DIALYSOL-ACID CONCENTRATE LIQUID, GRANUSOL-ACID CONCENTRATE POWDER, RENALSOL-ACETATE CONCENTRATE LIQUID & POWDER, BIOSOL

K981043 · Solution Technologies · KPO · May 26, 1998 · Gastroenterology, Urology

Device Facts

• Record ID: K981043
• Device Name: DIALYSOL-ACID CONCENTRATE LIQUID, GRANUSOL-ACID CONCENTRATE POWDER, RENALSOL-ACETATE CONCENTRATE LIQUID & POWDER, BIOSOL
• Applicant: Solution Technologies
• Product Code: KPO · Gastroenterology, Urology
• Decision Date: May 26, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5820
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

THIS CONCENTRATE IS FORMULATED TO BE USED WITH A THREE STREAM HEMODIALYSIS MACHING WHICH IS CALIBEATED FOR ACID AND BICARBONATE CONCENTRATES. THIS CONCENTRATE IS FORMULATED TO BE USED WITH A TWO STEEAM HEMODIAYSIS MACHINE CALIBRATEN TO AN ACETATE CONCENTRATED DICUTION RATIO OF 1:34. THIS CONCENTRATE IS FORMULATED TO BE USED WITH A THEEE STREAM HEMODIALYSIS MACHINE WHICH 18 CALIBRATED FOR ACID AND BICARBONATE CONCENTRATES.

Device Story

Dialysate concentrates (liquid and powder forms: Dialysol, Granusol, Renalsol, Biosol) function as chemical components for hemodialysis. Concentrates are mixed with water and bicarbonate/acid components by hemodialysis machines to create dialysate solution. Used in clinical settings by trained personnel. Output is the dialysate fluid used to remove waste products and balance electrolytes in patients with renal failure. Facilitates extracorporeal blood purification.

Clinical Evidence

No clinical data provided; substantial equivalence based on chemical formulation and compatibility with established hemodialysis machine standards.

Technological Characteristics

Liquid and powder dialysate concentrates (acid, bicarbonate, acetate). Formulated for specific dilution ratios (e.g., 1:34 for acetate) and machine stream configurations (two-stream or three-stream).

Indications for Use

Indicated for use in patients undergoing hemodialysis requiring acid, bicarbonate, or acetate dialysate concentrates. Must be used with compatible three-stream or two-stream hemodialysis machines calibrated to specific dilution ratios.

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.

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows a logo for the Department of Health. The logo consists of a stylized, abstract symbol that resembles a series of curved lines or waves. The text "DEPARTMENT OF HEALTH" is arranged vertically along the left side of the symbol, with the letters oriented to be read from top to bottom.

Fublic Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 2085C

MAY 2 6 1998

Mr. William J. Griswold, Jr. Solution Technology 4825 South 850 East South Ogden, Utah 84403

Re: K981043 Dialysol, Granusol, Renalsol and Biosol Liquid and Powder Dialysate Concentrate Dated: March 18, 1998 Received: March 20, 1998 Regulatory Class: II 21 CFR §876.5820/Product code: 78 KPO

Dear Mr. Griswold:

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 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 Feleral Resulations, 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 resonse to your premarket notification submission does not affect any obligation you might have under sections 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 (2) 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/dsmaln.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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510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: DIALYSATE ACID CONCENTRATE (LIQUID & Powere)

Indications For Use:

THIS CONCENTRATE IS FORMILIATED TO BE USED WITH A THREE STREAM HEMODIALYSIS MACHING WHICH IS CALIBEATED FOR ACID AND BICARBONATE CONCENTRATES.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Robert D. Netheny/

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

510(k) Number K981047

Description Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

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310(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: DIALYSATE ACETATE CONCENTRATE (LIQUID & POWDER) Indications For Use:

THIS CONCENTRATE IS FORMULATED TO BE USED WITH A TWO STEEAM HEMODIAYSIS MACHINE CALIBRATEN TO AN ACETATE CONCENTRATED DICUTION RATIO OF 1:34

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Robert R.Stling
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K981043

. )scription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

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K981043 ﮈ10(k) Number (if known): ________

Device Name: DIALYSATE BICARBONATE CONCENTRATE ( LIQUID & POWIDER)

Indications For Use:

THIS CONCENTRATE IS FORMULATED TO BE USED WITH A THEEE STREAM HEMODIALYSIS MACHINE WHICH 18 CALIBRATED FOR ACID AND BICARBONATE CONCENTRATES.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Robert R. Sither/

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number (98104 7

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)