DIALGUARD ENDOTOXIN REMOVAL DEVICE

K993806 · Clarigen, Inc. · FIP · Aug 14, 2000 · Gastroenterology, Urology

Device Facts

• Record ID: K993806
• Device Name: DIALGUARD ENDOTOXIN REMOVAL DEVICE
• Applicant: Clarigen, Inc.
• Product Code: FIP · Gastroenterology, Urology
• Decision Date: Aug 14, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5665
• Device Class: Class 2

Intended Use

The DialGuard™ device is intended to be used for the reduction of endotoxin from: 1. Dialysate prior to entering the dialyser 2. Water prior to its use for preparation of dialysate 3. Water prior to use for regenerating dialysers. DialGuard™ is intended to be used on a regular preventative basis during hemodialysis treatments.

Device Story

DialGuard™ is a water purification device designed to reduce endotoxin levels in dialysate and water used in hemodialysis. The device consists of a polysulfone housing containing an agarose-based affinity resin, fitted with Quick Connect couplings. It is installed in the fluid path prior to the artificial kidney (dialyzer). During hemodialysis, the device acts as a filter to capture endotoxins, consistently reducing levels to ≤ 0.05 EU/mL. It is intended for regular preventative use by clinical staff in a dialysis setting. By maintaining lower endotoxin levels in the dialysate, the device aims to improve the safety of the dialysis process for the patient.

Clinical Evidence

No clinical data. Evidence is based on bench testing, including flow rate and pressure studies, endotoxin removal efficacy (demonstrating reduction to ≤ 0.05 EU/mL), dialysate composition maintenance (conductivity and ion composition testing), leachables testing, and biocompatibility testing.

Technological Characteristics

Polysulfone housing; agarose-based affinity resin; Quick Connect couplings. Sanitizable. Positioned prior to dialyzer. Mechanical filtration/affinity binding principle. No energy source. Standalone device.

Indications for Use

Indicated for reduction of endotoxin in dialysate and water used for dialysate preparation or dialyzer regeneration during hemodialysis treatments.

Regulatory Classification

Identification

A water purification system for hemodialysis is a device that is intended for use with a hemodialysis system and that is intended to remove organic and inorganic substances and microbial contaminants from water used to dilute dialysate concentrate to form dialysate. This generic type of device may include a water softener, sediment filter, carbon filter, and water distillation system.

Special Controls

*Classification.* Class II (special controls). The device, when it is a water purification subsystem disinfectant, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

Predicate Devices

• RenaGuard™ Dialysate Filter (K945136)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the word "CLARIGEN" in bold, black letters. To the left of the word is a black graphic that resembles a crescent moon with two circles attached to the bottom. In the upper right corner of the image, the letters "AUG" are visible.

# AUG 1 4 2000

# 510(k) SUMMARY

#### Submitter Information: 1.

Name:

Clarigen, Incorporated

5922 Farnsworth Court, Carlsbad, California 92008 Address:

Contact Person: Edit Hegyi, M.D., Ph.D.

760-929-4996 Phone Number:

Fax Number: 760-929-2279

November 05, 1999 Date Prepared:

Clarigen, Inc. 5922 Farnsworth Court Carlsbad, CA 92008 Phone [phone]. 929 2279 Fax Email [e-mail]

170

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#### 2. Device Name

Proprietary name: Common name: Classification name: Product Code:

DialGuard™ Filter for the removal of endotoxin from dialysate and water Water Purification Subsystem per 21 CFR 876.5665 78 FIP

#### 3. Predicate Device

RenaGuard™ Dialysate Filter 510(k) Number K945136

#### Device Description 4.

DialGuard™ is a device used for the reduction of endotoxin from dialysate and water. It consists of a polysulfone housing filled with an affinity resin with polysulfone endcaps. The endcaps are fitted with Quick Connect couplings.

#### 5. Indications for Use

| Device | Indications for Use |
|------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| DialGuard™ | DialGuard™ is intended to be used to<br>remove endotoxin from dialysate,<br>water used to prepare dialysate, and<br>water used to regenerate dialysers. |
| RenaGuard™ | RenaGuard™ is intended to be used to<br>remove bacteria and endotoxin from<br>dialysate |

#### 6. Technological Characteristics

| | DialGuardTM | RenaGuardTM |
|----------------------|------------------------------|----------------------------|
| Case Material | polysulfone | polycarbonate |
| Sanitizable | yes | yes |
| Position on Dialyzer | Prior to artificial kidney | Prior to artificial kidney |
| Materials | agarose based affinity resin | hollow fiber membrane |

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#### 7. Safety and Effectiveness

The following testing was conducted to support substantial equivalence as a filter to remove endotoxin from dialysate and water for dialysate:

Flow Rate Pressure Studies Endotoxin Removal from water and dialysate

The maintenance of Dialysate Composition through the use of:

Conductivity and Ion Composition testing leachables testing Biocompatibility Testing.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or movement.

### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### AUG 1 4 2000

Edit Hegyi, M.D., Ph.D. Vice President Research and Development Clarigen, Inc. 5922 Farnsworth Court Carlsbad, CA 92008

Re: K993806

DialGuard™ Endotoxin Removal Device for treatment of dialysate and dialysis water Dated: June 23, 2000 Received: June 26, 2000 Regulatory Class; II 21 CFR §876.5665/Procode: 78 FIP

Dear Dr. Hegyi:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to teach review devilles 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). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act finding in 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 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 Rearly and Clark Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practive requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will regulation (FLT) in the coonply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements on region in the Federal Register. Please note: this response to your premarket notfication submission does not affect any obligation you micht have under sections 531 through 542 of the Act for devices under Radiation Cantrol product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predication 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 and additionally 809.10 for in witco diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation and "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (80) 638-2041 or (301) 443-557 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Daniel G. Schultz, M.D.

Daniel G. Schultz, M.D. Captain, USPHS Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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### K993806

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## Statement of Indications for Use

The DialGuard™ device is intended to be used for the reduction of endotoxin from:

- 1. Dialysate prior to entering the dialyser
- 2. Water prior to its use for preparation of dialysate
- 3. Water prior to use for regenerating dialysers.

DialGuard™ is intended to be used on a regular preventative basis during hemodialysis treatments. Experimental data indicates that DialGuard TM will consistently reduce endotoxin levels to ≤ 0.05 EU/mL. (AAMI standard for water for dialysate is < 5.0 EU/mL. Currently, there are no standards set for dialysate).

Prescription Use
(Per 21 CFR 801.109)

Daniel A. Dyson
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT and Radiological Devic 510(k) Number