DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER

K962814 · Denver Biomaterials, Inc. · KPM · Apr 14, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K962814
• Device Name: DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER
• Applicant: Denver Biomaterials, Inc.
• Product Code: KPM · Gastroenterology, Urology
• Decision Date: Apr 14, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5955
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Denver® Pleural Effusion Shunt with External Pump Chamber, Catalog No. 42-9005 is indicated for use in transferring pleural fluid, resulting from chylothorax or intractable pleural effusion, from the pleural cavity to the peritoneal cavity. The device is intended to be used in adult, pediatric, and neonatal patients.

Device Story

Sterile, single-use, non-pyrogenic pleuro-peritoneal shunt; consists of 15.5 Fr. fenestrated pleural and peritoneal catheters connected by a flexible pump chamber with two one-way valves. Implanted with catheters in pleural and peritoneal cavities; polyester cuffs placed subcutaneously for tissue ingrowth; pump chamber remains external. Patient or caregiver manually compresses pump chamber to transfer fluid; one-way valves ensure unidirectional flow and prevent reflux. Barium sulfate stripe allows X-ray/fluoroscopy visualization. Facilitates management of intractable pleural effusion or chylothorax by shunting fluid to the peritoneal cavity for absorption.

Clinical Evidence

No clinical data provided; relies on published scientific literature indicating pleuro-peritoneal shunting is a safe and effective procedure.

Technological Characteristics

Materials: Silicone rubber, polyester cuffs. Dimensions: 15.5 Fr. fenestrated catheters. Features: Two one-way valves, integral barium sulfate stripe for radiopacity. Single-use, non-pyrogenic, sterile. No software or electronic components.

Indications for Use

Indicated for adult, pediatric, and neonatal patients with chylothorax or intractable pleural effusion requiring transfer of pleural fluid to the peritoneal cavity.

Regulatory Classification

Identification

A peritoneo-venous shunt is an implanted device that consists of a catheter and a pressure activated one-way valve. The catheter is implanted with one end in the peritoneal cavity and the other in a large vein. This device enables ascitic fluid in the peritoneal cavity to flow into the venous system for the treatment of intractable ascites.

Special Controls

*Classification.* Class II. The special controls for this device are FDA's:(1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ” (2) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),” and (3) Backflow specification and testing to prevent reflux of blood into the shunt.

Predicate Devices

• Denver® Pleural Effusion Shunt (Catalog No. 42-9000)
• Cook, Inc. Pneumothorax Set
• Quinton Tenckhoff Peritoneal Dialysis Catheter

Submission Summary (Full Text)

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# Summary of Safety and Effectiveness

## Denver® Pleural Effusion Shunt with External Pump Chamber

### SUBMITTER INFORMATION

Denver Biomaterials, Inc.
6851 Highway 73
Evergreen, Colorado 80439 USA

Lynne Leonard
Director, Regulatory Affairs/Quality Assurance

### DEVICE COMMON NAME

Pleuro-peritoneal Shunt

### DEVICE CLASSIFICATION NAME

78
21 CFR 876.5955 (Peritoneo-venous Shunt, #79KPM).

### IDENTIFICATION OF SUBSTANTIALLY EQUIVALENT DEVICE(S)

The Denver® Pleural Effusion Shunt with External Pump Chamber, Catalog No. 42-9005, is substantially equivalent in intended use to the Denver® Pleural Effusion Shunt, Catalog No. 42-9000. Both devices have the same intended use; both are single-use, non-pyrogenic, sterile, pleuro-peritoneal shunts. With the exception of the polyester cuffs and longer catheters on the Denver® Pleural Effusion Shunt with External Pump Chamber, the two devices are identical in configuration, materials and manufacturing processes.

B. The Denver® Pleural Effusion Shunt with External Pump Chamber, Catalog No. 42-9005 is also substantially equivalent to the Cook, Inc. Pneumothorax Set in that both have a radiopaque catheter designed to be placed with one end in the pleural space and the other end external to the body.

C. The Denver® Pleural Effusion Shunt with External Pump Chamber, Catalog No. 42-9005 is also substantially equivalent to the Quinton Tenckhoff Peritoneal Dialysis Catheter in that both have a radiopaque catheter designed to be placed with one end in the peritoneal cavity and the other end external to the body.

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## DEVICE DESCRIPTION:

The Denver® Pleural Effusion Shunt with External Pump Chamber is a sterile, non-pyrogenic device, for single use only. It is not to be resterilized. The one-piece device consists of a 15.5 Fr. fenestrated pleural catheter and a 15.5 Fr. fenestrated peritoneal catheter, separated by a flexible pump chamber containing two one-way valves. The flexible pump chamber is designed to be manually pumped by the patient or caregiver to transfer pleural fluid from the pleural cavity into the peritoneal cavity. The valves in the pump chamber permit flow in one direction only. The second valve in the pump chamber serves as a check valve for the first, helping to prevent reflux of fluid into the peritoneal catheter when the pump chamber is pumped.

Each catheter has a polyester cuff located between the pump chamber and the catheter's fenestrations. When the device is placed in a patient, the pleural and peritoneal catheters are implanted into the pleural and peritoneal cavities, respectively, with the cuffs subcutaneous to permit tissue ingrowth into the cuff. The pump chamber remains outside the patient's body. The entire device is made of silicone rubber, with the exception of the cuffs, which are polyester. Both the pleural and peritoneal catheters contain an integral barium sulfate stripe to permit visualization by x-ray or fluoroscopy.

## INTENDED USE

The Denver® Pleural Effusion Shunt with External Pump Chamber, Catalog No. 42-9005 is indicated for use in transferring pleural fluid, resulting from chylothorax or intractable pleural effusion, from the pleural cavity to the peritoneal cavity. The device is intended to be used in adult, pediatric, and neonatal patients.

## SCIENTIFIC LITERATURE

Published studies indicate that pleuro-peritoneal shunting is a safe and effective procedure.

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