FRESENIUS ON LINE CLEARANCE MONITOR WITH THE ADDITION OF ACCESS FLOW DETERMINATION

K991520 · Fresenius Medical Care North America · KDI · Jul 30, 1999 · Gastroenterology, Urology

Device Facts

• Record ID: K991520
• Device Name: FRESENIUS ON LINE CLEARANCE MONITOR WITH THE ADDITION OF ACCESS FLOW DETERMINATION
• Applicant: Fresenius Medical Care North America
• Product Code: KDI · Gastroenterology, Urology
• Decision Date: Jul 30, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5860
• Device Class: Class 2

Intended 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 and for access flow estimation for those patients undergoing acute or chronic hemodialysis.

Device Story

The Fresenius On Line Clearance Monitor functions as an integrated module for the Fresenius 2008H hemodialysis machine. It performs real-time monitoring of dialysis treatment by calculating urea clearance and estimating vascular access flow. The device processes data derived from the hemodialysis circuit to provide clinicians with quantitative metrics regarding treatment efficacy and access patency. Used in clinical settings by healthcare professionals, the output assists in managing dialysis therapy and identifying potential access complications. By providing continuous or periodic assessment of clearance and flow, the device supports optimized dialysis delivery and early detection of access dysfunction, potentially improving patient outcomes during acute or chronic hemodialysis sessions.

Clinical Evidence

No clinical data provided in the document; substantial equivalence determination based on regulatory review of the 510(k) submission.

Technological Characteristics

Module for Fresenius 2008H hemodialysis machine; utilizes integrated sensing for urea clearance and access flow estimation; software-based processing; operates within the hemodialysis circuit environment.

Indications for Use

Indicated for patients undergoing acute or chronic hemodialysis requiring monitoring of dialysis treatment urea clearance and access flow estimation.

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.”

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 30 1999

Mr. Arthur Eilinsfeld Manager, Regulatory Affairs Fresenius Medical Care North America Two Ledgemont Center 95 Havden Avenue Lexington, MA 02420

Re: K991520

On Line Clearance Monitor with the Addition of Access Flow Estimation Capability Dated: April 30, 1999 Received: May 3, 1999 Regulatory Class: III 21 CFR §876.5860/Procode: 78 KDI

·

Dear Mr. Eilinsfeld:

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 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 (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 requlations affecting your device can be found in the Code of Federal Requlations, 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 cevices), piease 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.

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

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# Fresenius Medical Care

Appendix 2

# INDICATIONS FOR USE STATEMENT

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Fresenius On Line Clearance Monitor with the addition of Access Flow Estimation Capability.

### 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 and for access flow estimation for those patients undergoing acute or chronic hemodialysis.

David L. Ingram

(Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological Devic 941520 510(k) Number.

Please Do Not Write Below This Line - Continue On Another Page If Needed

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use × (Per 21 CFR 801.109) OR

Over- the-Counter Use_

## Fresenius Medical Care North America

Corporate Headquarters: Two Ledgemont Center 95 Hayden Avenue Lexington, MA 02420 [phone]

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