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

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.

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: | [phone] |
| 4.4 Fax: | [phone] |
| 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.

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30 Elder Dr oll Free: 1.888.DSI.WATER

**Fax: [phone]**

10(k) Summa

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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 [phone] or [phone]

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

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