RENAFLO II HF 2000 HEMOFILTER

K000028 · Minntech Corp. · KDI · Apr 4, 2000 · Gastroenterology, Urology

Device Facts

• Record ID: K000028
• Device Name: RENAFLO II HF 2000 HEMOFILTER
• Applicant: Minntech Corp.
• Product Code: KDI · Gastroenterology, Urology
• Decision Date: Apr 4, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Renaflo® II HF 2000 Hemofilter is intended for use in patients with fluid overload. uremia and/or electrolyte disturbances associated with oligoanuria acute renal failure. It may also be used when removal of excess fluid is indicated, such as patients in pulmonary edema or congestive heart failure refractory to diuretic therapy.

Device Story

Renaflo II HF 2000 Hemofilter is a high-permeability hemofilter used for extracorporeal blood treatment. Device consists of glycerin-free, microporous, hollow-fiber polysulfone membrane housed in polycarbonate casing with polyurethane potting. During clinical use, blood flows through hollow fibers while ultrafiltrate is removed through ports. Device facilitates removal of excess fluid and solutes from blood in patients with renal failure or fluid overload. Operated by trained clinicians in clinical settings. Output is processed blood returned to patient; clinical benefit includes correction of electrolyte imbalances, uremia, and fluid status. Device is a larger surface area version of the predicate Renaflo II HF 1200.

Clinical Evidence

Bench testing only. Performance testing included ultrafiltration rate vs. transmembrane pressure, pressure drop vs. blood flow rate, protein rejection, minimum blood flow rate, and blood path integrity.

Technological Characteristics

Materials: Polysulfone membrane, polycarbonate housing, polyurethane potting. Design: Hollow fiber, 1.98 m² surface area, 132 ml priming volume. Max transmembrane pressure: 500 mmHg. Connections: ISO blood ports, Luer ultrafiltration ports. Non-software device.

Indications for Use

Indicated for patients with fluid overload, uremia, and/or electrolyte disturbances associated with oligoanuria acute renal failure, or patients with pulmonary edema or congestive heart failure refractory to diuretic therapy.

Regulatory Classification

Identification

A high permeability hemodialysis system is a device intended for use as an artificial kidney system for the treatment of patients with renal failure, fluid overload, or toxemic conditions by performing such therapies as hemodialysis, hemofiltration, hemoconcentration, and hemodiafiltration. Using a hemodialyzer with a semipermeable membrane that is more permeable to water than the semipermeable membrane of the conventional hemodialysis system (§ 876.5820), the high permeability hemodialysis system removes toxins or excess fluid from the patient's blood using the principles of convection (via a high ultrafiltration rate) and/or diffusion (via a concentration gradient in dialysate). During treatment, blood is circulated from the patient through the hemodialyzer's blood compartment, while the dialysate solution flows countercurrent through the dialysate compartment. In this process, toxins and/or fluid are transferred across the membrane from the blood to the dialysate compartment. The hemodialysis delivery machine controls and monitors the parameters related to this processing, including the rate at which blood and dialysate are pumped through the system, and the rate at which fluid is removed from the patient. The high permeability hemodialysis system consists of the following devices:(1) The hemodialyzer consists of a semipermeable membrane with an in vitro ultrafiltration coefficient (K uf ) greater than 8 milliliters per hour per conventional millimeter of mercury, as measured with bovine or expired human blood, and is used with either an automated ultrafiltration controller or anther method of ultrafiltration control to prevent fluid imbalance.(2) The hemodialysis delivery machine is similar to the extracorporeal blood system and dialysate delivery system of the hemodialysis system and accessories (§ 876.5820), with the addition of an ultrafiltration controller and mechanisms that monitor and/or control such parameters as fluid balance, dialysate composition, and patient treatment parameters (e.g., blood pressure, hematocrit, urea, etc.). (3) The high permeability hemodialysis system accessories include, but are not limited to, tubing lines and various treatment related monitors (e.g., dialysate pH, blood pressure, hematocrit, and blood recirculation monitors).

Special Controls

*Classification.* Class II. The special controls for this device are FDA's:(1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Device—Part I: Evaluation and Testing,’ ” (2) “Guidance for the Content of 510(k)s for Conventional and High Permeability Hemodialyzers,” (3) “Guidance for Industry and CDRH Reviewers on the Content of Premarket Notifications for Hemodialysis Delivery Systems,” (4) “Guidance for the Content of Premarket Notifications for Water Purification Components and Systems for Hemodialysis,” and (5) “Guidance for Hemodialyzer Reuse Labeling.”

