AMERIWATER SOLUTION MIX AND DISTRIBUTION SYSTEM FOR HEMODIALYSIS

K051031 · Ameriwater · FIN · Jan 6, 2006 · Gastroenterology, Urology

Device Facts

• Record ID: K051031
• Device Name: AMERIWATER SOLUTION MIX AND DISTRIBUTION SYSTEM FOR HEMODIALYSIS
• Applicant: Ameriwater
• Product Code: FIN · Gastroenterology, Urology
• Decision Date: Jan 6, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5820
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AmeriWater Solution Mix and Distribution System for Hemodialysis is intended to be used in a hemodialysis facility to mix and deliver, to the point(s) of use, bicarbonate and acid solutions necessary for hemodialysis. Federal law restricts this device to sale by or on the order of a physician for use in hemodialysis applications. The AmeriWater Bicarb Mix and Distribution System (Dual Tanks) is intended to be used in a hemodialysis facility to mix and deliver, to the point(s) of use, bicarbonate and acid solutions necessary for hemodialysis. The AmeriWater Solution Mixing System (Single Tank) is intended to be used in a hemodialysis facility to mix and deliver, to the point(s) of use, bicarbonate and acid solutions necessary for hemodialysis. The AmeriWater Acid Concentrate Distribution System is intended to be used in a hemodialysis facility to store and deliver, to the point(s) of use, acid concentrate(s) necessary for hemodialysis. The AmeriWater Wallbox for Dialysis is intended to be used in a hemodialysis facility as the point of connection for water, bicarbonate, and acid solution, for use in hemodialysis applications.

Device Story

System mixes and distributes bicarbonate and acid concentrates for hemodialysis; utilizes facility-provided purified water. Components include Bicarb Mix and Distribution System (single/dual tanks), Acid Concentrate Distribution System, and wall-mounted connection boxes. Bicarb system features automatic fill/mix, high-vortex pumping, and pressurized distribution. Acid system stores and recirculates concentrate for consistent delivery. Wall boxes provide connection points for water, acid, and bicarbonate at the dialysis machine. Operated by facility staff in clinical hemodialysis settings. Output is the delivery of prepared dialysis solutions to the point of care. Benefits include automated, consistent, and efficient preparation and distribution of hemodialysis fluids.

Clinical Evidence

Bench testing only.

Technological Characteristics

System components include mixing tanks, pumps, and wall-mounted connection boxes. Features include automatic fill/mix, high-vortex pumping, and pressurized recirculation. Connectivity is limited to physical plumbing and connection interfaces at the point of use. No software or electronic control algorithms described.

Indications for Use

Indicated for use in hemodialysis facilities to mix, store, and distribute bicarbonate and acid solutions to dialysis machines at points of use. Prescription use only.

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

• Better Water Central Concentrate Delivery System for Dialysis, Central Bicarbonate Mixing/Delivery System (1992793)

Submission Summary (Full Text)

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PAGE 1 OF 1

JAN 6 2006

N 6 2006

August 16, 2005

1 303 Stanley Avenue Dayton, Ohio 45404 Phone: [phone] Phone: [phone] Fax: [phone] www.ameriwater.com

Subject: 510 (K) SUMMARY

| 510 (K) Number: | K051031 |
|----------------------|-----------------------------------------------------------------------------------------|
| AmeriWater Contact: | Brian R. Bowman, Quality Manager |
| Proprietary Name: | AmeriWater Solution Mix and Distribution System for Hemodialysis |
| Common Name: | Mixing and distribution system for bicarbonate and acid concentrates for hemodialysis. |
| Classification Name: | Tank, Holding, Dialysis and Accessories |
| Classification: | Class II Medical Device under §876.5665<br>Panel: Gastroenterology<br>Product Code: FIN |

Intended Use: The AmeriWater Solution Mix and Distribution System for Hemodialysis is intended to be used in a hemodialysis facility to mix and deliver, to the protitis) of use, bicarbonate and acid solutions necessary for hemodialysis. Federal law restricts this point(o) or use, blockburns necessary for use in hemodialysis and applications

Device Description: The AmeriWater Bicarb Mix and Distribution System utilizes purified water from the dialysis facility's water purification system to mix bicarbonate solution and to distribute the solution to the solution to the The system features automatic fill and mix, high vortex pumped mixing action, lightly point(s) of use. pressurized distribution, and efficient disinfection. A single tanks punplex, lightly, lightly Mixing System, is also available to mix solutions from concentrate.

