BIPRO MODEL SDS-CB200

K033118 · Medical Solutions International · FIN · Jun 28, 2004 · Gastroenterology, Urology

Device Facts

• Record ID: K033118
• Device Name: BIPRO MODEL SDS-CB200
• Applicant: Medical Solutions International
• Product Code: FIN · Gastroenterology, Urology
• Decision Date: Jun 28, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5820
• Device Class: Class 2

Intended Use

BiPro Model SDS-CB200 is intended for use in a hemodialysis facility for mixing and distribution of sodium bicarbonate (bicarb) to remote points of use. The bicarb is then mixed with purified water and acid to create the dialysate solution used in hemodialysis.

Device Story

BiPro Model SDS-CB200 is a semi-automatic mixing and distribution system for hemodialysis bicarbonate concentrate. The device utilizes a mix tank to combine bicarbonate powder with RO water; a mix pump then transfers the resulting solution to a loop (day) tank for distribution to dialysis machine stations. Used in clinical hemodialysis facilities; operated by trained staff. The system ensures consistent bicarbonate concentrate availability for dialysate preparation. Benefits include streamlined preparation of dialysate solutions for patient treatment.

Clinical Evidence

Bench testing only. The device was tested to meet safety requirements of ANSI/AAMI RD62:2001, Water Treatment Equipment for Hemodialysis Applications.

Technological Characteristics

Semi-automatic mixing and distribution system. Includes mix tank, mix pump, and loop (day) tank. Designed for hemodialysis applications. Tested to ANSI/AAMI RD62:2001 standards.

Indications for Use

Indicated for use in hemodialysis facilities to prepare and distribute sodium bicarbonate concentrate for the creation of dialysate solution used in 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, Inc Bicarb System (K003560)

Submission Summary (Full Text)

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KC33/18
Page 1 of 2

JUN 2 8 2004

# 510(k) Summary

### Date: 9/26/03

### Submitter:

Jack Dillon Medical Solutions International, Inc 11522 West 90th St. Overland Park, KS 66214 Ph: 913-438-9700 Fx: 913-438-9701 [e-mail]

### Contact Person:

Jarvis Stirn 938 Tennessee St. Lawrence, KS 66044 Ph: 785-843-0144 [e-mail]

### Device Identification:

Trade Name/Proprietary Name: BiPro Model SDS-CB200 Device: Mixing and distribution system of bicarbonate for dialysis. Common Name:

### Classification Name and Reference:

| Classification Names: | TANK, HOLDING, DIALYSIS AND<br>ACCESSORIES |
|--------------------------------|------------------------------------------------------------------------------|
| Classification: | Class II, 21 CFR 876.5820<br>Panel: Gastroenterology<br>Product Code: 78 FIN |
| Premarket Notification Number: | No Prior Related Premarket Notification<br>Submissions. |

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### Indications for Use:

Indications for Ose. Dirro Model BDS - OD Sodium bicarbonate (bicarb) to remote points of use. The bicarb is then distribution of southin cleared and to create the dialysate solution used in hemodialysis.

### Device Description:

The Medical Solutions BiPro Models provide semi-automatic mixing of bicarb I he Medical Donations as a hemodialysis patient stations. A mix tank is used for the mixing of bicarb concentrates and RO water. After mixing the bicarb solution, it is transferred to a loop (day) tank, via the mix pump, where the bicarb solution is distributed to the dialysis machine.

