The Venofer® Pump Module is an optional accessory for use on Fresenius 2008T Hemodialysis Machines and is intended to administer Venofer®, an iron sucrose, to treat iron deficiency anemia in patients with chronic kidney disease undergoing hemodialysis, where Venofer®, in conjunction with hemodialysis, is prescribed by a physician.

Device Description

The Venofer Pump Module is an optional module for use on Fresenius 2008T Hemodialysis Machines. The module is designed to administer Venofer, an iron sucrose supplement, during dialysis treatments. The Venofer Pump Module is to be used in accordance with the approved Venofer Indications for Use and the physician's prescription.

The Venofer Pump Module is intended to provide ease and consistent delivery of Venofer, an iron sucrose supplement, indicated for the treatment of iron deficiency anemia for Hemodialysis dependent-chronic kidney disease patients. Anemia commonly occurs in patients with chronic kidney disease undergoing Hemodialysis and effective anemia management is recognized as an important factor in improving the outcomes of these patients. Iron deficiency is a frequent contributing factor which complicates the treatment of anemia in chronic kidney disease patients. Iron sucrose is commonly delivered to improve iron status in patients who have chronic kidney disease. Venofer is an injectable iron preparation drug approved for treatment of iron deficiency and is the most commonly used drug to treat iron deficiency anemia in dialysis patients. Renal Solutions has developed the Venofer Pump Module that provides the means to deliver Venofer when undergoing Hemodialysis on a Fresenius 2008T Dialysis System.

The Venofer Pump Module fits into the module compartment of existing Fresenius 2008T Machines and consists of a control panel, vial holder, fluid detector, and a peristaltic pump.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Fresenius Model 2008T Hemodialysis Machine with Venofer Pump Module." This document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed study with acceptance criteria and performance data for a novel device. Therefore, much of the requested information regarding acceptance criteria, sample sizes, expert ground truth, adjudication methods, and comparative effectiveness studies is not available in the provided text.

Based on the information given, here's what can be extracted:

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

This information is not provided in the document. The submission is for a medical device accessory and states that non-clinical testing was performed, but it doesn't detail specific acceptance criteria or quantitative performance results in a table format. It generally claims the device is "as safe, as effective, and performs at least as safely and effectively as the legally marketed devices identified as predicate devices."

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

This information is not provided in the document. The text mentions "non-clinical testing" but does not specify sample sizes or data provenance.

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):

This information is not provided in the document. The nature of the device (a pump for administering medication during hemodialysis) suggests that ground truth would likely be established through engineering and medical performance standards, rather than expert-derived ground truth in the way a diagnostic imaging AI might.

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

This information is not provided in the document.

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:

This information is not applicable and not provided in the document. The Venofer Pump Module is an accessory for a hemodialysis machine, administering medication. It is not an AI-assisted diagnostic tool that would typically involve human "readers" or an MRMC study.

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

This information is not applicable in the context of an AI algorithm. The device is a physical pump module. The document states, "Like the Heparin Pump, the Venofer Pump Module is not a stand alone device. The Venofer Pump Module cannot operate unless it is connected to the 2008T Hemodialysis Machine." This refers to its operational dependency on the larger hemodialysis machine, not a standalone AI performance evaluation.

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

This information is not explicitly stated in the document. Given the device's function, ground truth for its performance would likely be established through engineering specifications, flow rate accuracy, absence of adverse events, and efficacy of drug delivery as measured by standard medical parameters (e.g., successful iron administration without pump-related complications), rather than categorical labels like pathology or expert consensus on image interpretation. The submission relies on "verification, safety, performance and software testing."

8. The sample size for the training set:

This information is not provided in the document. The device is a physical pump, not an AI algorithm that undergoes a "training set" in the machine learning sense.

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

This information is not provided in the document, as it's not an AI device with a training set.

Summary

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Venofer Pump 510(k) Premarket Notification

Section 5: 510(k) Summary

510(k) Summary

JUL - 9 2010

Official Contact	David J. VanellaSenior Vice President, Quality SystemsRenal Solutions, Inc.770 Commonwealth DriveWarrendale, Pa 15086Phone: (724) 720-2840FAX: (724) 772-6925
Date	July 8, 2010
Classification Name	Dialyzer, High Permeability With Or Without SealedDialysate System
Regulation Number	876.5860
Product Code	KDI
Common/Usual Name	Hemodialysis System
Proprietary Name	Fresenius Model 2008T Hemodialysis Machine
Predicate Devices	Allient 1500 Sorbent Hemodialysis SystemFresenius 2008T Hemodialysis System
Reason for submission	New Device

Substantial Equivalence

The addition of the Venofer Pump Module on the Fresenius Model 2008T Hemodialysis Machine leverages the company's Heparin Pump design previously used in the Allient 1500 Sorbent Hemodialysis System. The proposed predicate device for the Venofer Pump Module is the Heparin Pump, a component of the Allient 1500 Sorbent Hemodialysis System that was cleared by the FDA in 2007 under K070739.

The Venofer Pump Module device is substantially equivalent to the predicate device in terms of the following:

Intended use .
Environment of use .
. Operating principle
Technology ●

Like the Heparin Pump, the Venofer Pump Module is not a stand alone device. The Venofer Pump Module cannot operate unless it is connected to the 2008T Hemodialysis Machine. In addition, similar to the Heparin Pump, the Venofer Pump delivers the contents of the vial into the extracorporeal blood set (not directly into

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Venofer Pump

._K093964
pg. 2 of 2

510(k) Premarket Notification

Section 5: 510(k) Summary

the patient). Therefore, similar to the Heparin Pump, the Venofer Pump is considered an accessory to the Fresenius Model 2008T Hemodialysis Machine and thus would also carry the same classification as KDI, 876.5860.

Indication for Use

Fresenius Model 2008T Hemodialysis Machine is indicated for acute and chronic dialysis therapy.

Intended Use/General Safety and Effectiveness

Non-Clinical Testing

The non-clinical testing submitted, referenced, and relied on in this 510(k) premarket notification included verification, safety, performance and software testing of the Venofer Pump module as part of the Fresenius 2008T Hemodialysis System. The conclusions drawn from this testing demonstrates that the Fresenius 2008T Hemodialysis System is as safe, as effective, and performs at least as safely and effectively as the legally marketed devices identified as predicate devices to which it was compared.

Device Description

The Venofer Pump Module fits into the module compartment of existing Fresenius 2008T Machines and consists of a control panel, vial holder, fluid detector, and a peristaltic pump.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes forming its body, representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-Gt Silver Spring, MD 20993-0002

Mr. David J. Vanella Senior Vice President, Quality Systems Renal Solutions®, Inc. 770 Commonwealth Drive, Suite 101 WARRENDALE PA 15086

JUL - 9 2010

Re: K093964

Trade/Device Name: Fresenius 2008T Hemodialysis Machine with Venofer Pump Module Regulation Number: 21 CFR §876.5860 Regulation Name: High permeability hemodialysis system

Regulatory Class: II Product Code: KDI Dated: July 7, 2010

Received: July 8, 2010

Dear Mr. Vanella:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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); medical device reporting of medical device-related

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adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Janine M. Morris

Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Venofer® Pump

510(k) Premarket Notification

Section 4: Indications for Use Statement

Indications for Use Statement

510(k) Number (if known): N/A

Device Name: Fresenius 2008T Hemodialysis Machine with Venofer Pump Module

Indications for Use:

Same as K080964

Fresenius 2008T is indicated for acute and chronic dialysis therapy.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal, and
Radiological Devices
510(k) Number K093964

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.”