(71 days)
The Sterile Hypodermic Syringe for Single Use is intended for dispensing/ administering fluids, and collecting/ sampling of fluid in medical practice. Their function is mechanical.
The sterile Insulin Syringe for single use with fixed needle is a device is a device intended for medical purposes for the manual aspiration of insulin, and for the injection of insulin, and for the injection of insulin into parts of the body below the surface skin.
The Sterile Hypodermic Needle for single use is intended for use with syringes and injection devices for general purpose fluid injection/aspiration.
Not Found
The provided text is a 510(k) Summary for medical devices (syringes and needles) and does not contain information typically found in a study proving a device meets acceptance criteria for complex AI/ML-driven diagnostic devices. Specifically, this document is a premarket notification for general medical devices, not a study report. Therefore, most of the requested information regarding AI/ML device performance evaluation methods (such as sample size for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) is not applicable or present in this document.
However, I can extract the device acceptance criteria implicitly mentioned and the general conclusion regarding meeting those criteria.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Meet all design specifications. | "Laboratory testing was conducted to validate and verify that Double-Dove Syringes and Needle met all design specifications..." (Section 7) |
| Be substantially equivalent to predicate devices (K980987, K071630, K070440). | "...and was substantially equivalent to the predicate device." (Section 7) |
| "The subject device, Double-Dove Syringes and Needle, is substantially equivalent to the predicate device." (Section 8) | |
| FDA's conclusion: "...have determined the device is substantially equivalent..." (Page 4) | |
| Function for intended use: |
- Sterile Hypodermic Syringe: dispensing/administering fluids, collecting/sampling of fluid.
- Sterile Insulin Syringe: manual aspiration of insulin, injection of insulin.
- Sterile Hypodermic Needle: use with syringes for fluid injection/aspiration. | The successful substantial equivalence determination implies that the devices are expected to perform their stated intended uses as safely and effectively as their predicate devices. |
Study Details (Based on available information and understanding of 510(k) for these types of devices)
-
Sample size used for the test set and the data provenance:
- Sample Size: Not specified. For physical medical devices like syringes and needles, testing typically involves a sufficient number of units to demonstrate statistical confidence in meeting specific physical and chemical standards (e.g., sterility, fluid tightness, material compatibility, needle sharpness, break force, etc.).
- Data Provenance: Not specified, but generally, such testing is performed in accredited laboratories. Given the sponsor's location (Shanghai, China), the testing would likely have been conducted in China, potentially at their own facilities or a contract research organization. The document indicates "Laboratory testing was conducted."
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. For these types of devices, "ground truth" is established through engineering and quality control tests comparing performance against defined standards (e.g., ISO standards, ASTM standards) and predicate device specifications, rather than expert interpretation of diagnostic images or clinical observations.
-
Adjudication method for the test set:
- Not Applicable. Adjudication methods like 2+1 or 3+1 are used in diagnostic studies (especially for AI/ML) where there is ambiguity in human interpretation. For physical device testing, the results are typically quantitative measurements against objective pass/fail criteria.
-
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 premarket notification for physical medical devices (syringes and needles), not an AI-assisted diagnostic device. Therefore, no MRMC study or AI assistance is relevant.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an algorithm or software device.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Objective Standards and Predicate Device Performance: The "ground truth" here would be established by:
- International and national standards for sterile medical devices (e.g., ISO, ASTM).
- Performance specifications based on predicate devices.
- Measured physical, chemical, and biological properties (e.g., sterility, dimensional accuracy, mechanical strength, material safety).
- Objective Standards and Predicate Device Performance: The "ground truth" here would be established by:
-
The sample size for the training set:
- Not Applicable. There is no "training set" as this is not an AI/ML device.
-
How the ground truth for the training set was established:
- Not Applicable. No training set is involved.
In summary: The document confirms that laboratory testing was conducted to verify that the Double-Dove Syringes and Needles met all design specifications and were substantially equivalent to the predicate devices. This type of regulatory submission for general medical devices relies on objective physical and chemical testing against established standards and predicate device performance, rather than the complex clinical study paradigms used for AI/ML diagnostic tools.
§ 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).