(32 days)
The Venture™ Wire Control Catheter is indicated for directing, steering, controlling, and supporting a guide wire to access discreet regions of the coronary and peripheral vasculature. It may also be used for manual delivery of saline solution or diagnostic contrast agents.
The Venture Wire Control Catheter is a single use, over-the-wire support catheter with a radiopaque deflectable tip. A rotating knob at the handle controls the tip deflection angle. The tip can be deflected continuously up to about 90° from the catheter axis. The device is compatible with all 0.014" guidewires. It is torqueable and can be use to instantaneously shape, and control the curvature of the guidewire while in use as well as provide support to the guidewire when needed. A luer attachment is also provided to allow for the manual injection of dye through the guidewire lumen of the catheter
The provided text describes a 510(k) premarket notification for a medical device, the Venture Wire Control Catheter. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical studies with specified acceptance criteria and detailed performance metrics as one might find for novel device applications.
Therefore, the requested information elements related to detailed acceptance criteria, specific performance metrics, and studies proving these criteria are largely not present in the provided document. The submission primarily relies on demonstrating that the new device has "the same indication for use, principles of operation, and technological characteristics" as a previously cleared predicate device (Venture Wire Control Catheter K040922) and that any differences "do not raise new questions of safety or efficacy."
However, I can extract the available information and indicate where details are missing.
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter / Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional Equivalence | "The Venture™ in this submission has the same indication for use, principles of operation, and technological characteristics as the previously cleared predicate devices." |
| "Differences between this device and its predicate devices do not raise new questions of safety or efficacy." | |
| Biocompatibility | Compliance with ISO 10993-1. |
| Sterilization | Compliance with ISO 11135: 1994(E) (Validation and routine control of ETO sterilization). |
| Packaging Integrity | Compliance with ASTM D-4169 (Packaging Integrity Testing). |
| Compliance with ISO 11607 (Packaging for terminally sterilized medical devices). | |
| Catheter Performance | Compliance with ISO 10555 (Part 1 and Part 4). |
| Overall Performance | "Test results demonstrate that the device meets or exceeds the requirements of these standards and performs substantially equivalent to the predicate devices." |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. The document mentions "performance test data" and "test results" but does not detail the number of units tested.
- Data Provenance: Not specified. The performance tests are likely laboratory bench tests and material tests conducted by the manufacturer (Velocimed Inc.) in Minneapolis, MN, where the company is located. There is no indication of clinical studies, human subject data, or country of origin for such data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable. The ground truth for the engineering and material tests would be established by the specifications of the referenced ISO and ASTM standards, not by clinical expert consensus.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set
- Adjudication Method: Not applicable. The "test set" here refers to engineering and material tests, which are objective and do not require expert adjudication for ground truth.
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
- MRMC Study: No. This is a medical catheter and not an AI-powered diagnostic device, so an MRMC study is not relevant or described.
- Effect Size of AI: Not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used
- Type of Ground Truth: The ground truth for the performance data mentioned (biocompatibility, sterilization, packaging, catheter performance) is based on international and national standards (ISO 10555, ISO 10993-1, ASTM D-4169, ISO 11607, ISO 11135). The "truth" is whether the device meets the objective requirements and specifications outlined in these standards.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This submission is for a physical medical device, not a machine learning model, so there is no concept of a "training set."
9. How the ground truth for the training set was established
- How Ground Truth for Training Set was Established: Not applicable, as there is no training set mentioned or implied.
§ 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).