VENOFER PUMP

K121497 · Renal Solutions, Inc. · KDI · Aug 17, 2012 · Gastroenterology, Urology

Device Facts

• Record ID: K121497
• Device Name: VENOFER PUMP
• Applicant: Renal Solutions, Inc.
• Product Code: KDI · Gastroenterology, Urology
• Decision Date: Aug 17, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

Venofer Pump is an optional, microprocessor-controlled module for Fresenius 2008 Series Hemodialysis Machines; designed to administer Venofer® during dialysis. Components include control panel, vial holder, fluid detector, and peristaltic pump. Powered by host hemodialysis machine. Used in clinical settings by healthcare providers to automate iron delivery. Output consists of controlled fluid administration; assists clinicians in managing anemia in dialysis patients. Version 1.3 adds compatibility with Medisystems Streamline® Blood Tubing Sets.

Clinical Evidence

Bench testing only. No clinical data provided. Verification testing included functional performance testing, system-level hazard analysis, electromagnetic compatibility (IEC 60601-1-2:2007), and biocompatibility (ISO 10993-1:2009). Software testing included architecture review, unit testing, and traceability analysis.

Technological Characteristics

Microprocessor-controlled peristaltic pump module. Patient-fluid contacting materials tested per ISO 10993-1:2009. Powered by Fresenius 2008 Series Hemodialysis Machine. Includes control panel, vial holder, and fluid detector. Software-controlled operation.

Indications for Use

Indicated for patients with chronic kidney disease undergoing hemodialysis who require treatment for iron deficiency anemia, as prescribed by a physician.

Regulatory Classification

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).

Special Controls

*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.”

Predicate Devices

• Venofer Pump (K103564)

Reference Devices

• Medisystems Streamline® Blood Tubing Set (K080807)

Submission Summary (Full Text)

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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: [phone]

FAX: ' [phone]

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)

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#### Venofer Pump Version 1.3

· Special 510(k)

#### Section 6: 510(k) Summary

## Indication for Use

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.

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.

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### Venofer Pump Version 1.3 Special 510(k)

### Section 6: 510(k) Summary

| 510(k) Verification Testing | 510(K) Verification Testing Activities |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Venofer Pump Performance<br>Testing | Functional testing was performed to demonstrate<br>that the device performs as designed and<br>expected. The following information is included: |
| The performance (verification)<br>test results support the<br>performance characteristics of<br>the Venofer Pump. | Specific verification tests conducted Description of the acceptance criteria System-level hazard analysis that confirms<br>that the device does not perform in an<br>unexpected and/or unsafe manner |
| Venofer Pump Safety Testing | Product safety testing demonstrates that the<br>device performs per the FDA Consensus<br>Standards, as identified below: |
| The verification test results<br>support the safety<br>characteristics of the Venofer<br>Pump. | Electromagnetic compatibility (EMC) testing<br>(IEC 60601-1-2: 2007 - Medical Electrical<br>Equipment - Part 1-2: General Requirements<br>for Safety - Collateral Standard:<br>Electromagnetic Compatibility - |
| Biocompatibility testing was<br>performed on all new materials<br>that are patient-fluid contacting | Requirements for Testing<br>Biocompatibility Testing (AAMI / ANSI / ISO<br>10993-1:2009 Biological evaluation of<br>medical devices Part 1: Evaluation & testing) |
| Venofer Pump Software Testing | Software testing demonstrates the device<br>software meets the design input requirements.<br>The following documents were reviewed and<br>updated: |
| The testing includes the<br>required documentation as<br>described in the guidance titled<br>Guidance for the Content of<br>Premarket Submissions for<br>Software | 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.

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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)

.

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#### 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

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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 [phone] or [phone] 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

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#### 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:

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.

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