The ClearFlux™ Dialyzer Reprocessing System is indicated for the reprocessing of polysulfone-based high-flux dialyzers for reuse, for preprocessing the dialyzers prior to their assignment to patients for first use, and for tracking the reprocessed dialyzer for use only by the patient to whom the dialyzer was initially assigned. The steps used in reprocessing hemodialyzers with the ClearFlux™ System include: (1) pre-cleaning, (2) cleaning, (3) rinsing, (4) volume and leak testing, and (5) disinfecting the dialyzers in accordance with the "AAMI Recommended Practice for Reuse of Hemodialyzers." The ClearFlux™ System performs the patented in-situ two-phase cleaning cycle during reprocessing, which recovers the total cell volume and the clearance of small and middle molecules of the dialyzers to levels that are approximately equivalent to those of new dialyzers. The ClearFlux™ Dialyzer Reprocessing System is also indicated for performing record keeping of the dialyzer processing operation. The ClearFlux™ Dialyzer Reprocessing System is indicated to be used only with the ClearFlux Formula™ cleaning solution.
Device Story
ClearFlux™ Dialyzer Reprocessing System automates cleaning, disinfection, and performance testing of polysulfone-based high-flux dialyzers. System hardware includes ClearFlux™ Machine, oil-less air compressor with HEPA filter, bar code reader, and printers. Software (CRMS) tracks dialyzer assignments and reprocessing history. Process utilizes patented two-phase flow cleaning (hydropneumatic design combining high air pressure with ClearFlux Formula™ cleaning solution) to restore total cell volume (TCV) and molecular clearance to near-new levels. System performs pre-cleaning, cleaning, rinsing, volume/leak testing, and disinfection. Operated by technicians/administrators in clinical settings. Output includes processed dialyzers and digital/printed records for patient-dialyzer tracking. Benefits include safe dialyzer reuse, reduced waste, and maintained clinical performance equivalent to new devices.
Clinical Evidence
Bench testing only. No clinical data. In vitro studies confirmed recovery of TCV and small/middle molecule clearance to levels equivalent to new dialyzers. Testing included cytotoxicity, Scanning Electron Microscopy, X-Ray Photoelectron Spectroscopy, Size Exclusion Chromatography, Complement Activation, Albumin Loss, Hydraulic Permeability, and Pressure Leak tests.
Technological Characteristics
System uses hydropneumatic two-phase flow cleaning process. Components: ClearFlux™ Machine, oil-less air compressor with HEPA filter, bar code reader, label/report printers. Software: ClearFlux™ Records Management System (CRMS). Connectivity: Wireless hub between machine and system computer. Cleaning agents: Peracetic Acid Disinfectant, ClearFlux Formula™ cleaning solution, optional Formula 409 NF. Materials: Polysulfone-based high-flux dialyzers.
Indications for Use
Indicated for in vitro cleaning, disinfection, and performance recovery (TCV and small/middle molecule clearance) of reusable polysulfone-based high-flux dialyzers. Includes preprocessing prior to first use and tracking for patient-specific reuse. For prescription use only.
Regulatory Classification
Identification
A hemodialysis 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 an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.(1) The extracorporeal blood system and accessories consists of tubing, pumps, pressure monitors, air foam or bubble detectors, and alarms to keep blood moving safely from the blood access device and accessories for hemodialysis (§ 876.5540) to the blood compartment of the dialyzer and back to the patient. (2) The conventional dialyzer allows a transfer of water and solutes between the blood and the dialysate through the semipermeable membrane. The semipermeable membrane of the conventional dialyzer has a sufficiently low permeability to water that an ultrafiltration controller is not required to prevent excessive loss of water from the patient's blood. This conventional dialyzer does not include hemodialyzers with the disposable inserts (Kiil type) (§ 876.5830) or dialyzers of high permeability (§ 876.5860). (3) The dialysate delivery system consists of mechanisms that monitor and control the temperature, conductivity, flow rate, and pressure of the dialysate and circulates dialysate through the dialysate compartment of the dialyzer. The dialysate delivery system includes the dialysate concentrate for hemodialysis (liquid or powder) and alarms to indicate abnormal dialysate conditions. This dialysate delivery system does not include the sorbent regenerated dialysate delivery system for hemodialysis (§ 876.5600), the dialysate delivery system of the peritoneal dialysis system and accessories (§ 876.5630), or the controlled dialysate delivery system of the high permeability hemodialysis system § 876.5860). (4) Remote accessories to the hemodialysis system include the unpowered dialysis chair without a scale, the powered dialysis chair without a scale, the dialyzer holder set, dialysis tie gun and ties, and hemodialysis start/stop tray.
