(46 days)
Not Found
No
The summary describes a mechanical drainage system and does not mention any AI or ML components or functionalities.
Yes
The device is indicated for palliation of dyspnea and providing pleurodesis (resolution of pleural effusion), which are therapeutic interventions.
No
Explanation: The device is described as a drainage kit for removing fluid from the chest to palliate symptoms and provide pleurodesis. It is used for treatment/management, not for diagnosing a condition.
No
The device description explicitly details physical components like a vacuum bottle, drainage line, and procedure pack, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for the drainage of fluid from the pleural space within the body. This is a therapeutic and palliative procedure performed in vivo (within a living organism).
- Device Description: The description details a catheter and drainage system designed to remove fluid from the chest. This aligns with an in vivo medical device, not a device used to test samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (like blood, urine, tissue, etc.) to provide information about a patient's health status, diagnose a condition, or monitor treatment.
IVD devices are specifically designed to perform tests on samples taken from the body to provide diagnostic information. This device's function is to physically remove fluid from the body for therapeutic purposes.
N/A
Intended Use / Indications for Use
The Pleurx Drainage Kits are used in conjunction with the Pleural Catheter. The devices are intended for long-term, intermittent drainage of symptomatic, recurrent, please of off usings, including malignant pleural effusions and other pleural effusions that do not respond to treamma of the underlying disease.
The Denver Pleurx Catheter Kit and the Denver Pleurx Drainage Kit/Vacuum Bottle are indicated for intermittent long term drainage of symptomatic, recurrent pleural effusion, including malignant pleural effusion and other recurrent effusions that do not respond to medical management of the underlying disease. The devices are indicated for 1) the palliation of dyspnea due to pleural effusion and 2) providing pleurodesis (resolution of the pleural effusion).
Product codes
DWM
Device Description
The Pleurx Drainage Kit includes a vacuum bottle with drainage line that is connected to the Pleurx catheter for removing fluid that has accumulated in the chest. It also includes a rooedure pack that includes all the supplies needed to perform the drainage procedure and to replace the dressing over the catheter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
chest, pleural
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 sponsor used the following techniques to determine that the modified design is substantially equivalent to that of the currently marketed product.
- Verifying that the key safety-critical performance parameter, flow rate, was within the . specification for the currently marketed device.
- Verifying that other aspects of the revised bottle design met the specifications set for . them.
- Applying risk management techniques to assess the potential impact of the changes on . device safety, and adopting appropriate risk control measures.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
KOS1084
JUN 1 3 2005
6. 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 March 17, 2005.
Device Identification
This special 510(k) is for a modification to the Denver Pleurx Drainage Kit.
Intended Use
The Pleurx Drainage Kits are used in conjunction with the Pleural Catheter. The devices are intended for long-term, intermittent drainage of symptomatic, recurrent, please of off usings, including malignant pleural effusions and other pleural effusions that do not respond to treamma of the underlying disease.
Device Description
The Pleurx Drainage Kit includes a vacuum bottle with drainage line that is connected to the Pleurx catheter for removing fluid that has accumulated in the chest. It also includes a rooedure pack that includes all the supplies needed to perform the drainage procedure and to replace the dressing over the catheter.
Summary of the change
The special 510(k) addresses changes in the vacuum bottle/drainage line assembly. These changes include
- A larger bottle size has been introduced .
- A change in material �
- A change in shape .
- A change in the sealing/vacuum access mechanism .
- A change in the length and diameter of the drainage line .
- A change in the sterilization approach, which will maintain sterility of the drainage line � but will not sterilize the interior of the vacuum bottle.
This 510(k) also identified minor changes that had been made previously, including a change in the skin antiseptic from povidone-iodine to 70% alcohol.
1
Substantial Equivalence to Currently Marketed Device
The sponsor used the following techniques to determine that the modified design is substantially equivalent to that of the currently marketed product.
- Verifying that the key safety-critical performance parameter, flow rate, was within the . specification for the currently marketed device.
- Verifying that other aspects of the revised bottle design met the specifications set for . them.
- Applying risk management techniques to assess the potential impact of the changes on . device safety, and adopting appropriate risk control measures.
2
Image /page/2/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 facing to the right. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
JUN 1 3 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Denver Biomedical, Incorporated C/O Ms. Nancy Sauer Director, Regulatory Affairs Quality Assurance Evergreen Research, Incorporated 433 Park Point Drive, Suite 140 Golden, Colorado 80401
Re: K051084
Trade/Device Name: Pleurx Catheter and Drainage Kits/Vacuum Bottle Regulation Number: 870.5050 Regulation Name: Patient Care Suction Apparatus Regulatory Class: II Product Code: DWM Dated: May 26, 2005 Received: May 31, 2005
Dear Ms. Sauer:
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 either 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.
3
Page 2 - Ms. Sauer
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 (Sections 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) 276-0115. 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.
Sincerely yours,
Jennie H. Michie Omd.
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
4
Indications for Use
510(k) Number (if known):
Device Name: __ PLEURX CATHETER AND DRAINAGE KITS/VACUUM BOTTLE
Indications for Use:
The Denver Pleurx Catheter Kit and the Denver Pleurx Drainage Kit/Vacuum Bottle are indicated for intermittent long term drainage of symptomatic, recurrent pleural effusion, including malignant pleural effusion and other recurrent effusions that do not respond to medical management of the underlying disease. The devices are indicated for 1) the palliation of dyspnea due to pleural 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)
Quattie H. Michie Dms.
(Division Sign-Off Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number:_KO51084
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(Posted November 13, 2003)