The Rockwell Medical Technologies' Dri-Sate™Mixer is designed to mix the Rockwell Medical Technologies Dri-Sate Acid Concentrate Mixes with purified water to produce an acid concentrate solution for hemodialysis for use in 3-stream (acid concentrate, bicarbonate concentrate, and water) hemodialysis machines / monitors. The Rockwell Medical Supply LLC. Dri-Sate Acid Concentrate Solutions which are mixed in the Dri-Sate Mixer™ are indicated for use in acute and chronic hemodialysis and to be used with the appropriate hemodialysis machine/ monitor and bicarbonate concentrate

Device Description

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' Dri-Sate™ Mixer is designed to be used with the Rockwell Medical Supply, LLC. Dri-Sate™ Acid Concentrate Hemodialysis Mixes which contain salt, sugar, and non-sugar and water containing solutions and powders. These are 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 Dri-Sate™ Acid hemodialysis Mixes which have been presented in a previously cleared 510K Notification (K981003) 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 glacial acetic 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. 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 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. The molecular weigh cut-off 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 and non-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.

AI/ML Overview

The provided text does not contain information about acceptance criteria or a study proving the device meets them in the context of performance metrics like accuracy, sensitivity, or specificity. Instead, the document describes a 510(k) submission for a medical device (Rockwell Medical Technologies' Dri-Sate™ Mixer) that sought to demonstrate substantial equivalence to a predicate device.

Here's a breakdown of why the requested information cannot be extracted from the provided text:

Nature of the Device: The Dri-Sate™ Mixer is a device designed to mix solutions for hemodialysis. It is not a diagnostic device or an AI-powered system that would typically have performance metrics like sensitivity, specificity, or rely on expert ground truth for evaluation. It's a mechanical mixing apparatus.
510(k) Submission Focus: The 510(k) process primarily focuses on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use, technological characteristics, and raises no new safety or effectiveness questions. It doesn't typically require extensive performance studies with acceptance criteria in the way a novel therapeutic or diagnostic device might.
Absence of Performance Data: The document explicitly states:
- "In vitro testing was not performed was not included in this 510(k) Notification."
- "Clinical testing was not performed."

Therefore, based on the provided text, I cannot complete the table or answer most of your detailed questions because the type of study and data you're asking about were not part of this 510(k) submission.

However, I can extract the following relevant information regarding the absence of such studies:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric Category	Acceptance Criteria	Reported Device Performance
In vitro Performance	Not applicable	Not performed
Measurement Accuracy / Mixing Uniformity	Not specified	N/A
Clinical Performance	Not applicable	Not performed
Patient Outcome Improvement / Safety	Not specified	N/A
Substantial Equivalence (Primary Criterion)	Not explicitly stated as "acceptance criteria" but implied by the 510(k) process: same intended use, similar technological characteristics, no new safety/effectiveness concerns.	Device found substantially equivalent to Fresenius USA, Inc. Hemodialysis Concentration Dissolution Unit P/N 89-290-09 (K944493).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

No test set was used as no in vitro or clinical testing was performed for this 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable as no test set was used and no ground truth was established by experts for performance evaluation. The device is a mixer, not a diagnostic tool requiring expert interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable as no test set was used.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, a multi-reader multi-case comparative effectiveness study was not done. This device is not an AI-assisted tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a mechanical mixer, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable as no performance studies requiring ground truth were conducted.

8. The sample size for the training set

Not applicable as no training set was used.

9. How the ground truth for the training set was established

Not applicable as no training set was used.

Summary

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Rockwell Medical Technologies

KID SETS

Rockwell Medical Technologies Dri-Sate™ Mixe

Section 16. 510(k) Summary

510K(k) SUMMARY

SUBMITTER:	Rockwell Medical Technologies28025 Oakland OaksWixom, MI 48393Phone: 248-546-0040
DATE PREPARED:	October 14th, 1998
DEVICE NAME:	Dri-Sate Mixer for Preparation of AcidifiedDialysate Concentrate
CLASSIFICATION NAMES:	Accessory to Hemodialysis - Hemodialysis BathConcentrate Mixing Device
PREDICATE DEVICE:	Fresenius USA, Inc. Hemodialysis ConcentrationDissolution Unit P/N 89-290-09

Device Description:

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Rockwell Medical Technologies Dri-Sate™ Mixer

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. 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 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. The molecular weigh cut-off 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 and non-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.

TABLE I

Stream 1	Stream 2 Acidified Concentrate Proportioning Ratios	Stream 3: Bicarbonate Concentrate Proportioning Ratios
Water	1:35.83 or 1:44.00 or 1:34.00	1:19.13 or 1:27.57 or 1:25.16

The Rockwell Medical Technologies Dri-Sate™ Acid Concentrate Mixes for hemodialysis have been previously cleared for marketing in the US under a 510(k) Notification on June 16th, 1998 (510(k) Number K981003).

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Predicate Devices:

The Rockwell Medical Technologies Dri-Sate™ Mixer for Dri-Sate™ acid concentrate solutions is substantially equivalent to the Fresenius USA, Inc. Hemodialysis Concentration Dissolution Unit P/N 89-290-09 (510(k) Number K944493).

Examination of the information pertaining to the Rockwell Medical Technologies Dri-Sate™ Mixer demonstrates that this device is substantially 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 ' Dri-Sate™Mixer is designed to mix the Rockwell Medical Technologies Dri-Sate Acid Concentrate Mixes with purified water to produce an acid concentrate solution for hemodialysis for use in 3-stream (acid concentrate, bicarbonate concentrate, and water) hemodialysis machines / monitors. The Rockwell Medical Supply LLC. Dri-Sate Acid Concentrate Solutions which are mixed in the Dri-Sate Mixer™ 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 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.

Clinical Test Results:

Clinical testing was not performed

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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 features a stylized depiction of a human figure, represented by three overlapping profiles, suggesting a sense of community and care. The profiles are positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA", which is arranged in a circular fashion around the figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 5 1999

Jeffrey R. Shideman, Ph.D. Rockwell Medical Technologies, Inc. 28025 Oakland Oaks Court Wixom. MI 48393

Re: K983618 Dri-Sate™ Mixer for Preparation of Acidified Dialysate Dated: June 15, 1999 Received: June 21, 1999 Requlatory Class: Il 21 CFR §876.5820/Procode: 78 KPO

Dear Dr. Shideman:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 vour device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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.

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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4004

Page / of /

510 (k) NUMBER (IF KNOWN): K983618

DEVICE NAME: Rockwell Medical Technologies, Inc. Dri-Sate Mixer for Preparation of Acidified Dialysate

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)

David G. Hanson

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological De 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.