(15 days)
No
The description focuses on a mechanical drainage system and does not mention any AI/ML components or functionalities.
Yes
The device is intended to relieve symptoms associated with pleural effusion by draining accumulated fluid from the pleural cavity, which is a therapeutic purpose.
No
Explanation: The device description clearly states that the Asept Pleural Drainage System is used to "drain accumulated fluid from the pleural cavity to relieve symptoms associated with pleural effusion." It is a treatment device, not one used for identifying the nature or cause of a medical condition.
No
The device description clearly outlines physical components like a catheter, valve, and drainage kit, indicating it is a hardware-based medical device.
Based on the provided information, the Asept Pleural Drainage System 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 provide information for diagnosis, monitoring, or screening.
- Asept Pleural Drainage System Function: The Asept Pleural Drainage System is a medical device used to drain fluid from the pleural cavity. It is a physical device that interacts directly with the patient's body to remove accumulated fluid. It does not perform any diagnostic testing on a sample.
- Intended Use: The intended use is for "long-term, intermittent drainage of symptomatic, recurrent, pleural effusions." This describes a therapeutic intervention, not a diagnostic test.
- Device Description: The description clearly states it's a "tunneled, long term catheter used to drain accumulated fluid." This is a drainage device, not a diagnostic device.
- Lack of Diagnostic Elements: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information.
Therefore, the Asept Pleural Drainage System falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Asept Pleural Drainage System is intended for long-term, internittent drainage of symptomatic, recurrent, pleural effusions; including malignant pleural effusions and other pleural effusions that do not respond to treatment of the underlying disease.
Product codes
DWM
Device Description
The Asept Pleural Drainage System is a tunneled, long term catheter used to drain accumulated fluid from the pleural cavity to relieve symptoms associated with pleural effusion. The catheter is implanted in the patient's pleural cavity enabling the patient to perform intermittent pleural effusion drainage at home or hospital. The primary components of the system are the Asept indwelling Pleural Catheter and the Asept Drainage Kit. The proximal end of the indwelling catheter has a valve that prevents fluid or air from moving in or out of the pleural space until the valve is breached. The valve can be breached by the Asept Pleural Drainage catheter connected to wall suction or pleurovac or vacuum bottles. The Asept Pleural Drainage System provides patients with a convenient way to relieve pleural effusion symptoms at home.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pleural cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
home or hospital
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)
In vitro testing was performed on the Asept Pleural Drainage System to assure reliable design and performance in accordance with BS EN 1618-1997. Testing includes leakage, flow rate, tensile strength, and corrosion. Clinical studies were not deemed necessary since in vitro testing was sufficient to demonstrate safety and effectiveness by way of comparison to legally marketed predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K010642/K011831/K051084/K052436
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
510(k) Summary of Safety and Effectiveness
The following section is included as required by the Safe Medical Device Act (SMDA) of 1990.
| Name: | PFM Medical, Inc |
|---|---|
| Address: | 2605 Temple Heights Drive |
| Suite A | |
| Oceanside, CA 92056 | |
| Contact Person: | SALVADORE F. PALOMARES, RAC |
NOV - 6 2009
510(k) Summary of Safety and Effectiveness
1 2307
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is:
| Trade Name: | Asept Pleural Drainage System |
|---|---|
| Common Name: | Tunneled Thoracic Catheter and Accessories |
| Classification: | DWM |
| Equivalent Devices: | |
|---|---|
| Manufacturer: | Denver Biomedical (Cardinal Health) |
| Name: | Pleurx Pleural Catheter |
| 510(k) #: | K010642/K011831/K051084/K052436 |
Device Description:
The Asept Pleural Drainage System is a tunneled, long term catheter used to drain accumulated fluid from the pleural cavity to relieve symptoms associated with pleural effusion. The catheter is implanted in the patient's pleural cavity enabling the patient to perform intermittent pleural effusion drainage at home or hospital. The primary components of the system are the Asept indwelling Pleural Catheter and the Asept Drainage Kit. The proximal end of the indwelling catheter has a valve that prevents fluid or air from moving in or out of the pleural space until the valve is breached. The valve can be breached by the Asept Pleural Drainage catheter connected to wall suction or pleurovac or vacuum bottles. The Asept Pleural Drainage System provides patients with a convenient way to relieve pleural effusion symptoms at home.
Intended Use:
The Asept Pleural Drainage System is intended for long-term, internittent drainage of symptomatic, recurrent, pleural effusions; including malignant pleural effusions and other pleural effusions that do not respond to treatment of the underlying disease.
Performance Data:
In vitro testing was performed on the Asept Pleural Drainage System to assure reliable design and performance in accordance with BS EN 1618-1997. Testing includes leakage, flow rate, tensile strength, and corrosion.
Clinical studies were not deemed necessary since in vitro testing was sufficient to demonstrate safety and effectiveness by way of comparison to legally marketed predicate device.
Biocompatibility:
Materials used in the Asept Pleural Drainage System meet the requirements of ISO 10993 or identical to legally marketed device.
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Image /page/1/Picture/0 description: The image shows the seal of the Department of Health & Human Services-USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the perimeter. In the center of the seal is an emblem that features a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus is depicted with a staff entwined by two snakes and topped with wings.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
PFM Medical, Incorporated C/O Mr. Mark Job Responsible Third Party Official Regulatory Technology Services L.L.C. 1394 25th Street Northwest Buffalo, Minnesota 55313
NOV - 6 2009
Re: K093307
Trade/Device Name: Asept Pleural Drainage System Regulation Number: 21 CFR 870.5050 Regulation Name: Patient Care Suction Apparatus Regulatory Class: II Product Code: DWM Dated: October 21, 2009 Received: October 22, 2009
Dear Mr. Job:
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 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.
2
Page 2- Mr. Job
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours,
Susan Francis
Susan Runner, D.D.S., M.A. Acting Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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510(k):
Asept Pleural Drainage System Device Name:
The Asept Pleural Drainage System is intended for Indications for Use: 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.
× Prescription Use (Per 21 CFR 801 Subpart D) AND/OR Over the Counter Use (21 CFR 807 Subpart C)
(Please Do Not WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Pearce
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K093307