### Statement of Substantial Equivalence:

Statement of Substantially Equivalentially equivalent in intended use, features, functions, and technological characteristics to the Mar Cor Services, Inc Bicarb System (K003560)

### Performance: Safety and Effectiveness Information:

Medical Solutions BiPro Systems have been voluntarily tested to meet the safety requirements ANSI/AAMI RD62: 2001 Water Treatment Equipment for Hemodialysis Applications. The ANSI/AAMI RD62: 2001 Water Treatment Equipment for Hemodialysis Applications is a revision of the ANSI/AAMI RD5: 1992 Hemodialysis Systems.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 8 2004

Mr. Jack Dillon Medical Solutions International, Inc. 11522 West 90th Street SHAWNEE MISSION KS 66215

Re: K033118

Trade/Device Name: BiPro Model SDS-CB200 Regulation Number: 21 CFR §876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: 78 FIN Dated: April 29, 2004 Received: April 29, 2004

Dear Mr. Dillon:

We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section I ro(x) prematically equivalent (for the indications
referenced above and have determined the device and seriese merketed in interstate referenced above and nave decimined the actroed predicate devices marketed in interstate for use stated in the enclosure) to regally manced producal Device Ameridaents, or to
commerce prior to May 28, 1976, the enactment as a securiers of the Federal Food. Drug commerce prior to May 26, 1970, the chacultence with the provisions of the Federal Food, Drug,
devices that have been reclassified in accordance with the provisions of PMA) devices that have been reclassined in accordance while approval applioation (PMA).
and Cosmetic Act (Act) that do not require approval of a providens of the Act. The and Cosmetic Act (Act) that do not require approvate or are startest provisions of the Act. The Act. The Act. The Act. The You may, therefore, market the device, subject or the gentles for annual registration, listing of
general controls provisions of the Act include requirements michrending and general controls provisions of the Act Herado requirement 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 (see above) into critics case in the major regulations affecting your device can be
it may be subject to additional controls. Exist. if may be subject to additional controls. Extraing magos In addition, FDA may
found in the Code of Federal Regulations, Title 21, Parts Register Tound in the Code of Pederal Regatements, and the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA stisualite of a sudominer equirements of the Act
that FDA has made a determination that your device for accepcies. You must that IDA has made a decemination ina your arres by other Federal agencies. You must or any Federal Statutes and regulations annines of of not limited to: registration and listing comply with all the Act sTequirenchis; metalling practice requirements as set
(21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice the electronic (2) CFR Part 807); labeling (21 CFR Patr 800); government 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR 1000 1050 forth in the quanty Systems (QS) regulation (21 -542 of the Act); 21 CFR 1000-1050.
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)
The are and the comment of the of Substantial equivalence of your device to a le This letter will allow you to begin market in a beautes of your device of your device to a legally
premarket notification. The FDA including of substantial course and thus, premarket notification. The FDA tinding of substantial call of 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
s and the many of the former of the following numbers, based on the regula If you desire specific advice for your device on our laooling regulario (
contact the Office of Compliance at one of the following numbers, based on the regulation 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 advertising of your device, please contact the Additionally, for questions on the promotion and as a seculture cataliation ontitled, "Misbranding
Office of Compliance at [phone]. Association entitled, "Misoraneral Office of Compliance at (301) Sylands in Art 807.97 you may obtain. Other general
by reference to premarket notification" (21CFR Part be obtived from the Division of Small by reference to premarket nothication (21C. Act may be obtained from the Division of Small
information on your responsibilities under the Act may be obtained from the Univers information on your responsibilities three Asstance at its toll-free number [phone] or
Manufacturers, International and Consumer Assistance at its today, http:// Manufacturers, International and Colisumier Assistance at to con 2011
[phone] or at its Internet address http://www.fda.gov/odrh/dsma/dsmamain.html.

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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## Indications for Use

510(k) Number (if known): K033118

Device Name: BiPro Bicarb Mixing/Distribution System (BiPro SDS-CB200)

Indications For Use:

BiPro Model SDS-CB200 is intended for use in a hemodialysis facility for mixing and Dirro Model DDB ODDood ande (bicarb) to remote points of use. The bicarb is then mixed with purified water and acid to create the dialysate solution used in hemodialysis.

Prescription Use __ X (Part 21 CFR 801 Subpart D) AND/OR

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)

Nancy C Brogdon

(Division Sign-C Division of Reproduct ive, A Division of Radiological Devices 510(k) Number

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