(145 days)
The BD 1mL Luer-Lok™ Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection.
The BD 1mL Luer-Lok™ Hypodermic Syringe with BD Hypodermic Needle or BD Eclipse™ Hypodermic Needle is intended for use by health care professionals for general purpose injection and aspiration of fluid from vials, ampoules and parts of the body below the surface of the skin.
The BD Eclipse™ Hypodermic Needle contains a mechanism that covers the needlepoint after use. In the activated position the needle cover guards against accidental needle sticks during normal handling and disposal of the used needle/syringe combination.
The BD 1mL Luer-Lok™ Insulin Syringe is intended for subcutaneous injection of U-100 insulin.
The BD 1mL Luer-Lok™ Hypodermic Syringe and BD 1mL Luer-Lok™ Insulin Syringe are three-piece sterile, single use, hypodermic syringes with male 6% (Luer) conical lock fittings, which are connectable to a compatible female 6% (Luer) connector. The syringe assemblies for both products are identical and consist of a lubricated styrene acrylic copolymer barrel with a graduated scale, a lubricated synthetic rubber stopper and a polypropylene plunger rod. The plunger rod is pulled back to aspirate fluids or depressed to inject or expel fluids. The barrel scale of the BD 1mL Luer-Lok™ Hypodermic Syringe incorporates a scale graduated in units of milliliters, while the barrel scale of the BD 1mL Luer-Lok™ Insulin Syringe incorporates a scale graduated in units of insulin.
The BD 1mL Luer-Lok™ Hypodermic Syringe is provided sterile by an irradiation sterilization method in a syringe only configuration or with a BD Hypodermic Needle or BD Eclipse™ Hypodermic Needle.
The BD 1mL Luer-Lok™ Insulin Syringe is provided sterile by an irradiation sterilization method in a syringe only configuration.
The modified BD 1mL Luer-Lok™ Hypodermic Syringe, BD 1mL Luer-Lok™ Hypodermic Syringe with BD Hypodermic Needle or BD Eclipse™ Hypodermic Needle and BD 1mL Luer-Lok™ Insulin Syringe include a change in the barrel resin material from a polycarbonate resin to a styrene acrylic copolymer resin. The syringe performance characteristics are equivalent to the predicate device.
The document describes a 510(k) premarket notification for Becton, Dickinson and Company for various 1mL Luer-Lok™ syringes. The submission claims substantial equivalence to predicate devices based on non-clinical testing.
Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Functional Testing | ||
| Break Out Force | Equivalent to predicate | Equivalent to predicate |
| Sustaining Force | Equivalent to predicate | Equivalent to predicate |
| Dimensional Stability of Barrel | Equivalent to predicate | Equivalent to predicate |
| ID (inner diameter) | Equivalent to predicate | Equivalent to predicate |
| Strip/resistance to overriding | Equivalent to predicate | Equivalent to predicate |
| Unscrewing torque | Equivalent to predicate | Equivalent to predicate |
| Barrel Scale Permanency | Equivalent to predicate | Equivalent to predicate |
| Sticktion | Equivalent to predicate | Equivalent to predicate |
| Biocompatibility Testing | ||
| Cytotoxicity | No specific criteria listed, implied "Pass" or "Non-cytotoxic" by nature of biocompatibility testing. | (Implied: Pass, as no issues reported) |
| Hemolysis | Per ISO 10993-4, Non-hemolytic | Non-hemolytic (Implied: Pass) |
| Acute Systemic Toxicity | Per ISO 10993-11, Non-toxic | Non-toxic (Implied: Pass) |
| Intracutaneous Reactivity | Per ISO 10993-10, Non-Irritant | Non-Irritant (Implied: Pass) |
| Sensitization | Per ISO 10993-10, Non-Sensitizer | Non-Sensitizer (Implied: Pass) |
| Material-Mediated Pyrogenicity | Per ISO 10993-11 and USP 151, Non-Pyrogenic | Non-Pyrogenic (Implied: Pass) |
| LAL Endotoxin | Per USP and USP, Pass | Pass |
| Genotoxicity | Per ISO 10993-3, Non-mutagenic | Non-mutagenic (Implied: Pass) |
| Subacute/Subchronic toxicity | Per ISO 10993-11, Non-toxic | Non-toxic (Implied: Pass) |
| Chemical Extractable Analysis | Per ISO 10993-18, acceptable extractables/leachables profile | Acceptable extractables/leachables profile (Implied: Pass) |
| Insulin compatibility (BD 1mL Luer-Lok™ Insulin Syringe only) | Pass | Pass |
Study Proving Acceptance Criteria:
The study that proves the device meets the acceptance criteria is titled "Non-Clinical Testing" and "design verification testing." The document states that "the results of these tests demonstrate that the BD 1mL Luer-Lok™ Hypodermic Syringe, BD 1mL Luer-Lok™ Hypodermic Syringe with BD Hypodermic Needle or BD Eclipse™ Hypodermic Needle and BD 1mL Luer-Lok™ Insulin Syringe performed in an equivalent manner to the predicate devices."
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: The document does not specify the sample size used for any of the non-clinical or design verification tests.
- Data Provenance: The data provenance is implied to be from internal testing conducted by Becton, Dickinson and Company. The country of origin is not explicitly stated, but the company is based in Franklin Lakes, New Jersey, USA. The testing is retrospective in the sense that it evaluates the performance of a manufactured device against established criteria.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Number of Experts: This information is not provided in the document.
- Qualifications of Experts: This information is not provided in the document. For non-clinical testing of medical devices, "experts" typically refer to qualified laboratory personnel or engineers with expertise in the relevant testing methodologies and standards (e.g., ISO 10993 for biocompatibility).
4. Adjudication Method for the Test Set:
- The document does not describe any adjudication method. For non-clinical testing, adjudication (like 2+1 or 3+1 for clinical evaluations) is generally not applicable in the same way. The results are typically quantitative measurements or qualitative assessments against defined standards.
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:
- No MRMC comparative effectiveness study was done. This submission is for a medical device (syringes), not an AI-powered diagnostic or interpretive tool that would involve human "readers" or AI assistance. The document explicitly states: "Clinical testing was not required for this submission."
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No standalone algorithm performance study was done. This device is a physical medical instrument (syringe), not an algorithm or AI system.
7. The Type of Ground Truth Used:
- The "ground truth" for the non-clinical testing is implicitly based on established performance standards and predicate device performance. For functional tests like "Break Out Force" or "Sustaining Force," the ground truth is often a range of acceptable values or comparability to the predicate device's performance. For biocompatibility tests, the ground truth is defined by international standards (e.g., ISO 10993 series) which specify methodologies and acceptance criteria (e.g., "non-hemolytic," "non-toxic"). Similarly, for insulin compatibility, the ground truth is simply a "Pass" result against a defined test.
8. The Sample Size for the Training Set:
- This information is not applicable. Since this device is a physical product and not an AI/ML algorithm, there is no "training set" in the context of machine learning. The design and manufacturing process would involve engineering principles and material science, not data-driven model training.
9. How the Ground Truth for the Training Set Was Established:
- This information is not applicable as there is no training set for this type of medical device submission.
§ 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).