BIOSEARCH SYRING FLUSHING/CLEANING PUMP FOR BIOSEARCH ENDOSCOPIC INSTRUMENTS
Device Facts
| Record ID | K964871 |
|---|---|
| Device Name | BIOSEARCH SYRING FLUSHING/CLEANING PUMP FOR BIOSEARCH ENDOSCOPIC INSTRUMENTS |
| Applicant | Biosearch Medical Products, Inc. |
| Product Code | FEB · Gastroenterology, Urology |
| Decision Date | Mar 3, 1997 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.1500 |
| Device Class | Class 2 |
Indications for Use
The Syringe Flushing/Cleaning Pump is intended to clean the Biosearch Endoscopic Instruments. The Syringe Flushing/Cleaning Pump is a device that helps remove debris that may get trapped inside the Biosearch Endoscopic Instrument.
Device Story
Device is a manual syringe-based flushing/cleaning pump for Biosearch endoscopic instruments. Input is cleaning fluid/water via a syringe; device transforms input by directing fluid through a threaded connector into the instrument's flushing port. Dual check valve ensures efficient fluid transfer and prevents leakage. Used in clinical settings by healthcare professionals to remove debris from endoscopic instruments, facilitating sanitary cleaning. Device has no patient contact.
Clinical Evidence
Bench testing only. Materials underwent USP Class VI biological reactivity testing, including systemic injection, intracutaneous injection, implantation, MEM elution, cytotoxicity, and hemolysis tests. All materials met the requirements for their respective USP classifications.
Technological Characteristics
Constructed from medical-grade plastics including PolyVinyl Chloride, Polyurethane (Tecothane TT-1080A, Pellethane 2363), Polycarbonate (HPS2-1125), Silastic (RX50, 7-4735, 7-4750, 7-4765, Q-7-480, 6860), Cyrolite (G20-300-001, G20-100-001), and Radel R-5100. Features a threaded connector for port attachment and a dual check valve for fluid management. Manual operation.
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
- Mill-Rose Cleaning Adapter (K922204)
Related Devices
- K122740 — JETPREP FLUSHING DEVICE OL-103037, JETPREP FLUSHING DEVICE OL-133037, JETPREP FLUSHING DEVICE OL-168037, JETPREP FLUSHIN · Jetprep, Ltd. · Dec 10, 2012
- K092461 — IRRIGATION PUMP, IRRIGATION BIOPSY VALVE, ,MODEL 00711520, 00711139, 00711140 · United States Endoscopy Group, Inc. · Nov 5, 2009
- K213833 — SCOPE BUDDY PLUS Endoscope Flushing Aid · Medivators, Inc. · Jan 14, 2022
- K111274 — JETPREP FLUSHING DEVICE OL-103037 / OL-133037 / OL-168037 / PE-105038 / PE-150038 / PE-170038 / FU-169038 · Jetprep, Ltd. · Apr 4, 2012
- K160403 — SmartStart Air/Water and Suction Valves · Endochoice, Inc. · May 19, 2016
