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

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.

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.

Predicate Devices

• MAR COR Services Bicarb System (K003560)

Submission Summary (Full Text)

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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 | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

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 [phone]. 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 [phone] 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 ________________________________________________________________________________________________________________________________________________________________