FIBERFLO HOLLOW FIBER CAPSULE WATER FILTERS

K983126 · Minntech Corp. · FIP · Mar 8, 1999 · Gastroenterology, Urology

Device Facts

• Record ID: K983126
• Device Name: FIBERFLO HOLLOW FIBER CAPSULE WATER FILTERS
• Applicant: Minntech Corp.
• Product Code: FIP · Gastroenterology, Urology
• Decision Date: Mar 8, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5665
• Device Class: Class 2

Intended Use

The FiberFlo™ Capsule Water Filter is intended to filter bacteria, endotoxin and particulate matter from water used for hemodialysis applications.

Device Story

FiberFlo™ Hollow Fiber Capsule Water Filter consists of encapsulated microporous polysulfone membrane in polycarbonate housing; designed to filter bacteria, endotoxin, and particulate matter from water used in hemodialysis applications. Device installed in product water supply lines. Operates via physical filtration through hollow fiber membrane. Benefits patient by reducing contaminants in water used for hemodialysis.

Clinical Evidence

Bench testing only. Performance testing included pressure drop vs. flow rate, endotoxin rejection, minimum/maximum water flow rates, and extractables testing.

Technological Characteristics

Microporous polysulfone membrane; polycarbonate housing; polyurethane potting. Porosity options: 50, 100, 200 micron. Sanitizable. Designed for installation in product water supply lines.

Indications for Use

Indicated for filtering bacteria, endotoxin, and particulate matter from water used in hemodialysis applications.

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

• FiberFlo™ Hollow Fiber Water Filters

Submission Summary (Full Text)

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MINNTECH MAR-03-99 WED 11:27 AM

FAX NO. 6125533387

387 K983/P.036

3/8/99

. . . .

# 510(k) SUMMARY

#### 1. Submitter Information:

| Name: | Fibercor®, Division of Minntech Corporation | |
|-----------------|-------------------------------------------------------|--|
| Address: | 14605 28th Avenue North, Minneapolis, Minnesota 55447 | |
| Contact Person: | Mark Murphy | |
| Date Prepared: | September 4, 1998 | |

#### 2. Device Name:

| Proprietary name: | Fiberllo™ Hollow Fiber Capsule Water Filters |
|----------------------|--------------------------------------------------|
| Common name: | Capsule Filters |
| Classification name: | Water Purification Subsystem per 21 CFR 876.5665 |

#### 3. Predicato Devicc:

FiberIllo™ Hollow Fiber Water Filters

#### Devicc Description: 4.

The FiberFlo™ Hollow Fiber Capsule Water Filters consist of encapsulated microporous polysulfone membrane in a polycarbonate housing with multiple endcap connections to filter endotoxins, bacteria and particulates from water.

#### ડ. Indications for Use:

| Device | Indications |
|--------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Fibercor®FiberFlo™™<br>Hollow Fiber Capsule<br>Water Filters | The FiberFlo™ series of Hollow Fiber Capsule Water<br>Filters is intended to filter bacteria, endotoxin and<br>particulate matter from water used for hemodialysis<br>applications. |
| Fibercor® FiberFlo™<br>Hollow Fiber Water<br>Filters | The FiberFlo™ Cartridge series of Hollow Fiber Water<br>Filters is designed to filter bacteria, endotoxin and<br>particulate matter from water used by medical devices. |

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#### 6. Technological Characteristics:

A comparison of the FiberFlo™ Hollow Fiber Capsule Water Filters and predicate

| Characteristic | FiberFlo™ Hollow Fiber Capsule Water Filters | FiberFlo™ Hollow Fiber Water Filters |
|-----------------------|----------------------------------------------|--------------------------------------|
| Case Material | Polycarbonate | Polypropylene |
| Potting Material | Polyurethane | Polyurethane |
| Microporous Membrane | Polysulfone | Polysulfone |
| Membrane Porosity | 50, 100 and 200 micron | 50, 100 and 200 micron |
| Sanitizable | Yes | Yes |
| Water System location | Product water supply lines | Product water supply lines |

#### 7. Performance Testing:

The following performance testing was conducted to support substantial equivalence as a water filter for its intended use: Pressure Drop vs. Flow Rate, Endotoxin Rejection, Minimum and Maximum Water Flow Rates and Extractables testing.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 8 1999

Mr. Mark Murphy Regulatory Affairs Associate MINNTECH® Corporation 14605 28th Avenue North Minneapolis. MN 55447

Re: K983126

FiberFlo™ Capsule Water Filter Dated: December 7, 1998 Received: December 8, 1998 Regulatory Class: II 21 CFR 876.5665/Procode: 78 FIP

Dear Mr. Murphy:

We have reviewed vour 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 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). 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice 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 verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic 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 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 and additionally 809.10 for in vitro 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 entitled, "Misbranding by reference to premarket notification"(21 CFR 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 [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

CART Daniel S. Stadler, M.D.

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Image /page/2/Picture/15 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an abstract design that resembles an eagle or bird-like figure.

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### Indications for Usc

510(k) Number (if known): K983126

FiberFloTM Capsule Water Filter Device Name:

Indications for Use:

The FiberFlo™ Capsule Water Filter is intended to filter bacteria, endotoxin and particulate matter from water used for hemodialysis applications.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Pcr 21 CFR 801.109)

OR

Over-the -counter-use (Optional Format 1-2-96)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number. K983126/8⁰⁰¹