(141 days)
This device is intended for the subcutaneous injection of insulins.
This device is consisting of barrel, plunger, piston, cannula (which is tixed in the barrel nozzle lumen), top cap and cannula cap (orange color) with different gauges and cannula length.
The provided document describes the IMC Insulin Syringe, a Class II medical device, and its substantial equivalence to a predicate device (BD Insulin Syringe: K024112). The performance data section, which is crucial for understanding acceptance criteria and proof of device performance, focuses on two key characteristics: "Hub/needle bond strength" and "Graduation" (volume accuracy).
Here's an analysis of the provided information based on your requested points:
Acceptance Criteria and Device Performance for IMC Insulin Syringe
1. Table of acceptance criteria and the reported device performance
| Performance Characteristics | Test Method | Acceptance Criteria | Reported Device Performance (IMC Insulin Syringe) | Predicate Device Performance (BD Insulin Syringe K024112) |
|---|---|---|---|---|
| Hub/needle bond strength | ISO 7894: 1993 | 25G-30G: >22N | Meets Standard Criteria | Meets Standard Criteria |
| Graduation (Volume Accuracy) | ISO 8537:1991(E) | A- Volumes less than half the nominal capacity: +/-(1.5% of the nominal capacity + 2% of the expelled volume) | Meets Standard Criteria | Meets Standard Criteria |
| B - Volumes equal to or greater than half the nominal capacity: +/- (5% of the expelled volume) | Meets Standard Criteria | Meets Standard Criteria |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size used for the test set for either the hub/needle bond strength or graduation tests. It also does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable and not provided as the tests relate to physical performance characteristics of a device (bond strength, volume accuracy) rather than diagnostic interpretations or expert consensus on patient data.
4. Adjudication method for the test set
This information is not applicable and not provided due to the nature of the tests (engineering performance metrics). Adjudication methods are typically relevant for subjective assessments or when discrepancies arise in expert interpretations of data.
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
A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI or diagnostic imaging devices where human interpretation is involved. The IMC Insulin Syringe is a physical insulin delivery device, not a diagnostic or AI-powered system.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
A standalone performance evaluation (as defined for AI algorithms) was not applicable and not done. This device does not involve an algorithm. The reported performance data (hub/needle bond strength, graduation) are intrinsic physical properties of the syringe.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance criteria is based on established international standards (ISO 7894:1993 for hub/needle bond strength and ISO 8537:1991(E) for graduation). These standards define objective, measurable physical properties and their acceptable limits.
8. The sample size for the training set
This information is not applicable and not provided. The IMC Insulin Syringe is a physical device, not a machine learning model, so there is no concept of a "training set" in this context.
9. How the ground truth for the training set was established
This information is not applicable and not provided for the same reason as point 8.
Summary of Study Proof:
The proof that the IMC Insulin Syringe meets the acceptance criteria is stated as "Meets Standard Criteria" for both the Hub/needle bond strength and Graduation (volume accuracy) tests. These tests were conducted according to international standards ISO 7894:1993 and ISO 8537:1991(E), respectively. The document asserts that the IMC Insulin Syringe's performance is substantially equivalent to the predicate device (BD Insulin Syringe K024112) based on these performance characteristics, along with similarities in intended use, materials, and other features. The specific raw data or detailed test reports, including sample sizes and statistical analysis, are not included in this 510(k) summary but would have been part of the full submission to the FDA.
§ 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).