VENOFER PUMP

K103564 · Renal Solutions, Inc. · KDI · Feb 10, 2011 · Gastroenterology, Urology

Device Facts

• Record ID: K103564
• Device Name: VENOFER PUMP
• Applicant: Renal Solutions, Inc.
• Product Code: KDI · Gastroenterology, Urology
• Decision Date: Feb 10, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

Venofer Pump 1.1 is an optional module for Fresenius 2008T Hemodialysis Machines; designed to administer Venofer (iron sucrose) during dialysis. Device components include control panel, vial holder, fluid detector, and peristaltic pump. Operated by clinical staff in dialysis settings. Device automates iron sucrose delivery during hemodialysis treatment; output is controlled infusion of medication. Benefits include efficient, physician-prescribed iron supplementation for patients with chronic kidney disease-related anemia.

Clinical Evidence

No clinical data. Evidence consists of non-clinical verification testing, including performance testing, system-level hazard analysis, electromagnetic compatibility (IEC 60601-1-2: 2007), biocompatibility (AAMI/ANSI/ISO 10993-1:2009), and software verification/validation.

Technological Characteristics

Optional module for Fresenius 2008T Hemodialysis Machine; features peristaltic pump, fluid detector, vial holder, and control panel. Biocompatibility per AAMI/ANSI/ISO 10993-1:2009; EMC per IEC 60601-1-2:2007. Software-controlled operation.

Indications for Use

Indicated for patients with chronic kidney disease undergoing hemodialysis who require treatment for iron deficiency anemia via Venofer (iron sucrose) administration, 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 (K093964)

Submission Summary (Full Text)

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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 Drive<br>Warrendale, Pa 15086<br>Phone: [phone]<br>FAX: [phone] |
| Official Contact | David J. Vanella<br>Senior Vice President, Quality Systems |
| Date Prepared | January 7, 2011 |
| Device Information | |
| Name | Venofer Pump, for use on the Fresenius<br>2008T Hemodialysis Machine |
| Common/Usual Name | Hemodialysis System |
| Product Code | KDI |
| Classification Name | Dialyzer, High Permeability With Or Without<br>Sealed 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.

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.

# 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 Testing<br>The performance (verification)<br>testing results support the<br>performance characteristics of the<br>Venofer Pump. | Functional testing that demonstrates that<br>the device performs as designed and<br>expected, includes the following:<br>The specific verification tests<br>conducted A description of all test protocol<br>including: objective of the tests test articles used in the tests test methods and procedures pre-defined acceptance or pass/fail<br>criteria. System-level hazard analysis that<br>confirms that the device does not<br>perform in an unexpected and/or<br>unsafe 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 results<br>support the safety characteristics of | Product safety testing that demonstrates that<br>the device performs per the FDA Consensus<br>Standards, as identified below: |
| the Venofer Pump.<br>Biocompatibility testing was<br>performed on all new materials that<br>are patient-fluid contacting | Electromagnetic compatibility (EMC)<br>testing (IEC 60601-1-2: 2007 - Medical<br>Electrical Equipment - Part 1-2: General<br>Requirements for Safety - Collateral<br>Standard: Electromagnetic Compatibility<br>- Requirements for Testing Biocompatibility Testing (AAMI / ANSI /<br>ISO 10993-1:2009 Biological evaluation<br>of medical devices Part 1: Evaluation &<br>testing ) |
| Venofer Pump Software Testing<br>The testing includes the required | Software testing that demonstrates the<br>device software meets the design input<br>requirements. The device was tested and<br>Includes the following |
| documentation as described in the<br>guidance titled Guidance for the<br>Content of Premarket Submissions<br>for Software | Structure chart of flow chart describing<br>software architecture Summary of software development<br>procedures, including changes made to<br>the software Software requirements specification with<br>traceability back to the hazard analysis Verification and validation test plans,<br>including pass/fail criteria and traceability<br>back to the requirements; System level test results Current software version number and<br>date 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 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.

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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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 [phone] or [phone] 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)