(577 days)
The device is intended to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein. The maximum use time of the infusion sets shall not exceed 24 hours. The intravenous infusion needle should be used for only single dose administration and not to be left in place for more than 2 hours.
The proposed devices are indicated for the delivery of fluids from a container to a patient's vascular system through an infusion needle under the action of gravity. The proposed devices have 8 different configurations with 4 different filter sizes, and they are provided sterile and single use. The proposed devices include 32 models.
This document describes a 510(k) premarket notification for "Infusion Sets for Single Use." This is a medical device application that demonstrates "Substantial Equivalence" to a predicate device. This type of submission relies on non-clinical testing to support its claims, rather than clinical studies with human participants. Therefore, several of the requested categories are not applicable (N/A) to this document.
Here's a breakdown of the requested information based on the provided text:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a tabulated format with specific numerical targets. Instead, it refers to conformity with established international and US standards for medical devices. The "reported device performance" is implicitly that the device conforms to these standards, making it "substantially equivalent" to the predicate device and safe for its intended use.
| Acceptance Criterion (Standard) | Reported Device Performance |
|---|---|
| ISO 8536-4:2010 (Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed) | Conforms |
| ISO 8536-14:2016 (Clamps and flow regulators) | Conforms |
| ISO 80369-7:2016 (Small-bore connectors for intravascular or hypodermic applications) | Conforms |
| ISO 80369-20:2015 (Small-bore connectors - Common test methods) | Conforms |
| ISO 7864:2016 (Sterile hypodermic needles for single use) | Conforms |
| ISO 9626:2016 (Stainless steel needle tubing) | Conforms |
| ISO 10993-7:2008 (Ethylene oxide sterilization residuals) | Conforms (No Cytotoxicity, No Skin Sensitization, No Intracutaneous reactivity, No Acute Systematic Toxicity, No Pyrogen, No Hemolysis reported) |
| USP (Bacterial Endotoxins Test) | Conforms (Endotoxin Limit: 20 EU per device) |
| USP (Particular Matter in Injections) | Conforms |
| ISO 10993-5:2009 (Test for in vitro cytotoxicity) | Conforms (No Cytotoxicity) |
| ISO 10993-4:2017 (Selection of Test for Interaction with Blood) | Conforms (No Thromboresistance, No Complement Activation, No Hemolysis) |
| ISO 10993-10:2010 (Tests for irritation and skin sensitization) | Conforms (No Skin Sensitization, No Intracutaneous reactivity) |
| ISO 10993-11:2017 (Tests for systemic toxicity) | Conforms (No Acute Systematic Toxicity) |
| ASTM F756-2017 (Assessment of Hemolytic Properties of Materials) | Conforms (No Hemolysis) |
| USP (Pyrogen Test) | Conforms (No Pyrogen) |
| ASTM F88/F88M-15 (Seal Strength of Flexible Barrier Materials) | Conforms |
| ASTM F1929-15 (Detecting Seal Leaks in Porous Medical Package by Dye Penetration) | Conforms |
| ASTM D4169-16 (Performance Testing of Shipping Containers and Systems) | Conforms |
| Sterilization Assurance Level (SAL) | 10-6 |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The document does not specify the exact sample sizes used for each individual non-clinical performance and biocompatibility test. It simply states that "Non-clinical tests were conducted to verify that the proposed device met all design specifications." For in-vitro tests, typical sample sizes are relatively small and determined by the specific ISO/ASTM standard.
- Data Provenance: The testing was conducted as part of the submission by Jiangsu Suyun Medical Materials Co., Ltd. from China. The types of tests (Performance Testing, Biocompatibility Testing, Sterility, Shipping and Shelf-life) are generally performed prospectively in a lab setting rather than being retrospective analyses of existing data. The specific country of origin for the data acquisition (i.e., where the labs are located) is not explicitly stated beyond the sponsor's location.
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 is N/A. For non-clinical device testing, "ground truth" is established by adhering to widely accepted international and national standards (e.g., ISO, ASTM, USP). The "experts" are the qualified laboratory personnel performing the standardized tests, and their qualifications are in conducting these specific test methods, not in clinical interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is N/A. Adjudication methods are typically relevant for clinical studies or studies involving subjective human assessment (like image interpretation). Non-clinical performance and biocompatibility tests are objective measurements against predefined criteria in standards, not subject to individual interpretation requiring adjudication.
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 is N/A. This submission is for a physical medical device (infusion sets), not an AI/software device that involves human readers or image interpretation. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is N/A. This submission is for a physical medical device, not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance and safety is based on established international and national standards and test methods. For example, the ISO 8536 series for infusion equipment, ISO 10993 series for biocompatibility, and various USP and ASTM standards define the accepted methods and criteria for assessing device attributes like flow rate, mechanical integrity, material safety, and sterility.
8. The sample size for the training set
This is N/A. This is a 510(k) submission for a physical medical device, not a machine learning or AI model that requires a training set.
9. How the ground truth for the training set was established
This is N/A. As mentioned above, there is no training set for a physical medical device.
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.