(133 days)
GuideLiner catheters are intended to be used in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, and to facilitate placement and exchange of guidewires and other interventional devices.
The GuideLiner V2 is a single-lumen catheter offered in four sizes (5.5F, 6F, 7F, and 8F) and is compatible with 6F, 7F, and 8F guide catheters. GuideLiner V2 has a working length of 150 cm and may be placed over either an exchange length or 180 cm guidewire. The larger sizes of GuideLiner catheters are intended to be used within the proximal portions of the coronary vasculature to provide support and/or facilitate use of multiple interventional devices. The distal portion of the device is a 25 cm, single-lumen catheter constructed with a PTFE liner, stainless steel coil, various durometers of Pebax (polyether block amide) resin, and a silicone wipe on the outside diameter of the lumen. The catheter lumen is reflowed to the distal end of a stainless steel push wire. A Pebax paddle-style hub is over molded onto the proximal end of the push wire. GuideLiner V2 catheters have two radiopaque platinum-iridium marker bands – one located 2 mm from the distal tip and one located 1 cm distal from the proximal shaft lumen opening. The devices have two non-radiopaque positioning marks located at 95cm (single mark) and 105cm (double mark) from the distal tip, respectively.
The provided text describes a 510(k) summary for the GuideLiner® V2 catheter. This type of submission focuses on demonstrating substantial equivalence to a predicate device through engineering and performance testing, rather than clinical efficacy studies. Therefore, many of the requested elements for evaluating AI/algorithm performance (e.g., sample size for test set, expert qualifications, MRMC study, training set details) are not applicable to this submission.
Here's an analysis based on the information provided, highlighting the acceptance criteria and the studies conducted:
Acceptance Criteria and Study that Proves the Device Meets the Acceptance Criteria:
The GuideLiner® V2 catheter received 510(k) clearance based on demonstrating substantial equivalence to its predicate device, the GuideLiner catheter (K091750). The studies conducted for this submission are primarily non-clinical, focusing on engineering verification and biocompatibility.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly list quantitative acceptance criteria in a tabled format for each test. Instead, it states that "Results of the verification testing and biomaterial assessments met the specified acceptance criteria and did not raise new safety or performance questions." This implies that the device performance for each test met pre-defined internal specifications for safety and functionality, generally aligned with the predicate device's performance characteristics or industry standards for similar devices.
| Acceptance Criteria Category | Specific Tests Conducted | Reported Device Performance |
|---|---|---|
| Functional / Performance | Simulated anatomy/concomitant device use | Met specified acceptance criteria |
| Kink resistance | Met specified acceptance criteria | |
| Tensile | Met specified acceptance criteria | |
| Torque | Met specified acceptance criteria | |
| Dimensional verifications | Met specified acceptance criteria | |
| Visual inspections | Met specified acceptance criteria | |
| Biocompatibility | Cytotoxicity | Met specified acceptance criteria |
| Sensitization | Met specified acceptance criteria | |
| Irritation/intracutaneous reactivity | Met specified acceptance criteria | |
| Acute systemic toxicity | Met specified acceptance criteria | |
| Material-mediated pyrogens | Met specified acceptance criteria | |
| Hemocompatibility (Hemolysis, Coagulation, Prothrombin time, Hematological parameters, Complement activation, Thrombogenicity) | Met specified acceptance criteria |
2. Sample size used for the test set and the data provenance
Not Applicable (N/A) / Not Provided. This type of information (sample size of a test set, data provenance for clinical/image data) is typical for AI/algorithmic device submissions involving real-world data and clinical performance metrics. For this catheter, the "test set" refers to the physical units of the device subjected to various engineering and biocompatibility tests. The document does not specify the number of units tested for each criterion, nor is "data provenance" a relevant concept in the same way as for clinical data. The tests were likely performed in a laboratory setting by the manufacturer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
N/A / Not Provided. This information is relevant for AI/algorithm performance studies where expert consensus or review establishes the "ground truth" for diagnostic or predictive tasks. For a medical device like a catheter, "ground truth" relates to physical specifications and performance under defined conditions, which are typically assessed through engineering measurements and established lab protocols, not expert clinical interpretation of test results in the same way.
4. Adjudication method for the test set
N/A / Not Provided. Adjudication methods (e.g., 2+1, 3+1) are used to resolve discrepancies in expert interpretation when establishing ground truth for clinical cases in AI/algorithm performance studies. Since expert clinical review of a "test set" for ground truth is not applicable here, neither is an adjudication method. Device performance is determined by objective measurements against predefined engineering specifications.
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. This is a non-AI medical device; therefore, an MRMC comparative effectiveness study involving human readers and AI assistance was not conducted and is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This device does not incorporate an algorithm; therefore, a standalone algorithm performance study was not conducted.
7. The type of ground truth used
The "ground truth" for this device's performance is established by engineering specifications, regulatory standards, and established laboratory testing protocols. For example, tensile strength would have a numerical "ground truth" value that the device must meet, determined by industry standards for such materials and intended use. Biocompatibility tests have "ground truth" endpoints (e.g., cell viability, lack of systemic toxicity) defined by ISO standards and regulatory guidelines.
8. The sample size for the training set
N/A / Not Provided. This device does not use machine learning, so there is no concept of a "training set." The design and manufacturing process are informed by established engineering principles and prior device experience (including the predicate device), not through training on a dataset in the AI sense.
9. How the ground truth for the training set was established
N/A / Not Provided. As there is no training set for an AI/ML algorithm, this question is not applicable.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).