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The Apogee Closed System Intermittent Catheterization Kit is intended to be used to drain urine from the patient's bladder into a collection bag.

The Apogee Closed System Intermittent Catheterization Kit is a single-use, disposable, pre-lubricated catheter contained in a sterile collection bag. The Closed System Intermittent Catheter is intended to be user to drain urine from the bladder. When it is not practical or feasible for the patient to drain the bladder into a commode or bedpan, the urine may be drained into the collection bag of the Closed System Intermittent Catheterization Kit. The Closed System Intermittent Catheterization Kit is designed with a collection bag and introducer which provide the mechanism for inserting and advancing the catheter to the bladder without direct hand contact to the catheter, thereby, reducing possibility of contamination.

This 510(k) summary does not contain information regarding acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary for a medical device (Apogee Closed System Intermittent Catheterization Kit) and a letter from the FDA stating that the device is substantially equivalent to legally marketed predicate devices.

The information provided focuses on:

• Device Identification: Manufacturer, device name, common name, classification, product code.
• Predicate Devices: Names and 510(k) numbers of similar devices.
• Device Description: Physical characteristics and components.
• Intended Use/Indications For Use: The medical purpose of the device.
• Regulatory Correspondence: FDA's determination of substantial equivalence.

There is no mention of specific performance acceptance criteria (e.g., fluid flow rates, sterility effectiveness, material biocompatibility, or leak-proof design) nor any study data to demonstrate that the device meets such criteria. A 510(k) submission typically includes such data in a separate section or in referenced reports, but it is not part of this summary document. Therefore, I cannot complete the table or answer the specific questions about study details.

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