USFILTER BICARBONATE MIXING AND DISPENSING (BICARB) SYSTEM
K031502 · Usfilter · FIN · Aug 27, 2004 · Gastroenterology, Urology
Device Facts
Record ID
K031502
Device Name
USFILTER BICARBONATE MIXING AND DISPENSING (BICARB) SYSTEM
Applicant
Usfilter
Product Code
FIN · Gastroenterology, Urology
Decision Date
Aug 27, 2004
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 876.5820
Device Class
Class 2
Indications for Use
The USFilter Bicarbonate Mixing and Dispensing (Bicarb) System is intended to be used in a Hemodialysis facility to allow safe and effective delivery of concentrates as well as central mixing and delivery of sodium bicarbonate solution necessary for a hemodialysis treatment.
Device Story
The USFilter Bicarbonate Mixing and Dispensing (Bicarb) System is a stationary unit used in hemodialysis facilities to automate the preparation and distribution of bicarbonate solution. The system utilizes a mix tank and a distribution tank, both constructed of polyethylene. It operates by mixing bicarbonate concentrate with water (RO or DI water meeting AAMI standards). The system features integrated float switches for level control: a high-level float in the mix tank prevents overfilling by closing the fill valve, and a low-level float in the distribution tank triggers a warning light and audible alarm if levels drop below 25 gallons. The system uses TEFC motors for mixing and distribution pumps. It is operated by facility staff to ensure consistent, safe delivery of dialysis concentrates, reducing manual labor and potential for error in solution preparation. The output is a ready-to-use bicarbonate solution delivered to hemodialysis machines, facilitating the clinical treatment process.
Clinical Evidence
No clinical data. Bench testing only.
Technological Characteristics
Materials: Polyethylene tanks, schedule 80 PVC piping. Energy: 115 VAC, single phase, 20 AMP. Components: TEFC motors (1/2 hp mix pump, 1/8-1/9 hp distribution pump). Control: Float-based mechanical level sensing for fill valves and alarms. Connectivity: Standalone. Sterilization: Not specified.
Indications for Use
Indicated for use in hemodialysis facilities for the central mixing and delivery of sodium bicarbonate solution and concentrates required for hemodialysis treatment.
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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## AUG 27 2004
## 510(k) Summary
1
USFilter/lonpure, Inc. in accordance with the requirements of 21 CFR§807.92 is submitting this summary of 510(k)-safety and effectiveness information.
Submitter's Identification USFilter/lonpure, Inc. 725 Wooten Road Colorado Springs, CO 80915 719-570-9600
Date Summary Prepared 26 March 2003 , (Rev.4 - 02 August 2004)
#### Official Correspondent/Contact 2
Douglas L. Rufenacht 725 Wooten Road Colorado Springs, CO 80915 719-550-2055
#### Name of the Device 3
USFilter Bicarbonate Mixing and Dispensing (Bicarb) System
#### Substantial Equivalence 4
MAR COR Services, Inc. MAR COR Services Bicarb System K003560
#### Device Description 5
The consistent mixing and delivery of bicarbonate solution for use in hemodialysis
#### 6 Intended Use
The USFilter Bicarbonate Mixing and Dispensing (Bicarb) System is intended to be used in a Hemodialysis facility to allow safe and effective delivery of concentrates as well as central mixing and delivery of sodium bicarbonate solution necessary for a hemodialysis treatment.
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#### Comparison to Substantial Equivalence Devices 7
The USFilter Bicarbonate Mixing and Dispensing (Bicarb) System unit contains the same fundamental scientific technology as the substantial equivalent device. Please reference the following Chart of Comparison:
| Specifications and<br>Technical Information | USFilter<br>BICARB50SYS &<br>BICARB100SYS | | MAR COR<br>MCB 210-50 & MCB 210-<br>100 | |
|---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|
| Indications for Use: | The USFilter Bicarbonate Mixing<br>and Dispensing (Bicarb) System<br>is intended to be used in a<br>Hemodialysis facility to allow safe<br>and effective delivery of<br>concentrates as well as central<br>mixing and delivery of sodium<br>bicarbonate solution necessary<br>for a hemodialysis treatment. | | The Bicarb Mixing and Distribution<br>System (Bicarb System) designed<br>and manufactured by Mar Cor<br>Services is, safe, reliable and easy<br>to use. This system will reduce staff<br>time by providing consistent bicarb<br>mixing, and through system<br>cleaning and disinfection. | |
| Utility Requirements | | | | |
| Water Feed: | RO or DI water produced to AAMI<br>standards for Hemodialysis | | RO or DI water produced to AAMI<br>standards for Hemodialysis | |
| Electrical<br>requirements: | 115 VAC, Single Phase, 20 AMP | | 115 VAC, Single Phase, 20 AMP | |
| Drain: | 1" Minimum | | 1" Minimum | |
| Physical Dimensions | 50 | 100 | 50 | 100 |
| Length: | 70" | 83" | 85" | 85" |
| Depth: | 27" | 35" | 32" | 32" |
| Height: | 60" | 60" | 57" | 61" |
| Operating Weight: | 1800 LBS | 2500 LBS | 1300 LBS | 2050 LBS |
| Dimensional/Operating Room | | | | |
| Width: | 6' 10" | | 6' 10" | |
| Depth: | 3' 3" | | 3' 3" | |
| Height: | 6" 0" | | 6" 0" | |
| Installation Piping | | | | |
| Feedwater: | ½" schedule 80 PVC | | ½" schedule 80 PVC | |
| Loop Distribution: | ¾" schedule 80 PVC | | ¾" schedule 80 PVC | |
| Loop Return: | ¾" schedule 80 PVC | | ¾" schedule 80 PVC | |
| Drain: | 1" schedule 80 PVC | | 1" schedule 80 PVC | |
| System Floats | | | | |
| Mix Tank Float: | The mix tank is equipped with a<br>high level float that will close the<br>fill valve if the water in the tank<br>exceeds 100 gallons (50 gallons<br>for 50 gallon systems). The fill<br>valve controller will not reactivate<br>unless the water level is below<br>the float level. | | The mix tank is equipped with a<br>high level float that will close the fill<br>valve if the water in the tank<br>exceeds 100 gallons (50 gallons for<br>50 gallon systems). The fill valve<br>controller will not reactivate unless<br>the water level is below the float<br>level. | |
