(21 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 30 and 60cc/mL Syringes consist of 3 main parts, a barrel, plunger, and gasket. 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 syringes are individually packed in a 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.
The provided document is a 510(k) summary for the TERUMO® Syringe with/without needle, which is a medical device. This type of device is a physical product and not an AI/ML-driven software device. Therefore, the questions related to AI/ML specific performance, such as sample sizes for test and training sets, expert ground truth, adjudication methods, MRMC studies, and standalone algorithm performance, are not applicable to this submission.
However, I can extract the acceptance criteria and performance information relevant to this physical medical device.
1. Table of Acceptance Criteria and Reported Device Performance
The submission states that the Terumo Syringe without needle, 30 and 60cc/mL, was "subjected to the following tests." While explicit numerical acceptance criteria values are not provided in this summary, the completion of these tests with acceptable results is implied for substantial equivalence.
| Acceptance Criteria (Test) | Reported Device Performance |
|---|---|
| Leakage (Aspiration and Injection) | Tested (implied to have met criteria for substantial equivalence) |
| Plunger Mobility | Tested (implied to have met criteria for substantial equivalence) |
| Tip-hub fitting | Tested (implied to have met criteria for substantial equivalence) |
| Gasket fit | Tested (implied to have met criteria for substantial equivalence) |
| Nominal graduation capacity | Tested (implied to have met criteria for substantial equivalence) |
| Plunger stopper strength | Tested (implied to have met criteria for substantial equivalence) |
| Dead Space | Tested (implied to have met criteria for substantial equivalence) |
| Conical fitting | Tested (implied to have met criteria for substantial equivalence) |
| Biocompatibility | Tested in accordance with ISO 10993-1, results demonstrate blood contacting materials are biocompatible. (Specifically for "Externally Communicating Device, Limited contact" classification) |
| Sterilization Assurance Level (SAL) | Validated in accordance with ISO 11137-1995 to a SAL of 10^-6. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable as this is a physical device submission, not an AI/ML software submission involving data sets. Device testing would typically involve a sample size of physical units to perform the listed tests. The document does not specify the exact number of units tested for each criterion, but it confirms the tests were conducted. The device manufacturer is Terumo (Philippines) Corporation, and the product is manufactured in Biñan, Laguna, Philippines.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable as there is no "ground truth" in the context of an AI/ML algorithm for a physical syringe. The tests are directly measuring the physical properties and performance of the device against established standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as there is no "adjudication" in the context of an AI/ML algorithm for a physical syringe. Device testing results are typically objectively measured against 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
This is not applicable as this is a physical device and does not involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as this is a physical device and does not involve a standalone algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
This is not applicable. The "ground truth" for a physical syringe is its adherence to engineering specifications and performance standards established by regulatory bodies (e.g., ISO, FDA).
8. The sample size for the training set
This is not applicable as this is a physical device and does not involve a training set for an algorithm.
9. How the ground truth for the training set was established
This is not applicable as this is a physical device and does not involve a training set or its associated ground truth establishment.
§ 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).