The Venofer Pump is an optional accessory for use with the Fresenius 2008 Series Hemodialysis Machines and is intended to administer Venofer® 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 is an optional module for use on Fresenius 2008 Series Hemodialysis Machines and is designed to administer Venofer® during dialysis treatments and consists of a control panel, vial holder, fluid detector, and a peristaltic pump. The module is a self contained microprocessor controlled device that receives its power from the Fresenius 2008 Hemodialysis machine.

AI/ML Overview

The provided text describes the Venofer Pump Version 1.3, an optional accessory for hemodialysis machines. This submission is a "Special 510(k)" for modifications to support the use of an additional blood tubing set. The document focuses on demonstrating substantial equivalence to a previously cleared device (K103564) and confirming that the modifications do not raise new questions of safety or effectiveness.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Verification Tests Conducted	Reported Device Performance/Outcome
Venofer Pump Performance	Functional testing to demonstrate the device performs as designed and expected.	The performance (verification) test results support the performance characteristics of the Venofer Pump. It was confirmed that the device does not perform in an unexpected and/or unsafe manner (system-level hazard analysis). Specific details of the performance metrics are not explicitly provided beyond this general statement.
Venofer Pump Safety	Electromagnetic compatibility (EMC) testing (IEC 60601-1-2: 2007)	Product safety testing demonstrates that the device performs per the FDA Consensus Standards. This specifically includes EMC testing.
	Biocompatibility testing (AAMI / ANSI / ISO 10993-1:2009)	Biocompatibility testing was performed on all new materials that are patient-fluid contacting. The verification test results support the safety characteristics of the Venofer Pump. (No specific numerical results or pass/fail criteria are provided, only that testing was performed and supported safety).
Venofer Pump Software	Software architecture SDD (Software Design Description) Unit test System and software requirements Traceability	Software testing demonstrates the device software meets the design input requirements. The testing includes required documentation as described in the guidance titled "Guidance for the Content of Premarket Submissions for Software." (No specific metrics like bug rates, code coverage, or pass/fail percentages are provided, only a general statement of meeting design input requirements and review of documentation). The phrase "Software release history" is also listed as documentation reviewed, suggesting a process was followed.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size used for the test set for any of the verification activities (functional, safety, or software).
The data provenance is not specified in terms of country of origin or whether it was retrospective or prospective. The studies described are non-clinical (verification) testing, not clinical trials on human subjects.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. Given that the studies are non-clinical verification tests, the "ground truth" would likely be established by engineering specifications, regulatory standards, or consensus standards, rather than expert clinical judgment in the traditional sense for medical imaging or diagnostic devices.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies involving human readers/interpreters, not for non-clinical device verification testing.

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 MRMC comparative effectiveness study was done. This device is a pump for administering medication, not an AI-powered diagnostic or assistive device for human readers.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

No standalone algorithm performance study was done in the context of AI. The "standalone" performance described would be the functional performance of the pump itself, which was tested during "Venofer Pump Performance Testing." The device is a physical pump, not a diagnostic algorithm.

7. The Type of Ground Truth Used

For the non-clinical verification testing described:

Performance Testing: The "ground truth" would be the device's design specifications and expected functional behavior.
Safety Testing: The "ground truth" would be established by FDA Consensus Standards (e.g., IEC 60601-1-2 for EMC, AAMI / ANSI / ISO 10993-1 for biocompatibility).
Software Testing: The "ground truth" would be the software design input requirements and functional specifications.

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided. The Venofer Pump is a physical medical device, not an AI/machine learning algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable and therefore not provided. As mentioned above, the device is not an AI/machine learning algorithm.

Summary

{0}------------------------------------------------

K121497.
pg. 1 of 4

Venofer Pump Version 1.3 Special 510(k)

AUG 1 7 2012

Section 6: 510(k) Summary

510(k) Summary

Submitter's Information

Name

Address

Renal Solutions, Inc.

