(177 days)
The Terumo Syringe with/without needle is a sterile hypodermic syringe for single use, intended for the aspiration of fluids and blood, or for the injection of fluids immediately after filling.
The Terumo Syringe with/without needle is a hypodermic standard piston syringe, available in volumes from 1 ml, 2 ml, 10 ml and 50 ml, with a luer taper tip for single use, made of plastic material and a synthetic rubber gasket. The needle is made from stainless steel.
The provided text describes a 510(k) submission for a medical device, the Terumo® Syringe with/without Needle. It focuses on demonstrating substantial equivalence to predicate devices and adherence to relevant standards, rather than presenting a study of the device's diagnostic performance or algorithm effectiveness. As such, many of the requested categories for acceptance criteria and study details are not relevant or cannot be extracted from this type of regulatory document.
However, I can extract information related to the device's performance testing against a recognized standard, which serves as its primary acceptance criteria in this context.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| Mechanical Performance: | |
| EN ISO 7886-1 (1993) | |
| (Sterile hypodermic syringes for single use - Part 1: Syringes for manual use) | "The Terumo syringe with/without needle was tested in accordance with EN ISO 7886-1 (1993)." |
| Implicitly, the device meets the performance requirements of this standard for its mechanical and functional aspects. The submission states, "None of the obtained data raises any new issues of safety and effectiveness." | |
| Needle Properties: | |
| (Reference to cleared Neolus Needles, K001572) | "For the needle properties, reference is made to the cleared Neolus Needles compared to in the submitted file K001572." |
| This indicates that the needles used with the syringe meet the established properties of the predicate Neolus Needles. | |
| Hemocompatibility: | |
| EN ISO 10993-4 (2002) and amendment (2006) | |
| (Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood) | "In accordance with the new requirements stipulated in EN ISO 10993-4 (2002) and its amendment (2006) the hypodermic needles were also subjected to additional hemocompatibility testing. A declaration for compliance with the requirements of these tests can be found on page 177." |
| This indicates testing was performed and compliance was declared, implying the device meets these criteria. | |
| Sterility Assurance Level (SAL): | |
| EN 550 ("Sterilization of Medical Devices: Validation and routine control of ethylene oxide sterilization") | |
| ISO 11135 ("Medical Devices: Validation and routine control of ethylene oxide sterilization") | |
| EN 556-1 ("Sterilization of Medical Devices - Requirements for medical devices to be designated "STERILE" - Part - 1: Requirements for terminally sterilized medical devices") | "The sterility of the Terumo Syringe with/without needle is assured by using a validated sterilization method qualified in accordance with EN 550... and ISO 11135... to a sterility assurance level (SAL) of 10^-6 as required by EN 556-1..." |
| This confirms the device achieves the required SAL. | |
| Ethylene Oxide Residual Levels: | |
| ISO 10993-7 ("Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals") | "Ethylene oxide residual levels and Ethylene Chlorohydrin residual levels resulting from EtO sterilization are in compliance with ISO 10993-7..." |
| This confirms the device complies with the residual limits. | |
| Biocompatibility: | |
| EN ISO 10993-1 ("Biological Evaluation of Medical Devices. Part-1: Evaluation and testing.") | "The device is tested for biocompatibility requirements in accordance with the tests stipulated in EN ISO 10993-1... The results of the testing demonstrate that the device is biocompatible." |
| This confirms the device meets biocompatibility requirements. | |
| Expiration Dating: | |
| (No specific standard mentioned, but a characteristic of medical devices) | "The expiration dating for the Terumo Syringe with/without needle has been established at 5 years." |
| This indicates a tested and validated shelf-life. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The document mentions "testing" and "data" but does not quantify the sample sizes used for each specific test (e.g., how many syringes were tested for dimensional accuracy, or how many batches for sterility).
- Data Provenance: The device is manufactured by Terumo Europe N.V., in Belgium. The submission states the device "was tested in accordance with EN ISO 7886-1 (1993)", suggesting the testing was performed, or overseen, by the manufacturer or a certified testing facility in relation to its European operations. The description is of the device's inherent physical and material properties, rather than clinical data from human subjects. It's a laboratory/engineering performance study, not a clinical study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This document describes laboratory and engineering performance testing against established international standards. There is no "ground truth" established by human experts in the sense of clinical diagnoses or interpretations. The "truth" is defined by the objective pass/fail criteria of the scientific/engineering standards.
4. Adjudication method for the test set:
- Not applicable. This relates to clinical studies with human review, which is not what this document describes. Performance is assessed against quantitative metrics and methods specified within the referenced ISO/EN 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:
- Not applicable. This device is a manual syringe, not an AI-assisted diagnostic or therapeutic tool. Therefore, MRMC studies and AI performance metrics are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a manual syringe, not an algorithm.
7. The type of ground truth used:
- For the performance testing, the "ground truth" is defined by the objective, quantitative criteria and test methods specified in the referenced international standards (e.g., EN ISO 7886-1, EN ISO 10993 series, EN 550, ISO 11135, EN 556-1). This includes measurements of physical properties, chemical residual levels, and biological responses.
8. The sample size for the training set:
- Not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established:
- Not applicable. There is no "training set" for this device.
§ 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).