(212 days)
BD Insulin Syringes are intended for subcutaneous injection of U-100 insulins.
The BD Insulin Syringe, 0.3mL size, is a plastic syringe designed for subcutaneous injection of a desired dose of U-100 insulins. The product is a single use, sterile, non-toxic, non-pyrogenic, disposable syringe that consists of a needle, barrel, cannula shield, stopper, plunger, and plunger cap. The needle is a single ended lubricated stainless-steel cannula, which is permanently attached to the barrel nozzle with an adhesive. The needle is covered by a polyethylene cannula shield which is placed on the barrel. The barrel is molded from polypropylene with the exterior permanently marked with the proper scale markings. The stopper is attached to the plunger and a polyethylene cap is placed over the plunger rod. All products are gamma sterilized. The BD Insulin Syringe, 0.3mL size, are packaged in polybags as self-contained syringes. The subject device operates on the principle of a piston syringe and has a shelf life of 5 years.
The provided text describes a 510(k) premarket notification for the BD Insulin Syringe (0.3mL). This document is primarily focused on demonstrating substantial equivalence to a predicate device, rather than presenting a study to prove a device meets specific clinical acceptance criteria. Therefore, many of the requested details about a clinical study, such as sample sizes for test and training sets, expert qualifications, and ground truth methodologies, are not applicable or provided.
However, the document does list conformity to recognized standards and performance testing for the device's physical and biological properties.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not provide a specific table of "acceptance criteria" against which "reported device performance" is explicitly measured in a comparative numerical way for clinical efficacy. Instead, it states that the device conforms to recognized standards and passed specific performance testing.
| Acceptance Criteria Category | Standard/Test | Reported Device Performance |
|---|---|---|
| Material/Design | ISO 9626 | Conforms |
| Syringe Performance | ISO 8537 | Conforms |
| Biocompatibility | ISO 10993-1 | Cytotoxicity: Passed |
| Sensitization: Passed | ||
| Irritation: Passed | ||
| Acute Systemic & Pyrogenicity: Passed | ||
| Subacute/Subchronic Toxicity: Passed | ||
| Genotoxicity: Passed | ||
| Particulate Matter | USP | Met USP acceptance criteria |
| USP | Met USP acceptance criteria | |
| Sterility | ISO 11137-2 | Complies |
| ANSI/AAMI/ISO TIR13004:2013/(R)2016 | Complies | |
| LAL assay | Met endotoxin limit (non-Pyrogenic) | |
| SAL | 10^-6 | |
| Sterile Barrier Integrity | Microbial Ingress (analytical test procedures) | Passed |
| Syringe Air Bubble Leak (analytical test procedures) | Passed | |
| Packaging Integrity | ASTM D4169-16 | All packaging deemed acceptable for protection of product and sterility maintenance |
| Shelf-life | Accelerated stability testing | Validated 5-year shelf-life |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document describes performance testing (material, sterility, biocompatibility, etc.) but does not detail the sample sizes for these tests, nor does it specify the provenance of the data in terms of country or whether it was retrospective/prospective. As this is not a clinical study, these details would not typically be present.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable as this submission is for a medical device (insulin syringe) and describes physical, chemical, and biological testing, not an algorithmic or diagnostic device requiring expert interpretation for ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as this submission is for a medical device (insulin syringe) and describes performance testing, not a study involving human interpretation or adjudication for a test set.
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-assisted diagnostic devices, which is not the subject of this 510(k) submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance study of an algorithm was not done. This type of study is relevant for AI algorithms, which is not the subject of this 510(k) submission.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The concept of "ground truth" (in the sense of expert consensus, pathology, or outcomes data) is not applicable to the performance testing described for this medical device. The "ground truth" for physical and biological tests are the established standards and test specifications (e.g., ISO 9626, ISO 8537, USP , ISO 10993-1, etc.) against which the device's measurable physical and chemical properties and biological reactions are evaluated.
8. The sample size for the training set
This information is not applicable as this submission describes a medical device (insulin syringe) and does not involve AI/machine learning requiring training data.
9. How the ground truth for the training set was established
This information is not applicable as this submission describes a medical device (insulin syringe) and does not involve AI/machine learning requiring a training set or its associated ground truth.
§ 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).