(175 days)
The BD Plastipak ™ Syringe is intended for single use by health care professionals for general purpose fluid aspiration/injection.
The 3mL and 20mL BD Plastipak™ Syringe is a three-piece, single use, sterile or bulk non-sterile (BNS) hypodermic syringe with Luer Slip or male 6% (Luer Lock) connection, which are connectable to a compatible female 6% (Luer) connector. The syringe assemblies consist of a lubricated polypropylene barrel with a graduated scale, a lubricated thermoplastic elastomer 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 Plastipak™ Syringe incorporates a scale graduated in units of milliliters.
The BD Plastipak™ Syringe is provided sterile by Irradiation or Ethylene Oxide Gas (EtO) sterilization methods in a syringe only configuration or with a BD Hypodermic Needle, BD SafetyGlide™ Hypodermic Needle or BD Eclipse™ Hypodermic Needle. The BD Plastipak™ Syringe is also provided in a bulk nonsterile, syringe only configuration.
The provided text describes the acceptance criteria and the study that proves the device meets those criteria for the BD Plastipak™ Syringe.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Standard) | Reported Device Performance |
|---|---|
| Startup Time (ISO7886-2) | Subject device met the pre-established acceptance criteria per ISO7886-2. |
| Volumetric Accuracy (Manual Use, tolerance on graduated capacity) (ISO7886-1 and ISO 7886-2) | Subject device met the pre-established acceptance criteria per ISO7886-1 and ISO7886-2. |
| Sterility Product (N/A for BNS) (ISO 11135, ISO 11137 and PH Eur. 5.0) | Subject device met the pre-established acceptance criteria per ISO 11135, ISO 11137 and PH Eur. 5.0. |
| Stopper Separation from plunger (ISO7886-1) | Subject device met the pre-established acceptance criteria per ISO7886-1. |
| Liquid leakage past stopper under pressure (back rib) (ISO7886-1 and ISO7886-2) | Subject device met the pre-established acceptance criteria per ISO7886-1 and ISO7886-2. |
| Liquid leakage past stopper under pressure (front rib) (ISO7886-1 and ISO7886-2) | Subject device met the pre-established acceptance criteria per ISO7886-1 and ISO7886-2. |
| Air Leakage past Stopper in aspiration (ISO7886-1 and ISO7886-2) | Subject device met the pre-established acceptance criteria per ISO7886-1 and ISO7886-2. |
| Dead space (ISO7886-1 and ISO7886-2) | Subject device met the pre-established acceptance criteria per ISO7886-1 and ISO7886-2. |
| Maximum Usable Capacity (ISO7886-1) | Subject device met the pre-established acceptance criteria per ISO7886-1. |
| Fiducial Line (ISO7886-1) | Subject device met the pre-established acceptance criteria per ISO7886-1. |
| Hard Height (ISO7886-2) | Subject device met the pre-established acceptance criteria per ISO7886-2. |
| Short-Term Flow Rate Accuracy (incl Stiction) (ISO 7886-2) | Subject device met the pre-established acceptance criteria per ISO7886-2. |
| Overall Percentage Error (ISO7886-2) | Subject device met the pre-established acceptance criteria per ISO7886-2. |
| Max Variation in Flow Rate (ISO7886-2) | Subject device met the pre-established acceptance criteria per ISO7886-2. |
| Plunger Movement Forces (Pump) (ISO7886-2) | Subject device met the pre-established acceptance criteria per ISO7886-2. |
| Syringe Compliance (ISO7886-2) | Subject device met the pre-established acceptance criteria per ISO7886-2. |
| Uniform Stopper Appearance (ISO7886-1 and ISO7886-2) | Subject device met the pre-established acceptance criteria per ISO7886-1 and ISO7886-2. |
| Scale - Graduation Line Intervals (ISO7886-1 and ISO7886-2) | Subject device met the pre-established acceptance criteria per ISO7886-1 and ISO7886-2. |
| Scale - Unit of measure (ISO7886-1 and ISO7886-2) | Subject device met the pre-established acceptance criteria per ISO7886-1 and ISO7886-2. |
| Scale Lines (ISO7886-1 and ISO7886-2) | Subject device met the pre-established acceptance criteria per ISO7886-1 and ISO7886-2. |
| Scale Numbering (ISO7886-1 and ISO7886-2) | Subject device met the pre-established acceptance criteria per ISO7886-1 and ISO7886-2. |
| Scale Length (ISO7886-1 and ISO7886-2) | Subject device met the pre-established acceptance criteria per ISO7886-1 and ISO7886-2. |
