(223 days)
The Infusion Sets for Single Use with Needles is intended to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein.
The Infusion Sets for Single Use with Needles is intended to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein. It consists of basic configuration and optional components. The basic configuration consists of protective cap of spike, spike, drip chamber, flow regulator, flexible tube, conical fitting, and injection needle/intravenous needle. Air vent, fluid filter, clamp, and injection site are optional components. The device is provided sterile and single use.
The provided document is a 510(k) summary for a medical device (Infusion Sets for Single Use with Needles) and does not describe a study involving an AI/Machine Learning device that utilizes a test set, expert readers, or ground truth in the way a diagnostic AI would.
Instead, this document focuses on demonstrating substantial equivalence to a previously cleared predicate device by comparing technical characteristics and performance standards. The "acceptance criteria" and "study" described here refer to non-clinical performance testing to ensure the device meets specified engineering and safety standards, rather than evaluating diagnostic accuracy of an AI model.
Therefore, many of the requested categories for AI/ML device studies (such as sample size for test set, number of experts for ground truth, MRMC studies, effect size of AI assistance, standalone performance, and training set details) are not applicable to this 510(k) submission.
Here's an interpretation of the document's content in a way that aligns with your request as much as possible, focusing on the quality and performance testing described:
Device: Infusion Sets for Single Use with Needles (K221069)
Type of Study: Non-Clinical Performance Testing and Biocompatibility Testing for Substantial Equivalence Determination. This is not an AI/ML diagnostic performance study.
1. Table of Acceptance Criteria and Reported Device Performance
For medical devices like infusion sets, acceptance criteria are typically defined by recognized international and national standards. The "performance" is demonstrated by showing compliance with these standards.
| Acceptance Criteria Category/Standard | Reported Device Performance/Compliance |
|---|---|
| Biocompatibility | |
| ISO 10993-5:2009 (Cytotoxicity) | No Cytotoxicity |
| ISO 10993-10:2010 (Irritation and Skin Sensitization) | No Intracutaneous Reactivity, No Skin Sensitization |
| ISO 10993-11:2017 (Systemic Toxicity) | No Acute Systemic Toxicity, No Subacute Systemic Toxicity |
| ISO 10993-4:2017 & ASTM F756-17 (Interactions with Blood/Hemolysis) | No Hemolysis, No different from control device (for Complement Activation), No thrombosis (for In vivo vein thromboresistance) |
| Sterilization | |
| ISO 10993-7:2008 (Ethylene Oxide Sterilization Residuals) | Complies (EO sterilized, SAL 10^-6) |
| ASTM F88/F88M-15, F1929-15, F1886/F1886M-16 (Seal Integrity) | Complies (Tested for Sterility, Dye Penetration, Visual Inspection) |
| USP & (Pyrogen & Bacterial Endotoxins) | No Pyrogen, Endotoxin Limit: 20 EU per device |
| Physical/Functional Performance | |
| ISO 7864:2016 (Sterile hypodermic needles) | Complies (Needle performance meets requirements despite different gauges/types than predicate) |
| ISO 9626:2016 (Stainless Steel Needle Tubing) | Complies (Needle performance meets requirements) |
| ISO 80369-7:2016 (Small-bore connectors - intravascular/hypodermic) | Complies |
| ISO 80369-20:2015 (Small-bore connectors - Common test methods) | Complies |
| ISO 8536-4:2019 (Infusion sets for single use, gravity feed) | Complies (Performance tests conducted, results meet requirements despite different capacity/length than predicate; "Infusion Set Performance" in table) |
| ISO 8536-14:2016 (Clamps and flow regulators) | Complies (Assumed, as part of general infusion set compliance) |
| USP (Particular Matter in Injections) | Complies |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify exact sample sizes for each non-clinical test (e.g., number of infusion sets tested for flow rate, sterility, etc.). It generally states that "Non clinical tests were conducted to verify that the proposed device met all design specifications." Regulatory standards often dictate minimum sample sizes for such tests, but these are not enumerated in the summary.
- Data Provenance: The testing was conducted by Sichuan Prius Biotechnology Co., Ltd. (China). The data represents laboratory testing results performed on the manufactured devices. The studies are by nature prospective, as they are specifically conducted to support the 510(k) submission for the new device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This concept is not applicable. For non-clinical performance and biocompatibility testing, "ground truth" is established by adherence to validated international standards and test methods (e.g., ISO, ASTM, USP). The expertise lies in the qualifications of the testing laboratories and personnel conducting these specific, standardized tests (e.g., chemists, material scientists, engineers, microbiologists). The document does not specify how many or the qualifications of the testing personnel, as it's assumed to be part of standard quality system requirements for medical device manufacturing and testing.
4. Adjudication Method for the Test Set
- This concept is not applicable. Performance testing results are either compliant with the specified standard and acceptance criteria or they are not. There is no "adjudication" in the sense of reconciling differing expert opinions or interpretations, as would be the case in subjective diagnostic AI assessments.
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 is not an AI/ML device, nor is it a diagnostic imaging device that involves human reader interpretation. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm or AI device. The device itself (infusion set) functions independently of human interpretation concerning its core performance metrics (e.g., flow rate, sterility, tensile strength).
7. The type of ground truth used
- Ground Truth: For this type of device, "ground truth" is defined by established international and national standards, regulatory requirements, and validated test methods. Compliance with these standards (e.g., ISO for biological evaluation, physical properties; ASTM for material properties, package integrity; USP for sterility, pyrogens) indicates that the device performs as intended and is safe. The document repeatedly states, "Comply with ISO X," "meets the requirements of ISO Y," or "test result can meet the requirements."
8. The sample size for the training set
- Not applicable. There is no concept of a "training set" for this type of medical device which undergoes compliance testing rather than AI model training.
9. How the ground truth for the training set was established
- Not applicable, as there is no training set.
§ 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.