ROCKWELL MEDICAL SUPPLY, LLC. DRI-SATE ACID CONCENTRATE MIXES

K981003 · International Medical Products, Inc. · KPO · Jun 16, 1998 · Gastroenterology, Urology

Device Facts

• Record ID: K981003
• Device Name: ROCKWELL MEDICAL SUPPLY, LLC. DRI-SATE ACID CONCENTRATE MIXES
• Applicant: International Medical Products, Inc.
• Product Code: KPO · Gastroenterology, Urology
• Decision Date: Jun 16, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5820
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

Dri-Sate Acid Concentrate Mixes are chemical formulations (salts, sugars, water) used in hemodialysis. The device functions as a component of a three-stream proportioning system in hemodialysis machines; it is mixed with purified water and a bicarbonate concentrate to create the final dialysate solution. This solution is heated and circulated through the dialysate compartment of a hemodialyzer, separated from patient blood by a semi-permeable membrane. The concentration gradient established by the dialysate facilitates the removal of waste products (e.g., urea, creatinine, potassium) and toxins from the blood of patients with acute or end-stage renal failure. The device is intended for clinical use by trained personnel in facilities equipped with compatible hemodialysis monitors.

Clinical Evidence

No clinical data. Bench testing was performed to verify chemical composition and formulation ranges, confirming equivalence to the predicate device.

Technological Characteristics

Chemical concentrate solutions and powders for hemodialysis. Formulated for use in three-stream proportioning hemodialysis machines with specific dilution ratios (e.g., 1:35.83, 1:44.00, 1:34.00 for acid; 1:19.13, 1:27.57, 1:25.16 for bicarbonate). Non-mechanical, chemical-based device.

Indications for Use

Indicated for patients requiring acute or chronic hemodialysis treatment.

Regulatory Classification

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.

Predicate Devices

• Renal Systems Sta-Pak Bicarbonate Hemodialysis Bath Concentrate Solutions & Powders (Unknown 510(k))

Submission Summary (Full Text)

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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.<br>Rockwell Medical Supply, LLC.<br>28025 Oakland Oaks<br>Wixom, MI 48393<br>Phone: [phone] |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------|
| DATE PREPARED: | March 10th, 1998 |
| DEVICE NAME: | Dri-Sate Acid Concentrate Mix |
| CLASSIFICATION NAMES: | Concentrate Solutions for Hemodialysis<br>Accessories to Hemodialysis |
| PREDICATE DEVICE: | Dial Medical, Inc. Acetate-Based<br>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

> 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: Acidifie<br>Concentrate<br>Proportioning Ratios | Stream 3: Bicarbonate<br>Concentrate<br>Proportioning Ratios |
|----------|-----------------------------------------------------------|--------------------------------------------------------------|
| Water | 1:35.83 or 1:44.00 or<br>1:34.00 | 1:19.13 or 1:27.57 or<br>1:25.16 |

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 Systems<br>Hemodialysis<br>Concentrate Solutions |
|----------------------------|-------------------------------------------------------------------------------------------------|
| Intended Use | Renal Systems Sta-Pak<br>Bicarbonate<br>Hemodialysis Bath<br>Concentrate Solutions<br>& Powders |
| 510K<br>Number<br>Document | Unknown |
| Approval Date | Unknown |
| FDA Regulatory Class | II |

#### Intended Use:

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.

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.

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#### CONFIDENTIAL

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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:

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.

(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)