(269 days)
Not Found
No
The device description details a purely mechanical system for fluid transfer, with no mention of computational analysis, algorithms, or learning capabilities.
Yes
The device is indicated for use in transferring pleural fluid resulting from chylothorax or intractable pleural effusion, which are medical conditions, thereby preventing or treating a disease or condition.
No.
The device is designed to transfer fluid from one body cavity to another, which is a therapeutic function, not a diagnostic one. While its catheters contain barium sulfate stripes for visualization (which could be part of a diagnostic process), the device itself is not performing the diagnosis.
No
The device description clearly outlines a physical, implantable medical device made of silicone rubber and polyester, with catheters, a pump chamber, and valves. It is not software-only.
Based on the provided information, the Denver® Pleural Effusion Shunt with External Pump Chamber is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body (in vitro).
- Device Function: The Denver® Pleural Effusion Shunt is an implantable device designed to transfer fluid within the body from the pleural cavity to the peritoneal cavity. It is a therapeutic device, not a diagnostic one.
- Lack of Diagnostic Testing: The description does not mention any testing of samples or analysis of biological markers. Its purpose is purely mechanical fluid transfer.
- Intended Use: The intended use is to treat conditions like chylothorax or intractable pleural effusion by physically moving fluid, not to diagnose these conditions.
Therefore, the Denver® Pleural Effusion Shunt falls under the category of a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for 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.
Product codes
KPM
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Pleural cavity, peritoneal cavity
Indicated Patient Age Range
Adult, pediatric, and neonatal patients.
Intended User / Care Setting
Patient or caregiver
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Published studies indicate that pleuro-peritoneal shunting is a safe and effective procedure.
Key Metrics
Not Found
Predicate Device(s)
K962814, Cook, Inc. Pneumothorax Set, Quinton Tenckhoff Peritoneal Dialysis Catheter
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.5955 Peritoneo-venous shunt.
(a)
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.(b)
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.
0
K 962814
ρ 192
APR 1 4 1997
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
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, nonpyrogenic, 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.
18
The Denver® Pleural Effusion Shunt with External Pump B. 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.
The Denver® Pleural Effusion Shunt with External Pump c. 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.
1
962819
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.