ACID CONCENTRATE AND POWDER, ACETATE CONCENTRATE LIQUID AND POWDER, AND BICARBONATE CONCENTRATE LIQUID AND POWDER

K990507 · Althin Biopharm, Inc. · KPO · May 7, 1999 · Gastroenterology, Urology

Device Facts

• Record ID: K990507
• Device Name: ACID CONCENTRATE AND POWDER, ACETATE CONCENTRATE LIQUID AND POWDER, AND BICARBONATE CONCENTRATE LIQUID AND POWDER
• Applicant: Althin Biopharm, Inc.
• Product Code: KPO · Gastroenterology, Urology
• Decision Date: May 7, 1999
• 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 machine which is calibrated for acid and bicarbonate concentrates. This concentrate is formulated to be used with a three stream hemodialysis machine which is calibrated for acid and bicarbonate concentrates. This concentrate is formulated to be used with a two stream hemodialysis machine calibrated to an acetate concentrate dilution ratio of 1:34.

Device Story

Dialysate concentrates (liquid and powder) for hemodialysis; used as chemical components in hemodialysis machines. Acid and bicarbonate concentrates function with three-stream machines; acetate concentrate functions with two-stream machines at 1:34 dilution ratio. Used in clinical settings by trained healthcare professionals to prepare dialysate solution for patient treatment. Provides necessary electrolyte balance for extracorporeal blood purification.

Clinical Evidence

No clinical data provided; bench testing/regulatory compliance assumed for substantial equivalence.

Technological Characteristics

Liquid and powder chemical concentrates for hemodialysis. 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 patients requiring hemodialysis treatment using three-stream machines (acid/bicarbonate) or two-stream machines (acetate, 1:34 dilution).

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/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle with three lines forming its body and wings. The eagle is facing to the left. 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

MAY 7 1999

Mr. Jean Sauriol President and Director of Regulatory Affairs Althin Biopharm, Inc, 3885, boul. Industriel Laval, Quebec H7L 4S3

Re: K990507 Dialysate Concentrate For Hemodialysis (Liquid and Powder) Dated: February 9, 1999 Received: February 18, 1999 Requiatory Class: Il 21 CFR 876.5820/Procode: 78KPO

Dear Mr. Sauriol:

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 legally marketed predicate 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 III (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 (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 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/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D. Acting 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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K990507 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: Dialysate Bicarbonate Concentrate (Liquid and Powder)

Indications For Use:

This concentrate is formulated to be used with a three stream hemodialysis machine which is calibrated for acid and bicarbonate concentrates.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 990505 510(k) Number.

Prescription Use_ (Per 21CFR 801.109)

OR

Over-The-Counter Use_

(Optional Format 1-2-96)

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510(k) Number (if known): K990507

Device Name: Dialysate Acid Concentrate (Liquid and Powder)

Indications For Use:

This concentrate is formulated to be used with a three stream hemodialysis machine which is calibrated for acid and bicarbonate concentrates.

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Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Reproductive, Abdominal, ENT. and Radiological Dev 510(k) Number Prescription Use_ ﺎﺕ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ OR Over-The-Counter Use_ (Per 21CFR 801.109)

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Dialysate Acetate Concentrate (Liquid and Powder)

Indications For Use:

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This concentrate is formulated to be used with a two stream hemodialysis machine calibrated to an acetate concentrate dilution ratio of 1:34.

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| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------------------|----------------------|
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal, ENT, and Radiological Devices | |
| 510(k) Number | K990507 |
| Prescription Use | |
| (Per 21CFR 801.109) | |
| | OR |
| | Over-The-Counter Use |

(Optional Format 1-2-96)