← Product Code [ODG](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/ODG) · K961048 # OLYMPUS MH-246R BALLOON SHEATH (K961048) _Olympus America, Inc. · ODG · Sep 16, 1996 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/ODG/K961048 ## Device Facts - **Applicant:** Olympus America, Inc. - **Product Code:** [ODG](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/ODG.md) - **Decision Date:** Sep 16, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 876.1500 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology ## Indications for 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. ## Regulatory 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](/device/K872027.md)) - Olympus GF-UM-3/EU-M3 ([K882061](/device/K882061.md)) - Olympus EUS-20 System ([K926514](/device/K926514.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} 510 (k) SUMMARY SEP 16 1996 K961048 # OLYMPUS MH-246R BALLOON SHEATH **Device Name:** Olympus MH-246R Balloon Sheath **Common/Usual Name:** Balloon Sheath **Classification Name:** Endoscope and Accessories **Predicate Devices:** Olympus GF-UM2/EU-M2 K872027 GF-UM-3/EU-M3 K882061 EUS-20 System K926514 **Submitted By:** (Contact Person) Mr. Barry Sands Olympus America Inc. Endoscope Division Two Corporate Center Drive Melville, New York 11747-3157 (516) 844-5474 **Summary Preparation Date:** February 23, 1996 ## Statement of 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 Description The MH-246R Balloon Catheter consists of two sections - insertion section and connector section. The insertion section is constructed of a balloon with the light shielding cover, insertion tube, and adapter. The connector section consists of a connector body, probe lock ring, sheath lock ring, and irrigation port. The insertion section is connected to the connector body through a sheath locking ring, while the ultrasonic probe is inserted into the balloon sheath through a probe locking ring. The water filled syringe is connected to the irrigation port via an extension tube and three-way stopcock. The insertion section with the balloon will be provided sterile and intended for single use only. The connector section can be reused after proper cleaning and sterilization as outlined in the instruction manual. 28 {1} K 96 / 0 48 ## General Safety When compared to the predicate devices, Olympus MH-246R Balloon Sheath does not incorporate any significant change in intended use, method of operation, material, or design that could affect the safety or effectiveness. 29 --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/ODG/K961048](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/ODG/K961048) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com