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.

The Pleurx Catheter Access Kit is intended to provide access to the Pleurx Catheter for aspiration and catheter maintenance.

The Pleurx Catheter Insertion Stylet is intended to aid in the percutaneous insertion of the Pleurx Catheter into the pleural space.

The Valved Peelable Introducers are intended for use in the percutaneous insertion of a catheter into the pleural space.

Device Description

The Pleurx Pleural Cather 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.

AI/ML Overview

The provided document describes the 510(k) submission for the CareFusion Pleurx Pleural Catheter System. This submission focuses on expanding the indications for use and adding accessories to an existing legally marketed device. Therefore, the information provided primarily concerns non-clinical testing for substantial equivalence, rather than a clinical study evaluating the device's performance against specific acceptance criteria for efficacy or accuracy in the way an AI/ML device would be assessed.

Here's a breakdown of the requested information based on the provided text, with notes where the information is not applicable (N/A) due to the nature of the device and submission:

1. Table of Acceptance Criteria and Reported Device Performance

For this device, the "acceptance criteria" are compliance with various recognized standards for medical device safety and performance, and the "reported device performance" is the conclusion that the device meets or exceeds these standards, demonstrating substantial equivalence to predicate devices. There are no specific quantitative clinical performance metrics (like sensitivity, specificity, or accuracy) reported that would be typical for an AI/ML device.

Characteristic	Acceptance Criteria (Standard/Test/FDA Guidance)	Reported Device Performance
Biocompatibility	AAMI/ANSI/ISO 10993-1:2009 Biological evaluation of Medical Devices Part 1: Evaluation and Testing	Met requirements
Biocompatibility	AAMI/ANSI/ISO 10993-3: 2003 (R) 2009 Biological Evaluation of Medical Devices - Part 3 Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity	Met requirements
Biocompatibility	AAMI/ANSI/ISO 10993-4: 2002 (R) 2009 Biological Evaluation of Medical Devices - Part 4 Selection of Tests for Interaction with Blood	Met requirements
Biocompatibility	AAMI/ANSI/ISO 10993-5: 2009 Biological Evaluation of Medical Devices - Part 5 Tests for In Vitro Cytotoxicity	Met requirements
Biocompatibility	AAMI/ANSI/ISO 10993-6: 2007 (R) 2010 Biological Evaluation of Medical Devices - Part 6 Tests for Local Effects After Implantation	Met requirements
Residuals	AAMI/ANSI/ISO 10993-7:2008 Biological evaluation of Medical Devices Part 7: Ethylene Oxide Sterilization Residuals	Met requirements
Biocompatibility	AAMI/ANSI/ISO 10993-10: 2010 Biological Evaluation of Medical Devices - Part 10 Tests for Irritation and Skin Sensitivity	Met requirements
Biocompatibility	AAMI/ANSI/ISO 10993-11: 2006 Biological Evaluation of Medical Devices - Part 11 Tests for Systemic Toxicity	Met requirements
Biocompatibility	USP <661> Containers - Plastics, Physiochemical Tests	Met requirements
Performance	EN 1617:1997 Sterile Drainage Catheters and Accessory Devices for Single Use	Met requirements
Performance	EN 1618:1997 Catheters Other Than Intravascular Catheters - Test Methods for Common Properties	Met requirements
Performance	ISO 11070 Sterile, Single-use Intravascular Catheters	Met requirements
Performance	ANSI/AAMI/ISO 11607-1,2:2006 Packaging for Terminally Sterilized Medical Devices	Met requirements
Performance	ASTM F1980-07 Accelerated Aging of Sterile Barrier Systems	Met requirements
Performance	ISO 11138-1,2:2006 Sterilization of healthcare products - Biological Indicators	Met requirements
Performance	ISO 11737-1,2:2006 Sterilization of Medical Devices - Microbiological Methods Part 1 & 2	Met requirements
Performance	ISO 11135:2007 Medical Device, Validation and Routine Control of Ethylene Oxide Sterilization	Met requirements
Performance	AAMI TIR28:2009 Product Adoption and Process Equivalency for Ethylene Oxide Sterilization	Met requirements
Overall Conclusion	All performance requirements based on recognized standards for safety and effectiveness	The results of the non-clinical tests show that the CareFusion Pleurx Pleural Catheter System meets or exceed all performance requirements, and are substantially equivalent to the predicate devices.

