(197 days)
U&U Sterile Piston Syringes is intended for use by health care professionals for general purpose fluid aspiration/ injection.
U&U Sterile Piston Syringes is intended for use by health care professionals for general purpose fluid aspiration.
The piston syringe is a device intended for medical purposes, consisting of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male Luer Slip/Lock connector (nozzle) for attaching the female Luer connector (hub) of a hypodermic single lumen needle, or for attaching other devices with a female Luer. The syringe is sterilized by EtO gas. And it is a Non-Pyrogenic and single use device. The mainly raw materials are PP, PE and rubber.
The provided document is a 510(k) summary for the U&U Sterile Piston Syringe. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with specific acceptance criteria and performance data in the format requested.
Therefore, the information needed to directly answer many of the questions regarding acceptance criteria, specific study details, and performance metrics for the device itself is not present in this regulatory submission. This document highlights that the device conforms to existing standards but doesn't provide the detailed study results that would typically be associated with performance validation.
However, based on the information provided, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
The document states that the device "Conforms to ISO7886-1" for performances and "Conforms to ISO10993" for biocompatibility. These international standards provide the acceptance criteria for piston syringes and biocompatibility, respectively. The reported performance is that the device meets these standards. Detailed numerical results or specific pass/fail rates for individual tests within these standards are not provided in this summary.
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| Performance: Conforms to ISO7886-1 (Sterile hypodermic syringes for single use) | Device conforms to ISO7886-1 |
| Biocompatibility: Conforms to ISO10993 (Biological evaluation of medical devices) | Device conforms to ISO10993 |
| Labeling: Meets 21 CFR Part 801 | Device meets 21 CFR Part 801 |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the 510(k) summary. The summary refers to the device "conforming" to standards, which implies testing was conducted, but details on sample size, test set design, or data provenance are absent.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable and not provided. This device is a piston syringe, a physical medical instrument, not an AI or diagnostic system that requires expert interpretation for ground truth establishment. Its performance is evaluated against engineering and biological standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided. Adjudication methods are typically used in studies involving human interpretation or subjective assessments, which is not the primary mode of evaluation for a piston syringe's performance against ISO 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
This information is not applicable and not provided. This device is a piston syringe and not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and not provided. This device is a physical medical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is established by the technical specifications and test methods defined within the ISO7886-1 and ISO10993 standards. For example, for ISO 7886-1, "ground truth" would be objective measurements of force, leakage, volume accuracy, etc., against predefined limits. For ISO 10993, "ground truth" would be the results of specific biological tests (cytotoxicity, irritation, sensitization, etc.) against established safety thresholds.
8. The sample size for the training set
This information is not applicable and not provided. This device is a physical medical instrument and does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
This information is not applicable and not provided for the same reason as above.
§ 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).