |
|---|---|---|
| Tensile Test | Device maintains integrity under tensile force, meets design specifications. | Performed; results provide reasonable assurance of conformance. |
| Tip Flexibility Test | Tip maintains appropriate flexibility for intended use without breaking or deforming adversely. | Performed; results provide reasonable assurance of conformance. |
| Fracture Test | Device does not fracture under specified conditions. | Performed; results provide reasonable assurance of conformance. |
| Flexing Test | Device withstands repeated flexing without degradation. | Performed; results provide reasonable assurance of conformance. |
| Torque Strength Test | Device withstands specified torque without damage or failure. | Performed; results provide reasonable assurance of conformance. |
| Torque Response Test | Device transmits torque effectively and predictably. | Performed; results provide reasonable assurance of conformance. |
| Biocompatibility Testing | Device materials are biocompatible (e.g., non-toxic, non-irritating, non-sensitizing). | Performed; results provide reasonable assurance of conformance. |
| Bioburden Testing | Device meets specified microbial load limits. | Performed; results provide reasonable assurance of conformance. |
| Endotoxin Testing | Device meets specified endotoxin limits. | Performed; results provide reasonable assurance of conformance. |
| EtO Residual Testing | Device meets specified limits for Ethylene Oxide residuals (if EtO sterilized). | Performed; results provide reasonable assurance of conformance. |
Note: The document states that "The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a wire guide." This implies that the device met its internal acceptance criteria for each test, but the specific numerical thresholds for these criteria are not disclosed in this summary.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for any of the tests. The testing typically involves a representative number of units to demonstrate product consistency and performance.
- Data Provenance: Not applicable in the context of "country of origin of the data" or "retrospective or prospective" as these tests are laboratory-based, pre-market engineering and safety assessments of a manufactured medical device, not clinical data sets. The testing was conducted internally by Cook Incorporated.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. This device is a physical medical instrument, not an AI or diagnostic tool that relies on expert interpretation of data to establish ground truth for performance. The "ground truth" for these engineering tests is based on established scientific and engineering principles, material specifications, and regulatory standards.
4. Adjudication Method for the Test Set
- Not Applicable. See point 3. The tests are objective measurements of physical properties, not subjective interpretations requiring adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance.
- Not Applicable. This is a hardware device (wire guide), not an AI or software product. MRMC studies are used for evaluating diagnostic performance of AI or imaging technologies in conjunction with human readers.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done.
- Not Applicable. See point 5.
7. The Type of Ground Truth Used
- Device-Specific Engineering and Material Specifications, and Regulatory Standards: The "ground truth" for the tests (Tensile, Flexibility, Fracture, etc.) is based on meeting the defined engineering parameters and safety standards relevant to a guide wire for cardiovascular use. For biocompatibility, bioburden, endotoxin, and EtO residuals, the ground truth is defined by established international standards (e.g., ISO) and regulatory limits for patient safety.
8. The Sample Size for the Training Set
- Not Applicable. There is no "training set" in the context of this traditional hardware medical device. Training sets are relevant for machine learning algorithms.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. See point 8.
Ask a specific question about this device
Page 1 of 1