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The ROCAP Heparin Flush Syringe 100 U/mL is indicated for use to maintain patency of indwelling venous access devices.

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I am sorry, but the provided text is a 510(k) clearance letter for a medical device (Heparin IV Flush Syringe). It does not contain information on acceptance criteria, device performance, study details, sample sizes, expert qualifications, or ground truth establishment. This type of information is usually found in a separate study report or regulatory submission document.

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The ROCAP Heparin Flush Syringe 10 U/mL is indicated for use to maintain patency of indwelling venous access devices.

Heparin Flush Syringe, 10 U/mL

This document is a 510(k) clearance letter from the FDA for a Heparin IV Flush Syringe. It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, this document does not contain any information regarding acceptance criteria or a study that proves the device meets acceptance criteria. The letter only states that the device is substantially equivalent, allowing it to be marketed. There are no details about performance metrics, study designs, sample sizes, ground truth establishment, or expert involvement as requested in the prompt.

Therefore, I cannot provide the requested information from the provided text.

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The ROCAP Normal Saline Flush Syringe is indicated for use to maintain patency of indwelling venous access devices.

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This document is a 510(k) clearance letter from the FDA for a medical device called the "Normal Saline IV Flush Syringe" (ROCAP Division of Sabratek Corporation). This letter grants clearance based on substantial equivalence, which means the device is considered as safe and effective as a legally marketed predicate device.

Crucially, this document is an FDA clearance letter and does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria.

A 510(k) clearance evaluates substantial equivalence to a predicate device, not necessarily a new study proving specific performance metrics against pre-defined acceptance criteria. While the manufacturer would have submitted data to the FDA to demonstrate substantial equivalence, this specific letter does not include the details of that data or any explicit acceptance criteria.

Therefore, I cannot provide the requested information from this document. To answer your questions, one would need access to the 510(k) submission itself or other regulatory documents that detail the performance studies and acceptance criteria.

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