NATURALYTE, MODEL # 08-4004-1

K982813 · Kaybath, Inc. · KPO · Nov 6, 1998 · Gastroenterology, Urology

Device Facts

• Record ID: K982813
• Device Name: NATURALYTE, MODEL # 08-4004-1
• Applicant: Kaybath, Inc.
• Product Code: KPO · Gastroenterology, Urology
• Decision Date: Nov 6, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5820
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

KayBath acid concentrate for bicarbonate dialysis is indicated in the treatment of acute and chronic renal failure during the hemodialysis procedure, with the appropriate hemodialysis machine.

Device Story

Device consists of liquid or powder hemodialysis concentrate solutions containing salts (sodium, magnesium, calcium, potassium), dextrose, and glacial acetic acid. Used in conjunction with AAMI-standard reverse osmosis water and bicarbonate dialysate. Proportioned in a 3-stream hemodialysis machine; streams unite to form dialysate flowing countercurrent to blood through a dialyzer. Acetic acid maintains pH (7.1-7.4) to prevent calcium carbonate precipitation in proportioning systems and provides buffer capacity. Dialyzer membrane acts as selective barrier; urea, nitrogen, and potassium pass from blood to dialysate for removal. Operated by clinical staff in dialysis settings. Output is a purified blood stream; clinical decision-making relies on electrolyte/solute removal rates tailored to patient needs via specific concentrate formulas.

Clinical Evidence

No clinical data performed. Bench testing not performed; equivalence based on descriptive comparison of chemical composition and formulation to currently marketed predicate devices.

Technological Characteristics

Liquid or powder concentrate containing sodium, magnesium, calcium, potassium, dextrose, and glacial acetic acid. Formulated using AAMI-standard reverse osmosis water. Proportioned in 3-stream hemodialysis machines. No specific materials of construction or software components described.

Indications for Use

Indicated for patients with acute and chronic renal failure requiring 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

• Fresenius USA, Acid Concentrate for Bicarbonate Dialysis (K810925)

Submission Summary (Full Text)

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K982813

6 1998 NOV

# 510(k) SUMMARY

| SUBMITTER: | Bonnie Nakayama, RN, CNN, MBA<br>KayBath, Inc.<br>95-1509 Ainamakua Drive, #32<br>Mililani, HI 96789<br>Phone: [phone] |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Bonnie Nakayama |
| DATE PREPARED: | August 1, 1998 |
| DEVICE NAME: | Dialysate Concentrate for Hemodialysis<br>(Liquid or Powder) |
| CLASSIFICATION NAME: | Concentrate Solutions for Hemodialysis<br>Accessories to Hemodialysis |
| PREDICATE DEVICE: | Fresenius USA, Acid Concentrate for<br>Bicarbonate Dialysis |

# Device Description:

KayBath hemodialysis concentrate solutions contain various salts (sodium, magnesium, calcium and potassium), along with dextrose and glacial acetic acid. Pharmaceutical grade water, produced by a reverse osmosis pump under AAMI Standards, is used to mix the salts, dextrose and acetic acid. The solution is formulated and intended for the express purpose of performing hemodialysis. The acidified dialysate is proportioned inside commercially available hemodialysis machines with water and bicarbonate dialysate. The three streams of liquid unite to become the dialysate that runs countercurrent to the blood through the dialyzer at 500cc/min. See Table 6-1. The hemodialysis device provides the means to maintain the temperature, conductivity, electrolyte balance, flow rate and pressure of the dialysate. The dialyzer consists of hundreds of hollow strands of a cellulosic or synthetic membrane inside a cylinder. The membrane serves as a selective barrier to the passage of molecules beyond a certain molecular

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weight. While the blood travels through the hollow strands, undesirable substances in the blood, such as urea, nitrogen, potassium, etc., pass through the semipermeable membrane into the dialysate and are flushed down the drains.

| PROPORTIONING RATIO | | |
|---------------------|-------------|-----------|
| Stream 1 | Stream 2 | Stream 3 |
| water | bicarbonate | acid |
| | dialysate | dialysate |
| 42.28 | 1.72 | 1 |

