(30 days)
The BD Emerald™ Saf-T Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose aspiration and injection of fluids.
The BD Emerald™ Saf-T Single Use, Hypodermic Syringe is a three-piece sterile, single use, hypodermic syringe with a 6% Luer taper tip and an integrated Sharps Injury Prevention Feature. The syringe is provided in the following syringe sizes: 3ml, 5ml, and 10ml. All sizes will be available with a 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, a polypropylene plunger rod and a polypropylene sharps injury prevention feature. The sharps injury prevention feature consists of a pivoting cover that can be manually rotated forward after use, allowing for secure encapsulation of the needlepoint. 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.
The provided text describes the 510(k) submission for the BD Emerald™ Saf-T Single Use Hypodermic Syringe. This is a medical device modification and the acceptance criteria and supporting studies are focused on demonstrating substantial equivalence to predicate devices, rather than establishing de novo performance for a new type of device. Therefore, many of the typical elements requested for AI/Software as a Medical Device (SaMD) studies (like MRMC studies, training set details, or ground truth establishment by experts for specific diagnostic tasks) are not applicable here.
Here's an analysis based on the provided document:
Acceptance Criteria and Study Details for BD Emerald™ Saf-T Single Use Hypodermic Syringe
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are primarily based on meeting established international standards and demonstrating equivalence to predicate devices, rather than specific performance metrics like sensitivity/specificity for a diagnostic task.
| Acceptance Criteria Category | Specific Criteria / Standard Met | Reported Device Performance |
|---|---|---|
| Intended Use | Same as predicate devices | Yes, "intended for use by health care professionals for general purpose aspiration and injection of fluids." |
| Operating Principle | Same as predicate devices | Yes |
| Manual Use Requirements | Meet ISO 7886-1:1993 | "Successfully tested to meet the applicable requirements outlined in ISO 7886-1: 1993" |
| Material Biocompatibility | Comply with ISO 10993-1:2009 | "Successfully tested to meet the applicable requirements outlined in ISO 10993-1: 2009" |
| Sterility Assurance Level (SAL) | 10⁻⁶ | "Sterilized to a Sterility Assurance Level (SAL) of 10-6" |
| Needle Requirements (if applicable) | Meet ISO 7864:1993, ISO 9626:2001 | "Needles... meet the applicable requirements outlined in ISO 7864:1993, Sterile Hypodermic Needles for Single Use and ISO 9626: 2001" |
| Sterilization Process | Meet ISO 11135-1 | "Successfully tested to meet the applicable requirements outlined in ISO 11135-1" |
| Design Verification Testing | Equivalent performance to predicate devices | "Results of Design Verification tests demonstrate that the BD Emerald™ Saf-T Single Use, Hypodermic Syringe performed in an equivalent manner to the predicate devices" |
| Does not raise new safety/effectiveness issues | No new issues compared to predicate devices | "The differences between... do not raise new issues of safety or effectiveness." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" in the context of an AI/SaMD study, as this is a medical device (syringe) rather than a software algorithm. The "testing" refers to physical and biological performance tests.
- Sample Size: Not explicitly stated as a single "test set" size. The document refers to various tests conducted according to international standards (e.g., ISO 7886-1). These standards typically define sampling plans and sample sizes for the specific tests (e.g., tensile strength, flow rate, biocompatibility). These numbers are not provided in this summary.
- Data Provenance: Not applicable in the context of country of origin for clinical imaging data or retrospective/prospective studies. The data provenance would be the manufacturing facility and laboratories where the physical and biological tests were performed.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Number of Experts: Not applicable. The "ground truth" for a mechanical device like a syringe is adherence to engineering specifications and performance standards through physical measurement and biological testing. It does not involve expert image interpretation or diagnostic adjudication.
- Qualifications of Experts: Not applicable in the context of radiologists or similar clinical experts. The "experts" involved would be engineers, material scientists, and laboratory technicians proficient in performing and interpreting the results of the relevant ISO standard tests.
4. Adjudication Method
- Adjudication Method: Not applicable. There is no concept of adjudication for a test set in the way it is used for clinical diagnostic performance studies. Performance is measured against physical and biological specifications.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic algorithms where human readers interpret medical images or data. This device is a physical medical instrument (syringe).
- Effect Size of Human Readers with/without AI: Not applicable.
6. Standalone (Algorithm Only) Performance Study
- Standalone Study: No, a standalone algorithm performance study was not done. This device is not an algorithm; it is a physical syringe.
7. Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" implicitly used for this device's performance evaluation is adherence to established international standards (e.g., ISO 7886-1, ISO 10993-1, ISO 11135-1) and internal design specifications. These standards define measurable physical, chemical, and biological properties that the device must meet.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device is a physical product, not a machine learning model. There is no "training set" in the AI/ML sense. The design and manufacturing processes are refined through engineering and quality control, but this is not analogous to training data for an algorithm.
9. How Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable, as there is no training set for an algorithm. The design and development of the BD Emerald™ Saf-T syringe would have been guided by engineering principles, user needs, regulatory requirements, and historical data from previous syringe designs, with verification and validation against established standards.
§ 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).