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.
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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 (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" (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,
## 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: 847.473.7790
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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:
OCT 24 2012.
.
## 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 | (847) 473-7404 | | |
| Fax number | (847) 473-7790 | | |
| 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.
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.