770 Commonwealth Drive

Warrendale, Pa 15086

Phone: (724) 720-2840

FAX: ' (724) 720-2874

Official Contact

David J. Vanella

Senior Vice President, Quality Assurance & Regulatory Affairs

Date Prepared

Device Information

Name

Common/Usual Name

Product Code

Classification Name

Regulation Number

Proprietary Name

Unmodified Device

Reason for Submission

Venofer Pump

5/18/2012

Hemodialysis System

KDI

Dialyzer, High Permeability With Or Without Sealed Dialysate System

876.5860

Venofer Pump

Venofer Pump (K103564)

Modifications were made to support the use of an additional Blood Tubing Set, the Medisystems Streamline® (K080807).

Renal Solutions, Inc. Venofer® Pump 1.3 Special 510(k)

ﺎ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ

{1}------------------------------------------------

Venofer Pump Version 1.3

· Special 510(k)

Section 6: 510(k) Summary

Indication for Use

Device Description

The Venofer Pump is to be used in accordance with the approved Venofer Indications for Use and the physician's prescription.

Substantial Equivalence

The Venofer Pump 1.3 is substantially equivalent to the unmodified device (Venofer Pump K103564) in terms of its intended use, environment of use. operating principles, and technology. The Venofer Pump is currently used with Fresenius CombiSet Blood Tubing Sets. Modifications were made to support the use of the Venofer Pump with Medisystems Streamline® Blood Tubing Sets (K080807).

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

The verification (non-clinical) testing information consists of the 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.

{2}------------------------------------------------

Venofer Pump Version 1.3 Special 510(k)

Section 6: 510(k) Summary

510(k) Verification Testing	510(K) Verification Testing Activities
Venofer Pump PerformanceTesting	Functional testing was performed to demonstratethat the device performs as designed andexpected. The following information is included:
The performance (verification)test results support theperformance characteristics ofthe Venofer Pump.	Specific verification tests conducted Description of the acceptance criteria System-level hazard analysis that confirmsthat the device does not perform in anunexpected and/or unsafe manner
Venofer Pump Safety Testing	Product safety testing demonstrates that thedevice performs per the FDA ConsensusStandards, as identified below:
The verification test resultssupport the safetycharacteristics of the VenoferPump.	Electromagnetic compatibility (EMC) testing(IEC 60601-1-2: 2007 - Medical ElectricalEquipment - Part 1-2: General Requirementsfor Safety - Collateral Standard:Electromagnetic Compatibility -
Biocompatibility testing wasperformed on all new materialsthat are patient-fluid contacting	Requirements for TestingBiocompatibility Testing (AAMI / ANSI / ISO10993-1:2009 Biological evaluation ofmedical devices Part 1: Evaluation & testing)
Venofer Pump Software Testing	Software testing demonstrates the devicesoftware meets the design input requirements.The following documents were reviewed andupdated:
The testing includes therequired documentation asdescribed in the guidance titledGuidance for the Content ofPremarket Submissions forSoftware	Software architecture SDD Unit test System and software requirements Software release history Traceability

The conclusions drawn from this testing demonstrate that the Venofer Pump is as safe, as effective, and performs as safely and effectively as the legally marketed devices identified as predicate devices to which it was compared.

{3}------------------------------------------------

K121497
Pg. 4 of 4

Venofer Pump Version 1.3

Special 510(k)

Section 6: 510(k) Summary

General Safety and Effectiveness

The Venofer Pump 1.3 is an updated version of the Venofer Pump (K103564). 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.

・ Renal Solutions, Inc. Venofer® Pump 1.3 Spècial 510(k)

{4}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

AUG 17 2012

Mr. David Vanella Senior Vice President OA/RA Renal Solutions, Inc. 770 Commonwealth Drive, Suite 101 WARRENDALE PA 15086

Re: K121497

Trade/Device Name: Venofer Pump Regulation Number: 21 CFR§ 876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: KDI Dated: May 21, 2012 Received: May 21, 2012

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 (reporting of medical

{5}------------------------------------------------

device-related 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,

Benjamin K. Twitchell

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{6}------------------------------------------------

Venofer Pump Version 1.3

Special 510(k)

Section 5: Indications for Use

Indications for Use Statement

KI21497 510(k) Number (if known): AHA

Device Name: Venofer Pump

Indications for Use:

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) Renal Solutions, Inc. Page 1 of | Venofer® Pump 1.3 Special 510( ctive. Gastro-R

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.”