B. BRAUN BICARBONATE DIALYSATE

K041683 · B.Braun Medical, Inc. · KPO · Aug 27, 2004 · Gastroenterology, Urology

Device Facts

• Record ID: K041683
• Device Name: B. BRAUN BICARBONATE DIALYSATE
• Applicant: B.Braun Medical, Inc.
• Product Code: KPO · Gastroenterology, Urology
• Decision Date: Aug 27, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5820
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

B. Braun Bicarbonate Dialysate is indicated for use with renal replacement therapy systems that utilize sterile bicarbonate dialysate.

Device Story

B. Braun Bicarbonate Dialysate is a sterile, non-pyrogenic solution for use in renal replacement therapy. The device consists of a flexible two-chamber bag containing bicarbonate solution in one chamber and electrolyte solution in the other, separated by a peel seam. To prepare the 5,000 mL ready-to-use solution, the user presses the small chamber to break the peel seam and rocks the bag to mix the contents. The solution is intended for use with compatible renal replacement therapy systems. It provides the necessary dialysate fluid for patients undergoing renal replacement therapy, facilitating the removal of waste products and fluid balance management.

Technological Characteristics

Sterile, non-pyrogenic bicarbonate dialysate solution. Provided in a flexible two-chamber bag system with a peel seam for on-site mixing. 5,000 mL volume.

Indications for Use

Indicated for use with renal replacement therapy systems requiring sterile bicarbonate dialysate. Patient population not specified.

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

• Gambro PrismaSate Dialysis Solutions for Continuous Renal Replacement Therapy (K013448)

Submission Summary (Full Text)

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K041683 Page 1 of 1

## AUG 27 2004

## 510(k) Summary 8.0

| SUBMITTER: | B. Braun Medical Inc.<br>901 Marcon Boulevard<br>Allentown, PA 18109-9341<br>[phone], ext. 2516 |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact: Jennifer A. Pung, Senior Analyst, Regulatory Affairs |
| DEVICE NAME: | B. Braun Bicarbonate Dialysate |
| COMMON OR USUAL NAME: | Bicarbonate Dialysate |
| DEVICE CLASSIFICATION: | Class II, 21 CFR § 876.5820, Hemodialysis System and Accessories (Product Code KPO) |
| PREDICATE DEVICE: | Gambro Renal Products - Gambro PrismaSate Dialysis Solutions for Continuous Renal Replacement Therapy (K013448) |
| DESCRIPTION: | The B. Braun Bicarbonate Dialysate Solutions are a family of sterile, non-pyrogenic, bicarbonate dialysate solutions. The solutions will be provided in flexible two-chamber bags, with bicarbonate solution in one chamber and electrolyte solution in the other chamber. The chambers are separated by a peel seam. The 5,000 mL ready-to-use solution is obtained by pressing on the small chamber of the bag until the peel seam opens, and then rocking the bag back and forth to mix the contents. |
| INTENDED USE: | B. Braun Bicarbonate Dialysate is indicated for use with renal replacement therapy systems that utilize sterile bicarbonate dialysate. |
| SUBSTANTIAL EQUIVALENCE: | The B. Braun Bicarbonate Dialysate has a similar composition range, container/closure system, and indications for use as the PrismaSate Dialysis Solutions marketed by Gambro under the 510(k) Premarket Notification K013448. |

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or other bird with three curved lines representing its wings or feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 7 2004

Ms. Jennifer A. Pung Senior Analyst, Regulatory Affairs B. Braun Medical, Inc. 901 Marcon Blvd. ALLENTOWN PA 18109-9341

Re: K041683

Trade/Device Name: B. Braun Bicarbonate Dialysate Regulation Number: 21 CFR §876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: 78 KPO Dated: June 18, 2004 Received: June 21, 2004

Dear Ms. Pung:

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 (PMA), it may be subject to 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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## Indications for Use Statement 2.0

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Page _________________________________________________________________________________________________________________________________________________________________________

| 510(k) Number (if known): | K041683 |
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Device Name:

B. Braun Bicarbonate Dialysate

Indications For Use:

Prescription Use

(Per 21 CFR 801.109)

B. Braun Bicarbonate Dialysate is indicated for use with renal replacement therapy systems
. D. Draun Droaise bicarbonate dialysate.

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

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

OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

X

Daniel A. Syverson

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