ULTRASOUND GASTROSCOPE GF TYPE UM30P

K963023 · Olympus America, Inc. · FDS · Feb 7, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K963023
• Device Name: ULTRASOUND GASTROSCOPE GF TYPE UM30P
• Applicant: Olympus America, Inc.
• Product Code: FDS · Gastroenterology, Urology
• Decision Date: Feb 7, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The Olympus GF-UM30P Ultrasonic Endoscope is intended to be used in combination with the Ultrasound System, EU-M20 or EU-M30, for endoscopic ultrasound imaging of the gastrointestinal tract wall, biliary and pancreatic duct, and surrounding organs. This instrument also provide for Endoscopic Ultrasound (EUS) guided fine needle aspiration (FNA) to acquire submucosal tissue.

Device Story

Mechanically scanning ultrasonic endoscope; operates in B-mode; utilizes de-aerated water immersion or balloon contact method; provides 250° scan. Enables ultrasonic guidance of endoscopic accessories (biopsy forceps, aspiration needles) by aligning sonographic scan plane with accessory entry path. Used in GI tract by physicians; provides real-time ultrasound imaging to facilitate tissue sampling and diagnostic visualization. Benefits include improved targeting for submucosal tissue acquisition compared to conventional radial scanners.

Clinical Evidence

Bench testing only.

Technological Characteristics

Insertion tube diameter 11.7 mm; working length 1265 mm; 250° scan angle; B-mode imaging; mechanical scanning mechanism. Ancillary MAJ-213 balloon provided clean, requires EtO sterilization. Device components marketed non-sterile, requiring manual reprocessing.

Indications for Use

Indicated for patients requiring endoscopic ultrasound imaging of the gastrointestinal tract, biliary and pancreatic ducts, and surrounding organs, and for those requiring EUS-guided fine needle aspiration for submucosal tissue acquisition.

Regulatory Classification

Identification

An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Special Controls

*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.

Predicate Devices

• GF/JF/CF-UM20 (K926514)

Submission Summary (Full Text)

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FEB - 7 1997
ATTACHMENT I
510(K) SUMMARY
K963023

# OLYMPUS GF TYPE UM30P ULTRASONIC ENDOSCOPE

Device Name: Olympus GF-UM30P Ultrasonic Endoscope and related ancillary equipment

Common/Usual Name: Olympus Ultrasonic Endoscopes

Classification Name: Endoscope and Accessories

Predicate Devices: GF/JF/CF-UM20 (K926514)

Submitted By: Mr. Subhash Patel
(Contact Person) Olympus America Inc.
Regulatory Affairs
2 Corporate Center Drive
Melville, NY 11747
[phone]

Summary Preparation Date: January 27, 1997 (revised)

## Statement of Intended Use:

The Olympus GF-UM30P Ultrasonic Endoscope is intended to be used in combination with the Ultrasound System, EU-M20 or EU-M30, for endoscopic ultrasound imaging of the gastrointestinal tract wall, biliary and pancreatic duct, and surrounding organs. This instrument also provide for Endoscopic Ultrasound (EUS) guided fine needle aspiration (FNA) to acquire submucosal tissue.

## Device Description

In examining the GI tract, endoscopic ultrasound may be indicated. The conventional type ultrasound endoscope does not provide the capability for ultrasonic guidance of endoscopic accessories (i.e. biopsy forceps, aspiration biopsy needles, etc.) The mechanically radially scanning GF-UM30P ultrasound endoscope provides this capability since the direction of the sonographic scan coincides with the geometric plane in which the accessory enters.

The subject devices operates in B mode using the de-aerated water immersion or balloon contact method and offers a 250° scan. The outer diameter of the insertion tube is 11.7 mm and it's working length is 1265 mm.

Both subject and predicate devices have similar design, construction, intended use, and method of operation. The only difference between the two is that the subject device's scanning plane is parallel, rather than perpendicular, to the axis of the insertion tube. The Olympus Endoscopic Ultrasound System, EU-M20, received marketing clearance in the 510(k) # K926514.

The MAJ-213 Balloon will be provided clean and should be EtO sterilized before use. The balloon is intended for single use only and should be discarded after use. All other components and related ancillary equipment of the subject device will be marketed non sterile and can be reprocessed as described in the Instruction Manuals.

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