(189 days)
The TERUMO Hybria Closed System Safety I.V. Catheter is inserted into the patient's vascular system for short term use (
The TERUMO® Hybria™ Closed System Safety I.V. Catheter is a device consisting of an over-the needle, peripheral intravascular catheter made of a slender, flexible, radio-opaque, plastic catheter, integrated extension tubing with a Y or I adaptor (needleless access port and/or filter cap available) and one touch clamp, and a passive needle-shielding mechanism.
The design of the TERUMO® Hybria™ Safety I.V. catheter can be described as a closed system since it protects clinicians and patients from blood exposure during the catheter insertion procedures. Since the needle is withdrawn through a septum that seals after the needle has been removed and ports of the Y or I adapter attached to pre-connected tubing to the IV catheter are closed, blood remains within the TERUMO® Hybria™ Safety I.V. catheter during catheter insertion.
The pressure exerted on the needle as it passes through the septum wipes blood from the needle, further reducing potential blood exposure. The one touch clamp on the integrated extension tubing is provided to minimize blood exposure when connecting with an infusion set.
The provided text describes a 510(k) premarket notification for the TERUMO® Hybria™ Closed System Safety I.V. Catheter. This document primarily focuses on establishing substantial equivalence to previously marketed predicate devices rather than proving the device meets specific acceptance criteria through a standalone study with detailed performance metrics.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not provide specific, quantifiable acceptance criteria or a performance table in the typical sense of a clinical or analytical study. Instead, it relies on demonstrating that the new device's specifications (dimensions, flow rates, etc.) are comparable to its predicate devices, implying that if the predicates met their performance criteria, this device would as well. The provided tables (pages 4-6) list the physical specifications of various configurations of the Terumo Hybria catheter, including gauge, length, outer diameter, inner diameter, cannula gauge, tube length, tube OD/ID, adaptor type, connector type, wing type, flow rate, priming volume, and lumen volume. These are design specifications, not performance criteria with associated pass/fail thresholds.
For example, a "flow rate" is listed, but there's no defined acceptance criterion like "Flow rate must be ±X% of predicate device" or "Flow rate must exceed Y ml/min for Z application."
Therefore, a table of explicit acceptance criteria and corresponding performance cannot be constructed from this document. The "performance" assessment is described as "bench tests and simulated use study" which demonstrated "substantial equivalence."
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes used for the "bench tests and simulated use study." It also does not explicitly state the data provenance (e.g., country of origin of the data, retrospective or prospective). Given that it's a 510(k) for a device with a physical function, these studies would typically be conducted in a laboratory setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. For a physical device like an IV catheter, "ground truth" often refers to engineering specifications, established testing standards, or performance in simulated use protocols rather than expert clinical consensus on an output like image interpretation.
4. Adjudication Method for the Test Set
This information is not provided. Adjudication methods (e.g., 2+1, 3+1) are typically relevant for studies where human interpretation of data is being assessed, such as medical imaging. For a physical device, testing against predefined engineering specifications is more common.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly described or mentioned in this document. MRMC studies are generally relevant for evaluating the impact of AI algorithms or diagnostic tools on human reader performance, which is not applicable to a physical medical device like an IV catheter.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, this question is not applicable as the device is a physical IV catheter and not an algorithm or AI system.
7. The Type of Ground Truth Used
The types of "ground truth" implicitly used for this device would be:
- Engineering Specifications: The design parameters (e.g., catheter gauge, length, flow rate) listed in the tables are the 'ground truth' for manufacturing.
- Performance Standards: The "bench tests and simulated use study" would have been conducted against established performance standards for IV catheters, likely related to patency, insertion force, flow continuity, and the integrity of the needle safety mechanism.
- Biocompatibility Standards: Biocompatibility was evaluated in accordance with ISO 10993-1, which provides the 'ground truth' for material safety. Sterility was validated according to ISO 11135-2007, and EtO residuals to ISO 10993-7.
8. The Sample Size for the Training Set
This question is not applicable as the device is a physical IV catheter and not an AI/algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
This question is not applicable as the device is a physical IV catheter and not an AI/algorithm that requires a training set.
Summary of the Study and Evidence Presented:
The study described is a set of "bench tests and simulated use study" ([7]) conducted on the TERUMO® Hybria™ Closed System Safety I.V. Catheter. The purpose of these tests was to demonstrate substantial equivalence to predicate devices. This means the study aimed to show that the new device performs comparably to devices already on the market (K991406 TERUMO® SURFLASH® I.V. Catheter, K923702 Becton Dickinson Saf-T-Intima Closed I.V. Catheter System, K032843 Becton Dickinson Nexiva Closed IV Catheter System) in terms of intended use, design, technology/principles of operation, materials, and performance.
Specific details about the methodology, sample sizes, or outcome thresholds for these bench and simulated-use tests are not provided in this 510(k) summary. The document relies on the assertion that these tests were performed and demonstrated equivalence, alongside adherence to relevant ISO standards for biocompatibility and sterilization. The core argument for acceptance is the demonstrated equivalence to already approved devices, indicating that the new device does not raise "any new issues of safety or effectiveness."
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).