(72 days)
The Terumo Disposable Hypodermic Syringe, with or without hypodermic single lumen needle, is used for injecting fluids into or withdrawing fluids from the body. The syringe is designed for manual use.
The Terumo Disposable Hypodermic Syringe, with or without a hypodermic single lumen needle, is a sterile, single use, standard piston syringe, designed for manual use. The syringe is available in 3, 5, 10, 20, 30 and 60 cc/ml volumes, with luer slip, luer lock, eccentric slip tip, or catheter tip configurations.
The provided text describes the Terumo Disposable Hypodermic Syringe and its substantial equivalence to a previously cleared device (K771205). The information primarily focuses on design, materials, and compliance with various international standards, rather than a clinical study with a detailed test set, ground truth, and expert evaluation for AI performance. Therefore, many of the requested categories related to AI performance, expert validation, and advanced study designs cannot be fully addressed from the given text.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The device is stated to meet the same range of performance acceptance criteria as its predicate device and complies with several international standards. Specific quantitative criteria and exact reported performance values are not provided, only compliance statements.
| Acceptance Criteria / Standard | Reported Device Performance |
|---|---|
| ISO 594-1:1986 | Complies |
| ISO 594-2:1986 | Complies |
| Japan Ministry of Health and Welfare Notification No. 442: 12/28/70 (Section II, Item #3 barrel volume) | Complies |
| ISO 7886-1 (Leakage) | Complies |
| ISO 7886-1 (Aspiration) | Complies |
| ISO 7886-1 (Injection) | Complies |
| ISO 7886-1 (Plunger Mobility/Gasket Slide) | Complies |
| ISO 7886-1 (Dead Space) | Complies |
| ISO 7886-1 (Silicone Quantity) | Complies |
| ISO 7886-1 (Graduation Location) | Complies |
| ISO 594-1, ISO 594-2 (Conical Fitting/Luer Taper) | Complies |
| Japan Ministry of Health & Welfare, No. 442: 12/28/70 (Barrel Volume) | Complies |
| Sterility Assurance Level (SAL) | 10^-6 (validated per EN 556) |
| Biocompatibility (Blood contacting materials) | Found to be biocompatible (per FDA G95-1) |
| Expiration Dating | 5 years (60 months) |
2. Sample size used for the test set and the data provenance
Not applicable in the context of a substantial equivalence submission for a hypodermic syringe. This submission relies on engineering and manufacturing tests against standards, not a clinical test set with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth for the mechanical and material performance of a syringe is established by testing against engineering specifications and international standards, not by expert consensus on clinical data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically used in clinical studies for interpretation of ambiguous cases, which is not relevant for the performance testing of a syringe.
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 is a medical device for manual fluid injection/withdrawal, not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done
Not applicable, as this is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the device's performance is compliance with established international and national standards (e.g., ISO 594-1, ISO 7886-1, Japan Ministry of Health and Welfare Notification No. 442) for mechanical, material, and safety aspects, as well as validated sterility and biocompatibility testing.
8. The sample size for the training set
Not applicable, as this is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 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).