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 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.

AI/ML Overview

The provided 510(k) notification for the CitraPure® Dry Acid Concentrate for Bicarbonate Dialysis does not present acceptance criteria in the typical format of performance metrics with thresholds. Instead, the entire submission is focused on demonstrating substantial equivalence to predicate devices based on chemical composition and intended use.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Chemical composition within the range of predicate devices	"The results of these tests confirmed that the proposed device is substantially equivalent to the proposed device for these parameters."
Same range of chemical compositions, packaging, and formulations as predicate devices	"Comparing the proposed device to the predicate devices utilize the same range of chemical compositions, packaging and formulations. There are no significant differences."
Safe, effective, and performs as well as predicate device	"Testing performed ... indicates that it is safe, effective, and performs as well as the predicate device, when used in accordance with the instructions for use."
Intended use aligns with predicate device	"This indication statement is essentially the same as the indication statement for the predicate device."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not explicitly stated. The "in vitro testing" likely involved laboratory analysis of the chemical composition of the CitraPure® concentrate. The number of batches or samples tested is not provided.
Data Provenance: The testing was "in vitro," implying laboratory-based testing on the manufactured product. There is no mention of country of origin for the data or whether it was retrospective or prospective in the context of clinical data, as no clinical data was collected.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Experts: Not applicable. The "ground truth" for chemical composition would be established through analytical chemistry techniques and comparison to product specifications or predicate device data, not by expert interpretation in the way, for example, a radiologist interprets images.
Qualifications: Not applicable for establishing chemical ground truth. The analyses would be performed by qualified laboratory technicians and chemists.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. Given that the testing involved chemical composition analysis, there would not be an adjudication process involving multiple human reviewers like in a clinical study. The determination of "substantial equivalence" based on chemical parameters would be a direct comparison against established specifications or predicate device data.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study: No. The device is a medical concentrate, not an imaging or diagnostic device that would typically involve human readers. Clinical testing was explicitly stated as "not performed."

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

Standalone Performance: Not applicable. This concept pertains to AI/ML devices where the algorithm performs a task independently. The CitraPure® concentrate is a chemical product, not an algorithm. The "performance" refers to its chemical properties and intended function as a component in dialysis.

7. Type of Ground Truth Used

Type of Ground Truth: The ground truth for the "non-clinical tests" (in vitro testing) was based on chemical composition analysis and comparison to predicate device specifications/data. This is akin to a "laboratory standard" or "established chemical profile."

8. Sample Size for the Training Set

Sample Size for Training Set: Not applicable. Chemical concentrates do not have "training sets" in the context of AI/ML algorithms. The manufacturing process itself (which determines the composition) implicitly involves quality control and formulation development, but this is distinct from training a machine learning model.

9. How the Ground Truth for the Training Set Was Established

How Ground Truth for Training Set Was Established: Not applicable. As there is no training set in the AI/ML sense, there is no ground truth to be established for it. The formulation of the CitraPure® concentrate would have been developed and refined through standard chemical engineering and manufacturing processes to achieve the desired composition, which then aligns with the predicate devices.

Summary

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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.30142 Wixom Road - Wixom, MI 18393 USAPhone 248-960-9009 – fax 248-960-9119NOV 17 200
DATE PREPARED:	July 19th, 2006
DEVICE NAME:	CitraPure® Acid Concentrate
CLASSIFICATION NAMES:	Concentrate Solutions for HemodialysisAccessories to Hemodialysis
PREDICATE DEVICE:	Rockwell Medical Technologies Dri-Sate® Acid ConcentrateRockwell Medical Technologies Acidified ComponentConcentrates Containing Di-Acetate for BicarbonateDialysisAdvanced Renal Technologies DRYalysate Acid ConcentrateAdvanced Renal Technologies Citrasate Dialysate AcidConcentrate Liquia

Device Description:

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:

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 (800) 638-2041 or (240) 276-3150

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)

Page of

David h. Leygon
(Division Sign-Off)

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

Regulation Number and Section

§ 876.5820 Hemodialysis system and accessories.

(a)
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.
(b)
Classification. (1) Class II (performance standards) for hemodialysis systems and all accessories directly associated with the extracorporeal blood system and the dialysate delivery system.(2) Class I for other accessories of the hemodialysis system remote from the extracorporeal blood system and the dialysate delivery system, such as the unpowered dialysis chair, hemodialysis start/stop tray, dialyzer holder set, and dialysis tie gun and ties. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.