Who is the manufacturer of SMALL BOWEL ANALYSIS SOFTWARE?

Sandhill Scientific, Inc. filed the 510(k) submission for SMALL BOWEL ANALYSIS SOFTWARE (K942247).

What is the FDA product code for SMALL BOWEL ANALYSIS SOFTWARE?

FFX. It is classified under 21 CFR 876.1725 as a Class 2 device in the Gastroenterology, Urology panel.

What is the regulatory pathway for SMALL BOWEL ANALYSIS SOFTWARE?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like SMALL BOWEL ANALYSIS SOFTWARE?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

SMALL BOWEL ANALYSIS SOFTWARE

K942247 · Sandhill Scientific, Inc. · FFX · Apr 9, 1996 · Gastroenterology, Urology

Device Facts

Record ID	K942247
Device Name	SMALL BOWEL ANALYSIS SOFTWARE
Applicant	Sandhill Scientific, Inc.
Product Code	FFX · Gastroenterology, Urology
Decision Date	Apr 9, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 876.1725
Device Class	Class 2
Attributes	Software as a Medical Device

Intended Use

The Small Bowel software is intended to arrange information from continuous recordings of small bowel pressure into concise, reproducible, consistent reports to assist in the interpretation of motility data. The software provides visual guidance for data interpretation and is not considered in and of itself to be diagnostic without skilled interpretation.

Device Story

Software processes continuous small bowel pressure recordings; transforms amplitude vs. time data into concise, reproducible reports. Calculates motility metrics: duration, mean, maximum, median, motility index, frequency, and cycle values for contractions and clusters. Used in clinical settings by skilled professionals to assist interpretation of complex, sporadic motility traces. Provides visual guidance; does not perform automated diagnosis. Safety ensured via electrical isolation of catheter/sensors per UL544.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Software-based data processing and reporting system. Inputs: continuous pressure transducer signals. Electrical safety: UL544 compliant isolation. Output: quantitative motility reports (duration, mean, max, median, motility index, frequency, cycle values).

Indications for Use

Indicated for clinical interpretation of small bowel motility data derived from continuous pressure recordings.

Regulatory Classification

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.

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Submission Summary (Full Text)

{0} K942247 # APPENDIX A APR - 9 1996 ## Safety and Effectiveness Continuous recordings provide information in the form of amplitude versus time, but it is difficult to understand because of the visual complexity of the record due to channel separation and duration of the recorded traces and sporadic nature of the activity. The software reports arranges the information in concise, reproducible, consistent reports that are more consistent than visual analysis. The Small Bowel software adds no new information, but takes existing information and rearranges it to make it more accessible to interpretation. Source information has dimensions of amplitude and time while the software presents the same information including numerous calculated results, such as duration, mean, maximum and median, motility index, frequency and cycle values for contractions and clusters (groups of contractions). Safety is assured in that the catheter and the sensors used to transduce the pressures are connected to fully electrically isolated amplifiers as per UL544. The software only provides visual guidance for data interpretation. It is not considered in and of itself to be diagnostic without skilled interpretation.