(19 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 Iml Terumo Syringe with/without Needle consists of 3 main parts or 4 parts, i.e., a barrel, plunger, gasket and a hypodermic needle (for with 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. The needle is made from stainless steel. The 1 ml Terumo Syringe with/without Needle is individually packed in peel blister that ensures the sterility of the device until the package is opened. The product is sterilized by electron beam sterilization. The product is for single use only and is not intended for reuse.
Here's an analysis of the provided 510k summary regarding the acceptance criteria and the study that proves the device meets those criteria:
This document is a 510(k) premarket notification for a medical device that demonstrates substantial equivalence to a predicate device, rather than proving performance against novel acceptance criteria through a clinical study. Therefore, many of the requested fields related to AI/MRMC studies or detailed ground truth establishment for novel algorithms are not applicable.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from Performance Section) | Reported Device Performance (from Performance Section) |
|---|---|
| Leakage (Aspiration and Injection) | Subjected to testing |
| Plunger Mobility | Subjected to testing |
| Plunger Gasket Fit | Subjected to testing |
| Plunger Stopper Strength | Subjected to testing |
| Deadspace | Subjected to testing |
| Nominal Graduation Capacity | Subjected to testing |
| Packaging Seal Strength | Subjected to testing |
| Biocompatibility (blood contacting materials) | Tested in accordance with ISO 10993-1; results demonstrate materials are biocompatible. |
| Sterility (SAL) | Validated in accordance with ISO 11137-1995 to a SAL of 10⁻⁶. |
| Manufacturing Controls | Included visual, functional, dimensional, and sterility tests. |
Study Proving Acceptance Criteria:
The document states that the "1ml Terumo Syringe with/without needle submitted in this premarket notification was subjected to the following tests," listing the performance criteria mentioned above. It also explicitly states, "The 1ml Terumo Syringe with/without needle is substantially equivalent in intended use, materials, design, technology and principles of operation and performance to cleared Terumo Syringes with/without needle cleared under K023271."
This indicates that the "study" proving acceptance criteria is bench testing for the listed performance characteristics and material biocompatibility/sterility validation as per international standards, followed by a demonstration of substantial equivalence to an already cleared predicate device (K023271). The specific numerical results or detailed methodology for each test are not provided in this summary but would have been part of the full submission.
2. Sample size used for the test set and the data provenance
The document does not specify the sample sizes for the bench tests. Data provenance is not applicable in the context of bench testing for a physical medical device; the tests would have been performed in a laboratory setting by the manufacturer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable since this is a physical medical device undergoing bench testing and not an AI/diagnostic device requiring expert ground truth establishment for a test set.
4. Adjudication method for the test set
This is not applicable as there is no 'ground truth' in the sense of expert review for diagnostic output. Bench testing results would be objective measurements against defined specifications.
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
No, an MRMC comparative effectiveness study was not done. This device is a manual syringe and does not involve AI or human "readers" in its operation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. This device is a physical, manually operated syringe.
7. The type of ground truth used
The "ground truth" for this device's performance is based on predefined engineering specifications and international standards, such as ISO 10993-1 for biocompatibility and ISO 11137-1995 for sterilization. For example, for "deadspace," the ground truth is a specific maximum allowable volume. For "leakage," the ground truth is a pass/fail against a specific pressure or volume.
8. The sample size for the training set
This is not applicable as there is no "training set" for a physical medical device like a syringe.
9. How the ground truth for the training set was established
This is not applicable as 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).