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Vaxcel ™ PICC with PASV®Valve Technology is indicated for use in establishing peripheral access to the central venous system for administration of fluids including, but not limited to, hydration agents, and piotics, chemotherapy, analgesics, nutitional therapy, and blood products, and blood indicated for blood specimen withdrawal.

The Vaxcel™ PICC with PASV® Valve Technology is indicated for use in establishing peripheral access to the central venous system for administration of fluids including, but not limited to, hydration agents, antibiotics, chemotherapy, analgesics, nutritional therapy and blood products. It is also indicated for blood specimen withdrawal.

The provided text is a 510(k) summary for the Vaxcel™ PICC with PASV® Valve Technology. It focuses on establishing substantial equivalence to a predicate device and does not contain information about acceptance criteria, detailed study designs (such as sample sizes for test or training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance), or the type of ground truth used for a device that relies on interpretation or measurement.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or information regarding the study details you requested, as this information is not present in the provided document. The document primarily addresses regulatory aspects of device approval based on substantial equivalence.

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The Catheter Innovations Implantable Port is designed for patients who require long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, antibiotics, chemotherapy, analgesics, nutritional therapy, and blood products. They are also indicated for blood specimen withdrawal.

Catheter Innovations. Inc. Implantable Ports are constructed using a combination of traditional implanted port/catheter technology and materials which are well known and proven in the art (over fifteen years of successful use), Bard Access Systems BardPort™ Implanted Ports with Groshong® catheters-hereafter referred to as BardPorts™ (over eleven years in use) and our own previously approved 510(k) technology. The Catheter Innovations ports, like the BardPorts™ and other traditional ports are implanted within the body. They are used for access to the circulatory system for repeatable or periodic infusion of fluids and/or aspiration of blood. Like many currently marketed ports the Catheter Innovations ports have smooth, contoured titanium (or proposed polysulfone plastic) port bodies with either one (single-lumen) or two (dual-lumen) independent reservoirs.

A radiopaque silicone catheter with one or two lumens is provided with each port body. The catheter may come attached to the port body by the manufacturer or unattached depending on user preference. If the catheter comes attached to the port, at the time of use the health practitioner measures and cuts off the distal end of the catheter to the desired length. If the catheter is not attached to the port when it is purchased, the catheter is placed, then cut off at the proximal end to the desired length and attached to the port by the practitioner. The port is then placed in a small pocket made just under the skin. The port bodies are designed to facilitate secure seating and anchoring in the port pocket.

The ports are accessed by inserting a non-coring needle through the skin and into the self-sealing silicone septum which caps the port body reservoirs.

Both BardPorts™ and Catheter Innovations ports contain a thin silicone membrane within their construction. In both cases these membranes have a small slit or cut through them that acts as a valve. In the BardPorts™ this valve is located at the distal end of the attached catheter. In the Catheter Innovations ports the valve is located in a small plastic polysulfone housing which comes attached to the port body. The catheter is connected to this port through this housing. In both examples the valve is used to control the flow of fluids both into and out of the blood stream. The valve remains closed when the ports are not in use and when subjected to normal central venous pressures. When positive fluid pressure is applied through the reservoir, the valve opens, allowing infusion through the catheter. When negative pressure (aspiration) is applied, the valve opens, allowing for withdrawal of blood into a syringe.

This submission describes a special 510(k) device modification for Intravascular Implanted Ports (K993860). The modification involves changing the material of the port body from titanium to polysulfone plastic.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document refers to the "FDA Guidance on 510(k) Submissions for Implanted Infusion Ports" (October 1990) for all performance characteristics. While specific numerical acceptance criteria are not explicitly stated in the provided text, the overall conclusion is that the modified device meets or exceeds the performance of the predicate devices.

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

• Sample Size: Not explicitly stated. The document mentions "performance test results" and "comparison of all other Catheter Innovations port catheter performance characteristics were made to the range of values found for the performance of the predicate BardPort™ with Hickman® and Groshong® catheters." However, the specific number of units tested for the modified device is not provided.
• Data Provenance: Not explicitly stated. The study was conducted by Catheter Innovations, Inc. The data is likely internal performance testing data. It is not specified if the data is retrospective or prospective, or from which country.

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

This information is not applicable to this type of device modification submission. Device performance was assessed through physical and functional testing against established FDA guidance, not through expert-evaluated "ground truth" labels.

4. Adjudication Method for the Test Set:

This information is not applicable. Device performance was assessed through physical and functional testing against established FDA guidance, not through human adjudication of results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improvement with AI vs. without AI Assistance:

This information is not applicable. This is a device modification for an implantable port, not an AI-assisted diagnostic or treatment device.

