B. BRAUN MODIFIED BICARBONATE DIALYSATE

K052393 · B.Braun Medical, Inc. · KPO · Nov 9, 2005 · Gastroenterology, Urology

Device Facts

• Record ID: K052393
• Device Name: B. BRAUN MODIFIED BICARBONATE DIALYSATE
• Applicant: B.Braun Medical, Inc.
• Product Code: KPO · Gastroenterology, Urology
• Decision Date: Nov 9, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.5820
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

B. Braun Modified Bicarbonate Dialysate is a sterile, non-pyrogenic solution used in hemodialysis. 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 renal replacement therapy systems in clinical settings. It provides the necessary dialysate for hemodialysis procedures, supporting the removal of waste products and excess fluids from the patient's blood.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Sterile, non-pyrogenic bicarbonate dialysate solution. Provided in a flexible two-chamber bag with a peel seam for mixing. No electronic components, software, or energy sources.

Indications for Use

Indicated for hemodialysis in patients requiring renal replacement therapy using systems compatible with sterile bicarbonate dialysate.

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

• B. Braun Bicarbonate Dialysate (K041683)

Submission Summary (Full Text)

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K052393

## NOV - 9 2005

7.0 510(k) Summary

| SUBMITTER: | B. Braun Medical Inc.<br>901 Marcon Boulevard<br>Allentown, PA 18109-9341<br>[phone]<br>Contact: Christine Ford<br>Sr. Regulatory Affairs Analyst |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DEVICE NAME: | B. Braun Modified 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: | B. Braun Bicarbonate Dialysate |
| DESCRIPTION: | The B. Braun Modified 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 Modified Bicarbonate Dialysate is indicated for hemodialysis use with renal replacement therapy systems that utilize sterile bicarbonate dialysate |
| SUBSTANTIAL EQUIVALENCE: | The B. Braun Modified Bicarbonate Dialysate has a similar composition range and the same container/closure system and indications for use as the B. Braun Bicarbonate Dialysate solutions previously cleared under the B. Braun Medical, Inc. 510(k) Premarket Notification K041683. |

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Image /page/1/Picture/2 description: The image shows a logo with a bird-like symbol inside a circle. The bird is stylized with three curved lines representing its body and wings. The text "Department of Health & Human Services" is written around the circle's perimeter, with the words arranged to follow the curve of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20050

NOV - 9 2005

Ms. Christine Ford Sr. Regulatory Affairs Analyst B. Braun Medical, Inc. 901 Marcon Blvd. ALLENTOWN PA 18103-9341

Re: K052393

Trade/Device Name: B. Braun Modified Bicarbonate Dialysate Regulation Number: 21 CFR §876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: KPO Dated: October 13, 2005 Received: October 14, 2005

Dear Ms. Ford:

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) 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 Division of Small 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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## 2.0 Indications for Use Statement

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510(k) Number (if known): K052393

B. Braun Modified Bicarbonate Dialysate Device Name:

Indications For Use:

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

Prescription Use X (Per 21 CFR 801.109)

OR

Over-The-Counter Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C. brogdon
(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices

Radiological Devices
510(k) Number K052393