(90 days)
The Ulti Guard Home Insulin Syringe Dispenser and Sharps Container by Ulti Med Inc. is intended to be used to transport, store and dispense insulin syringes in the home. After use the syringes are to be deposited into the container for safe storage and eventual disposal according to local regulations.
The Ulti Guard Home syringe contains 100 UltiCare insulin syringes. Syringes can be selectively removed as needed, and used syringes conveniently deposited back into the top of the container for safe storage. Ulti Guard syringes and container are single use only.
The provided 510(k) summary for the UltiGuard Home Insulin Syringe Dispenser and Sharps Container describes a device designed for the safe dispensing, storage, and disposal of insulin syringes in the home.
Here's an analysis of the acceptance criteria and the study as described in the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Impact Resistance | Acceptable performance (to ensure integrity during use/disposal) | Tested with acceptable results |
| Puncture Resistance | Acceptable performance (to prevent sharps from protruding) | Tested with acceptable results |
| Leak Resistance | Acceptable performance (to contain any residual fluid) | Tested with acceptable results |
| Sharps Access | Acceptable (presumably to safely allow depositing sharps, but prevent accidental access) | Tested with acceptable results |
| Stability | Acceptable (to remain upright and secure during use) | Tested with acceptable results |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for each test (Impact Resistance, Puncture Resistance, etc.). It only mentions that the device "has been tested."
The data provenance is not specified. It is presumed to be from Ulti Med Inc.'s internal testing labs, but the country of origin is not mentioned, nor is it explicitly stated whether the tests were retrospective or prospective, though performance testing for a 510(k) is typically prospective.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable to the type of device and study being described. For a physical medical device like a sharps container, "ground truth" is established by performance against pre-defined engineering and safety standards, not by expert interpretation of data.
4. Adjudication Method for the Test Set
This is not applicable. Adjudication methods like "2+1" or "3+1" are used in studies involving expert review of medical images or other clinical data where there might be inter-reader variability. For physical device performance testing, the results are typically objectively measured against established criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (e.g., AI in radiology) where human readers interpret medical cases. The UltiGuard is a physical sharps container and dispenser, not a diagnostic device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
No, a standalone study was not done. This concept applies to AI algorithms. The UltiGuard is a physical device, and its performance is assessed directly, not through an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is based on objective engineering and safety standards related to the physical properties of a sharps container. These standards dictate how a container must perform under specific conditions (e.g., what force it must withstand without puncturing, how much liquid it can contain without leaking). The document states that the device was tested for "Impact Resistance, Puncture Resistance, Leak Resistance Sharps Access and Stability," implying that these tests were conducted against established regulatory or industry benchmarks for such devices.
8. The Sample Size for the Training Set
This is not applicable. The UltiGuard is a physical medical device, not an AI model or algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
This is not applicable, as there is no training set for this type of device.
§ 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).