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Gastrointestinal Motility System, Capsule

Page Type
Product Code
Definition
Used to evaluate GI motility disorders and indicated for use in evaluating patients with suspected motility disorders.
Physical State
Small ingestible capsule transmits motility data to a wireless receiver worn by the subject. Data from the receiver is dowloaded into a personal computer (PC) and analyzed with custom software.
Technical Method
Ingestible telemetric capsule that transmits GI motility data to a wireless receiver worn by the patient.
Target Area
Device is swallowed, and passes through the GI tract
Regulation Medical Specialty
Gastroenterology and Urology
Review Panel
Gastroenterology and Urology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
876.1725
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 876.1725 Gastrointestinal motility monitoring system

§ 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).

Gastrointestinal Motility System, Capsule

Page Type
Product Code
Definition
Used to evaluate GI motility disorders and indicated for use in evaluating patients with suspected motility disorders.
Physical State
Small ingestible capsule transmits motility data to a wireless receiver worn by the subject. Data from the receiver is dowloaded into a personal computer (PC) and analyzed with custom software.
Technical Method
Ingestible telemetric capsule that transmits GI motility data to a wireless receiver worn by the patient.
Target Area
Device is swallowed, and passes through the GI tract
Regulation Medical Specialty
Gastroenterology and Urology
Review Panel
Gastroenterology and Urology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
876.1725
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 876.1725 Gastrointestinal motility monitoring system

§ 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).