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The CODAN™ SafeFeed Enteral Feeding Reservoir is intended for the storage and delivery of liquid medication, formula, and breast milk.

The CODAN™ SafeFeed Enteral Feeding Reservoir is disposable and for single patient use only.

The provided text is a 510(k) premarket notification letter from the FDA regarding the CODAN™ SafeFeed Enteral Feeding Reservoir. It outlines the regulatory approval of the device and its intended use. However, it does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies (MRMC or standalone AI performance).

Therefore, I cannot fulfill your request for this specific information based on the provided document. The document focuses on regulatory approval and substantial equivalence to a predicate device, not detailed performance studies.

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The CODAN IV Administration Set B400 Sp is indicated to facilitate the infusion of IV fluids from a plastic bag or solution container, into the patient.

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I apologize, but the provided text from the FDA 510(k) clearance letter for the CODAN IV Administration Set B400 Sp does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.

The document is a clearance letter, confirming that the FDA has reviewed the submission and found the device substantially equivalent to legally marketed predicate devices. It discusses:

• The device name and regulation details.
• The FDA's determination of substantial equivalence.
• General controls provisions and additional controls that may apply.
• Contact information for specific advice.
• Indications for Use: "The CODAN IV Administration Set B400 Sp is indicated to facilitate the infusion of IV fluids from a plastic bag or solution container, into the patient."

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for the test set and data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study details.
6. Standalone performance details.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This information would typically be found in the 510(k) summary or other supporting documentation submitted to the FDA, but it is not present in the clearance letter provided.

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CODAN US IV Administration sets, In-line sets and Connect Sets are indicated for use to facilitate the continuous and bolus infusion of IV fluids, pain control includes in the systems.

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The provided text does not contain information about the acceptance criteria or a study proving that a device meets those criteria. The document is a 510(k) premarket notification letter from the FDA to CODAN US Corporation regarding their "IV Administration and Connect Sets." It confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and a detailed study as that information is not present in the provided text.

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The CODAN US Extension Set is indicated to facilitate the infusion of IV fluids from a plastic bag or solution container into the patient.

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The provided text is a 510(k) clearance letter from the FDA for a medical device called "Extension Set Light-Safe BC565." This document outlines the regulatory approval of the device and confirms its substantial equivalence to a legally marketed predicate device.

However, the letter does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, or ground truth establishment.

The document is purely a regulatory clearance and does not detail the technical performance or validation studies of the device. Therefore, I cannot generate the requested table and information based on the provided text.

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The CODAN IV Administration Set is indicated to facilitate the infusion of IV fluids from a plastic bag or solution container into the patient.

Not Found

This document is a 510(k) premarket notification letter from the FDA regarding an I.V. Administration Set. It does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval and substantial equivalence to legally marketed predicate devices, not on the performance metrics of the device itself.

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The CODAN Chemospike is a transfer pin system for the safe preparation and withdrawal of medication and cytotoxic agents. It is designed to prevent the withdrawar of modication aring reconstitution of the drug in the vial and withdrawal of the drug from the vial.

CODAN Chemospike

I am sorry, but the provided text is a letter from the FDA to a medical device manufacturer (CODAN US Corporation) regarding the substantial equivalence of their "CODAN Chemospike" device to a predicate device. This document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methodologies that would allow me to populate the requested table and answer the study-related questions.

The document primarily focuses on regulatory approval based on substantial equivalence, which is a different type of assessment than a performance study with detailed acceptance criteria.

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