(210 days)
Deltaven Closed I.V. Catheter systems are catheters for short-term peripheral venous access that allow the collection of blood samples and administration of fluids intravascularly.
Deltaven Closed I.V. Catheter systems are equipped with a passive system for the prevention of accidental needlestick injuries.
Blood is contained within the device during the catheter insertion process, aiding the prevention of blood exposure. The device can be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of procedure.
Deltaven Closed I.V. Catheter systems 16-24 gauge catheters are suitable for use with pressure injectors rated for a maximum of 330 psi when the access ports and stopcocks are removed and a direct connection is made with the proximal luer lock connector.
Deltaven Closed I.V. Catheter systems 26G are not suitable for the administration at high pressure.
The devices consist of an over-the-needle, peripheral intravascular catheter made of polyurethane, integrated extension tubing with Luer lock adaptor and slide clamp. The devices are also equipped with a Luer lock final adaptor (single entry version) or a Y Luer lock final adapter (dual entry version).
Deltaven Closed I.V. Catheters are available in five versions, as follows:
- Deltaven XiV Max
- . Deltaven XiV Max Y
- Deltaven XiV Max SC ●
- Deltaven XiV Max Y-NL ●
- Deltaven XiV Max SC-NL
The same versions are available with the needle provided with a notch along its surface that permits the early visualization of blood return inside the catheter tube. This version is generally named as Deltaven XV Max Fast Flash and is available in five versions, as follows:
- . Deltaven XiV Max Fast Flash
- Deltaven XiV Max Y Fast Flash
- Deltaven XiV Max SC Fast Flash
- Deltaven XiV Max Y- NL Fast Flash
- . Deltaven XiV Max SC-NL Fast Flash
The devices provided with single entry Luer lock adaptors are also equipped with:
- Luer lock white cap
- 3 way stopcock
- 3 way stopcock and needleless valve ●
The devices provided with dual entry Luer lock adaptors are also equipped with:
- Luer lock white cap ●
- Needleless valve connector
The provided document describes the Deltaven Closed I.V. Catheter Systems and its substantial equivalence to a predicate device (BD Nexiva Closed IV Catheter System, K102520). The document outlines various bench/performance/non-clinical tests conducted to support this claim, referencing relevant ISO standards.
Here's an analysis of the acceptance criteria and the study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that in all testing, "the pre-determined acceptance criteria were met." However, it does not explicitly list the specific quantitative acceptance criteria or the numerical performance results for each test. Instead, it refers to compliance with ISO standards.
Here's a table based on the mentioned tests and the general statement of compliance:
| Test Category | Specific Test (Referenced Standard if applicable) | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| Biocompatibility | Cytotoxicity, Irritation, Acute Systemic Toxicity, Material-Mediated Pyrogen, Bacterial-Mediated Pyrogen, Genotoxicity, Sub-Chronic Toxicity, Implantation, Hemolysis, Complement Activation, In Vivo Thrombogenicity, LAL testing | Compliance with ISO 10993 series requirements | Met biocompatibility requirements |
| Physical/Mechanical (ISO 594-1, 594-2, 80369-7) | Gauging | Compliance with ISO 594-1 and 594-2 | Criteria met |
| Liquid leakage | Compliance with ISO 594-2, 594-1, and 80369-7 | Criteria met | |
| Air leakage during aspiration | Compliance with ISO 594-2 and 594-1 | Criteria met | |
| Sub-atmospheric pressure air leakage | Compliance with ISO 80369-7 | Criteria met | |
| Unscrewing torque | Compliance with ISO 594-2 and 80369-7 | Criteria met | |
| Separation force | Compliance with ISO 594-2 and 80369-7 | Criteria met | |
| Easy to assembly | Compliance with ISO 594-2 | Criteria met | |
| Resistance of overriding | Compliance with ISO 594-2 and 80369-7 | Criteria met | |
| Stress cracking | Compliance with ISO 594-2 and 80369-7 | Criteria met | |
| Leakage by pressure decay | Compliance with ISO 80369-7 | Criteria met | |
| Catheter/Needle Properties (ISO 9626, 10555-1, 10555-5) | Radio-detectability | Compliance with ISO 10555-1 | Criteria met |
| Surface testing | Compliance with ISO 9626, 10555-1, and 10555-5 | Criteria met | |
