(283 days)
Becton Dickinson insulin syringes are intended for subcutaneous injection of U-100 insulins
The subject BD Insulin Syringes are a plastic syringe designed for subcutaneous injection of a desired dose of U 100 insulin. The BD Insulin Syringe consists of a graduated barrel, plunger rod and needle/hub assembly. The BD Insulin Syringes are sterile, single use, and non-pyrogenic. These devices operate on the principles of a piston syringe. The BD Insulin Syringe with 6mm length cannula have a sub-brand name of BD Veo™ Insulin Syringe.
This document describes the premarket notification (510(k)) for the BD Insulin Syringe (K190054). The information provided focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study proving a device meets specific acceptance criteria in the context of diagnostic performance or clinical outcomes.
However, based on the non-clinical testing section, we can infer the acceptance criteria for various performance aspects and that the device met these criteria through testing.
Here's an interpretation of the requested information, focusing on the available details from the document:
1. A table of acceptance criteria and the reported device performance
Since this is a 510(k) submission for an insulin syringe, the "acceptance criteria" discussed are largely related to functional performance and biocompatibility, as defined by international standards. The document states that the "Results of testing demonstrated the BD Insulin Syringes met requirements for its intended use" for all listed tests. Specific numerical acceptance criteria are not provided in this summary, but rather the standards against which compliance was demonstrated.
| Acceptance Criteria (Standards Met) | Reported Device Performance |
|---|---|
| ISO 8537:2016 Sterile single-use syringes, with or without needle, for insulin (for functional performance tests) | Met all requirements for intended use |
| ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices (for functional performance tests) | Met all requirements for intended use |
| ISO 10993:2019 Biological evaluation of medical devices (for biocompatibility tests) | Met all requirements as safe and effective |
| ASTM F2148: 2013 Standard Practice for Evaluation of Delayed Contact Hypersensitivity Using the Murine Local Lymph Node Assay (LLNA) | Met all requirements for intended use |
| ISO 11137-1:2006/Amd 2013(E) Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices | Met all requirements for intended use |
| ISO 11137-2:2013(E) Sterilization of health care products -Radiation - Part 2: Establishing the sterilization dose | Met all requirements for intended use |
| ISO 11137-3: 2017(E) Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control | Met all requirements for intended use |
| ISO 11737-1:2018(E) Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products | Met all requirements for intended use |
Specific functional performance tests mentioned under ISO 8537 and ISO 9626 (for which the device met requirements):
- Air Leakage
- Cannula Pull Force
- Hub Pull Force
- Liquid Leakage
- Needle Break-Off Force
- Penetration Force
- Scale Print Permanency
- Shield Pull Force
- Syringe Filling Force
- Syringe Injection Force (Force to Expel Water)
- Volumetric Accuracy
- Dead Space
- Corrosion Resistance
Specific biocompatibility tests mentioned under ISO 10993 (for which the device met requirements):
- Cytotoxicity
- Sensitization (GP Max)
- Sensitization, Intracutaneous Reactivity
- Irritation
- Acute Systemic Toxicity
- Material Mediated Pyrogenicity
- Subacute/Subchronic Toxicity
- Hemocompatibility
- Genotoxicity (Bacterial and Mammalian)
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 exact sample sizes used for each non-clinical performance and biocompatibility test. It mentions that "required testing was conducted to validate the cumulative modifications." The data provenance (e.g., country of origin) is not detailed, but it would typically be internal testing conducted by Becton Dickinson. These are prospective tests conducted on manufactured devices.
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 is not applicable to this type of device submission. The "ground truth" for a medical syringe is its physical and chemical properties and functional performance, which are evaluated against international standards by laboratory testing, not by expert consensus on clinical images or diagnoses.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a clinical study involving human readers or interpretation. The performance is objectively measured against established criteria in laboratory settings.
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
Not applicable. This is not an AI/imaging device or a diagnostic device, and no MRMC study was performed or required.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this device, the "ground truth" is defined by the technical specifications and performance requirements outlined in the referenced international standards (e.g., ISO 8537, ISO 9626, ISO 10993). Compliance with these standards, as measured by objective laboratory tests, serves as the basis for demonstrating safety and effectiveness.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI or machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
§ 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).