(16 days)
Not Found
Not Found
No
The description focuses on a physical catheter and drainage system with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is indicated for the relief of symptoms associated with pleural effusion and for the instillation of medications for pleurodesis, which are therapeutic actions.
No
Explanation: The device is described as being used for drainage and instillation of medication, providing a means for therapy and symptom relief, not for diagnosing a condition.
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 tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to analyze these samples outside of the body.
- Device Description: The description clearly states that the Pleurx Pleural Catheter is a silicone tube that is partially implanted in the chest cavity. It is used for draining fluid from the pleural space within the body.
- Intended Use: The intended use is for the drainage of symptomatic, recurrent pleural effusion and for the instillation of medications into the pleural space. These are therapeutic and management procedures performed on the patient, not diagnostic tests performed on samples.
Therefore, the Denver® Pleurx® Pleural Catheter Kit and the Denver® Pleurx® Drainage Kit are medical devices used for treatment and management, not for in vitro diagnostic testing.
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 and the Denver® Pleurx® Drainage Kit are indicated for intermittent, long-term drainage of symptomatic, recurrent pleural effusion, including malignant pleural effusion and other pleural effusions that do not respond to the medical management of the underlying disease. These devices are indicated for 1) the palliation of symptoms associated with recurrent pleural effusions and 2) the pleurodesis (resolution of the pleural effusion).
Product codes (comma separated list FDA assigned to the subject device)
74 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 io anchor the catheter and may provide a barrier against infection. The external portion of the te anoner the causes and and 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.
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 new tubing has been found to be equivalent to the previous tubing by
-
- Comparing the dimensional specifications
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- Comparing the physical property specifications
- Testing to ensure that the bond strength between the tubing and the external valve assembly 3. remains within specification.
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- Testing to ensure that the bond strength between the tubing and the cuff material meets the approved specification.
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- Testing to verify that the tubing meets acceptable standards for biocompatibility for a device in long-term contact with tissue.
The new fabric has been found to be equivalent to the original fabric by a review of material specifications (both are polyester double velour) and by selecting a fabric that has previously been cleared by FDA for use as a cuff material in the chest wall.
- Testing to verify that the tubing meets acceptable standards for biocompatibility for a device in long-term contact with tissue.
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
JUN 2 8 2001
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 June 6, 2001.
Device Identification
This special 510(k) is for a modification to the Denver Pleural Catheter. The modification is a change in supplier for the tubing used to fabricate the catheter and a change in the velour fabis a change in supplier for the cathere made of the modified materials has been found substantially equivalent to the legally 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 io anchor the catheter and may provide a barrier against infection. The external portion of the te anoner the causes and and 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 two material changes: a change in supplier for the tubing used to fabricate the catheter and a change in the fabric used to fabricate the cuff.
The new tubing has been found to be equivalent to the previous tubing by
-
- Comparing the dimensional specifications
-
- Comparing the physical property specifications
- Testing to ensure that the bond strength between the tubing and the external valve assembly 3. remains within specification.
-
- Testing to ensure that the bond strength between the tubing and the cuff material meets the approved specification.
1
-
- Testing to verify that the tubing meets acceptable standards for biocompatibility for a device in long-term contact with tissue.
The new fabric has been found to be equivalent to the original fabric by a review of material specifications (both are polyester double velour) and by selecting a fabric that has previously been cleared by FDA for use as a cuff material in the chest wall.
- Testing to verify that the tubing meets acceptable standards for biocompatibility for a device in long-term contact with tissue.
Special 510(k): Pleurx Material Changes
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three wavy lines representing its wings.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 8 2001
Ms. Bonnie Vivian Denver Biomedical, Inc. 14998 W. 6th Ave., Bldg. E-700 Golden, CO 80401
Re: K011831
Trade Name: Pleurx pleural catheter and drainage kits Regulation Number: 870.5050 Regulatory Class: II (two) Product Code: 74 DWM Dated: June 11, 2001 Received: June 12, 2001
Dear Ms. Vivian:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent 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). You may, therefore, market the device, subject to the general controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and labeling, and prohibitions against misbranding and adulteration.
3
Page 2 - Ms. Bonnie Vivian
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed nredicate 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 the labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4639. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours.
Denk Tillh
-James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
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Koll83 510(k) Number (if known):_ Device Name: Pleura Pleural Catheter
Indications For Use:
The Denver® Pleurx® Pleural Catheter Kit and the Denver® Pleurx® Drainage Kit are
nt of the The Denver® Pleurx® Pleural Catheter Kir and and more of symptomatic, recurrent pleural effusion,
indicated for intermittent, long-term drainage of symptomatic, cost respond indicated for intermittent, long-lenn urantege or offer and other that do not respond to
including malignant pleural effusion and other are indicated for 1) the including malignant pleural circusion and out of the devices are indicated for 1 ) the medical management of the underlying discuser below be and the pleurodesis (resolution of the pleural effusion).
(Please Do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Cardiovascular & Respiratory Devices
510(k) Number KO11831
of Cardiovascular scular & Respiratory
(Optional Format 3-10-98)