ROCKWELL MEDICALTECHNOLOGIES, INC. CITRAPURE

K062399 · Rockwell Medical Technologies, Inc. · KPO · Nov 17, 2006 · Gastroenterology, Urology

Device Facts

• Record ID: K062399
• Device Name: ROCKWELL MEDICALTECHNOLOGIES, INC. CITRAPURE
• Applicant: Rockwell Medical Technologies, Inc.
• Product Code: KPO · Gastroenterology, Urology
• Decision Date: Nov 17, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5820
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Rockwell Medical Technologies, Inc. CitraPure® Acid Concentrate powders/liquidsfor 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

CitraPure® Acid Concentrate consists of powders and liquids containing salts and sugars; formulated for use in hemodialysis. Device functions by being proportioned/mixed with purified water and bicarbonate concentrate within a three-stream hemodialysis machine. Acidified concentrate enters one stream; bicarbonate/chloride/sodium concentrate enters second; water enters third. Streams mix to create final hemodialysis solution. Used in clinical settings by healthcare professionals. Benefits patients by providing necessary chemical composition for hemodialysis treatment.

Clinical Evidence

No clinical data. Bench testing performed to verify chemical composition and range of composition.

Technological Characteristics

Chemical concentrate for hemodialysis; powders and liquids. Formulated for three-stream proportioning systems. Complies with AAMI standards for purified water. No electronic or software components.

Indications for Use

Indicated for patients requiring acute or chronic hemodialysis. Used in conjunction with compatible hemodialysis machines and bicarbonate concentrate.

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 Technologies Dri-Sate® Acid Concentrate
• Rockwell Medical Technologies Acidified Component
• Concentrates Containing Di-Acetate for Bicarbonate Dialysis
• Advanced Renal Technologies DRYalysate Acid Concentrate
• Advanced Renal Technologies Citrasate Dialysate Acid Concentrate Liquia

Submission Summary (Full Text)

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K06 2399 Page 1 of 2

510K Notificati CitraPure® Dry Acid Concentrate for Bicarbonate Dialysis July 3156, 2006

# 510(K) SUMMARY

| SUBMITTER: | Rockwell Medical Technologies, Inc.<br>30142 Wixom Road - Wixom, MI 18393 USA<br>Phone [phone] – fax [phone]<br>NOV 17 200 |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DATE PREPARED: | July 19th, 2006 |
| DEVICE NAME: | CitraPure® Acid Concentrate |
| CLASSIFICATION NAMES: | Concentrate Solutions for Hemodialysis<br>Accessories to Hemodialysis |
| PREDICATE DEVICE: | Rockwell Medical Technologies Dri-Sate® Acid Concentrate<br>Rockwell Medical Technologies Acidified Component<br>Concentrates Containing Di-Acetate for Bicarbonate<br>Dialysis<br>Advanced Renal Technologies DRYalysate Acid Concentrate<br>Advanced Renal Technologies Citrasate Dialysate Acid<br>Concentrate Liquia |

#### Device Description:

The Rockwell Medical Technologies, Inc. CitraPure® Acid Concentrate for Bicarbonate Dialysis powders and liguits 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 solutions and powders when proportioned/mixed with pre-treated or purified water meeting or exceeding AAMI Standards, may be used in conventional and commercially available hemodialysis machines or monitors as a hemodialysis solution. The hemodialysis concentrate solutions and powders presented in this 510K Notification are intended to be 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 and citric acid is proportioned into the second stream of the hemodialysis machine, and water is proportioned into the third stream. These three streams are then mixed to prepare a final proportioned hemodialysis solution.

#### Predicate Devices:

The Rockwell Medical Technologies, Inc. CitraPure® hemodialysis concentrate powders and liquids are substantially equivalent to the Rockwell Medical Technologies Dri-Sate® Acid Concentrate and the Advanced Renal Technologies DRYalsate concentrates for hemodialysis.

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K062399

510K Notification
CitraPure® Dry Acid Concentrate for Bicarbonate Dialysis
July 31st, 2006

# Intended Use:

The Rockwell Medical Technologies, Inc. CitraPure® Acid Concentrate powders/liquidsfor 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:

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 substantially equivalent to the proposed device for these parameters.

## Clinical Test Results:

Clinical testing was not performed.

#### Conclusions:

Testing performed on the Rockwell Medical Technologies CitraPure® Acid Concentrate powders/liquids 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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Image /page/2/Picture/1 description: The image shows a logo for the Department of Health. The logo features a stylized image of three curved lines that resemble a bird in flight. To the left of the bird image, the words "DEPARTMENT OF HEALTH" are arranged in a semi-circular fashion.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Mr. Rob Chioini President Rockwell Medical Technologies 30142 Wixom Road WIXOM MI 48393

NOV 17 2006

Rc: K062399

Trade/Device Name: CitraPure® Acid Concentrate Regulation Number: 21 CFR §876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: KPO Dated: August 11, 2006 Received: August 21, 2006

Dear Mr. Chioini:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave rottored your could 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 ass stated in the energient date of the Medical Device Amendments, or to devices that proc to may 20, 1970, and cordance with the provisions of the Federal Food, Drug, and Cosmetic nu v och recently 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 (Premarket 11 your de room of a subject to such additional controls. Existing major regulations affecting your Apploval, it ifally of basile of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Image /page/2/Picture/10 description: The image shows a circular logo with the text "1906 - 2006" at the top. The letters "FDA" are prominently displayed in the center of the logo. Below the letters, the word "Centennial" is written in a cursive font. Three stars are arranged in a horizontal line beneath the word "Centennial". The logo is surrounded by a dotted circle.

Promoting Tublio -

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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/edrh/industry/support/index.html.

Sincerely yours,

Nancy Chogdon

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): K062399

Device Name: Rockwell Medical Technologies CitraPure®

Indications for Use:

The Rockwell Medical Technologies CitraPure® Acid Concentrate powders/liquids for bicarbonate dialysate are indicated for use in acute and chronic hemodialysis and are to be used with the appropriate hemodialysis machine/monitor and bicarbonate concentrate.

Prescription Use V (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)

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David h. Leygon
(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number