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The EOCVC Catheters are indicated for hemodynamic monitoring through blood sampling, pressure monitoring, and oxygen saturation measurements.

PediaSat Catheters are indicated for hemodynamic monitoring through blood sampling, pressure monitoring, and oxygen saturation measurements in adults and/or pediatric patients.

The pressure injectable EOCVC Oligon catheters are indicated for short term (

The Edwards Oximetry Central Venous Catheter is a non-balloon catheter that provides the means for infusion of solutions, measuring pressure, and taking blood samples through the distal lumen (terminates at the catheter tip), the proximal lumen (terminates 7 cm proximal to the tip), and the medial lumen (terminates 5 cm proximal to the tip). Edwards Oximetry Central Venous Catheter also provides the means for continuously monitoring oxygen saturation using an Edwards Lifesciences oximetry monitor or compatible bedside module.

The PediaSat oximetry catheters are non-balloon catheters that provide the means for infusion of solutions, measuring pressure, and taking blood samples. These catheters also provide the means for continuously monitoring oxygen saturation using an Edwards Lifesciences oximetry monitor or compatible bedside module.

The EOCVC Oligon catheter is a non-balloon catheter that provides the means for infusion of solutions measuring pressure injecting contrast media, and taking blood samples through the distal lumen (terminates 7 cm proximate to the tip), and the medial lumen (terminates 5 cm proximal to the tip). The EOCVC Oligon catheter also provides the means for continuously monitoring oxygen saturation using an Edwards Lifesciences monitor and compatible bedside module. All catheters are manufactured with a polyurethane-based Oligon polymer (containing silver, platinum, and carbon black) which has antimicrobial properties.

Oxygen saturation is monitored by fiberoptic reflectance spectrophotometry. The amount of light absorbed, refracted, and reflected depends on the relative amounts of oxygenated and deoxygenated hemoglobin in the blood.

The PediaSat Oximetry Catheter is a 3 lumen catheter available with a diameter of 4.5 French (F) and 8 cm in length. The EOCVC Oximetry Catheters are 3 lumen catheters available with a diameter of 8.5F and in lengths of 16 and 20 cm. EOCVC and PediaSat catheters are manufactured from polyurethane.

A suture loop and a specially molded box clamp are provided with each EOCVC (Oligon and non-Oligon) and PediaSat Oximetry Catheter to facilitate suturing of the catheter at the site of insertion. The suture loop and box clamp can be placed anywhere along the catheter body at the discretion of the clinician.

The dilator, included with each catheter, is indicated for enlarging the opening in a vessel for preparation of percutaneous entry of the catheter.

The EOCVC (Oligon and non-Oligon) and PediaSat Kits consist of accessories previously cleared for marketing as well as accessories that are the subject of this submission.

This submission is for clearance of proposed modifications to the accessories (suture loop, box clamp and dilator) for use with the previously cleared EOCVC Oligon (K160645), PreSep (now EOCVC), and PediaSat (K053609) Oximetry Catheter Kits. Additional accessories are listed on table below.

The provided text is a 510(k) summary for the Edwards Oximetry Central Venous Catheter (EOCVC), Edwards Oligon Oximetry Central Venous Catheter, and PediaSat Oximetry Catheters. The submission aims for clearance of proposed modifications to accessories (suture loop, box clamp, and dilator) for use with previously cleared catheters. The study described focuses on demonstrating the substantial equivalence of these modified accessories to predicate device accessories.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample sizes used for the functional and performance testing of the accessories. It only mentions that "Testing was conducted." The provenance of the data (e.g., country of origin, retrospective or prospective) is also not specified. These studies are typically conducted in a laboratory setting by the manufacturer.

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. The testing described appears to be primarily bench testing and performance verification against engineering specifications, rather than clinical studies requiring expert ground truth establishment in a medical context.

4. Adjudication Method for the Test Set

Not applicable in this context. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where expert consensus is needed to establish ground truth from subjective evaluations (e.g., image interpretation). The tests described are objective engineering and performance verification tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study investigates the impact of a device on human reader performance, usually in diagnostic imaging. The submission focuses on the substantial equivalence of modified catheter accessories through bench and performance testing.

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

Not applicable. This device is a physical medical catheter and its accessories, not an algorithm or AI system.

