The Fresenius 2008K and the Fresenius 3008 proportion concentrate and prepare and deliver deaerated dialysate fluid at the desired conductivity, temperature and specified pressure. The ultrafiltration control method is identical in both the Fresenius 2008K and the Fresenius 3008. which control ultrafiltration during dialysis by withdrawing a defined volume of fluid from the closed dialysate circuit. The primary difference between the Fresenius 2008K and the 3008 is the new user interface.

AI/ML Overview

The provided text is a 510(k) Premarket Notification for the Fresenius 2008K Dialysate Delivery System. This submission focuses on demonstrating substantial equivalence to a predicate device (Fresenius 3008 Dialysate Delivery System) rather than proving performance against specific acceptance criteria for a new type of diagnostic or AI-powered device.

Therefore, many of the requested categories related to acceptance criteria, study design for performance, ground truth establishment, expert involvement, and AI-specific metrics (like MRMC studies or effect size of AI assistance) are not applicable to this type of regulatory submission.

Here's an analysis based on the available information:

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

Not Applicable. This 510(k) submission for the Fresenius 2008K Dialysate Delivery System does not establish new performance acceptance criteria in the way a submission for a novel diagnostic or AI device would. Instead, it aims to demonstrate that its performance is equivalent to an already legally marketed predicate device (Fresenius 3008). The "acceptance criteria" are effectively that the new device performs fundamentally the same and for the same intended use as the predicate.
The document states: "The technological characteristics of the Fresenius 2008K are equivalent to those of the Fresenius 3008. Both the Fresenius 2008K and the Fresenius 3008 proportion concentrate and prepare and deliver deaerated dialysate fluid at the desired conductivity, temperature and specified pressure. The ultrafiltration control method is identical in both the Fresenius 2008K and the Fresenius 3008. which control ultrafiltration during dialysis by withdrawing a defined volume of fluid from the closed dialysate circuit."

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

Not Applicable. There is no mention of a "test set" in the context of clinical data or patient samples as would be used for a diagnostic device. The evaluation relied on "software validation, functional testing, and release testing" of the device itself.
The data provenance is industrial testing, not patient data.

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)

Not Applicable. As there is no test set based on clinical cases requiring expert interpretation, no experts were used for this purpose. The device's functionality was evaluated against engineering and design specifications.

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

Not Applicable. No clinical test set or human adjudication process is described.

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

Not Applicable. This is not an AI-powered device.

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

Not Applicable. This is not an AI-powered device. The device operates independently for its intended function (dialysate delivery).

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

Operational Ground Truth: The "ground truth" for this device's performance is its ability to correctly proportion concentrate, prepare, and deliver dialysate fluid at specified conductivity, temperature, and pressure, and to perform ultrafiltration control as designed. This is verified through "software validation, functional testing, and release testing" conducted by the manufacturer, rather than clinical outcomes or expert labels.

8. The sample size for the training set

Not Applicable. This is not a machine learning device, so there is no "training set." The device is built following established engineering principles and validated through testing.

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

Not Applicable. There is no training set for this device.

Summary

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Fresenius 2008K 510(k) Premarket Notification

Summary of Safety and Effectiveness

This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of SMDA 1990.

A. Submitter's Information:

Name:	Fresenius Medical Care North America
Address:	95 Hayden AveTwo Ledgemont CenterLexington, MA 02420
Phone:	1-781-402-9068
Fax:	(781) 402-9082
Contact Person:	Arthur Eilinsfeld, Regulatory Affairs Manager
Date of Preparation:	December 10, 1999

B. Device Name:

Trade Name:	Fresenius 2008K Dialysate Delivery System
Common/Usual Name:	Hemodialysis Delivery Equipment
Classification Name:	Sealed Dialysate Delivery System

C. Predicate Device Name:

. Fresenius 3008 Dialysate Delivery System (#K921456, 4/20/94)

D. Device Description/Indications for Use:

The indications for use for the Fresenius 2008K are identical to those of the Fresenius 3008 and are as follows:

The Fresenius 2008K is indicated for acute and chronic dialysis therapy.

Fresenius 2008K 510(k) Submission 12/15/1999

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Fresenius 2008K 510(k) Premarket Notification

Summary of Safety and Effectiveness

E. Substantial Equivalence:

510(k) Substantial Equivalence Decision Making Process

1. Is the product a device?

YES - The Fresenius 2008K is a device pursuant to 21 CFR §201 [321] (h).

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

YES - The intended use for the Fresenius 2008K is the same as that for the Fresenius 3008 and is as follows:

Intended Use

The Fresenius 2008K is indicated for acute and chronic dialysis therapy.

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

NO - The technological characteristics of the Fresenius 2008K are equivalent to those of the Fresenius 3008. Both the Fresenius 2008K and the Fresenius 3008 proportion concentrate and prepare and deliver deaerated dialysate fluid at the desired conductivity, temperature and specified pressure. The ultrafiltration control method is identical in both the Fresenius 2008K and the Fresenius 3008. which control ultrafiltration during dialysis by withdrawing a defined volume of fluid from the closed dialysate circuit. The primary difference between the Fresenius 2008K and the 3008 is the new user interface.

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 2008K and demonstrates that it is substantially equivalent to the Fresenius 3008.

Fresenius 2008K 510(k) Submission 12/15/1999

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Fresenius 2008K 510(k) Premarket Notification

Summary of Safety and Effectiveness

F. Safety Summary

The Fresenius 2008K software validation, functional testing, and release testing rigorously tested the features of the 2008K. The results of this testing indicate that the Fresenius 2008K is safe and effective for its intended use.

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 2008K. This information promotes safe and effective use of the device.

Signature

Arthur Eilinsfeirt, Regulatory Affairs Manager

12/16/99
Date

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Arthur Eilinsfeld Regulatory Affairs Manager Fresenius Medical Care, North America Two Ledgemont Center 95 Hayden Avenue Lexington, Massachusetts 02420

MAR 1 6 2000

Re: K994267

Fresenius 2008K Dialysate Delivery System Dated: December 16, 1999 Received: December 17, 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 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 and prohibitions 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 (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 requlation may result in requlatory 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 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 predication for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809,10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4591. 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" (21CFR 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmaldsmamain.html".

Sincerely yours,

Daniel G. Schultz, M.D. Captain, USPHS Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

Image /page/3/Picture/14 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is an abstract image of a bird in flight, composed of three curved lines.

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Indications for Use Statement

Device Name:

Fresenius 2008K Dialysate Delivery System

Indications for Use:

The Fresenius 2008K is indicated for acute and chronic dialysis therapy.

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)	✓
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Over-The-Counter Use
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David A. Symm
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices

510(k) Number	K994267
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Fresenius Medical Care North America Corporate Headquarters: Two Ledgemont Center 95 Hayden Avenue Lexington, MA 02420 (781) 402-9000

Regulation Number and Section

§ 876.5860 High permeability hemodialysis system.

(a)
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).
(b)
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.”