ARGYLE TURKEL NEONATAL/PEDIATRIC THORACIC CATHETER INSERTION TRAY AND THORACIC CATHETER SYSTEM
Device Facts
| Record ID | K960574 |
|---|---|
| Device Name | ARGYLE TURKEL NEONATAL/PEDIATRIC THORACIC CATHETER INSERTION TRAY AND THORACIC CATHETER SYSTEM |
| Applicant | Sherwood Medical Co. |
| Product Code | FHO · Gastroenterology, Urology |
| Decision Date | Aug 5, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.1500 |
| Device Class | Class 2 |
| Attributes | Therapeutic, Pediatric |
Intended Use
The Neonatal/Pediatric Thoracic Catheter is a sterile, single use indwelling catheter, used to create a patent open passageway between the chest cavity and atmosphere or a Chest Drainage Unit (CDU). The catheter is intended to prevent pressure from developing in the chest, averting lung collapse and providing a means for fluid to drain from the chest cavity.
Device Story
Procedure tray containing components for chest drainage; includes sterile, single-use indwelling thoracic catheter (8, 10, 12 Fr). Catheter assembly features blunt, multi-sideholed, spring-loaded inner cannula coaxially housed within sharp-beveled hollow needle, all within polyurethane tapered catheter. Used by clinicians to create patent passageway between chest cavity and atmosphere or Chest Drainage Unit (CDU). Facilitates fluid drainage and pressure relief to prevent lung collapse. Percutaneous placement via trocar.
Clinical Evidence
Bench testing only.
Technological Characteristics
Polyurethane tapered catheter; blunt, multi-sideholed, spring-loaded inner cannula; sharp-beveled hollow needle. Sterile, single-use. Sizes: 8, 10, 12 Fr. Four distal side-holes for drainage.
Indications for Use
Indicated for neonatal and pediatric patients requiring chest drainage procedures to prevent pressure buildup in the chest cavity and avert lung collapse.
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
- Argyle Turkel Safety Pneumothorax Procedure Tray (K934428)
- Argyle Trocar Catheters & Trocar Catheter Kits (preamendment)
Related Devices
- K964519 — CURITY THORACENTESIS TRAY · Kendall Healthcare Products Co. Div.Of Tyco Health · Dec 20, 1996
- K111315 — MULTIPURPOSE DRAINAGE CATHETER · Navilyst Medical, Inc. · Jun 8, 2011
- K152069 — Exodus Array Multipurpose Drainage Catheter, Exodus Nuance Nephrostomy Drainage Catheter, Exodus Believe Biliary Drainage Catheter · Navilyst Medical, Inc. · Sep 24, 2015
- K032050 — PERIVAC KIT · Boston Scientific Corp · Aug 8, 2003
- K163321 — Rocket Indwelling Pleural Catheter (IPC) Insertion Kit · Rocket Medical Plc · Aug 17, 2017
