DRI-SATE DRY ACID CONCENTRATE FOR BICARBONATE DIALYSATE

K022500 · Rockwell Medical Technologies, Inc. · KPO · Dec 23, 2002 · Gastroenterology, Urology

Device Facts

• Record ID: K022500
• Device Name: DRI-SATE DRY ACID CONCENTRATE FOR BICARBONATE DIALYSATE
• Applicant: Rockwell Medical Technologies, Inc.
• Product Code: KPO · Gastroenterology, Urology
• Decision Date: Dec 23, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5820
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Rockwell Medical Technologies, Inc., Dri-Sate Dry Acid Concentrates for Bicarbonate Dialysate are indicated for use in acute and chronic hemodialysis and to be used with the appropriate hemodialysis machine/ monitor and bicarbonate concentrate.

Device Story

Dri-Sate Dry Acid Concentrates consist of salt, sugar, and non-sugar powders; formulated for use in bicarbonate hemodialysis. Device requires mixing with purified water and bicarbonate concentrate in a three-stream hemodialysis machine. Final proportioned solution is heated and perfused through the dialyzer fluid compartment. Semi-permeable membrane facilitates removal of waste products (urea, creatinine, potassium) from patient blood via concentration gradient. Used in clinical settings for acute and chronic renal failure patients. Output is a hemodialysis solution that enables toxin removal; clinical decision-making relies on selecting specific formulations to meet individual patient requirements for molecule/toxin removal rates.

Clinical Evidence

No clinical data. Evidence limited to in vitro bench testing confirming chemical composition and range of composition.

Technological Characteristics

Dry acid concentrate powder; chemical composition includes sodium diacetate, salts, and sugars. Designed for three-stream hemodialysis machines with specific dilution ratios (e.g., 1:34.00, 1:44.00). No electronic components, software, or energy sources. Sterilization not specified.

Indications for Use

Indicated for patients with acute or chronic renal failure requiring hemodialysis.

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

• Rockwell Medical Dri-Sate Acid Concentrate Mixes (K981003)
• Fresenius USA, Inc. Granuflo Dialysate Concentrate (K911459)

Submission Summary (Full Text)

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510K Notification DRI-SATE Dry Acid Concentrate for Bicarbonate Dialysis July 22 . 2002

# 510(k) SUMMARY

| SUBMITTER: | Rockwell Medical, Technologies, Inc.<br>30142 Wixom Road<br>Wixom, MI 48393<br>Phone: [phone] |
|-----------------------|--------------------------------------------------------------------------------------------------------|
| DATE PREPARED: | July 22nd, 2002 |
| DEVICE NAME: | Dri-Sate Dry Acid Concentrate Mixes<br>for Bicarbonate Dialysate |
| CLASSIFICATION NAMES: | Concentrate Solutions for Hemodialysis<br>Accessories to Hemodialysis |
| PREDICATE DEVICE: | Rockwell Medical Dri-Sate Acid Concentrate Mixes<br>Fresenius USA, Inc. Granuflo Dialysate Concentrate |
| Device Description: | |

DEC 2 3 2002The Rockwell Medical Technologies. Inc. DRI-SATE Dry Acid Concentrates containing sodium diacetate, for bicarbonate dialysis contain salt, sugar, and non-sugar and powders formulated and intended for use in hemodialysis when mixed or proportioned with the appropriate volume of purified water and bicarbonate concentrate / powder. These powders when proportioned/ mixed in a three-stream dialysis machine with pre-treated or purified water meeting or exceeding AAMI Standards and a bicarbonate concentrate solution, may be used in conventional and commercially available hemodialysis machines or monitors as a The hemodialysis powders presented in this 510K Notification are intended to be hemodialysis solution. used in three stream hemodialysis machines in which an acidified concentrate is proportioned into one stream, a bicarbonate, chloride and sodium concentrate solution which has been prepared by mixing the powder with a specified volume of water, is proportioned into the second stream of the hemodialysis machine, and water is proportioned into the third streams are then mixed to prepare a final proportioned hemodialysis solution. These types of a final hemodialysis solutions are commonly referred to as "Bicarbonate Hemodialysis Solutions." These proportioned hemodialysis solutions are then heated to body temperature and then perfused through the dialysis fluid compartment of artificial kidneys These bicarbonate hemodialysis solutions are separated from the patient's blood by or hemodialyzers. means of a semi-permeable cellulosic or non-cellulosic membrane which serves as a molecular weight selective barrier to the passage of molecules beyond a certain molecular weight. The molecular weigh cutoff of each type of membrane may vary depending on the membrane type, manufacturing process, etc. The semi-permeable membrane in a hemodialyzer permits the passage of smaller molecular weight (less than 5,000 Daltons for conventional cellulosic membranes), ionized molecules, waste products and toxins (i.e. blood urea nitrogen, creatinine, potassium, etc.) contained in the patient's blood circulating through the dialyzer, to pass through the semi-permeable membrane into the bicarbonate hemodialysis solutions, exit the hemodialyzer, enter the hemodialysis monitor and exit the monitor and are ultimately discarded. The ionic and molecular composition of the hemodialysis solution establishes the concentration gradient between the blood and the hemodialysis solution passing through the hemodialyzer which permits the effective removal of waste products and toxins found in excess in the patient's blood during acute and end-stage renal failure.

