The DiPure Deionization Tanks are exchangeable mix bed tanks intended to remove ions from the water to a sufficient level to allow safe treatment of Hemodialysis patients. These deionization tanks are not to be used alone, but are intended to be a part of a larger water treatment system employing adequate pre-treatment and post-treatment. Upon exhaustion, these tanks will be replaced with other tanks containing newly regenerated resin, or new resin altogether. The DiPure Carbon Exchange Tanks are activated carbon tanks intended to remove chlorine and chloramines from the water to allow safe treatment of Hemodialysis patients. These carbon tanks are not to be used alone, but are intended to be a part of a larger water treatment system employing adequate pre-treatment and post-treatment. Upon exhaustion, these tanks are replaced with other tanks containing new activated carbon.
Device Story
Device consists of exchangeable tanks for hemodialysis water purification; includes mixed bed resin deionization tanks and activated carbon tanks. Input is municipal or source water; output is purified water meeting AAMI standards. Tanks feature machined PVC schedule 80 heads, stand pipes, fill ports, and distributor baskets. Used in clinical dialysis settings as part of larger water treatment systems. Healthcare providers monitor chlorine/chloramine levels before patient shifts. Upon exhaustion, tanks are replaced with regenerated or new media. Benefits include removal of dissolved solids, chlorine, and chloramines to ensure safe water for hemodialysis treatment.
Clinical Evidence
No clinical data. Bench testing only. Device relies on established water purification technology (ion exchange and activated carbon filtration) consistent with AAMI standards for hemodialysis water.
Technological Characteristics
Tanks filled with mixed bed resin or activated carbon (iodine number ≥900). Components include machined PVC schedule 80 heads, stand pipes, fill ports, and distributor baskets. Materials are NSF/FDA approved. System configuration utilizes dual carbon filters in series. Mechanical filtration/purification principle. No software or electronic components.
Indications for Use
Indicated for hemodialysis patients requiring purified water. Deionization tanks remove ions; carbon tanks remove chlorine and chloramines. Not for standalone use; must be integrated into larger water treatment systems with pre- and post-treatment.
Regulatory Classification
Identification
A water purification system for hemodialysis is a device that is intended for use with a hemodialysis system and that is intended to remove organic and inorganic substances and microbial contaminants from water used to dilute dialysate concentrate to form dialysate. This generic type of device may include a water softener, sediment filter, carbon filter, and water distillation system.
Special Controls
*Classification.* Class II (special controls). The device, when it is a water purification subsystem disinfectant, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
Predicate Devices
AmeriWater Dialysis Deionizer and Carbon Exchange Tanks (K991519)
Submission Summary (Full Text)
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# KO83712
PAGE 1 OF 2
JUL 1,0 2009
## Pre-Market Notification 510(K) Summary
## Water Purification Components for Hemodialysis
| Date | December 4, 2008 |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Prepared/Submitted By | DiPure, LLC<br>DiPure Water Technologies<br>1919 Edwards Street<br>Houston, Texas 77007 |
| Contact | Tim Marco<br>President/General Manager<br>713.686.4049 |
| Device Name | Carbon and DI Exchange Tanks for Hemodialysis |
| Device Classification | Class II Medical Device, 21 CFR 876.5665<br>Product Code 78 FIP |
| Predicate Device | AmeriWater Dialysis Deionizer and Carbon Exchange Tanks<br>Registration Number K991519 |
| Device Description | DiPure's DI Exchange Tanks for Dialysis are approved tanks<br>filled with mixed bed resin. Connectors are used in<br>conjunction with a machined PVC schedule 80 head, stand<br>pipe, fill port, and distributor basket. Our tanks are designed<br>to supply AAMI standard water for dialysis through ion<br>exchange. The DI exchange tanks are based on the<br>Ameriwater Dialysis Deionizer Exchange Tanks.<br><br>DiPure's Carbon Exchange Tanks for Dialysis are approved<br>tanks filled with activated carbon. Connectors are used in<br>conjunction with a machined PVC schedule 80 head, stand<br>pipe, fill port, and distributor basket. These tanks are<br>designed to remove chlorine and chloramines. These tanks<br>are based on the Ameriwater Carbon Exchange Tanks. |
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# K083712 PAGE 2 OF 2
### Indications for Use
Comparison to Predicate AmeriWater Device
The DiPure Deionization Tanks are exchangeable/rechargeable mix bed tanks intended to remove ions from the water to a sufficient level to allow safe treatment of Hemodialysis patients. These deionization tanks are not to be used alone, but are intended to be a part of a larger water treatment system employing adequate pretreatment and post-treatment. Upon exhaustion, these tanks will be replaced with other tanks containing newly regenerated resin, or new resin altogether.
