(53 days)
The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection.
The modified BD Single Use, Hypodermic Syringe is a three-piece single use, hypodermic syringe with a 6% (Luer) connector in 1ml Luer Slip, 3ml and 5ml Luer Lok and Luer Slip syringe sizes. The syringe assembly consists of a plastic barrel with a graduated scale, a synthetic rubber stopper, and a plastic plunger rod. The changes to the modified device from the predicate include a new synthetic stopper material and a new silicone based stopper lubricant formulation. The syringe performance characteristics are equivalent to the predicate device. The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection.
The modified BD Single Use, Hypodermic Syringe are provided sterile, by either EO or an Irradiation sterilization method, in a syringe only configuration or with a pre-attached or side-by-side hypodermic needle.
The provided text describes a 510(k) summary for a BD Single Use, Hypodermic Syringe, focusing on its substantial equivalence to a predicate device and its performance characteristics. This is a medical device submission, and the "study" referred to is the design verification testing.
Here's a breakdown of the requested information based on the provided text:
1. Table of acceptance criteria and the reported device performance
| Performance Characteristic | Test Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Functional Testing | |||
| Sustaining Force | Determination of forces required to operate plunger (ISO 7886-1 - Annex G) | Per ISO 7886-1 | Performed in an equivalent manner to the predicate device |
| Break-Out Force | Determination of forces required to operate plunger (ISO 7886-1 - Annex G) | Per ISO 7886-1 | Performed in an equivalent manner to the predicate device |
| Pump Sticktion / Force | Determination of forces required to move the piston (ISO 7886-2 - Annex C) | Per ISO 7886-2 | Performed in an equivalent manner to the predicate device |
| Stopper Seal | Water Leakage Test (ISO 7886-1 - Annex D) | Per ISO 7886-1 | Performed in an equivalent manner to the predicate device |
| Autoclavability | Water Leakage Test (ISO 7886-1 - Annex D) After Syringe autoclave for 15mins at 270°F | Per ISO 7886-1 | Performed in an equivalent manner to the predicate device |
| Chemical Testing (Extractables) | |||
| Zinc | ISO 7886-1 | Per ISO 7886-1 | Performed in an equivalent manner to the predicate device |
| Lead, Tin, Iron | ISO 7886-1 | Per ISO 7886-1 | Performed in an equivalent manner to the predicate device |
| Cadmium | ISO 7886-1 | Per ISO 7886-1 | Performed in an equivalent manner to the predicate device |
| pH shift | ISO 7886-1 | Per ISO 7886-1 | Performed in an equivalent manner to the predicate device |
| Biocompatibility Testing | |||
| Cytotoxicity | ISO10993-5:1999 | Non-Toxic | Non-Toxic |
| Hemolysis | ISO10993-4:2002/A:2006 | Non-Toxic | Non-Toxic |
| Acute Systemic Toxicity | ISO10993-11:2006 | Non-Toxic | Non-Toxic |
| Intracutaneous Reactivity | ISO10993-10:2002/A1:2006 | Non-Irritant | Non-Irritant |
| Murine Local Lymph Node Assay | ISO10993-10:2002/A1:2006 | Non-Sensitizer | Non-Sensitizer |
| Pyrogenicity | ISO10993-11:2006 | Non-Pyrogenic | Non-Pyrogenic |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated in the provided text for each specific test. The document generally refers to "Design Verification tests" that were performed.
- Data Provenance: The tests were conducted as part of the "Design Verification testing" for the modified BD Single Use, Hypodermic Syringe. This is a prospective testing approach conducted by the manufacturer, Becton, Dickinson and Company, for a 510(k) submission in the USA (Franklin Lakes, NJ).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable to this type of device submission or the nature of the testing performed. The "ground truth" here is defined by meeting the specified ISO standards and biocompatibility criteria through objective physical and chemical testing, not by expert interpretation of complex data (like in image diagnosis).
4. Adjudication method for the test set
This is not applicable. The outcome of these tests are objective measurements and biological responses against defined standards, not subjective interpretations 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
This is not applicable. This submission is for a medical device (hypodermic syringe), not an AI-assisted diagnostic tool. Therefore, MRMC studies and AI effectiveness are irrelevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. As stated above, this is not an AI algorithm.
7. The type of ground truth used
The "ground truth" for the performance characteristics relies on:
- International Standards: Meeting the requirements and specifications defined by ISO 7886-1 and ISO 7886-2 for functional and chemical properties.
- Biocompatibility Standards: Meeting the criteria defined by various parts of ISO 10993 for biological safety.
- Predicate Device Equivalence: The tests also aimed to demonstrate equivalent performance to the predicate device (K980987).
8. The sample size for the training set
This is not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
This is not applicable. No training set was used.
§ 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).