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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.

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.

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AMSINO INTRAVASCULAR 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.

Not Found

This document is a 510(k) premarket notification decision letter from the FDA for the Amsino I.V. Administration Set. It states that the device is substantially equivalent to legally marketed predicate devices.

This document describes a regulatory approval for an I.V. administration set, not a software device or an AI/ML medical device. Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not applicable to this submission.

The letter is a notification of the FDA's finding of substantial equivalence, which allows the company to market the device. It does not contain performance study data or acceptance criteria in the format typically provided for novel medical devices or AI/ML technologies.

The "Indications For Use" provided in the enclosure merely describes the intended purpose of the device: "AMSINO INTRAVASCULAR 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."

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