(27 days)
BD Insulin Syringes are intended for the subcutaneous injection of insulins
The BD Insulin Syringes - Ultra-Fine™ and Ultra-Fine™ II are designed for the subcutaneous injection of a desired dose of insulin. The syringe has a graduated barrel, a plunger rod and needle/hub assembly. The needle shield is colored orange. The Ultra-Fine™ Insulin Syringe has a 30g x 1/2" (12.7mm) needle and is available in 1cc (100 units), 1/2 cc (50 units), and 1/3 cc (30 units) sizes. The Ultra-Fine™ II 31g x 1/2" (8mm) needle and is available in 1cc (100 units), ½ cc (50 units), and 1/3 cc (30 units) sizes. These devices operate on the principles of a piston syringe. The syringe fluid path is sterile (gamma irradiation sterilization), non-toxic, non-pyrogenic and single use, disposable.
Here's an analysis of the provided information regarding the BD Insulin Syringe K024112, focusing on acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Measured Performance Aspect) | Reported Device Performance (as stated in the 510(k) summary) |
|---|---|
| Needle pull-out force | Demonstrated equivalence to predicate devices (K941657 and K955235) |
| Hub pull-off forces | Demonstrated equivalence to predicate devices (K941657 and K955235) |
| Needle angularity | Demonstrated equivalence to predicate devices (K941657 and K955235) |
| Needle break-off testing | Demonstrated equivalence to predicate devices (K941657 and K955235) |
| Dose accuracy | Demonstrated equivalence to predicate devices (K941657 and K955235) |
Note: The 510(k) summary does not specify quantitative acceptance limits (e.g., "pull-out force must be > 5 N"). Instead, the acceptance criteria are implicitly met by demonstrating "equivalence" to the predicate devices across these performance aspects.
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide details on the specific sample sizes used for each of the "bench tests" or the data provenance (e.g., country of origin, retrospective/prospective). It only states that "Bench tests relating to the performance of the needle length were conducted."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable to this type of device and study. The "ground truth" for the performance tests of an insulin syringe is based on objective physical measurements and engineering specifications, not expert consensus on interpretations like in medical imaging.
4. Adjudication Method for the Test Set
This is not applicable. As mentioned above, the performance tests involve objective physical measurements, not subjective interpretations requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not performed. This type of study is typically relevant for diagnostic devices where human readers interpret medical images or data, and the focus is on how an AI system can assist or replace human performance. The BD Insulin Syringe is a physical medical device, not a diagnostic AI tool.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
A standalone study was not performed. This concept applies to AI algorithms. The BD Insulin Syringe is a physical device, and its performance is evaluated through bench tests directly on the device itself.
7. Type of Ground Truth Used
The ground truth used for the performance tests was based on objective engineering and physical measurements demonstrating the functional characteristics of the syringe (e.g., force required for needle pull-out, accuracy of dose delivery). The standard for comparison (the "ground truth" for demonstrating acceptable performance) was the performance of the predicate devices (K941657 and K955235).
8. Sample Size for the Training Set
This information is not applicable as this is not an AI/machine learning device. The study involves bench testing of a physical product, not training of an algorithm.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as this is not an AI/machine learning device, and there is no "training set."
§ 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).