(141 days)
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 the pleural effusion)," which are therapeutic purposes aimed at alleviating symptoms and resolving a medical condition.
No
The device is indicated for drainage and palliation of symptoms related to pleural effusions, as well as providing pleurodesis. It is not used to diagnose a medical condition.
No
The device description clearly states the primary components are a catheter and drainage kits, which are physical hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for draining fluid from the pleural space within the body to relieve symptoms and potentially induce pleurodesis. This is a therapeutic and management procedure performed in vivo (within the living organism).
- Device Description: The description focuses on a catheter system for draining fluid, which is consistent with an in vivo procedure.
- Lack of IVD Characteristics: There is no mention of analyzing samples in vitro (outside the body) to diagnose, monitor, or screen for diseases or conditions. IVDs typically involve reagents, assays, or instruments used to test biological samples like blood, urine, or tissue.
Therefore, the Pleurx Pleural Catheter Kits and associated components are medical devices used for a therapeutic procedure, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Pleurx Pleural Catheter Kits 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).
The Pleurx Drainage Kits and Drainage Line Set are indicated for use only with the Pleurx Catheter for intermittent drainage. The Drainage Line Kit is used to drain fluid using standard wall suction, water seal drainage system, vacuum bottle or other appropriate method.
The Pleurx Dressing Kits are indicated for dressing of a catheter and exit site.
Product codes
DWM
Device Description
The Pleurx Pleural Catheter System provides patients with a convenient method to relieve pleural effusion symptoms at home. The primary components of the Pleurx Catheter System are the Pleurx Pleural Catheter and the Pleurx Drainage Kits.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
N/A - No clinical tests were conducted for this submission
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
化 112831 510(k) SUMMARY
A summary of 510(k) safety and effectiveness information in accordance with 21 CFR 807.92.
ﺔ ﺗ
| SUBMITTER INFORMATION | |
|---|---|
| Name | CareFusion |
| Address | 1500 Waukegan Road MPWM, McGaw Park, IL 60085 USA |
| Phone number | (847) 473-7404 |
| Fax number | (847) 473-7990 |
| Establishment | |
| Registration Number | 1423507 |
| Name of contact person | Joy Greidanus |
| Date prepared | February 10, 2012 |
| NAME OF DEVICE | |
| Trade or proprietary | |
| name | Pleurx Pleural Catheter System |
| Common or usual name | Pleural Drainage Catheter |
| Classification name | Patient Care Suction Apparatus |
| Classification panel | Anesthesiology |
| Regulation | Class II per 21CFR §870.5050, Procode DWM |
| Product Code(s) | Multiple |
| Legally marketed | |
| device(s) to which | |
| equivalence is claimed | CareFusion Pleurx Catheter Kit and the Denver Pleurx Drainage Kit/Vacuum |
| Bottle : K051084 & K052436 | |
| Bard Aspira Pleural Drainage System: K110409 | |
| Reason for 510(k) | |
| submission | Change to materials, expanding the indications for use, and updates to the |
| instructions for use. | |
| Device description | The Pleurx Pleural Catheter System provides patients with a convenient |
| method to relieve pleural effusion symptoms at home. The primary | |
| components of the Pleurx Catheter System are the Pleurx Pleural | |
| Catheter and the Pleurx Drainage Kits. |
1
| Intended use of the device | The Pleurx Pleural Catheter Kits 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
- the palliation of dyspnea due to pleural effusion
and 2) providing pleurodesis (resolution of the
pleural effusion). |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The Pleurx Drainage Kits and Drainage Line Set are
indicated for use only with the Pleurx Catheter for
intermittent drainage. The Drainage Line Kit is used
to drain fluid using standard wall suction, water seal
drainage system, vacuum bottle or other appropriate
method. |
| | The Pleurx Dressing Kits are indicated for dressing
of a catheter and exit site. |
יי
SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED .
. . . . . . . . . . . . . . . . . . TO.THE PREDICATE DEVICE
| Characteristic | New Device | Predicates:
CareFusion Pleurx Pleural Catheter
System (K051084, K052436)
Bard Aspira Pleural Catheter System
(K110409) |
|----------------------|--------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| Catheter Description | Internal: fenestrations, radiopaque
markings & cuff
External: valve | Same |
| Method | Percutaneously tunneled - indwelling | Same |
| Means of Drainage | Wall suction, water seal drainage
system, portable suction, vacuum
bottles or other appropriate method | Wall suction, water seal drainage system,
vacuum bottles, syringe, drainage bag or
other appropriate method |
SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE
| Performance Test Summary | |
|---|---|
| Characteristic | Standard/Test/FDA Guidance |
| Biocompatibility | ISO 10993-1:2009 Biological evaluation of Medical Devices Part 1: Evaluation and |
| Testing | |
| Residuals | ISO 10993-7:2008 Biological evaluation of Medical Devices Part 7: Ethylene Oxide |
| Sterilization Residuals | |
| Performance | EN 1617:1997 Sterile Drainage Catheters and Accessory Devices for Single Use |
| Performance | EN 1618:1997 Catheters Other Than Intravascular Catheters - Test Methods for |
| Common Properties |
2
| Performance | ANSI/AAMI/ISO 11607-1,2:2006 Packaging for Terminally Sterilized Medical Devices |
|---|---|
| Performance | ISO 11138-1,2:2006 Sterilization of Healthcare products - Biological Indicators |
| Performance | ISO 11737-1,2:2006 Sterilization of Medical Devices - Microbiological Methods Part |
| 1 & 2 | |
| Performance | ISO 11135:2007 Medical Device, Validation and Routine Control of Ethylene Oxide |
| Sterilization | |
| Specification | ASTM F560-08 (excluding part 7) Standard Specification for Unalloyed Tantalum for |
| Surgical Implants | |
| SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL | |
| EQUIVALENCE AND/OR OF CLINICAL INFORMATION | |
| N/A - No clinical tests were conducted for this submission | |
| CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA |
ﺔ ﻓ
The results of the non-clinical tests show that the CareFusion Pleural Catheter System meets or exceed all performance requirements, and is substantially equivalent to the predicate devices.
·
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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized image of a caduceus, a symbol often associated with medicine and healthcare. The caduceus consists of a staff with two snakes coiled around it.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Joy Greidanus Manager, Regulatory Affairs CareFusion 1500 Waukegan Road McGaw Park, Illinois 60085
FEB 1 6. 2012'
Re: K112831
Trade/Device Name: Pleurx Pleural Catheter System Regulation Number: 21 CFR 870.5050 Regulation Name: Patient Care Suction Apparatus Regulatory Class: II Product Code: DWM Dated: February 13, 2012 Received: February 14, 2012
Dear Ms. Griedanus:
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 me reachar Food, Drag, Drag, and Cherefore, 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 (1 wirly of 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.
4
Page 2 - Ms. Griedanus
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/MedicalDevices/Safety/ReportaProblem/default.htm 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Nh fac
Anthony D. Watson, B.S., M.S., M.B.A. 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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Image /page/5/Picture/0 description: The image shows the CareFusion logo. The logo consists of a stylized globe with a shield-like shape embedded within it on the left, followed by the word "CareFusion" in a bold, sans-serif font on the right. The globe and text are both in black against a white background.
1500 Waukegan Road McGaw Park, Illinois 60085-6787 847.473.7404 FAX 847 473 7790
Indication for Use
Pleurx Pleural Catheter System
510(k) Number (if known):
Device Name:
Indications For Use:
The Pleurx Pleural Catheter Kits 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).
The Pleurx Drainage Kits and Drainage Line Set are indicated for use only with the Pleurx Catheter for intermittent drainage. The Drainage Line Kit is used to drain fluid using standard wall suction, water seal drainage system, vacuum bottle or other appropriate method.
The Pleurx Dressing Kits are indicated for dressing of a catheter and exit site.
Prescription Use X_ (Per 21 CFR 801.109) or Over-The Counter Use (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE)
Concurrence of CDRH, Office of Device Evaluation (ODE)
L. Schattner
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control. Dental Devices
V 112831
510(k) Number:
11