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

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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Pleurx Pleural Catheter System. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a study where the device performance is measured against specific acceptance criteria in a clinical setting.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details cannot be fully extracted from this document. The submission relies on non-clinical (bench) testing to support its claims of substantial equivalence for a labeling update.

Here's what can be inferred and what cannot:

1. Table of acceptance criteria and the reported device performance:

This 510(k) submission updates previously cleared device labeling to include the use of sclerosing agents (Talc and Bleomycin) with the Pleurx Pleural Catheter System. The acceptance criteria for this specific submission relate to the validation of this change through biocompatibility and bench testing. The "performance data" section lists standards and tests conducted, implying that the device "passed" or met the requirements of these standards. However, no specific quantitative acceptance criteria or corresponding reported device performance values are provided for the device's clinical function in this document.

For example, for Biocompatibility, the acceptance criterion would be "meets ISO 10993-1, -3, -4, -5, -6, -10, -11 requirements" and the reported device performance is "passed" or "met." The specific metrics and thresholds for each test are not detailed in this summary.

Characteristic	Acceptance Criteria (Implied)	Reported Device Performance (Implied)
Biocompatibility	Meets requirements of listed ISO 10993 standards	Passed
Residuals	Meets requirements of AAMI/ANSI/ISO 10993-7	Passed
Performance (e.g., sterilization, packaging)	Meets requirements of listed EN, ISO, ASTM, AAMI standards	Passed

2. Sample size used for the test set and the data provenance:

Test set sample size: Not specified. The document refers to "non-clinical tests," which likely involve a number of samples for each bench test conducted according to the standards.
Data provenance: Non-clinical (bench) testing data. The country of origin is not specified, but the standards cited are international (ISO, EN, ASTM, AAMI).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. Given this is a non-clinical (bench) testing submission, expert opinion for establishing a "ground truth" in the clinical sense is not relevant. The "ground truth" for these tests would be the established pass/fail criteria within the cited international standards by which the device was evaluated.

4. Adjudication method for the test set:

Not applicable. This type of adjudication is typically for clinical studies where subjective assessments might be involved. For bench testing, the results are typically objective measurements against a standard.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is not an AI/software device and no MRMC study was conducted. The document explicitly states: "N/A – No clinical tests were conducted for this submission."

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

Not applicable. This is not an AI/software device.

7. The type of ground truth used:

For the non-clinical tests, the "ground truth" is defined by the specific test method and acceptance criteria outlined in the cited international standards (e.g., ISO 10993 for biocompatibility, ISO 11135 for ethylene oxide sterilization).

8. The sample size for the training set:

Not applicable. This is not an AI/software device, so there is no training set in that context.

9. How the ground truth for the training set was established:

Not applicable, for the same reason as above.

Summary

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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

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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

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Indications for Use

510(k) Number (if known) K141965

Device Name Pleurx Pleural Catheter System

Indications for Use (Describe)

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)
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X Prescription Use (Part 21 CFR 801 Subpart D)

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

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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	(847) 362-8103
Fax number	(312) 949-0583
Establishment RegistrationNumber	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) towhich equivalence is claimed	CareFusion Pleurx Catheter System: K121849
Reason for 510(k) submission	Updates to labeling to include the use of sclerosing agents Talc andBleomycin with the Pleurx Pleural Catheter System.
Device description	The Pleurx Pleural Catheter 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, including malignantpleural effusion and other recurrent effusions that do not respond tomedical management of the underlying disease. The devices are indicatedfor 1) the palliation of dyspnea due to pleural effusion and 2) providingpleurodesis (resolution of the pleural effusion).
Intended use of the device	The Pleurx Drainage Kits and Drainage Line Set are indicated for use onlywith the Pleurx Catheter for intermittent drainage. The Drainage Line Kit isused to drain fluid using standard wall suction, water seal drainagesystem, vacuum bottle or other appropriate method.
Intended use of the device	The Pleurx Catheter Access Kit is intended to provide access to the PleurxCatheter 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.

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

Characteristic	New Device	Predicate
Catheter Description	Internal: fenestrations,radiopaque markings & cuffExternal: valve	Same as predicate: CareFusion PleurxCatheter Systems: K121849
Method	Percutaneously tunneled -indwelling	Same as predicate: CareFusion PleurxCatheter Systems: K121849
Access Kit Description	Unique access tip, valved closedsystem to inject and withdrawfluids.	Same as predicate: CareFusion PleurxCatheter Systems: K121849
Materials of Construction	Silicone, Barium Sulfate,Polyester, Polyisoprene,Polypropylene, Colorant, ABS,Ink, Adhesive	Same as predicate: CareFusion PleurxCatheter 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: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

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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 Pleural Catheter System is as safe, as effective, and performs as well as the legally marketed predicate device.

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).