B.BRAUN PREMIXED DIALYSATE

K034066 · B.Braun Medical, Inc. · KPO · Mar 3, 2004 · Gastroenterology, Urology

Device Facts

• Record ID: K034066
• Device Name: B.BRAUN PREMIXED DIALYSATE
• Applicant: B.Braun Medical, Inc.
• Product Code: KPO · Gastroenterology, Urology
• Decision Date: Mar 3, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5820
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

B. Braun Premixed Dialysate consists of sterile, non-pyrogenic electrolyte solutions provided in single-use flexible PVC bags (1000 mL to 5000 mL). These solutions are used with renal replacement therapy systems that require sterile premixed dialysate. Physicians prescribe specific electrolyte compositions from the available family of solutions to meet individual patient needs. The device functions as the dialysate fluid in renal replacement procedures, facilitating the removal of waste products and fluid balance management. It is intended for clinical use by healthcare professionals in settings where renal replacement therapy is performed.

Clinical Evidence

No clinical data provided; substantial equivalence is based on chemical composition, manufacturing, and sterilization process comparisons to legally marketed predicate devices.

Technological Characteristics

Sterile, non-pyrogenic electrolyte solutions in flexible PVC bags (1000-5000 mL). Designed for use with renal replacement therapy systems. Sterilization process is consistent with predicate devices.

Indications for Use

Indicated for use with renal replacement therapy systems requiring sterile premixed dialysate. Patient population includes individuals requiring renal replacement therapy; specific age or gender not restricted.

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

• NxStage Premixed Dialysate (K022913)
• Gambro PrismaSate Dialysis Solutions (K013448)
• Baxter Premixed Dialysate for Hemodiafiltration (K910270)

Submission Summary (Full Text)

{0}------------------------------------------------

KO34066

## mar - 3 2004

## 510(k) Summary 8.0

| SUBMITTER: | B. Braun Medical Inc.<br>901 Marcon Boulevard<br>Allentown, PA 18109-9341<br>[phone], ext. 2280<br>Contact: Patricia D. Wilson, Regulatory Affairs Specialist |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DEVICE NAME: | B. Braun Premixed Dialysate |
| COMMON OR USUAL<br>NAME: | Premixed Dialysate |
| DEVICE<br>CLASSIFICATION: | Class II, 21 CFR § 876.5820, Hemodialysis System and<br>Accessories (Product Code KPO) |
| PREDICATE DEVICE: | NxStage Medical, Inc. - NxStage Premixed Dialysate<br>(K022913)<br>Gambro Renal Products – Gambro PrismaSate Dialysis<br>Solutions for Continuous Renal Replacement Therapy<br>(K013448)<br>Baxter Healthcare Corporation -Baxter Premixed Dialysate for<br>Hemodiafiltration (K910270) |
| DESCRIPTION: | The B. Braun Premixed Dialysate Solutions are a family of<br>premixed dialysate solutions which are sterile, non-pyrogenic<br>solutions to be provided in single use flexible PVC bags<br>varying in sizes from 1000 mL to 5000 mL. The premixed<br>dialysate solutions are intended for use with renal replacement<br>therapy systems that utilize sterile premixed dialysate. A<br>family of dialysate solutions will allow the physician to<br>prescribe different electrolyte compositions that meet the<br>specific needs of individual patients. |
| INTENDED USE: | B. Braun Premixed Dialysate is indicated for use with renal<br>replacement therapy systems that utilize sterile premixed<br>dialysate. |
| SUBSTANTIAL<br>EQUIVALENCE: | B. Braun believes that, within the meaning of the Medical<br>Device Amendments of 1976, the B. Braun Premixed<br>Dialysate addressed in this 510(k) premarket notification<br>is substantially equivalent to the following medical devices<br>in commercial distribution: |

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K034066 page 2 of 2

## SUBSTANTIAL EQUIVALENCE (continued):

- NxStage Premixed Dialysate (K022913, cleared 10/21/02) .
- PrismaSate Dialysis Solutions (K013448, cleared 01/15/02) .
- Baxter Premixed Dialysate for Hemodiafiltration . (K910270, cleared 04/18/91)

The B. Braun Premixed Dialysate includes the same chemical composition range, and has the same manufacturing, packaging, and sterilization process as the NxStage Premixed Dialysate (K022913). The B. Braun Premixed Dialysate is also similar to the Gambro PrismaSate Solutions (K013448), and Baxter Premixed Dialysate (K910270), with regard to composition, sterility, and packaging.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three stripes extending from its back.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 3 2004

Ms. Patricia Wilson Regulatory Affairs Specialist B. Braun Medical, Inc. 901 Marcon Boulevard ALLENTOWN PA 18109

Re: K034066

Trade/Device Name: B. Braun Premixed Dialysate Regulation Number: 21 CFR §876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Codc: 78 KPO Dated: Deccmber 30, 2003 Received: December 31, 2003

Dear Ms. Wilson:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreased 976, the enactment date of the Medical Device Amendments, or to conniner of the 11th 11th 20, 11:10 accordance with the provisions of the Federal Food, Drug, de neces that have been require approval of a premarket approval application (PMA). and Cosmetion (110) and the device, subject to the general controls provisions of the Act. The r ou may, diereler, mains of the Act include requirements for annual registration, listing of general controls provisions of nactice, 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 your device is elamititional 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 i Rase be actived that i Dr Princem that your device complies with other requirements of the Act that 1177 Hass Interes and regulations administered by other Federal agencies. You must of any I edular Battatoo and one of including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set (21 CFR Part 801), as only (QS) regulation (21 CFR Part 820); and if applicable, the electronic rently in and ation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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l'age 2

This letter will allow you to begin marketing your device as described in your Section 510(k)
the first and the first of the said the similars of your device to a locally This letter will allow you to begill marketing your avones of your device of your device to a legally premarket notification. The PDA miding of basification 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
r the regulation (2010-11-24, 11-4 in increases on the regulation It you desire specific advice tor your device on on the following numbers, based on the regulation number at the top of the letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, for questions on the promotion on the regulation entitled, "Misoranding
Office of Compliance at [phone]. Also, possessed on be includes and and Office of Compliance at [phone]. This, production of Super the Division of Sma by reference to premarket nouncation (27 or the Act may be obtained from the Division of Small information on your responsionities under the researce at its toll-fried mumber [phone] or
Manufacturers, International and Consumer Assistance at its toll-fremation h Manufacturers, International and Collsamler I assistement of the Courcedridsmaldsmamain.html.

Sincerely yours,

Nancy C. Brogdon

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 Statement 2.0

Page _

| 510(k) Number (if known): | K034066 |
|---------------------------|---------|
|---------------------------|---------|

Device Name:

B. Braun Premixed Dialysate

Indications For Use:

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use **__**

Nancy C. Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number. K034066

000005

510(k) Premarket Notification B. Braun Premixed Dialysate