(27 days)
The TERUMO® 31G ThinPro™ 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. This syringe with 31G needle is indicated for general use and for pediatric patients.
The TERUMO® 31G ThinPro™ 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 3/10 cc, 1/2 cc, and 1 cc volumes with a 31 gauge by 3/8 inch fixed hypodermic single lumen needle. Each syringe includes unit markings (3/10 cc = 1/2 unit markings, 1/2 cc = single unit markings, and 1 cc = two unit markings).
The provided text is for a 510(k) premarket notification for the TERUMO® 31G ThinPro Insulin Syringe. This type of submission focuses on demonstrating substantial equivalence to a previously cleared device, rather than providing extensive independent performance studies with detailed acceptance criteria and standalone algorithm performance as would be common for AI/ML devices.
Therefore, many of the requested sections (sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, training set details) are not applicable to this type of medical device submission.
Here's a breakdown of the information that can be extracted or inferred from the provided text, and how it relates to the questions:
1. A table of acceptance criteria and the reported device performance
For a 510(k) submission like this, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to predicate devices, especially regarding performance characteristics. Specific quantitative acceptance criteria or detailed performance metrics are typically not provided in the summary of a 510(k) unless there's a novel performance claim requiring new testing.
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance |
|---|---|
| Intended Use: Manual aspiration and injection of fluids (particularly insulin). Indicated for general and pediatric use. | "The performance of this device is equivalent to the predicates." The device shares the same intended use. |
| Design: Piston syringe with fixed hypodermic single lumen needle (3/10 cc, 1/2 cc, 1 cc volumes, 31 gauge by 3/8 inch needle, unit markings). | "The TERUMO® 31G ThinPro™ Insulin Syringe submitted in this 510k is substantially equivalent in intended use, design, technology/principles of operation, materials and performance to the cleared TERUMO® Insulin Syringe (K822083, K992802, & K001474 - Pediatric Indication) and the Becton Dickinson® Ultra-Fine™ II Insulin Syringe (K955235)." The description matches the predicates. |
| Technology/Principles of Operation: Manual operation. | "This device is operated manually." Same as predicates. |
| Materials: Materials used are safe and equivalent to predicate devices. | "The materials used in this device are the same as used in the TERUMO® Insulin Syringe (K822083, K992802, & K001474 - Pediatric Indication)." |
| Performance: Device functions similarly to predicate devices in terms of fluid delivery, needle integrity, and other relevant physical/functional characteristics. | "The performance of this device is equivalent to the predicates." "Differences between the devices do not raise any new issues of safety or effectiveness." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not explicitly stated. For substantial equivalence, performance testing typically involves verifying that the new device meets the same specifications as the predicate. This might involve internal testing, but specific sample sizes and detailed test protocols are usually not part of the 510(k) summary.
- Data Provenance: Not applicable/Not stated. This isn't a data-driven device in the sense of AI/ML, so "data provenance" as related to patient data isn't a concept that applies here. Performance testing would be done on the manufactured syringes themselves.
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)
- Not applicable. "Ground truth" in the context of expert consensus is relevant for AI/ML validation. For a physical medical device like a syringe, "ground truth" refers to established engineering specifications and performance standards which are evaluated through standard laboratory testing, not expert interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. See point 3.
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 is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Engineering Specifications and Performance Standards: For a syringe, the "ground truth" would be objective measurements against established engineering specifications (e.g., fluid volume accuracy, needle gauge, needle tip sharpness, material biocompatibility, sterility, plunger force) and performance standards (e.g., ISO standards for hypodermic syringes).
8. The sample size for the training set
- Not applicable. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established
- Not applicable. See point 8.
In Summary:
The provided text describes a TERUMO® 31G ThinPro™ Insulin Syringe seeking 510(k) clearance by demonstrating substantial equivalence to existing predicate devices. The "study" for this type of submission focuses on proving that the new device has the same intended use, design, technology, materials, and performance as the predicates, and that any differences do not raise new questions of safety or effectiveness. This is typically achieved through design analysis, material biocompatibility testing, and functional performance testing against established industry standards or internal specifications, rather than clinical trials or AI/ML specific validation methodologies.
§ 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).