← Product Code [FHO](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FHO) · K960574

# ARGYLE TURKEL NEONATAL/PEDIATRIC THORACIC CATHETER INSERTION TRAY AND THORACIC CATHETER SYSTEM (K960574)

_Sherwood Medical Co. · FHO · Aug 5, 1996 · Gastroenterology, Urology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FHO/K960574

## Device Facts

- **Applicant:** Sherwood Medical Co.
- **Product Code:** [FHO](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FHO.md)
- **Decision Date:** Aug 5, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 876.1500
- **Device Class:** Class 2
- **Review Panel:** Gastroenterology, Urology
- **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.

## 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

- Argyle Turkel Safety Pneumothorax Procedure Tray ([K934428](/device/K934428.md))
- Argyle Trocar Catheters & Trocar Catheter Kits (preamendment)

## Submission Summary (Full Text)

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{0}

JUL 26 '96 02:53PM SHERWOOD LAW
P.2

510(k) Summary of Safety & Efficacy: Argyle Turkel Neonatal/
Pediatric Thoracic Catheter Insertion Tray

Submitted by: Sherwood Medical Co., 1915 Olive St.,
St. Louis, MO 63103, (314) 621-7788
Contact: Dennis Pozzo, Regulatory Affairs Manager
Date Prepared: revised July 26, 1996

K960574
AUG - 5 1996

The Argyle Turkel Neonatal/Pediatric Thoracic Catheter
Insertion Tray will include all components commonly required to
perform a chest drainage procedure in a single procedure-ready
package. This procedure tray will be available in several
configurations of tray components. This device is a Class II
device per 21 CFR 870.1300 or 880.6740, Procode: 74DQR or 80CSS.

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. The
catheter will be available in 8, 10 and 12 fr sizes.

The device incorporates a blunt, multi-sideholed, spring-
loaded inner cannula coaxially housed within a conventional
sharp-beveled hollow needle. This entire assembly is housed
within polyurethane tapered catheter, which is used as a standard
small bore percutaneously placed thoracic catheter. The tapered
catheter incorporates four distal side-holes to facilitate
drainage.

The Argyle Turkel Neonatal/Pediatric Thoracic Catheter
Insertion Tray is substantially equivalent to Sherwood Medical's
currently marketed Argyle Turkel Safety Pneumothorax Procedure
Tray (K934428) in that both share the same basic 1) components,
2) intended use and 3) the catheters are introduced in the chest
via a trocar. The major differences are: 1) the proposed device
will be indicated specifically for neonatal/pediatric use and 2)
the addition of a 10 & 12 Fr catheter for the neonatal/pediatric
tray.

The Argyle Turkel Neonatal/Pediatric Thoracic Catheter
Insertion Tray is substantially equivalent to Sherwood Medical's
currently marketed Argyle Trocar Catheters & Trocar Catheter Kits
(preamendment) in that they all: 1) have the same intended use
and 2) utilize trocars to introduced the catheters into the
chest. The major differences are: 1) the proposed device will be
indicated specifically for neonatal/pediatric use and 2) the
proposed device is a "safety" device.

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**Source:** [https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FHO/K960574](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FHO/K960574)

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