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As indicated in 21 CFR 870.1200, to sample blood, to monitor blood pressure, or to introduce substances into the heart and vessels . These catheters may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused, and duration of therapy. The catheters may be used with power injectors for which the maximum rated pressure is 300 psi.

The subject catheter is a short term, single use, diagnostic intravascular catheter of various gauges and lengths which is designed to provide access to the vascular system. It is a radiopaque, VIALON® catheter for which the labeling sets forth the conditions of use with power injectors.

This device is a Diagnostic Intravascular Catheter (INSYTE®, INSYTE-W®, and INSYTE® AUTOGUARD™ Catheters) intended to provide access to the vascular system for monitoring blood pressure, sampling blood, or introducing substances into the heart and vessels. The key modification for this 510(k) submission is the explicit clarification that the catheters are suitable for use with power injectors, with a maximum rated pressure of 300 psi.

Based on the provided information, there is no acceptance criteria or study that proves the device meets specific performance metrics in the context of AI/ML or diagnostic accuracy. This document is a 510(k) premarket notification for a medical device (intravascular catheter) where the primary assertion is substantial equivalence to a predicate device, with an added clarification regarding use with power injectors.

Therefore, many of the requested elements for an AI/ML device (e.g., sample size for test sets, ground truth establishment, MRMC studies, standalone performance) are not applicable or not provided in this regulatory submission.

Here's an attempt to answer the questions based only on the provided text, highlighting what is not applicable or not present:

1. A table of acceptance criteria and the reported device performance

   There are no specific quantitative acceptance criteria or reported device performance metrics provided in the document related to diagnostic accuracy or AI/ML performance. The basis for clearance is substantial equivalence to a predicate device, with the addition of a clarified intended use with power injectors.

   The "performance" referred to in the "Summary of Safety and Efficacy" relates to the inherent function of the catheter, not a diagnostic output. The document states:

   Acceptance Criteria (Implied)	Reported Device Performance
   Functional equivalence to predicate device	Cleared as substantially equivalent to the Becton Dickinson Vascular Access INSYTE®, INSYTE-W®, and INSYTE® AUTOGUARD™ brand catheters.
   Suitability for intended use with power injectors (300 psi max)	Labeling clarified to include use with power injectors up to 300 psi.
   Safety and Efficacy	Assumed through substantial equivalence determination and compliance with general controls.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

   Not applicable. This is a 510(k) for a physical medical device (catheter), not an AI/ML diagnostic software. There is no "test set" in the context of an AI/ML algorithm's performance evaluation mentioned in this document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

   Not applicable. As this is not an AI/ML diagnostic submission, there is no mention of experts establishing a ground truth for a test set.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

   Not applicable. No test set or adjudication method is mentioned.

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

   Not applicable. This is not an AI-assisted diagnostic device, so no MRMC study comparing human readers with and without AI assistance was performed.

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

   Not applicable. There is no AI algorithm being submitted.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

   Not applicable. There is no AI algorithm requiring ground truth data.

8. The sample size for the training set

   Not applicable. There is no AI algorithm that requires a training set mentioned in this document.

9. How the ground truth for the training set was established

   Not applicable. There is no AI algorithm or training set discussed.

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The intended use is to provide access to the vascular system to administer fluids intravenously. The device is also suitable for sampling blood and monitoring blood pressure.

The subject catheter is a single use intravascular administration set of various gauges and lengths which is designed to provide access to the vascular system. It is stainless steel needle set with butterfly wings and a short extension set.

The provided text is related to a 510(k) premarket notification for K970259, an Intravascular Administration Set. This is a medical device application for a physical product (infusion set), not a software or AI-based diagnostic device.

Therefore, the concepts of "acceptance criteria," "device performance," "sample size for test/training sets," "ground truth," "experts," "adjudication methods," and "MRMC comparative effectiveness studies" as they relate to algorithm or AI performance are not applicable to this submission.

The submission focuses on demonstrating substantial equivalence to a predicate device for an existing physical product, primarily by clarifying the "intended use."

Here's how to interpret the provided information in the context of a physical device:

1. A table of acceptance criteria and the reported device performance: Not applicable in the AI sense. For a physical device, acceptance criteria would typically relate to manufacturing specifications (e.g., material strength, flow rate, sterility, dimensions), and device performance would be confirmed through testing those physical characteristics. The document states "The device is unchanged," implying it already meets the established physical performance criteria of the predicate device.

2. Sample size used for the test set and the data provenance: Not applicable. There's no "test set" of data in the AI sense. Any testing would be physical product testing, not data analysis.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. "Ground truth" in this context would be physical specifications or clinical outcomes, not expert labeling of images or data.

4. Adjudication method: Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This is for assessing AI's impact on human readers, not a physical infusion set.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithm.

7. The type of ground truth used: Not applicable in the AI sense. For a physical device, "ground truth" would be established physical standards, material properties, sterility testing results, etc.

