FRESENIUS ICARE MONITORING SYSTEM

K021060 · Fresenius Medical Care North America · FKP · Nov 13, 2002 · Gastroenterology, Urology

Device Facts

• Record ID: K021060
• Device Name: FRESENIUS ICARE MONITORING SYSTEM
• Applicant: Fresenius Medical Care North America
• Product Code: FKP · Gastroenterology, Urology
• Decision Date: Nov 13, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5820
• Device Class: Class 2
• Attributes: Software as a Medical Device

Indications for Use

The Fresenius iCare Monitoring System is a computer-based hemodialysis treatment monitoring system for adjunctive use with the Fresenius 2008 series dialysate delivery system when the patient is attended by trained personnel. This monitoring system is contraindicated as the sole method of monitoring a patient during hemodialysis.

Device Story

The Fresenius iCare Monitoring System is a computer-based software system designed for adjunctive monitoring of hemodialysis treatments. It interfaces with the Fresenius 2008 series dialysate delivery system to provide additional oversight during dialysis. The system is intended for use in clinical settings where patients are attended by trained personnel. It is explicitly contraindicated as the sole monitoring method, serving instead as a supplementary tool for healthcare providers. By providing computer-based monitoring, the system assists clinicians in observing treatment parameters, thereby supporting clinical decision-making and potentially enhancing patient safety during hemodialysis procedures.

Clinical Evidence

Bench testing only. Validation testing was performed to verify system features, confirming the device is safe and effective for its intended use.

Technological Characteristics

Computer-based monitoring system; adjunctive to Fresenius 2008 series dialysate delivery system. Software-based monitoring functionality.

Indications for Use

Indicated for adjunctive monitoring of hemodialysis patients undergoing treatment with Fresenius 2008 series dialysate delivery systems. Contraindicated as the sole method of patient monitoring; requires attendance by trained personnel.

Regulatory Classification

Identification

A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.(1) The extracorporeal blood system and accessories consists of tubing, pumps, pressure monitors, air foam or bubble detectors, and alarms to keep blood moving safely from the blood access device and accessories for hemodialysis (§ 876.5540) to the blood compartment of the dialyzer and back to the patient. (2) The conventional dialyzer allows a transfer of water and solutes between the blood and the dialysate through the semipermeable membrane. The semipermeable membrane of the conventional dialyzer has a sufficiently low permeability to water that an ultrafiltration controller is not required to prevent excessive loss of water from the patient's blood. This conventional dialyzer does not include hemodialyzers with the disposable inserts (Kiil type) (§ 876.5830) or dialyzers of high permeability (§ 876.5860). (3) The dialysate delivery system consists of mechanisms that monitor and control the temperature, conductivity, flow rate, and pressure of the dialysate and circulates dialysate through the dialysate compartment of the dialyzer. The dialysate delivery system includes the dialysate concentrate for hemodialysis (liquid or powder) and alarms to indicate abnormal dialysate conditions. This dialysate delivery system does not include the sorbent regenerated dialysate delivery system for hemodialysis (§ 876.5600), the dialysate delivery system of the peritoneal dialysis system and accessories (§ 876.5630), or the controlled dialysate delivery system of the high permeability hemodialysis system § 876.5860). (4) Remote accessories to the hemodialysis system include the unpowered dialysis chair without a scale, the powered dialysis chair without a scale, the dialyzer holder set, dialysis tie gun and ties, and hemodialysis start/stop tray.

Predicate Devices

• Fresenius FDS08

Submission Summary (Full Text)

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## Fresenius iCare Monitoring System 510(k) Premarket Notification

a

NOV 1 3 2002

## Summary of Safety and Effectiveness

### E. Substantial Equivalence:

&201 [321] (h).

### 1. Is the product a device?

YES - The Fresenius iCare Monitoring System is a device pursuant to 21 CFR

## 2. Does the new device have the same intended use?

YES - The Indications for Use for the Fresenius iCare Monitoring System is equivalent to that for the Fresenius FDS08 and is as follows:

### Intended Use

The Fresenius iCare Monitoring System is a computer-based hemodialysis treatment monitoring system for adjunctive use with the Fresenius 2008 series dialysate delivery system when the patient is attended by trained personnel.

This monitoring system is contraindicated as the sole method of monitoring a patient during hemodialysis.

### 3. Does the device have technological characteristics that raise new types of safety or effectiveness questions?

NO - The Fresenius iCare Monitoring System is an updated version of the Fresenius FDS08. As such, the technological characteristics of the Fresenius iCare Monitoring System are equivalent to those of the Fresenius FDS08.

### 4. Does descriptive or performance information demonstrate equivalence?

YES - Fresenius Medical Care North America believes that the information provided in this submission clearly describes the Fresenius iCare Monitoring System and demonstrates that it is substantially equivalent to the Fresenius FDS08.

### F. Safety Summary

The iCare Monitoring System validation rigorously tested the features of the Fresenius iCare System. The results of this testing indicate that the iCare System is safe and effective for its intended use.

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## Fresenius iCare Monitoring System 510(k) Premarket Notification

. .

## Summary of Safety and Effectiveness

### G. General Safety and Effectiveness Concerns

The device labeling contains an Operator's Manual, which includes indications for use, cautions and warnings, as well as the general operating instructions required for proper use of the device. In addition, training and support is provided to clinics that use the Fresenius iCare Monitoring System. This information promotes safe and effective use of the device.

Arthur Eilinsfeld

Arthur Eilinsfeld Director of Regulatory Affairs

10/1/02
Date

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with three curved lines representing its body or wings.

#### Public Health Service

NOV 1 3 2002

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Arthur Eilinsfeld Director of Regulatory Affairs Fresenius Medical Care North America 95 Hayden Avenue LEXINGTON MA 02420

Re: K021060

Trade/Device Name: Fresenius iCare Monitoring System Regulation Number: 21 CFR §876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: 78 FKP Dated: August 16, 2002 Received: August 19, 2002

Dear Mr. Eilinsfeld:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C Crozdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Fresenius Medical Care

### Indications for Use Statement

### Device Name:

Fresenius iCare Monitoring System

### Indications for Use:

The Fresenius iCare Monitoring System is a computer-based hemodialysis treatment monitoring system for adjunctive use with the Fresenius 2008 series dialysate delivery system when the patient is attended by trained personnel.

This monitoring system is contraindicated as the sole method of monitoring a patient during hemodialysis.

#### 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

Wind G. Ayymm

(Division Sign-Off) Division of Reproductive, Abdon and Partiningical Device 5 long Number

Fresenius Medical Care North America