The AmerilWater Acid Concentrate Distribution System is used to store and distribute the acid concentrate(s) required for hemodialysis to the suited in and distributed by the act concentrate(s)
Distribution, System, in mined ne point(s) of use. Solution stored in and distributed by Distribution System is mixed prior to being transferred to the system. Lightly pressurized distribution and recirculation provides steady, consistent delivery.

AmeriWater Wall Boxes are recessed boxes located at the point(s) of use that are intended to provide acid, bicarb, and/or water connections connections of the point(s) or use that and the medialysis facility. Walling boxes are available in several configurations the the mires used in the nemodalysis facility. Wall dialysis machine fittings are professionally installed by AmeriWater.

Statement of Substantial Equivalence: The AmeriWater Solution Mix and Distribution System for Hemodialysis is substantially equivalent in intended use, function, and technology to the Better Water Central Concentrate Delivery System for Dialysis, Central Bicarbonate Mixing/Delivery System (1992793).

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 6 2006

Mr. Brian R. Bowman Quality Manager AmeriWater® 1303 Stanley Avenue DAYTON OH 45404

Re: K051031

Trade/Device Name: AmeriWater Solution Mix and Distribution System for Hemodialysis Regulation Number: 21 CFR §876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: FIN Dated: November 23, 2005 Received: November 28, 2005

Dear Mr. Bowman:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin matteeing your device of your device to a legally premarket notification: The FDA midnig of basiant --------------------------------------------------------------------------------------------------------------------------proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire sfiectific advice for your dortes on one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation entitled, "Thisostanians on your responsibilities under the Act from the 807.97). I ou may obtain outcr general international and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C. Hogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

K051031 5 (0(k) Number (f known)

AmeriWater Solution Mix and Distribution System for Hemodialysis Device Name:

The AmeriWater Solution Mix and Distribution System for Hemodialysis is intended Indications For Use The Amerivater Solution Mix and Distribution Oyetsman (s) of use, and the point(s) of use, to be used in a nemodialysis necessary for hemodialysis. Federal law restricts bicarboriate and acid solutions nooleously for represent for use in hemodialysis applications

AmeriWater Bicarb Mix and Distribution System, Models 00BC55-55, 00BC100-100, and 00BC100-200
10 hotel in a AmeriWater Bicarb Mix and Distribution System for Hemolialysis is intended to be used in a
(Dual Tanks): The AmeriWater Bicarb Mix and Distribution System for hemocialysis (Dual Tanks): The Amerivater Bicard Mix and Distribution of Stockbirgs one ons been belief in themodialysis.
hemodialysis facility to mix and deliver, to the point(s) of use hemodialysis facility to mix and deliver, to the point(s) or assi blanchan i ruse in hemodialysis applications.

AmeriWater Solution Mixing System, Model 00BC100 (Single Tank): The AmeriWater Solution Mixing AmeriWater Solution Mixing System, Moder Society to the point(s) of the point(s) of the point(s) of the point(s) of the order of a System is intended to be used in a nemodalysis. Tablity to mix and active to sale by or on the order of a physician for use in hemodialysis applications.

AmeriWater Acid Concentrate Distribution System, Models 00AS130, 00AS300, and 00A5500: The AmeriWater Acid Concentrate Distribution Dystem, ned in a hemodialysis facility of store and
AmeriWater Acid Concentrate Distribution System is intended to sections his do AmeriWater Acid Concentrate Distribution System is themsed to boysis. Federal law restricts this device to deliver, to the point(3) of doo, asia for use in hemodialysis applications.

AmeriWater Wallboxes for Dialysis: The AmeriWater Wallbox for Dialysis in intended to be used in a Ameriwater Wallboxes Tor Dialysis. The Ainentrator Trader, bicarbonate, and acid solution, for use in hemodialysis facility as the point of this device to sale by or on the order of a physician for use in hemodialysis applications.

> × Preseription Use Part 21 OFR 501 Subpart Di

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Over-The-Counter Use _ i21 CFR 801 Subpart O:

IPLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED !

Concurrence of CDRH Office of Device Evaluation (CDE):

Daniel L. Ingram

(Division Sign-Off Division of Reproductive. Abdominal and Radiological Devic

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510(k) Number