DIALYSIS SERVICES, INC., TYPHOON BICARB MIXING AND DISTRIBUTION SYSTEM
K060333 · Dialysis Services, Inc. · FIN · Sep 8, 2006 · Gastroenterology, Urology
Device Facts
Record ID
K060333
Device Name
DIALYSIS SERVICES, INC., TYPHOON BICARB MIXING AND DISTRIBUTION SYSTEM
Applicant
Dialysis Services, Inc.
Product Code
FIN · Gastroenterology, Urology
Decision Date
Sep 8, 2006
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 876.5820
Device Class
Class 2
Indications for Use
The TYPHOON by Dialysis Services, Inc. is intended to be used for the safe and effective mixing and distributing of a bicarbonate solution in a hemodialysis facility.
Device Story
System mixes and distributes bicarbonate solution for hemodialysis clinics; utilizes tanks, pumps, piping, and level control sensors. Input: RO or DI water meeting AAMI standards. Operation: User selects fill increments (50, 75, or 100 gallons); system automatically fills tanks. Monitoring: Level sensors trigger audible/visual alarms when bicarbonate levels drop to 10 gallons; system can automatically switch between tanks. Output: Mixed bicarbonate solution for hemodialysis. Used in clinical settings by facility staff. Benefits: Consistent, automated mixing and distribution process; reduces manual handling; ensures continuous supply via automatic tank switching.
Clinical Evidence
No clinical data. Bench testing only.
Technological Characteristics
System components: Polyethylene tanks, TEFC motors (1/3 hp mix, 1/4 hp distribution), schedule 80 PVC piping. Power: 115 VAC, single phase, 20 amp. Connectivity: Standalone. Control: Automated level-sensing fill and alarm system. Sterilization: Not applicable (fluid contact materials identical to cleared devices).
Indications for Use
Indicated for mixing and distributing bicarbonate solutions for hemodialysis treatments in a clinical facility. 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
USFilter Bicarbonate Mixing and Dispensing System (K031502)
Submission Summary (Full Text)
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| Services, Inc | TYPHOON Bicarb System 510(k) Submission |
|------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| | K060333 |
| SEP - 8 2006 | PAGE 1 OF 4 |
| 4.0 510(k) Summary of Safety and Effectiveness | |
| 4.1 Submitter: | Dialysis Services, Inc.<br>130 Elder.<br>Springfield, TN 37172 |
| 4.2 Establishment Registration Number: | 3004486997 |
| 4.3 Phone: | (615) 384-4810 |
| 4.4 Fax: | (615) 384-4847 |
| 4.5 Date Prepared: | 02-06-2006 |
| 4.6 Contact Person: | Mike Sterling |
| 4.7 Device Names: | |
| | Trade Name: TYPHOON Bicarb Mixing & Distribution System |
| | Common Name: Bicarb Mixing & Distribution System |
| | Classification Name: Hemodialysis Systems and Accessories (21 CFR 876.5820) Class II Critical Medical Device |
| | Product Code: 78 FIP |
| 4.8 Predicate Device: | USFilter Bicarbonate Mixing and Dispensing System<br>K031502 |
| | 510(k) Summary |
DETVASE
130 Elder Dr.
4.9 Device Description: Device is designed to provide the user with a system for consistent and easy to use system by which they may be able to mix and distribute bicarbonate solution for use in a hemodialysis clinic.
4.10 Intended Use: The TYPHOON by Dialysis Services, Inc. is intended to be used for the safe and effective mixing and distributing of a bicarbonate solution in a hemodialysis facility.
Fax: 615,384,4847
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4.11 Predicate Device: The Dialysis Services Typhoon Bicarbonate Mixing and Distribution System and its components are substantially equivalent to the USFilter Bicarbonate Mixing and Dispensing System, K031502. Both the predicate device system and the Dialysis Services, Inc TYPHOON systems ufilize similar technology. Further comparisons are made in the chart below.
Image /page/1/Figure/3 description: The image contains the text '10(k) Summa'. The text is vertically oriented and appears to be part of a title or heading. The font is bold and the letters are closely spaced together.
Image /page/1/Figure/4 description: The image shows the text "Page 12" in bold black font. The text is likely a page number from a document. The number 12 is written in a slightly larger font size than the word "Page".
