(164 days)
The KAVS Catheter is intended to temporarily inhibit blood flow in isolated sections of peripheral veins in order to inject physician prescribed medications.
The KAVS catheter is an intravascular catheter that is introduced into the patient's vein for short-term therapeutic use. The catheter has a balloon at the distal end, that when expanded, will temporarily block the blood flow in that segment of the vein. This allows the physician to inject medication through the central lumen of the catheter for patient treatment. Once the treatment is complete the physician can then remove the medication, prior to removing the catheter.
The KAVS catheter is a double-lumen catheter made of radio-opaque polyurethane, which is equipped with a latex balloon at the distal end. At the proximal end of the coaxial catheter there is a double attachment, consisting of a Luer-lock adapter for access to the main catheter lumen, for injection of prescribed medication, and a laterally mounted Luer-lock adapter with a stopcock for filling the balloon. The rounded catheter tip is closed, underneath the balloon there are three openings, which serve as outlet openings for the main catheter lumen.
The provided document is a 510(k) premarket notification for a medical device called the KAVS Catheter. It focuses on establishing substantial equivalence to predicate devices rather than presenting a study demonstrating its performance against specific acceptance criteria in the manner typically seen for new diagnostic or AI-driven devices.
Therefore, many of the requested categories for acceptance criteria and study details are not applicable or cannot be extracted directly from this document. This submission is for a catheter, a physical device, not a diagnostic algorithm or a device requiring extensive clinical performance studies in the same way an AI system would.
Here's a breakdown based on the information available in the document, and what is not applicable:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in terms of measurable performance metrics (e.g., sensitivity, specificity, accuracy). The acceptance criteria for this type of device focus on equivalence to predicate devices in terms of safety, effectiveness, and performance.
- Reported Device Performance: Not detailed in terms of quantitative clinical outcomes. The performance is described functionally (temporarily blocks blood flow, allows medication injection, prevents wash away).
| Acceptance Criteria (Implied from 510(k) process) | Reported Device Performance (from submission) |
|---|---|
| Substantially equivalent to predicate devices | Yes, claimed to be substantially equivalent in design and function. |
| Safe | Claimed as safe as predicate devices. |
| Effective | Claimed as effective as predicate devices. |
| Performs as well as or better than predicate device | Claimed to perform as well as or better than predicate devices, specifically "prevents the prescribed medication from being washed away by normal blood flow. This results in a controlled contact time of the medication with the venous wall for an improved therapeutic use." |
| Intended Use as specified | Catheter temporarily inhibits blood flow in isolated sections of peripheral veins to inject physician prescribed medications. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. This document does not describe a clinical study with a "test set" in the context of an AI or diagnostic device. The submission relies on demonstrating substantial equivalence to existing devices through design comparison, material characteristics, and intended use.
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)
- Not applicable. No such "ground truth" establishment for a test set is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No adjudication method for a test set is described.
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
- Not applicable. This is not an AI-assisted device, nor does the submission describe an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. The "ground truth" in this context is the established safety and effectiveness of the predicate devices based on their prior regulatory clearance and market experience. The KAVS Catheter aims to match this established profile.
8. The sample size for the training set
- Not applicable. This document describes a physical medical device, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
- Not applicable. As above, no training set is relevant to this submission.
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).