8. The sample size for the training set: Not applicable. There is no AI model to train.

9. How the ground truth for the training set was established: Not applicable.

Summary based on the provided text:

The submission K970259 for the Intravascular Administration Set (E-Z SET® and Saf-T E-Z SET®) is a physical medical device 510(k) application. It is not an AI or software device. The primary purpose of this submission is to clarify the intended use of an unchanged device, adding suitability for blood sampling and pressure monitoring. Substantial equivalence is claimed based on the fact that the device itself has not changed from its previously marketed predicate. Therefore, the questions posed about AI-specific acceptance criteria, study methodologies, and performance metrics are not relevant to this document.

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The kit contains a midline catheter suitable to sample blood or administer drug solutions, blood products, or other fluids intravenously. Other components are used in the course of placing the catheter as indicated above.

The subject kit contains a long term, single use, single or dual lumen, intravascular catheter of various French sizes and lengths which is designed to provide access to large veins such as the baslic or cephalic veins. It also contains drugs and devices for preparing the insertion site, placing the catheter, securing the catheter and dressing the site.

This document (K964048) is a 510(k) Premarket Notification for a medical device. It describes the device, its intended use, and claims substantial equivalence to a predicate device. However, this document does not contain acceptance criteria for device performance or a study proving that the device meets such criteria.

The purpose of a 510(k) submission is to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. This is primarily done by comparing technological characteristics, intended use, and safety/efficacy profiles. It is not typically the place where detailed clinical performance studies proving acceptance criteria are presented in the format you've requested.

Therefore, I cannot provide the information you asked for based on the provided text. The document focuses on:

• Device Identification: Name, manufacturer, classification.
• Predicate Device: Identification of a similar, already marketed device.
• Description: Physical characteristics of the device.
• Intended Use: What the device is designed to do.
• Technological Comparison: How the new device is similar to (and differs slightly from) the predicate, emphasizing the "shorter" length as the primary difference from the "FIRST PICC™" catheter while maintaining similar materials and design.

To find information on acceptance criteria and performance studies, you would typically need to look for:

• Clinical trial reports: If a clinical study was conducted.
• Design Validation documentation: Internal company documents detailing testing and validation.
• Performance Standards: Industry or regulatory standards that the device might need to meet (though these are not explicitly listed as "acceptance criteria" for this specific device's performance in the provided text).
• Subsequent regulatory filings or literature: If the device has been studied further or evaluated after its initial clearance.

In summary, the provided K964048 document does not offer the details required to fill out your table and answer your specific questions regarding acceptance criteria and performance studies.

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to provide access to the vascular system to sample blood or administer drug solutions, blood products, or other fluids intravenously.

The subject catheter is a long term, single use, dual lumen, intravascular catheter of various French sizes and lengths which is designed to provide access to large veins such as the baslic or cephalic veins. It is inserted into the vascular system through a spittable introducer catheter.

This submission describes a medical device, specifically a "Midline Catheter with Dual Lumens," and seeks to establish its substantial equivalence to a predicate device. However, the provided text does not contain the information necessary to describe acceptance criteria or a study proving the device meets those criteria in the context of device performance,
such as accuracy or efficacy. The document focuses on regulatory identification and comparison to a predicate device based on material and design, not on performance metrics.

Therefore, I cannot generate the requested table and details about a performance study. The provided text is insufficient for this purpose.

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The intended use is to provide access to the vascular system to sample blood or administer drug solutions, blood products, or other fluids intravenously.

The subject catheter is a short term, single use, intravascular catheter of various French sizes and lengths which is designed to provide access to large veins such as the baslic or cephalic veins. It is inserted into the vascular system through a spittable introducer catheter.

This document is a 510(k) summary for a medical device (an intravascular catheter) and does not contain information about acceptance criteria or a study proving device performance in the way typically found for AI/ML-driven medical devices.

The information provided describes the device's intended use, its comparison to a predicate device, and manufacturing details. It does not include any of the requested elements pertaining to AI/ML device performance studies, such as:

• Acceptance criteria tables
• Sample sizes for test or training sets
• Data provenance
• Expert involvement (ground truth, adjudication)
• MRMC studies
• Standalone performance
• Ground truth types

Therefore, I cannot fulfill your request based on the provided input.

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The intended use is to facilitate the placement of other devices such as guidewires, central venous catheters, peripherally inserted central venous catheters, and probes in the vascular system.

The subject catheter is a short term, single use introducer catheter of various gauges and lengths which is designed to split and peel away following use. It is inserted into the vascular system over a needle.

This document (K954906) is a 510(k) premarket notification for an introducer catheter. It outlines the device description, intended use, and comparison to predicate devices for demonstrating substantial equivalence. It does not contain information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert involvement, or AI-related aspects.

Therefore, I cannot provide the requested information as it is not present in the provided text.

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