(357 days)
Sterile Hypodermic Syringe for Single Use, with/without needle:
The sterile hypodermic syringe for single use, with/without needle is intended for use in the aspiration of fluids for medical purposes.
Sterile Hypodermic Needle for Single use:
The sterile hypodermic needle for single use is intended for use with syringes in the aspiration of fluids for medical purposes.
Sterile Hypodermic Syringe for Single Use, with/without needle:
The sterile hypodermic syringe for single use, with/without needle is intended for used in the aspiration and injection of fluids for medical purposes.
Sterile Hypodermic Needle for Single use:
The sterile hypodermic needle for single use is intended for use with syringes in the aspiration and injection of fluids for medical purposes.
The device is delivered in the following configurations:
Needle Gauge: 18,19,20,21,22,23,24,25,26,27,28,29,30G
Needle Length: 1/6"-1 1/2"
Syringe Volume: 1,2,3,5,10,20,30,50,60,100 ml
Sterile Hypodermic Syringe for Single Use, with/without needle and Sterile Hypodermic Needle for Single use materials are as noted in the table below:
Needle cap: PP
Needle tube: Stainless Steel
Needle hub: PP
Barrel: PP
Plunger stopper: Isoprene rubber
Plunger: PP
Ink: Black
Lubricant: Silicone oil
Adhesive: Epoxy resin
Colorant: PP masterbatch
The contact level of the subject device is blood path, indirect, and the contact duration is limited contact (
I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the format you specified.
The document is a 510(k) premarket notification for "Sterile Hypodermic Syringe for Single Use, with/without Needle, Sterile Hypodermic Needle for Single Use." It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific performance acceptance criteria.
Here's what is missing from the text to fulfill your request:
- A table of acceptance criteria and the reported device performance: While the document mentions compliance with various ISO standards (e.g., ISO 80369-7, ISO 7886-1), it does not explicitly list the specific acceptance criteria for each parameter within these standards, nor does it present the reported device performance against those criteria in a tabular format. It only states that "All of the pre-determined acceptance criteria were met."
- Sample size used for the test set and the data provenance: The document indicates that "bench testing" was performed for performance and that "verification test" was done for biocompatibility and sterility, but it does not specify the sample sizes used for these tests or the data provenance (e.g., country of origin, retrospective/prospective).
- Number of experts used to establish the ground truth... and the qualifications: This information is typically relevant for studies involving human interpretation or subjective assessment, such as image analysis devices. For a physical medical device like a syringe or needle, "ground truth" would be established by objective measurements and standardized tests, not expert consensus. Therefore, this question is not applicable in this context.
- Adjudication method: Similar to the point above, adjudication methods like 2+1 or 3+1 are used for resolving disagreements among experts in subjective assessments. This is not applicable to the performance testing of a syringe or needle.
- If a multi reader multi case (MRMC) comparative effectiveness study was done...: This type of study is for evaluating diagnostic devices where human readers interpret data. It is not relevant to the described medical device.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: This is relevant for AI/ML-driven devices and is not applicable here.
- The type of ground truth used: As mentioned, for this type of device, ground truth is established through adherence to international standards and objective measurement, not expert consensus, pathology, or outcomes data in the usual sense.
- The sample size for the training set: This refers to the development of AI/ML models, which is not applicable to this device.
- How the ground truth for the training set was established: Not applicable.
The document primarily provides a list of ISO standards that the device complies with, stating general compliance rather than detailed performance results against quantifiable acceptance criteria for each specific test. It explicitly states, "No clinical testing was performed" and "No clinical study is included in this submission," further indicating the absence of human-centric studies.
§ 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).