(17 days)
The B. Braun Injekt® piston syringes are intended to be used to inject fluid into, or withdraw fluids from, the body.
The B. Braun piston syringe is a 2-piece syringe consisting of a calibrated hollow barrel and a movable plunger without a plunger tip. One end of the barrel has a male connector (nozzle), which permits attachment to a female connector (hub). Both luer lock and luer slip nozzles are available, with centric and eccentric configurations.
The provided text is a 510(k) summary for the B. Braun Injekt® Piston Syringe. This document focuses on establishing substantial equivalence to a predicate device, rather than presenting a performance study with detailed acceptance criteria and results as would be typical for a novel device or software.
Therefore, the requested information regarding acceptance criteria, a study proving the device meets those criteria, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC/standalone studies cannot be extracted from the provided text. The document states:
"There are no differences between the predicate and proposed devices that raise new issues of safety and effectiveness."
This statement indicates that the submission relies on the established safety and effectiveness of the predicate device (NIPRO disposable hypodermic syringes with or without needle - K051574) and asserts that the proposed device is sufficiently similar, rather than providing independent performance data for the B. Braun Injekt® Piston Syringes against specific acceptance criteria.
However, based on the information that is available, here's a breakdown:
| Information Category | Details from Provided Text |
|---|---|
| 1. Acceptance Criteria and Reported Device Performance | Not explicitly stated. The submission relies on establishing substantial equivalence to the predicate device (NIPRO disposable hypodermic syringes with or without needle - K051574) rather than presenting specific acceptance criteria and performance data for the B. Braun Injekt® Piston Syringe. |
| 2. Sample size used for the test set and data provenance | Not applicable. No specific test set or performance study is detailed. The substantial equivalence argument implies that the device's design and intended use are similar enough to the predicate that a new comprehensive performance study is not deemed necessary by the submitter for 510(k) clearance. |
| 3. Number of experts used to establish the ground truth for the test set and qualifications | Not applicable. No test set or ground truth establishment process is described. |
| 4. Adjudication method for the test set | Not applicable. No test set or adjudication process is described. |
| 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done | No. This type of study is not mentioned or implied in the 510(k) summary for this device. |
| 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done | Not applicable. This device is a physical medical device (piston syringe), not a software algorithm. |
| 7. The type of ground truth used | Not applicable. No ground truth is mentioned. |
| 8. The sample size for the training set | Not applicable. No training set is mentioned as this is a physical device, not an AI or software-driven system needing a training set. |
| 9. How the ground truth for the training set was established | Not applicable. No training set or ground truth establishment is mentioned. |
§ 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).