(80 days)
Intended for the subcutaneous infusion of fluid medicines.
FlowEase [Subcutaneous] Infusion Set is a single use disposable device intended for the subcutaneous infusion of fluid medicines.
The FlowEase [Subcutaneous] Infusion Set consists of a copolyester blend Female ISO 594-2 Luer Lock Connector attached to a 24 inch length of non-DEHP PVC Tubing that is connected to a non-DEHP PVC Hub with wings. The Hub holds a 24-Gauge thin wall AISI 304 stainless steel Needle with a 90° bend at the distal end.
A medical grade UV-curable acrylated urethane Adhesive is placed on the outside bend of the needle to secure it within the Hub.
The FlowEase [Subcutaneous] Infusion Set also includes a HDPE Bantam Slide Clamp used to start and stop fluid flow. The needle is supplied covered with an LDPE Needle Protector, and the Female Luer Lock Connector is covered with an ABS Male ISO 594-2 Luer Lock Cap.
The FlowEase [Subcutaneous] Infusion Set will be marketed with a 24-Gauge thin wall needle that will be available in three needle lengths: 6 mm, 9 mm, and 12 mm. Each set will be packaged with a commercially available dressing, used to hold the device in place on the patient.
The FlowEase [Subcutaneous] Infusion Set is provided Gamma sterilized and non-pyrogenic. Each Set is packaged individually in a medical grade thermoformed copolyester tray with a Tyvek® lid, labeled according to needle size.
Here's an analysis of the provided text regarding the FlowEase Subcutaneous Infusion Set, focusing on the requested information:
Analysis of Acceptance Criteria and Device Performance Study
Based on the provided 510(k) summary, specific acceptance criteria and detailed device performance studies (like those for an AI/ML medical device) are not explicitly described in the manner requested. This document is a traditional 510(k) premarket notification for a Class II medical device, an infusion set. For such devices, "acceptance criteria" are generally met through adherence to recognized standards, functional testing, and demonstrating substantial equivalence to predicate devices, rather than through performance metrics like sensitivity, specificity, or AUC, as would be common for AI/ML devices.
The document primarily focuses on demonstrating substantial equivalence to already cleared predicate devices.
Let's address each of your points based on the available information:
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Table of Acceptance Criteria and Reported Device Performance
As noted above, specific performance metrics with acceptance criteria like sensitivity/specificity are not detailed here. The "performance" described is about meeting general functional and safety requirements through testing against established standards.
Acceptance Criteria (Implied) Reported Device Performance Functional performance Verified through functional testing. Biocompatibility Verified through biocompatibility testing. Safety Verified through functional and biocompatibility testing. Sterility Provided Gamma sterilized. Non-pyrogenic Provided non-pyrogenic. Risk Management Conducts risk analysis according to ISO 14971:2007. Substantial Equivalence "Substantially equivalent to the predicate devices with regard to technological characteristics, performance, and intended use." -
Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. For a traditional medical device like an infusion set, "test set" and "data provenance" often refer to laboratory or bench testing on a certain number of devices, rather than a clinical dataset in the way an AI/ML study would define it. The document states "functional and biocompatibility testing" was done, but specific sample sizes and the nature/origin of the data are not detailed. It is highly likely this was bench/lab testing, not human subject data.
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Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided and is generally not applicable to the type of device and submission method (traditional 510(k) for an infusion set) described. Ground truth as established by experts (e.g., radiologists) is typical for diagnostic AI devices, not for a physical device like an infusion set where performance is measured objectively against standards.
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Adjudication Method for the Test Set
This information is not provided and is not applicable for this type of device and submission. Adjudication methods (e.g., 2+1, 3+1) are common in clinical trials or expert review processes, which are not detailed as part of the "functional and biocompatibility testing" for this infusion set.
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If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done and is not mentioned. Such studies are relevant for diagnostic devices (especially imaging-based AI) to assess how AI assistance impacts human reader performance. This device is an infusion set, not a diagnostic tool.
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If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, a standalone algorithm performance study was not done. This device is a physical medical device, not a software algorithm.
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The Type of Ground Truth Used
The "ground truth" for this device's performance relies on objective measurements from functional and biocompatibility testing performed against established standards (e.g., ISO standards for luer locks, tubing integrity, material compatibility). It's not based on expert consensus, pathology, or outcomes data in the way an AI diagnostic would be. The overarching "ground truth" for regulatory clearance is "substantial equivalence" to predicate devices demonstrated through these tests.
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The Sample Size for the Training Set
This information is not provided and is not applicable. This device is a physical medical product, not an AI/ML model that requires a training set.
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How the Ground Truth for the Training Set Was Established
This information is not provided and is not applicable, as there is no "training set" for this physical device.
Summary of Device and Approval:
The FlowEase Subcutaneous Infusion Set is a single-use, disposable device for subcutaneous infusion of fluid medicines. It consists of a luer lock connector, tubing, a hub with wings, a 24-gauge stainless steel needle, an adhesive, a slide clamp, and a needle protector. It comes in 6mm, 9mm, and 12mm needle lengths. The device is Gamma sterilized and non-pyrogenic.
The submission is a traditional 510(k), and the primary method of demonstrating safety and effectiveness is through proving substantial equivalence to existing predicate devices (Baxter SUB-Q-Set, RMS Subcutaneous Needle Set, and Evans SubQ). This equivalence is asserted based on:
- Similar intended use.
- Similar technological characteristics.
- Verification through functional and biocompatibility testing.
- Adherence to risk analysis principles (ISO 14971:2007).
The FDA concurred with the substantial equivalence conclusion and cleared the device for market on June 29, 2012.
§ 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.