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

This information is not applicable. This is a device modification for an implantable port, not an algorithm.

7. The Type of Ground Truth Used:

The "ground truth" for evaluating the modified device's performance was the established physical and performance characteristics of predicate devices as outlined in the "FDA Guidance on 510(k) Submissions for Implanted Infusion Ports" (October 1990). This involved comparing the new device's test results to the known performance and specifications of approved similar devices already on the market.

8. The Sample Size for the Training Set:

This information is not applicable. This is a device modification, and the "training set" concept is not relevant in this context. Device performance is evaluated through testing against established standards and predicate devices, not through a machine learning model.

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

This information is not applicable for the reasons stated in point 8.

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The Catheter Innovations Implantable Port is designed for patients who require long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, antibiotics, chemotherapy, analgesics, nutritional therapy, and blood products. It is also indicated for blood specimen withdrawal.

Catheter Innovations, Inc. Implantable Ports are constructed using a combination of traditional implanted port/catheter technology which is well known in the art (over fifteen years of successful use), Bard Access Systems BardPort™ Implanted Ports with Groshong® catheters-hereafter referred to as BardPorts™ (over eleven years in use) and its own previously approved 510(k) technology. The Catheter Innovations ports, like the BardPorts™ and other traditional ports, are implanted within the body and are used for access to the circulatory system for repeatable or periodic infusion of fluids and/or aspiration of blood. Like many currently marketed ports the Catheter Innovations ports have smooth, contoured titanium port bodies with either one (single-lumen) or two (dual-lumen) independent reservoirs. A radiopaque silicone catheter with one or two lumens is provided with each port body. The catheter may come attached to the port body by the manufacturer or un-attached depending on user preference. If the catheter comes attached to the port, at the time of use the health practitioner measures and cuts off the distal end of the catheter to the desired length. If the catheter is not attached to the port when it is purchased, the catheter is placed, then cut off at the proximal end to the desired length and attached to the port by the practitioner. The port is then placed in a small pocket made just under the skin. The port bodies are designed to facilitate secure seating and anchoring in the port pocket. The port bodies are accessed by inserting a non-coring needle through the skin and into the self-sealing silicone septum which caps these reservoirs. Both BardPorts™ and Catheter Innovations ports contain a thin silicone membrane within their construction. In both cases these membranes have a small slit or cut through them that acts as a valve. In the BardPorts™ this valve is located at the distal end of the attached catheter. In the Catheter Innovations ports the valve is located in a small plastic polysulfone housing which comes attached to the port body. The catheter is connected to this port through this housing. In both examples the valve is used to control the flow of fluids both into and out of the blood stream. The valve remains closed when the ports are not in use and when subjected to normal central venous pressures. When positive fluid pressure is applied through the reservoir, the valve opens, allowing infusion through the catheter. When negative pressure (aspiration) is applied, the valve opens, allowing for withdrawal of blood into a syringe.

The provided text describes a Premarket Notification (510(k)) for Catheter Innovations, Inc.'s Dual-Lumen Implantable Ports. The submission aims to demonstrate substantial equivalence to predicate devices, namely BardPort™ Implanted Ports with Groshong® catheters and Hickman® catheters.

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

The submission does not explicitly state quantitative acceptance criteria or specific numerical performance targets. Instead, the "acceptance criteria" are implied to be "substantial equivalence" to the predicate devices for all performance characteristics itemized in the "FDA Guidance on 510(k) Submissions for Implanted Infusion Ports" (October 1990).

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

The document does not specify a "test set" in terms of a distinct group of patients or a specific number of new devices tested separately from general performance comparisons. The study appears to be an engineering or design validation comparison rather than a clinical trial with a defined patient test set.

• Sample Size: Not explicitly stated for any specific "test" of the Catheter Innovations device. The performance characteristics were compared to "the range of values found for the performance of the predicate BardPort™ with Hickman® and Groshong® catheters." This suggests comparison against existing data or specifications of the predicate devices.
• Data Provenance: Not specified. The study seems to rely on "performance test results" and "physical characteristic comparisons" which would typically be conducted in a lab environment. There is no mention of country of origin for any data or whether it's retrospective or prospective.

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

This information is not provided. Given that the submission is for a 510(k) focusing on substantial equivalence through physical and performance characteristic comparisons, the "ground truth" would be established through engineering specifications, test methods, and existing data/performance of the predicate devices, rather than expert clinical consensus on a "test set."

