PLEURX PLEURAL CATHETER SYSTEM PLEURX CATHETER ACCESS KIT PLEURX SLIDE VALVED PEELABLE INTRODUCER

K122422 · Care Fusion · PNG · Oct 24, 2012 · Gastroenterology, Urology

Device Facts

• Record ID: K122422
• Device Name: PLEURX PLEURAL CATHETER SYSTEM PLEURX CATHETER ACCESS KIT PLEURX SLIDE VALVED PEELABLE INTRODUCER
• Applicant: Care Fusion
• Product Code: PNG · Gastroenterology, Urology
• Decision Date: Oct 24, 2012
• Decision: SESK
• Submission Type: Traditional
• Regulation: 21 CFR 876.5630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Pleurx Peritoneal Catheter System is indicated for intermittent, long term drainage of symptomatic, recurrent, malignant ascites that does not respond to medical management of the underlying disease, for the palliation of symptoms related to recurrent malignant ascites and for peritoneal placement only. The Pleurx Drainage Bottle Kits and Drainage Line Set are indicated for use either with the Pleurx Peritoneal Catheter or Pleurx Pleural 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 Drainage Bag Kit is indicated for use only with the Pleurx Peritoneal Catheter for intermittent drainage. 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 peritoneal space. The Valved Peelable Introducers are intended for use in the percutaneous insertion of a catheter into the peritoneal space.

Device Story

Pleurx Peritoneal Catheter System provides home-based drainage for malignant ascites. System includes indwelling tunneled catheter with valve, fenestrations, and cuff; drainage kits (bottles, bags, lines); insertion stylet; and valved peelable introducers. Catheter placed percutaneously into peritoneal space. Patients or caregivers perform intermittent drainage using vacuum bottles, wall suction, or water seal systems. Device facilitates fluid removal to palliate symptoms. Access kit allows for aspiration and maintenance. System enables long-term management of recurrent fluid accumulation, reducing need for repeated clinical procedures.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing only, including biocompatibility, sterilization residuals, and mechanical performance testing.

Technological Characteristics

Indwelling tunneled catheter with valve, fenestrations, radiopaque markings, and cuff. Materials evaluated per ISO 10993-1. Sterilization via ethylene oxide (ISO 11135, ISO 10993-7). Performance testing per EN 1617, EN 1618, ISO 11070, ASTM F1980. Packaging per ISO 11607.

Indications for Use

Indicated for patients with symptomatic, recurrent, malignant ascites unresponsive to medical management; intended for intermittent, long-term peritoneal drainage and symptom palliation.

Regulatory Classification

Identification

(1) A peritoneal dialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions, and that consists of a peritoneal access device, an administration set for peritoneal dialysis, a source of dialysate, and, in some cases, a water purification mechanism. After the dialysate is instilled into the patient's peritoneal cavity, it is allowed to dwell there so that undesirable substances from the patient's blood pass through the lining membrane of the peritoneal cavity into this dialysate. These substances are then removed when the dialysate is drained from the patient. The peritoneal dialysis system may regulate and monitor the dialysate temperature, volume, and delivery rate together with the time course of each cycle of filling, dwell time, and draining of the peritoneal cavity or manual controls may be used. This generic device includes the semiautomatic and the automatic peritoneal delivery system.(2) The peritoneal access device is a flexible tube that is implanted through the abdominal wall into the peritoneal cavity and that may have attached cuffs to provide anchoring and a skin seal. The device is either a single use peritioneal catheter, intended to remain in the peritoneal cavity for less than 30 days, or a long term peritoneal catheter. Accessories include stylets and trocars to aid in the insertion of the catheter and an obturator to maintain the patency of the surgical fistula in the abdominal wall between treatments. (3) The disposable administration set for peritoneal dialysis consists of tubing, an optional reservoir bag, and appropriate connectors. It may include a peritoneal dialysate filter to trap and remove contaminating particles. (4) The source of dialysate may be sterile prepackaged dialysate (for semiautomatic peritoneal dialysate delivery systems or “cycler systems”) or dialysate prepared from dialysate concentrate and sterile purified water (for automatic peritoneal dialysate delivery systems or “reverse osmosis” systems). Prepackaged dialysate intended for use with either of the peritoneal dialysate delivery systems is regulated by FDA as a drug.