2. Sample Size Used for the Test Set and the Data Provenance

This information is N/A. The document states, "N/A - No clinical tests were conducted for this submission." The testing described is non-clinical (biocompatibility, performance characteristics like sterilization, packaging integrity, etc.) and refers to compliance with standards rather than a test set of patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is N/A as no clinical test set requiring expert ground truth was conducted.

4. Adjudication Method for the Test Set

This information is N/A as no clinical test set requiring adjudication was conducted.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance.

This information is N/A. This is not an AI/ML device, and no MRMC study was conducted.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done.

This information is N/A. This is not an AI/ML device.

7. The Type of Ground Truth Used

This information is N/A as no clinical ground truth was established for this submission. The "ground truth" for this submission is adherence to recognized non-clinical performance standards and substantial equivalence to legally marketed predicate devices.

8. The Sample Size for the Training Set

This information is N/A. This is not an AI/ML device, and therefore no training set was used.

9. How the Ground Truth for the Training Set Was Established

This information is N/A. This is not an AI/ML device, and therefore no training set or its associated ground truth was established.

Summary of the Study Proving Acceptance Criteria:

The study proving the device meets its "acceptance criteria" is a series of non-clinical bench tests and evaluations demonstrating compliance with a comprehensive list of national and international standards related to biocompatibility, sterilization, packaging, and general catheter performance. The submission concludes that these non-clinical tests collectively show the CareFusion Pleurx Pleural Catheter System meets or exceeds all performance requirements and is substantially equivalent to existing predicate devices. No clinical studies were conducted for this specific 510(k) submission, as it focused on expanding indications and adding accessories to an already legally marketed device by demonstrating equivalence to previously cleared devices and adherence to established non-clinical performance and safety standards.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for CareFusion. The logo consists of a circular icon on the left and the word "CareFusion" on the right. The icon appears to contain a stylized image of two hands forming a heart shape.

OCT
18
2012

ı ••

ー

510(k) SUMMARY K121849

A summary of 510(k) safety and effectiveness information in accordance with 21 CFR 807.92.

SUBMITTER INFORMATION
Name	CareFusion
Address	1500 Waukegan Road MPWM, McGaw Park, IL 60085 USA
Phone number	(847) 473-7404
Fax number	(847) 473-7790
Establishment RegistrationNumber	1423507
Name of contact person	Joy Greidanus
Date prepared	October 17, 2012
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) towhich equivalence is claimed	CareFusion Pleurx Catheter Systems: K112831 & K113854Bard Aspira Pleural Drainage System: K110409Martech (MEDCOMP) Valved Tearaway Introducer: K090394Greatbatch (MedAmicus) Incorporated FlowGuard Peelable Introducer:K040150
Reason for 510(k) submission	Expanding the indications for use and adding accessories.
Device description	The Pleurx Pleural Cather System provides patients with a convenientmethod to relieve pleural effusion symptoms at home. The primarycomponents of the Pleurx Catheter System are the Pleurx PleuralCatheter and the Pleurx Drainage Kits.
Intended use of the device	The Pleurx Pleural Catheter Kits are indicated for intermittent, long termdrainage of symptomatic, recurrent, pleural effusion, includingmalignant pleural effusion and other recurrent effusions that do notrespond to medical management of the underlying disease. Thedevices are indicated for 1) the palliation of dyspnea due to pleuraleffusion and 2) providing pleurodesis (resolution of the pleural effusion).The Pleurx Drainage Kits and Drainage Line Set are indicated for useonly with the Pleurx Catheter for intermittent drainage. The DrainageLine Kit is used to drain fluid using standard wall suction, water sealdrainage system, vacuum bottle or other appropriate method.The Pleurx Dressing Kits are indicated for dressing of a catheter andexit site.The Pleurx Catheter Access Kit is intended to provide access to thePleurx Catheter for aspiration and catheter maintenance.The Pleurx Catheter Insertion Stylet is intended to aid in thepercutaneous insertion of the Pleurx Catheter into the pleural space.The Valved Peelable Introducers are intended for use in thepercutaneous insertion of a catheter into the pleural space.
SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPAREDTO THE PREDICATE DEVICE
Characteristic	New Device	Predicates:CareFusion Pleurx Catheter System:K112831 & K113854Bard Aspira Pleural Catheter SystemK110409Martech (MEDCOMP) Valved TearawayIntroducer: K090394Greatbatch (MedAmicus) IncorporatedFlowGuard Peelable Introducer:K040150
Catheter Description	Internal: fenestrations,radiopaque markings & cuffExternal: valve	Same
Method	Percutaneously tunneled -indwelling	Same
Valved Peelable Introducersdescription	Peelable sheath, dilator,hub, valve	Same
Access Kit Description	Provides access for sampleaspirations and cathetermaintenance	Same
Insertion Stylet	Reduces fluid loss, providesstiffening	Same

