The Rockwell Medical Supply LLC. Dri-Sate Acid Concentrate Solutions and powders 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 Description

The Rockwell Medical Supply, LLC. Dri-Sate Acid Concentrate Mixes / hemodialysis concentrate solutions and powders contain salt, sugar, and non-sugar and water containing solutions and powders are formulated and intended for use in hemodialysis when mixed or proportioned with the appropriate volume of purified water and bicarbonate solution/powder. These solutions and powders when proportioned/ mixed with pretreated 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 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 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 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.

AI/ML Overview

Here's an analysis of the provided text regarding acceptance criteria and the study conducted for the Rockwell Medical Supply, LLC. Dri-Sate Acid Concentrate Mixes:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state defined acceptance criteria with numerical targets. Instead, the basis for approval is "substantial equivalence" to a predicate device. The performance is reported in terms of chemical composition and functionality.

Acceptance Criteria Category	Specific Criteria (Implicit via Substantial Equivalence)	Reported Device Performance
Chemical Composition	Chemically equivalent to the predicate device	"confirmed that the proposed device is substantially equivalent to the proposed device for these parameters."
Intended Use	Same as predicate device	"This indication statement is essentially the same as the indication statement for the predicate device."
Technological Characteristics	Same range of chemical compositions, packaging, and formulations as predicate device	"both devices utilize the same range of chemical compositions, packaging and formulations. There are no significant differences."
Safety and Effectiveness	Safe, effective, and performs as well as the predicate device	"indicates that it is safe, effective, and performs as well as the predicate device, when used in accordance with the instructions for use."

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

Sample Size for Test Set: The document does not specify a quantitative sample size for the "in vitro testing." It only generally mentions "testing was performed."
Data Provenance: The testing was "in vitro testing." The country of origin is not explicitly stated, but given the submission to the FDA, it is presumed to be relevant to the US market or conducted according to US regulatory standards. The testing appears to be retrospective in the sense that it's comparing a new product to an existing predicate.

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

This information is not applicable as the study described is a non-clinical, in vitro chemical comparison study, not one requiring expert human interpretation of medical data. There is no "ground truth" established by experts in the context of diagnostic or interventional performance.

4. Adjudication Method for the Test Set

This is not applicable for an in vitro chemical comparison. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving human interpretation or subjective assessments.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not performed."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable as the device is a medical concentrate solution, not an algorithm or AI-driven system. The "standalone" performance here would refer to the chemical properties of the concentrate itself, which was assessed through in vitro testing.

7. The Type of Ground Truth Used

For this specific device, the "ground truth" used for comparison was the chemical composition and performance characteristics of the predicate device (Renal Systems Hemodialysis Concentrate Solutions / Renal Systems Sta-Pak Bicarbonate Hemodialysis Bath Concentrate Solutions & Powders), as determined by testing. There was no pathology, expert consensus on clinical findings, or outcomes data used as the ground truth.

8. The Sample Size for the Training Set

This information is not applicable. The device is a chemical concentrate, not a machine learning model. Therefore, there is no "training set" in the context of an AI algorithm.

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

This information is not applicable for the reasons stated in point 8.

Summary

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K981003

JUN 16 1998

510K Notification Rockwell Medical Supply, LLC. Dri-Sate Acid Concentrate Mixes March 10th, 1998

510K(k) SUMMARY

SUBMITTER:	Rockwell Medical, LLC.Rockwell Medical Supply, LLC.28025 Oakland OaksWixom, MI 48393Phone: 810-546-0040
DATE PREPARED:	March 10th, 1998
DEVICE NAME:	Dri-Sate Acid Concentrate Mix
CLASSIFICATION NAMES:	Concentrate Solutions for HemodialysisAccessories to Hemodialysis
PREDICATE DEVICE:	Dial Medical, Inc. Acetate-BasedConcentrate

Device Description:

CONFIDENTIAL 000123

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510K Notificatio Rockwell Medical Supply, LLC. Dri-Sate Acid Concentrate Mixes

March 10th, 1998

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 The concentrate mixes and solutions presented in this 510K Notification are rates. designed or formulated to be used with hemodialysis machines that proportion according to the following dilution ratios:

TABLE	I
-------	---

Stream 1	Stream 2: AcidifieConcentrateProportioning Ratios	Stream 3: BicarbonateConcentrateProportioning Ratios
Water	1:35.83 or 1:44.00 or1:34.00	1:19.13 or 1:27.57 or1:25.16

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 components. The concentrations of these various molecular components are varied in the final hemodialysis solution within physiological and nonphysiological 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 Supply, LLC. Concentrate Solutions for Acetate Dialysate are substantially equivalent to the Renal Systems Sta-Pak acid component of the bicarbonate hemodialysis bath concentrate solutions / powders.

Examination of the information pertaining to the Rockwell Medical Supply, LLC. Acetate hemodialysis concentrate for bicarbonate hemodialysis demonstrates that this device is substantially equivalent in composition, intended use, packaging and labeling to other hemodialysis solutions and 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.

000124 CONFIDENTIAL

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510K Notification Rockwell Medical Supply, LLC. Dri-Sate Acid Concentrate Mixes March 10th, 1998

Page 3 of 3

TABLE I

PREDICATE DEVICE

Device Name	Renal SystemsHemodialysisConcentrate Solutions
Intended Use	Renal Systems Sta-PakBicarbonateHemodialysis BathConcentrate Solutions& Powders
510KNumberDocument	Unknown
Approval Date	Unknown
FDA Regulatory Class	II

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 device, both 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 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 LLC 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.

000125

CONFIDENTIAL

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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 three abstract shapes resembling human figures or birds in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the emblem.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 16 1998

Rockwell Medical Supply LLC c/o Jeffrey R. Shideman, Ph.D. International Medical Products, Inc. 4503 Moorland Avenue Minneapolis, MN 55435

Re: K981003 Dri-Sate Acid Concentrate Mixes Dated: March 10, 1998 Received: March 18, 1998 Regulatory Class: II 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 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 your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject ి ప్ర to such additional controls. Existing major regulations 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 (OS) 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/dsmaldsmamain.html".

Sincerely yours

Lillian Yin, Ph.D.

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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K981003 510(k) Number (if known):

Rockwell Nedical Supply, LLC Dri-Sate Acid Concentrate Mixe Device Name:

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 981003 510(k) Number Prescription Use .. Over-The-Counter Use l OR (Per 21 CFR 801.109) (Optional Format 1-2-96)

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.