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K060333
AGE 3 OF 4 PAGE
| Technical Specifications and<br>Information | Dialysis Services, Inc.<br>TYPHOON | USFilter BICARB50SYS &<br>BICARB100SYS |
|---------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Requirements | | |
| Inlet Water: | RO or DI water which meets<br>AAMI standards for Hemodialy-<br>sis | RO or DI water which meets<br>AAMI standards for Hemodi-<br>alysis |
| Drain: | Minimum of 1" | Minimum of 1" |
| Electrical: | 115 vac, Single Phase, 20 amp | 115 vac, Single Phase, 20 amp |
| Piping: | | |
| Water Inlet: | 1" schedule 80 PVC | 1/2" schedule 80 PVC |
| Loop Feed: | 3/4" schedule 80 PVC, or 5/8"<br>polyethylene | 3/4" schedule 80 PVC |
| Loop Return: | 3/4" schedule 80 PVC, or 5/8"<br>polyethylene | 3/4" schedule 80 PVC |
| Drain: | 1 ½" schedule 80 PVC | 1" schedule 80 PVC |
| Level Controls: | | |
| Mix Tank Level Control: | The Dialysis Services TYPHOON<br>gives the user the ability to mix<br>and distribute from both tanks,<br>so there is not a separate Mix<br>and Distribution tank. Because<br>of this, both tanks utilize the<br>same level control sensor and<br>operate the same. The sensor | The mix tank is equipped with<br>a high level float that closes<br>the fill valve if the water in the<br>tank exceeds 100 gals. (50<br>gals. for a 50 gal. system). The<br>fill valve will not reactivate<br>unless the water level is below<br>float level. |
| Distribution Tank Level Control: | automatically allows the sys-<br>tem to fill in 50 gal., 75 gal.,<br>and 100 gal. increments (user<br>selected). The level sensor<br>controls the fill valve with these<br>levels. In addition, when the<br>bicarbonate level drops to 10<br>gallons in the tank being used,<br>it will give an audible and vis-<br>ual alarm and/or automati-<br>cally switch tanks. (See Opera-<br>tor's Manual for details) | The distribution tank is<br>equipped with a low-level<br>float that lights a warning light<br>if the bicarbonate in the tank<br>drops below 25 gals. if the dis-<br>tribution tank is allowed to go<br>empty, and audible alarm will<br>sound. |
| Technical Specifications and<br>Information | Dialysis Services, Inc.<br>TYPHOON | USFilter BICARB50SYS & BI-<br>CARB100SYS |
| | Pumps: | |
| Mix Pump: | 1/3 hp Totally Enclosed Fan<br>Cooled (TEFC) motor | 3/4 hp Totally Enclosed Fan<br>Cooled (TEFC) motor |
| Distribution Pumps: | 1/4 hp Totally Enclosed Fan<br>Cooled (TEFC) motor | 1/9 hp Totally Enclosed Fan<br>Cooled (TEFC) motor |
| | Material | |
| Tank Materials: | Polyethylene | Polyethylene |
10(k) Summar
Page 13
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#### Dialysis Services, me
# 4.12 Non-Clinical Performance Data:
The Dialysis Services, Inc. TYPHOON Bicarb Mixing and Distribution System utilizes similar components and fluid confact materials as other items currently cleared for use in hemodialysis
# 4.13 Clinical Testing:
N/A
# 4.14 Biocompatibility Testing:
Dialysis Services, Inc. certifies that most materials and components utilized in the TYPHOON Bicarb System are identical to those previously cleared and regisfered with the FDA. Additional testing is provided in Section 9.0 of this submission.
#### 4.15 Conclusions:
As with the USFilter Bicarbonate Mixing and Distribution System, the Dialysis Services, Inc, TYPHOON Bicarbonate Mixing and Distribution System is intended to consistently mix and distribute bicarbonate solution for use in hemodialysis.
Page 14
30 Elder Dr oll Free: 1.888.DSI.WATER
**Fax: 615.384.4847**
10(k) Summa
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with outstretched wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird-like figure.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Mr. Mike Sterling VP/COO Dialysis Services, Inc. 3620 Kelton Jackson Road SPRINGFIELD TN 37172
Re: K060333
Trade/Device Name: Dialysis Services, Inc. TYPHOON Bicarb Mixing and Distribution System Regulation Number: 21 CFR §876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: FIN Dated: August 23, 2006 Received: August 24, 2006
Dear Mr. Sterling:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your boother is of if your is substantially equivalent (for the indications for referenced as over and harv to legally marketed predicate devices marketed in interstate commerce use stated in the encrosure) to regally manovical Device Amendments, or to devices that provision in accordance with the provisions of the Federal Food, Drug, and Cosmetic nave been rectablined in ure approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general therefore, mainer the active, basyer reasurements for annual registration, listing of devices, good controls provibitions or and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket r your device is etablined (oo such additional controls. Existing major regulations affecting your Apploval), it thay be saoject to sach aderal Regulations, Title 21, Parts 800 to 898. In addition, FDA device our of loand announcements concerning your device in the Federal Register.
Image /page/4/Picture/10 description: The image shows a circular logo with the text "FDA Centennial" and the years "1906-2006". The logo features the letters "FDA" in a bold, stylized font above the word "Centennial". There are three stars below the word "Centennial". The logo is surrounded by a circular border with additional text.
noting Public J
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Page 2 -
ミ
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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrl/industry/support/index.html.
Sincercly vours,
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
510(k) Number (if known):_ K060333
Device Name: Dialysis Services, Inc. TYPHOON Bicarb Mixing and Distribution System
Indications For Use:
The bicarbonate mixing and distribution system and its components consisting of; tanks, pumps, piping, and controls, are designed to consistently, safely, and effectively mix and distribute bicarbonate solutions for hemodialysis treatments.
NOTE: Federal Law restricts this device to sale by or on the order of a physician for use as a bicarbonate mixing and distribution system for hemodialysis.
Prescription Use V (Part 21 CFR 801 Subpart D) ANDIOR
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)
David h. Layman
(Division Sian-Off Division of Reproductive. and Radiological Devices 510(k) Number
Page 1 of 1
(vers 6/25/05)
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.
