(49 days)
The ILT Support Catheter with or without the advancing mechanism is indicated to be used in conjunction with a steerable guidewire in order to access discreet regions of the vasculature. Once the region has been accessed, an exchange of one guidewire for another can occur. The ILT Support Catheter may also be used to provide a conduit for the delivery of saline solutions or diagnostic contrast agents.
The ILT Support Catheter is a single-lumen intravascular catheter intended for percutaneous use. It is designed to be used in conjunction with a 0.014" steerable guidewire to gain access to locations within the cardiovascular system that are remote from the site of insertion. Once accessed, guidewires may be exchanged within the catheter. The ILT Support Catheter may also be used for The ILT Support Catheter may also be used to provide a conduit for the delivery of saline solutions or diagnostic contrast agents. The effective length of the ILT Support Catheter is a nominal 135 cm. The nominal maximum outside diameter is 0.037". The distal region incorporates a radiopaque marker band to aid in visualization under fluoroscopy. The inside diameter of the ILT Support Catheter shaft will accommodate a commercially available 0.014" guidewire. The ILT-Support Catheter Advancing Mechanism is a handle with a connecting luer in the proximal region that is mated to the ILT Support Catheter. The handle includes and advancing mechanism that allows for incremental advancement of the guidewire. This advancing mechanism allows for free movements of the guidewire through the catheter shaft. The ILT Support Catheter and the ILT-Support-Catheter-Advancing-Mechanism are packaged in a Tyvek® covered tray and heat-sealed to form a sterile barrier. The packaged catheter is sterilized by ethylene oxide gas. The ILT Support Catheter is provided "STERILE" and "Non-pyrogenic", and is intended for single use only.
Here's an analysis of the provided text to extract information about the acceptance criteria and study proving device performance:
Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly list quantitative acceptance criteria in a table format with corresponding reported performance values. Instead, it describes general claims of performance based on testing.
| Acceptance Criteria Category | Specific Criteria (Inferred from text) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Device materials must be biocompatible. | "Biocompatibility test results indicate that the device materials are biocompatible." |
| Functional Performance | Device must satisfy functional performance requirements when used as indicated. | "Performance test results indicate that the device satisfies functional performance requirements when used as indicated." |
| Sterility | Device must be sterile and non-pyrogenic. | "The packaged catheter is sterilized by ethylene oxide gas. The ILT Support Catheter is provided "STERILE" and "Non-pyrogenic"." |
| Material/Design Equivalence | Modified device (without advancing mechanism) must be substantially equivalent to the predicate device. | "The results of testing demonstrate that the ILT Support Catheter with out the advancing mechanism is substantially equivalent to the predicate device..." |
| Intended Use Safety/Accuracy | Device must be capable of safely and accurately performing the stated intended use. | "...and is capable of safely and accurately performing the stated intended use." |
Study Information
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Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify a numerical sample size for the "test set" (i.e., the number of devices or components tested). It generally refers to "Biocompatibility testing and in vitro bench studies."
- Data Provenance: The studies were "in vitro bench studies" performed by IntraLuminal Therapeutics, Inc. The country of origin of the data is not specified beyond the company's location in Carlsbad, CA, USA. The studies appear to be prospective, as they were conducted to evaluate the device prior to clearance.
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Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- This information is not provided in the document. The studies described are primarily bench and biocompatibility tests, not clinical studies requiring expert ground truth for interpretation.
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Adjudication Method for the Test Set:
- This information is not applicable and not provided. The studies reported are not clinical trials requiring adjudication of results by multiple experts.
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If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC comparative effectiveness study was not done. The document describes bench and biocompatibility studies, not studies involving human readers or comparative effectiveness in a clinical setting.
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If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, a standalone (algorithm only) performance study was not done. This device is a physical medical catheter, not an AI/algorithm-based diagnostic or therapeutic tool.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the biocompatibility tests would be established by standardized toxicological assays and material science principles.
- For the in vitro bench studies, the "ground truth" would be the engineering specifications and functional parameters being evaluated (e.g., specific dimensions, material strength, flow rates).
- No expert consensus, pathology, or outcomes data is mentioned as ground truth for these studies.
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The sample size for the training set:
- This information is not applicable and not provided. This device is a physical medical catheter, not an AI/algorithm-based system that uses training sets.
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How the ground truth for the training set was established:
- This information is not applicable and not provided for the same reason as above.
§ 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).