(242 days)
The SarMed Single Use Esophageal Manometry Catheters and Ano-Rectal Manometry Catheters are intended for Manometry analysis of Gastro-Intestinal and Ano-Rectal Tract.
The SarMed Single Use Esophageal Manometry Catheters and Ano-Rectal Manometry Catheters are indicated for patients where Gastro-Intestinal and Ano-Rectal tracts pressure measurements are required, such as for detection of GI tract disorders. The products are to be used by a trained physician.
The SarMed Single Use Esophageal Manometry and Ano-Rectal Manometry Catheters are available in some different configurations, respect to number of lumen and number of tubes. They are designed to be connected to a manometric infusion pump and allow, by the way of a defined number of holes, the measurement of pressure on the Gastro-Intestinal and Ano-Rectal Tract.
This document is a 510(k) Premarket Notification for SarMed Single Use Esophageal Manometry Catheters and Single Use Ano-Rectal Manometry Catheters. It describes the device, its intended use, indications for use, and a comparison to predicate devices. It does not contain acceptance criteria or a study demonstrating device performance against specific metrics.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them from the provided text. The document focuses on establishing substantial equivalence to legally marketed predicate devices, rather than presenting de novo performance study results with specific performance metrics.
Specifically, the document states:
- "The SarMed Single Use Esophageal Manometry Catheters and Ano-Rectal Manometry Catheters has been tested for biocompatibility and meets the requirements of ISO 10993-1 schemes, for the intended use of the devices." (Page 1)
- "The catheters in object are technologically equivalent to the predicate devices above listed, both in physical than in design characteristics." (Page 1)
- The FDA letter confirms "substantial equivalence (for the indications for use stated in the enclosure) to legally marketed predicate devices." (Page 2)
This indicates that the submission relies on demonstrating similarity to existing devices and meeting a general biocompatibility standard, not on a new clinical or performance study with defined acceptance criteria and detailed performance metrics.
§ 876.1725 Gastrointestinal motility monitoring system.
(a)
Identification. A gastrointestinal motility monitoring system is a device used to measure peristalic activity or pressure in the stomach or esophagus by means of a probe with transducers that is introduced through the mouth into the gastrointestinal tract. The device may include signal conditioning, amplifying, and recording equipment. This generic type of device includes the esophageal motility monitor and tube, the gastrointestinal motility (electrical) system, and certain accessories, such as a pressure transducer, amplifier, and external recorder.(b)
Classification. Class II (performance standards).