(120 days)
The 50 ml Terumo Syringes for administration of UV sensitive medicines are sterile hypodermic syringes for single use, intended for the aspiration of fluids and blood, or for the injection of fluids immediately after filling. Intended for manual use or for use with power driven syringe pumps. The opaque color of the barrel allows the administration of UV sensitive medicines.
The 50 ml Terumo Syringe for Administration of UV Sensitive Medicines is a hypodermic standard piston syringe for single use, with a 6 % luer lock tip, made of plastic material and a synthetic rubber gasket. The barrel of the syringes has an opaque color to avoid the transmission of UV light. The 6% luer lock tip allows the use with power driven syringe pumps.
The provided text describes a 510(k) summary for the "50 ml Terumo Syringe for Administration of UV Sensitive Medicines." This document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study against specific acceptance criteria for algorithm performance.
Therefore, many of the requested elements for describing the acceptance criteria and the study that proves the device meets them, particularly those related to AI algorithm performance (like sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, and how ground truth for training was established), are not applicable to this type of medical device submission.
The "Performance" section explicitly states: "The 50 ml Terumo Syringe was tested in accordance with EN ISO 7886-1 (1997) and EN ISO 7886-2 (1997). Other testing included barrel transmission and UV protection of the opaque barrel." This indicates that the acceptance criteria are defined by these international standards for syringes and specific tests related to the UV-sensitive aspect of the device.
Here's a breakdown based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard/Test) | Reported Device Performance |
|---|---|
| EN ISO 7886-1 (1997) | Tested in accordance |
| EN ISO 7886-2 (1997) | Tested in accordance |
| Barrel Transmission | Tested (implied satisfactory) |
| UV Protection (Opaque Barrel) | Tested (implied satisfactory) |
| EN 550: "Sterilization of Medical Devices: Validation and routine control of ethylene oxide" | Sterility assured to SAL of 10⁻⁶ |
| ISO 11135: "Medical Devices: Validation and routine control of ethylene oxide sterilization" | Sterility assured to SAL of 10⁻⁶ |
| EN 556-1: "Sterilization of Medical Devices - Requirements for medical devices to be designated "STERILE" - Part - 1: Requirements for terminally sterilized medical devices" | Sterility assured to SAL of 10⁻⁶ |
| EN ISO 10993-7: "Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals" | Ethylene oxide residual levels in compliance |
| FDA General Program Memorandum #G95-1 (5/1/95): Use of International Standard ISO-10993. "Biological Evaluation of Medical Devices Part-1: Evaluation and testing" | Blood contacting materials biocompatible |
| Expiration Dating | Established at 5 years |
2. Sample size used for the test set and the data provenance
The document does not specify sample sizes for the performance testing. The provenance of the data is implicit as it's a device manufactured by Terumo Europe N.V., suggesting the testing was conducted to European and international standards. It's a new device, so the testing would be prospective in nature, demonstrating compliance with specified standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable for a medical device like a syringe. Performance is measured against predefined engineering and biological standards, not expert interpretations of medical images or conditions.
4. Adjudication method for the test set
Not applicable. Performance is based on direct physical and chemical measurements against established 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 physical syringe, not an AI algorithm.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical syringe, not an AI algorithm.
7. The type of ground truth used
The "ground truth" for this device is defined by the requirements outlined in the referenced international standards (e.g., ISO, EN standards) and FDA biocompatibility guidelines. For example, for sterility, the ground truth is a sterility assurance level (SAL) of 10⁻⁶ as defined in EN 556-1. For biocompatibility, the ground truth is "biocompatible" as determined by tests recommended in FDA guidance and ISO 10993-1.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires 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).