DIACAP ULTRA DIALYSIS FLUID FILTER

K052764 · B. Braun Medizintechnologie GmbH · FKQ · Jun 9, 2006 · Gastroenterology, Urology

Device Facts

• Record ID: K052764
• Device Name: DIACAP ULTRA DIALYSIS FLUID FILTER
• Applicant: B. Braun Medizintechnologie GmbH
• Product Code: FKQ · Gastroenterology, Urology
• Decision Date: Jun 9, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5820
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Diacap Ultra dialysis fluid filter is intended to filter bacteria and endotoxins from dialysate used for hemodialysis treatments.

Device Story

Diacap Ultra is a sterile, non-pyrogenic dialysis fluid filter used in hemodialysis machines. It functions as a physical barrier to remove bacteria and endotoxins from dialysate. The device consists of a hollow core polysulfone and polyvinylpyrrolidone membrane housed in polycarbonate with Hansen-type connectors and silicone O-rings. It is intended for clinical use by healthcare professionals during hemodialysis procedures to ensure dialysate purity, thereby reducing patient exposure to contaminants.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Hollow core polysulfone and polyvinylpyrrolidone membrane; polycarbonate housing and headers; silicone O-rings; polyethylene port caps; Hansen-type connectors. Sterile, non-pyrogenic.

Indications for Use

Indicated for filtering bacteria and endotoxins from dialysate used in hemodialysis treatments.

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

• DialGuard (K993806)
• Dialclear Ultrafilter (K003957)
• FibreFlo (K983126)

Submission Summary (Full Text)

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

## B BRAUN

B. Braun Medizintechnologie GmbH
Division Medizintechnik

Postfach 11 20
D-34209 Melsungen

K052764
Page 1 of 1

## 7.0 510(k) Summary

| APPLICANT: | B. Braun Medizintechnologie GmbH<br>Schwarzenberger Weg 73-79<br>34212 Melsungen, Germany | | JUN - 9 2006 |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--------------|
| SUBMITTER: | B. Braun Medical Inc.<br>901 Marcon Boulevard<br>Allentown, PA 18109-9341<br>[phone], ext. 2376<br>Contact: Scott J. Pease, Mgr., Regulatory Affairs | | |
| DEVICE NAME: | Diacap Ultra Dialysis Fluid Filter | | |
| COMMON OR USUAL<br>NAME: | Dialysis Fluid Filter to Remove Bacteria and Endotoxins | | |
| DEVICE<br>CLASSIFICATION: | Class II, 21 CFR §876.5820, System, Dialysate Delivery, Single<br>Patient, Product Code: FKP | | |
| PREDICATE DEVICE: | K993806 Clarigen, Inc., DialGuard™<br>K003957 GAMBRO® Renal Products, Dialclear™ Ultrafilter<br>K983126 Minntech FibreFlo | | |
| DESCRIPTION: | The Diacap Ultra dialysis fluid filter is sterile, non-pyrogenic dialysis<br>fluid filter for use with machines providing hemodialysis treatments.<br>The device is composed of a hollow core polysulfone and<br>polyvinylpyrrolidone membrane, polycarbonate housing and headers<br>(end-caps) with Hansen type connectors, silicone O-rings, and<br>polyethylene port caps. | | |
| INTENDED USE: | The Diacap Ultra dialysis fluid filter is intended to filter bacteria and<br>endotoxins from dialysate used for hemodialysis treatments. | | |
| SUBSTANTIAL<br>EQUIVALENCE: | The Diacap Ultra is similar in indications for use and design to the<br>DialGuard™ Endotoxin Removal Device for treatment of dialysate<br>and dialysis water, previously cleared in Clarigen, Inc. 510(k)<br>K993806, the Dialclear™ Ultrafilter, previously cleared in<br>GAMBRO® Renal Products 510(k) K003957 and the FioberFlo<br>previously cleared in Minntech Corp. 510(k) K983126. | | |

510(k) for Diacap Ultra

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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 a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a bird in flight. The logo is black and white.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

JUN - 9 2006

Mr. Scott J. Pease Manager, Regulatory Affairs B. Braun Medical, Inc. 901 Marcon Blvd. ALLENTOWN PA 18109

Re: K052764

Trade/Device Name: DIACAP Ultra Dialysis Fluid Filter Regulation Number: 21 CFR 876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: FKQ Dated: June 1, 2006 Received: June 2, 2006

Dear Mr. Pease:

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.

Image /page/1/Picture/10 description: The image shows the FDA Centennial logo, which includes the years 1906-2006. The logo is circular and contains the letters FDA in bold. Below the letters, the word Centennial is written in a smaller font. The text "Protecting and Promoting Public Health" is written in a decorative font below the logo.

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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,

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.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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/cdrl/industry/support/index.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 of

| 510(k) Number (if known): | k052764 |
|---------------------------|------------------------------------|
| Device Name: | Diacap Ultra Dialysis Fluid Filter |

Indications For Use:

The Diacap Ultra Dialysis Fluid Filter is intended to filter bacteria and endotoxins from 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 II NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE

E)
ancyl Brodon
(Division Sign-Off)
Division of Reproductive, Abdominal,

Radiological Devices
510(k) Number K052764

510(k) for Diacap Ultra

28 September 2005