AMERIWATER SOLUTION MIX AND DISTRIBUTION SYSTEM FOR HEMODIALYSIS
K051031 · Ameriwater · FIN · Jan 6, 2006 · Gastroenterology, Urology
Device Facts
Record ID
K051031
Device Name
AMERIWATER SOLUTION MIX AND DISTRIBUTION SYSTEM FOR HEMODIALYSIS
Applicant
Ameriwater
Product Code
FIN · Gastroenterology, Urology
Decision Date
Jan 6, 2006
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 876.5820
Device Class
Class 2
Indications for Use
The AmeriWater Solution Mix and Distribution System for Hemodialysis is intended to be used in a hemodialysis facility to mix and deliver, to the point(s) of use, bicarbonate and acid solutions necessary for hemodialysis. Federal law restricts this device to sale by or on the order of a physician for use in hemodialysis applications. The AmeriWater Bicarb Mix and Distribution System (Dual Tanks) is intended to be used in a hemodialysis facility to mix and deliver, to the point(s) of use, bicarbonate and acid solutions necessary for hemodialysis. The AmeriWater Solution Mixing System (Single Tank) is intended to be used in a hemodialysis facility to mix and deliver, to the point(s) of use, bicarbonate and acid solutions necessary for hemodialysis. The AmeriWater Acid Concentrate Distribution System is intended to be used in a hemodialysis facility to store and deliver, to the point(s) of use, acid concentrate(s) necessary for hemodialysis. The AmeriWater Wallbox for Dialysis is intended to be used in a hemodialysis facility as the point of connection for water, bicarbonate, and acid solution, for use in hemodialysis applications.
Device Story
System mixes and distributes bicarbonate and acid concentrates for hemodialysis; utilizes facility-provided purified water. Components include Bicarb Mix and Distribution System (single/dual tanks), Acid Concentrate Distribution System, and wall-mounted connection boxes. Bicarb system features automatic fill/mix, high-vortex pumping, and pressurized distribution. Acid system stores and recirculates concentrate for consistent delivery. Wall boxes provide connection points for water, acid, and bicarbonate at the dialysis machine. Operated by facility staff in clinical hemodialysis settings. Output is the delivery of prepared dialysis solutions to the point of care. Benefits include automated, consistent, and efficient preparation and distribution of hemodialysis fluids.
Clinical Evidence
Bench testing only.
Technological Characteristics
System components include mixing tanks, pumps, and wall-mounted connection boxes. Features include automatic fill/mix, high-vortex pumping, and pressurized recirculation. Connectivity is limited to physical plumbing and connection interfaces at the point of use. No software or electronic control algorithms described.
Indications for Use
Indicated for use in hemodialysis facilities to mix, store, and distribute bicarbonate and acid solutions to dialysis machines at points of use. 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.
Predicate Devices
Better Water Central Concentrate Delivery System for Dialysis, Central Bicarbonate Mixing/Delivery System (1992793)
Submission Summary (Full Text)
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PAGE 1 OF 1
JAN 6 2006
N 6 2006
August 16, 2005
1 303 Stanley Avenue Dayton, Ohio 45404 Phone: 937/461-8833 Phone: 800/535-5585 Fax: 9371461-1988 www.ameriwater.com
Subject: 510 (K) SUMMARY
| 510 (K) Number: | K051031 |
|----------------------|-----------------------------------------------------------------------------------------|
| AmeriWater Contact: | Brian R. Bowman, Quality Manager |
| Proprietary Name: | AmeriWater Solution Mix and Distribution System for Hemodialysis |
| Common Name: | Mixing and distribution system for bicarbonate and acid concentrates for hemodialysis. |
| Classification Name: | Tank, Holding, Dialysis and Accessories |
| Classification: | Class II Medical Device under §876.5665<br>Panel: Gastroenterology<br>Product Code: FIN |
Intended Use: The AmeriWater Solution Mix and Distribution System for Hemodialysis is intended to be used in a hemodialysis facility to mix and deliver, to the protitis) of use, bicarbonate and acid solutions necessary for hemodialysis. Federal law restricts this point(o) or use, blockburns necessary for use in hemodialysis and applications
Device Description: The AmeriWater Bicarb Mix and Distribution System utilizes purified water from the dialysis facility's water purification system to mix bicarbonate solution and to distribute the solution to the solution to the The system features automatic fill and mix, high vortex pumped mixing action, lightly point(s) of use. pressurized distribution, and efficient disinfection. A single tanks punplex, lightly, lightly Mixing System, is also available to mix solutions from concentrate.
