(93 days)
The syringe filling device replaces standard, sharp hypodermic needles and all other syringe filling devices and accessories for syringe filling from vials and ampoules. Once the syringe is filled, the filling device is detached from the syringe. The syringe is then reattached to the blunt plastic cannula which provides access to fluid path for injection/aspiration of fluids. The blunt plastic cannula is intended for use with Abott Life Shield, McGaw Safeline and Baxter Interlink systems. The B-D TWINPAK offers the convenience of delivering a syringe filling device and a blunt plastic cannula for access into split septum IV sites for injection/aspiration of fluids.
The B-D® TWINPAK™ is an assembly consisting of currently marketed and previously approved devices incorporated into a protective shield - TWINPAK comprises the following legally marketed devices.
- B-D Blunt Plastic Cannula {cleared for marketing 510(K) #K964654]
- Syringe Filling Device {SFD} This is a 20G x ½" steel cannula, which is exactly the same as legally marketed device by Becton Dickinson, B-D® Tubing Adapter, Reorder #8210.
Devices (1) and (2) without their respective original shields are assembled into a plastic shield, as shown in figure. A plastic cap is also placed over the syringe filling device. The TWINPAK™ can be sold by itself or with a syringe.
Here's a breakdown of the acceptance criteria and study details for the Becton Dickinson TWINPAK™, based on the provided document:
Acceptance Criteria and Reported Device Performance
| Criteria | Acceptance Statement / Method | Reported Device Performance |
|---|---|---|
| Dose Drawing | "The cannula geometry allows for the full dose to be withdrawn from the vial and to determine equivalence with predicate devices." | |
| Measurement tolerance: +/- 0.2cc for single dose vials, +/- 0.1cc for multiple dose vials. | "The SFD is equivalent for dose drawing to the predicate devices and the full dose can be withdrawn." | |
| Vial Stopper Particulate Matter | "To determine if vial stopper particulate matter is generated with the SFD and predicate devices." | |
| Filters examined for visible stopper particulate matter. | "The SFD is equivalent to the predicate devices for generation of vial stopper particulate matter during vial access." | |
| Vial Stopper Access (Leakage) | "To determine if equivalent vial stopper leakage occurs while aspirating fluids with the SFD and predicate devices." | |
| Leakage defined as fluid dripping. | "The SFD is equivalent for vial stopper access to the predicate devices." | |
| Ampoule Access | "The criteria to determine that the SFD could access an ampoule was if the SFD cannula was longer than the shoulder length of the ampoule (as defined by ISO 9187-1 and ISO 9187-2)." | "The SFD cannula length is greater than the shoulder length for all ampoules identified under nominal dimensions. The SFD is equivalent to the predicate device for the ability to access ampoules." |
| Sharpness (vs. Standard Hypodermic) | "SFD cannula is 10 times less sharp than an equivalent gauge standard hypodermic needle." Measured by peak penetration force in Dental Dam (higher force = less sharp). | "The SFD is 10 times less sharp than an equivalent gauge standard hypodermic needle." |
| Vial Stopper Penetration Force (vs. B-D Vial Access Cannula) | "Vial stopper penetration force is substantially reduced when comparing the SFD to the B-D Vial Access Cannula." Measured by peak penetration force in various vial stoppers. | "Vial stopper penetration force is substantially reduced when comparing the SFD to the B-D Vial Access Cannula." |
Study Details
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Sample Size used for the test set and the data provenance:
- Dose Drawing: 30 vials per cannula type.
- Vial Stopper Particulate Matter: 30 vials per cannula type.
- Vial Stopper Access:
- 30 single dose vials (penetrated one time each, total 30 penetrations per cannula type).
- 30 multiple dose vials (penetrated ten times each, total 300 penetrations per cannula type).
- Penetration force testing in Dental Dam: 30 cannula per cannula type.
- Penetration force testing into various vials: 30 cannula per cannula type.
- Data Provenance: Not explicitly stated, but the submission is from Becton Dickinson and Company, implying internal testing/data. It is a retrospective study since it was conducted as part of the 510(k) submission process.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as these are performance characteristic tests (e.g., force measurements, visual inspection for particulate matter, leakage observation, dimensional comparison), not diagnostic interpretations requiring expert consensus.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable due to the nature of the tests.
-
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. This is a medical device (syringe filling device and blunt plastic cannula) clearance, not an AI-assisted diagnostic tool.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a physical medical device.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For Dose Drawing, Vial Stopper Particulate Matter, Vial Stopper Access, and Penetration Force Testing: The ground truth is based on quantitative measurements (e.g., fluid volume, force readings) and direct visual observations against defined criteria (e.g., "visible stopper particulate matter," "fluid dripping").
- For Ampoule Access: The ground truth is established by dimensional comparison against international standards (ISO 9187-1 and ISO 9187-2).
-
The sample size for the training set:
- Not applicable. This is not a machine learning model.
-
How the ground truth for the training set was established:
- Not applicable. This is not a machine learning model.
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).