(256 days)
Not Found
No
The summary describes a mechanical drainage system and does not mention any AI or ML components or functions.
Yes
The device is described as "intermittent, long term drainage of symptomatic, recurrent, pleural effusion" and "palliation of dyspnea effusion and providing pleurodesis (resolution of the pleural effusion)", which directly addresses a disease state and aims to restore health.
No
The device is a Pleurx Pleural Catheter System, which is used for long-term drainage of pleural effusions for palliation of symptoms and providing pleurodesis. It is a therapeutic device, not a diagnostic one.
No
The device description clearly states the primary components are a "Pleural Catheter" and "Drainage Kits," which are physical medical devices, not software.
Based on the provided text, 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.
- Device Function: The description clearly states the device is a "Pleural Catheter System" used for "intermittent, long term drainage of symptomatic, recurrent, pleural effusion." This is a therapeutic device used to drain fluid from the body, not a diagnostic test performed on a sample.
- Intended Use: The intended use is for "drainage," "palliation of dyspnea effusion," and "providing pleurodesis." These are all related to managing a condition, not diagnosing it.
The device is a medical device, but it falls under the category of therapeutic devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The 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 effusion and 2) providing pleurodesis (resolution of the pleural effusion). The Pleural Catheter Kits are indicated for adults only.
The Pleur X Lockable Drainage Line is used to drain fluid using standard wall suction, water seal drainage system, vacuum bottle, or other appropriate method.
The Pleur X Access Valve attaches only to the PleurX Valve Kit is intended to repair the Pleur X Catheter and replace the PleurX Valve. The PleurX Valve Kit is indicated for adults only.
The Pleur X LP Catheter Mini Kit is 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 effusion and providing pleurodesis (resolution of the pleural effusion). The PleurX Low Profile Catheter is indicated for adults only.
Product codes (comma separated list FDA assigned to the subject device)
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
Pleural
Indicated Patient Age Range
Adults only
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)
Summary of Non-Clinical Tests Conducted for Determination of Substantial Equivalence
Performance Test Summary
- Biocompatibility:
- AAMI/ANSI/ISO 10993-1:2009 Biological evaluation of Medical Devices Part 1: Evaluation and Testing
- AAMI/ANSI/ISO 10993-5: 2009 Biological Evaluation of Medical Devices – Part 5 Tests for In Vitro Cytotoxicity
- AAMI/ANSI/ISO 10993-6: 2007 (R) 2010 Biological Evaluation of Medical Devices – Part 6 Tests for Local Effects After Implantation
- AAMI/ANSI/ISO 10993-10: 2010 Biological Evaluation of Medical Devices – Part 10 Tests for Irritation and Skin Sensitivity
- ISO 10993-17:2002 Biological evaluation of medical devices --Establishment of allowable limits for leachable substances
- ISO 10993-18:2005 Biological evaluation of medical devices -- Chemical characterization of materials
- Residuals:
- AAMI/ANSI/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
- EN 1618:1997 Catheters Other Than Intravascular Catheters - Test Methods for Common Properties
- ANSI/AAMI/ISO 11607-1:2006/(R)2010 Packaging for Terminally Sterilized Medical Devices- Part 1:Requirements For Materials, Sterile Barrier Systems And Packaging Systems [Including: Amendment 1 (2014)]
- ANSI/AAMI/ISO 11607-2:2006/(R)2010 Packaging for Terminally Sterilized Medical Devices- Part 2: Validation Requirements For Forming, Sealing And Assembly Processes [Including: Amendment 1 (2014)]
- ASTM F1980-07 Accelerated Aging of Sterile Barrier Systems
- ISO 11138-1, 2nd Ed Sterilization of healthcare products - Biological Indicators - Part 1: General Requirements
- ISO 11737-1 2nd Ed Sterilization of Medical Devices – Microbiological Methods Part 1
- ISO 11135 2nd Ed Sterilization of Health-Care Products -Ethylene Oxide – Requirements for the Development, Validation and Routine Control of a Sterilization Process for Medical Devices
- AAMI TIR28:2009(R)2013 Product Adoption and Process Equivalency for Ethylene Oxide Sterilization
- ISO 14630 Non-active Surgical Implants - General Requirements
- ASTM F2052 Measurement of Magnetically Induced Displacement Force on Medical Devices in the MR Environment
- ASTM F2119 Evaluation of MR Image Artifacts from Passive Implants
- ASTM F2182 A Measurement of Radiofrequency Induced Heating on or Near Passive Implants During MRI
- ASTM F2213 Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
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
The results of the non-clinical tests show that the CareFusion Pleural Catheter System is as safe, as effective, and performs as well as the legally marketed predicate devices.
