BICARD MIXING SYSTEM

K030366 · Dialysis Systems, Inc. · FIN · Apr 19, 2004 · Gastroenterology, Urology

Device Facts

• Record ID: K030366
• Device Name: BICARD MIXING SYSTEM
• Applicant: Dialysis Systems, Inc.
• Product Code: FIN · Gastroenterology, Urology
• Decision Date: Apr 19, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5820
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of the Dialysis Systems Inc. Bicarbonate Mixing System is the mixing of water and sodium bicarbonate powder for hemodialysis treatment and the delivery of the mixture to the treatment floor.

Device Story

DSI Bicarb Mixing System performs batch mixing of sodium bicarbonate powder with water to create liquid concentrate for hemodialysis. System utilizes a mixing tank, external closed-loop circuit, pump, and eductor. Powder is drawn from an additive hopper into the fluid stream via the eductor; mixing is achieved through eductor action, return flow, and internal tank nozzles. The resulting concentrate is transferred to a loop tank for delivery to the treatment floor. Device is intended for clinical use in hemodialysis settings.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

System consists of a mixing tank, pump, eductor, and recirculation nozzles. Operates via mechanical fluid circulation and eductor-based powder induction. Standalone batch mixing system. No software or electronic control algorithms described.

Indications for Use

Indicated for the preparation of bicarbonate liquid concentrate from sodium bicarbonate powder and water for use 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

• Sodium Bicarbonate Mixers/Delivery Systems (K970674)

Submission Summary (Full Text)

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Premarket Notification 510(k) Submittal DSI Bicarb Mixing System

APR 1 9 2004

## 5 510(k) Summary

K030366
Page 1 of 1

Submitter Information: Dialysis Systems, Inc. Company Name: 2000 Blair Boulevard Company Address: Nashville, TN 37212 615-292-0333 Company Phone [phone] Company Fax: 1. Mark Vesligaj Contact Person(s): 2. Michael Peterson January 17, 2003 Prepared: Bicarbonate Mixing System Trade Name: Hemodialysis System and Accessories Classification Name: (21 CFR 876.5820) G.E.M. Water Systems, International Substantial Equivalence: Sodium Bicarbonate Mixers/Delivery Systems 510(k)# K970674 This device is intended for the mixing of sodium Intended Use: bicarbonate powder with water for hemodialysis treatment. Dialysis Systems Inc.'s Bicarbonate Mixing System Device Description: provides for batch mixing of bicarbonate liquid concentrate and transfer to a loop tank. The mixing tank works in conjunction with an external closed-loop mixing circuit that includes a pump and an eductor. The pump circulates liquid from the mixing tank, through the eductor and back into the mixing tank. The eductor is connected to a sodium bicarbonate additive hopper. A measured amount sodium bicarbonate additive is drawn into the mixing tank by the flow of fluid through the eductor. Mixing of the powder to create a bicarbonate liquid concentrate is accomplished by the mixing action of the eductor, the return flow to the mix tank and by further mixing action created by nozzles as the fluid is re-

circulated back into the mix tank.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird with three wavy lines extending from its body.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 9 2004

Mr. Mark Vesligaj Jagotrab Vice President Dialysis Systems, Inc. 2003 Blair Boulevard NASHVILLE TN 37212

Re: K030366

Trade/Device Name: DSI BiCarb Mixing System Regulation Number: 21 CFR 876.§5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: 78 FIN Dated: March 29, 2004 Received: April 1, 2004

Dear Mr. Vesligaj Jagotrab:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, 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 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.

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This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will allow you to begin harteeing your ential equivalence of your device to a legally premarket nothication. The PDA muling of the increasing 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 If you desire specific advice for your dones on but 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, 101 questions of the promote the regulation entitled, "Misbranding Other of Compliance at [phone] Part 807.97) you may obtain. Other general by reterence to premation on your responsibilities under the Act may be obtained from the Division of Straal Manufacturers, International and Consumer Assistance at its toll-free number [phone] or Manufacturers, International and Solleamhttp://www.fda.gov/cdrh/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

Page 2

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## Indications for Use

510(k) Number (if known): K030366

Device Name: Bicarbonate Mixing System

Indications for Use:

The intended use of the Dialysis Systems Inc. Bicarbonate Mixing System is the mixing of water and sodium bicarbonate powder for hemodialysis treatment and the delivery of the mixture to the treatment floor.

Prescription Use P (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Lygum

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _

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