(89 days)
Transend EX Platinum Guidewire is intended for general intravascular use, including the neuro and peripheral vasculature. The wire can be torqued to facilitate the selective placement of diagnostic or therapeutic catheters. This device is not intended for use in coronary arteries. A torque device (pin vise) is included with the wire to facilitate directional manipulation of the guidewire. A guidewire introducer is included with each wire to facilitate the introduction of the guidewire into catheter hubs or hemostatic valves.
The BSC Transend EX Platinum Guidewire with hydrophilic coating and accessories are intended for general intravascular use including the peripheral and neurovasculature. The devices will be provided sterile, and are intended for one procedure use only. Testing and evaluation included tip tensile, tip flexibility, torque strength, torque response, coating adherance, coating extraction, lubricity testing, biocompatibility and in vivo testing.
The provided text describes the 510(k) Premarket Notification for the BSC Transend EX Platinum Guidewire. This document details the regulatory approval process for a medical device and typically does not include detailed clinical study reports with acceptance criteria, performance metrics, and information on training/test sets as would be found in a study for an AI/ML device.
However, based on the information provided, I can infer some aspects and highlight what is not present given the nature of a 1997 510(k) for a guidewire, which predates the common rigorous study designs for AI/ML devices.
Here's an analysis based on the provided text, structured according to your requested information, with explicit notes about what is absent:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Performance Metric | Reported Device Performance/Conclusion |
|---|---|---|
| Mechanical Properties | Tip Tensile Strength | Not explicitly quantified in this summary, but included in "Testing and evaluation" and considered safe and effective. |
| Tip Flexibility | Not explicitly quantified in this summary, but included in "Testing and evaluation" and considered safe and effective. | |
| Torque Strength | Not explicitly quantified in this summary, but included in "Testing and evaluation" and considered safe and effective. "The wire can be torqued to facilitate the selective placement of diagnostic or therapeutic catheters." | |
| Torque Response | Not explicitly quantified in this summary, but included in "Testing and evaluation" and considered safe and effective. | |
| Coating Properties | Coating Adherence | Not explicitly quantified in this summary, but included in "Testing and evaluation" and considered safe and effective. |
| Coating Extraction | Not explicitly quantified in this summary, but included in "Testing and evaluation" and considered safe and effective. | |
| Lubricity | Not explicitly quantified in this summary, but included in "Testing and evaluation" and considered safe and effective. | |
| Biocompatibility | Biocompatibility Testing | Not explicitly quantified, but included in "Testing and evaluation" and considered safe and effective, implying it met relevant standards. |
| In Vivo Performance | In Vivo Testing (for general intravascular use, peripheral/neurovasculature) | Not explicitly quantified, but included in "Testing and evaluation" and ultimately concluded as "safe and effective for its intended use" based on "technological characteristics and safety and performance testing." This implies acceptable performance in animal or limited human use, consistent with 510(k) requirements for similar devices. |
| Overall Conclusion | Safety and Effectiveness for intended use | "The Transend EX Platinum Guidewire has been shown to be safe and effective for its intended use." |
Missing Information: For a 1997 510(k) submission for a non-AI/ML device, the acceptance criteria are generally qualitative or involve meeting established mechanical and biological standards (e.g., ISO or ASTM for guidewires) rather than numerical performance metrics like sensitivity/specificity for an AI algorithm. The document states "Testing and evaluation included..." a list of tests, implying that the device met the acceptance criteria for each of these tests, which are typically defined by internal company standards or recognized consensus standards. Specific numerical targets for tensile strength, flexibility, etc., are not disclosed in this summary but would have been part of the full submission.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. For mechanical and biocompatibility testing of a guidewire, the "test set" would refer to the number of guidewire units subjected to each specific test (e.g., how many wires for tensile strength, how many samples for biocompatibility). This information is not in the provided summary.
- Data Provenance: Not applicable in the context of clinical data for an AI/ML device. For a physical device like a guidewire, testing is typically done in a laboratory setting (in vitro) and potentially animal studies (in vivo). The summary mentions "in vivo testing," but doesn't specify the exact nature (animal vs. human), location, or retrospective/prospective nature.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This concept is not applicable for the approval of this physical guidewire device. "Ground truth" established by experts is primarily relevant for diagnostic devices, especially those involving image interpretation where expert consensus is used to label data.
- For a guidewire, safety and effectiveness are established through engineering tests (mechanical, material science) and biological tests (biocompatibility, in-vivo performance) against pre-defined specifications and regulatory standards, not expert annotation of a test set.
4. Adjudication Method for the Test Set
- Not applicable. Adjudication methods (e.g., 2+1, 3+1) are used for resolving discrepancies in expert labeling of data, which is common in AI/ML performance studies for diagnostic tasks. This does not apply to the testing of a mechanical guidewire.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC study was not done. MRMC studies are used to assess the comparative performance of human readers, often with and without AI assistance, on diagnostic tasks involving case-based data. This guidewire is a therapeutic/interventional device, not a diagnostic one.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. There is no algorithm for this device. The "performance" being evaluated is the physical guidewire itself, not an AI algorithm.
7. The Type of Ground Truth Used
- The "ground truth" for this device's evaluation would be defined by engineering specifications, material science standards, and biocompatibility standards. For example, a guidewire's tensile strength would be measured against a pre-defined engineering specification. Biocompatibility would be assessed against ISO standards. In-vivo performance would likely be assessed against functional outcomes (e.g., successful navigation, lack of adverse events) in an animal model or limited human use. There is no concept of "expert consensus," "pathology," or "outcomes data" in the sense of labeling a dataset for an AI model.
8. The Sample Size for the Training Set
- Not applicable. This is not an AI/ML device, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable. There is no training set or associated ground truth for this device.
In summary, the provided document is a 510(k) summary for a medical device cleared in 1997. It describes a physical product (a guidewire) and its regulatory pathway. The concepts of "acceptance criteria" and "study" in this context refer to engineering, biocompatibility, and functional testing to demonstrate substantial equivalence to predicate devices, rather than the rigorous statistical and clinical study methodologies typically associated with modern AI/ML device performance evaluation against specific performance metrics on labeled datasets.
§ 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.