← Product Code [ODC](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/ODC) · K970110 # BARD FLEXIBLE ENDOSCOPY INJECTION SYSTEM (651019) (K970110) _Bard Medical Div. · ODC · Feb 19, 1997 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/ODC/K970110 ## Device Facts - **Applicant:** Bard Medical Div. - **Product Code:** [ODC](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/ODC.md) - **Decision Date:** Feb 19, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 876.1500 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology - **Attributes:** Therapeutic ## Intended Use The Bard® Flexible Endoscopy Injection System is indicated as an accessory for currently available endoscopes to provide for delivery of injectable materials into tissues in the urinary bladder and lower urinary tract via percutaneous access through a pre-placed 20 Fr. (minimum) introducer. The system is designed for use with flexible endoscopes no larger than 18 Fr. and having a working channel accommodating 5 Fr. instrumentation. ## Device Story System consists of endoscopic injection needle, working channel protector, stainless steel stabilizer sheath, and medical tape. Used as accessory for flexible endoscopes to deliver injectable materials into urinary bladder/lower urinary tract tissues. Percutaneous access via pre-placed 20 Fr. introducer. Physician operates device during endoscopic procedures. Stabilizer sheath fits over endoscope; needle passes through working channel. Provides targeted delivery of therapeutic agents; facilitates minimally invasive urological interventions. ## Clinical Evidence Bench testing only. ## Technological Characteristics Components: 23-gauge 304 stainless steel non-coring needle, 5 Fr. USP Class VI polymer catheter shaft, 304 stainless steel stabilizer sheath, USP Class VI polymer working channel protector. Dimensions: 26-inch catheter length. Manual operation; no energy source. Non-electronic. ## 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 - Bard® Endoscopic Injection System ([K933815](/device/K933815.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} Bard Urological Division C. R. Bard, Inc. 8195 Industrial Blvd. Covington, GA 30209-2695 K 970 110 8193 BARD FEB 19 1997 # SECTION VI ## 510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990. ### A. Submitter's Information: Submitter's Name: C. R. Bard, Inc. Address: 8195 Industrial Boulevard Covington, Georgia 30209 Contact Person: Donna J. Wilson Phone: (770) 784-6135 FAX: (770) 784-6419 Date of Preparation: January 9, 1997 ### B. Device Name: Trade Name: Bard® Flexible Endoscopy Injection System Common/Usual Name: Flexible Endoscopy Injection System Classification Name: Endoscope and Accessories, Class II ### C. Predicate Device Names: Trade Name: Bard® Endoscopic Injection System - VI.1 - 480-06 {1} K970110 p273 ## D. Device Description: The Bard® Flexible Endoscopy Injection System consists of an endoscopic injection needle with an endoscopic working channel protector, a stainless steel endoscopic stabilizer sheath and optional medical tape for affixation purposes. ## E. Intended Use: The Bard® Flexible Endoscopy Injection System is indicated as an accessory for currently available endoscopes to provide for delivery of injectable materials into tissues in the urinary bladder and lower urinary tract via percutaneous access through a pre-placed 20 Fr. (minimum) introducer. The system is designed for use with flexible endoscopes no larger than 18 Fr. and having a working channel accommodating 5 Fr. instrumentation. ## F. Technological Characteristics Summary: Table VI-A provides a tabular comparison of the technological characteristics of the Bard® Flexible Endoscopy Injection System versus the predicate device. - VI.2 - {2} K970110 p. 1 of 3 # TABLE VI-A: COMPARISON CHART TO PREDICATE DEVICE | Device Feature | Bard® Flexible Endoscopy Injection System | #K933815 Bard® Endoscopic Injection System (Predicate Device) | | --- | --- | --- | | Injection Needle Luer Lock Hub | USP Class VI Polymer* | USP Class VI Polymer | | Injection Needle Strain Relief | USP Class VI Polymer* | USP Class VI Polymer | | Injection Needle Catheter Shaft | 5 Fr., 26" USP Class VI Polymer | 5 Fr., 13.14" USP Class VI Polymer | | Injection Needle | 23 Gauge 0.25" Stainless Steel (304 grade) Non-Coring Needle | 23 Gauge 0.5" Stainless Steel (304 grade) Non-Coring Needle | | Endoscopic Stabilizer | 304 Stainless Steel Tube fitting over an 18 Fr. (max.) flexible endoscope and through a preplaced 20 Fr. percutaneous introducer | USP Class VI Polymer tube with positive stop fitting inside endoscopes accommodating 7 Fr. instrumentation | | Stabilizer Affixation | Medical tape for securing stabilizer sheath to flexible endoscope shaft | Working channel cap fitting over positive stop of stabilizer | | Endoscopic Working Channel Protector | USP Class VI Polymer tube used as a protective sheath for insertion of the injection needle | None | * Materials and dimensions identical to predicate device. - VI.3 - --- **Source:** [https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/ODC/K970110](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/ODC/K970110) **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