The AmerilWater Acid Concentrate Distribution System is used to store and distribute the acid concentrate(s) required for hemodialysis to the suited in and distributed by the act concentrate(s)
Distribution, System, in mined ne point(s) of use. Solution stored in and distributed by Distribution System is mixed prior to being transferred to the system. Lightly pressurized distribution and recirculation provides steady, consistent delivery.
AmeriWater Wall Boxes are recessed boxes located at the point(s) of use that are intended to provide acid, bicarb, and/or water connections connections of the point(s) or use that and the medialysis facility. Walling boxes are available in several configurations the the mires used in the nemodalysis facility. Wall dialysis machine fittings are professionally installed by AmeriWater.
Statement of Substantial Equivalence: The AmeriWater Solution Mix and Distribution System for Hemodialysis is substantially equivalent in intended use, function, and technology to the Better Water Central Concentrate Delivery System for Dialysis, Central Bicarbonate Mixing/Delivery System (1992793).
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 6 2006
Mr. Brian R. Bowman Quality Manager AmeriWater® 1303 Stanley Avenue DAYTON OH 45404
Re: K051031
Trade/Device Name: AmeriWater Solution Mix and Distribution System for Hemodialysis Regulation Number: 21 CFR §876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: FIN Dated: November 23, 2005 Received: November 28, 2005
Dear Mr. Bowman:
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 your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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); 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.
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This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin matteeing your device of your device to a legally premarket notification: The FDA midnig of basiant --------------------------------------------------------------------------------------------------------------------------proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire sfiectific advice for your dortes on one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation entitled, "Thisostanians on your responsibilities under the Act from the 807.97). I ou may obtain outcr general international and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address
http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon 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
K051031 5 (0(k) Number (f known)
AmeriWater Solution Mix and Distribution System for Hemodialysis Device Name:
The AmeriWater Solution Mix and Distribution System for Hemodialysis is intended Indications For Use The Amerivater Solution Mix and Distribution Oyetsman (s) of use, and the point(s) of use, to be used in a nemodialysis necessary for hemodialysis. Federal law restricts bicarboriate and acid solutions nooleously for represent for use in hemodialysis applications
AmeriWater Bicarb Mix and Distribution System, Models 00BC55-55, 00BC100-100, and 00BC100-200
10 hotel in a AmeriWater Bicarb Mix and Distribution System for Hemolialysis is intended to be used in a
(Dual Tanks): The AmeriWater Bicarb Mix and Distribution System for hemocialysis (Dual Tanks): The Amerivater Bicard Mix and Distribution of Stockbirgs one ons been belief in themodialysis.
hemodialysis facility to mix and deliver, to the point(s) of use hemodialysis facility to mix and deliver, to the point(s) or assi blanchan i ruse in hemodialysis applications.
AmeriWater Solution Mixing System, Model 00BC100 (Single Tank): The AmeriWater Solution Mixing AmeriWater Solution Mixing System, Moder Society to the point(s) of the point(s) of the point(s) of the point(s) of the order of a System is intended to be used in a nemodalysis. Tablity to mix and active to sale by or on the order of a physician for use in hemodialysis applications.
AmeriWater Acid Concentrate Distribution System, Models 00AS130, 00AS300, and 00A5500: The AmeriWater Acid Concentrate Distribution Dystem, ned in a hemodialysis facility of store and
AmeriWater Acid Concentrate Distribution System is intended to sections his do AmeriWater Acid Concentrate Distribution System is themsed to boysis. Federal law restricts this device to deliver, to the point(3) of doo, asia for use in hemodialysis applications.
AmeriWater Wallboxes for Dialysis: The AmeriWater Wallbox for Dialysis in intended to be used in a Ameriwater Wallboxes Tor Dialysis. The Ainentrator Trader, bicarbonate, and acid solution, for use in hemodialysis facility as the point of this device to sale by or on the order of a physician for use in hemodialysis applications.
> × Preseription Use Part 21 OFR 501 Subpart Di
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Over-The-Counter Use _ i21 CFR 801 Subpart O:
IPLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED !
Concurrence of CDRH Office of Device Evaluation (CDE):
Daniel L. Ingram
(Division Sign-Off Division of Reproductive. Abdominal and Radiological Devic
Face of 1
510(k) Number
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.
