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The DECap™ is a non-vented cap that is intended to seal male or female luer locks that are part of typical medical devices such as manifolds, stopcocks or sets.

The DECap™ is a non-vented cap.

The provided document is a 510(k) clearance letter for a medical device called "DECap™". It primarily focuses on the regulatory approval for marketing the device based on its substantial equivalence to a legally marketed predicate device.

Unfortunately, this document does not contain the detailed information necessary to answer your request regarding acceptance criteria and the specifics of a study proving the device meets those criteria.

The document states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976...".

This means the device was cleared because it was shown to be substantially equivalent to an existing device, not necessarily through a new study with explicit acceptance criteria for its performance. The 510(k) pathway often relies on demonstrating that a new device is as safe and effective as a predicate device, which can involve performance data but doesn't always require a comprehensive study against pre-defined acceptance criteria in the same way a PMA (Premarket Approval) might.

Therefore, I cannot provide the requested information from this document. The document does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample size, data provenance, or details of a test set.
3. Number or qualifications of experts for ground truth.
4. Adjudication method.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study.
6. Information about a standalone algorithm performance study.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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The NAC PRN Needleless Access Connector is an accessory to an Intravascular Administration Set used as a secondary sterile injection site for delivery of fluids to a patient's vascular system through a cannula inserted into a vein or artery.

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I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a medical device called the "NAC PRN Needleless Access Connector." While it confirms the device's substantial equivalence to a predicate device and its regulatory classification, it does not contain any information about acceptance criteria for device performance or any studies that demonstrate the device meets such criteria.

The letter is a regulatory approval document, not a scientific study report. Therefore, I cannot extract the requested information regarding acceptance criteria, reported performance, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies from this text.

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Intravascular Administration Set and Extension Set is a device used to serve as a conduit for delivery of I.V. fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. Additional indications for use of this device is to provide multiple secondary sterile injection sites for other infusion fluids. The device may include a drip chamber with a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container, an infusion line filter, a 2 or 3 port manifold or I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a Y-site injection site, a PRN injection site, a Y-site with integral check valve, a Spin-Loc connector and one or more Roller/Slide/Pinch clamps.

Intravascular Administration Set/Extension Set

This document is a 510(k) clearance letter from the FDA for an "Intravascular Administration Set/Extension Set." It does not contain information about acceptance criteria, device performance studies, or details relevant to the performance evaluation of a medical device based on specific metrics like sensitivity, specificity, or accuracy.

The letter primarily:

• Confirms substantial equivalence: States that the device is substantially equivalent to legally marketed devices.
• Outlines regulatory requirements: Refers to general controls, special controls, GMP regulations, and other relevant FDA provisions.
• Approves marketing: Allows the manufacturer to begin marketing the device.
• Specifies intended use: Provides a brief description of the device's function as a conduit for IV fluids and details some of its components.

Therefore, I cannot provide a response to your request as the provided text does not contain the necessary information regarding:

1. Acceptance criteria and reported device performance: No performance metrics are mentioned.
2. Sample size and data provenance: No study data is presented.
3. Number and qualifications of experts for ground truth: Not applicable as no ground truth was established for this type of regulatory submission.
4. Adjudication method: Not applicable.
5. MRMC comparative effectiveness study: Not conducted or mentioned.
6. Standalone performance: Not conducted or mentioned.
7. Type of ground truth: Not applicable.
8. Training set sample size: Not applicable.
9. Ground truth establishment for training set: Not applicable.

This type of FDA letter is a regulatory approval, not a scientific publication detailing a device's performance study.

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This device is intended to be used as a conduit for the delivery of I.V. fluids from a container to a patient's vascular system through a needle or cather inserted into a vein. Additionally, this device is intended to serve as an injection site for other influsion fluids. This device is intended to be used only by trained professionals in a clinical or hospital environment.

The KippMed I.V. Manifold is substantially equivalent to the Braun Safesite Manifold, Minor differences in design specifications have been listed in Table One. Both devices are intended to provide connections to an I.V. Administration Set. Both devices provide a multi-port connector with a female leur-lock adapter, three normally closed backcheck valves and a connection adapter. The inlet connection adapter for both devices includes a free-spinsing hub/leur lock to connect to I.V. lines. Both devices are sterile and nonpyrogenic.

This document (K970255) describes an I.V. Manifold, a low-risk medical device. The information requested in your prompt (acceptance criteria, study details, sample sizes, expert qualifications, etc.) is typically associated with studies for higher-risk devices, particularly those involving AI/ML components or complex diagnostic functions with human interpretation.

For this I.V. Manifold, the "acceptance criteria" and "study" are focused on demonstrating substantial equivalence to a predicate device and confirming basic safety and performance requirements, not on diagnostic accuracy, reader performance, or AI efficacy.

Here's a breakdown based on the provided text, addressing your points where applicable, and explaining why others are not relevant for this type of submission:

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

For this device, the "acceptance criteria" are essentially demonstrating substantial equivalence to the predicate device in terms of design, materials, intended use, and meeting basic safety standards (sterilization, biocompatibility). The "reported device performance" refers to the device meeting these equivalence points and safety validations.

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

This information is not applicable and not provided in the document. The "tests" for this device are primarily related to:

• Sterilization validation: This typically involves laboratory testing on a statistically significant sample of devices to demonstrate the Sterility Assurance Level (SAL). The specific sample size or provenance is not detailed in this summary but would be part of the full validation report.
• Biocompatibility testing: This involves in vitro and potentially in vivo tests on the raw materials and finished components. Specific sample sizes for these material tests are not in the summary.
• Bench testing for functional equivalence: This would confirm aspects like leak integrity, flow rates, and connection strength. The document mentions "minor differences in design specifications" and a comparison in "Table 1," implying such testing was done, but details are not provided. These are typically laboratory tests.

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. There is no concept of "ground truth" or "expert readers" in the context of an I.V. manifold submission. This device performs a mechanical function, not a diagnostic one requiring human interpretation of data.

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

Not applicable for the same reasons as point 3.

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 device is an I.V. manifold; it does not involve AI, human readers, or diagnostic interpretation.

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

Not applicable. This device is not an algorithm.

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

Not applicable. The "truth" for this device is its physical integrity, sterility, biocompatibility, and functional equivalence to its predicate. These are established through validated testing methodologies, not expert consensus on diagnostic findings or clinical outcomes data in the way you might see for an AI diagnostic device.

8. The sample size for the training set

Not applicable. This device does not use machine learning or AI, and therefore has no "training set."

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

Not applicable for the same reasons as point 8.

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