(411 days)
The SOL-CARE IV Bag Safety Connector is designed for drug administration to I.V. bag without using sharp hypodermic needle attached to a drug pre-filled syringe. It incorporates a shielded needle to allow safe access through the injection port of I.V. bag.
The device provides a simple, cost-effective solution to an everyday problem - how to make drug additions to an IV bag without using an exposed hypodermic needle attached to a drug-filled syringe. It incorporates a shielded needle to allow safe access through the 'rubber bung' on the INJECTION tail of an IV bag.
The provided text describes the SOL-CARE IV Bag Safety Connector, a medical device designed for drug administration to IV bags, and its substantial equivalence to a predicate device (Inviro Medical Blunt Fill Needle). However, the document does not contain information about acceptance criteria or a study proving the device meets said criteria in the context of AI/ML performance.
The document is a 510(k) summary for a medical device which is a physical product (a safety connector for IV bags), not an AI/ML powered device, software, or algorithm. Therefore, the requested information regarding AI/ML performance, such as sample sizes for test and training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, is not applicable and not present in the provided text.
The closest information available that might be interpreted as "acceptance criteria" and "device performance" in a general sense (for a physical device) relates to performance standards and conformity to specific ISO and EN standards.
Here's the information that is available in the document, framed as closely as possible to your request for a non-AI/ML device:
1. A table of (physical device) acceptance criteria and the reported device performance
The document lists numerous tests conducted according to international standards (ISO, EN) for medical devices. The "reported device performance" is implicitly stated as "met the appropriate requirements" for each standard. Specific numerical acceptance criteria or performance metrics are not detailed in this summary, but rather implied by adherence to the named standards.
| Acceptance Criteria (based on standards) | Reported Device Performance |
|---|---|
| EN ISO 7864:2016 (Sterile hypodermic needles for single use) | Met appropriate requirements |
| EN ISO 80369-7:2016 (Small-bore connectors) | Met appropriate requirements |
| EN ISO 9626:2016 (Stainless Steel needle tubing) | Met appropriate requirements |
| ISO 11607-1-2:2017 (Packaging for sterilized medical devices) | Met appropriate requirements |
| ISO 11135:2014 (Sterilization with Ethylene oxide) | Met appropriate requirements |
| ISO 10993-1:2018 (Biological evaluation of medical devices) | Met appropriate requirements |
| Detailed Tests (per ISO 7864, 80369-7, 8536-4, 9626) | Met appropriate requirements |
| Cleanliness, Defects of Needle/Point, Lubricant, Needle Gauge, Needle Stiffness, Needle Resistance to Breakage, Bond Between Needle hub and Needle, Patency of Lumen, Distance from Needle tip to Protector Tube, Connection Strength Between Protection tube and Needle Hub, Penetration Force, Luer connection testing, Flow Rate, Priming Volume, Particulate Contamination, Limits for acidity or alkalinity, Limits of Extractable Metals, Needle Resistance to Corrosion, Reducing Substance, Metal Ions, Titration Acidity or Alkalinity, Residue on Evaporation, UV Absorption of extract Solution | Successfully completed |
| Sterilization and Packaging Tests (per ISO 11607, 10993-7) | Met appropriate requirements |
| Sterilization (EO/ECH residue), Appearance, Dimension, Printing, Tearing Force, Clean Peel, Dye Penetration, UDI Identification, Sticker readability and integrity | Successfully completed |
| Biological Tests (per ISO 10993-4, 10993-5, 10993-10, 10993-11) | Met appropriate requirements |
| Cytotoxicity, Sensitization, Irritation of Intracutaneous Reactivity, Acute Systemic Toxicity, Material Mediated Pyrogenicity, Hemocompatibility, Partial Thromboplastin (PTT), Platelet Count, Haematology | Successfully completed |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided because the device is a physical medical device, not an AI/ML algorithm requiring a dataset. The testing refers to physical tests on product samples.
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 provided. Ground truth in the context of expert consensus is relevant for AI/ML diagnostic or prognostic models, not for the physical performance testing of a medical connector described here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided, as it is relevant for AI/ML algorithm evaluation, not physical device testing.
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
No MRMC study was done, as this is a physical medical device, not an AI/ML system assisting human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable and therefore not performed. The device is a physical connector, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
"Ground truth" as understood in AI/ML is not applicable here. The testing involves standardized laboratory tests to confirm physical, chemical, and biological properties according to established medical device standards. The "truth" is determined by whether the device's characteristics fall within the specified limits of these standards.
8. The sample size for the training set
This information is not provided. Training sets are relevant for AI/ML model development, not for the type of device described.
9. How the ground truth for the training set was established
This information is not provided, as it is relevant for AI/ML model development.
In summary: The provided 510(k) pertains to a physical medical device. The information requested regarding acceptance criteria and studies for AI/ML performance is not found in the document because the device itself is not an AI/ML product. The document details extensive non-clinical (laboratory) testing to demonstrate substantial equivalence to a predicate device and compliance with relevant international standards for medical devices.
§ 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.