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 Description

The Fresenius iCare Monitoring System is a computer-based hemodialysis treatment monitoring system. It is an updated version of the Fresenius FDS08.

AI/ML Overview

The provided text is a 510(k) Premarket Notification for the "Fresenius iCare Monitoring System". This document focuses on establishing substantial equivalence to a predicate device (Fresenius FDS08) rather than detailing a study that proves the device meets specific performance acceptance criteria through quantitative metrics.

Therefore, many of the requested categories cannot be filled as the information is not present in the provided text. The document primarily asserts "equivalence" and "safety and effectiveness" without providing the underlying data from studies that would demonstrate these claims in a detailed, quantitative manner.

Here's a breakdown of what can and cannot be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Not specified	Not specified

Explanation: The document states that "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." However, it does not provide any specific quantitative acceptance criteria or the measured performance of the device against those criteria (e.g., accuracy, precision, sensitivity, specificity, or specific tolerances for monitored parameters). The focus is on demonstrating substantial equivalence to a predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample size for test set: Not specified
Data provenance: Not specified

Explanation: The document refers to "validation" and "rigorous testing" but does not detail the protocols, sample sizes, or nature of the test data used for these activities.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Number of experts: Not specified
Qualifications of experts: Not specified

Explanation: There is no mention of experts being used to establish a "ground truth" in the context of performance evaluation for this monitoring system. The validation activities are generally expected to compare the device's output against known inputs or established reference methods, but the document does not elaborate on this.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Adjudication method: Not specified

Explanation: Since no details on expert-based ground truth establishment or comparative evaluations are provided, there is no mention of an adjudication method.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

MRMC study done: No
Effect size of improvement: Not applicable

Explanation: The device is described as a "computer-based hemodialysis treatment monitoring system for adjunctive use." It is not an AI-assisted diagnostic or interpretation system that would typically undergo an MRMC study comparing human performance with and without AI. It monitors parameters, and its safety relies on it being "attended by trained personnel" and not being the "sole method of monitoring."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Standalone performance study done: Not explicitly detailed, but implied by the "validation rigorously tested the features" statement. However, no performance metrics are given.

Explanation: The document asserts the system's "safety and effectiveness for its intended use" based on its validation. This validation would inherently involve evaluating the algorithm's performance in monitoring. However, specific standalone performance metrics (e.g., accuracy of measurement, speed, or reliability under various conditions) are not disclosed in this summary. The device's intended use is adjunctive, meaning it's not designed to operate without human oversight.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Type of ground truth: Not specified

Explanation: The document does not detail how the accuracy or reliability of the monitoring system's measurements or alerts (which would constitute its "ground truth") were established during validation tests.

8. The sample size for the training set

Sample size for training set: Not applicable (or not specified if the system involves machine learning).

Explanation: The device is described as a "computer-based hemodialysis treatment monitoring system." While computer-based systems can involve algorithms, the document doesn't indicate it's a machine learning or AI system that requires a distinct "training set" in the modern sense. It appears to be an update to an existing monitoring system, implying rule-based or deterministic algorithms rather than data-driven learning.

9. How the ground truth for the training set was established

How ground truth was established for training set: Not applicable.

Explanation: As above, if a training set was not explicitly used (as in an ML model), then the establishment of its ground truth is not relevant to this document.

Summary

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Fresenius iCare Monitoring System 510(k) Premarket Notification

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

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	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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:

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)

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

Regulation Number and Section

§ 876.5820 Hemodialysis system and accessories.

(a)
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.
(b)
Classification. (1) Class II (performance standards) for hemodialysis systems and all accessories directly associated with the extracorporeal blood system and the dialysate delivery system.(2) Class I for other accessories of the hemodialysis system remote from the extracorporeal blood system and the dialysate delivery system, such as the unpowered dialysis chair, hemodialysis start/stop tray, dialyzer holder set, and dialysis tie gun and ties. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.