MARTECH ENDOSCOPIC INJECTION NEEDLE
Device Facts
| Record ID | K960519 |
|---|---|
| Device Name | MARTECH ENDOSCOPIC INJECTION NEEDLE |
| Applicant | Martech Medical Products, Inc. |
| Product Code | FBK · Gastroenterology, Urology |
| Decision Date | May 1, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.1500 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended Use
The Martech Endoscopic Injection Needle is indicated for use as an accessory for currently marketed endoscopes to provide for delivery of injectable materials into tissues during endoscopic procedures. As with currently marketed endoscopic injection needles, the Martech Endoscopic Injection Needle may be used in a variety of endoscopic procedures for the delivery of a variety of injectable materials which have received approval for use by the FDA. The type of material to be injected will be dependent on the nature of the endoscopic procedure, but such materials may include for example: delivery of collagen during cystoscopic procedures; delivery of sclerosing agents during esophagoscopic and gastroscopic procedures; delivery of local anesthetics during cystoscopic or laryngoscopic procedures; or delivery of saline or contrast media during colonoscopic procedures.
Device Story
Sterile, disposable, nonpyrogenic endoscopic accessory; 23-gauge stainless steel needle attached to 5 French flexible polycarbonate catheter with luer lock hub. Designed for insertion into endoscope working channels (≥5 French). Tapered transition between needle and catheter facilitates smooth passage. Available in lengths up to 200 cm for various endoscopes (bronchoscopes, gastroscopes, colonoscopes). Operated by clinicians during endoscopic procedures to deliver injectable agents into tissues. Output is physical delivery of fluid/material via standard syringe connected to luer hub. Benefits include precise, minimally invasive targeted tissue injection.
Clinical Evidence
Bench testing only. Device design and materials verified against performance requirements for endoscopic accessories.
Technological Characteristics
Materials: 23-gauge stainless steel needle, 5 French polycarbonate catheter. Luer lock hub conforms to ANSI/HIMA MD70.1-1983. Dimensions: up to 200 cm length, fits ≥5 French working channels. Sterilization: sterile, nonpyrogenic.
Indications for Use
Indicated for patients undergoing endoscopic procedures requiring tissue injection of FDA-approved materials (e.g., collagen, sclerosing agents, anesthetics, saline, contrast media) via endoscope working channels.
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 Needle (K933812)
- Mill-Rose Endoscopic Injection Needle (K820973)
Related Devices
- K982890 — ADVANCED UROSCIENCE INJECTION NEEDLE · Advanced Uroscience, Inc. · Oct 26, 1998
- K042615 — CARBON MEDICAL TECHNOLOGIES ENDOSCOPIC INJECTION NEEDLE · Carbon Medical Technologies, Inc. · Nov 5, 2004
- K172227 — Endoscopic Injection Needle · Carbon Medical Technologies, Inc. · Aug 23, 2017
- K051905 — UROPLASTY RIGID ENDOSCOPIC NEEDLE · Uroplasty, Inc. · Aug 29, 2005
- K121337 — UROPLASTY RIGID ENDOSCPIC NEEDLES · Uroplasty, Inc. · Aug 3, 2012
