(28 days)
The Vascular Solutions Sclero-Kit is indicated for delivery of sclerosing agents. Sclerosing agents may be used for treatment of small uncomplicated varieosities of the lower extremities that show simple dilation with competent valves.
Each kit is provided sterile and contains disposable 10ml syringe, 3ml syringe with needle, butterfly needle with attached extension tubing and syringe connector.
The provided text describes a 510(k) submission for the Vascular Solutions Sclero-Kit, an injection kit for delivering sclerosing agents.
Based on the information provided, here's a breakdown of the requested details:
Acceptance Criteria and Device Performance
There are no formal acceptance criteria defined in terms of specific performance metrics (e.g., accuracy, sensitivity, specificity, or error rates) for this device in the provided document. This is typical for Class I or II devices undergoing a 510(k) pathway, especially when substantial equivalence to predicate devices is established without new clinical claims.
Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Explicitly Stated) | Reported Device Performance |
|---|---|
| Functional Suitability for Intended Use | Non-clinical testing (design verification and biocompatibility assessments) confirmed "the suitability of the Sclero-Kit for its intended use." |
| Substantial Equivalence to Predicate Devices | The Sclero-Kit is "substantially equivalent to the predicate needle and syringe devices." The kit components are equivalent to these predicate devices. |
| Performance as Intended | "The testing performed confirms that the Sclero-Kit will perform as intended." |
Study Information
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: No clinical test set was used. The submission explicitly states: "No clinical evaluations of this product have been conducted."
- Data Provenance: Not applicable, as no clinical testing was performed.
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, as no clinical test set was used.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable, as no clinical test set was used.
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 MRMC study was performed. The device is an injection kit, not an AI-assisted diagnostic or treatment device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a medical kit, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the non-clinical testing, the "ground truth" was likely established through engineering specifications, material standards, and established biocompatibility testing protocols for medical devices. The "suitability for intended use" and "performance as intended" were verified against these engineering and manufacturing standards.
8. The sample size for the training set
- Not applicable, as no algorithm or AI component is involved.
9. How the ground truth for the training set was established
- Not applicable, as no algorithm or AI component is involved.
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).