| Scale Position (ISO7886-1 and ISO7886-2) | Subject device met the pre-established acceptance criteria per ISO7886-1 and ISO7886-2. |
| Marking - Syringe Barrel (ISO7886-1 and ISO7886-2) | Subject device met the pre-established acceptance criteria per ISO7886-1 and ISO7886-2. |
| Air leakage past stopper in aspiration (vacuum) (ISO7886-1) | Subject device met the pre-established acceptance criteria per ISO7886-1. |
| Stopper separation from plunger (ISO7886-1) | Subject device met the pre-established acceptance criteria per ISO7886-1. |
| Sterilization: Irradiation (ISO 11137-1 and ISO 11137-2) | Subject device met the pre-established acceptance criteria per ISO 11137-1 and ISO 11137-2. |
| Sterilization: Ethylene Oxide (EtO) (ISO 11135 and ISO 10993-7) | Subject device met the pre-established acceptance criteria per ISO 11135 and ISO 10993-7. |
| Biocompatibility: Cytotoxicity (ISO 10993-5 and 10993-12, USP ) | Non-cytotoxic |
| Biocompatibility: Hemolysis (ISO 10993-4 and 10993-12) | Non-hemolytic |
| Biocompatibility: Acute Systemic Toxicity (ISO 10993-11 and 10993-12) | Non-toxic |
| Biocompatibility: Intracutaneous Reactivity (ISO 10993-10 and 10993-12, USP ) | Non-Irritant |
| Biocompatibility: Sensitization (ISO 10993-10) | Non-Sensitizer |
| Biocompatibility: Pyrogenicity (ISO 10993-11, 10993-12 and USP 151) | Non-Pyrogenic |
| Biocompatibility: Elastomeric Closures for Injections (USP ) | Met Type I and II closures |
| Biocompatibility: ISO 7886-1: Acidity/Alkalinity and Extractable Metals (ISO 7886-1) | Pass |
| Biocompatibility: Extractables/Leachables Assessment (ISO 10993-17 and 18) | Pass |
| Biocompatibility: Particulate Matter (USP ) | Pass |
| Biocompatibility: Endotoxin LAL (USP ) | Pass |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes for each test in the test set. It mentions "non-clinical/design verification testing" was performed, indicating a test set was used to verify each of the listed criteria against the established standards (e.g., ISO, USP). The data provenance is not explicitly stated in terms of country of origin or retrospective/prospective nature, but it implies internal testing by Becton, Dickinson and Company.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The "ground truth" for this type of device (syringe) is typically established by adherence to recognized international and national standards (ISO, USP, PH Eur.) rather than expert consensus on individual cases.
4. Adjudication method for the test set
This information is not applicable and not provided. The testing involves objective measurements against established standards, not interpretation by experts requiring adjudication.
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
A Multi-Reader, Multi-Case (MRMC) comparative effectiveness study was not performed. This type of study is relevant for diagnostic devices involving human interpretation (e.g., medical imaging AI), which is not the nature of a syringe.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a physical medical instrument (syringe), not an algorithm or AI system. The tests are focused on the physical and functional performance of the syringe.
7. The type of ground truth used
The ground truth for this device's performance is based on established international and national standards and specifications, such as ISO 7886 (Syringes for medical use), ISO 11135 (Sterilization of health care products - Ethylene oxide), ISO 11137 (Sterilization of health care products - Radiation), ISO 10993 (Biological evaluation of medical devices), USP (United States Pharmacopeia), and PH Eur. (European Pharmacopoeia). These standards define acceptable parameters and testing methodologies.
8. The sample size for the training set
This information is not applicable. The BD Plastipak™ Syringe is a manufactured medical device, not a machine learning model, so there is no "training set" in the context of data for an algorithm. The design and manufacturing process would involve internal testing and validation, but not a training set as understood in AI/ML.
9. How the ground truth for the training set was established
This information is not applicable for the reasons stated in point 8.
§ 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).