Since different patients have different requirements for the removal rates and quantities of various molecules and toxins (i.e. blood urea nitrogen, creatinine, potassium, phosphate, magnesium, chloride, sodium calcium water, etc.) in acute and chronic renal failure, it necessitates having a variety of different bicarbonate containing hemodialysis solutions to satisfy the needs of all acute and end-stage renal failure patients. In addition, there a number of different types of hemodialysis machines which have different proportioning rates. The concentrate mixes and solutions presented in this 510K Notification are designed

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K022500
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DRI-SATE Dry Acid Concentrate for Bicarb

or formulated to be used with hemodialysis machines that proportion according to the following dilution ratios:

| | Collection of the Children and Children and Children and Children Particle of Children and Children and<br>Stream 2 Seidified Concentrate Strenn 3. Bienchon | STATE POLICE<br>and the same of the comments of the many of the many of the may be |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| Water<br>Comprehender Comments of the Compress of Children and Children and Children and Children Company Comments of Children Comments of Children Comments of Children Comments of Ch | . 1.35.83 or 1:44.00 or 1<br>1:34.00 | 1:19.13 or 1:27.57 or 1:25.16 |

It is for these reasons that a manufacturer of these hemodialysis solutions and powders must provide a number of different formulations to contain varying concentrations of the various molecular weight The concentrations of these various molecular components are varied in the final components. hemodialysis solution within physiological and non-physiological ranges to permit the efficient removal of lack thereof from the patient's blood during hemodialysis. Please refer to the Labeling Section of this 510K for a complete listing of each formulation.

### Predicate Devices:

The Rockwell Medical Technologies, Inc. . Dri-Sate hemodialysis concentrate powders are equivalent to the Rockwell Medical Dri-Sate Acid concentrate powders for bicarbonate hemodialysis as well as the Fresenius USA, Inc., Granuflo/Gramulate Powder Dialysate Concentrates. Documentation concerning these hemodialysis bath concentrate powders is provided in Part B. of this Section.

Information contained within this section of this 510K Notification provides pertinent information on the proposed hemodialysis powders for bicarbonate hemodialysis and compares it to the same information for other commercially available hemodialysis bath concentrate powders. The Rockwell Medical Technologies, Inc. hemodialysis concentrate powders utilize the same chemicals and compositions as the predicate devices.

Examination of the enclosed information pertaining to the Rockwell Medical Technologies, Inc. hemodialysis concentrate powders for bicarbonate hemodialysis demonstrates that this device is substantially equivalent in composition, intended use, packaging to other hemodialysis concentrate powders currently approved for commercial distribution in the United States by the FDA. There are no significant differences between these marketed products and our proposed device.

| Device Name | Rockwell Medical Dri-Sate Acid Concentrate Mixes | Fresenius USA, Inc. Granullo Concentrates |
|----------------------|--------------------------------------------------------------------|--------------------------------------------------------------------|
| Intended Use | Acid Concentrate for Bicarbonate-containing hemodialysis solutions | Acid Concentrate for Bicarbonate-containing hemodialysis solutions |
| 510K Document Number | K981003 | K911459 |
| Approval Date | June 16th, 1998 | July 17th, 1991 |
| FDA Regulatory Class | II | II |

### Intended Use:

The Rockwell Medical Technologies, Inc., Dri-Sate Dry Acid Concentrates for Bicarbonate Dialysate are indicated for use in acute and chronic hemodialysis and to be used with the appropriate hemodialysis machine/ monitor and bicarbonate concentrate.

This indication statement is essentially the same as the indication statement for the predicate device.

### Technological Characteristics:

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510K Notification DRI-SATE Dry Acid Concentrate for Bicarbonate Dialysis July 22" . 2002

Comparing the proposed device to the predicate devices utilize the same range of chemical compositions, packaging and formulations. There are no significant differences.

### Summary of Non-Clinical Tests:

In vitro testing was performed to determine the chemical composition and range of composition.. The results of these tests confirmed that the proposed device is equivalent to the proposed device for these parameters.

#### Clinical Test Results:

Clinical testing was not performed

#### Conclusions:

Testing performed on the Rockwell Medical Technologies, Inc. Dri-Sate Acid Concentrate Solutions and Powders for Bicarbonate Dialysate indicates that it is safe, effective, and performs as well as the predicate device, when used in accordance with the instructions for use.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville . MD 20850

Mr. Gerald A. Fritz Director of Quality/Operations Rockwell Medical Technologies, Inc. 30142 Wixom Road WIXOM MI 48393

- Re: K022500 Trade/Device Name: DRI-SATE Dry Acid · Concentrates for Bicarbonate · Dialysate Regulation Number: 21 CFR 876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: 78 KPO Dated: October 28, 2002 Received: October 31, 2002
Dear Mr. Fritz:

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.

Image /page/3/Picture/9 description: The image shows a partial view of a document or logo, with the words "DEPARTMENT OF HEALTH" visible along a curved path, suggesting a circular seal or emblem. The text is in bold, sans-serif font. To the right of the text, there are abstract, black shapes that appear to be part of a design or symbol, possibly stylized waves or lines. The background is white, providing contrast to the black text and shapes.

DEC 23 2002

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This letter will allow you to begin marketing your device as described in your 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:

| 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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrh/dsma/dsmamain.html.

Sincerely yours.

Nancy Clingdon

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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#### 6022500 510 (k) NUMBER (IF KNOWN):

DEVICE NAME: Rockwell Medical Technologies, Inc., Dri-Sate Dry acid Concentrates for Bicarbonate Dialysate ":

## INDICATIONS FOR USE:

Indications for Use Statement

The Rockwell Medical Technologies, Inc., Dri-Sate Dry Acid Concentrates for Bicarbonate Dialysate are indicated for use in acute and chronic hemodialysis and to be used with the appropriate hemodialysis machine/ monitor and bicarbonate concentrate.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109) OR
Over-The-Counter-Use
(Optional Format 1-2-96)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
O(k) Number
KO22502

0001 = 4