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The proposed devices are indicated for the gravity infusion of fluids from a container to a patient's vascular system through an IV catheter or infusion needle. . There are ten different models, each a different configuration comprised of various components which may include: protective cap, spike, air filter, drip chamber, precision filter, flexible tube, injection site, roller clamp, flow regulator, pinch clamp and luer lock connector. The devices are provided sterile and are single use.

AI/ML Overview

This document describes the regulatory submission for an "Infusion Set for Single Use" (K162601). As an intravascular administration set, this device is a Class II product.

Here's an analysis of the provided text in relation to acceptance criteria and supporting studies:

Table of acceptance criteria and reported device performance:

The document explicitly states that "Non clinical tests were conducted to determine that the proposed device met all design specifications to claim Substantially Equivalence (SE) to the predicate device."

Acceptance Criteria (Standard/Test)	Reported Device Performance
ISO 8536-4:2010 AMD 1 2013	Complies
ISO 8536-12:2007 AMD 1 2012	Complies
ISO 594-1:1986	Complies
ISO 594-2:1998	Complies
ISO 10993-7:2008	Complies
ASTM F 88/F88M-09	Complies
USP38-NF33	Complies
ISO 10993-5:2009 (Cytotoxicity)	Complies / Conform with ISO 10993 requirements
ISO 10993-10:2010	Complies
ISO 10993-11:2006	Complies
ASTM F 756-13 (Hemolysis Test)	Complies / Conform with ISO 10993 requirements
ISO 10993-1:2009	Complies
USP 38-NF 33 (Pyrogen Test)	Complies / Conform with ISO 10993 requirements
Microbial Ingress Testing	Complies
ASTM F838-15	Complies
Flow Regulator Performance	Complies
1.2 Micron Filter Test	Complies
Biocompatibility: Intracutaneous Reactivity	Conform with ISO 10993 requirements
Biocompatibility: Skin Sensitization	Conform with ISO 10993 requirements
Biocompatibility: Acute Systemic Toxicity	Conform with ISO 10993 requirements

Sample size used for the test set and the data provenance:

The document lists the standards and tests performed but does not specify the sample sizes used for each test or the provenance of the data. It only states that "Non clinical tests were conducted."
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. The tests seem to be primarily laboratory-based "non-clinical tests" against established standards, rather than expert-driven ground truth assessment in a clinical context.
Adjudication method for the test set:

This information is not provided as the assessment relies on compliance with established technical standards, not expert adjudication of clinical outcomes.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

This information is not applicable/not provided. The device is an infusion set, not an AI-powered diagnostic or assistive technology for human readers. No MRMC study was conducted.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

This information is not applicable/not provided as the device is not an algorithm.
The type of ground truth used:

The "ground truth" for the device meeting acceptance criteria is based on compliance with international and national standards for medical devices (e.g., ISO, ASTM, USP) and internal specifications. For biocompatibility, general conformity with ISO 10993 requirements serves as the ground truth.
The sample size for the training set:

This information is not applicable/not provided. The device is a physical medical device (infusion set), not a machine learning model, so there is no "training set."
How the ground truth for the training set was established:

This information is not applicable/not provided as there is no training set for this type of device.

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