(413 days)
The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection.
The BD Single Use, Hypodermic Syringe is a three-piece, sterile, single use hypodermic syringe with a 6% (Luer) male connector in 3ml, 5ml and 10ml Luer-Lok syringe sizes. The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection. The syringe assembly consists of a lubricated polypropylene 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 syringe barrel incorporates a male 6% (Luer) connector which is connectable to a compatible female 6% (Luer) connector. The modified BD Single Use, Hypodermic Syringe includes a new resin material in the barrel of the syringe. The syringe performance characteristics are equivalent to the predicate device.
The provided document describes the acceptance criteria and the study that proves the device meets those criteria for the BD Single Use, Hypodermic Syringe.
Here's the breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The document states that the subject device met all predetermined acceptance criteria. The specific acceptance criteria are broadly described by the tests performed, and the reported performance is that the device performed in an equivalent manner to the predicate device and met the acceptance criteria.
| Acceptance Criteria Category/Test | Reported Device Performance |
|---|---|
| Performance Tests | |
| Break Out Force | Performed in an equivalent manner to the predicate device |
| Sustaining Force | Performed in an equivalent manner to the predicate device |
| Flange Bend Force | Performed in an equivalent manner to the predicate device |
| Dimensional Stability of Barrel ID (inner diameter) | Performed in an equivalent manner to the predicate device |
| Barrel Scale Permanency | Performed in an equivalent manner to the predicate device |
| Barrel Impact Test | Performed in an equivalent manner to the predicate device |
| ISO 7886 and ISO 594 Leakage Testing | Performed in an equivalent manner to the predicate device |
| Sterilization Validation | |
| ISO 11137-2:2013 (Gamma Irradiation process) | Validated per standard |
| SAL | 10-6 |
| Biocompatibility Evaluation (ISO 10993-1:2009) | |
| Cytotoxicity (Per ISO 10993-5) | Non-cytotoxic |
| Hemolysis (Per ISO 10993-4) | Non-hemolytic |
| Acute Systemic Toxicity (Per ISO 10993-11) | Non-toxic |
| Intracutaneous Reactivity (Per ISO 10993-10) | Non-Irritant |
| Sensitization (Per ISO 10993-10) | Non-Sensitizer |
| Pyrogenicity (Per ISO 10993-11 and USP ) | Non-Pyrogenic |
| Acidity/Alkalinity/Extractable Metals (Per ISO 7886-1) | Met acceptance criteria |
| Chemical Extractables Analysis (Per ISO 10993-18) | No toxicologically significant differences in extractables profiles |
| Overall | Met all predetermined acceptance criteria and demonstrated substantial equivalence to the predicate device. |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample sizes for each specific test (e.g., how many syringes were tested for "Break Out Force"). It mentions "design verification testing" for the performance tests and "biocompatibility evaluation" for the biological tests. The data provenance is not specified, but it can be inferred that these are prospective tests conducted on the newly designed device.
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 tests performed are primarily engineering and biological tests, not clinical evaluations requiring expert interpretation of results in the traditional sense of medical image analysis or diagnostic studies. The "ground truth" here is established by adherence to recognized international standards (ISO, USP) and predefined performance specifications.
4. Adjudication method for the test set
This information is not applicable and therefore not provided. Given the nature of the tests (physical, chemical, biological), standard adjudication methods like 2+1 or 3+1 consensus, typically used for qualitative or subjective assessments (e.g., image interpretation), are not relevant. The results are quantitative measurements against predefined criteria or qualitative observations against biological safety 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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for medical devices that involve human interpretation, particularly in diagnostic imaging and AI-assisted diagnoses. The BD Single Use, Hypodermic Syringe is a physical device for fluid aspiration/injection, and its evaluation does not involve human readers or AI assistance in this context. 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, a standalone (algorithm only) performance study was not done. This device is not an algorithm or AI-driven system.
7. The type of ground truth used
The ground truth for this device is based on:
- Adherence to recognized international standards (e.g., ISO 7886, ISO 594, ISO 11137-2:2013, ISO 10993 series, USP ).
- Predetermined acceptance criteria for specific performance parameters (e.g., "Non-cytotoxic," "Non-hemolytic," "met acceptance criteria" for Acidity/Alkalinity/Extractable Metals).
- Equivalence to a legally marketed predicate device (K980987 BD Single Use, Hypodermic Syringe) in terms of intended use, materials, and performance characteristics.
8. The sample size for the training set
This information is not applicable and therefore not provided. This device is not an AI/ML model, so there is no concept of a "training set" in the context of its evaluation. The evaluation involves testing physical properties and biological compatibility.
9. How the ground truth for the training set was established
This information is not applicable as there is no training set for this device.
§ 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).