| Distribution Tank<br>Float: | The distribution tank is equipped<br>with a low-level float that lights a<br>warning light if the bicarbonate in<br>the tank drops below 25 gallons.<br>If the distribution tank is allowed<br>to go empty an audible alarm will<br>sound. | | The distribution tank is equipped<br>with a low-level float that lights a<br>warning light if the bicarbonate in<br>the tank drops below 25 gallons. If<br>the distribution tank is allowed to go<br>empty an audible alarm will sound. | |
| Pumps | | | | |
| Mix Pump: | ½ hp Totally Enclosed Fan<br>Cooled (TEFC) motor | | ½ hp Totally Enclosed Fan Cooled<br>(TEFC) motor | |
| Distribution Pump: | 1/9 hp TEFC motor | | 1/8 hp TEFC motor | |
| Tank Material: | Polyethylene | | Polyethylene | |
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### Discussion of Non-Clinical Test Performed for Determination of Substantial 8 Equivalence is as follows:
The USFilter Bicarbonate Mixing and Dispensing (Bicarb) System is an existing device actively marketed by USFilter with a long performance record. This submission seeks to obtain approval so as to begin marketing this device as part of a water system for use in hemodialysis.
#### Discussion of Clinical Test Performed: 9
N/A
#### Biocompatibility Testing: 10
USFilter certifies that all materials utilized in the design, manufacture, and operation of the USFilter Bicarbonate Mixing and Dispensing (Bicarb) System are utilized in the predicate device as well as used in other registered devices and systems currently sold by USFilter and registered with the Food and Drug Administration. The tables in appendix D provide the detailed break down of these materials as well as a documented review in accordance with Appendix C of FDA document G95-1. It is the contention of USFilter that as per the results of the review documented in appendix D no further testing is required.
#### 11 Conclusions:
As was true for the MAR COR Services Bicarb System, the USFilter Bicarbonate Mixing and Dispensing (Bicarb) System is intended to provide consistent bicarbonate mixing and distribution for Hemodialysis applications.
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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with three stripes extending from its head, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 7 2004
Mr. Douglas Rufenacht Validation Manager and Regulatory Compliance USFilter Process Water Systems High Purity Systems 725 Wooten Road COLORADO SPRINGS CO 80915
Re: K031502
KU31302
Trade/Device Name: USFilter Bicarbonate Mixing and Dispensing (Bicarb) System Regulation Number: 21 CFR §876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: 78 FIN Dated: August 20, 2004 Received: August 23, 2004
Dear Mr. Rufenacht:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt have teviewed your becamined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regally interest date of the Medical Device Amendments, or to commerce prior to May 20, 1970, are eccordance with the provisions of the Federal Food, Drug, devices that have been roomstilled in quire approval of a premarket approval application (PMA). and Costhere 710 (110) that to nevice, subject to the general controls provisions of the Act. The 1 ou may, uicierore, market the act include requirements for annual registration, listing of general controls provisions of the rice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (500 a00 regulations affecting your device can be it may be subject to adultions, 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 Ficase be advised that I Drive issuation that your device complies with other requirements of the Act that I DA has made a active regulations administered by other Federal agencies. You must of any I ederal statutes and roginements, including, but not limited to: registration and listing comply with an the riot 5 requirements, as and 801); good manufacturing practice requirements as set (21 CFR Part 607), labornig (21 OF Reason), government (20); and if applicable, the clectronic forth in the quality bysteins (QD) rog to the Act); 21 CFR 1000-1050.
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l'are 2
This letter will allow you to begin marketing your device as described in your Section 10(k).
The station and the market of alling of edicantial equivalence of your device to This letter will allow you to begin marketing your device of your device of your device to a le;sally
premarket notification. The FDA finding of substanted of your device an premarket notification. The FDA inding of substantal Quivation or your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), phease
s on the secure of the comments of the following numbers, based on the reg If you desire specific advice for your device on our labourig region in and on the regulation
contact the Office of Compliance at one of the following numbers, based on the r number at the top of the letter:
| 8xx. 1xxx | (301) 594-4591 |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advectising of your device, please contact the Additionally, for questions on the promotion and are mote the regulation entitled, "Misbranding
Office of Compliance at (301) 594-4639. Also, planse note the regulation of t Office of Compliance at (301) Syland St. Also, production oveganization Other general
by reference to premarket notification" (21CFR Part 807.97) you may obtain. Division o by reference to premarket notification (21CFA i are oo 1779 yoed firon the Division of Small
information on your responsibilities under the Act may be obtained from the (800) information on your responsibilities under Asstance at its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its today, main html. Manufacturers, International and Collishiner Fisistance a the re-ri-
Sincerely yours,
Nancy C. Brogdon
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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## Indication for Use
The USFilter Bicarbonate Mixing and Dispensing (Bicarb) System is intended to be used in a Hemodialysis facility to allow safe and effective delivery of concentrates as well as central mixing and delivery of sodium bicarbonate solution necessary for a hemodialysis treatment.
*Prescription Use*
Daniel A. Seymore
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 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.
