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510(k) Data Aggregation
(63 days)
Becton Dickinson insulin syringes are intended for subcutaneous injection of U-100 insulin.
The subject BD Insulin Syringes (BD Ultra-Fine™ Insulin Syringe, BD Ultra-Fine™ II Insulin Syringe, BD Insulin Syringes with the BD Ultra-Fine™ needle and BD Insulin Syringes with Micro-Fine™ IV Needle) are a 1.0mL self-contained plastic syringe designed for subcutaneous injection of a desired dose of insulin. The BD Insulin Syringe consists of a graduated barrel, plunger rod and needle/hub assembly. It is available in various needle gauge sizes (27G, 28G, 29G, 30G and 31G) and various needle lengths (6mm, 8mm, 12.7mm and 16mm). The BD Insulin Syringes are sterile, single use, and non-toxic. The fluid path of the syringe is sterile and non-pyrogenic. These devices operate on the principles of a piston syringe.
The document describes the acceptance criteria and the study that proves the device meets those criteria for the BD Ultra-Fine™ Insulin Syringe and related insulin syringes.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with numerical targets. Instead, it describes general categories of testing and confirms that the results were "acceptable" and met "requirements for its intended use." Based on the provided text, the acceptance criteria are implicitly defined by compliance with ISO standards and the demonstrated equivalence to predicate devices.
| Acceptance Criteria Category | Reported Device Performance (as stated in the document) |
|---|---|
| Biocompatibility (per ISO 10993-1) | - Cytotoxicity: Acceptable - Hemolysis: Acceptable - Acute Systemic Toxicity: Acceptable - Intracutaneous Reactivity: Acceptable - Pyrogenicity: Acceptable - Sensitization: Acceptable - Comparative Extractables/Leachables: Acceptable - Primary Dermal Irritation: Acceptable |
| Device Functional Performance | - Cannula-Syringe Bond: Acceptable (met requirements) - Scale Mark Permanency: Acceptable (met requirements) - Scale Mark Legibility: Acceptable (met requirements) - Drug Compatibility/Stability: Acceptable (met requirements) |
| Sterility | Yes (Gamma Irradiation), SAL 10^-6 |
| Single Use Only | Yes |
| Non-pyrogenic | Yes |
| Substantial Equivalence to Predicate Devices | Demonstrated through analysis and testing of modifications. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes used for any of the described tests (biocompatibility or functional performance tests).
The data provenance is from non-clinical testing performed by Becton, Dickinson and Company. The document does not provide information regarding the country of origin of the data or whether it was retrospective or prospective, as these are non-clinical (laboratory) tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable as the study described is non-clinical performance and biocompatibility testing of medical devices, not a study involving human subjects or expert assessment of clinical data to establish ground truth. The "ground truth" here is determined by objective laboratory measurements against established standards (ISO 10993-1, ISO 8537) and internal company specifications.
4. Adjudication Method for the Test Set
This information is not applicable to non-clinical laboratory testing. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for independent review of patient cases.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study involves human readers interpreting cases, often with and without AI assistance, to measure diagnostic performance. The described study focuses on the physical and chemical properties and performance of an insulin syringe.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This concept is not applicable to this device. A standalone algorithm performance study relates to AI/machine learning algorithms. The device in question is a physical insulin syringe, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this non-clinical testing is established by:
- Compliance with International Standards: Specifically ISO 10993-1 (Biological evaluation of medical devices) and ISO 8537 (Sterile single-use syringes, with or without needle, for insulin).
- Established Test Methodologies: Standardized laboratory tests for properties like cytotoxicity, bond strength, scale readability, and material compatibility.
- Substantial Equivalence: Comparison against the performance characteristics of predicate devices already cleared by the FDA.
8. The Sample Size for the Training Set
This information is not applicable. There is no "training set" as this is not a machine learning or AI-based device. The testing focuses on manufacturing processes, materials, and mechanical/chemical performance.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as above.
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