(186 days)
The I.V. Administration Set intended use is to deliver sterile, infusion fluid from a container to the patient with or without flow control features.
The I.V. Extension Set may act as an extension of other infusion tubing intravenous fluids from a container to patient.
The propose device, I.V. Administration Set, is a single used device. It has seven models. The models and their features are listed in Table 1. There are seven different models, each configuration comprise of various components which may include: IV Chamber, Tubing, Roller Clamp, Y Site, Needle Free Valve, Slide Clamp, Back Check Valve, Male Luer Lock, 3 Way Stop Cock, Female Luer Lock, Flow Regulator, Rotating Luer Lock, T-Connector, Luer Lock Cap, Hanger, Drop, Female Luer Connector and Cap. The devices are provided sterile and single use. The proposed devices are sterilized by EO to achieve a SAL 10-6 and supplied in sterility maintenance package which could maintain the sterility of the device during the shelf life of 3 years.
Here's a breakdown of the acceptance criteria and study information based on the provided document, restructured to address your specific points.
First, it's important to note that this document is a 510(k) Premarket Notification for an I.V. Administration Set. This type of submission relies on demonstrating substantial equivalence to a predicate device, rather than proving independent effectiveness from scratch. Therefore, the "acceptance criteria" and "study" described herein are primarily focused on showing that the new device performs as safely and effectively as a legally marketed predicate, meeting relevant industry standards. It's not a study proving the clinical effectiveness of the device itself (like an AI algorithm's diagnostic performance), but rather its engineering performance and biocompatibility to ensure equivalent safety and function compared to existing devices.
1. Table of Acceptance Criteria and Reported Device Performance
For an I.V. Administration Set, the acceptance criteria are generally defined by compliance with recognized international standards (ISO, ASTM, USP) and demonstrating equivalent performance to the predicate device across critical parameters. The "reported device performance" is essentially that the proposed device demonstrated compliance with these standards and equivalency through non-clinical testing.
| Acceptance Criterion (Standard/Test) | Reported Device Performance |
|---|---|
| Functional/Performance Standards | |
| ISO 8536-4:2019 (Infusion sets for single use, gravity feed) | Complies (Performance Test Report) |
| ISO 8536-12:2007 AMD 1 2012 (Check valves) | Complies (Check valves Performance Test Report) |
| ISO 8536-14:2016 (Clamps and flow regulators) | Complies (Flow regulator Performance Test Report) |
| ISO 80369-7:2016 (Small-bore connectors for intravascular/hypodermic applications) | Complies (Luer Compliance Performance Test Report) |
| ASTM F88/F88M-15 (Seal Strength of Flexible Barrier Materials) | Complies |
| ASTM F1929-15 (Detecting Seal Leaks in Porous Medical Package by Dye Penetration) | Complies |
| Performance Testing - Bench (Particulate contamination, leakage, tensile strength, dimension, flow rate, filter efficiency, drip chamber, injection site) | Meets all design specifications. |
| Performance Testing - Microbial Ingress Test | Complies |
| Biocompatibility Standards | |
| ISO 10993-4:2017 (Interactions with blood) | Complies (Hemolysis Test Report) |
| ISO 10993-5:2009 (In vitro cytotoxicity) | Complies (Cytotoxicity Test Report) - No cytotoxicity. |
| ISO 10993-10:2010 (Irritation and skin sensitization) | Complies (Guinea Pig Maximization Test Report, Intracutaneous Reactivity Test Report) - No skin sensitization, no intracutaneous reactivity. |
| ISO 10993-11:2017 (Systemic Toxicity) | Complies (Systemic Toxicity Test Report) - No systemic toxicity. |
| ASTM F756-17 (Assessment of hemolytic properties) | (Covered by ISO 10993-4) |
| Sterilization & Endotoxin Standards | |
| ISO 11135:2014 (Ethylene oxide sterilization) | Complies (achieved SAL 10^-6) |
| USP 43-NF 38 (Bacterial Endotoxins Test) | Complies (Endotoxin Limit: 20 EU per device) |
| USP 43-NF 38 (Pyrogen Test) | Complies (Pyrogen Test Report) - No potential febrile reaction. |
| Shelf Life/Integrity | |
| ASTM F1980-16 (Accelerated Aging of Sterile Barrier Systems) | Complies (3 years shelf life maintained sterility) |
Note on "Remark" column from original table: The document highlights differences between the proposed device and the predicate in configuration, flow rate, pore size, and patient-contact material. For each difference, the applicant provides a justification that it does not affect the safety and effectiveness based on specific testing or the range of the parameter. For example, for "Flow Rate" and "Pore Size," the proposed device's values are stated to be within the predicate's range or to meet declared requirements. For "Patient-contact Material" and "Biocompatibility," comprehensive testing showed no adverse effects despite material differences.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify exact sample sizes for each non-clinical test (e.g., number of devices tested for leakage, tensile strength, or biocompatibility). It states "Non clinical tests were conducted to verify that the proposed device met all design specifications." For in-vitro tests and bench testing for device performance, samples are tested to statistical validity for the specific test method outlined in the standards (e.g., ISO, ASTM).
- Data Provenance: The testing was "non-clinical," meaning it was bench testing and in-vitro laboratory testing of the physical device components and assembled products. The manufacturer is BQ PLUS Medical Co., Ltd in Songjiang, Shanghai, China. The testing was presumably conducted by or on behalf of the manufacturer, likely in China. The data is prospective, generated specifically for this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this 510(k) submission. This is not a study involving human interpretation of medical images or data requiring expert consensus or ground truth establishment in a clinical sense. The "ground truth" for the performance criteria is defined by the technical specifications of the standards (e.g., a specific tensile strength value, a defined flow rate, a negative cytotoxicity result). These are objective measurements from laboratory and bench tests, not subjective interpretations by medical experts.
4. Adjudication Method for the Test Set
This is not applicable. Since the testing is objective and based on validated laboratory and bench test methods from international standards, there is no need for an adjudication method as would be required for subjective clinical assessments or image interpretations. The results are quantitative measurements against predefined pass/fail criteria.
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 not applicable. This submission is for a conventional medical device (I.V. Administration Set), not an AI/Software as a Medical Device (SaMD) that assists human readers. No MRMC study was performed, and human readers are not involved in the "reading" or "interpretation" of data generated by this device in a diagnostic sense.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. This is not an AI/Software as a Medical Device (SaMD). The "standalone performance" here would refer to the device's ability to meet its technical specifications independently, which is what the non-clinical bench testing demonstrated.
7. The Type of Ground Truth Used
The "ground truth" used for this device's acceptance is objective laboratory and bench test results against pre-defined specifications and compliance requirements of recognized international standards (e.g., ISO, ASTM, USP).
- Examples include measured flow rates, leakage rates, material properties (tensile strength, seal strength), biological responses (cytotoxicity, hemolysis), and sterility assurance levels.
- It is not based on expert consensus, pathology, or clinical outcomes data in the usual sense, as no clinical study was performed (or required for this type of 510(k)).
8. The Sample Size for the Training Set
This is not applicable. This is not an AI/machine learning device that requires a "training set" of data. The device's performance is based on its physical design, manufacturing processes, and materials, which are verified through the non-clinical testing described.
9. How the Ground Truth for the Training Set was Established
This is not applicable, as there is no training set for this type of medical device submission.
§ 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.