(11 days)
The UltiGuard Home Insulin Pen Needle Dispenser and Sharps Container by Ulti Med Inc. is intended to be used to transport, store and dispense insulin pen needles in the home. After use the used pen needle can be placed back into the container for safe storage and eventual disposal according to local regulations.
The UltiGuard Home Insulin Pen Needle Dispenser and Sharps Container contains 100 insulin pen needles. Pen needles can be removed from the dispenser as needed, and used pen needles can be removed and deposited back into the top of the container for safe storage. When all 100 pen needles have been used and discarded into the container, the container is disposed according to local regulations. The disposable pen needles and UltiGuard container are intended for single use only.
The UltiGuard™ Home Insulin Pen Needle Dispenser and Sharps Container is a Class II medical device (product code MMK) intended for home use to transport, store, and dispense insulin pen needles, and to safely store used pen needles for eventual disposal. The device's acceptance criteria and the study proving it meets these criteria are outlined below:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standards Met) | Reported Device Performance |
|---|---|
| BS 7320 (1990): Specifications for Sharps Containers | The device meets this standard. |
| ASTM F2132 (2001): Puncture Resistance of Materials Used in Containers for Discarded Medical Needles | The device meets this standard. |
| Substantial Equivalence to Predicate Device (K021983) | Substantially equivalent in intended use, function, and basic composition. |
2. Sample Size and Data Provenance
The provided 510(k) summary does not specify a sample size for any test set nor does it provide details on data provenance (e.g., country of origin or whether data was retrospective or prospective). The evaluation is based on compliance with established standards and comparison to a predicate device.
3. Number and Qualifications of Experts for Ground Truth
The summary does not mention the use of experts to establish ground truth for a test set. The assessment is based on compliance with engineering standards and substantial equivalence, not clinical performance requiring expert interpretation.
4. Adjudication Method
No adjudication method is mentioned as there was no test set requiring expert review.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was conducted or mentioned in the provided text. The device is a physical container and dispenser, not an AI or imaging diagnostic tool that would typically involve a multi-reader multi-case study.
6. Standalone Performance Study
A standalone performance evaluation was done in the sense that the device was tested against specific engineering standards (BS 7320 and ASTM F2132). The conclusion of the submission relies on the device's ability to meet these published standards, demonstrating its physical and material performance characteristics relevant to its function as a sharps container and dispenser.
7. Type of Ground Truth Used
The "ground truth" for this device's acceptance is based on compliance with recognized engineering standards (BS 7320 and ASTM F2132) and detailed descriptive data demonstrating its technical characteristics and intended use are substantially equivalent to a legally marketed predicate device. This is a non-clinical assessment.
8. Sample Size for Training Set
The concept of a "training set" is not applicable here as the device is a physical product and not an AI or machine learning algorithm.
9. How Ground Truth for Training Set Was Established
Similarly, the establishment of ground truth for a training set is not applicable given the nature of the device and the substantial equivalence pathway used for its clearance.
§ 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).