(78 days)
The Terumo Syringe with/without needle is intended to be used for medical purposes to inject fluids into or withdraw fluids from the body.
The Terumo Syringe with/without needle consists mainly of 3 parts or 4 parts: a barrel, a plunger, a gasket and a needle (for the needle type). Barrel is made from polypropylene and is designed with clear graduations and figures for easy use. The gasket is made from a highly inert thermoplastic elastomer material facilitates smooth movement of the plunger and aids the user in controlling dosage. The needle is made from stainless steel and the needlepoint is carefully designed to minimize resistance at the skin surface and aids in smooth, easy insertion. The Terumo Syringe with/without Needle is individually packed in peel blister that ensures the sterility of the device until the package is opened.
This document describes the 510(k) summary for the Terumo Syringe with/without Needle. It demonstrates substantial equivalence to a predicate device, K980181, rather than proving performance against specific acceptance criteria in a quantitative study. Therefore, some of the requested information, such as sample sizes, expert qualifications, and specific effect sizes, are not applicable or not provided in the given text.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not present a table of specific quantitative acceptance criteria with corresponding performance metrics. Instead, it lists various tests performed to demonstrate safety and efficacy and asserts that the device is "safe and effective during handling and for the duration of its expiration." The implicit acceptance criterion for each test is that the new device performs acceptably and equivalently to the predicate device.
| Performance Test | Reported Device Performance |
|---|---|
| Cleanliness | Not explicitly quantified, but implied to be acceptable. |
| Leakage Test | Not explicitly quantified, but implied to be acceptable. |
| Sliding Resistance | Not explicitly quantified, but implied to be acceptable. |
| Plunger and Gasket Fit Force | Not explicitly quantified, but implied to be acceptable. |
| Nozzle-needle Fit Force | Not explicitly quantified, but implied to be acceptable. |
| Initial Movement Force | Not explicitly quantified, but implied to be acceptable. |
| Stopper Force | Not explicitly quantified, but implied to be acceptable. |
| Dead Space | Not explicitly quantified, but implied to be acceptable. |
| Equal to Nominal Capacity Graduation Tolerance | Not explicitly quantified, but implied to be acceptable. |
| Between Main Capacity Graduation Tolerance | Not explicitly quantified, but implied to be acceptable. |
| Primary Container Seal Strength | Not explicitly quantified, but implied to be acceptable. |
| Silicone Amount Determination | Not explicitly quantified, but implied to be acceptable. |
| Elution Test Method | Not explicitly quantified, but implied to be acceptable. |
| Analysis of Heavy Metals | Not explicitly quantified, but implied to be acceptable. |
| Determination of pH | Not explicitly quantified, but implied to be acceptable. |
| Sterility Assurance Level (SAL) | 10⁻⁶ (validated in accordance with ISO 11137) |
| Performance (aged and non-aged devices) | Aging process does not adversely affect device performance. |
2. Sample Sizes Used for the Test Set and Data Provenance
The document does not specify the sample sizes used for the various performance tests. The data provenance is Terumo (Philippines) Corporation, and the tests were likely conducted prospectively as part of the device development and validation process.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. This is a medical device clearance based on substantial equivalence, not an AI or diagnostic tool requiring expert ground truth for a test set. The "ground truth" here is compliance with established performance standards and equivalence to a predicate device.
4. Adjudication Method for the Test Set
Not applicable. This is a medical device clearance based on substantial equivalence, not an assessment requiring adjudication of diagnostic outcomes.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This device is a manual syringe, and its performance evaluation does not involve human readers interpreting diagnostic cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. The device is a manual syringe, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" in this context is based on:
- Compliance with recognized standards: For tests like cleanliness, leakage, and sterility (ISO 11137).
- Engineering specifications and design requirements: For physical and mechanical properties.
- Demonstrated performance of the legally marketed predicate device: The new device must perform comparably to the predicate.
8. The Sample Size for the Training Set
Not applicable. This is a medical device, not a machine learning model, so there is no "training set."
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).