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An intravascular catheter, inserted peripherally for long-term administration of solutions for parenteral nutrition and/or administration of drugs

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The provided text is a 510(k) premarket notification letter from the FDA to Vygon US LLC regarding their Nutriline and Nutriline Twinflow Catheters. This document does not contain any information about acceptance criteria or a study proving the device meets those criteria.

The letter primarily:

• Confirms the review of the 510(k) submission (K052475).
• States that the device is substantially equivalent to legally marketed predicate devices.
• Informs the manufacturer about general controls and other applicable regulations.
• Encloses the "Indications for Use" for the device.

Therefore, I cannot provide the requested information from the given text. A 510(k) summary or a more detailed submission document would typically contain such study information if it were required for the substantial equivalence demonstration.

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• Percutaneous lumbo-peritoneal shunting may be utilized in the treatment of . communicating hydrocephalus. It is designed to shunt CSF from the subarachnoid space to the peritoneal cavity.
• The shunting may be used for evaluation or treatment of normal pressure ● communicating hydrocephalus.
• A percutaneous lumbo-peritnoeal shunt is also useful in the management of . persistent cerebrospinal fluid fistulas, bulging cranial and suboccipital decompressions and transient CSF absorption defects, e.g. post meningitic or post-hemorrhagic hydrocephalus.
• Lumbar Drainage System is intended for use as a means of temporary external Eumbar Drainage Cyclinage Cyonitoring and collection of cerebrospinal fluid from the diversion, proboute metesigned for use with the Phoenix Fifth Ventricle Collection Bag.

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This document is a 510(k) premarket notification decision letter from the FDA for Lumbar Drainage Systems and Lumbo-Peritoneal Shunts. It states that the devices are substantially equivalent to legally marketed predicate devices and can be marketed.

The document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

Therefore, I cannot provide the requested information.

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The packaging tray is intended to be used as a non-reusable protective pack, which allows EO sterilization of the product and maintains sterility for a specified length of time, and protects the product from damage during transport, delivery and storage.

Packaging Tray and Accessories

This is a 510(k) clearance letter for a "Packaging Tray and Accessories" (K040707) and its indications for use. This document confirms the device's substantial equivalence to a predicate device but does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria.

Therefore, I cannot extract the requested information regarding acceptance criteria and study details from this document. This letter is an administrative approval of market clearance, not a performance study report.

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