PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT

K141965 · Care Fusion · DWM · Jul 2, 2015 · Cardiovascular

Device Facts

• Record ID: K141965
• Device Name: PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT
• Applicant: Care Fusion
• Product Code: DWM · Cardiovascular
• Decision Date: Jul 2, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5050
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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 Catheter Access Kit is intended to provide access to the Pleurx Catheter to inject or withdraw fluids.

Device Story

Pleurx Pleural Catheter System provides home-based drainage of symptomatic, recurrent pleural effusions. System consists of percutaneously tunneled, indwelling pleural catheter and associated drainage kits. Catheter features internal fenestrations, radiopaque markings, cuff, and external valve. Access kit allows injection or withdrawal of fluids, including sclerosing agents (Talc, Bleomycin). Device used by patients or caregivers for intermittent drainage; fluid drained via vacuum bottle, wall suction, or water seal system. System facilitates symptom relief (dyspnea) and pleurodesis. No electronic components or software.

Clinical Evidence

No clinical tests were conducted for this submission. Substantial equivalence is supported by non-clinical bench testing and biocompatibility evaluations.

Technological Characteristics

Materials: Silicone, Barium Sulfate, Polyester, Polyisoprene, Polypropylene, Colorant, ABS, Ink, Adhesive. Design: Percutaneously tunneled, indwelling catheter with internal fenestrations, radiopaque markings, cuff, and external valve. Sterilization: Ethylene Oxide (ISO 11135:2007). Standards: ISO 10993 series (biocompatibility), EN 1617/1618, ISO 11070, ISO 11607, ASTM F1980-07.

Indications for Use

Indicated for patients with symptomatic, recurrent pleural effusion (including malignant) unresponsive to medical management. Used for palliation of dyspnea and to provide pleurodesis.

Regulatory Classification

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.

Predicate Devices

• CareFusion Pleurx Catheter System (K121849)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, overlapping each other to create a sense of depth and connection.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 2, 2015

CareFusion Joy Greidanus Regulatory Affairs Manager 75 North Fairway Drive Vernon Hills, IL 60061

Re: K141965

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: June 30, 2015 Received: July 1, 2015

Dear Ms. Greidanus:

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

{1}------------------------------------------------

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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. 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) K141965

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, mcluding 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 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 Catheter Access Kit is intended to provide access to the Pleurx Catheter to inject or withdraw fluids

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

# 510(k) SUMMARY K141965

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 | [phone] |
| Fax number | [phone] |
| Establishment Registration<br>Number | 1423507 |
| Name of contact person | Joy Greidanus |
| Date prepared | July 2, 2015 |
| 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<br>which equivalence is claimed | CareFusion Pleurx Catheter System: K121849 |
| Reason for 510(k) submission | Updates to labeling to include the use of sclerosing agents Talc and<br>Bleomycin with the Pleurx Pleural Catheter System. |
| Device description | The Pleurx Pleural Catheter System provides patients with a convenient<br>method to relieve pleural effusion symptoms at home. The primary<br>components of the Pleurx Catheter System are the Pleurx Pleural<br>Catheter and the Pleurx Drainage Kits. |
| Intended use of the device | The Pleurx Pleural Catheter Kits are indicated for intermittent, long term<br>drainage of symptomatic, recurrent, pleural effusion, including malignant<br>pleural effusion and other recurrent effusions that do not respond to<br>medical management of the underlying disease. The devices are indicated<br>for 1) the palliation of dyspnea due to pleural effusion and 2) providing<br>pleurodesis (resolution of the pleural effusion). |
| Intended use of the device | The Pleurx Drainage Kits and Drainage Line Set are indicated for use only<br>with the Pleurx Catheter for intermittent drainage. The Drainage Line Kit is<br>used to drain fluid using standard wall suction, water seal drainage<br>system, vacuum bottle or other appropriate method. |
| Intended use of the device | The Pleurx Catheter Access Kit is intended to provide access to the Pleurx<br>Catheter to inject or withdraw fluids. |
| | The predicate Catheter Access Kit indication is for aspiration and catheter maintenance. This intended use was expanded to include injection or withdrawal of sclerosing agents; Talc and Bleomycin. This change was validated through biocompatibility testing and bench testing. |

{4}------------------------------------------------

## SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE

| Characteristic | New Device | Predicate |
|---------------------------|---------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|
| Catheter Description | Internal: fenestrations,<br>radiopaque markings & cuff<br>External: valve | Same as predicate: CareFusion Pleurx<br>Catheter Systems: K121849 |
| Method | Percutaneously tunneled -<br>indwelling | Same as predicate: CareFusion Pleurx<br>Catheter Systems: K121849 |
| Access Kit Description | Unique access tip, valved closed<br>system to inject and withdraw<br>fluids. | Same as predicate: CareFusion Pleurx<br>Catheter Systems: K121849 |
| Materials of Construction | Silicone, Barium Sulfate,<br>Polyester, Polyisoprene,<br>Polypropylene, Colorant, ABS,<br>Ink, Adhesive | Same as predicate: CareFusion Pleurx<br>Catheter Systems: K121849 |
| | | |

### CONCLUSION OF DEVICE COMPARISON

The technological characteristics of the proposed devices are substantially equivalent to the predicate.

### 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:<br>Evaluation and Testing |
| Biocompatibility | AAMI/ANSI/ISO 10993-3: 2003 (R) 2009 Biological Evaluation of Medical Devices -<br>Part 3 Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity |
| Biocompatibility | AAMI/ANSI/ISO 10993-4: 2002 (R) 2009 Biological Evaluation of Medical Devices -<br>Part 4 Selection of Tests for Interaction with Blood |
| Biocompatibility | AAMI/ANSI/ISO 10993-5: 2009 Biological Evaluation of Medical Devices - Part 5<br>Tests for In Vitro Cytotoxicity |
| Biocompatibility | AAMI/ANSI/ISO 10993-6: 2007 (R) 2010 Biological Evaluation of Medical Devices -<br>Part 6 Tests for Local Effects After Implantation |
| Residuals | AAMI/ANSI/ISO 10993-7:2008 Biological evaluation of Medical Devices Part 7:<br>Ethylene Oxide Sterilization Residuals |
| Biocompatibility | AAMI/ANSI/ISO 10993-10: 2010 Biological Evaluation of Medical Devices - Part 10<br>Tests for Irritation and Skin Sensitivity |
| Biocompatibility | AAMI/ANSI/ISO 10993-11: 2006 Biological Evaluation of Medical Devices - Part 11<br>Tests for Systemic Toxicity |
| Biocompatibility | USP <661> Containers - Plastics, Physiochemical Tests |
| 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<br>Common Properties |
| Performance | ISO 11070 Sterile, Single-use Intravascular Catheters |

{5}------------------------------------------------

| Performance | ANSI/AAMI/ISO 11607-1,2:2006 Packaging for Terminally Sterilized Medical Devices |
|--------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|
| Performance | ASTM F1980-07 Accelerated Aging of Sterile Barrier Systems |
| 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<br>1 & 2 |
| Performance | ISO 11135:2007 Medical Device, Validation and Routine Control of Ethylene Oxide<br>Sterilization |
| Performance | AAMI TIR28:2009 Product Adoption and Process Equivalency for Ethylene Oxide<br>Sterilization |
| SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL<br>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 device.