The Venofer® Pump 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.

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

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 fits into the module compartment of Fresenius 2008T Machines and consists of a control panel, vial holder, fluld detector, and a peristaltic pump.

AI/ML Overview

This document is a 510(k) Summary for the Venofer Pump Version 1.1, a device intended to administer Venofer (iron sucrose) during hemodialysis. This filing is a "Special 510(k)" for a modification to an existing device (Venofer Pump K093964).

Crucially, this document focuses on demonstrating substantial equivalence through non-clinical verification testing (performance, safety, and software) and does NOT describe a study involving human patients or a process for establishing ground truth from expert consensus for diagnostic accuracy.

Therefore, most of the requested information regarding clinical studies, sample sizes, expert involvement, and ground truth establishment will not be applicable or available in this specific document.

Here's an analysis based on the provided text:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria Category	Reported Device Performance (Summary from this document)
Venofer Pump Performance Testing	Functional testing demonstrated that the device performs as designed and expected. This included specific verification tests with defined objectives, test articles, test methods and procedures, and pre-defined acceptance or pass/fail criteria. A system-level hazard analysis confirmed the device does not perform in an unexpected and/or unsafe manner. (Specific quantitative performance metrics are not detailed in this summary.)
Venofer Pump Safety Testing	Product safety testing demonstrated that the device performs per FDA Consensus Standards. This included: - Electromagnetic Compatibility (EMC): Tested to IEC 60601-1-2: 2007.- Biocompatibility: Tested to AAMI / ANSI / ISO 10993-1:2009 for all new patient-fluid contacting materials. (Specific quantitative results or pass/fail criteria for these tests are not detailed in this summary.)
Venofer Pump Software Testing	Software testing demonstrated the device software meets the design input requirements. This included: - Structure chart/flow chart of software architecture.- Summary of software development procedures, including changes.- Software requirements specification with traceability to hazard analysis.- Verification and validation test plans, including pass/fail criteria and traceability to requirements.- System-level test results.- Current software version number and date of latest revision. (Specific quantitative test results or detailed pass/fail criteria are not detailed in this summary.)

Study Proving Device Meets Acceptance Criteria:

The study referenced is the "510(k) Verification Testing Non-Clinical Summary" which includes "Performance, Safety, and Software Testing." The document emphasizes that "The conclusions drawn from this testing demonstrates that the Venofer Pump 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."

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: This refers to the number of devices or components tested, not patient data. The document does not specify the exact number of units or test iterations for the performance, safety, or software verification tests. It generally refers to "the device" implying tests were conducted on one or more representative units.
Data Provenance: Not applicable. This is not a study involving patient data. The testing was non-clinical (laboratory/engineering) and would have been conducted by the manufacturer, Renal Solutions, Inc. (USA).
Retrospective or Prospective: Not applicable. This applies to clinical data collection, not non-clinical device verification.

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. This device is a pump for administering medication, not an AI/diagnostic device that requires expert-established ground truth from medical imaging or patient data. The "ground truth" for this device's performance is its adherence to engineering specifications, safety standards, and software requirements, which are verified through the non-clinical testing described.

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

Not Applicable. Adjudication methods like 2+1 or 3+1 refer to how discrepancies in expert opinions are resolved to establish a definitive ground truth in diagnostic studies. This is a non-clinical device verification, so such adjudication is not performed. Acceptance was based on pre-defined pass/fail criteria for engineering and safety tests.

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

No. An MRMC study is relevant for diagnostic devices that assist human readers (e.g., radiologists interpreting images). This device is a pump, not an AI-assisted diagnostic tool.

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

Not Applicable in the traditional sense of an AI algorithm. This is a hardware device with embedded software. The "standalone" performance was effectively what the document refers to as "Venofer Pump Performance Testing" and "Venofer Pump Software Testing" – verifying the device and its embedded software performed according to specifications and safety requirements without human intervention during the test cycles, but it's not an AI algorithm performing a diagnostic task.

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

Not Applicable/Defined Differently. For this type of device, "ground truth" is defined by:
- Engineering Specifications: The pre-defined functional requirements and performance parameters of the pump (e.g., flow rate accuracy, pressure limits).
- Regulatory Standards: Compliance with recognized FDA Consensus Standards (e.g., IEC 60601-1-2 for EMC, ISO 10993-1 for Biocompatibility).
- Software Requirements: The predefined design input requirements for the device's embedded software.
- Hazard Analysis: Confirmation that the device does not perform in an unexpected and/or unsafe manner.

8. The sample size for the training set

Not Applicable. This device does not use machine learning or AI that requires a "training set" of data. Its functionality is based on deterministic programming and electro-mechanical design, not learned patterns from data.

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

Not Applicable. As there is no training set for an AI algorithm, there is no ground truth to establish for it.

