(260 days)
Not Found
No
The document describes a mechanical drainage system and does not mention any computational or analytical capabilities that would suggest the use of AI/ML.
Yes.
The device is used for the "palliation of symptoms related to recurrent malignant ascites," which directly addresses the symptomatic relief of a medical condition.
No
The device is described as a system for drainage and palliation of symptoms related to malignant ascites, not for diagnosing a condition.
No
The device description clearly outlines physical components like a catheter and drainage kits, and the performance studies focus on bench-level testing of these physical attributes (cuff adherence, tensile strength, leakage, etc.). There is no mention of software as a primary or standalone component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the drainage of symptomatic, recurrent, malignant ascites and the palliation of symptoms. This is a therapeutic and palliative intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a catheter system designed to drain fluid from the peritoneal cavity. This is a physical device used for fluid removal, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, or the drained ascites fluid itself) to provide diagnostic information. The focus is on the physical removal of fluid to alleviate symptoms.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.
N/A
Intended Use / Indications for 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, and for the palliation of symptoms related to recurrent malignant ascites.
The PleurX Lockable Drainage Line is used to drain fluid using standard wall suction, water seal drainage system, vacuum bottle or other appropriate method.
The PleurX Access Valve attaches only to the PleurX Catheter. The PleurX Valve Kit is intended to repair the PleurX Catheter and replace the PleurX Valve.
The PleurX LP Catheter Mini Kit is indicated for intermittent, long term drainage of symptomatic, recurrent, malignant ascites that does not respond to medical management of the underlying disease, and for the palliation of symptoms related to recurrent malignant ascites.
Product codes
PNG
Device Description
The PleurX Peritoneal Catheter System provides patients with a convenient method to relieve malignant ascites symptoms at home. The primary components of the PleurX Catheter System are the PleurX Peritoneal Catheter and the PleurX Drainage Kits.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 cuff adherence, tensile strength, leakage, imaging, flow rate, tissue ingrowth, biocompatibility, sterilization and EO residuals. No clinical tests were conducted for this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.5630 Peritoneal dialysis system and accessories.
(a)
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.
(b)
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.
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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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three lines representing its wings.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 3, 2016
CareFusion Tamara Brey Regulatory Affairs Advisor 75 North Fairway Drive Vernon Hills, IL 60061
Re: K160437
Trade/Device Name: PleurX Peritoneal Catheter System Regulation Number: 21 CFR 876.5630 Regulation Name: Peritoneal dialysis system and accessories Regulatory Class: Class II Product Code: PNG Dated: October 3. 2016 Received: October 4, 2016
Dear Tamara Brey:
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. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. 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.
1
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.
In addition, we have determined that your device kit contains Lidocaine and ChloraPrep which are subject to regulation as drugs.
Our substantially equivalent determination does not apply to the drug components of your device. We recommend you first contact the Center for Drug Evaluation and Research before marketing your device with the drug components. For information on applicable Agency requirements for marketing these drugs, we suggest you contact:
Director, Division of Drug Labeling Compliance Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane Rockville, Maryland 20857 (301) 594-0101
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
2
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 yours,
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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Indications for Use
510(k) Number (if known) K160437
Device Name PleurX Peritoneal Catheter System
Indications for Use (Describe)
The Pleur X Peritoneal Catheter System is indicated for intermittent. Iong term drainage of symptomatic, recurrent, malignant ascites that does not respond to medical management of the underlying disease, and for the palliation of symptoms related to recurrent malignant ascites.
The Pleur X Lockable Drainage Line is used to drain fluid using standard wall suction, water seal drainage system, vacuum bottle or other appropriate method.
The Pleur X Access Valve attaches only to the PleurX Catheter. The PleurX Valve Kit is intended to repair the PleurX Catheter and replace the Pleur X Valve.
The Pleur X LP Catheter Mini Kit is intermittent, long term drainage of symptomatic, recurrent, malignant ascites that does not respond to medical management of the underlying disease, and for the palliation of symptoms related to recurrent malignant ascites.
Type of Use (Select one or both, as applicable)
| ❌ Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) SUMMARY - K160437
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) 362-9485 |
| Fax number | (312) 949-9245 |
| Establishment Registration | |
| Number | 1423507 |
| Name of contact person | Tamara Brey |
| Date prepared | February 15, 2016 |
| DESCRIPTION OF DEVICE | |
| Trade or proprietary name | PleurX Peritoneal Catheter System |
| Common or usual name | Peritoneal Catheter, peritoneal, long-term, indwelling |
| Classification name | Peritoneal dialysis system and accessories |
| Classification panel | Gastroenterology/Urology |
| Regulation | Class II per 21CFR §876.5630, Procode PNG |
| Product Code(s) | Multiple |
| Legally marketed device(s) to | |
| which equivalence is claimed | CareFusion PleurX Catheter System: K122422, and |
| Bard Aspira Peritoneal Drainage System: K110396 | |
| Reason for 510(k) submission | This 510(k) submission is for a change in material formulation and |
| concentration, and minor design modifications to the devices cleared | |
| under K122422. | |
| Device description | The PleurX Peritoneal Catheter System provides patients with a |
| convenient method to relieve malignant ascites symptoms at home. The | |
| primary components of the PleurX Catheter System are the PleurX | |
| Peritoneal Catheter and the PleurX Drainage Kits. | |
| Intended use of the device | 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, and for the | |
| palliation of symptoms related to recurrent malignant ascites. | |
| The PleurX Lockable Drainage Line is used to drain fluid using standard | |
| wall suction, water seal drainage system, vacuum bottle or other | |
| appropriate method. | |
| The PleurX Access Valve attaches only to the PleurX Catheter. The | |
| PleurX Valve Kit is intended to repair the PleurX Catheter and replace the | |
| PleurX Valve. | |
| The PleurX LP Catheter Mini Kit is indicated for intermittent, long term | |
| drainage of symptomatic, recurrent, malignant ascites that does not | |
| respond to medical management of the underlying disease, and for the | |
| palliation of symptoms related to recurrent malignant ascites. |
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palliation of symptoms related to recurrent malignant ascites.
SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE
| Characteristic | New Device | Predicate |
|---|---|---|
| Catheter Description | Internal: fenestrations, | |
| radiopaque markings & cuff | ||
| External: valve | Same as predicate: CareFusion PleurX | |
| Catheter Systems: K122422 | ||
| Method | Percutaneously tunneled - | |
| indwelling | Same as predicate: CareFusion PleurX | |
| Catheter Systems: K122422 | ||
| Access Valve Description | Unique access tip, valved closed | |
| system to inject and withdraw | ||
| fluids. | Same as predicate: Bard Aspira Drainage | |
| System: K110396 | ||
| Materials of Construction | Silicone, Barium Sulfate, | |
| Polyester, Polyisoprene, | ||
| Polypropylene, Colorant, ABS, | ||
| Ink, Adhesive | Same as predicate: CareFusion PleurX | |
| Catheter Systems: K122422 |
CONCLUSION OF DEVICE COMPARISON
The technological characteristics of the proposed devices are substantially equivalent to the predicates.
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 cuff adherence, tensile strength, leakage, imaging, flow rate, tissue ingrowth, biocompatibility, sterilization and EO residuals.
| Performance Test Summary | |
|---|---|
| Performance | BS EN 1617: 1997, Sterile Drainage Catheters and Accessory Devices for Single Use |
| Performance | BS EN 1618: 1997, Catheters other than Intravascular Catheters - Test Methods for Common Properties |
| Biocompatibility | ISO 10993-1: Part 1, Biological Evaluation of Medical Devices : Evaluation and Testing within a Risk Management Process. |
| Biocompatibility | AAMI / ANSI / ISO 10993-5:2009/(R) 2014: Part 5, Biological Evaluation of Medical Devices -- Tests For In Vitro Cytotoxicity |
| Biocompatibility | ISO 10993-06 Second Edition 2007-04-15: Part 6 Biological Evaluation Of Medical Devices - Tests For Local Effects After Implantation. |
| Residuals | ISO 10993-7 Second Edition 2008-10-15: Part 7, Biological Evaluation Of Medical Devices - Ethylene Oxide Sterilization Residuals [Including: Technical Corrigendum 1 (2009)] |
| Biocompatibility | ISO 10993-10 Third Edition 2010-08-01: Part 10, Biological Evaluation Of Medical Devices - Tests For Irritation And Skin Sensitization. |
| Biocompatibility | ISO 10993-17:2002: Part 17, Biological evaluation of medical devices - Establishment of allowable limits for leachable substances |
| Biocompatibility | ISO 10993-18:2005: Part 18, Biological evaluation of medical devices - Chemical characterization of materials |
| Performance | ISO 11135 2nd Ed: Sterilization of Health-Care Products -Ethylene Oxide - Requirements for the Development Validation and Routine Control of a Sterilization. |
6
| Process for Medical Devices | |
|---|---|
| Performance | ISO 11138-1 2nd Ed: Sterilization of Health Care Products - Biological Indicators - |
| Part 1: General Requirements | |
| Performance | ISO 11737-1 2nd Ed: Sterilization of Medical Devices – Microbiological Methods |
| Part 1 | |
| Performance | AAMI TIR28:2009(R) 2013: Product Adoption and Process Equivalency for Ethylene |
| Oxide Sterilization | |
| Performance | AAMI / ANSI / ISO 11607-1:2006/(R)2010: Packaging For Terminally Sterilized |
| Medical Devices - Part 1:Requirements For Materials, Sterile Barrier Systems And | |
| Packaging Systems [Including: Amendment 1 (2014)] | |
| Performance | AAMI/ANSI/ISO 11607-2:2006/(R)2010: Packaging For Terminally Sterilized Medical |
| Devices - Part 2: Validation Requirements For Forming, Sealing And Assembly | |
| Processes [Including: Amendment 1 (2014)] | |
| Performance | ASTM F1980-07: Accelerated Aging of Sterile Barrier Systems |
| Performance | ISO 14630: Non-active Surgical Implants - General Requirements |
| Performance | ASTM F2052: Measurement of Magnetically Induced Displacement Force on |
| Medical Devices in the MR Environment | |
| Performance | ASTM F2119: Evaluation of MR Image Artifacts from Passive Implants |
| Performance | ASTM F2182: A Measurement of Radiofrequency Induced Heating on or Near |
| Passive Implants During MRI | |
| Performance | ASTM F2213: Measurement of Magnetically Induced Torque on Medical Devices in |
| the Magnetic Resonance Environment | |
| SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL | |
| 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 PleurX Peritoneal Catheter System is as safe, as effective, and performs as well as the legally marketed predicate devices.