(79 days)
The Feel-tech disposable sterile insulin syringes are intended for injection of U100 insulin only.
The Feel-ject insulin syringe consists of a calibrated hollow barrel which can contain the medication and the distal end of barrel is fixed with needle. The needle cannot be exchanged after assembling because needle is fixed in the barrel nozzle lumen. The plunger and gasket are the same shape as the conventional insulin syringes. The needle cap cover is intended to provide physical protection to the needle tube. The cap is color coded orange, same as equivalent insulin syringes. The syringes are available in 0.5 ml/cc and 1 ml/cc sizes. They are supplied with a sterile fluid path, (EO), non-toxic, and non pyrogenic, for single use only, disposable. The devices operate on the principles of common piston syringes.
The provided text describes a 510(k) premarket notification for the Feel-ject Insulin Syringe. This type of regulatory submission establishes substantial equivalence to a predicate device, rather than focusing on novel device performance metrics or studies in the way an AI/ML medical device might. Therefore, many of the requested categories are not directly applicable or reported in this document.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (Target/Threshold) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Suitable for patient contact | Bench tests demonstrated "as safe, as effective" |
| Mechanical Testing | Functionally equivalent to predicate | Bench tests demonstrated "performs in a substantially equivalent manner" |
| Sterility | Sterile, non-pyrogenic | "Sterility testing including EO residues" demonstrated "as safe, as effective" |
| EO Residues | Acceptable levels | "Sterility testing including EO residues" demonstrated "as safe, as effective" |
| Non-toxic | Non-toxic | "non-toxic" (stated in description) |
| Non-pyrogenic | Non-pyrogenic | "non pyrogenic" (stated in description) |
Missing Information: Specific quantitative acceptance criteria (e.g., specific thresholds for biocompatibility tests, deflection limits for mechanical tests, sterility assurance levels) are not provided in this summary. The assessment is qualitative, relying on "as safe, as effective, and performs in a substantially equivalent manner" to the predicate device.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The text mentions "Bench tests were performed" but does not detail the sample sizes for these tests or the data provenance. These are physical product tests, not analyses of data sets in the context of AI/ML.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable/provided. For a physical medical device like an insulin syringe, "ground truth" is typically established through adherence to pre-defined engineering and quality standards, not expert labels on a dataset. The document refers to "bench tests" to demonstrate equivalence to a predicate device.
4. Adjudication Method for the Test Set
This information is not applicable/provided. Adjudication methods (like 2+1, 3+1) are typically used for establishing ground truth in AI/ML performance studies where expert consensus is needed. For bench testing of a physical device, the results are typically objectively measured against predefined specifications.
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
This information is not applicable. An insulin syringe is a physical device, not an AI/ML algorithm that assists human readers. Therefore, an MRMC study related to AI assistance is not relevant to this product.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This is a physical, non-AI medical device. There is no algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established by conformance to established engineering standards, biocompatibility requirements, and sterility standards, demonstrating equivalence to a legally marketed predicate device (UltiCare™ Disposable Syringes and Needles K062702). This is verified through objective "bench tests" rather than expert consensus on medical images or pathology.
8. The Sample Size for the Training Set
This information is not applicable/provided. This device does not involve a "training set" in the context of AI/ML.
9. How the Ground Truth for the Training Set was Established
This information is not applicable/provided. As above, there is no "training set" for this physical device.
In summary, the provided document for the Feel-ject Insulin Syringe is a 510(k) summary focused on demonstrating substantial equivalence to a predicate device through bench testing of physical characteristics and compliance with manufacturing standards, rather than the type of performance study for an AI/ML medical device many of the questions are geared towards.
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).