BARD FLEXIBLE ENDOSCOPY INJECTION SYSTEM (651019)
Device Facts
| Record ID | K970110 |
|---|---|
| Device Name | BARD FLEXIBLE ENDOSCOPY INJECTION SYSTEM (651019) |
| Applicant | Bard Medical Div. |
| Product Code | ODC · Gastroenterology, Urology |
| Decision Date | Feb 19, 1997 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.1500 |
| Device Class | Class 2 |
| 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.
Indications for Use
Indicated for delivery of injectable materials into tissues in the urinary bladder and lower urinary tract via percutaneous access. Designed for use with flexible endoscopes ≤ 18 Fr. with working channels accommodating 5 Fr. instrumentation.
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
- Bard® Endoscopic Injection System (K933815)
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