(30 days)
Not Found
Not Found
No
The device description focuses on a physical catheter and drainage system, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is described as assisting in the palliative management and potential resolution of pleural effusions, which are medical conditions, and it is implanted in the body for long-term treatment.
No
The device is described as a catheter system intended for drainage of pleural effusions, which is a therapeutic intervention, not a diagnostic one. Its purpose is to remove fluid, not to identify or characterize a disease.
No
The device description clearly states it is a silicone tube that is partially implanted in the chest cavity, indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The Pleurx Pleural Catheter is a physical device implanted in the chest cavity to drain fluid. It does not analyze or test specimens taken from the body.
- Intended Use: The intended use is for the physical drainage of fluid from the chest cavity for symptom management and potential pleurodesis. This is a therapeutic and management function, not a diagnostic one based on analyzing specimens.
Therefore, the Pleurx Pleural Catheter falls under the category of a medical device used for treatment and management, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Pleurx Pleural Catheter is intended for long-term, intermittent drainage of symptomatic, recurrent, pleural effusions, including malignant pleural effusions and other pleural effusions that do not respond to treatment of the underlying disease.
The Denver® Pleurx Pleural Catheter Kit (#50-7000) and the Denver® Pleurx Drainage Kit (#50-7500) are indicated for intermittent, long term drainage of symptomatic, recurrent, pleural effusion, including malignant pleural effusion and other recurrent effusions that do not respond entrailing monagement of the underlying disease. The devices are indicated for 1) the palliation to modiour management effusion and 2) providing pleurodesis (resolution of the pleural effusion.
Product codes (comma separated list FDA assigned to the subject device)
DWM
Device Description
The Pleurx Pleural Catheter is a silicone tube that is partially implanted in the chest cavity. A cuff is included in the tunneled portion of the catheter. The cuff promotes tissue ingrowth, which helps to anchor the catheter and may provide a barrier against infection. The external portion of the catheter includes a valve that remains closed until it is opened with a specific drainage line. When the drainage line is in place, a vacuum source can be used to drain fluid that builds up in the chest cavity.
The special 510(k) covers a minor material change: a change in the supplier of the fabric used to make the cuff. The alternate fabric has been found to be equivalent to the previously used fabric by
- . Reviewing biocompatibility data to ensure that the fabric is suitable for use in a long-term tissue implant.
- Selecting a fabric with similar physical and chemical specifications .
- Testing to ensure that the bond strength between the tubing and the cuff remains within . specification.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
chest cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The alternate fabric has been found to be equivalent to the previously used fabric by
- . Reviewing biocompatibility data to ensure that the fabric is suitable for use in a long-term tissue implant.
- Selecting a fabric with similar physical and chemical specifications.
- Testing to ensure that the bond strength between the tubing and the cuff remains within specification.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.5050 Patient care suction apparatus.
(a)
Identification. A patient care suction apparatus is a device used with an intrathoracic catheter to withdraw fluid from the chest during the recovery period following surgery.(b)
Classification. Class II (performance standards).
0
510(k) Summary
Sponsor Information
Denver Biomedical, Inc. 14998 W. 6th Ave., Bldg. E700 Golden, CO 80401 303-279-7500
Contact Person: Jeff Hill, RA/QA Coordinator
This 510(k) summary was prepared on August 31, 2005.
Device Identification
This special 510(k) is for a modification to the Denver Pleural Catheter. The modification is to add an alternate supplier for the velour fabricate the cuff. The catheter made with the alternate cuff material has been found substantially equivalent to the previously marketed catheter.
Intended Use
The Pleurx Pleural Catheter is intended for long-term, intermittent drainage of symptomatic, recurrent, pleural effusions, including malignant pleural effusions and other pleural effusions that do not respond to treatment of the underlying disease.
Device Description
The Pleurx Pleural Catheter is a silicone tube that is partially implanted in the chest cavity. A cuff is included in the tunneled portion of the catheter. The cuff promotes tissue ingrowth, which helps to anchor the catheter and may provide a barrier against infection. The external portion of the catheter includes a valve that remains closed until it is opened with a specific drainage line. When the drainage line is in place, a vacuum source can be used to drain fluid that builds up in the chest cavity.
Summary of the change
The special 510(k) covers a minor material change: a change in the supplier of the fabric used to make the cuff.
The alternate fabric has been found to be equivalent to the previously used fabric by
- . Reviewing biocompatibility data to ensure that the fabric is suitable for use in a long-term tissue implant.
- Selecting a fabric with similar physical and chemical specifications .
- Testing to ensure that the bond strength between the tubing and the cuff remains within . specification.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is positioned to the right of a circular text that reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA".
OCT 6 - 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Jeff Hill RA/QA Coordinator Denver Biomedical, Incorporated 14998 West 6th Avenue, Building E700 Golden. Colorado 80401
Re: K052436 Trade/Device Name: Pleurx Pleural Catheter Kit Regulation Number: 21 CFR 870.5050 Regulation Name: Patient Care Suction Apparatus Regulatory Class: II Product Code: DWM Dated: September 2, 2005 Received: September 7, 2005
Dear Mr. Hill:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Hill
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincercly yours,
Chiu Liu, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Pleurx Pleural Catheter Kit
Indications for Use:
The Denver® Pleurx Pleural Catheter Kit (#50-7000) and the Denver® Pleurx Drainage Kit (#50-7500) are indicated for intermittent, long term drainage of symptomatic, recurrent, pleural effusion, including malignant pleural effusion and other recurrent effusions that do not respond entrailing monagement of the underlying disease. The devices are indicated for 1) the palliation to modiour management effusion and 2) providing pleurodesis (resolution of the pleural effusion.
Prescription Use _ × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K052426
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