(14 days)
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No
The summary describes modifications to a hemodialysis machine, focusing on hardware and software updates for control, monitoring, and data transfer. There is no mention of AI or ML algorithms for diagnosis, treatment optimization, or predictive analysis.
Yes
The device is indicated for acute and chronic dialysis therapy, which involves treating conditions like kidney failure and fluid overload. This directly addresses medical conditions, making it a therapeutic device.
No
Explanation: The Fresenius 2008T Hemodialysis Machine is indicated for acute and chronic dialysis therapy, which is a treatment for kidney failure. It is designed to provide hemodialysis treatment by controlling and monitoring dialysate and extracorporeal blood circuits. This describes a therapeutic device, not a diagnostic one. While it monitors certain parameters (venous and arterial blood pressures, presence of air and blood), this monitoring is for the purpose of controlling and ensuring the proper functioning of the treatment, not for diagnosing a condition.
No
The device is a hemodialysis machine, which is a complex hardware system with integrated software for control and monitoring. The description explicitly details hardware components and their functions.
Based on the provided text, the Fresenius 2008T Hemodialysis Machine is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is "for acute and chronic dialysis therapy." This describes a treatment process performed on a patient, not a test performed on a sample taken from a patient.
- Device Description: The description details how the machine controls and monitors the blood and dialysate circuits during the dialysis process. It focuses on the physical process of filtering blood, not on analyzing biological samples to provide diagnostic information.
- Lack of IVD Characteristics: The text does not mention any components or functions related to analyzing biological samples (like blood, urine, etc.) to diagnose a condition, monitor a disease state, or screen for a condition.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The Fresenius 2008T Hemodialysis Machine is a therapeutic device used to treat kidney failure by filtering the patient's blood.
N/A
Intended Use / Indications for Use
Fresenius 2008T Hemodialysis Machine is indicated for acute and chronic dialysis therapy.
Product codes (comma separated list FDA assigned to the subject device)
78KDI
Device Description
The Fresenius 2008T Hemodialysis Machine (K113427) is indicated for acute and chronic dialysis therapy. It is designed to provide hemodialysis treatment by controlling and monitoring both the dialysate and extracorporeal blood circuits. In the extracorporeal blood circuit, blood is continuously circulated from the patient through a dialyzer, where toxins are filtered out through a semi-permeable membrane, and returned to the patient. During this process, the extracorporeal blood circuit is monitored for venous and arterial blood pressures, and for the presence of air and blood.
The display screen of the 2008T Hemodialysis Machine is shared between the hemodialysis machine and the CDX PC (optional) running the third party MDDS (Medical Device Data Systems) program. The blue CDX Key located on the fold-down keyboard allows switching between the Dialysis Screen and the MDDS screen. The user interface of the 2008T machine which includes a keyboard, touchpad and touch-screen, is operational in both the dialysis mode and the CDX mode, whichever is actively displayed.
Modifications to the previously cleared 2008T Hemodialysis Machine include:
- . Heparin and Sodium Variation System (SVS) Status: Addition of visual indication (display) on the home screen and dialysate screen.
- . Dialysate Flow Button: Addition of Dialysate Flow ON-OFF button in the Dialysate Screen.
- Applications Installed Display: Addition of text identifying which applications . (Apps) have been loaded is added to the machine's opening screen.
- Configurator: Software modification to support the transfer of machine . configuration information between machines during installation or upgrade in service mode.
- . Sodium Variation System (SVS) as an Optional Feature: Addition of SVS selection in service mode to make the existing SVS feature optional.
The following modification was implemented following a regulatory assessment that the change did not affect the fundamental scientific technology or intended use of the device. Based on FDA guidance "Deciding When to Submit a 510(k) for a Change to an Existing Device", Fresenius Medical Care North America determined that this modification did not necessitate a 510(k) submission:
- Wireless Adapter: A dual band (i.e. 2.5Ghz and 5Ghz) wireless adapter provides the . wireless network link for the CDX PC, and supports 802.11a/b/g/n. This new wireless adapter replaces the obsolete wireless adapter (unmodified device) and maintains the latest wireless technology.
Additionally, this submission includes minor maintenance modifications made to the Functional Board Software (V.2.34) of the 2008T Hemodialysis Machine since the last clearance (K113427).
Treatment modalities for the modified Fresenius 2008T Hemodialysis Machine remain identical to those for the unmodified 2008T (K113427):
The 2008T Hemodialysis Machine is a hemodialysis system used for the treatment of patients with acute or chronic kidney failure, fluid overload or toxemic conditions. Therapies include hemodialysis, hemofiltration and hemo-concentration. The 2008T Hemodialysis Machine will accommodate the use of both low flux and high permeability, high flux dialyzers.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance and safety tests were conducted to ensure the safety and effectiveness of the device after the proposed modifications.
