(30 days)
Balloon BS-3 is intended to be used in combination with FUJIFILM double balloon endoscopes to assist with insertion inside the upper or lower digestive tract at medical facilities under the management of physicians.
Do not use this product for any other purpose. It is not intended for use for any neonates, infants or children.
Balloon BS-3 is a pre-sterilized, single-use accessory used for fixing the endoscope in the body cavity. The device is fixed at the tip or bending portion of the endoscope and is inflated by filling air from the operation part of the endoscope with a special pump. The device is used for a natural opening of the human body to perform enlargement of a lumen, coelom or body cavity in order to enable and facilitate insertion of the endoscope.
This is a 510(k) summary for a medical device called "Balloon BS-3," an endoscopic accessory. The document does not describe an AI/ML device, therefore, the requested information about acceptance criteria and studies for an AI/ML device is not applicable.
The document primarily focuses on demonstrating substantial equivalence to a predicate device (Balloon BS-2) through comparison of technological characteristics and performance data related to sterility, biocompatibility, and inflation rate.
Here's an overview of the information provided in the document:
- Device Name: Balloon BS-3
- Intended Use: To be used in combination with FUJIFILM double balloon endoscopes to assist with insertion inside the upper or lower digestive tract. Not for neonates, infants, or children.
- Predicate Device: Balloon BS-2 (K143556)
Performance Data and Conclusions:
The document states that the following tests were conducted:
- Sterility: Evaluated using ISO 11135:2014 and ASTM F1980-16.
- Biocompatibility: Evaluated using ISO 10993-1:2018, ISO 10993-5:2009, ISO 10993-7:2008, ISO 10993-10:2010.
- Comparative bench testing: Conducted on the subject and predicate devices to evaluate the rate of inflation.
- Additional evaluation: The subject device was additionally evaluated against ISO 8600-1:2015.
The overall conclusion is that "Bench testing demonstrates that the subject device is as safe and effective as the predicate device. Thus, Balloon BS-3 is substantially equivalent to the listed predicate device."
§ 876.1500 Endoscope and accessories.
(a)
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.(b)
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.