Special Controls

*Classification.* Class II (special controls). The following accessories are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9: A catheter finger grip that is non-patient contacting and intended for single use with a peritoneal catheter; a continuous ambulatory peritoneal dialysis (CAPD) belt; and a catheter stand that does not include weigh scales.

Predicate Devices

• CareFusion Pleurx Catheter Systems (K113854)
• Bard Aspira Pleural Drainage System (K110396)
• Martech (MEDCOMP) Valved Tearaway Introducer (K090394)
• Greatbatch (MedAmicus) Incorporated FlowGuard Peelable Introducer (K040150)

Submission Summary (Full Text)

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Image /page/0/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" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or body.

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

July 18, 2017

CareFusion Joy Greidanus Regulatory Affairs Manager 1500 Waukegan Road McGaw Park, IL 60085

Re: K122422

> Trade/Device Name: Pleurx Peritoncal Catheter System Regulation Number: 21 CFR §876.5630 Regulation Name: Peritoneal dialysis system and accessories Regulatory Class: II Product Code: PNG Dated: August 8, 2012 Received: August 9, 2012

Dear Joy Greidanus:

This letter corrects our substantially equivalent letter of October 24, 2012.

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.

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Page 2 - Joy Greidanus

You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR 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/ResourcesforYou/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,

## Benjamin R. Fisher -S

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K12 2422

CareFusion - August 2012 - Traditional 510(k): Pleurx Peritoneal Catheter System

Image /page/2/Picture/2 description: The image shows the CareFusion logo. The logo consists of a stylized symbol on the left and the word "CareFusion" on the right. The symbol appears to be a shield with a figure inside, possibly representing protection or care. The text "CareFusion" is in a bold, sans-serif font, making it easily readable.

1500 Waukegan Road cGaw Park, Illinois 60085-6787 FAX: [phone]

510(k) Number (if known):

K122422
Unknown at this time

Unknown at this time

Device Name:

Pleurx Peritoneal Catheter System

Indications For Use:

The Pleux Peritoneal Catheter System is indicated for intermittent, long term drainage of symptomatic, recurrent, malignant ascites that does not respond to medical management of the underlying disease, for the palliation of symptoms related to recurrent malignant ascites and for peritoneal placement only.

The Pleurx Drainage Bottle Kits and Drainage Line Set are indicated for use either with the Pleurx Peritoneal Catheter or Pleural 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 Drainage Bag Kit is indicated for use only with the Pleurx Peritoneal Catheter for intermittent drainage.

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 peritoneal space.

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

Prescription Use_X_(Per 21 CFR 801 Subpart D) (Per 21 CFR 807 Subpart C) . And/Or Over-The Counter Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K122422

3

00112

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Image /page/3/Picture/0 description: The image shows the logo for CareFusion. The logo consists of a circular icon to the left of the company name. The icon contains a shield-like shape within the circle. The text "CareFusion" is written in a bold, sans-serif font.

:

OCT 24 2012.

