(143 days)
The PW Guidewires are intended to facilitate placement of balloon dilatation catheters or other intravascular devices during percutaneous transluminal coronary angioplasty (PCTA) and percutaneous transluminal angioplasty (PTA). The PW Guidewires are not to be used in cerebral blood vessels.
The Tatara Vascular, LLC PW Guidewires are steerable guidewires with a maximum diameter of 0.014" (0.36mm) and nominal length of 180cm. The wires are constructed from a stainless steel solid core wire with two grind profiles that distinguish the gram stiffness of the wire. The core wire transitions to an angled tip of either 0.30mm or 0.75 mm in length. The distal end of the guidewires have a radiopaque coil. A hydrophilic coating is applied to the distal portion of the guidewires. The proximal portion of the guidewires is coated with polytetrafluoroethylene (PTFE).
The provided text describes a 510(k) premarket notification for a medical device, the Tatara Vascular, LLC PW Guidewires. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel clinical effectiveness with extensive human-in-the-loop or standalone AI studies.
Therefore, the information regarding acceptance criteria and performance is primarily focused on non-clinical laboratory testing to show that the new device performs as intended and is comparable to predicate devices. There is no mention of studies involving human readers, AI assistance, or complex diagnostic accuracy metrics as typically seen in AI/ML device submissions.
Here's a breakdown based on the provided text, addressing your questions to the extent possible:
Acceptance Criteria and Device Performance
Since this is a guidewire, the acceptance criteria are based on physical and mechanical properties and material safety, not diagnostic accuracy.
-
Table of Acceptance Criteria and Reported Device Performance:
The document lists the types of non-clinical laboratory tests performed. While it states "met the required acceptance criteria," it does not provide a specific table with numerical acceptance criteria values or the quantitative reported device performance for each test. It only lists the tests performed and a general statement of compliance.
| Test Performed | Statement of Performance Against Acceptance Criteria |
|---|---|
| Tensile Strength | Met required acceptance criteria |
| Torque Strength | Met required acceptance criteria |
| Torqueability | Met required acceptance criteria |
| Tip Flexibility | Met required acceptance criteria |
| Tip Load | Met required acceptance criteria |
| Coating Adhesion | Met required acceptance criteria |
| Simulated Use | Met required acceptance criteria |
| Resistance to Wire Fracture | Met required acceptance criteria |
| Dimensional Verification | Met required acceptance criteria |
| Catheter Compatibility | Met required acceptance criteria |
| Radiopacity Testing | Met required acceptance criteria |
| Biocompatibility (ISO 10993-1) | Suitable for intended use |
Study Details (Relevant to Device Substantial Equivalence, Not AI/ML)
-
Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified in the document. The tests performed are non-clinical bench tests; thus, "sample size" would refer to the number of guidewires tested for each physical property. This information is typically detailed in the full test reports, not usually in the 510(k) summary.
- Data Provenance: The data originates from non-clinical laboratory testing (bench testing) of the Tatara Vascular, LLC PW Guidewires. It is not patient data, and therefore, concepts like "retrospective or prospective" or "country of origin of the data" are not applicable in this context.
-
Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- This question is not applicable to this type of device submission. Ground truth for a guidewire's mechanical properties is established through standardized engineering and materials testing methods using calibrated equipment, not by human expert consensus on images or outcomes.
-
Adjudication Method for the Test Set:
- Not applicable. As described above, there's no human interpretation or adjudication involved in establishing the performance of a guidewire in bench tests.
-
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. This type of study is relevant for diagnostic devices, particularly those involving AI/ML for image interpretation. The PW Guidewires are a mechanical interventional device, and their substantial equivalence is demonstrated through engineering performance and material safety, not by comparative effectiveness studies with human readers.
-
Standalone (Algorithm Only Without Human-in-the-loop Performance) Study:
- No. This question is specific to AI/ML algorithms. The device described is a physical guidewire, not an AI algorithm.
-
Type of Ground Truth Used:
- The "ground truth" for the performance of the guidewire in non-clinical testing is based on engineering specifications, material science principles, and established international standards (e.g., ISO 10993-1 for biocompatibility). Performance is measured objectively via test equipment.
-
Sample Size for the Training Set:
- Not applicable. There is no "training set" in the context of a physical medical device like a guidewire. Training sets are used for machine learning models.
-
How the Ground Truth for the Training Set Was Established:
- Not applicable. As there is no training set, this question is irrelevant to this device submission.
In summary, the provided document details the regulatory pathway for a conventional medical device (a guidewire) seeking 510(k) clearance by demonstrating substantial equivalence. The focus is on showing the device meets established engineering, material, and safety standards through non-clinical testing, rather than complex clinical studies involving human interpretation or AI performance metrics.
§ 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.