FRESENIUS F SERIES HEMOCONCENTRATORS F400,F500,F700,F800,F400TS,F500TS,F700S,F800TS

K974584 · Fresenius USA, Inc. · KDI · May 14, 1998 · Gastroenterology, Urology

Device Facts

• Record ID: K974584
• Device Name: FRESENIUS F SERIES HEMOCONCENTRATORS F400,F500,F700,F800,F400TS,F500TS,F700S,F800TS
• Applicant: Fresenius USA, Inc.
• Product Code: KDI · Gastroenterology, Urology
• Decision Date: May 14, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Fresenius F Series Hemoconcentrators are indicated to relieve or mitigate overhydration in patients undergoing cardiopulmonary procedures and to increase the concentration of cells and proteins in the blood.

Device Story

Hollow fiber-type hemoconcentrator; polysulfone capillary fibers bundled/potted with polyurethane in polyurethane jacket. Input: diluted blood from cardiopulmonary bypass circuit. Operation: passive filtration of plasma water across semi-permeable polysulfone membrane; plasma water exits via filtrate port; concentrated blood exits via venous port. Used in operating room by perfusionists/clinicians. Output: concentrated blood returned to patient; excess fluid removed. Benefits: manages fluid balance; increases hematocrit/protein concentration. Tubing sets (PVC) optional. Four models (F400, F500, F700, F800) vary by fiber count/filtration capacity.

Clinical Evidence

Bench testing only. Comparative in vitro studies evaluated F400, F500, F700, and F800 against predicates (F40, F60). Endpoints: ultrafiltration rates, concentration rates, sieving coefficients (large/small proteins), hemolysis (plasma hemoglobin), and pressure drop. Results showed equivalent hemolysis and molecular weight cutoff (~65,000 Daltons). Performance characterized per EN 1283 standard.

Technological Characteristics

Hollow fiber-type filter; polysulfone capillary fibers (200 micrometer diameter); polyurethane potting/housing; Hansen-type filtrate fittings; PVC tubing sets. Passive filtration principle. Sterilized. No software/electronics.

Indications for Use

Indicated for patients undergoing cardiopulmonary procedures requiring relief or mitigation of overhydration and concentration of blood cells and proteins.

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

• Bard HC40 Hemoconcentrator (K971180)
• Amicon Diafilter 30 (K902837)
• Minntech Hemocor HPH 1000 (K923139)
• Baxter Bentley Quick Prime HQ 7000 (K903641)
• Research Medical Biofilter 140 (K951344 and K970739)

Reference Devices

• Fresenius F40
• Fresenius F60

Submission Summary (Full Text)

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MAY 1 4 1998

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# 510(k) Summary for the Fresenius F Series Hemoconcentrators

Submitter's Name and Address:

Phone Number: Telefax Number: Contact Person:

Date Summary Prepared:

Device Trade Name:

Common name:

Classification Name:

Legally Marketed Device to which substantial equivalence is claimed: Fresenius USA, Critical Care Division 2637 Shadelands Drive Walnut Creek, CA 94598 [phone] [phone] Virginia Singer

December 5, 1997

Fresenius F Series Hemoconcentrators

High Flux Hemoconcentrator

High Permeability Hemodialysis System

Bard HC40 Hemoconcentrator (K971180) Amicon Diafilter 30 (K902837) Minntech Hemocor HPH 1000 (K923139) Baxter Bentley Quick Prime HQ 7000 (K903641) Research Medical Biofilter 140 (K951344 and K970739)

### Intended Use:

The Fresenius F Series Hemoconcentrators are indicated to relieve or mitigate overhydration in patients undergoing cardiopulmonary procedures and to increase the concentration of cells and proteins in the blood.

### Device Features:

A complete description of the Fresenius Hemoflow Series Dialyzer, the same product as the F Series Hemoconcentrators, has been submitted in previous premarket notifications. There have been no modifications to this device to adapt it for hemoconcentration. The Fresenius Hemoflow Series Dialyzer is a hollow fiber-type filter. Fresenius-produced polysulfone capillary fibers are bundled and potted with polyurethane into an artificial kidney jacket manufactured from polyurethane. Screw-type end caps, manufactured from polyurethane, have twist lock connectors for the connection of venous and arterial blood lines. Two filtrate ports are located on the filter adjacent to the filtrate chambers. The ports have Hansen-type fittings for connection of filtrate tubing. For hemoconcentration, only the filtrate port on the venous end of the filter is used; the other port on the arterial end is capped.

There are four (4) models within the F Series Hemoconcentrators family. The difference between the four models in the F Series Hemoconcentrators is the number of fibers contained within the artificial kidney jacket. As the number of fibers contained in the filter increases, the diameter of the filter and the filtration capacity increases proportionally. Each model will be manufactured with a tubing set (F400TS, F500TS, F700TS, F800TS); other models will be manufactured with tubing adapter, only (F400, F500, F700, F800).

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# Technological Characteristics of the Subject Device Compared with Predicate Devices

The 510(k) "Substantial Equivalence Decision Making Process (Detailed)" decision tree (ODE Guidance Memo #K86-3) was used to make a determination of substantial equivalence (reference Exhibit IV-1 included in this section). The answers to questions identified on this decision tree lead to a determination of substantial equivalence.

#### Does the New Device Have the Same Indication Statements? 1.0

Yes. The F Series Hemoconcentrators (F400, F500, F700, and F800), Bard HC40 Hemoconcentrator, Amicon Diafilter 30, Minntech Hemocor HPH 1000, Baxter Bentley Quick Prime HQ 7000, and Research Medical Biofilter 140 are all indicated for the removal of excess fluid from blood in cardiopulmonary procedures.

