(92 days)
The AMSINO® I.V. ADMINISTRATION SET is a device intended to administer fluids from a container to a patient's vascular system through a catheter inserted into a vein.
The AMSINO® I.V. ADMINISTRATION SET is a single use, latex-free, Non-DEHP, gravity feed, sterile device sterilized with Ethylene Oxide Gas. It is used to administer fluids from a container to a patient's vascular system through a catheter inserted into a vein. It is comprised of various components such as: bag, spike, drip chamber (vented and non-vented), Y-site, burette, tubing, flow controller, drip selector, clamp, check valve, latex-free injection site, needleless injection site, flashbulb, filter, manifold, stopcock, flash bulb, luer connectors and bag hanger.
This submission is an extension of the original approval (K973107) and covers the following AMSINO Product Line:
AMSINO® STANDARD I.V. ADMINISTRATION SET AMSafe® I.V. ADMINISTRATION SET (identical to the Amsino Standard I.V. Administration set, except it is marketed for Emergency Medical Services group/personnel)
AMSafe3® I.V. ADMINISTRATION SET (identical to AmSafe I.V. Administration Set, with the exception of the drip selector option.)
AMSINO offers both standard and custom sets with tubing of various sizes and lengths with a choice of 10, 15, 20 and 60 drops per ml to meet customer requirements and specifications. Customers may request I.V. Administration sets with varying configuration containing any combination of the parts per the table:
Tubing
Drip Chamber
Needleless injection site
Split Septum Injection Site
Bag Spike
Clamp
Flow Controller
Drip Selector
Filter
Rotating male luer lock
Male or Female luer lock
Check Valve
Bag Hanger
Y-site
stopcock
manifold
The provided document describes a Special 510(k) Premarket Notification for a modification to the AMSINO® I.V. ADMINISTRATION SET. This submission primarily focuses on demonstrating substantial equivalence to a previously cleared device (K973107) rather than a de novo device requiring extensive clinical studies to establish safety and effectiveness.
Therefore, the "study that proves the device meets the acceptance criteria" in the traditional sense of a human clinical trial is not applicable here. Instead, the submission relies on bench performance testing, biocompatibility, and sterilization validations to show that the modified device performs as intended and is as safe and effective as the predicate device.
Here's an analysis of the provided information based on your requested categories:
1. A table of acceptance criteria and the reported device performance
The document lists several performance criteria the device meets, primarily referencing ISO standards and/or AMSINO's internal testing criteria. However, specific quantitative acceptance criteria values and corresponding reported device performance values are generally not provided in this summary document. Instead, it makes statements of compliance.
| Acceptance Criterion (Test Type) | Reported Device Performance |
|---|---|
| Bench Performance Testing: | Meets requirements according to ISO 8536-4 (when appropriate) and/or AMSINO's testing and acceptance criteria |
| Closure Piercing Device (Spike) Features | Meets requirements |
| Air Inlet Device Characteristics | Meets requirements |
| Connector Performance (to prevent leakage) | Meets requirements |
| Drip Chamber and Drip Tube Performance | Meets requirements |
| Flow Regulator Performance | Meets requirements |
| Flow characteristics | Meets requirements |
| Tensile Strength of Connectors | Meets requirements |
| Self-sealing injection site challenge test | Meets requirements |
| Injection Port Access to Failure (needleless) | Meets requirements |
| Biocompatibility & Hemocompatibility: | Biocompatible and Hemocompatible; test results indicate neither sensitivity nor toxicity (based on ISO 10993-1 guidelines including Cytotoxicity, Sensitization, Irritation, Systemic Cytotoxicity, and Hemocompatibility testing) |
| Sterility: | Sterilized by Ethylene Oxide (validated per ISO 11135-1:2007) |
| Pyrogenicity: | Tested for pyrogenicity (status: meets requirements) |
| Microbial Ingress Challenge Test: | Demonstrates a 4-log reduction of microorganisms against gram negative and gram positive organisms using proper aseptic technique |
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 explicitly state the sample sizes for the various bench tests, biocompatibility tests, or microbial ingress tests. It only states that these tests were conducted and the device "meets requirements" or "demonstrates a 4-log reduction." The data provenance is internal to Amsino International, Inc. (Pomona, CA, USA) and the testing would be considered prospective for the purpose of this submission, meaning the tests were conducted specifically to support this application.
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 section is not applicable to this type of device and submission. The "ground truth" for the performance criteria is established by recognized international standards (like ISO) and internal engineering/quality specifications, not expert consensus in the medical image interpretation sense. The experts involved would be the engineers and quality assurance personnel at Amsino International responsible for designing, testing, and validating the device and its manufacturing processes. Their qualifications are not detailed.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of medical data (e.g., images) by multiple readers. This is not applicable to the bench testing, biocompatibility, or sterilization validation performed for this I.V. administration set.
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. The device is an I.V. administration set, not an AI-powered diagnostic tool requiring human readability studies.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. The device 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 this device's performance is based on established engineering and materials science principles, international standards (e.g., ISO 8536-4, ISO 10993-1, ISO 11135-1), and Amsino's internal product specifications. This would involve:
- Physical/Mechanical Properties: Measured values against predefined tolerance ranges.
- Biocompatibility: Laboratory test results (e.g., cell viability, irritation scores) compared against acceptable limits derived from ISO 10993.
- Sterility: Sterility assurance levels (SAL) achieved through validated processes per ISO 11135-1.
- Microbial Ingress: Measured reduction in microbial count against a defined log reduction target.
8. The sample size for the training set
This is not applicable. This is a physical medical device, not an AI/machine learning model that requires a training set.
9. How the ground truth for the training set was established
This is not applicable for the reasons stated above.
§ 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.