(21 days)
The Quick-serter infusion set insertion system (Quickserter), model 395, is indicated for use as an aid for insertion of the Maersk Medical A/S Contour infusion sets.
The MiniMed Quick-serter is a manually operated, spring-loaded infusion set insertion device. It is similar in features and intended use to the MiniMed Sof-serter infusion set insertion system. The device has been designed for use exclusively with the Maersk Medical A/S Contour infusion sets. The device is contraindicated for use with other infusion sets.
The provided document is a 510(k) premarket notification for a medical device called the MiniMed® Quick-serter™ infusion set insertion system. This document is a regulatory submission to the FDA, primarily focused on demonstrating substantial equivalence to a predicate device. It does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically found in clinical or performance evaluation reports.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts and their qualifications for ground truth establishment.
- Adjudication method for the test set.
- MRMC comparative effectiveness study results.
- Standalone performance analysis.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This document focuses on:
- Device Description: A manually operated, spring-loaded infusion set insertion device.
- Intended Use: To help make insertion of Maersk Medical A/S Contour infusion sets simpler, with minimal discomfort, and to improve consistency.
- Predicate Device: MiniMed® Sof-serter™ infusion set insertion system.
- Technological Comparison: Both are spring-driven; differences are limited to compatibility with specific infusion sets and do not affect safety or effectiveness.
- Regulatory Outcome: FDA found the device substantially equivalent to a legally marketed predicate device.
In summary, the provided text describes a regulatory submission for premarket clearance and does not include the detailed performance study information you've requested. Such information would typically be found in dedicated performance studies, clinical trial reports, or validation summaries, which are not part of this 510(k) summary.
§ 880.6920 Syringe needle introducer.
(a)
Identification. A syringe needle introducer is a device that uses a spring-loaded mechanism to drive a hypodermic needle into a patient to a predetermined depth below the skin surface.(b)
Classification. Class II (performance standards).