(21 days)
The TERUMO® U-100 Insulin Syringe, with fixed hypodermic single lumen needle, is a device intended for medical purposes for the manual aspiration of fluids, and for the injection of fluids into parts of the body below the surface of the skin. This device is intended particularly for the aspiration and injection of insulin.
The Terumo U-100 Insulin Syringe is a sterile, single use piston syringe with a fixed hypodermic single lumen needle, designed for manual use. The syringe is available in 1/2cc and 3/10cc volumes with a 30 gauge by 3/8 inch fixed hypodermic single lumen needle.
This document refers to a 510(k) premarket notification for a medical device, which seeks to demonstrate "substantial equivalence" to a predicate device rather than fulfilling specific, quantitative acceptance criteria through a comparative effectiveness study in the way an AI/ML device might. Therefore, many of the requested categories for AI/ML device studies are not directly applicable.
However, I can extract the relevant information regarding performance and the study conducted to demonstrate equivalence.
Here's an interpretation based on the provided text:
Description of Device: TERUMO® U-100 Insulin Syringe, a sterile, single-use piston syringe with a fixed hypodermic single lumen needle, in 1/2cc and 3/10cc volumes with a 30 gauge by 3/8 inch fixed hypodermic single lumen needle. Intended for manual aspiration and injection of fluids, particularly insulin.
Acceptance Criteria for an AI Device and Reported Device Performance:
Not directly applicable as this is a medical syringe, not an AI device. The acceptance criteria here are focused on demonstrating "substantial equivalence" to predicate devices based on design, technology, materials, and performance. The "performance" aspect is demonstrated through testing that shows it functions comparably to existing, cleared devices.
Table of Acceptance Criteria and Reported Device Performance (as best as can be inferred for a medical device):
| Acceptance Criteria (Inferred for Substantial Equivalence) | Reported Device Performance (Demonstrated by Testing) |
|---|---|
| Intended Use Equivalence: Device intended for medical purposes for manual aspiration of fluids and injection of fluids (especially insulin), matching predicate devices. | The TERUMO® U-100 Insulin Syringe demonstrated substantial equivalence in intended use to the cleared Terumo Medical Corporation U-100 Insulin syringe (K822083) and the Becton Dickinson® Ultra Fine II Insulin Syringe (K955235). |
| Design/Technology/Principles of Operation Equivalence: Device design, technology, and operational principles are similar to predicate devices (manual operation, piston syringe with fixed hypodermic needle). | The TERUMO® U-100 Insulin Syringe demonstrated substantial equivalence in design, technology/principles of operation to the cleared Terumo Medical Corporation U-100 Insulin syringe (K822083) and the Becton Dickinson® Ultra Fine II Insulin Syringe (K955235). |
| Material Equivalence: Materials used in manufacturing are the same as the predicate device. | The materials used in the manufacture of the TERUMO® U-100 Insulin Syringe are the same materials used in the manufacture of the predicate device (K822083). Blood contacting materials were found to be biocompatible (in accordance with ISO-10993). |
| Performance Equivalence: Device functions comparably to predicate devices, ensuring safe and effective fluid aspiration/injection. This includes sterility, functionality, absence of particulate matter, and biocompatibility. | The performance of the TERUMO® U-100 Insulin Syringe was demonstrated to be equivalent to the cleared TERUMO U-100 Insulin Syringe (K822083) and the Becton-Dickinson® Ultra Fine II Insulin Syringe (K955235). |
Specific tests include:
- Sterilization Validation: Achieved Sterility Assurance Level (SAL) of 10⁻⁶ (EN 556).
- Manufacturing Control Tests: Functional and sterility tests performed on every lot.
- LAL Testing: Performed on production samples from every lot.
- Biocompatibility: Blood contacting materials tested per FDA General Program Memorandum #G95-1 (ISO-10993) and found biocompatible.
- Expiration Dating: Established at 5 years (60 months). |
| No New Issues of Safety or Effectiveness: Differences between the subject device and predicate devices do not introduce new safety or effectiveness concerns. | The conclusion explicitly states that "Differences between the devices cited in this section do not raise any new issues of safety or effectiveness." |
Study Details (as they apply to a non-AI medical device submission):
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Sample size used for the test set and the data provenance: Not explicitly stated as a "test set" in the context of an AI study. Instead, the "testing" involved:
- Validation of sterilization conditions (EN 556).
- Manufacturing control tests (functional and sterility) on "production samples from every lot number."
- LAL testing on "production samples from of every lot number."
- Biocompatibility testing on "blood contacting materials."
The specific number of units or samples for each of these tests is not quantified in the provided text, nor is the country of origin specified beyond implying manufacturing process validation. This is a retrospective submission based on compliance with standards and ongoing manufacturing controls.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI device usually refers to expert-labeled data. Here, "ground truth" is established by adherence to recognized medical device standards and established scientific methods for evaluating sterility, biocompatibility, and functionality. There's no panel of experts reviewing "cases."
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Not an AI study involving human readers.
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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 is a physical medical device (syringe), not an AI system.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" is based on established medical device standards and scientific testing methodologies to ensure sterility, functionality, biocompatibility, and manufacturing quality. For example, a "Sterility Assurance Level (SAL) of 10⁻⁶" is a quantitative standard.
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The sample size for the training set: Not applicable. This is not an AI device that requires a training set.
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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).