(130 days)
Weigao Disposable Empty Cartridge Syringe is intended for use in the withdrawal and administration of fluid in accordance with the best judgment of the physician.
The subject device of Weigao Disposable Empty Cartridge Syringe is an empty cartridge syringe that consists of a hollow barrel and a movable plunger. The syringes are designed for manual use. The applicant syringe's main components are made of glass.
The provided text is a 510(k) summary for a medical device called "Weigao Disposable Empty Cartridge Syringe." It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain specific acceptance criteria, detailed study results, sample sizes for test or training sets, ground truth establishment methods, expert qualifications, or details about comparative effectiveness studies (MRMC) or standalone performance.
The document primarily focuses on demonstrating that the device is substantially equivalent to a pre-existing device (K820164, Empty Sterile Carpuject® Cartridge) based on shared technical characteristics and safety/effectiveness.
Here's a breakdown of the information that can be extracted, and what is missing based on your request:
Information Present:
- Device Name: Weigao Disposable Empty Cartridge Syringe
- Intended Use: "Weigao Disposable Empty Cartridge Syringe is intended for use in the withdrawal and administration of fluid in accordance with the best judgment of the physician."
- Predicate Device: K820164, Empty Sterile Carpuject® Cartridge (by Hospira, Inc.)
- Testing Conducted (general):
- Biocompatibility tests (following ISO 10993)
- Performance bench tests (following ISO 11040-4, ISO 7886-1, ISO 9626)
- Device Description: "an empty cartridge syringe that consists of a hollow barrel and a movable plunger. The syringes are designed for manual use. The applicant syringe's main components are made of glass."
- Key Specifications Mentioned: "Model 1 ml Slim with scale marks (fixed with Needle 27G)"
Missing Information (Crucial for your request):
- A table of acceptance criteria and the reported device performance: This document only states that performance bench tests were conducted following certain ISO standards (ISO 11040-4, ISO 7886-1, ISO 9626). It does not provide the specific acceptance criteria defined within those standards for this device, nor does it report the actual results of these tests (e.g., specific force measurements, leakage rates, etc.) against any criteria.
- Sample sizes used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this is a physical device and the testing refers to bench tests against standards, not diagnostic performance with human interpretation.
- Adjudication method for the test set: Not applicable for this type of device and testing.
- 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-powered diagnostic system.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.
- The type of ground truth used: For physical performance tests, the "ground truth" would be the engineering specifications and requirements outlined in the ISO standards. The document only lists the standards, not the specific pass/fail criteria from them.
- The sample size for the training set: Not applicable. This is a physical device, not a machine learning model.
- How the ground truth for the training set was established: Not applicable.
Conclusion:
Based on the provided text, it's impossible to create the requested table of acceptance criteria and reported device performance, or to answer the majority of your questions. The document is a regulatory summary demonstrating substantial equivalence for a physical medical device, not a detailed study report for an AI or diagnostic tool. It indicates that certain types of tests were conducted according to international standards (ISO 10993, ISO 11040-4, ISO 7886-1, ISO 9626), but it does not specify the acceptance criteria used or the quantitative results achieved by the 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).