(122 days)
The Syringe with or without needle is intended for dispensing/administering fluids, and collecting/ sampling of fluid in medical practice.
The insulin syringe (U-100) with fixed needle is a device intended for medical purposes for the manual aspiration of U-100 insulin, and for the injection of U-100 insulin into parts of the body below the surface skin.
The Hypodermic Needle for single use is intended for use with syringes and injection devices for general purpose fluid injection/aspiration.
| Device Name | Intended Use | Nozzel | Nominal Capacity / Gauge | Material | Remark |
|---|---|---|---|---|---|
| Syringe | Syringe is intended for dispensing/ administering fluids, and collecting/ sampling of fluid in medical practice. | Luer Slip | 1ml、2ml、3ml、5ml、10ml、20ml、30ml、50ml | PP/PE | With or Without Needle |
| Insulin Syringe | Insulin syringe (U-100) with fixed needle is a device intended for medical purposes for the manual aspiration of U-100 insulin, and for the injection of U-100 insulin into parts of the body below the surface skin. | Fixed | 0.3ml、0.5ml、1ml | PP/PE | With Fixed Needle |
| Hypodermic Needle | Hypodermic Needle is intended for use with syringes and injection devices for general purpose fluid injection/aspiration. | Female 6% Luer Conical Socket | 16G, 18G, 19G, 20G, 21G, 22G, 23G, 24G, 25G, 26G, 27G, 28G, 29G, 30G | SUS 304 Stainless Steel / PP | - |
This is a 510(k) premarket notification for general hospital devices (syringes and needles), not an AI/ML medical device. Therefore, many of the requested categories for AI/ML device evaluation are not applicable.
Here's the information that can be extracted relevant to acceptance criteria and device performance:
Acceptance Criteria and Device Performance for Syringes and Needles
This document describes a 510(k) submission for conventional medical devices (syringes and needles), not an AI/ML medical device. As such, the acceptance criteria are based on compliance with established international standards for these types of devices, rather than performance metrics like sensitivity, specificity, or AUC typically used for AI/ML.
1. Table of Acceptance Criteria and the Reported Device Performance:
| Device | Acceptance Criteria (Standard Compliance) | Reported Device Performance |
|---|---|---|
| Syringe (with/without needle) | Performance: Conforms to ISO 7886-1 and ISO 7864 | |
| Biocompatibility: Conforms to ISO 10993 | ||
| Sterility: EtO Sterilization | ||
| Nozzle: Luer Slip | ||
| Gradations Legibility: Legible | ||
| Barrel Transparency: Transparent and clear | ||
| Labeling: Meet FDA requirements | Performance: "Conforms to ISO 7886-1 and ISO 7864" | |
| Biocompatibility: "Conforms to ISO 10993" | ||
| Sterility: "EtO Sterilization" | ||
| (All reported to be equivalent to predicate device) | ||
| Insulin Syringe (U-100) with fixed needle | Performance: Conforms to ISO 8537 | |
| Biocompatibility: Conforms to ISO 10993 | ||
| Sterility: EtO Sterilization | ||
| Nozzle: Fixed | ||
| Gradations Legibility: Legible | ||
| Barrel Transparency: Transparent and clear | ||
| Labeling: Meet FDA requirements | Performance: "Conforms to ISO 8537" | |
| Biocompatibility: "Conforms to ISO 10993" | ||
| Sterility: "EtO Sterilization" | ||
| (All reported to be equivalent to predicate device) | ||
| Hypodermic Needle for single use | Performance: Conforms to ISO 7864 | |
| Biocompatibility: Conforms to ISO 10993 | ||
| Sterility: EtO Sterilization | ||
| Nozzle: Female 6% luer conical socket | ||
| Labeling: Meet FDA requirements | Performance: "Conforms to ISO 7864" | |
| Biocompatibility: "Conforms to ISO 10993" | ||
| Sterility: "EtO Sterilization" | ||
| (All reported to be equivalent to predicate device) | ||
| General Acceptance (all devices) | Physical properties: Meet design specifications (e.g., nominal capacity, needle gauge, material properties) | Bench tests conducted to verify compliance with design specifications and standards. (Results state "the proposed devices comply with the following standards...") |
Study Proving Device Meets Acceptance Criteria:
The study proving the device meets the acceptance criteria is a non-clinical bench testing summary.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated in the provided document. The document mentions "Bench tests were conducted," implying laboratory testing on a sample of devices, but the exact number of units tested is not provided.
- Data Provenance: The tests were "Bench tests" which typically means laboratory-controlled testing. There is no mention of country of origin for the data or whether it was retrospective or prospective in the context of clinical data, as this is a non-clinical submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. For this type of device (syringes and needles), "ground truth" is established by adherence to engineering performance standards (ISO standards) and material specifications, verified through objective bench testing. It does not involve expert interpretation or clinical ground truth as would be relevant for an AI/ML diagnostic device.
4. Adjudication method for the test set:
- Not applicable. No adjudication method is described because there is no subjective interpretation or clinical assessment involved in establishing ground truth for these physical devices. Compliance is determined by objective measurements against established standard parameters.
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:
- Not applicable. This submission is for physical medical devices (syringes and needles), not an AI/ML diagnostic or assistive device. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/ML device.
7. The type of ground truth used:
- The "ground truth" for these devices is defined by international consensus standards (ISO 8537, ISO 7886-1, ISO 594-1, ISO 594-2, ISO 7864, ISO 10993) and the design specifications of the device (e.g., nominal capacity, material composition, transparency, legibility of gradations). These are objective, measurable criteria.
8. The sample size for the training set:
- Not applicable. This submission is for physical medical devices, not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. See point 8.
§ 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).