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K091360
Page 1 of 3
NOV - 3 2010
## 510(k) Summary Submitted in Accordance with 21 CFR 807.92
| 510(k) Submitted: | Novaflux Technologies<br>1 Wall Street<br>Princeton, New Jersey 08540 |
|------------------------|-----------------------------------------------------------------------|
| Telephone: | (609) 683-0215 |
| Fax: | (609) 683-5003 |
| Contact Person: | Mohamed E. Labib, Ph.D.<br>President and CEO |
| Date Summary Prepared: | April 26, 2010 |
| Trade Name: | ClearFlux™ Dialyzer Reprocessing System |
| Common Name: | Dialyzer Reprocessing System |
| Device Classification: | Dialyzer Reprocessing System, Product Code LIF |
Device Description: The ClearFlux™ Dialyzer Reprocessing System includes hardware and software designed to preprocess dialyzers before their first use by patients, to assign preprocessed dialyzers to patients, and to reprocess the dialyzer for reuse by the same patient to whom the dialyzer was originally assigned. The ClearFlux™ System employs the Novaflux patented two-phase flow cleaning process which is to be used only with the ClearFlux Formula™ (Cleaning Solution) in reprocessing reusable polysulfone-based high-flux dialyzers, and recovers the total cell volume (TCV) and the clearance of small and middle molecules of the dialyzers to levels that are approximately equivalent to those of new dialyzers.
Panel 78 - unclassified
The ClearFlux™ Dialyzer Reprocessing System consists of the following hardware and software components: the ClearFlux™ Machine(s), which performs the actual processing of the dialyzer; the ClearFlux™ Records Management System (CRMS), a patient-dialyzer tracking software loaded onto a System Computer to manage dialyzer reprocessing and reuse; a System Computer; a wireless hub for communication between the ClearFlux™ Machine(s) and the CRMS on the System Computer; a bar code reader to maintain identification of the dialyzers, the ClearFlux™ Machine(s), and the users of the System (e.g., technicians, administrators); a label printer to print the labels for the dialyzers, as well as to print the bar codes for the dialyzers. the users, and the ClearFlux™ Machine(s); a report printer; and an oil-less air compressor with a HEPA filter to provide the filtered airflow necessary for the operation of the ClearFlux™ Machine(s). The ClearFlux™ Dialyzer Reprocessing System (with one System Computer loaded with the CRMS
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software) can operate and track the dialyzer reprocessing operations of up to 12 ClearFlux™ Machines.
The chemicals used by the ClearFlux™ System include: Peracetic Acid Disinfectant used in the preprocessing and reprocessing of the dialyzers and in the daily and weekly disinfection of the fluid pathways of the ClearFlux™ Machine(s); the ClearFlux Formula™, a proprietary cleaning solution used exclusively in the ClearFlux™ Dialyzer Reprocessing System and in the weekly cleaning of the fluid pathways of the ClearFlux™ Machine(s); and optionally, Formula 409 NF for the weekly cleaning of the fluid pathways of the ClearFlux™ Machine(s).
Intended Use: The ClearFlux™ Dialyzer Reprocessing System is indicated for the in vitro cleaning and disinfection of reusable polysulfone-based high-flux dialyzers, the recovery of the total cell volume (TCV) of the dialyzers, and the recovery of the small and middle molecules clearance of the dialyzers after processing. The ClearFlux™ Dialyzer Reprocessing System preprocesses polysulfone-based high-flux dialyzers prior to their first use. The ClearFlux™ Dialyzer Reprocessing System is indicated to be used only with the ClearFlux Formula™ cleaning solution. The ClearFlux™ Dialyzer Reprocessing System tracks and maintains dialyzer reprocessing operations, as well as dialyzer assignments to patients, and dialyzer reprocessing and reuse.
Substantially Equivalent Devices:
- K860674, K914580, K931336, DRS-4® Dialyzer Reprocessing System, Seratronics, Inc.