| Corrosion testing | Compliance with ISO 9626 and 10555-1 | Criteria met | |
| Peak tensile force | Compliance with ISO 10555-1 | Criteria met | |
| Freedom from leakage under pressure | Compliance with ISO 10555-1 | Criteria met | |
| Freedom from leakage during aspiration | Compliance with ISO 10555-1 | Criteria met | |
| Needle material | Compliance with ISO 9626 | Criteria met | |
| Needle stiffness | Compliance with ISO 9626 | Criteria met | |
| Resistance of tubing to breakage | Compliance with ISO 9626 | Criteria met | |
| Catheter unit | Compliance with ISO 10555-5 | Criteria met | |
| Strength union between needle hub and needle tube | Compliance with ISO 10555-5 | Criteria met | |
| Vent fitting | Compliance with ISO 10555-5 | Criteria met | |
| Sharps Injury Protection (ISO 23908) | Safety Closed IV Catheter system activation test | Compliance with ISO 23908:2011 | Criteria met |
| Challenging safety device test | Compliance with ISO 23908:2011 | Criteria met | |
| Simulated Clinical Use Test | Compliance with FDA "Guide for Industry and staff Medical Devices with Sharp injury Prevention Features" and ISO 23908:2011 | Criteria met | |
| Additional Performance Testing | Priming volume | Verified/Validated | Criteria met |
| Clinical significant hydration | Verified/Validated | Criteria met | |
| Pressure resistance (up to 330 psi) | Verified/Validated for 16-24G, 26G excluded | Criteria met (for applicable gauges up to 330 psi) | |
| Tensile force of 15 N for 15 seconds between tube and hub | No breakage or separation | No breakage or separation (demonstrated for further SE) |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the exact sample sizes for any of the individual tests. It states that "Performance testing was provide to verify/validate the sharps injury prevention feature" and "Performance data has been provided to verify pressure injection up to 330 psi". For the tensile force test, it mentions "to samples of each device type."
The data provenance is not explicitly stated as retrospective or prospective, nor does it mention the country of origin. However, given that these are bench and performance tests on a medical device for regulatory submission, they are typically prospective tests performed in a controlled laboratory environment.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This section is not applicable as the document describes bench and performance testing of a physical medical device, not a diagnostic or AI-driven device requiring expert interpretation for ground truth. The "ground truth" for these tests would be the physical properties and performance characteristics measured against established engineering and medical device standards.
4. Adjudication Method for the Test Set:
This section is not applicable for the same reasons as point 3. Adjudication methods like 2+1 or 3+1 are used for establishing consensus among human experts for diagnostic accuracy studies, not for physical performance testing.
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 section is not applicable. The document describes a medical device (intravascular catheter system) and its performance, not an AI-driven diagnostic tool that would involve human readers or an MRMC study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
This section 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 medical device's performance testing is established by objective measurements and reference to internationally recognized technical standards (e.g., ISO 594, ISO 9626, ISO 10555, ISO 23908, ISO 80369, ISO 10993 series). This includes:
- Compliance with specified dimensions and tolerances.
- Performance within defined ranges (e.g., pressure resistance, flow rates).
- Absence of failures (e.g., leakage, breakage, separation).
- Demonstrated activation of safety mechanisms.
- Absence of biological adverse reactions (biocompatibility).
8. The Sample Size for the Training Set:
This section is not applicable. "Training set" refers to data used to train machine learning models. This document describes the testing of a physical medical device, which does not involve a training set in this context.
9. How the Ground Truth for the Training Set Was Established:
This section is not applicable for the same reason as point 8.
§ 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).