(154 days)
The Pre-Formed guidewires are intended to facilitate the introduction and placement of interventional devices within the chambers of the heart including those within transcatheter aortic valve procedures. This guidewire is not intended for use in the cerebrovasculature or coronary arteries.
The 0.035" diameter, 260cm-300cm length guidewire is composed of two primary wire components: a core and a coil. Both components are made of stainless steel per ASTM A313. The core wire is a stainless steel wire which forms the inner body of the guidewire. The coil component is the guidewire's outer layer and is a stainless steel wire coated in Green Polytetrafluoroethylene (PTFE). The coil and core components are weld together on the distal and proximal ends, forming the guidewire. The distal end of the guidewire contains a double-curve.
This document describes the qualification testing for a "Pre-Formed Guidewire" and compares it to a predicate device for a 510(k) submission.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document lists "applicable bench tests performed at baseline and aging," and states that "Test pieces were tested and inspected according to established requirements for visual/tactile, dimensional and mechanical attributes." It also states, "All test results support the claim of substantial equivalence." However, specific quantitative acceptance criteria (e.g., "tensile strength > X N") and the exact numerical results obtained for each test are not provided in this summary. The table below represents the categories of tests performed and the general statement of performance.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Dimensional | Met established requirements |
| FDA Device Compatibility | Met established requirements |
| FDA Tensile Strength | Met established requirements |
| FDA Tip Flexibility | Met established requirements |
| FDA Coating Adherence/Integrity | Met established requirements |
| FDA Catheter Compatibility | Met established requirements |
| Packaging Study | Met established requirements |
| Particulate | Met established requirements |
| ISO Visual | Met established requirements |
| ISO Fracture | Met established requirements |
| ISO Flex | Met established requirements |
| ISO Corrosion Resistance | Met established requirements |
| ISO Strength of Union | Met established requirements |
| ISO Radiopacity | Met established requirements |
| Body Stiffness | Met established requirements |
| Biocompatibility (Cytotoxicity, Kligman Maximization, Irritation/Intracutaneous Reactivity, Complement Activation Assay, Rabbit Pyrogen, Hemolysis, Thrombogenicity, Lee and White Coagulation, Unactivated Thromboplastin Time Assay, Acute Systemic Toxicity Test, Partial Thromboplastin Time Assay, USP Physicochemical Test, Inhibition and Enhancement) | Found to be acceptable per ISO 10993 series |
| GLP Animal Study Performance | Substantially equivalent to the legally marketed device; acceptable performance and safety. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated for each bench test, biocompatibility test, or the animal study. The document mentions "Test pieces were tested," implying multiple samples, but gives no numbers.
- Data Provenance: The document does not specify the country of origin for any data.
- Bench Testing: Performed by Lake Region Medical.
- Biocompatibility Testing: Performed by an unspecified lab.
- Animal Study: A GLP (Good Laboratory Practice) Animal Study was completed, implying it was conducted under controlled conditions, but the location is not mentioned.
- Retrospective or Prospective: All testing appears to be prospective as it was specifically conducted to demonstrate equivalence for this 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This type of information is generally not applicable to a medical device 510(k) submission for a guidewire. The "ground truth" for guidewire performance is established through objective, quantifiable physical, chemical, and biological testing as performed in the bench and animal studies, not through expert consensus on qualitative observations.
4. Adjudication Method for the Test Set
Not applicable. As noted above, the "ground truth" is based on objective measurements and established standards, rather than subjective interpretation requiring adjudication among experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret results, comparing their performance with and without AI assistance. This submission describes a physical medical device (guidewire) where performance is assessed through bench and animal testing.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI (algorithm-only) device. The device itself is a physical guidewire. Human intervention is inherently part of its use (e.g., a physician manipulating the guidewire).
7. The Type of Ground Truth Used
The "ground truth" for the Pre-Formed Guidewire's performance and safety was established through a combination of:
- Bench Testing: Objective measurements against established requirements for visual/tactile, dimensional, and mechanical attributes, often guided by standards like ISO 11070:1998 and FDA guidance.
- Biocompatibility Testing: Compliance with ISO 10993 series standards, involving various biological assays directly measuring material interaction with biological systems.
- GLP Animal Study: In-vivo evaluation of performance and safety, comparing the new device to a predicate device in a living system. This assesses real-world interaction and outcomes, often including histological and physiological assessments.
8. The Sample Size for the Training Set
Not applicable. This is a traditional 510(k) for a physical medical device, not an AI or machine learning algorithm. Therefore, there is no "training set" in the context of data for model development.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set.
§ 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.