Agents: Disinfectant - Peracetic Acid
Cleaning solutions - Bleach
Measures: TCV, Leak Rate (pressure decay), Ultrafiltration
- K904210, Renatron II® Dialyzer Reprocessing System, Minntech Corp.
- Agents: Peracetic Acid cleaning solution and disinfectant, Formula 409 NF machine cleaner
Measures: TCV, Leak Rate (negative pressure leak)
- K024076, Maky® 21.1 Dialyzer Reprocessing System, HDC Maquinolas, LLC Agents: "any acceptable cleaning agent" including bleach or peracetic
- acid; "any choice of acceptable germicides" including bleach, peracetic acid, formaldehyde and glutaraldehyde
Measures: TCV, Leak Rate (pressure decay)
Process: "The aggressive agitation process is a result of a hydropneumatic design that combines high air pressure with a cleaning agent, forcing particles out of the dialyzer."
- K834447, ECHO MM-1000® Automated Dialyzer Reprocessor, Mesa Laboratories, Inc.
- Agents: Disinfectants glutaraldehyde, formaldehyde, peracetic acid System cleaning - disinfectant, bleach
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## Measures: TCV, Leak Rate (pressure decay)
- Non-clinical Performance Studies: Test results confirm that the patented ClearFlux™ two-phase flow process recovers the TCV and the clearance of small and middle molecules of reusable polysulfone-based high-flux dialvzers to levels that are approximately equivalent to those of new dialyzers, and that the ClearFlux™ process does not cause adverse effects on the dialyzers. The tests include: Cytotoxicity, Scanning Electron Microscopy, X-Ray Photoelectron Spectroscopy, Size Exclusion Chromatography, Total Cell Volume, Complement Activation, Albumin Loss, Clearance of Small Molecules, Clearance of Middle Molecules, Hydraulic Permeability and Pressure Leak. The results from these tests support the effectiveness of the ClearFlux™ System, as indicated.
- Summary: Novaflux Technologies has performed in vitro and functional tests to show that the ClearFlux™ Dialyzer Reprocessing System does not have adverse effects on polysulfone-based high-flux dialyzers processed with the patented two-phase flow cleaning process, and that the ClearFlux™ System recovers the TCV and the clearance of small and middle molecules to levels that are approximately equivalent to those of new dialyzers.
- Conclusion: The information provided in the 510(k) supports the claim that the ClearFlux™ Dialyzer Reprocessing System is substantially equivalent to legally marketed predicate devices for the intended use in reprocessing polysulfone-based high-flux dialyzers for reuse.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular emblem with the department's name surrounding an abstract symbol. The symbol appears to be an stylized image of people.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Mohamed E. Labib, Ph.D. President and CEO Novaflux Technologies I Wall Street PRINCETON NJ 08540
3 2010 NOV
Re: K091360
Trade/Device Name: ClearFlux™ Dialyzer Reprocessing System Regulation Number: None Regulatory Class: Unclassified Product Code: LIF Dated: September 17, 2010 Received: September 20, 2010
Dear Dr. Labib:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must 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 of medical device-related
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Page 2
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Michael Lemur MD
Herbert P. Lerner, M.D., Director (Acting) 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): K091360
Device Name: ClearFlux™ Dialyzer Reprocessing System
Indications for Use:
The ClearFlux™ Dialyzer Reprocessing System is indicated for the reprocessing of polysulfone-based high-flux dialyzers for reuse, for preprocessing the dialyzers prior to their assignment to patients for first use, and for tracking the reprocessed dialyzer for use only by the patient to whom the dialyzer was initially assigned. The steps used in reprocessing hemodialyzers with the ClearFlux™ System include: (1) pre-cleaning, (2) cleaning, (3) rinsing, (4) volume and leak testing, and (5) disinfecting the dialyzers in accordance with the "AAMI Recommended Practice for Reuse of Hemodialyzers." The ClearFlux™ System performs the patented in-situ two-phase cleaning cycle during reprocessing, which recovers the total cell volume and the clearance of small and middle molecules of the dialyzers to levels that are approximately equivalent to those of new dialyzers. The ClearFlux™ Dialyzer Reprocessing System is also indicated for performing record keeping of the dialyzer processing operation. The ClearFlux™ Dialyzer Reprocessing System is indicated to be used only with the ClearFlux Formula™ cleaning solution.
Prescription Use ____________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-O ivision of Reproduc · ((k) Number
Page_1 of 1
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.
