(182 days)
The FindrWIRZ System is intended for use in the cardiovascular system for introduction and positioning of over-the-wire catheters and therapeutic devices during interventional procedures. A FindrWIRZ may also be used to manipulate and or reposition another FindrWIRZ. The FindrWIRZ System is not intended for use in the coronary or cerebral vasculature.
The FindrWIRZ System consists of the following components: A 0.035" x 90 cm FindrWIRZ A 0.025" x 260 cm FindrWIRZ Guide wire introducer Torque device Each FindrWIRZ is configured with a tapered core wire and a distal coil, the 0.035 FindrWIRZ has a proximal PTFE jacket and both wires have a hydrophilic coating. The distal tip of each wire has an encapsulated magnet of opposite polarization which is used for proximity sensing and connection of the two guide wires to facilitate manipulation and positioning of each other. The FindrWIRZ System is sterilized with 100% ethylene oxide.
The FindrWIRZ Guide Wire System is a medical device intended for use in the cardiovascular system for the introduction and positioning of over-the-wire catheters and therapeutic devices during interventional procedures. The provided document is a 510(k) summary, which outlines the device's safety and effectiveness compared to predicate devices. It does not contain detailed information about specific acceptance criteria or an explicit study that proves the device meets those criteria. Instead, it describes general functional testing and biocompatibility testing to support the claim of substantial equivalence.
Here's a breakdown of the information available and what is not explicitly stated in the provided text, structured as requested:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Functional Performance | Functional testing was conducted to support the claim of substantial equivalence and to demonstrate the FindrWIRZ Guide Wire System is safe and effective for its intended use. (Specific functional criteria like tip flexibility, torque response, pushability, or trackability are not detailed in this summary.) |
| Biocompatibility | The materials used in the FindrWIRZ Guide Wire System are commonly used materials in other medical devices. Results of testing demonstrate the FindrWIRZ Guide Wire System is biocompatible. (Specific tests performed, e.g., cytotoxicity, sensitization, irritation, are not detailed.) |
| Sterilization | The FindrWIRZ System is sterilized with 100% ethylene oxide. (Confirmation of sterility and shelf-life stability is implied but not explicitly detailed as performance criteria.) |
| Intended Use | The device is deemed safe and effective for its intended use: introduction and positioning of over-the-wire catheters and therapeutic devices during interventional procedures in the cardiovascular system, and for manipulation/repositioning of another FindrWIRZ. |
| Substantial Equivalence | Based on intended use, product testing, and information provided, the device is shown to be safe and effective for its intended use and substantially equivalent to the predicate devices (OnTrac, Cronus Wire, Radius Snare Device). |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "Functional testing" and "Results of testing" for biocompatibility but does not specify sample sizes for any test sets. It also does not provide any information regarding data provenance (e.g., country of origin, retrospective or prospective) as the testing appears to be primarily bench testing and material testing, not human clinical data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This information is not applicable and not provided in the document. The testing described is for the performance and biocompatibility of a physical medical device, not for an algorithm requiring expert-established ground truth.
4. Adjudication Method for the Test Set:
This information is not applicable and not provided in the document, as it relates to expert review of data, which is not described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done as this type of study is typically conducted for diagnostic algorithms or imaging interpretation, not for the functional assessment of a guide wire system.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
A standalone (algorithm only) performance study was not done as the FindrWIRZ Guide Wire System is a physical medical device and not an AI algorithm.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.):
The concept of "ground truth" as typically used for AI or diagnostic studies is not applicable here. The "ground truth" for the device's performance would be established through engineering specifications, material standards, and clinical requirements for guide wires, validated through bench testing, material testing, and potentially pre-clinical (animal) studies (though these are not detailed in the summary).
8. The Sample Size for the Training Set:
This information is not applicable and not provided as this device is not an AI algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable and not provided as the device is not an AI algorithm requiring a training set.
In summary: The provided 510(k) summary focuses on demonstrating substantial equivalence to predicate devices through functional and biocompatibility testing. It lacks detailed quantitative data on specific acceptance criteria and study methodologies, which is common for this type of regulatory submission for a physical medical device. The concepts of "ground truth," "expert adjudication," "sample size for test sets," and "AI performance studies" do not directly apply to the information presented for the FindrWIRZ Guide Wire System.
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.