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The intended use of the device is to convert regulated continuous suction to "intermittent suction" appropriate for aspiration of gastro-intestinal fluid into two separate chambers that are reversed in on/off phases. This permits gravity "refeeding" of the aspirate during the "off" phases of cach chamber's cycle, while maintaining "continuous suction" on the aspiration tube.

The proposed device interrupts externally supplied continuous suction to individually provide "intermittent suction" to one or two aspiration catheters positioned in the patient's gastrointesunal tract.

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I am sorry, but there is no information about acceptance criteria and study data for the device (MossMed Dual Intermittent Aspirator) in the provided text. The documents provided relate to the 510(k) summary and the FDA's substantial equivalence determination letter, which do not typically contain detailed performance studies or specific acceptance criteria tables.

The available information includes:

• Device Name: MossMed Dual Intermittent Aspirator
• Manufacturer: Hudson Research, Inc.
• Applicant: Moss Medical Products, Inc.
• Predicate Device: Continuous & Programmable Intermittent Aspirator - Impact Instrumentation, Inc. (K951423)
• Indications for Use: The device interrupts externally supplied continuous suction to individually provide "intermittent suction" to one or two aspiration catheters positioned in the patient's gastrointestinal tract.
• FDA Determination: Substantially equivalent to the predicate device.

To answer your request, I would need a document that specifically details performance data, study designs, acceptance criteria, and ground truth establishment for the MossMed Dual Intermittent Aspirator.

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