(30 days)
The Venture 038 catheter is indicated for directing, steering, controlling, and supporting a guidewire to access discrete regions of the peripheral vasculature. It may also be used for manual delivery of saline solution or diagnostic contrast agents.
The Venture 038 catheter is an over-the-wire single lumen catheter with a radiopaque deflectable distal tip. The deflectable distal tip is actuated by rotating a knob on the control handle of the proximal end of the catheter. The Venture 038 catheter has a working length of 120 cm or 70 cm and has a hydrophilic coating on the distal 45 cm of the catheter. The Venture 038 catheter provides support to 0.035" guidewires and is compatible with 6F introducer sheaths and 8F guide catheters.
The provided document is a 510(k) summary for the Venture 038 catheter, a medical device. It does not describe an AI/ML powered device or a study involving human readers or AI assistance. Therefore, many of the requested fields are not applicable.
1. Table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Simulated Use | Not specified (implied to meet functional requirements) | Passed |
| Kink Radius | Not specified (implied to meet functional requirements) | Passed |
| Visual Inspection | Not specified (implied to meet functional requirements) | Passed |
| Tip Deflection | Not specified (implied to meet functional requirements) | Passed |
| Tip Rotation | Not specified (implied to meet functional requirements) | Passed |
| Tensile Strength | Not specified (implied to meet functional requirements) | Passed |
| Liquid Leak | Not specified (implied to meet functional requirements) | Passed |
| Liquid Leak Under Pressure | Not specified (implied to meet functional requirements) | Passed |
| Injection Pressure | Not specified (implied to meet functional requirements) | Passed |
| Aspiration | Not specified (implied to meet functional requirements) | Passed |
| Corrosion | Not specified (implied to meet functional requirements) | Passed |
| Particulate Count | Not specified (implied to meet functional requirements) | Passed |
| Biocompatibility (Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Pyrogenicity, Hemolysis, Complement Activation, In Vitro Hemocompatibility, Coagulation, Thrombogenicity) | Per ISO 10993-1 | Passed |
Note: The document states "The results of the verification tests met the specified acceptance criteria," but it does not explicitly list the specific quantitative or qualitative acceptance criteria for each test. Instead, it generally indicates that the device passed these tests.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document describes bench tests and biocompatibility tests, not studies with test sets in the context of AI/ML or clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable as the document describes a physical medical device and its bench testing, not an AI/ML algorithm requiring expert ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the document does not describe a study involving adjudication of a test set by human experts.
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
This information is not applicable as the document describes a physical medical device and its bench testing, not an AI/ML powered device or a MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the document describes a physical medical device and its bench testing, not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable as the document describes a physical medical device and its bench testing, not an AI/ML algorithm requiring a ground truth in that context. The "ground truth" for the device's performance would be the physical properties and functional results observed during the bench tests, compared against design specifications and relevant standards.
8. The sample size for the training set
This information is not applicable as the document describes a physical medical device and its bench testing, not an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established
This information is not applicable as the document describes a physical medical device and its bench testing, not an AI/ML algorithm.
§ 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).