4. Adjudication Method for the Test Set

Not applicable. There is no mention of a human-centric "test set" or adjudication process.

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 is typically associated with diagnostic imaging devices or algorithms where human readers interpret cases. The device in question is an implantable port, and the submission focuses on its physical and functional equivalence to existing devices.

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

Yes, in essence, the performance assessment described is a "standalone" evaluation of the device's physical and functional characteristics. The "performance test results" and "physical characteristic comparisons" would have been conducted on the device itself, independent of human interaction in a clinical setting for the purpose of this 510(k) submission. There is no "algorithm" involved, but the device's inherent performance is evaluated.

7. The Type of Ground Truth Used

The "ground truth" for the comparison is the established physical characteristics and performance ranges/data of the predicate devices (BardPort™ with Groshong® and Hickman® catheters). This is based on:

• Predicate Device Specifications: "physical characteristics... identical to the predicate devices for all items listed in the 'FDA Guidance...'"
• Predicate Device Performance Data: "Comparison of all other Catheter Innovations port catheter performance characteristics were made to the range of values found for the performance of the predicate BardPort™ with Hickman® and Groshong® catheters."

This is akin to using established engineering standards and existing product performance as a benchmark.

8. The Sample Size for the Training Set

Not applicable. The concept of a "training set" is relevant for machine learning algorithms. This submission describes an implantable medical device, not an AI or algorithmic device.

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

Not applicable, as there is no "training set" in the context of this 510(k) submission for an implantable port.

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Catheter Innovations, Inc. PASV™ Dual Lumen Peripherally Inserted Central Catheter (PICC) is designed to establish peripheral access to the central venous system for administration of fluids including, but not limited to, hydration agents, antibiotics, chemotherapy, analgesics, nutritional therapy and blood products. It is also indicated for blood specimen withdrawal.

This product is effective for venous access in adults, children and infants who require intravenous therapy.

Catheter Innovations, Inc. PASV™ Dual Lumen Peripherally Inserted Central Catheters (PICC) have the same intended use as our Single Lumen PICC Catheters (K963097).

PASV™ Dual Lumen Peripherally Inserted Central Catheter (PICC)

I am sorry, but the provided text is a letter from the FDA regarding a 510(k) notification for a medical device (PASV™ Dual Lumen Peripherally Inserted Central Catheter (PICC)). It does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment. Therefore, I cannot fulfill your request to describe these details based on the given input.

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Catheter Innovations, Inc. PASV™ Dual Lumen Peripherally Inserted Midline Catheter is designed to establish peripheral access to the venous system for administration of fluids including, but not limited to, hydration agents, antibiotics, analgesics, and blood products. It is also indicated for blood specimen withdrawal.

This product is effective for venous access in adults, children and infants who require intravenous therapy.

Warning: The PASV™ Dual Lumen Peripherally Inserted Midline Catheter is NOT indicated for infusion of the following:

• Hypertonic nutrition solutions with final glucose concentrations . greater than 10%
• Continuously infused Vesicant Drugs .
• Any medication contraindicated for infusion into the peripheral . system

Catheter Innovations, Inc. PASV™ Dual Lumen Peripherally Inserted Midline Catheters have the same intended use as our Single Lumen Midline Catheters (K963215).

PASV™ Dual Lumen Peripherally Inserted Midline Catheter

The provided text is a 510(k) clearance letter from the FDA for a medical device called the PASV™ Dual Lumen Peripherally Inserted Midline Catheter. It indicates that the device has been found substantially equivalent to previously marketed devices. However, this document does not contain any information regarding the acceptance criteria, study design, or performance data for the device.

Therefore, I cannot extract the requested information from the provided text. The document is solely a regulatory clearance letter and not a technical study report.

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These extension sets are indicated for needle-free use in the intravenous delivery of fluids, including but not limited to, hydration fluids, chemotherapy, antibiotics, analgesics, and nutritional therapy. The sets are commonly connected to the external portion of indwelling vascular access catheters.

Catheter Innovations, Inc. Extension Sets with PASV™ Valve

I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA to a medical device manufacturer. It primarily confirms the substantial equivalence of the device (Catheter Innovations, Inc. Extension Sets with PASV™ Valve) to a predicate device and allows its marketing.

The document does not contain any information about:

• Acceptance criteria and reported device performance (in a table or otherwise).
• Details of any study conducted to prove the device meets acceptance criteria. This includes sample sizes, data provenance, ground truth establishment methods, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details.

Therefore, I cannot fulfill your request for this specific information based on the text provided.

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