(65 days)
The DuoPro Safety Syringe (DuoProSS™) is a sterile, single-use, disposable and non-reusable, manual, retractable safety syringe which is intended for injection of fluids into the body, while reducing the risk of sharps injuries and the potential for syringe reuse.
The DuoPro Safety Syringe (DuoProSS™) is a sterile, single-use, disposable and non-reusable, manual, retractable 3 mL safety syringe, provided with or without needle in various product configurations.
The provided text describes a 510(k) submission for a medical device, the DuoPro Safety Syringe (DuoProSS™). However, it does not contain the detailed performance study results, specific acceptance criteria, or the methodology (like expert consensus, sample sizes for training/test sets, or MRMC studies) that would typically be associated with software or AI-driven diagnostic devices.
The document is a premarket notification for a physical medical device (a syringe) and focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and bench testing of performance, rather than a clinical study evaluating diagnostic accuracy.
Therefore, many of the requested categories for AI/software-driven device evaluation are not applicable or not explicitly stated in this document.
Here's an attempt to answer based on the provided text, highlighting where information is absent:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Biocompatibility: Device materials are biologically safe. | Tests performed. Specific results not detailed, but implied to meet criteria for clearance. |
| Measurement of Latex Protein: Device is free from harmful levels of latex protein. | Tests performed. Specific results not detailed, but implied to meet criteria for clearance. |
| Packaging Integrity: Packaging maintains sterility and integrity. | Tests performed. Specific results not detailed, but implied to meet criteria for clearance. |
| Standards Conformity: Device meets relevant industry standards. | Tests performed. Specific results not detailed, but implied to meet criteria for clearance. |
| Simulated Use Test: Device performs as intended during simulated use, especially regarding safety features. | Bench testing shows that the performance of the DuoProSS™ is equivalent to the E.N.S.I. product (predicate device). This is the key "performance" claim. |
| Reduction of sharps injuries: Device effectively reduces this risk. | Stated as an intended function ("reducing the risk of sharps injuries"). Implied to be demonstrated through design and simulated use testing to be equivalent to predicate. |
| Reduction of potential for syringe reuse: Device effectively prevents reuse. | Stated as an intended function ("reducing... the potential for syringe reuse"). Implied to be demonstrated through design (manual, retractable, non-reusable) and simulated use testing to be equivalent to predicate. |
| Sterile, single-use, disposable, non-reusable: Meets these functional requirements. | Device described as meeting these characteristics. |
| Manual, retractable safety syringe: Functions as described. | Device described as meeting these characteristics. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. The document mentions "Bench testing" and "simulated use test" but does not provide the number of units tested.
- Data Provenance: Not applicable in the context of clinical data for an AI/software device. For the physical device, testing was conducted to demonstrate equivalence, likely in a lab setting by the manufacturer (M.K. Meditech Co., Ltd. in Taiwan).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This is not a study requiring expert readers to establish ground truth for a diagnostic image or data set. The performance testing relates to physical device functions and safety mechanisms.
4. Adjudication method for the test set
- Not applicable. As noted above, this is about physical device performance, not diagnostic accuracy evaluation.
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 software.
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 would be its functional specifications and safety requirements as defined by regulatory standards (e.g., ISO, FDA guidance) and the performance of the predicate device. For example, a "ground truth" for retraction would be successful, complete retraction every time without user error, as designed. For biocompatibility, it would be the absence of adverse biological reactions.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/machine learning device.
In summary, the provided 510(k) summary focuses on demonstrating that a new physical medical device is "substantially equivalent" to an already legally marketed predicate device. This is primarily done through comparing design, intended use, technological characteristics, and showing that "bench testing" supports equivalent performance. It is important to note that the depth of detail requested for AI/software devices (e.g., sample sizes for training/test, expert consensus, MRMC studies) is not typically part of a 510(k) summary for a physical, non-diagnostic 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).