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CareFusion – October 2012 - Traditional 510(k): Pleurx Pleural Catheter System

| CareFusion

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Fusion

PERFORMANCE DATA
SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OFSUBSTANTIAL 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 10993-3: 2003 (R) 2009 Biological Evaluation of Medical Devices -Part 3 Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity
Biocompatibility	AAMI/ANSI/ISO 10993-4: 2002 (R) 2009 Biological Evaluation of Medical Devices -Part 4 Selection of Tests for Interaction with Blood
Biocompatibility	AAMI/ANSI/ISO 10993-5: 2009 Biological Evaluation of Medical Devices - Part 5Tests 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 10Tests for Irritation and Skin Sensitivity
Biocompatibility	AAMI/ANSI/ISO 10993-11: 2006 Biological Evaluation of Medical Devices - Part 11Tests 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 forCommon Properties
Performance	ISO 11070 Sterile, Single-use Intravascular Catheters
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 Part1 & 2
Performance	ISO 11135:2007 Medical Device, Validation and Routine Control of Ethylene OxideSterilization
Performance	AAMI TIR28:2009 Product Adoption and Process Equivalency for Ethylene OxideSterilization
SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIALEQUIVALENCE 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 Pleurx Pleural Catheter System meets orexceed all performance requirements, and are substantially equivalent to the predicate devices.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized, curved lines. The overall design is simple and conveys a sense of national identity and the department's mission.

Public Health Service

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

OCT 1 8 2012

CareFusion Ms. Joy Greidanus Regulatory Affairs Manager 1500 Waukegan Road McGaw Park, Illinois 60085

Re: K121849

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: September 27, 2012 Received: September 28, 2012

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.

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Page 2- Ms. Greidanus

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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Nh for

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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CareFusion - June 2012 - Traditional 510(k): Pleurx Pleural Catheter System

Image /page/5/Picture/1 description: The image contains the logo for CareFusion. The logo consists of a circular graphic to the left of the company name. The graphic appears to be a stylized, abstract design within a circle, possibly representing interconnectedness or a symbol related to healthcare. The text "CareFusion" is written in a bold, sans-serif font, with the letters closely spaced together.

500 Waukegan Road Gaw Park Illinois 60085-6787 X: 847 473.7790

510(k) Number (if known):

K121849

Device Name:

Pleurx Pleural Catheter System

Indications For Use:

The Pleurx Dressing Kits are indicated for dressing of a catheter and exit site:

The Pleurx Catheter Access Kit is intended to provide access to the Pleurx Catheter for aspiration and catheter maintenance.

The Pleurx Catheter Insertion Stylet is intended to aid in the percutaneous insertion of the Pleurx Catheter into the pleural space.

The Valved Peelable Introducers are intended for use in the percutaneous insertion of a catheter into the pleural space.

Prescription Use______ (Per 21 CFR 801 Subpart D) And/Or Over-The Counter Use____________ (Per 21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE)

Concurrence of CDRH, Office of Device Evaluation (ODE)

y Shultr

eslology, General Hospital

510(k) Number: K121549

Regulation Number and Section

§ 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).