(254 days)
The device is indicated for the delivery of fluids from a container to a patient's vascular system.
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.
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:
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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."
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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.
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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.
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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.
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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.
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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.
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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."
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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.
§ 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.