(99 days)
The PBN Guidewires are intended for use to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.
The PBN Guidewires are made from a stainless steel or nitinol core wire surrounded by a stainless steel or tungsten spring. The PBN Guidewires will be provided uncoated, hydrophilic coated, or PTFE coated. The PBN Guidewires will be provided in the following diameters and lengths: .018 in. and .020 in. diameter, and 40 cm to 300 cm in length.
The provided text describes the PBN Guidewires and their substantial equivalence to a predicate device, focusing on functional and safety testing as well as technical comparison. However, it does not include specific acceptance criteria or an in-depth study report with detailed performance metrics, sample sizes for test sets, ground truth establishment, or human reader studies.
Based on the provided information, I can only extract limited details regarding acceptance criteria and the "study" (which is referred to as "Functional & Safety Testing" and "Technical Comparison").
Here's a breakdown of what can be inferred:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from testing) | Reported Device Performance |
|---|---|
| Tensile Strength (Comparable to predicate) | The results of the testing indicated that they are comparable to the predicate device. |
| Torqueability (Comparable to predicate) | The results of the testing indicated that they are comparable to the predicate device. |
| Tip Flexibility (Comparable to predicate) | The results of the testing indicated that they are comparable to the predicate device. |
| Coating Adherence/Integrity (Comparable to predicate) | The results of the testing indicated that they are comparable to the predicate device. |
| Intended Size (Comparable to predicate) | Found to be comparable to the predicate device. |
| Length (Comparable to predicate) | Found to be comparable to the predicate device. |
| Distal End Configuration (Comparable to predicate) | Found to be comparable to the predicate device. |
| Intended Anatomical Location of Distal End (Comparable to predicate) | Found to be comparable to the predicate device. |
| Proximal End Configuration (Comparable to predicate) | Found to be comparable to the predicate device. |
| Materials (Comparable to predicate) | Found to be comparable to the predicate device. |
| Labeling (Comparable to predicate) | Found to be comparable to the predicate device. |
Note: The actual numerical acceptance criteria for "tensile strength," "torqueability," etc., are not provided in the document. The performance is stated as "comparable to the predicate device," which itself serves as the de facto acceptance standard in this 510(k) submission.
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. The document states "The PBN guidewires were subjected to tensile strength, torqueability, tip flexibility, and coating adherence/integrity tests" and "The following attributes of the PBN guidewire were examined," but no number of samples or units tested is provided.
- Data Provenance: Not specified, but generally, such testing for a 510(k) submission would be conducted by the manufacturer (MDTECH Medical Device Technologies, Inc.) or a third-party lab on behalf of the manufacturer, and would be prospective testing of their devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not applicable as this submission relates to a medical device's physical and functional properties, not an AI or diagnostic imaging device requiring expert interpretation for ground truth. The "ground truth" here is the physical measurement and comparison to a predicate device.
4. Adjudication method for the test set
- Not applicable. This submission focuses on engineering and performance testing against a predicate device, not on expert consensus or adjudication of diagnostic findings.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This is a submission for a physical medical device (guidewire), not an AI algorithm or diagnostic tool that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, this is not applicable. This device is a guidewire, a physical medical instrument, not a software algorithm.
7. The type of ground truth used
- The "ground truth" for this device's evaluation is the performance and attributes of the identified predicate device (Microvenia Corporation Guidewires, K991898). The PBN Guidewires were determined to be substantially equivalent if their functional and safety characteristics, as well as specified attributes, were "comparable" to the predicate.
8. The sample size for the training set
- Not applicable. This document describes the evaluation of a physical medical device (guidewire), not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. As above, no training set was used.
§ 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.