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.
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 31, 2016
CareFusion Tamara Brey Advisor, Regulatory Management 75 North Fairway Drive Vernon Hills, Illinois 60061
Re: K160450
Trade/Device Name: Pleurx Pleural Catheter System Regulation Number: 21 CFR 870.5050 Regulation Name: Patient Care Suction Apparatus Regulatory Class: Class II Product Code: DWM Dated: September 26, 2016 Received: September 28, 2016
Dear Tamara Brey:
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. 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 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.
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 devicerelated 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K160450
Device Name Pleurx Pleural Catheter System
Indications for Use (Describe)
The 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 effusion and 2) providing pleurodesis (resolution of the pleural effusion). The Pleural Catheter Kits are indicated for adults only.
The Pleur X Lockable Drainage Line is used to drain fluid using standard wall suction, water seal drainage system, vacuum bottle, or other appropriate method.
The Pleur X Access Valve attaches only to the PleurX Valve Kit is intended to repair the Pleur X Catheter and replace the PleurX Valve. The PleurX Valve Kit is indicated for adults only.
The Pleur X LP Catheter Mini Kit is 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 effusion and providing pleurodesis (resolution of the pleural effusion). The PleurX Low Profile Catheter is indicated for adults only.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) SUMMARY K160450
A summary of 510(k) safety and effectiveness information in accordance with 21 CFR 807.92.
| SUBMITTER INFORMATION | |
|---|---|
| Name | CareFusion |
| Address | 75 North Fairway Drive, Vernon Hills, IL 60061 USA |
| Phone number | (847) 362-9485 |
| Fax number | (312) 949-9245 |
| Establishment Registration | |
| Number | 1423507 |
| Name of contact person | Tamara Brey |
| Date prepared | February 15, 2016 |
| DESCRIPTION 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 System: K141965, and |
| Bard Aspira Pleural Drainage System: K110409 | |
| Reason for 510(k) submission | This 510(k) submission is for a change in material formulation and |
| concentration, and minor design modifications to the devices cleared | |
| under K141965. | |
| 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. | |
| 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 1) the palliation of dyspnea due to pleural effusion and 2) providing | |
| pleurodesis (resolution of the pleural effusion). The PleurX Pleural | |
| Catheter Kits are indicated for adults only. | |
| The PleurX Lockable Drainage Line is used to drain fluid using standard | |
| wall suction, water seal drainage system, vacuum bottle, or other | |
| appropriate method. | |
| The PleurX Access Valve attaches only to the PleurX Catheter. The | |
| PleurX Valve Kit is intended to repair the PleurX Catheter. | |
| Catheter and replace the PleurX Valve. The PleurX Valve Kit is indicated | |
| for adults only. | |
| The PleurX LP Catheter Mini Kit is 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 providing | |
| pleurodesis (resolution of the pleural effusion). The PleurX Low Profile | |
| Catheter is indicated for adults only. |
4
SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE
| Characteristic | New Device | Predicate |
|---|---|---|
| Catheter Description | Internal: fenestrations, | |
| radiopaque markings & cuff | ||
| External: valve | Same as predicate: CareFusion Pleurx | |
| Catheter Systems: K141965 | ||
| Method | Percutaneously tunneled - | |
| indwelling | Same as predicate: CareFusion Pleurx | |
| Catheter Systems: K141965 | ||
| Access Valve Description | Unique access tip, valved closed | |
| system to inject and withdraw | ||
| fluids. | Same as predicate: Bard Aspira Drainage | |
| System: K110409 | ||
| Materials of Construction | Silicone, Barium Sulfate, | |
| Polyester, Polyisoprene, | ||
| Polypropylene, Colorant, ABS, | ||
| Ink, Adhesive | Same as predicate: CareFusion Pleurx | |
| Catheter Systems: K141965 | ||
| CONCLUSION OF DEVICE COMPARISON |
The technological characteristics of the proposed devices are substantially equivalent to the predicates.