The following tests were conducted:
Software Verification and Validation Testing
- . Software Verification (Functional Tests)
- . Regression
- Safety Systems Verification
- Simulated Dialysis Treatment
- . Production Test Procedure
- Unstructured and Static Code Verification .
Summative Usability Testing
Test results demonstrated that the modified 2008T Hemodialysis Machine functions as intended and met pre-determined acceptance criteria. Results of functional validation, summative usability testing and risk analysis indicate that the modified Fresenius 2008T Hemodialysis Machine is substantially equivalent to the named predicate device and remains safe and effective for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 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
Image /page/0/Picture/0 description: The image shows a 3D rendering of a funnel. The funnel is upside down, with the wide opening at the top and the narrow opening at the bottom. The funnel is made of a transparent material, and the inside of the funnel is visible. The funnel is empty.
Fresenius Medical Care
MAR - 6 2012
K120505
Pages 1 of 5
2008T Hemodialysis Machine Special 510(k) Notification
510(k) Summary
This 510(k) Summary is in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990. The content of this 510(k) summary is provided in conformance with 21 CFR Part 807.92.
| Name: | Fresenius Medical Care North America |
|---|---|
| Address: | 920 Winter Street |
| Waltham, MA 02451-1457 | |
| Phone: | (781) 699-4479 |
| Fax: | (781) 699-9635 |
| Contact Person: | Denise Oppermann, Senior Director |
| Regulatory Affairs - Devices | |
| Renal Therapies Group | |
| Date of Preparation: | 17 February 2012 |
Submitters Information
Device Name
| Trade Name: | Fresenius 2008T Hemodialysis Machine |
|---|---|
| Common Name: | Hemodialysis Delivery System |
| Classification Name: | High Permeability Hemodialysis System |
| Classification Number: | Class II per § 876.5860 |
| Product Code/Classification Panel: | 78KDI/Gastroenterology/Urology Panel |
Legally Marketed Predicate Device (Unmodified Device)
Fresenius 2008T Hemodialysis Machine (K113427).
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Image /page/1/Picture/0 description: The image shows the logo for Fresenius Medical Care. The logo consists of a stylized funnel shape above the text "Fresenius Medical Care". The funnel is made up of several horizontal lines that decrease in width as they go down, creating a three-dimensional effect.
Device Description
The Fresenius 2008T Hemodialysis Machine (K113427) is indicated for acute and chronic dialysis therapy. It is designed to provide hemodialysis treatment by controlling and monitoring both the dialysate and extracorporeal blood circuits. In the extracorporeal blood circuit, blood is continuously circulated from the patient through a dialyzer, where toxins are filtered out through a semi-permeable membrane, and returned to the patient. During this process, the extracorporeal blood circuit is monitored for venous and arterial blood pressures, and for the presence of air and blood.
The display screen of the 2008T Hemodialysis Machine is shared between the hemodialysis machine and the CDX PC (optional) running the third party MDDS (Medical Device Data Systems) program. The blue CDX Key located on the fold-down keyboard allows switching between the Dialysis Screen and the MDDS screen. The user interface of the 2008T machine which includes a keyboard, touchpad and touch-screen, is operational in both the dialysis mode and the CDX mode, whichever is actively displayed.
Modifications to the previously cleared 2008T Hemodialysis Machine include:
- . Heparin and Sodium Variation System (SVS) Status: Addition of visual indication (display) on the home screen and dialysate screen.
- . Dialysate Flow Button: Addition of Dialysate Flow ON-OFF button in the Dialysate Screen.
- Applications Installed Display: Addition of text identifying which applications . (Apps) have been loaded is added to the machine's opening screen.
- Configurator: Software modification to support the transfer of machine . configuration information between machines during installation or upgrade in service mode.
- . Sodium Variation System (SVS) as an Optional Feature: Addition of SVS selection in service mode to make the existing SVS feature optional.
The following modification was implemented following a regulatory assessment that the change did not affect the fundamental scientific technology or intended use of the device. Based on FDA guidance "Deciding When to Submit a 510(k) for a Change to an Existing
2
K 120505
Pages 3 of 5
Image /page/2/Picture/1 description: The image shows a diagram of a step-down transformer. The transformer has a core with windings on both sides. The primary winding has more turns than the secondary winding. The diagram illustrates how the voltage is reduced from the primary side to the secondary side.
Fresenius Medical Care
2008T Hemodialysis Machine Special 510(k) Notification
Device", Fresenius Medical Care North America determined that this modification did not necessitate a 510(k) submission:
- Wireless Adapter: A dual band (i.e. 2.5Ghz and 5Ghz) wireless adapter provides the . wireless network link for the CDX PC, and supports 802.11a/b/g/n. This new wireless adapter replaces the obsolete wireless adapter (unmodified device) and maintains the latest wireless technology.
