The Rockwell Medical Supply LLC. Concentrate Solutions for Acetate Dialysate are indicated for use in acute and chronic hemodialysis and to be used with the appropriate hemodialysis machine/ monitor.

Device Description

The Rockwell Medical Supply, LLC. Hemodialysis concentrate solutions and for acetate dialysate contain salt (acetate, sodium, calcium, potassium and chloride), sugar (dextrose), and water containing solutions formulated and intended for use in hemodialysis when mixed or proportioned with the appropriate volume of purified water. These solutions 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 presented in this 510K Notification are intended to be used in two stream hemodialysis machines in which an acetate concentrate is proportioned into one stream, and a specified volume of water is proportioned into the second stream of the hemodialysis machine proportioning system. These two streams are then mixed to prepare a final proportioned hemodialysis solution. These types of a final hemodialysis solutions are commonly referred to as "Acetate 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 acetate 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 cialyzer, to pass through the semi-permeable membrane into the acetate containing 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

The provided text is a 510(K) summary for a medical device: "Concentrate Solutions for Acetate Dialysate" by Rockwell Medical, LLC. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific performance criteria through a detailed study.

Therefore, many of the requested details about acceptance criteria, study design, and ground truth are not applicable or not provided in this type of regulatory submission. The document explicitly states: "Clinical testing was not performed."

Here's a breakdown of the information that can be extracted or inferred based on the supplied text:

Acceptance Criteria and Device Performance

Since this is a substantial equivalence submission, the "acceptance criteria" are implicitly met if the proposed device is found to be substantially equivalent to the predicate device. The primary "performance" demonstrated is that the device has the same chemical composition and intended use as the legally marketed predicate device.

Acceptance Criteria Category	Specific Criteria (Inferred from Substantial Equivalence Basis)	Reported Device Performance and Compliance
Intended Use	The intended use of the proposed device is the same as the predicate device.	"The Rockwell Medical Supply LLC. Concentrate Solutions for Acetate Dialysate are indicated for use in acute and chronic hemodialysis and to be used with the appropriate hemodialysis machine/ monitor." "This indication statement is essentially the same as the indication statement for the predicate device."
Technological Characteristics (Chemical Composition & Formulation)	The chemical composition and formulations of the proposed device are within the same range as the predicate device.	"Comparing the proposed device to the predicate devices utilize the same range of chemical compositions, packaging and formulations. There are no significant differences." "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."
Packaging & Labeling	The packaging and labeling of the proposed device are substantially equivalent to the predicate device.	"...substantially equivalent in composition, intended use, packaging and labeling to other acetate hemodialysis solutions currently approved for commercial distribution in the United States by the FDA." (No further details on specific labeling attributes are provided in the summary, but the general claim is made.)
Safety and Effectiveness	The device is safe, effective, and performs as well as the predicate device when used as intended. (This is an overall conclusion for substantial equivalence).	"Testing performed on the Rockwell Medical LLC Concentrate Solutions for Acetate Dialysate indicates that it is safe, effective, and performs as well as the predicate device, when used in accordance with the instructions for use." (This is a conclusion drawn from the substantial equivalence assessment, not from independent clinical trials described here).

Study Details Based on the Provided 510(K) Summary:

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable. There was no specific "test set" in the context of clinical performance evaluation. The "testing" referred to appears to be analytical/bench testing to confirm chemical composition.
- Data Provenance: The "in vitro testing" was performed by the submitter (Rockwell Medical, LLC). Specific details about the data's origin (e.g., country) are not provided, but it would have been conducted internally by Rockwell Medical. The study is akin to retrospective analytical comparison to the predicate device's established characteristics.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There was no clinical test set requiring expert ground truth. Ground truth for the chemical composition would be established through laboratory analysis following recognized standards/methods, not expert consensus in the clinical sense.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. As no clinical test set requiring human adjudication was involved.
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:
- Not applicable. This device is a solution for hemodialysis, not an AI-assisted diagnostic or therapeutic device that would involve human "readers" or an MRMC study.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm or AI device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this submission is the established chemical composition and operational characteristics of the predicate device. The proposed device's chemical parameters were compared against these established ranges via in vitro chemical analysis.
The sample size for the training set:
- Not applicable. This is not a machine learning or AI device that would require a "training set."
How the ground truth for the training set was established:
- Not applicable. No training set was used.

Summary

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510K(k) SUMMARY

SUBMITTER:	Rockwell Medical, LLC.Rockwell Medical Supply, LLC.28025 Oakland OaksWixom, MI 48393Phone: 810-546-0040	OCT 30
DATE PREPARED:	August 15th, 1997
DEVICE NAME:	Concentrate Solutions for AcetateDialysate
CLASSIFICATION NAMES:	Concentrate Solutions for HemodialysisAccessories to Hemodialysis
PREDICATE DEVICE:	Dial Medical, Inc. Acetate-BasedConcentrate

Device Description:

0 1997

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acetate containing 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 acetate containing hemodialysis solutions to satisfy the needs of all acute and end-stage renal failure patients. The solutions presented in this 510K Notification are designed or formulated to be used with hemodialysis machines that proportion according to the following dilution ratios:

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It is for these reasons that a manufacturer of these hemodialysis solutions 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 non-physiological ranges to permit the efficient removal of lack thereof from the patients 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 Dial Medical, Inc. Acetate hemodialysis bath concentrate solutions.

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

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TABLE I PREDICATE DEVICES

Device Name	Dial Medical ofFlorida HemodialysisBath ConcentrateSolutions
Intended Use	Acetate HemodialysisBath ConcentrateSolutions
510KDocumentNumber	K864285
Approval Date	March 7, 1987
FDA Regulatory Class	II

Intended Use:

The Rockwell Medical Supply LLC. Concentrate Solutions for Acetate Dialysate are indicated for use in acute and chronic hemodialysis and to be used with the appropriate hemodialysis machine/ monitor

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 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 Concentrate Solutions for Acetate 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/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

3 0 1997

Rockwell Medical Supply, LLC c/o Jeffrey R. Shideman, Ph.D. International Medical Products Corporation 7307 Glouchester Drive Edina, Minnesota 55435

Re: K973253

Rockwell Medical Supply, LLC, Concentrate Solutions for Acetate Dialysis Dated: August 15, 1997 Received: August 29, 1997 Regulatory class: II 21 CFR 8876.5820/Product code: 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 that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, 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 III (Premarket Approval), it may be subject 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 requirement, 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 sobes not affect any obligation you might have under sections 531 through 542 of the Act for devices under 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 question 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/dsmamain.html".

Sincerely yours

W.Liau Yu
Lillian Yin, Ph.D.

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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Page 1 of 1

510(k) Number (if known): __ K973253

Device Name:Roclwell Medical Supply, LLC Concentrate Solutions for Acetate Hemodialysis

Indications For Use:

The Rockwel-1 Medical Supply Concentrate Solutions for Acctate Hemodialysis are indicated for use in acute and chronic hemodialysis and to be used with the appropriate hemodialysis machine/ monitor.

(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
510(k) Number K973253

Prescription Use V (Per 21 CFR 801.109)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(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.