PERFORMANCE DATA
SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE
Performance Test Summary
| Characteristic | Standard/Test/FDA Guidance |
|---|---|
| Biocompatibility | AAMI/ANSI/ISO 10993-1:2009 Biological evaluation of Medical Devices Part 1: |
| Evaluation and Testing | |
| Biocompatibility | AAMI/ANSI/ISO 10993-5: 2009 Biological Evaluation of Medical Devices – Part 5 |
| Tests for In Vitro Cytotoxicity | |
| Biocompatibility | AAMI/ANSI/ISO 10993-6: 2007 (R) 2010 Biological Evaluation of Medical Devices – |
| Part 6 Tests for Local Effects After Implantation | |
| Residuals | AAMI/ANSI/ISO 10993-7:2008 Biological evaluation of Medical Devices Part 7: |
| Ethylene Oxide Sterilization Residuals | |
| Biocompatibility | AAMI/ANSI/ISO 10993-10: 2010 Biological Evaluation of Medical Devices – Part 10 |
| Tests for Irritation and Skin Sensitivity | |
| Biocompatibility | ISO 10993-17:2002 Biological evaluation of medical devices --Establishment of |
| allowable limits for leachable substances | |
| Biocompatibility | ISO 10993-18:2005 Biological evaluation of medical devices -- Chemical |
| characterization of materials | |
| Performance | EN 1617:1997 Sterile Drainage Catheters and Accessory Devices for Single Use |
5
| Performance | EN 1618:1997 Catheters Other Than Intravascular Catheters - Test Methods for
Common Properties |
|--------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance | ANSI/AAMI/ISO 11607-1:2006/(R)2010 Packaging for Terminally Sterilized Medical
Devices- Part 1:Requirements For Materials, Sterile Barrier Systems And Packaging
Systems [Including: Amendment 1 (2014)] |
| Performance | ANSI/AAMI/ISO 11607-2:2006/(R)2010 Packaging for Terminally Sterilized Medical
Devices- Part 2: Validation Requirements For Forming, Sealing And Assembly
Processes [Including: Amendment 1 (2014)] |
| Performance | ASTM F1980-07 Accelerated Aging of Sterile Barrier Systems |
| Performance | ISO 11138-1, 2nd Ed Sterilization of healthcare products - Biological Indicators - Part
1: General Requirements |
| Performance | ISO 11737-1 2nd Ed Sterilization of Medical Devices – Microbiological Methods Part
1 |
| Performance | ISO 11135 2nd Ed Sterilization of Health-Care Products -Ethylene Oxide –
Requirements for the Development, Validation and Routine Control of a Sterilization
Process for Medical Devices |
| Performance | AAMI TIR28:2009(R)2013 Product Adoption and Process Equivalency for Ethylene
Oxide Sterilization |
| Performance | ISO 14630 Non-active Surgical Implants - General Requirements |
| Performance | ASTM F2052 Measurement of Magnetically Induced Displacement Force on Medical
Devices in the MR Environment |
| Performance | ASTM F2119 Evaluation of MR Image Artifacts from Passive Implants |
| Performance | ASTM F2182 A Measurement of Radiofrequency Induced Heating on or Near
Passive Implants During MRI |
| Performance | ASTM F2213 Measurement of Magnetically Induced Torque on Medical Devices in
the Magnetic Resonance Environment |
| 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
The results of the non-clinical tests show that the CareFusion Pleural Catheter System is as safe, as effective, and performs as well as the legally marketed predicate devices.