FG-36UX, ULTRASOUND UPPER GI FIBERSCOPE

K961974 · Pentax Precision Instrument Corp. · ITX · Feb 10, 1997 · Radiology

Device Facts

• Record ID: K961974
• Device Name: FG-36UX, ULTRASOUND UPPER GI FIBERSCOPE
• Applicant: Pentax Precision Instrument Corp.
• Product Code: ITX · Radiology
• Decision Date: Feb 10, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1570
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The FG-36UX, Ultrasound Fiber Gastroscope, is intended to provide optical and sonographic visualization of, and therapeutic access to, the Upper Gastrointestinal Tract. The Upper GI Gastrointestinal Tract includes, but is not limited to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, Small Bowel, and underlying areas. The instrument is introduced per orally when the indications consistent with the requirement for procedure(s) are observed in Adult and Pediatric patient populations.

Device Story

FG-36UX is an ultrasound fiber gastroscope for upper GI tract visualization and therapy. Device features flexible insertion tube, control body, and bifurcated umbilicus connecting to external light source and Hitachi ultrasound scanners (EUB-405, -515, -555). Distal tip contains convex linear array electronic transducer for sonography, plus light-carrying bundles for optical visualization. Physician operates device via control body (angulation, air/water, suction, accessory elevator). Working channel allows introduction of biopsy forceps or other accessories. Device provides real-time optical and sonographic images to clinician, facilitating diagnosis and therapeutic intervention in the upper GI tract. Benefits include combined endoscopic and sonographic assessment of GI organs and underlying tissues.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Convex linear array electronic ultrasound transducer; fiber-optic illumination and visualization bundles; flexible insertion tube; compatible with external light sources and Hitachi EUB-series scanners. Immersible design. No software-based processing internal to the scope; signal processing performed by external Hitachi ultrasound scanner.

Indications for Use

Indicated for adult and pediatric patients requiring optical and sonographic visualization of or therapeutic access to the upper gastrointestinal tract, including the esophagus, stomach, duodenum, and small bowel.

Regulatory Classification

Identification

A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.

Predicate Devices

• FG-32UA, Ultrasound Upper GI Fiberscope (K904573)
• Penatx K953876
• FD-32A, Fiber Duodenoscope (K812810)
• EUB-405, Ultrasound Scanner (K924126)

Submission Summary (Full Text)

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DOCUMENT NUMBER: KS051
DATE PREPARED: 12-18-95
PREPARED BY: PAUL SILVA
510(K) SUMMARY
DEVICE: FG-36UX, FIBER ULTRASOUND UPPER GI GASTROSCOPE K961974

SUBMITTER INFORMATION: Paul Silva
Pentax Precision Instrument Corporation
30 Ramland Road
Orangeburg, NY, 1062
TEL: [phone]

FEB 10 1997

NAME OF DEVICE: Common Name: Ultrasound Fiber Gastroscope
Trade Name: FG-36UX, Ultrasound Upper GI Fiberscope
Classification Name: Diagnostic Ultrasound Transducer (74JOP) {892.1570}
Endoscope and Accessories (78KOG) {876.1500}

## PREDICATED DEVICE(S) INFORMATION:

FG-32UA, Ultrasound Upper GI Fiberscope
With Hitachi Scanner EUB: 410, 450, 515, 565
With Hitachi Scanner EUB 555
FD-32A, Fiber Duodenoscope
EUB-405, Ultrasound Scanner

Pentax K904573
Penatx K953876
Pentax K812810
Hitachi K924126

## DEVICE DESCRIPTION:

The FG-36UX Ultrasound Fiber Gastroscope, can be used with any Endoscopic Light Source (with the appropriate lightguide receptacle) and Hitachi Ultrasound Scanners (models EUB-405, -515, -555). The instrument has a flexible insertion tube (for entry into the body cavity), a control body, and umbilicus. The Umbilicus is bifurcated where one connector is connected to the light source and the other is connected a the Ultrasound Scanner. The control body includes controls for up/ down and left right angulation, accessory elevator, air/ water delivery, suction control, a biopsy inlet port, ultrasound balloon inflation port, and the viewing ocular. The device contains light carrying bundles, one to illuminate the body cavity, another to optically visualize anatomy. The instrument also contains a working channel through which biopsy devices, or other accessories, may be introduced (the instrument is supplied with two biopsy forceps). A convex linear array all electronic transducer is mounted in the distal tip of the insertion tube. The instrument is completely immersable (with the use of supplied cleaning accessories).

## INTENDED USE:

The FG-36UX, Ultrasound Fiber Gastroscope, is intended to provide optical and sonographic visualization of, and therapeutic access to, the Upper Gastrointestinal Tract. The Upper GI Gastrointestinal Tract includes, but is not limited to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, Small Bowel, and underlying areas. The instrument is introduced per orally when the indications consistent with the requirement for procedure(s) are observed in Adult and Pediatric patient populations.

## COMPARISON TO PREDICATED DEVICE(S):

The submission for substantial equivalence included design validation and verification data, certifications, and references to the predicate device submission. The submission for substantial equivalence was not based on an assessment of clinical performance data.