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Deltaven Fast Flash 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 Fast Flash 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 Fast Flash 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 Fast Flash 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).

The provided text describes a 510(k) summary for the Delta Med S.p.A Deltaven Fast Flash Closed I.V. Catheter Systems. This document pertains to a medical device (intravascular catheter) and not an AI/ML-driven device or an imaging device. Therefore, a study proving an AI device meets acceptance criteria, including elements like expert consensus, MRMC studies, or training/test set details, is not applicable to this document.

The document discusses acceptance criteria and the study that proves the device meets them in the context of a physical medical device (intravenous catheter), not an AI/ML system. The "acceptance criteria" here refer to the performance standards, regulatory requirements, and safety benchmarks for this type of medical device.

Here's a breakdown of the acceptance criteria and the study as described in the document, tailored to a medical device:

Acceptance Criteria for Deltaven Fast Flash Closed I.V. Catheter Systems

The acceptance criteria for the Deltaven Fast Flash Closed I.V. Catheter Systems are primarily based on established international and FDA-recognized standards for intravascular catheters, and proving substantial equivalence to a predicate device.

Table of Acceptance Criteria and Reported Device Performance

• Meet specifications for various components (e.g., extension line closure, catheter hub wings, needle sheath). | Functional tests were carried out on all material versions of the new designs. All tests were performed on finished sample devices after a standard ethylene oxide sterilization cycle. The test protocols and acceptance criteria were the same as those used in the predicate submission, indicating the device performed to the established specifications. Specific design changes and their impact were verified. |
  | Material Biocompatibility | - Meet biological safety standards for patient contact.
• Compliance with ISO 10993 series and FDA guidance on biocompatibility.
• Specific tests: Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Acute Systemic Toxicity, Subacute/Subchronic Toxicity, Haemocompatibility (ASTM hemolysis, Complement Activation, Thromboresistance), Genotoxicity (Bacterial Mutagenicity, In Vitro Mouse Lymphoma), Material Mediated Rabbit Pyrogen, EO residuals. | Biocompatibility tests were carried out on new, sterile, complete devices with the new materials, in accordance with ISO 10993-1:2018 and FDA guidance. All listed specific tests were performed: Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Acute Systemic Toxicity, Subacute/Subchronic Toxicity, Haemocompatibility (ASTM hemolysis, Complement Activation Sc5b-9, Thromboresistance), Genotoxicity (Bacterial Mutagenicity Test (Ames Assay), In Vitro Mouse Lymphoma), ISO Material Mediated Rabbit Pyrogen, and EO residuals. The results were deemed acceptable. |
  | Sterility | - Achieve a Sterilization Assurance Level (SAL) of 10-6.
• Compliance with ISO 11135:2014 for ethylene oxide sterilization validation. | The devices are sterilized by ethylene oxide (EO) to an SAL of 10-6. The sterilization process was validated according to ISO 11135:2014, using the half cycle overkill approach. The sterile packaging is unchanged from the predicate device and found acceptable. |
  | Pyrogenicity | - Endotoxin levels within acceptable limits via Limulus Amebocyte Lysate (LAL) test. | Sample devices produced with the new materials were tested for bacterial endotoxins using the LAL test and found to be within limits. |
  | Physical/Mechanical Performance (Bench Tests) | - Compliance with ISO 10555-1:2013 (General requirements for intravascular catheters).
• Compliance with ISO 10555-5:2013 (Over-needle peripheral catheters).
• Compliance with ISO 80369-7:2016 (Small-bore connectors for intravascular/hypodermic applications).
• Compliance with ISO 23908:2011 (Sharps injury protection features).
• Compliance with USP for particulate evaluation (no more than 10 microns and greater).
• Catheter Force at break: Conforms to ISO 10555-1.
• Cannula bonding strength: Conforms to ISO 10555-5.
• Flow rate: Conforms to ISO 10555-1.
• Pressure resistance: 330 psi (for 16-24 gauge). | Bench tests were carried out, and the results demonstrate that the devices meet the applicable technical requirements of the listed FDA-recognized standards. This includes satisfactory performance related to catheter force at break, cannula bonding strength, flow rate, and pressure resistance (330 psi for indicated gauges). Particulate testing per USP was also performed, and the devices met the acceptance criteria. |
  | Material/Shelf-life Stability | - Maintain performance after accelerated aging equivalent to 5 years shelf-life.
• Compliance with ASTM F 1980:2007. | Accelerated aging tests were conducted at 60 ℃ for 19 weeks, which is equivalent to 5 years of real-time shelf-life, in accordance with ASTM F 1980:2007. Functional tests were then performed on these aged samples and found acceptable. |
  | Indications for Use / Intended Use Equivalence | - Maintain the same indications for use as the predicate device (K171530).
• Not raise new or different questions of safety and effectiveness compared to the predicate device. | The Indications for Use statement for the subject device is unchanged from the predicate, K171530. The conclusion states that "The modified device does not raise new or different questions of safety and effectiveness and this conclusion is supported by non-clinical testing," confirming substantial equivalence. |

Study Details (Non-AI Device)

1. Sample Size Used for the Test Set and Data Provenance:

   • The document does not explicitly state the specific number of units used for each test (e.g., functional, biocompatibility, sterility) as a "sample size" in the way one would for a clinical trial or AI test set.
   • Instead, for medical devices, testing is performed on representative samples of the device, often according to guidelines within the referenced ISO standards (e.g., ISO 10993 specifies sample preparation, ISO 11135 specifies sample sizes for sterility validation).
   • Data provenance: The testing was performed by Delta Med S.p.A (Italy) through their various testing procedures and subcontractors. The tests are "non-clinical" (bench and lab-based), not from patient data.

2. Number of Experts Used to Establish Ground Truth and Qualifications:

   • Not applicable as this is a physical medical device, not an AI/ML system requiring expert labeling or ground truth establishment from medical images/data. The "ground truth" is defined by the physical and chemical properties of the device and its performance against engineering and biological standards.

3. Adjudication Method:

   • Not applicable. This concept pertains to resolving discrepancies in expert labeling for AI ground truth, which is not relevant here.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • Not applicable. This type of study is used for diagnostic AI systems where human readers interpret medical images. This document describes a physical medical device.

5. Standalone (Algorithm Only) Performance:

   • Not applicable. This device is not an algorithm. The performance evaluation is of the physical catheter and its components.

6. Type of Ground Truth Used:

   • The "ground truth" for this device is based on:
     • Standard Compliance: Adherence to internationally recognized standards (ISO, ASTM, USP) for materials, design, manufacturing, sterility, and performance.
     • Bench Test Results: Direct measurements and observations from laboratory testing (e.g., flow rate, force at break, particulate counts, endotoxin levels).
     • Biocompatibility Assay Results: Laboratory tests on biological interactions.
     • Predicate Device Performance: The established safety and effectiveness of the legally marketed predicate device (K171530).

7. Sample Size for the Training Set:

   • Not applicable. There is no "training set" as this is not an AI/ML device. The device itself is manufactured. The manufacturing process ensures consistency, and the testing evaluates that consistency and adherence to design specifications.

8. How the Ground Truth for the Training Set Was Established:

   • Not applicable for the reasons mentioned above. The design and manufacturing specifications are based on engineering principles, regulatory requirements, and historical data from similar devices.

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