← Product Code [FEB](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FEB) · K964871 # BIOSEARCH SYRING FLUSHING/CLEANING PUMP FOR BIOSEARCH ENDOSCOPIC INSTRUMENTS (K964871) _Biosearch Medical Products, Inc. · FEB · Mar 3, 1997 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-b%E2%80%94diagnostic-devices/FEB/K964871 ## Device Facts - **Applicant:** Biosearch Medical Products, Inc. - **Product Code:** [FEB](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FEB.md) - **Decision Date:** Mar 3, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 876.1500 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology ## 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 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](/device/K922204.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} K964871 MAR - 3 1997 bi@search MEDICAL PRODUCTS INC. > 510(k) SUMMARY < > SAFFETY & EFFECTIVENESS SUMMARY # BIOSEARCH SYRINGE ## FLUSHING/CLEANING PUMP FOR ## BIOSEARCH ENDOSCOPIC INSTRUMENTS Manufactured / Sold by: Biosearch Medical Products, Inc. 35 Industrial Parkway P.O. Box 1700 Somerville, NJ. 08876 {USA} Telephone: 1-908-722-5000 Fax: 1-908-722-5024 Contact Person: R. Soubia ROLAN SOUBRA Assistant to the Vice President of New Product Development Coordinator 12/2/96 date submitted Biosearch Medical Products, Inc. P.O. Box 1700 Somerville, NJ. 08876-1276 (USA) TEL: 908-722-5000 FAX: 908-722-5024 1 {1} Biosearch Medical Products, Inc. – 510(k) submission for: BIOSEARCH SYRINGE FLUSHING/CLEANING PUMP FOR BIOSEARCH ENDOSCOPIC INSTRUMENTS INTENDED USE STATEMENT: 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. ## DESCRIPTION OF THE DEVICE: The Disposable Syringe Flushing/Cleaning Pump for Biosearch Endoscopic Instruments, is a similar design to an existing legally marketed device. It is composed of a variety of medical grade plastics. The threaded connector is especially designed to fit the flushing port of the Biosearch Endoscopic device which impedes water leakage during the cleaning process. The dual check valve is an important feature because it provides an efficient transfer of the water, and/or cleaning fluid. This will provide a sanitary environment for the medical health professional to perform the extensive cleaning of the Biosearch Endoscopic Instruments. ![img-0.jpeg](img-0.jpeg) {2} Biosearch Medical Products, Inc. – 510(k) submission for: BIOSEARCH SYRINGE FLUSHING/CLEANING PUMP FOR BIOSEARCH ENDOSCOPIC INSTRUMENTS # EQUIVALENCE MATRIX ## (COMPARING CLEANING ADAPTERS FUNCTIONS) | NAME & 510(K) No. | For Cleaning Endoscopic Instruments | Connects to the proximal port | Uses a syringe to pump cleaning fluid | | --- | --- | --- | --- | | BIOSEARCH "BiosearchFlushing/Cleaning Pump for Biosearch Endoscopic Instruments" {This submission} | YES | YES | YES | | MILL-ROSE "Cleaning Adapter" {k922204} | YES | YES | YES | {3} PAGE 1 SAFETY & EFFECTIVENESS SUMMARY Biosearch Medical Products, Inc. BIOSEARCH SYRINGE FLUSHING/CLEANING PUMP FOR BIOSEARCH ENDOSCOPIC INSTRUMENTS ## NO PATIENT CONTACT | MATERIAL | TEST DATE | TEST PERFORMED | RESULTS | | --- | --- | --- | --- | | PolyVinyl Chloride | Vendor Supplied | USP tests for Systemic Injection Test,Intracutaneous Injection Test, Implantation test | Meets the requirements of USP Class VI Plastic | | Polyurethane Tecothane™ TT-1080A | 6/26/91-6/28/91 | MEM Elution Test | Meets the requirements of the Elution Test, USP XXII for the Elution Test | | Polyurethane Tecothane™ TT-1080A | 6/14/91-6/29/91 | Biological Test for Plastics Class VI | Meets the requirements of the USP XXII for the Biological Test of Plastic | | Polyurethane Pellethane2363 Series | Vendor Supplied | Acute Systemic Toxicity, Intracutaneous Toxicity, Implantation Test | Meets the requirements of the USP Class XI | | Polycarbonate HPS2-1125 | Vendor Supplied | Cytotoxicity,Hemolysis, Implantation,USP Class V Extractables, USP Physicochemical-Plastics | Meets the requirements of Class VI in Vivo & in Vitro Biological Reactivity,USP Physicochemical-Plastic | | Dow Corning RX50 CT Silastic Ribbon | | Cytotoxicity,Hemolysis, Implantation,USP Class V Extractables, USP Physicochemical-Plastics | Meets the requirements of Class VI in Vivo & in Vitro Biological Reactivity,USP Physicochemical-Plastic | 4 {4} PAGE 2 SAFETY & EFFECTIVENESS SUMMARY Biosearch Medical Products, Inc. BIOSEARCH SYRINGE FLUSHING/CLEANING PUMP FOR BIOSEARCH ENDOSCOPIC INSTRUMENTS # NO PATIENT CONTACT | MATERIAL | TEST DATE | TEST PERFORMED | RESULTS | | --- | --- | --- | --- | | Alpha PVC 2212/7 118 RSI Clear | 6/20/88 6/18/84-6/25/84 6/20/84 | USPXX Systemic Injection Test USPXX Intramuscular implantation, USP XX Intracutaneous Test, Direct Exposure Cytoxicity Test | Meets the USP Class VI requirements | | Cyrolite® G20-300-001 | Vendor Supplied | Systemic Toxicity, Intracutaneous Toxicity, MEM Elution, Hemolysis, Pyrogen, Guinea Pig Max. Implantation Test | Meets the USP Class VI requirements | | Cyrolite® G20-100-001 | Vendor Supplied | Systemic Toxicity, Intracutaneous Toxicity, Implantation Test Hemolysis, MEM Elution Pyrogen, Guinea Pig Max. | Meets the USP Class VI requirements Meets the USP Class VI requirements | | Radel R-5100 | Vendor Supplied | Systemic Toxicity, Intracutaneous Toxicity, Implantation Test | Meets the USP Class VI requirements | | Silastic Medical Grade{7-4735, 7-4750, 7-4765} | Vendor Supplied | Hemolysis, Intracutaneous Injection, Systemic Injection Intramuscular Implant | Meets the USP Class VI Plastic Tests | | Silastic Biomedical Grade Liquid {Q-7-480,6860} | Vendor Supplied | Hemolysis, Skin Sensitization USP Class V Extractables | Passes the Hemolysis Skin Sensitization,& USP Class V Extractables Tests | 5 --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-b%E2%80%94diagnostic-devices/FEB/K964871](https://fda.innolitics.com/submissions/HO/subpart-b%E2%80%94diagnostic-devices/FEB/K964871) **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