(88 days)
No
The description mentions a "microprocessor controlled device" but does not include any terms or descriptions indicative of AI or ML, such as algorithms, learning, training data, or specific AI/ML techniques. The performance studies focus on standard device verification and safety testing.
Yes
The device is described as administering Venofer to treat iron deficiency anemia in patients with chronic kidney disease undergoing hemodialysis, which indicates a therapeutic purpose.
No
The Venofer Pump is designed to administer Venofer® to treat iron deficiency anemia. It is an administering device, not a diagnostic one.
No
The device description explicitly lists hardware components such as a control panel, vial holder, fluid detector, and a peristaltic pump, indicating it is not software-only.
Based on the provided information, the Venofer Pump is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to administer a drug (Venofer®) to a patient during hemodialysis. This is a therapeutic intervention, not a diagnostic test performed on a sample taken from the body.
- Device Description: The device is a pump designed to deliver fluid (Venofer®) into the patient's bloodstream. It does not analyze biological samples to provide diagnostic information.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, reagents, or diagnostic measurements.
IVD devices are used to examine specimens derived from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The Venofer Pump's function is to deliver a substance into the body, not to analyze something from the body.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
KDI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Venofer Pump Performance Testing: Functional testing was performed to demonstrate that the device performs as designed and expected.
Specific verification tests conducted Description of the acceptance criteria System-level hazard analysis that confirms that the device does not perform in an unexpected and/or unsafe manner.
The performance (verification) test results support the performance characteristics of the Venofer Pump.
Venofer Pump Safety Testing: Product safety testing demonstrates that the device performs per the FDA Consensus Standards, as identified below: Electromagnetic compatibility (EMC) testing (IEC 60601-1-2: 2007 - Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility - Requirements for Testing).
Biocompatibility testing (AAMI / ANSI / ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation & testing) was performed on all new materials that are patient-fluid contacting. The verification test results support the safety characteristics of the Venofer Pump.
Venofer Pump Software Testing: Software testing demonstrates the device software meets the design input requirements. The following documents were reviewed and updated: Software architecture SDD Unit test System and software requirements Software release history Traceability. The testing includes the required documentation as described in the guidance titled Guidance for the Content of Premarket Submissions for Software.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.”
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
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.
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 Performance | |
| Testing | Functional testing was performed to demonstrate |
| that the device performs as designed and | |
| expected. The following information is included: | |
| The performance (verification) | |
| test results support the | |
| performance characteristics of | |
| the Venofer Pump. | Specific verification tests conducted Description of the acceptance criteria System-level hazard analysis that confirms |
| that the device does not perform in an | |
| unexpected and/or unsafe manner | |
| Venofer Pump Safety Testing | Product safety testing demonstrates that the |
| device performs per the FDA Consensus | |
| Standards, as identified below: | |
| The verification test results | |
| support the safety | |
| characteristics of the Venofer | |
| Pump. | Electromagnetic compatibility (EMC) testing |
| (IEC 60601-1-2: 2007 - Medical Electrical | |
| Equipment - Part 1-2: General Requirements | |
| for Safety - Collateral Standard: | |
| Electromagnetic Compatibility - | |
| Biocompatibility testing was | |
| performed on all new materials | |
| that are patient-fluid contacting | Requirements for Testing |
| Biocompatibility Testing (AAMI / ANSI / ISO | |
| 10993-1:2009 Biological evaluation of | |
| medical devices Part 1: Evaluation & testing) | |
| Venofer Pump Software Testing | Software testing demonstrates the device |
| software meets the design input requirements. | |
| The following documents were reviewed and | |
| updated: | |
| The testing includes the | |
| required documentation as | |
| described in the guidance titled | |
| Guidance for the Content of | |
| Premarket Submissions for | |
| 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.
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:
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