2008H ON LINE CLEARANCE MONITOR

K961465 · Fresenius USA, Inc. · KDI · Jul 3, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K961465
• Device Name: 2008H ON LINE CLEARANCE MONITOR
• Applicant: Fresenius USA, Inc.
• Product Code: KDI · Gastroenterology, Urology
• Decision Date: Jul 3, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5860
• Device Class: Class 2

Intended Use

The Fresenius On Line Clearance Monitor is a module that is incorporated into the Fresenius 2008H hemodialysis equipment to be used during a dialysis treatment to determine dialyzer clearance efficiency using changes in conductivity of the dialysate solution.

Device Story

The Fresenius On Line Clearance Monitor (OLC) is an integrated module for the Fresenius 2008H hemodialysis machine. It utilizes a second conductivity probe in the effluent dialysate line to monitor inlet and outlet dialysate conductivity. The device automatically modulates dialysate conductivity to create a sodium concentration gradient between blood and dialysate; it then measures the resulting flux of sodium. Because sodium and urea pass through dialysis membranes at similar rates, the device calculates sodium clearance as a surrogate for dialyzer urea clearance efficiency. The process is non-invasive, automated, and requires no operator intervention or blood sampling. It provides real-time clearance data to clinicians, reducing the need for manual blood-based urea analysis and assisting in the assessment of dialyzer performance during treatment.

Clinical Evidence

Clinical testing involved a modified 2008H hemodialysis machine used during patient treatments. The study compared clearance performance calculated by the OLC against identical blood-side urea measurements. Results indicated no statistically significant difference in clearance determinations between the OLC method and the standard blood-side urea analysis.

Technological Characteristics

Module integrated into Fresenius 2008H hemodialysis equipment. Hardware includes a second conductivity probe in the effluent dialysate line. Operates by measuring conductivity changes (sodium concentration) to calculate dialyzer clearance. Software-controlled modulation of dialysate conductivity. Non-invasive, automated operation.

Indications for Use

Indicated for use as a module with the Fresenius 2008H hemodialysis machine to determine dialysis treatment urea clearance efficiency in patients undergoing hemodialysis, using sodium conductivity as a surrogate solute marker.

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

• Colorado Medical equipment adaptor (K830190)
• Colorado Medical equipment adaptor (K841153)

Submission Summary (Full Text)

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Fresenius USA, Inc.
2637 Shadelands Drive
Walnut Creek, CA 94598
[phone]
[phone] (Fax)
(800)-227-2572
F961465
F
FRESENIUS USA

510 (k) Summary of Safety and Effectiveness Information for the Fresenius On Line Clearance Monitor

JUL - 3 1997

1. Applicant:

Fresenius USA, Inc
2637 Shadelands Drive
Walnut Creek, CA 94598

Contact Person: Thomas I. Folden
Director, Product Development

Telephone: [phone]
1-510 988-1958 (Fax)

Date Summary Prepared: April 15, 1996

2. Device Name: Fresenius On Line Clearance Monitor

3. Predicate Devices

Fresenius USA, Inc. claims that the On Line Clearance Monitor is substantially equivalent to equipment adaptors for determination of dialyzer performance using conductivity that were made commercially available and found substantially equivalent under premarket notifications K830190 and K841153. Fresenius also claims substantial equivalence to manual invasive blood urea determinations of dialyzer performance.

4. Intended Use

The Fresenius On Line Clearance Monitor is a module that is incorporated into the Fresenius 2008H hemodialysis equipment to be used during a dialysis treatment to determine dialyzer clearance efficiency using changes in conductivity of the dialysate solution.

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## 5. Device Description

The Fresenius On Line Clearance Monitor (OLC) is a module that is incorporated into the Fresenius 2008H hemodialysis equipment. The OLC consists of hardware modifications to the 2008H dialysate fluid circuit which includes a second conductivity probe in the effluent dialysate line and software. The dialyzer clearance determination is made using changes in dialysate conductivity (Sodium concentration). The software either increases or decreases the dialysate conductivity. This change in conductivity causes a sodium concentration gradient to be formed between the blood and dialysate sides of the dialyzer. Sodium is then either diffused into the blood or out of the blood depending whether the dialysate conductivity is high or low. Accurate conductivity readings of the inlet and outlet dialysate solution can be used to calculate the flux of sodium (or change in conductivity because of changes in sodium concentration) in the dialysate. This value can then be used to calculate the dialyzer clearance of sodium. The clearance of sodium has been used as a surrogate dialyzer performance solute since the beginning of dialysis since urea and Sodium (from NaCl) pass through the dialysis membrane at essentially the same rate.

The use of the On Line Clearance Monitor is non invasive and is performed automatically by the hemodialysis equipment with no effect to the patient or action of the operator and minimizes the need for blood based urea analysis and dialyzer performance determination.

## 6. Comparison of Technological Characteristics and Statement of Substantial Equivalence

The Fresenius On Line Clearance Monitor utilizes conductivity as a marker to determine dialyzer performance in the same manner as the Colorado Medical equipment adaptor previously found substantially equivalent under premarket notifications K 830190 and K841153 by monitoring the inlet and outlet dialysate conductivities with standard conductivity probes and calculating a clearance value for the dialyzer. The OLC also is equivalent to blood urea clearance determinations currently used clinically to rate dialyzer efficiency.

### Testing:

Non Clinical Testing: The use of Sodium (conductivity) as a clearance marker was compared to urea using a number of different dialyzer membranes and found that there was statistically significant correlation that the clearance values obtained were the same.

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Clinical Testing: A modified 2008H hemodialysis machine was used clinically to evaluate dialyzer performance during dialysis comparing clearance performance from the OLC to identical blood side urea measurements. The results of the testing indicated that there was no difference in the clearance determinations between the two methods.

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

Mr. Tom Földen
Director, Product Development
Fresenius USA
2637 Shadelands Drive
Walnut Creek, California 94598

JUL - 3 1997

Re: K961465
2008H On Line Clearance Monitor
Dated: April 2, 1997
Received: April 4, 1997
Regulatory class: III
21 CFR §876.5860/Product code: 78 KDI

Dear Mr. Földen:

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 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 requirement, 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/dsnamain.html".

Sincerely yours,


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

510(k) Number: K961465

Device Name: Fresenius 2008H On Line Clearance Monitor

Indications for Use:

The Fresenius On Line Clearance Monitor is intended to be used as a module with the Fresenius 2008H hemodialysis machine for determination of dialysis treatment urea clearance efficiency using Sodium conductivity as the surrogate solute marker.

Robert R. Nathig
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K961465

Prescription Use ☑
(Per 21 CFR 801.109)

Over-the-Counter Use