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To sample blood or administer drug solutions, blood products, and other fluids intravenously. 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 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.

The provided text describes a 510(k) premarket notification for an intravascular catheter, specifically the Becton Dickinson FIRST MIDCATH™ Catheter with Dual Lumens. This document focuses on establishing substantial equivalence to a predicate device and does not contain information about acceptance criteria for device performance, a study proving the device meets specific criteria, or any details related to AI/ML device performance or validation.

Therefore, I cannot fulfill the request as the necessary information is absent from the provided text. The document is concerned with regulatory approval based on equivalence to an existing device, not a performance study against specific acceptance criteria.

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To sample blood or administer drug solutions, blood products, and other fluids intravenously. 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 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.

The provided text describes a 510(k) premarket notification for an intravascular catheter (FIRST MIDCATH™ Catheter) and its substantial equivalence to a predicate device. This document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The 510(k) submission primarily focuses on:

• Device Identification: Name, common name, classification, and intended use.
• Predicate Device: Identification of the legally marketed device it claims substantial equivalence to.
• Description of Differences: States that the subject catheter differs from the predicate only in modified stylet and labeling.
• Regulatory Conclusion: The FDA's determination of substantial equivalence.

Therefore, I cannot provide the requested information, which typically would be found in a performance study report or clinical trial summary. The document explicitly states that the proposed catheter differs from the predicate only in the stylet and labeling, implying that its fundamental performance characteristics are assumed to be equivalent to the predicate without requiring new standalone performance studies.

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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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