PLEURX PLEURAL CATHETER SYSTEMS

K112831 · Care Fusion · DWM · Feb 16, 2012 · Cardiovascular

Device Facts

• Record ID: K112831
• Device Name: PLEURX PLEURAL CATHETER SYSTEMS
• Applicant: Care Fusion
• Product Code: DWM · Cardiovascular
• Decision Date: Feb 16, 2012
• 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 Dressing Kits are indicated for dressing of a catheter and exit site.

Device Story

Pleurx Pleural Catheter System provides home-based, intermittent drainage of symptomatic, recurrent pleural effusions. System consists of indwelling, percutaneously tunneled catheter with internal fenestrations, radiopaque markings, and cuff, plus external valve. Drainage performed via vacuum bottles, wall suction, or water seal systems. Used by patients or caregivers to relieve dyspnea and facilitate pleurodesis. Device enables long-term management of fluid accumulation without repeated thoracentesis, improving patient comfort and reducing clinical visits.

Clinical Evidence

No clinical tests were conducted for this submission; substantial equivalence is supported by non-clinical bench testing.

Technological Characteristics

Indwelling, percutaneously tunneled catheter with fenestrations, radiopaque markings, and cuff. Materials comply with ISO 10993-1 (biocompatibility) and ASTM F560-08 (tantalum). Performance testing per EN 1617 and EN 1618. Sterilization via ethylene oxide (ISO 11135). Connectivity: manual interface with vacuum bottles, wall suction, or water seal systems.

Indications for Use

Indicated for patients with symptomatic, recurrent pleural effusion (including malignant) unresponsive to medical management. Used for intermittent, long-term drainage to palliate dyspnea and 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 Kit (K051084)
• Denver Pleurx Drainage Kit/Vacuum Bottle (K052436)
• Bard Aspira Pleural Drainage System (K110409)

Submission Summary (Full Text)

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#### 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 | [phone] |
| Fax number | [phone] |
| Establishment<br>Registration Number | 1423507 |
| Name of contact person | Joy Greidanus |
| Date prepared | February 10, 2012 |
| NAME OF DEVICE | |
| Trade or proprietary<br>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<br>device(s) to which<br>equivalence is claimed | CareFusion Pleurx Catheter Kit and the Denver Pleurx Drainage Kit/Vacuum<br>Bottle : K051084 & K052436<br>Bard Aspira Pleural Drainage System: K110409 |
| Reason for 510(k)<br>submission | Change to materials, expanding the indications for use, and updates to the<br>instructions for use. |
| 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. |

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| Intended use of the device | The Pleurx Pleural Catheter Kits are indicated for<br>intermittent, long term drainage of symptomatic,<br>recurrent, pleural effusion, including malignant<br>pleural effusion and other recurrent effusions that do<br>not respond to medical management of the<br>underlying disease. The devices are indicated for<br>1) the palliation of dyspnea due to pleural effusion<br>and 2) providing pleurodesis (resolution of the<br>pleural effusion). |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The Pleurx Drainage Kits and Drainage Line Set are<br>indicated for use only with the Pleurx Catheter for<br>intermittent drainage. The Drainage Line Kit is used<br>to drain fluid using standard wall suction, water seal<br>drainage system, vacuum bottle or other appropriate<br>method. |
| | The Pleurx Dressing Kits are indicated for dressing<br>of a catheter and exit site. |

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

| Characteristic | New Device | Predicates:<br>CareFusion Pleurx Pleural Catheter<br>System (K051084, K052436)<br>Bard Aspira Pleural Catheter System<br>(K110409) |
|----------------------|--------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| Catheter Description | Internal: fenestrations, radiopaque<br>markings & cuff<br>External: valve | Same |
| Method | Percutaneously tunneled - indwelling | Same |
| Means of Drainage | Wall suction, water seal drainage<br>system, portable suction, vacuum<br>bottles or other appropriate method | Wall suction, water seal drainage system,<br>vacuum bottles, syringe, drainage bag or<br>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<br>Testing |
| Residuals | ISO 10993-7:2008 Biological evaluation of Medical Devices Part 7: Ethylene Oxide<br>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<br>Common Properties |

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| 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<br>1 & 2 |
| Performance | ISO 11135:2007 Medical Device, Validation and Routine Control of Ethylene Oxide<br>Sterilization |
| Specification | ASTM F560-08 (excluding part 7) Standard Specification for Unalloyed Tantalum for<br>Surgical Implants |
| 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 | |

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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.

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## 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 [phone] or [phone] 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 [phone]

## Indication for Use

Pleurx Pleural Catheter System

K112831

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