The Rockwell Medical Technologies' Bicarbonate Dialysate Concentrate Mixer is designed to mix the Rockwell Medical Technologies Concentrate Powders for Bicarbonate Dialysis with purified water to produce a bicarbonate concentrate solutions for hemodialysis for use in 3stream (acid concentrate, bicarbonate concentrate, and water) hemodialysis machines / monitors. The Rockwell Medical Technologies, Inc. Concentrate Powders for Bicarbonate Dialysis which are mixed with water in the Bicarbonate Dialysate Concentrate Mixer™ are indicated for use in acute and chronic hemodialysis.

Device Description

The Rockwell Medical Technologies' Bicarbonate Dialysate Concentrate Mixer is designed to mix the Rockwell Medical Technologies Dri-Sate Bicarbonate Concentrate Mixes with purified water to produce a bicarbonate concentrate solution for hemodialysis for use in 3-stream (acid concentrate, bicarbonate concentrate, and water) hemodialysis machines / monitors.

Hemodialysis therapy removes blood wastes by diffusion through a dialyzer membrane into a dialysate solution flowing on the opposite side of the dialyzer membrane. Hemodialysis also involves using a differential transmembrane pressure to ultrafilter water from the blood usually resulting in a net patient weight loss during the treatment.

The Rockwell Medical Technologies' Bicarbonate Dialysate Concentrate Mixer is designed to be used with The Rockwell Medical Supply, LLC. Dri-Sate™ Bicarbonate Concentrate Hemodialysis Mixes which contain sodium bicarbonate and sodium chloride and in another formulation, only sodium bicarbonate (for Cobe Machines). These Dri-Sate™ Bicarbonate Concentrate Hemodialysis Mixes have been previously cleared by the FDA in 510(k) Number K954527 on March 18, 1996. Copies of the 510(K) clearance letter and samples of the labels/instructions for use for these powders are included in Appendix II of this Notification. These are formulated and intended for use in hemodialysis when mixed or proportioned with the appropriate volume of purified water and acid concentrate in a three-stream hemodialysis machine.

These 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. These proportioned hemodialysis solutions are heated to body temperature and then perfused through the dialysis fluid compartment of artificial kidneys or hemodialyzers. These bicarbonate hemodialysis solutions are separated from the patient's blood by means of a semipermeable cellulosic or non-cellulosic membrane which serves as a molecular weight selective barrier to the passage of molecules beyond a certain molecular weight

AI/ML Overview

The provided text describes a 510(k) summary for the Rockwell Medical Technologies, Inc. Bicarbonate Dialysate Concentrate Mixer. Based on the information presented, here's an analysis regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state specific, quantifiable acceptance criteria (e.g., pH range, conductivity range, concentration accuracy) for the performance of the Bicarbonate Dialysate Concentrate Mixer.

Instead, the "performance" is implicitly defined by the device's substantial equivalence to predicate devices and its ability to produce a bicarbonate concentrate solution for hemodialysis as intended.

Acceptance Criteria (Implicit)	Reported Device Performance
Safety and Effectiveness: Device is safe, effective, and performs as well as the predicate device when used in accordance with instructions. (K032521, Conclusions)	"Testing performed on the Rockwell Medical Technologies, Inc. Bicarbonate Dialysate Concentrate Mixer indicates that it is safe, effective, and performs as well as the predicate device, when used in accordance with the instructions for use." (K032521, Conclusions)
Substantial Equivalence: Equivalent in composition, intended use, packaging, and labeling to currently approved mixing devices for hemodialysis concentrate solutions. (000052, Predicate Devices)	"Examination of the information pertaining to the Rockwell Medical Technologies Bicarbonate Dialysate Concentrate Mixer demonstrates that this device is equivalent in composition, intended use, packaging and labeling to other mixing devices for hemodialysis concentrate solutions currently approved for commercial distribution in the United States by the FDA." (000052, Predicate Devices)
Intended Use: Designed to mix Rockwell Medical Technologies Concentrate Powders for Bicarbonate Dialysis with purified water to produce a bicarbonate concentrate solution for hemodialysis. (000052, Intended Use; 000023, Indications for Use)	The device's design "is designed to mix the Rockwell Medical Technologies' Bicarbonate Dialysate Concentrate Mixes with purified water to produce a bicarbonate concentrate solution for hemodialysis..." (000051, Device Description) This statement is repeated as the Indications for Use. (000023)
Technological Characteristics: Utilizes the same methods and techniques as predicate devices for preparing hemodialysis concentrate solutions. (000052, Technological Characteristics)	"Comparing the proposed device to the predicate devices utilize the same methods and technique for preparing hemodialysis concentrate solutions. There are no significant differences." (000052, Technological Characteristics)

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

Test Set Sample Size: Not specified.
Data Provenance: The document explicitly states:
- "In vitro testing was not performed was not included in this 510(k) Notification." (000052, Summary of Non-Clinical Tests)
- "Clinical testing was not performed." (K032521, Clinical Test Results)
Therefore, there is no disclosed test set or primary data provenance in the provided document. The basis for the claims of safety, effectiveness, and substantial equivalence relies on comparison to predicate devices and the understanding of the underlying technology, rather than new empirical testing.