The DiPure Carbon Exchange Tanks are activated carbon tanks intended to remove chlorine and chloramines from the water to allow safe treatment of Hemodialysis patients. These carbon tanks are not to be used alone, but are intended to be a part of a larger water treatment system employing adequate pre-treatment and post-treatment. Upon exhaustion, these tanks are replaced with other tanks containing new activated carbon.
Deionization tanks from both DiPure and AmeriWater are utilized to remove dissolved solids from the water. Both utilize mixed bed resins, consisting of cation and anion resins to remove the charged particles in the water. Both utilize parts and materials that are NSF and/or FDA approved.
Activated carbon filtration is utilized by both DiPure and AmeriWater to filter out chlorine and chloramines from the water. DiPure uses carbon filter made from materials that are NSF and/or FDA approved. Both companies use two (2) carbon filters in a series configuration. Both DiPure and AmeriWater recommend the chlorine and chloramines are checked before each patient shift. Both companies utilize an activated carbon with an iodine number of 900 or greater. DiPure always recommends using dual carbon filters in series in every dialysis water system installed, including single patient systems.
In Summary, the DiPure water purification components and the AmeriWater predicate device components are substantially equivalent to one another. The core water purification components and technology are exactly the same.
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Image /page/2/Picture/0 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" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, rendered in a stylized, minimalist design.
## DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
## JUL 1 0 2009
Mr. Tim Marco President/General Manager DiPure, LLC DiPure Water Technologies 1919 Edwards Street HOUSTON TX 77007
Re: K083712
Trade/Device Name: Carbon and Deionized Exchange Tanks for Hemodialysis Regulation Number: 21 CFR §876.5665 Regulation Name: Water purification system for hemodialysis Regulatory Class: II Product Code: FIP Dated: June 22, 2009 Received: June 25, 2009
Dear Mr. Marco:
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.
If vour 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 (reporting of medical
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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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
> Sincerely yours. unu
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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## Indications for Use
#### 510(k) Number: K083712
### Device Name: Carbon and Deionized Exchange Tanks for Hemodialysis
#### Indications for Use:
The DiPure Deionization Tanks are exchangeable mix bed tanks intended to remove ions from the water to a sufficient level to allow safe treatment of Hemodialysis patients. These deionization tanks are not to be used alone, but are intended to be a part of a larger water treatment system employing adequate pre-treatment and post-treatment. Upon exhaustion, these tanks will be replaced with other tanks containing newly regenerated resin, or new resin altogether.
DiPure Deionization Tank Model Numbers:
DMB025 - . 25 cu ft Deionization Tank DMB05 - . 5 cu ft Deionization Tank DMB12 - 1.2 cu ft Deionization Tank DMB20 - 2.0 cu ft Deionization Tank DMB36 - 3.6 cu ft Deionization Tank
The DiPure Carbon Exchange Tanks are activated carbon tanks intended to remove chlorine and chloramines from the water to allow safe treatment of Hemodialysis patients. These carbon tanks are not to be used alone, but are intended to be a part of a larger water treatment system employing adequate pre-treatment and post-treatment. Upon exhaustion, these tanks are replaced with other tanks containing new activated carbon.
DiPure Carbon Tank Model Numbers:
DAC025 - .25 cu ft Carbon Tank DAC05 - .5 cu ft Carbon Tank DAC12 - 1.2 cu ft Carbon Tank DAC20 - 2.0 cu ft Carbon Tank DAC 36 - 3.6 cu ft Carbon Tank
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---------------------------------------------------------------|---------|
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K083712 |
Page 1 of 11
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.