7. The Type of Ground Truth Used

The ground truth used for these tests would primarily be engineering specifications and established performance benchmarks derived from the predicate devices and industry standards. For example, "tensile strength" would be compared against a defined maximum or minimum force, and "dimensional verifications" against specified measurements.

8. The Sample Size for the Training Set

Not applicable. The described study is not a machine learning study requiring a training set. It involves physical product testing.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set for this type of device submission.

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The pressure injectable PreSep Oligon Oximetry Catheters are indicated for short term (

The PreSep Oligon Oximetry Catheter is a pressure injectable antimicrobrial catheter intended to provide the means for infusion of solutions, measuring pressure, delivering contrast media and taking blood samples through the distal, proximal and medial lumens. The PreSep Oligon Oximetry Catheter also provides the means for continuously monitoring oxygen saturation using an Edwards Lifesciences oximetry monitor.

The PreSep Oligon Oximetry Catheter is a 3 lumen catheter available in 8.5 French, 16 and 20cm lengths. The lumens exit at the tip of the catheter for the distal; medial and proximal exit at the ports. The catheter is manufactured from a base material of barium sulfate-filled polyurethane. Barium sulfate makes the material more radiopaque. Carbon, silver, and platinum are added to the base material. The silver and platinum render the polymer antimicrobial, by oligodynamic iontophoresis. The antimicrobial agent is silver, which is ionized and electrochemically released from the inside and outside surfaces of the catheter material into the lumens and subcutaneous space. The Oligon polymer technology provides antimicrobial protection on both the inside and outside of the catheter.

With the use of the Oligon material, the catheter has demonstrated significant antimicrobial activity, within 48 hours after inoculation, against the following organisms: Staphylococcus epidermidis, Staphylococcus aureus, Enterococcus faecalis, Candida albicans, Escherichia coli, Serratia marcescens, Acinetobacter calcoaceticus, Corynebacterium diptheriae, Enterobacter aerogenes, Klebsiella pneumoniae, Staphylococcus aureus Gentamicin and Methicillin resistant (GMRSa), Pseudomonas aeruginosa, Candida glabrata, and VRE (Enterococcus faecium)

The provided text describes the 510(k) summary for the PreSep Oligon Oximetry Catheter (K160645). However, it does not contain the information requested regarding acceptance criteria and a study proving a device meets these criteria in the context of an AI/ML-based medical device.

The document discusses:

• The device's trade name, regulation, and classification.
• Indications for Use, which are for hemodynamic monitoring, blood sampling, infusion, continuous oxygen saturation monitoring, pressure injection of contrast media, and central venous pressure monitoring for short-term use (

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The PreSep Oligon Oximetry Catheters are indicated for hemodynamic monitoring through blood sampling, pressure monitoring and oxygen saturation measurements.

The PreSep Oligon Oximetry Catheters (K060093) are used with Edwards oximetry monitors to continuously measure oxygen saturation. The catheters also provide the means for infusion of solutions, measuring pressure and taking blood samples. The PreSep Oligon Oximetry Catheters can be used with an uncoated stainless steel guidewire or a PTFE-coated Nitinol core guidewire, which are included in kits or as separately packaged components.

This 510(k) summary describes a medical device, the PreSep Oligon Oximetry Catheters, and demonstrates its substantial equivalence to a predicate device, rather than providing a study proving performance against defined acceptance criteria in the typical sense of an AI/algorithm-driven device.

Therefore, many of the requested categories regarding AI-specific studies and ground truth establishment are not applicable. I will extract the relevant information from the provided text.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The provided document does not explicitly present a table of quantitative acceptance criteria for specific performance metrics (e.g., accuracy, sensitivity, specificity) with corresponding reported device performance values. Instead, it describes a comparative analysis to a predicate device for safety and effectiveness.

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

The document states "side-by-side comparative bench and pre-clinical performance testing."

• Sample Size: Not explicitly stated. The term "pre-clinical animal studies" implies a test set of animals, but the number is not provided. "Bench" studies typically involve physical device testing, not data samples in the same way an AI algorithm uses data.
• Data Provenance: Not explicitly stated (e.g., country of origin). The studies are described as "pre-clinical animal studies," indicating they were conducted in a controlled, non-human environment. The nature (retrospective/prospective) is not explicitly given, but "pre-clinical" and "bench" studies are typically prospective tests designed for device evaluation.

