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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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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:

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.

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The Delta Fly F20μ Micro Bore Winged Safety Needles and the Delta Fly Micro Bore Winged Safety Needles are intended for short term use to access the peripheral vascular system for intravenous administration of fluids using a syringe or other compatible / appropriate devices.

The Delta Med Delta Fly Winged Safety Needles are available in four versions, as follows:

• o Delta Fly F20μ Micro Bore Winged Safety Needle 25G x 35 cm
• . Delta Fly F20μ Micro Bore Winged Safety Needle 23G x 35 cm
• Delta Fly Micro Bore Winged Safety Needle 25G x 35 cm ●
• Delta Fly Micro Bore Winged Safety Needle 23G x 35 cm

The devices consist of a stainless steel needle encased in a body of plastic material, attached to a micro bore tube, ending proximally with a female Luer lock fitting closed by a final male Luer lock cap. The female Luer lock fitting includes a 20μ woven mesh filter in the F20μ versions of the device. The devices are equipped with a passive needle stick safety system for covering the tip of the needle upon needle withdrawal, in order to protect the operator from accidental needle stick injury.

To help identification between the two types (with and without filter), the male Luer lock proximal end cap is colored white on the versions with the filter and is transparent on the versions without the filter. To identify the needle size of each version, the winged body of the devices are color-coded blue for the 23G versions and orange for the 25G versions.

The distal end of the device is a stainless steel needle point has a triple bevel design. At the proximal end is a Luer lock fitting. Both device versions (with and without the mesh filter) have a final female connection in compliance with the requirements of ISO 594-2.

Delta Fly Micro Bore Winged Safety Needles are supplied for short term use only, sterile for single use, sterilized with ethylene oxide (EO) gas, and meet the biocompatibility requirements of ISO 10993-1:2009.

The provided document describes the Delta Fly F20u Micro Bore Winged Safety Needles and Delta Fly Micro Bore Winged Safety Needles. Here's an analysis of the acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied by adherence to established international standards and specific performance tests. The reported device performance indicates that these criteria were met.

2. Sample Sizes Used for the Test Set and Data Provenance

• Sample Size for Test Set: The document explicitly states that the Simulated Clinical Usage test was conducted at "four different hospitals to allow a sufficient number of healthcare professional who routinely use Winged Needles". However, the exact number of devices or uses tested is not specified within the provided text.
• Data Provenance: The manufacturer, Delta Med SpA, is located in Viadana (Mantova), Italy. Given the context, the tests were likely conducted in Italy or within Europe under the manufacturer's supervision, but the specific country of origin for the data (other than the manufacturer's location) for all tests is not detailed. The Simulated Clinical Usage test was performed at "four different hospitals," implying a prospective collection of data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

• Number of Experts: The Simulated Clinical Usage test involved "healthcare professional who routinely use Winged Needles." The exact number of individual healthcare professionals is not specified.
• Qualifications of Experts: They are described as "healthcare professional who routinely use Winged Needles," indicating practical experience with the device type. Specific qualifications (e.g., nurse, physician, years of experience) are not provided.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (like 2+1 or 3+1). The "Simulated Clinical Usage test" results state that "100% of the safety mechanism of the devices activated correctly" and "No tests failures occurred," suggesting observation and recording of outcomes without mentioning a specific adjudication process for discrepancies, if any. Given the nature of the test (device activation and failure), it might have been a direct observation without requiring expert adjudication in the traditional sense of diagnostic interpretation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The document describes performance testing and a simulated clinical usage test to demonstrate the device's functionality and safety, and substantial equivalence to predicate devices. It does not describe a multi-reader multi-case comparative effectiveness study comparing human readers with and without AI assistance. This device is a medical needle, not an AI diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable as the device is a physical medical needle, not an algorithm or AI system.

7. The Type of Ground Truth Used

For the performance tests (e.g., surface testing, corrosion, gauging, leakage, tensile strength, flow rate), the ground truth is established by compliance with specified international standards (ISO 594-2, ISO 9626, ISO 23908). This is a form of empirical and objective measurement against defined benchmarks.

For the "Simulated Clinical Usage test," the ground truth for "correct activation of the safety mechanism" and "test failures" would be based on direct observation and operational assessment by the participating healthcare professionals against the device's intended functionality and safety design.

8. The Sample Size for the Training Set

This question is not applicable as the device is a physical medical needle and does not involve AI or machine learning models that require 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 medical needle and does not involve AI or machine learning models that require a training set.

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