OLYMPUS MH-246R BALLOON SHEATH
Device Facts
| Record ID | K961048 |
|---|---|
| Device Name | OLYMPUS MH-246R BALLOON SHEATH |
| Applicant | Olympus America, Inc. |
| Product Code | ODG · Gastroenterology, Urology |
| Decision Date | Sep 16, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.1500 |
| Device Class | Class 2 |
Intended Use
The balloon sheath MH-246R is designed to be used with the Olympus Ultrasonic Probe UM-2R/3R for intraluminal ultrasonic imaging of the gastrointestinal tract wall and surrounding organs.
Device Story
Balloon sheath accessory for Olympus Ultrasonic Probes (UM-2R/3R); facilitates intraluminal ultrasonic imaging of GI tract wall/surrounding organs. Device comprises insertion section (balloon, light shielding cover, tube, adapter) and connector section (body, probe/sheath lock rings, irrigation port). Water-filled syringe connects to irrigation port via extension tube/stopcock to inflate balloon. Used in clinical endoscopy settings by physicians. Insertion section provided sterile/single-use; connector section reusable via cleaning/sterilization. Provides acoustic coupling medium for ultrasonic imaging; improves image quality/contact with tissue.
Clinical Evidence
Bench testing only; no clinical data provided. Substantial equivalence based on design and material similarity to predicate devices.
Technological Characteristics
Balloon sheath assembly; insertion section (balloon, light shielding cover, tube, adapter) and connector section (body, lock rings, irrigation port). Water-filled balloon for acoustic coupling. Single-use sterile insertion section; reusable connector section. Manual operation via syringe/stopcock.
Indications for Use
Indicated for intraluminal ultrasonic imaging of the gastrointestinal tract wall and surrounding organs in patients undergoing endoscopic ultrasound procedures.
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
- Olympus GF-UM2/EU-M2 (K872027)
- Olympus GF-UM-3/EU-M3 (K882061)
- Olympus EUS-20 System (K926514)
Related Devices
- K982734 — OLYMPUS MH-246R BALLOON SHEATH, FOR URINARY TRACT USE · The Olympus Optical Co. · Oct 5, 1998
- K982725 — OLYMPUS MH-246R BALLOON SHEATH, FOR FEMALE REPRODUCTIVE TRACT USE · Olympus America, Inc. · Oct 23, 1998
- K982733 — OLYMPUS MH-246R BALLOON SHEATH, FOR BRONCHIAL USE · The Olympus Optical Co. · Oct 28, 1998
- K992178 — BALLOON FOR ULTRASONIC ENDOSCOPES · N.M. Beale Co., Inc. · May 12, 2000
- K111028 — EUS BALLOON · United States Endoscopy Group, Inc. · Nov 1, 2011
