MODIFICATION TO: DRYAC ACID CONCENTRATE MIX FOR BICARBONATE HEMODIALYSIS

K052253 · Gambro Renal Products · KPO · Nov 2, 2005 · Gastroenterology, Urology

Device Facts

• Record ID: K052253
• Device Name: MODIFICATION TO: DRYAC ACID CONCENTRATE MIX FOR BICARBONATE HEMODIALYSIS
• Applicant: Gambro Renal Products
• Product Code: KPO · Gastroenterology, Urology
• Decision Date: Nov 2, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.5820
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Gambro DryAC acid concentrate mix for bicarbonate Hemodialysis is indicated for use with concentrated bicarbonate solution in 3-stream proportioning artificial kidney equipment using purified, AAMI standard water.

Device Story

DryAC is an acid concentrate mix used to prepare acid dialysis concentrate solutions for bicarbonate hemodialysis. It is intended for use with 3-stream proportioning artificial kidney equipment. The device requires purified, AAMI standard water for preparation. It is used in clinical settings by healthcare professionals to facilitate the hemodialysis process.

Technological Characteristics

Acid concentrate mix for preparation of dialysis solutions. Designed for use with 3-stream proportioning artificial kidney equipment. Requires AAMI standard water for dilution.

Indications for Use

Indicated for use with concentrated bicarbonate solution in 3-stream proportioning artificial kidney equipment using purified, AAMI standard water for patients undergoing bicarbonate hemodialysis.

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

• DryAC Acid Concentrate Mix for Bicarbonate Dialysis (K011368)

Submission Summary (Full Text)

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K05 2253

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## GAMBRO Renal Products

1845 Mason Avenue
Daytona Beach, FL 32117 Facility Registration No. 1051129 Special 510(k) Premarket Notification

Page 14 of 15

NOV - 2 2005

## 510(k) Summary (Page 1 of 1): 12.0

| Submitter's Name: | Fei Law, Quality and Regulatory Manager, U.S. Solutions |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Phone: | [phone] |
| Fax: | [phone] |
| Contact: | Fei law |
| Date Prepared: | 08/12/05 |
| Trade Name: | DryAC Acid Concentrate Mix for Bicarbonate Hemodialysis |
| Common Name: | Dialysate Concentrate for Bicarbonate Hemodialysis |
| Classification Name: | Dialysate Concentrate for Hemodialysis (Liquid or Powder) |
| Equivalent Predicate: | DryAC Acid Concentrate Mix for Bicarbonate Dialysis<br>Gambro Renal Products, K011368 |
| Device Description: | Gambro DryAC is an acid concentrate mix used for the preparation<br>of acid dialysis concentrate solutions that are used in bicarbonate<br>hemodialysis. |
| Intended Use: | Gambro DryAC acid concentrate mix for bicarbonate Hemodialysis<br>is indicated for use with concentrated bicarbonate solution in 3-<br>stream proportioning artificial kidney equipment using purified,<br>AAMI standard water. |
| Predicate Device<br>Comparison: | The modified Gambro DryAC device has the same intended use,<br>indication for use, chemical composition and ingredient<br>concentrations as the predicate device. There are no significant<br>technological changes.<br>The Gambro DryAC Acid Concentrate Mix for Bicarbonate Dialysis<br>described in this submission is, in our opinion, substantially<br>equivalent to the predicate device. |

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Image /page/1/Picture/2 description: The image shows a logo with a stylized bird figure. The bird is facing right and has three lines representing its wings. To the left of the bird, there is text arranged in a circular pattern, likely the name of an organization or department.

NOV - 2 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Fei Law Quality and Regulatory Manager U.S. Solutions Gambro Renal Products 1845 Mason Avenue DAYTONA BEACH FL 32117

Re: K052253

Trade/Device Name: DryAC Acid Concentrate Mix for Bicarbonate Hemodialysis Regulation Number: 21 CFR §876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: KPO Dated: September 23, 2005 Received: October 3, 2005

Dear Ms. Law:

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); Iabeling (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) 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), please contact the Office of Compliance at 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 807.97). You may obtain other general information on your responsibilities under the Act from the 001:57/: " Carmal Manufacturers, 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

510(k) Number (if known):

Device Name: DryAC Acid Concentrate Mix for Bicarbonate Hemodialysis

Indications For Use:

Gambro DryAC acid concentrate mix for bicarbonate hemodialysis is indicated for use with concentrated bicarbonate solution in 3-stream proportioning artificial kidney equipment using purified, AAMI standard water.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Jorint A. Simmon

510(k)

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