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510(k) Data Aggregation
(60 days)
The Insulator Wire Guide will be used either inside or alongside a urological catheter or electrosurgical catheter for catheter positioning or exchange in the urinary tract. When used with an electrosurgical catheter, the Insulator Wire Guide will decrease the risk of alternate site burns to the patient. This device is intended for one-time use.
The Insulator Wire Guide is used either inside or alongside a urological catheter or electrosurgical catheter for catheter positioning or exchange in the urinary tract. When used with a electrosurgical catheter, the Insulator Wire Guide will decrease the risk of alternate site burns to the primary material used in this device is TFE. TFE is widely used in the medical field and biocompatibility is assured. Performance testing was performed showing the device to meet requirements for a safe and effective insulated wire guide.
The Insulator Wire Guide is intended for use in the urinary tract for catheter positioning or exchange, either inside or alongside a urological or electrosurgical catheter. When used with an electrosurgical catheter, it aims to reduce the risk of alternate site burns to the patient. The device is for one-time use.
Here's an analysis of the provided information regarding acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety: Device decreases the risk of alternate site burns to the patient when used with an electrosurgical catheter. | "Performance testing was performed showing the device to meet requirements for a safe and effective insulated wire guide." |
| Effectiveness: Use for catheter positioning or exchange in the urinary tract. | "Performance testing was performed showing the device to meet requirements for a safe and effective insulated wire guide." |
| Biocompatibility: Materials used are safe for medical application. | "The primary material used in this device is TFE. TFE is widely used in the medical field and biocompatibility is assured." |
| Substantial Equivalence: Design, construction, materials, and indications for use are similar to predicate insulated wire guides (e.g., Protector Plus by Wilson-Cook Medical Inc.). | "The Insulator Wire Guide is substantially equivalent to predicate insulated wire guides in terms of indications for use, design, construction and materials equivalence." |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions "Performance testing was performed."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide information on the number of experts used, their qualifications, or how ground truth was established for any test set.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method used for a test set.
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
This section is not applicable. The device described is an "Insulator Wire Guide," a physical medical device, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance would not be relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This section is not applicable. As mentioned above, this is a physical medical device, not an algorithm, so standalone performance in the context of AI is not relevant.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The document does not explicitly state the type of ground truth used for "performance testing." It broadly refers to "requirements for a safe and effective insulated wire guide," suggesting the ground truth would be based on established engineering standards, material properties, and potentially bench testing results to demonstrate insulation and functional capabilities. For biocompatibility, the ground truth is established by the widespread and assured biocompatibility of TFE in the medical field.
8. The Sample Size for the Training Set
The document does not mention a "training set" as this is a physical device and not a machine learning model.
9. How the Ground Truth for the Training Set Was Established
The document does not mention a "training set" or its ground truth, as this is a physical device.
Summary of Study Information:
The provided 510(k) summary focuses on demonstrating substantial equivalence to predicate devices rather than detailed performance study results with specific acceptance criteria and outcome metrics. The submission relies on the established safety and effectiveness of the existing predicate devices and the known biocompatibility of the material (TFE). The "performance testing" mentioned is general and lacks specific details regarding methodology, sample sizes, or results against quantified acceptance criteria.
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