(14 days)
The Wuzhou Syringe, with/without needle for single use only, is intended to be used for medical purposes to inject fluids into or withdraw fluids from the body.
The Wuzhou Syringe, with/without needle, is a standard piston syringe 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 syringe is designed for manual use. It is available in 1, 2, 3, 5, 10, 20, 30, 50, 60 and 100ml volumes, with luer slip, luer lock, centrally or eccentrically tip configurations. Syringe with 50 ml volume is irrigating syringe.
The provided text describes a 510(k) premarket notification for a medical device, the Wuzhou Syringe, with/without needle. This submission demonstrates substantial equivalence to a predicate device, rather than providing a detailed study that proves the device meets specific acceptance criteria through novel performance data.
Therefore, many of the requested elements (e.g., sample size for test set, number of experts, MRMC studies, standalone algorithm performance, training set details) are not applicable to this type of regulatory submission. The information provided focuses on conformance to established standards and comparison to a legally marketed predicate device.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
Instead of specific acceptance criteria for a novel performance study, the document asserts conformance to various international and national standards. These standards define the "acceptance criteria" for the device's design, materials, and functional properties. The reported device performance is implicitly "conforms to" these standards and is "substantially equivalent" to the predicate device.
| Acceptance Criteria (Standards Conformed To) | Reported Device Performance |
|---|---|
| Mechanical/Physical Standards: | |
| GB 15810-2001 (ISO 7886-1) - Sterile Hypodermic Syringe for Single Use, Part 1: Syringe for manual use | Complies (implicitly, as part of substantial equivalence claim) |
| GB 15811-2001 (ISO 7864) - Sterile Hypodermic needles for Single Use | Complies (implicitly, as part of substantial equivalence claim) |
| GB/T 1962.1-2001 (ISO 594-1:1986) - Conical Fittings with a 6% Taper, Part 1: General Requirements | Complies (implicitly, as part of substantial equivalence claim) |
| GB/T 1962.2-2001 (ISO 594-2:1998) - Conical Fittings with a 6% Taper, Part 2: Lock Fitting | Complies (implicitly, as part of substantial equivalence claim) |
| GB18457-2001 (ISO 9626) - Stainless Steel Needle Tubing for Manufacture of Medical Devices | Complies (implicitly, as part of substantial equivalence claim) |
| Sterilization Standards: | |
| GB18279-2000 (ISO 11135) - Medical Devices - Validation and Routine Control for Ethylene Oxide Sterilization | Complies (implicitly, as part of substantial equivalence claim) |
| Biocompatibility Standards: | |
| ISO 10993-1 - Biological Evaluation of Medical Devices: Evaluation and Testing | Complies (implicitly, as part of substantial equivalence claim) |
| ISO 10993-5 - Tests for Cytotoxicity | Complies (implicitly, as part of substantial equivalence claim) |
| ISO 10993-10 - Tests for Irritation and Sensitization | Complies (implicitly, as part of substantial equivalence claim) |
| ISO 10993-4 - Tests for Interactions with Blood | Complies (implicitly, as part of substantial equivalence claim) |
| ISO 10993-11 - Test for Systemic Toxicity | Complies (implicitly, as part of substantial equivalence claim) |
| Clean Room Standards: | |
| JGJ71-1990 - Practice of constructing and verifying clean room | Complies (implicitly, as part of substantial equivalence claim) |
| GB/T 16292-1996 (FS/209E) - Test method for airborne particles in clean room (area) of the pharmaceutical industry | Complies (implicitly, as part of substantial equivalence claim) |
| General Guidance: | |
| FDA guidance document, "Guidance on the Content of Premarket Notification [510(k)] Submission for Piston Syringes", dated April 1993 | Followed for submission content |
| Substantial Equivalence to Predicate Device (K042500, DuoProSS Syringe) | "Substantially equivalent in intended use, labeling, design and materials, and specifications." |
| "The DuoProSS Syringe (K042500) manufactured by DuoProSS Meditech Corporation." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. Performance data, if collected for compliance with the listed standards, would typically involve specific sample sizes as per the respective standard's requirements (e.g., for mechanical, sterility, and biocompatibility testing). However, specific test set sample sizes for a clinical performance study are not provided or required for this type of submission.
- Data Provenance: The document implies that the device "complies with" various standards. This suggests that internal testing or third-party laboratory testing was conducted according to these standards. The manufacturing company is based in Wenzhou, China, so testing likely occurred in China or at accredited international labs. The data would be "prospective" in the sense that it was generated for the purpose of demonstrating compliance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. This submission is based on conformance to engineering and biological standards, not on expert-adjudicated clinical ground truth for a diagnostic or prognostic performance claim.
4. Adjudication Method 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 device is a manual piston syringe, not an AI-assisted diagnostic or therapeutic device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not Applicable. This device is a manual piston syringe, not an algorithm.
7. The Type of Ground Truth Used
- The "ground truth" for this submission is established by the definitions and requirements within the referenced international and national standards (e.g., ISO, GB) and the characteristics of the legally marketed predicate device. For example, the "ground truth" for sterility would be a negative bacterial growth result when tested according to ISO 11135. The "ground truth" for material composition is the actual composition of the materials used in manufacturing.
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. See point 8.
§ 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).