K160437 · Care Fusion · PNG · Nov 3, 2016 · Gastroenterology, Urology
Device Facts
Record ID
K160437
Device Name
PleurX Peritoneal Catheter System
Applicant
Care Fusion
Product Code
PNG · Gastroenterology, Urology
Decision Date
Nov 3, 2016
Decision
SEKD
Submission Type
Traditional
Regulation
21 CFR 876.5630
Device Class
Class 2
Attributes
Therapeutic
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.
Device Story
PleurX Peritoneal Catheter System provides home-based drainage of malignant ascites; system includes indwelling percutaneously tunneled catheter with internal fenestrations, radiopaque markings, and cuff; external access valve allows fluid withdrawal via vacuum bottle, wall suction, or water seal drainage. Device enables patients to manage symptoms independently at home, reducing clinical visits. Healthcare providers perform initial placement; patients or caregivers manage routine drainage. System facilitates palliation of ascites-related symptoms, improving patient quality of life.
Clinical Evidence
No clinical data. Substantial equivalence supported by bench-level performance testing including cuff adherence, tensile strength, leakage, flow rate, tissue ingrowth, biocompatibility (ISO 10993 series), sterilization validation (ISO 11135), and MRI safety (ASTM F2052, F2119, F2182, F2213).
Indicated for patients with symptomatic, recurrent, malignant ascites unresponsive to medical management; used for intermittent, long-term 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.
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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.
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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.
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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)
| | <span> <span style="font-size:16px">❌</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|--|-------------------------------------------------------------------------------------------------------------------------------|
| | <span> <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
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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<br>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<br>which equivalence is claimed | CareFusion PleurX Catheter System: K122422, and<br>Bard Aspira Peritoneal Drainage System: K110396 |
| Reason for 510(k) submission | This 510(k) submission is for a change in material formulation and<br>concentration, and minor design modifications to the devices cleared<br>under K122422. |
| Device description | The PleurX Peritoneal Catheter System provides patients with a<br>convenient method to relieve malignant ascites symptoms at home. The<br>primary components of the PleurX Catheter System are the PleurX<br>Peritoneal Catheter and the PleurX Drainage Kits. |
| Intended use of the device | The PleurX Peritoneal Catheter System is indicated for intermittent, long<br>term drainage of symptomatic, recurrent, malignant ascites that does not<br>respond to medical management of the underlying disease, and for the<br>palliation of symptoms related to recurrent malignant ascites.<br>The PleurX Lockable Drainage Line is used to drain fluid using standard<br>wall suction, water seal drainage system, vacuum bottle or other<br>appropriate method.<br>The PleurX Access Valve attaches only to the PleurX Catheter. The<br>PleurX Valve Kit is intended to repair the PleurX Catheter and replace the<br>PleurX Valve.<br>The PleurX LP Catheter Mini Kit is indicated for intermittent, long term<br>drainage of symptomatic, recurrent, malignant ascites that does not<br>respond to medical management of the underlying disease, and for the<br>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,<br>radiopaque markings & cuff<br>External: valve | Same as predicate: CareFusion PleurX<br>Catheter Systems: K122422 |
| Method | Percutaneously tunneled -<br>indwelling | Same as predicate: CareFusion PleurX<br>Catheter Systems: K122422 |
| Access Valve Description | Unique access tip, valved closed<br>system to inject and withdraw<br>fluids. | Same as predicate: Bard Aspira Drainage<br>System: K110396 |
| Materials of Construction | Silicone, Barium Sulfate,<br>Polyester, Polyisoprene,<br>Polypropylene, Colorant, ABS,<br>Ink, Adhesive | Same as predicate: CareFusion PleurX<br>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. |
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| | Process for Medical Devices |
|--------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance | ISO 11138-1 2nd Ed: Sterilization of Health Care Products - Biological Indicators -<br>Part 1: General Requirements |
| Performance | ISO 11737-1 2nd Ed: Sterilization of Medical Devices – Microbiological Methods<br>Part 1 |
| Performance | AAMI TIR28:2009(R) 2013: Product Adoption and Process Equivalency for Ethylene<br>Oxide Sterilization |
| Performance | AAMI / ANSI / ISO 11607-1:2006/(R)2010: Packaging For Terminally Sterilized<br>Medical Devices - Part 1:Requirements For Materials, Sterile Barrier Systems And<br>Packaging Systems [Including: Amendment 1 (2014)] |
| Performance | AAMI/ANSI/ISO 11607-2:2006/(R)2010: Packaging For Terminally Sterilized Medical<br>Devices - Part 2: Validation Requirements For Forming, Sealing And Assembly<br>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<br>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<br>Passive Implants During MRI |
| Performance | ASTM F2213: Measurement of Magnetically Induced Torque on Medical Devices in<br>the Magnetic Resonance Environment |
| 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 | |
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.
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