#### Does New Device Have Same Technological Characteristics (e.g., design, materials etc.)? 2.0

Yes. There are virtually no differences in technology and operation between the F Series Hemoconcentrator devices and the predicate devices. The core of the technology is the filter material within the hemoconcentrators housing. With the exception of the filter manufactured for Research Medical, Inc. (Biofilter 140), the filter material is polysulfone. The diameter of the polysulfone fibers is 200 micrometers, with the exception of the Amicon Diafilter that is 250 micrometers. The filtration capacity of the hemoconcentrator is dependent upon the number of fibers contained in the filter; the more fibers contained, the faster plasma water can be removed. In all marketed filters, plasma water is filtered from the diluted blood and exits the filter from a filtration port located on the side of the filter. Diluted blood enters the filter via the arterial blood port and concentrated blood exits the filter at the venous blood port.

The tubing sets that accompany hemoconcentration filters are virtually identical. They consist of ¼" ID 3/8" OD PVC tubing with suitable proximal end connectors and line clamps. The tubing set may or may not include a filtrate line, clamps, and filtrate collection bag. These filtrate line items (tubing, adapters, clamps, collections containers) are typically available in an operating room and, therefore, are optional with respect to a tubing kit.

#### 3.0 Are the Descriptive Characteristics Precise Enough to Ensure Equivalence?

No. Although, the structure of the F Series Hemoconcentrator and tubing sets are very similar to the predicate devices manufactured by Fresenius (F40 and F60) and their respective tubing sets, there may be subtle differences in the materials used to manufacture assemblies of other predicate devices (Amicon Diafilter 30, Minntech Hemocor HPH 1000, and Research Medical Biofilter 140) and in the manufacturing methods employed to build these devices. These differences could impact the filtration characteristics and biocompatibility of the product.

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## Are Performance Data Available to Assess Equivalence?

Yes. All blood/fluid contacting materials of the Fresenius F Series Hemoconcentrators and tubing sets have been subjected to biocompatibility testing consistent with FDA's modified ISO standards for biological evaluation of medical devices.

Comparative in vitro testing of the Fresenius F40, F50, F70, and F80 has been performed to assess end-to-end pressure drop, ultrafiltration rates, concentration rates of cellular blood components, sieving coefficients of a large and a small molecular weight plasma protein, and hemolysis. This testing served to characterize and contrast the performance of the predicate products (F40 and F60) relative to those products for which clearance is being requested (F400, F500, F700 and F800). The testing also served to demonstrate that, at maximum recommended transmembrane pressure and flow rate, the production of plasma hemoglobin was statistically the same for all devices evaluated.

Performance specifications of other hemoconcentrators not manufactured by Fresenius (eg. Amicon Diafilter 30, Minntech Hemocor HP 1000, and Research Medical Biofilter 140) were also compared to Fresenius in vitro data to demonstrate that under similar operating conditions (TMP, blood flow rate, hematocrit, protein content, temperature) filtration performance was relatively the same.

#### Does Performance Data Demonstrate Equivalence? 5.0

Based on the results of the testing cited above, Fresenius has demonstrated that: Yes.

- The performance of the F Series Hemoconcentrators is consistent with the draft specifications . for these products. Performance has been characterized according to a recognized international standard, EN 1283, Haemodialyzers, Haemodiafilters, Haemoconcentrators and Their Extracorporeal Circuits.
- . The ultrafiltration and concentration rates of the F Series Hemoconcentrators (F400, F500, F700, and F800) are relative consistent with the rates of predicate devices (F40 and F60) as demonstrated in in vitro studies. Differences in rates may be attributed to differences in Active Surface Area of the filter itself.
- As with the predicate devices (F40 and F60), no cellular blood components were lost in the . ultrafiltrate in the F Series Hemoconcentrators.
- The production of plasma hemoglobin (hemolysis) was equivalent for all devices studied. .
- Performance data also demonstrates that the molecular weight cutoff for all devices studied is . approximately 65,000 Daltons. This fact is supported by data that shows that minimal albumin was lost from the blood product and that a relatively small protein, beta-2microglobulin, was filtered with the plasma water.

CONCLUSION: Based on the information and test results provided in this premarket notification, the Fresenius F Series Hemoconcentrators and tubing sets are substantially equivalent to currently marketed hemoconcentrators.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 4 1998

Ms. Virginia Singer Regulatory Affairs Manager Fresenius USA, Inc. Critical Care Division 2637 Shadelands Drive Walnut Creek, CA 94598

Re: K974584

Fresenius F-series Hemoconcentrator Models F400, F400TS, F500, F500TS, F700 F700TS, F800, and F800TS Dated: April 3, 1998 Received: April 7, 1998 Regulatory Class: III 21 CFR 876.5860/Procode: 78 KDI

Dear Ms. Singer:

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 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). 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 probibitions 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 equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) 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 question on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-639. 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/dsmaldsmamain.html".

Sincerely vours

Lillian Yin, Ph.D.

Director, Division of Reproductive, Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use Statement

510(k) Number (if known);

Device Name:

Indications for Use:

K974584

Fresenius F Series Hemoconcentrators

The Fresenius F Series Hemoconcentrators are indicated to relieve or mitigate overhydration in patients undergoing cardiopulmonary procedures and to increase the concentration of cells and proteins in the blood.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Robert P. Sattinger

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 14584 510(k) Number .

**Prescription Use**
(Per 21 CFR 801.109)

OR

Over The Counter Use _