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510(k) Data Aggregation
(26 days)
The BD Emerald™ Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose aspiration and injection of fluids.
The BD Emerald™ Single Use, Hypodermic Syringe is a three-piece sterile, single use, hypodermic syringe with a 6% Luer taper tip that is provided in the following syringe sizes: 2ml, 3ml, 3ml, and 10ml. All sizes will be available with either a Luer Slip or Luer Lock tip and may be packaged as a syringe only, or syringe and needle combination.
The syringe assembly consists of a lubricated polypropylene barrel with a graduated scale, a resin stopper, and a polypropylene plunger rod. The polypropylene syringe barrel incorporates a male 6% (Luer) connector, and is connectable to a compatible female 6% (Luer) connector. The needle assembly consists of a lubricated stainless steel needle attached to a polypropylene hub with epoxy.
Here's an analysis of the provided 510(k) summary, aiming to extract details relevant to acceptance criteria and the study proving device performance:
Device: BD Emerald™ Single Use Hypodermic Syringe
The provided document is a 510(k) summary for a BD Emerald™ Single Use Hypodermic Syringe. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed clinical study demonstrating new performance criteria for a novel device. Therefore, many of the typical elements of a study proving a device meets acceptance criteria (like sample size for test sets, ground truth establishment for AI/imaging devices, MRMC studies, standalone algorithm performance) are not applicable in this context.
The "acceptance criteria" here are primarily based on meeting established international standards for medical devices of this type and demonstrating equivalent performance to predicate devices through design verification testing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from ISO Standards / Predicate Equivalence) | Reported Device Performance (as stated in the 510(k) summary) |
|---|---|
| Intended Use Equivalence: Same intended use as predicate devices. | The BD Emerald™ Single Use Hypodermic Syringe has the same intended use (general purpose aspiration and injection of fluids by healthcare professionals) as the predicate devices. |
| Operating Principle Equivalence: Operates under the same operating principle as predicate devices. | The BD Emerald™ Single Use Hypodermic Syringe operates under the same operating principle as the predicate devices. |
| Manual Use Requirements (ISO 7886-1): Meets requirements for manual use. | The BD Emerald™ Single Use Hypodermic Syringe meets the requirements for manual use as defined by ISO 7886-1. Performance Testing specifically states the device was "designed and successfully tested to meet the applicable requirements outlined in ISO 7886-1. Sterile Hypodermic Syringes for Single Use - Part 1: Syringes for Manual Use." |
| Material Biocompatibility (ISO 10993): Materials comply with ISO 10993 as applicable. | The device's materials comply with ISO 10993 as applicable to the intended use. Biocompatibility Testing states "The BD Emerald™ Single Use Hypodermic Syringe and needles have been designed and successfully tested to meet the applicable requirements outlined in ISO 10993-1, Biological Evaluation of Medical Devices Part 1: Evaluation and testing within a Risk Management Process." |
| Sterility Assurance Level (SAL) of 10^-6. | The device is sterilized to a Sterility Assurance Level (SAL) of 10^-6. Sterilization and Shelf-life Testing states "The BD Emerald™ Single Use Hypodermic Syringe and needles have been designed and successfully tested to meet the applicable requirements outlined in ISO 11135-1, Sterilization of Healthcare Products - Ethylene Oxide Sterilization Process for Medical Devices." |
| Equivalent Performance (Design Verification Testing): Demonstrates equivalent performance to predicate devices. | "The results of Design Verification tests demonstrate that the BD Emerald™ Single Use. Hypodermic Syringe performed in an equivalent manner to the predicate devices and is safe and effective when used as intended." The document also states the device has "similarities...in intended use, function and basic composition" and "testing to voluntary standards provides additional evidence that the BD Emerald™ Single Use Hypodermic Syringe is substantially equivalent to the predicate devices in terms of safety, efficacy and performance." |
| Needle Requirements (if included) (ISO 7864 & ISO 9626): Meets applicable requirements for hypodermic needles and tubing. | "The needles that may be included with the syringe meet the applicable requirements outlined in ISO 7864, Sterile Hypodermic Needles for Single Use and ISO 9626, Stainless Steel Needle Tubing for the Manufacture of Medical Devices." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify a numerical sample size for "design verification tests." These tests typically involve a defined number of units or batches tested per established protocol for each specific characteristic (e.g., force to activate plunger, leak tests, sterility tests). The 510(k) summary summarizes the conclusion of these tests rather than the details of the testing protocols.
- Data Provenance: Not explicitly stated as country of origin. This would be internal testing conducted by Becton, Dickinson and Company. The nature of the testing (design verification, performance, biocompatibility, sterilization) implies these are prospective tests performed on newly manufactured devices or prototypes.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. This phrase typically refers to human expert adjudication in studies involving assessment of images or clinical data (e.g., radiologist review). For a mechanical device like a syringe, "ground truth" is established by direct physical measurements against predefined specifications or performance standards by qualified engineers and technicians, not clinical "experts" in the same sense.
4. Adjudication Method for the Test Set
- Not applicable. See point 3. Testing involves objective measurements and comparisons to engineering specifications and ISO standards, not subjective adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, not done. MRMC studies are specific to evaluating diagnostic devices (e.g., imaging AI) where multiple human readers assess cases, and their performance with and without AI assistance is compared. This is a general-purpose medical device (syringe) and does not involve such a study design.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This device does not involve an algorithm.
7. The Type of Ground Truth Used
- Engineering Specifications and International Standards: For this type of device, "ground truth" is established by:
- Predefined engineering and design specifications for the syringe components and their performance characteristics (e.g., Luer taper dimensions, barrel volume accuracy, plunger force).
- The requirements and test methods outlined in international standards such as ISO 7886-1 (Sterile Hypodermic Syringes for Single Use), ISO 7864 (Sterile Hypodermic Needles for Single Use), ISO 9626 (Stainless Steel Needle Tubing), ISO 10993-1 (Biocompatibility), and ISO 11135-1 (Ethylene Oxide Sterilization). Performance against these quantifiable standards constitutes the "ground truth" for compliance.
8. The Sample Size for the Training Set
- Not applicable. This device does not utilize a training set in the context of machine learning or AI. Design and manufacturing processes are based on engineering principles and established quality control, not data-driven training in this manner.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. See point 8.
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