(223 days)
Intravenous Needle for Single Use is intended to administer fluid by using an infusion set to a patient's vascular system through the needle inserted into the vein.
Safety Intravenous Needle for Single Use is intended to administer fluid by using an infusion set to a patient's vascular system through the needle inserted into the vein, and the safety sheath is designed to prevent accidental needle sticks.
The proposed devices are intended to administer fluid by using an infusion set to a patient's vascular system through the needle inserted into the vein. It has two models, Intravenous Needle for Single Use and Safety Intravenous Needle for Single Use. For the Safety Intravenous Needle for Single Use, the safety sheath is designed to prevent accidental needlesticks. The proposed devices are provided sterile, single use.
The Intravenous Needle for Single Use consists of six components, 1) infusion needle 2) needle handle 3) flexible tube 4) needle protective cover 5) conical fitting 6) conical fitting protective cap. The Safety Intravenous Needle for Single Use consists of seven components, 1) infusion needle 2) needle handle 3) flexible tube 4) needle protective cover 5) conical fitting 6) conical fitting protective cap 7) Safety Sheath.
The provided text describes a 510(k) premarket notification for Intravenous Needles for Single Use and Safety Intravenous Needles for Single Use. This submission aims to demonstrate substantial equivalence to a predicate device, not to prove that the device meets specific acceptance criteria through a clinical study in the way typically associated with AI/software devices.
Therefore, many of the questions regarding acceptance criteria, study design, and performance metrics for AI devices are not applicable to this submission. This document pertains to a traditional medical device (intravenous needles), where performance is generally assessed through non-clinical bench testing and adherence to recognized standards.
Here's an breakdown of the relevant information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not present a single table of "acceptance criteria" and "reported device performance" in the context of an AI/software device. Instead, the performance is demonstrated through compliance with various international and ASTM standards for medical devices. The "acceptance criteria" are implied by these standards, and the "reported device performance" is a statement of compliance.
| Acceptance Criteria (Implied by Standard Compliance) | Reported Device Performance (Statement of Compliance) |
|---|---|
| Mechanical properties (e.g., strength, flexibility of needle tubing) | Complied with ISO 7864, ISO 9626 |
| Seal strength of flexible barrier materials | Complied with ASTM F88/F88M-15 |
| Seal integrity in porous medical package (dye penetration) | Complied with ASTM F1929-15 |
| Seal integrity for flexible packaging (visual inspection) | Complied with ASTM F1886/F1886M-16 |
| Ethylene oxide sterilization residuals | Complied with ISO 10993-7:2008 |
| Bacterial Endotoxins | Complied with USP |
| Particular Matter in Injections | Complied with USP |
| In vitro cytotoxicity | Complied with ISO 10993-5:2009 (No Cytotoxicity) |
| Interaction with blood (e.g., hemolysis, thromboresistance, complement activation) | Complied with ISO 10993-4:2017 (No Hemolysis, No thrombosis, No different from control group for Complement Activation) |
| Irritation and skin sensitization | Complied with ISO 10993-10:2010 (No intracutaneous reactivity, No skin sensitization) |
| Systemic toxicity (including subacute) | Complied with ISO 10993-11:2017 (No systemic toxicity, No Subacute Systemic Toxicity) |
| Hemolytic properties | Complied with ASTM F756-2017 (No Hemolysis) |
| Pyrogenicity | Complied with USP (No Pyrogen) |
| Small-bore connectors for intravascular/hypodermic applications | Complied with ISO 80369-7:2016 and ISO 80369-20:2015 |
| Labeling | Complied with 21 CFR part 801 |
| Sterilization Assurance Level (SAL) | 10^-6 |
| Endotoxin Limit | 20EU/device |
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 specify sample sizes for testing beyond the general statement of compliance with standards. These are non-clinical engineering and biocompatibility tests. Data provenance in terms of country of origin or retrospective/prospective does not apply here as it's not a clinical study. These tests would have been conducted by the manufacturer in China or by contracted laboratories.
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 question is not applicable. The ground truth for device performance in this context is established by the specifications and methodologies outlined in the referenced international standards (e.g., ISO, ASTM, USP). There are no "experts" in the sense of clinical specialists establishing a ground truth for a diagnostic outcome.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable. Adjudication methods are relevant for clinical studies with subjective interpretations, which is not the case for the non-clinical tests described.
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 question is not applicable. This is not an AI-assisted device, nor is it a diagnostic device where human "readers" would be involved in interpreting results.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the non-clinical tests is defined by the objective measurement criteria and methodologies specified in the cited international regulatory standards (e.g., ISO, ASTM, USP) for the physical and biological properties of the device.
8. The sample size for the training set
This question is not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
This question is not applicable.
§ 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.