TABLE 6-1

The clinical application of high-efficiency and high-flux treatments in the 1980s carefully defined the dialysate composition used to achieve a stable dialysis treatment. Table 6-2 shows the typical composition of dialysate components used in commonly prescribed high-efficiency and high-flux treatments. A sodium concentration of 140-142 mEq/L provides the best ionic concentration for achieving isotonic ultrafiltration in patients during dialysis, so that excess water loss from the blood is averted. The presence of acetic acid in the acid concentrate provides the appropriate pH controls to prevent calcium carbonate precipitation in the proportioning and valve systems. Precipitation of calcium carbonate in the proportioners can score their internal aspects and freeze up the proportioning systems. The use of 4 mEq/L of acetic acid in the final acid concentrate provides a safety margin to ensure the pH of the dialysate is between 7.1 and 7.4. The small amount of acetic acid is metabolized in the patient to bicarbonate and provides additional buffer capacity.

| TYPICAL COMPOSITION of DIALYSATE | |
|----------------------------------|------------------|
| Sodium | 100 mEq/L |
| Potassium | 0 to 3 mEq/L |
| Calcium | 2.5 to 3.5 mEq/L |
| Magnesium | 0.75 to 1 mEq/L |
| Acetic Acid | 2.5 to 4.5 mEq/L |
| Chloride | 100 to 107 mEq/L |
| Dextrose | 0 to 200 mg/dl |

TABLE 6-2

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Since different patients require different removal rates of certain substances, like calcium and potassium, a variety of different acidified dialysate formulas will need to be available:

| COMMONLY PRESCRIBED FORMULAS | | |
|------------------------------|-----------|-----------|
| Series No. | Potassium | Calcium |
| 4 | 1 mEq/L | 0 mEq/L |
| 5 | 1 mEq/L | 2.5 mEq/L |
| 6 | 1 mEq/L | 3.0 mEq/L |
| 7 | 2 mEq/L | 0 mEq/L |
| 8 | 2 mEq/L | 2.5 mEq/L |
| 9 | 2 mEq/L | 3.0 mEq/L |

TABLE 6-3

## Predicate Devices:

KayBath acidified concentrate solutions are substantially equivalent to Fresenius USA hemodialysis concentrates in composition, intended use, packaging and labeling, in addition to all the other makers of this solution. The composition is quite precise and uniform. There are no significant differences between those marketed products and this proposed device.

| Device Name: | Fresenius USA<br>Naturalyte Acid Concentrate for Bicarbonate<br>Dialysis |
|-----------------------|--------------------------------------------------------------------------|
| Intended Use: | Bicarbonate Dialysis Bath<br>Concentrate Solution |
| 510(k) Number: | K810925 |
| Approval Date: | April 6, 1981 |
| FDA Regulatory Class: | II |

Intended Use:

KayBath acid concentrate for bicarbonate dialysis is indicated in the treatment of acute and chronic renal failure during the hemodialysis procedure, with the appropriate hemodialysis machine. This indication statement is essentially the same as the indication statement of the predicate device.

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K78 2813 Page 4/4

#### Technological Characteristics:

In 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:

No in vitro testing was performed to determine the chemical composition and range of composition at this time. There are no important descriptive differences in comparison to the currenlty marketed product. The descriptive characteristics are precise enough to ensure comparability will be achieved when the proposed device is produced according to this description.

Clinical Test Results: Clinical testing was not performed.

#### Conclusions:

KayBath concentrate solutions for bicarbonate dialysis will be safe, effective, and perform as well as the predicate device, when used in accordance with industry standards.

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Image /page/4/Picture/2 description: The image shows a logo for the Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES" written around the perimeter. Inside the circle is an abstract image of a human figure. The figure is composed of three curved lines that form the shape of a person's head and shoulders.

NOV 6 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Bonnie Nakayama, R.N., C.N.N., M.B.A. KayBath, Inc. 95-547 Ukee Street, #110 Waipahu, HI 96797

Re: K982813 Concentrate Solutions for Hemodialysis Dated: July 15, 1998 Received: August 11, 1998 Regulatory Class: II 21 CFR 876.5820/Procode: 78 KPO

Dear Ms. Nakayama:

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 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 (2) 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 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), piease 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 Reproducti Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

7

KayBath Concentrate Solutions for Device Name: Bicarbonate Hemodialysis

Indications For Use: KayBath acid concentrate dialysate is administered with bicarbonate dialysate and AAMI quality water in a 3 stream proportioning artificial kidney equipment to perform hemodialysis in the ES ID population

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Segerson

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Division Sign Off

(Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological Devi 510(k) Number.

Prescription Use ,Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)