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

Not applicable, as no in vitro or clinical testing was performed for this 510(k) submission.

4. Adjudication Method for the Test Set

Not applicable, as no in vitro or clinical testing was performed for this 510(k) submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study was not done. The device is a concentrate mixer, not an imaging or diagnostic device that would typically involve human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, a standalone performance study was not done. This device is not an algorithm or AI system.

7. The Type of Ground Truth Used

Not applicable, as no in vitro or clinical testing was performed. The "ground truth" for the submission is based on the established safety and effectiveness of the predicate devices and the technological equivalence argument.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm.

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

Not applicable. This device is not an AI/ML algorithm.

Summary

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0 225321

510K Notification Rockwell Medical Technologies, Inc. Bicarbonate Dialysate Concentrate Mixer July 24th , 2002

Section 13. 510(k) Summary

JAN 0 3 2003

510(k) SUMMARY

SUBMITTER:	Rockwell Medical Technologies, Inc.
	30142 Wixom Road
	Wixom, MI 48393
	Phone: 248-960-9009
DATE PREPARED:	July 24th, 2002
DEVICE NAME:	Bicarbonate Dialysate Concentrate Mixer
CLASSIFICATION NAMES:	Accessory to Hemodialysis – Hemodialysis BathConcentrate Mixing Device
PREDICATE DEVICE:	Rockwell Medical Technologies' Dri-Sate™Mixer&
	Fresenius USA, Inc. Hemodialysis Concentration
	Dissolution Unit P/N 89-290-09

Device Description:

000051

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2252i

510K Notification Rockwell Medical Technologies, Inc. Bicarbonate Dialysate Concentrate Mixer July 24th , 2002

Predicate Devices:

The Rockwell Medical Technologies, Inc. Bicarbonate Dialysate Concentrate Mixer is substantially equivalent to the Rockwell Medical Technologies Dri-Sate™ Mixer for Dri-Sate™ acid concentrate solutions and to the Fresenius USA, Inc. Hemodialysis Concentration Dissolution Unit P/N 89-290-09. Examination of the information pertaining to the Rockwell Medical Technologies Bicarbonate Dialysate Concentrate Mixer demonstrates that this device is equivalent in composition, intended use, packaging and labeling to other mixing devices for hemodialysis concentrate solutions 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

Intended Use:

The Rockwell Medical Technologies' Bicarbonate Dialysate Concentrate Mixer is designed to mix the Rockwell Medical Technologies Concentrate Powders for Bicarbonate Dialysis with purified water to produce a bicarbonate concentrate solutions for hemodialysis for use in 3-stream (acid concentrate, bicarbonate concentrate, and water) hemodialysis machines / monitors. The Rockwell Medical Technologies, Inc. Concentrate Powders for Bicarbonate Dialysis which are mixed with water in the Bicarbonate Dialysate Concentrate Mixer™ are indicated for use in acute and chronic hemodialysis

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 methods and technique for preparing hemodialysis concentrate solutions. There are no significant differences.

Summary of Non-Clinical Tests:

In vitro testing was not performed was not included in this 510(k) Notification.

000052

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K032521

Clinical Test Results:

Clinical testing was not performed

Conclusions:

Testing performed on the Rockwell Medical Technologies, Inc. Bicarbonate Dialysate Concentrate Mixer 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/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the department's name encircling an abstract symbol. The symbol consists of three stylized human profiles facing right, arranged in a stacked formation. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

JAN 03 2003

ood and Drug Administration 00 Corporate Boulevard Rockville MD 20850

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

Re: K022521
Trade/Device Name: Bicarbonate Dialysate Concentrate Mixer . 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 (OS) 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 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. The

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	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy Cbrogdon

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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510 (k) NUMBER (IF KNOWN):

DEVICE NAME: Rockwell Medical Technologies, Inc., Bicarbonate Dialysate Concentrate Mixer

INDICATIONS FOR USE:

Indications for Use Statement

(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)

Over-The-Counter-Use (Optional Format 1-2-96)

Nancy C. Broadon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K022521

000023

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.