Predicate Devices

• Renaflo® II HF 1200 Hemofilter

Submission Summary (Full Text)

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 4 2000

Mr. Richard M. Ormsbee Regulatory Affairs Associate MINNTECH® Corporation 14605 28th Avenue North Minneapolis, MN 55447

Re: K000028 Renaflo II HF 2000 Hemofilter Dated: January 4, 2000 Received: January 5, 2000 Regulatory Class: III 21 CFR §876.5860/Procode: 78 KDI

Dear Mr. Ormsbee:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the rio is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce pror to May 26, 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 Cosmelic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include mistine of solled, color of the general, 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 Regulations, Title 21, Parts 800 to 895. A substantially equivation assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Reguistion (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 entilled, "Misbranding by reference to prematic notification" (21CFR 807.97). Other general information on your responsibilities under the Antonay be oblained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/odrh/dsmaldsmamain.html".

Sincerely yours,

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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Indications for Use

510(k) Number (if known):

K00028

Device Name:

Renaflo® II HF 2000 Hemofilter

Indications for Use:

The Renaflo® II HF 2000 Hemofilter is intended for use in patients with fluid overload. uremia and/or electrolyte disturbances associated with oligoanuria acute renal failure. It may also be used when removal of excess fluid is indicated, such as patients in pulmonary edema or congestive heart failure refractory to diuretic therapy.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use V (Per 21 CFR 801.109)

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

Daniel A. Seagram
(Division Sign-Off)

OR

Division Sign-Ott)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K000018

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K000028

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# 510(k) SUMMARY

#### Submitter Information: 1.

| Name: | Minntech Corporation |
|-----------------|-------------------------------------------------------|
| Address: | 14605 28th Avenue North, Minneapolis, Minnesota 55447 |
| Contact Person: | Richard M. Ormsbee |
| Date Prepared: | December 20, 1990 |

#### 2. Device Name:

| Proprietary name: | Minntech Renaflo® II HF 2000 Hemofilter |
|----------------------|-------------------------------------------------|
| Common name: | Hemofilter |
| Classification name: | Dialyzer, High Permeability per 21 CFR 876.5860 |

#### 3. Predicate Device:

Renaflo® II HF 1200 Hemofilter

#### 4. Device Description:

The Minntech Renaflo® II HF 2000 Hemofilter is made of glycerin-free, microporous, hollow fiber, polysulfone membrane encased in a polycarbonate housing having molded ultrafiltration ports and polycarbonate blood port header caps.

#### ડ. Indications for Use:

| Device | Indications |
|--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Minntech Renaflo® II<br>HF 2000 Hemofilter | The Renaflo® II HF 2000 Hemofilter is intended for use<br>in-patients with fluid overload, uremia and/or electrolyte<br>disturbances associated with oligoanuria acute renal<br>failure. It may also be use when removal of excess fluid is<br>indicated, such as patients in pulmonary edema or<br>congestive heart failure refractory to diuretic therapy. |

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K000028
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#### 6. Technological Characteristics:

| Characteristic | Renaflo ® II HF 2000 Hemofilter | Renaflo ® II HF 1200 Hemofilter |
|------------------------------------------|---------------------------------|---------------------------------|
| Housing | Polycarbonate | Polycarbonate |
| Potting Material | Polyurethane | Polyurethane |
| Membrane | Polysulfone | Polysulfone |
| Membrane Surface Area | 1.98 m² | 1.25 m² |
| Maximum Transmembrane<br>Pressure (mmHg) | 500 | 500 |
| Blood port connectors | ISO | ISO |
| Ultrafiltration ports | Luer | Luer |
| Priming volume (ml) | 132 | 83 |

A comparative summary of the Renaflo ® II HF 2000 and predicate device is as follows:

#### 7. Performance Testing:

The following performance testing was conducted to determine device effectiveness as a hemofilter: Ultrafiltration Rate vs. Transmembrane Pressure, Presure Drop vs. Blood Flow Rate, Protein Rejection, Minimum Blood Flow Rate & Blood Path Integrity.