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

Not Applicable. This device is a physical catheter, not an AI algorithm requiring expert ground truth for image or data interpretation. The "ground truth" would be objective measurements and observations from the bench and animal studies to assess the catheter's physical performance, safety, and functionality.

4. Adjudication Method for the Test Set

Not Applicable. Adjudication methods (like 2+1, 3+1) are typically used for establishing ground truth in human-AI studies involving subjective interpretations. For this device, the "adjudication" would be based on direct measurement, observation, and comparison to the predicate device's measured performance in the bench and animal studies.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size

Not Applicable. This is not an AI/software device whose performance depends on human-in-the-loop interaction. Therefore, an MRMC study comparing human readers with and without AI assistance was not conducted.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This is a physical medical device (catheter) with associated oximetry monitors. It is not an algorithm, so a standalone algorithm performance study is not relevant. The device itself performs the function.

7. The Type of Ground Truth Used

For a physical device like this, the "ground truth" for the test (verification and validation) would be based on:

• Physical Measurements and Observations: Direct measurements of catheter dimensions, material properties, flow rates, pressure readings, oxygen saturation readings, and observations of device interaction within the test environment (bench models, animal models).
• Biocompatibility Testing: Results from standardized tests to ensure the material is safe for contact with biological tissues.
• Predicate Device Performance: The established and legally marketed performance and safety profile of the predicate device serves as the benchmark against which the new device is compared to demonstrate substantial equivalence.

8. The Sample Size for the Training Set

Not Applicable. This is not an AI/machine learning device that requires a training set.

9. How the Ground Truth for the Training Set was Established

Not Applicable. As there is no training set for an AI algorithm, no ground truth was established for a training set in this context.

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The PreSep Oligon Oximetry Catheters are intended to provide the means for infusion of solutions, measuring pressure and taking blood samples through the distal, proximal and medial lumens. The PreSep Oligon Oximetry Catheters also provide the means for continuously monitoring oxygen saturation using an Edwards Lifesciences oximetry monitor.
The PreSep Oligon Oximetry Catheters are indicated for hemodynamic monitoring through blood sampling, pressure monitoring and oxygen saturation measurements.

The PreSep Oligon Oximetry Catheters are used with Edwards oximetry monitors to continuously measure oxygen saturation. These catheters also provide the means for infusion of solutions, measuring pressure and taking blood samples.

This is a 510(k) premarket notification for a medical device, which seeks to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to establish de novo performance criteria. Therefore, the traditional concept of "acceptance criteria" and a "study proving the device meets acceptance criteria" as would be seen in a clinical trial for a novel device, is not explicitly present in the provided text.

Instead, the submission focuses on demonstrating that the PreSep Oligon Oximetry Catheters are as safe and effective as the predicate devices through comparative analysis and functional/safety testing.

Based on the provided text, here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document
does not specify quantitative acceptance criteria (e.g., specific thresholds for accuracy, precision, or durability). The acceptance is based on demonstrating equivalence to the predicate devices.

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

The document does not provide details on the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective). The submission states "functional testing" was performed, but no specifics about the testing methodology or data are given.

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

This information is not provided in the document. Given that this is a 510(k) for an oximetry catheter, "ground truth" would likely refer to established methods for measuring oxygen saturation or relevant physiological parameters, and not typically involve a panel of experts reviewing images or clinical cases in the way an AI-based diagnostic device might.

4. Adjudication Method for the Test Set

This information is not provided.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not mentioned in the document. MRMC studies are typically used to assess the impact of medical imaging devices or AI algorithms on human reader performance, which doesn't directly apply to an oximetry catheter for continuous physiological monitoring. The comparative analysis focused on device characteristics and performance against predicate devices.

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

This concept is not applicable to this device. The PreSep Oligon Oximetry Catheter is a physical medical device for continuous physiological monitoring, not an algorithm, and therefore does not have "standalone" algorithmic performance in the context of AI.

7. The Type of Ground Truth Used

The document does not explicitly state the type of ground truth used. For an oximetry catheter, "ground truth" would generally refer to established, validated methods for measuring oxygen saturation (e.g., co-oximetry of blood samples) or other physiological parameters measured by the catheter (pressure, blood sampling). The functional testing would compare the device's measurements against these established methods or against the performance of the predicate devices.

8. The Sample Size for the Training Set

This information is not applicable as this is a physical medical device, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as this is a physical medical device, not an AI/ML algorithm that requires a training set.

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