(316 days)
The Disposable High Pressure Syringe is intended for the injection of contrast media or saline. This syringe is for single use and it shall be used with US legally marketed angiographic injectors.
The Disposable High Pressure Syringe is available in packs, which may include different configurations of syringes and accessories, the accessories include connector tube, Quick fill tube and Spike.
The syringes are plastic, disposable syringes, which are available in various models and configurations. They are intended to be used with an U.S. legally marketed angiography injector.
The connector tube is used to connect the syringe and the catheter. They are also available in three configurations, which are WLP Series tube with one syringe connector (used with single shot syringe), WLT Series tube and WLM Series tube with two syringe connectors (used with dual shot syringe). The three connector tubes can withstand maximum pressure of 350psi.
The Quick Fill Tube and the Spike is used to draw drug into the syringe.
The proposed devices are intended to be used with an U.S. legally marketed angiography injector; compatibilities are shown in Table 1.
This document is a 510(k) Pre-market Notification for a medical device called the "Disposable High Pressure Syringe" by Union Medical Shenzhen Co., Ltd. It details the device's indications for use, description, compatibility, and a comparison to a predicate device to demonstrate substantial equivalence.
Here's an analysis of the provided text, focusing on the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance:
The acceptance criteria for this device are largely based on compliance with a set of recognized international and national standards. The reported device performance is that it "complies" with these standards.
| Acceptance Criteria (Standard Compliance) | Reported Device Performance |
|---|---|
| ISO 10993-7:2008 (Ethylene oxide sterilization residuals) | Complies |
| ASTM F 88/F88M-2015 (Seal strength) | Complies |
| ASTM F1140/F1140M-13 (Internal pressurization failure resistance) | Complies |
| USP37-NF32 (Bacterial Endotoxins Limit) | Complies (implied by "complies with the following standards") |
| ISO 11737-2:2009 (Sterilization of medical devices - Microbiological methods) | Complies |
| ISO 7886-2:1996 (Sterile hypodermic syringes for single use with power-driven syringe pumps) | Complies |
| ISO 594-1:1986 (Conical fittings with 6% Luer taper - General Requirements) | Complies |
| ISO 594-2:1998 (Conical fittings with 6% Luer taper - Lock Fitting) | Complies |
| ISO 10993-4:2002 (Biological evaluation of medical devices - Interactions with blood) | Conforms to requirements of ISO 10993 series Standards |
| ISO 10993-5:2009 (Biological evaluation of medical devices - In Vitro cytotoxicity) | Conforms to requirements of ISO 10993 series Standards |
| ISO 10993-10:2010 (Biological evaluation of medical devices - Irritation and skin sensitization) | Conforms to requirements of ISO 10993 series Standards |
| ISO 10993-11:2006 (Biological evaluation of medical devices - Systemic toxicity) | Conforms to requirements of ISO 10993 series Standards |
| Intended Use | Meets the stated intended use: "The Disposable High Pressure Syringe is intended for the injection of contrast media or saline. This syringe is for single use and it shall be used with US legally marketed angiographic injectors." |
| Mode of Operation | Power-driven operation, single use |
| Sterility | EO Sterilized |
| Single Use | Yes |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
The document does not explicitly state the sample sizes used for the non-clinical tests. It only lists the standards to which the device complies. Therefore, details like the exact number of syringes tested for seal strength or biocompatibility are not provided.
The data provenance is also not explicitly stated. However, the sponsor is "Union Medical Shenzhen Co., Ltd." located in Shenzhen, China, and the designated submission correspondent is "Mid-Link Consulting Co., Ltd" in Shanghai, China. This suggests the testing and data generation likely occurred in China. The testing appears to be prospective, as it's part of a premarket submission to demonstrate compliance before market release.
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):
This information is not applicable to this submission. The device is a physical, disposable medical device (syringe), not an AI or diagnostic imaging device that requires human expert review to establish ground truth for a test set. The "ground truth" for this device is based on objective measurements and compliance with engineering and biological safety standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable. Adjudication methods are typically associated with subjective assessments or disagreements among experts in diagnostic or AI performance studies. For a physical device undergoing engineering and biological testing, the results are typically quantitative and objective, and do not involve "adjudication" in this sense.
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:
This information is not applicable. An MRMC study is not relevant for a disposable syringe. This type of study investigates the performance of diagnostic devices or AI algorithms when used by multiple readers with multiple cases.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not applicable. This refers to the performance of an AI algorithm operating independently, which is not relevant for a physical medical device like a syringe.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this device is established through:
- International and national standards: These standards define acceptable physical properties (e.g., seal strength, Luer taper), chemical properties (e.g., EO residuals, bacterial endotoxins), and biological properties (e.g., biocompatibility).
- Objective physical and chemical measurements: Laboratory tests measure parameters like pressure resistance, seal integrity, and residual chemicals.
- Biological assays: Tests assess cytotoxicity, irritation, sensitization, and systemic toxicity.
8. The sample size for the training set:
This information is not applicable. The concept of a "training set" refers to data used to train machine learning models. This device is a physical product, not an AI model, and therefore does not have a training set.
9. How the ground truth for the training set was established:
This information is not applicable for the same reason as point 8.
§ 870.1650 Angiographic injector and syringe.
(a)
Identification. An angiographic injector and syringe is a device that consists of a syringe and a high-pressure injector which are used to inject contrast material into the heart, great vessels, and coronary arteries to study the heart and vessels by x-ray photography.(b)
Classification. Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.