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## 510(k) SUMMARY K122422

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 | [phone] | | |
| Fax number | [phone] | | |
| Establishment<br>Registration Number | 1423507 | | |
| Name of contact person | Joy Greidanus | | |
| Date prepared | October 10, 2012 | | |
| NAME OF DEVICE | | | |
| Trade or proprietary<br>name | Pleurx Peritoneal Catheter System | | |
| Common or usual name | Catheter, peritoneal, long-term, indwelling | | |
| Classification name | Peritoneal Dialysis Systems and Accessories | | |
| Classification panel | Gastroenterology/Urology | | |
| Regulation | Class II per 21CFR §876.5630. Procode PNG | | |
| Product Code(s) | Multiple | | |
| Legally marketed<br>device(s) to which<br>equivalence is claimed | CareFusion Pleurx Catheter Systems: K113854<br>Bard Aspira Pleural Drainage System: K110396<br>Martech (MEDCOMP) Valved Tearaway Introducer: K090394<br>Greatbatch (MedAmicus) Incorporated FlowGuard Peelable Introducer:<br>K040150 | | |
| Reason for 510(k)<br>submission | Expanding the indications for use and adding accessories. | | |
| Device description | The Pleurx Peritoneal Catheter System provides patients with a convenient<br>method to relieve malignant ascites symptoms at home. The primary<br>components of the Pleurx Catheter System are the Pleurx Periloneal Catheter<br>and the Pleurx Drainage Kits. | | |
| Intended use of the<br>device | The Pleurx Peritoneal Catheter System is indicated for intermittent, long term<br>drainage of symptomatic, recurrent, malignant ascites that does not respond to<br>medical management of the underlying disease, for the palliation of symptoms<br>related to recurrent malignant ascites and for peritoneal placement only.<br><br>The Pleurx Drainage Bottle Kits and Drainage Line Set are indicated for use<br>either with the Pleurx Peritoneal Catheter or Pleurx Pleural Catheter for<br>intermittent drainage. The Drainage Line Kit is used to drain fluid using<br>standard wall suction, water seal drainage system, vacuum bottle or other<br>appropriate method.<br><br>The Pleurx Drainage Bag Kit is indicated for use only with the Pleurx<br>Peritoneal Catheter for intermittent drainage.<br><br>The Pleurx Dressing Kits are indicated for dressing of a catheter and exit site.<br><br>The Pleurx Catheter Access Kit is intended to provide access to the Pleurx<br>Catheter for aspiration and catheter maintenance.<br><br>The Pleurx Catheter Insertion Stylet is intended to aid in the percutaneous<br>insertion of the Pleurx Catheter into the peritoneal space.<br><br>The Valved Peelable Introducers are intended for use in the percutaneous<br>insertion of a catheter into the peritoneal space. | | |
| SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED<br>TO THE PREDICATE DEVICE | | | |
| Characteristic | New Device | | Predicates:<br>CareFusion Pleurx Catheter System: K113854<br>Bard Aspira Pleural Catheter System K110396<br>Martech (MEDCOMP) Valved Tearaway<br>Introducer: K090394<br>Greatbatch (MedAmicus) Incorporated<br>FlowGuard Peelable Introducer: K040150 |
| Catheter<br>Description | Internal: fenestrations, radiopaque<br>markings & cuff<br>External: valve | | Same |
| Method | Percutaneously tunneled - indwelling | | Same |
| Means of<br>Drainage | Wall suction, water seal drainage<br>system, portable suction, vacuum<br>bottles or other appropriate method | | Same |
| Valved<br>Peelable<br>Introducers | Peelable sheath, dilator, hub, valve | | Same |
| Access Kit | Provides access for sample<br>aspirations and catheter maintenance | | Same |
| Insertion Stylet | Reduces fluid loss, provides stiffening | | Same |
| 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 | | |
| 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 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 | | | |

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Image /page/5/Picture/0 description: The image contains the logo for CareFusion. The logo consists of a circular emblem on the left and the word "CareFusion" on the right. The emblem appears to be a stylized representation of a shield or protective symbol. The text "CareFusion" is written in a bold, sans-serif font.

## PERFORMANCE DATA

## SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE

Bench-level testing was carried out on the Pleurx Catheter System to demonstrate substantial equivalence. The performance testing requirements were determined by the predicate devices and further defined by the standards listed below. The testing conducted includes tensile strength, leakage, bond strength, deformation, security of connections, biocompatibility, aging, sterilization and residuals.

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 Peritoneal Catheter System meets or exceed all performance requirements, and are substantially equivalent to the predicate devices.