Summary

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Response to FDA Questions K103564

Venofer Pump Version 1.1 Special 510(k)

FEB 1 0 2011

Section 5: 510(k) Summary

510(k) Summary

Submitter's Information

Name	Renal Solutions, Inc.
Address	770 Commonwealth DriveWarrendale, Pa 15086Phone: (724) 720-2840FAX: (724) 772-6925
Official Contact	David J. VanellaSenior Vice President, Quality Systems
Date Prepared	January 7, 2011
Device Information
Name	Venofer Pump, for use on the Fresenius2008T Hemodialysis Machine
Common/Usual Name	Hemodialysis System
Product Code	KDI
Classification Name	Dialyzer, High Permeability With Or WithoutSealed Dialysate System
Regulation Number	876.5860
Proprietary Name	Venofer Pump
Unmodified Device	Venofer Pump (K093964)
Reason for Submission	Modification to existing device

Substantial Equivalence

The Venofer Pump 1.1 is substantially equivalent to the unmodified device (Venofer Pump K093964) in terms its intended use, environment of use, operating principles, and technology.

Renal Solutions, Inc.

Venofer® Pump 1.1 Special 510(k)

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Venofer Pump Version 1.1 Special 510(k)

Section 5: 510(k) Summary

Intended Use

The intended use of the Venofer Pump 1.1 is identical to the unmodified device.

Venofer Pump 510(k) Verification Testing Non-Clinical Summary

The verification (non-clinical) testing information consists of performance, safety, and software testing that was performed to verify the Venofer Pump meets its performance specifications and to demonstrate the device is substantially equivalent to the established predicate devices.

The following table summarizes the 510(k) verification testing activities performed. These include performance, safety and software testing, which demonstrates by technical examination that the Venofer Pump meets its performance specifications, the designated (FDA Consensus) standard requirements, and the software design input requirements.

510(k) Verification Testing	510(K) Verification Testing Activities
Venofer Pump Performance TestingThe performance (verification)testing results support theperformance characteristics of theVenofer Pump.	Functional testing that demonstrates thatthe device performs as designed andexpected, includes the following:The specific verification testsconducted A description of all test protocolincluding: objective of the tests test articles used in the tests test methods and procedures pre-defined acceptance or pass/failcriteria. System-level hazard analysis thatconfirms that the device does notperform in an unexpected and/orunsafe manner

510(k) Verification Testing

510(K) Verification Testing Activities

Venofer Pump Performance TestingThe performance (verification)testing results support theperformance characteristics of theVenofer Pump.

Functional testing that demonstrates thatthe device performs as designed andexpected, includes the following:The specific verification testsconducted A description of all test protocolincluding: objective of the tests test articles used in the tests test methods and procedures pre-defined acceptance or pass/failcriteria. System-level hazard analysis thatconfirms that the device does notperform in an unexpected and/orunsafe manner

Renal Solutions, Inc.

Venofer® Pump 1.1 Special 510(k)

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Venofer Pump Version 1.1 Special 510(k)

Section 5: 510(k) Summary

510(k) Verification Testing	510(K) Verification Testing Activities
Venofer Pump Safety Testing
The verification testing resultssupport the safety characteristics of	Product safety testing that demonstrates thatthe device performs per the FDA ConsensusStandards, as identified below:
the Venofer Pump.Biocompatibility testing wasperformed on all new materials thatare patient-fluid contacting	Electromagnetic compatibility (EMC)testing (IEC 60601-1-2: 2007 - MedicalElectrical Equipment - Part 1-2: GeneralRequirements for Safety - CollateralStandard: Electromagnetic Compatibility- Requirements for Testing Biocompatibility Testing (AAMI / ANSI /ISO 10993-1:2009 Biological evaluationof medical devices Part 1: Evaluation &testing )
Venofer Pump Software TestingThe testing includes the required	Software testing that demonstrates thedevice software meets the design inputrequirements. The device was tested andIncludes the following
documentation as described in theguidance titled Guidance for theContent of Premarket Submissionsfor Software	Structure chart of flow chart describingsoftware architecture Summary of software developmentprocedures, including changes made tothe software Software requirements specification withtraceability back to the hazard analysis Verification and validation test plans,including pass/fail criteria and traceabilityback to the requirements; System level test results Current software version number anddate of latest revision.

Renal Solutions, Inc. Venofer® Pump 1.1 Special 510(k)

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Response to FDA Questions K103564

Venofer Pump Version 1.1 Special 510(k)

Section 5: 510(k) Summary

The conclusions drawn from this testing demonstrates that the Venofer Pump 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.

General Safety and Effectiveness

The Venofer Pump 1.1 is an updated version of the Venofer Pump (K093964). The performance and technological characteristics of the modified device are equivalent to those of the unmodified device and raise no new types of safety or effectiveness questions.

Device Description

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

Renal Solutions, Inc. Venofer® Pump 1.1 Special 510(k)

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 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

FEB 10 201

Re: K103564

Trade/Device Name: Venofer Pump Regulation Number: 21 CFR §876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: KDI Dated: January 7, 2011 Received: January 11, 2011

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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Page 2

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/CDRHOffices/ucm 17-10-11-11-15 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 tolloffree 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,

Hubert Lemmer MD

Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health.

Enclosure

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KI03564

Venofer Pump Version 1.1 Special 510(k)

Section 5: Indications for Use Statement

Indications for Use Statement

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

Device Name: Venofer Pump

Indications for Use:

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

Prescription Use × (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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

tive, Gastro-Renal, and SIU(K) NUME

Renal Solutions, Inc. Venofer® Pump 1.1 Special 510(k)

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.”