Additionally, this submission includes minor maintenance modifications made to the Functional Board Software (V.2.34) of the 2008T Hemodialysis Machine since the last clearance (K113427).
Treatment modalities for the modified Fresenius 2008T Hemodialysis Machine remain identical to those for the unmodified 2008T (K113427):
The 2008T Hemodialysis Machine is a hemodialysis system used for the treatment of patients with acute or chronic kidney failure, fluid overload or toxemic conditions. Therapies include hemodialysis, hemofiltration and hemo-concentration. The 2008T Hemodialysis Machine will accommodate the use of both low flux and high permeability, high flux dialyzers.
Indications for Use
Fresenius 2008T Hemodialysis Machine is indicated for acute and chronic dialysis therapy.
Technological Characteristics
There are no changes to the technological characteristics of the unmodified Fresenius 2008T Hemodialysis Machine. The modified Fresenius 2008T Hemodialysis Machine that is the subject of this submission incorporates software modifications to address user preferences and provide additional user convenience (ease of use).
These modifications do not impact the safety and effectiveness of the device. These software modifications do not expand the capability or change the performance of the 2008T Hemodialysis Machine (K113427) and its intended use/indications for use. The
3
Image /page/3/Picture/0 description: The image shows the logo for Fresenius Medical Care. The logo consists of a stylized image of a funnel or inverted pyramid above the text "Fresenius Medical Care". The funnel is made up of several horizontal lines that decrease in size as they go down, creating a three-dimensional effect.
modified device is equivalent to the un-modified device in terms of water requirements, module options, functional options, performance limits, control parameters, compatible bloodlines, and language options.
The following technical specifications of the modified device remain the same as the unmodified device:
- Safety system .
- System performance .
- Environmental Requirements .
- Transportation and Storage condition ●
- User Interface (except proposed modifications) .
- Hardware and therapy settings .
- Accessories .
- Environmental Design �
- . Alarms
- Accuracy and Controls ●
- Protection against Mechanical Hazard .
- . Protection against Electrical Hazard
- . Protection against excessive temperature or other hazards
- Manufacturing location and manufacturing processes (assembly, fabrication, testing, . shipping, installation and service).
A risk analysis has been completed and potential hazards associated with the modifications are identified and mitigated. Mitigations are verified wherever applicable. All potential risks were deemed acceptable after mitigation. Performance and safety tests were conducted to ensure the safety and effectiveness of the device after the proposed modifications.
Performance Data
The performance of the modified device was evaluated according to existing FMCNA procedures, protocols, declared performance standards and guidelines of the quality system regulation (21 CFR 820). Design verification and validation tests were conducted to
4
Image /page/4/Picture/0 description: The image shows the Fresenius Medical Care logo. The logo consists of a stylized funnel shape above the text "Fresenius Medical Care". The funnel is made up of several horizontal lines that decrease in width from top to bottom, ending in a point.
K120505
Pages 5 of 5
ensure that the modifications described in this submission did not affect the essential performance of the device and the device functions as intended.
The following tests were conducted:
Software Verification and Validation Testing
- . Software Verification (Functional Tests)
- . Regression
- Safety Systems Verification
- Simulated Dialysis Treatment ●
- . Production Test Procedure
- Unstructured and Static Code Verification .
Summative Usability Testing
Conclusion
Test results demonstrated that the modified 2008T Hemodialysis Machine functions as intended and met pre-determined acceptance criteria. Results of functional validation, summative usability testing and risk analysis indicate that the modified Fresenius 2008T Hemodialysis Machine is substantially equivalent to the named predicate device and remains safe and effective for its intended use.
5
Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002
Ms. Denise Oppermann Senior Director, Regulatory Affairs Devices Fresenius Medical Care, North America 920 Winter Street WALTHAM MA 22451
MAR - 6 2012
Re: K120505
Trade/Device Name: Fresenius 2008T Hemodialysis Machine Regulation Number: 21 CFR§ 876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: KDI Dated: February 17, 2012 Received: February 21, 2012
Dear Ms. Oppermann:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass surfal 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). and Oosmeter Fror (110) has the device, subject to the general controls provisions of the Act. The r ou may, merelove, manel of the Act include requirements for annual registration, listing of general controls proficiting practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability adunction. Ticase note: UDTC: 00101 2014 16:00 abeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it your device is elassinod por ols. 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 round in the South of receivents concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease oc advised that I Dris blocking or our device complies with other requirements of the Act that I Dri has made a actuations administered by other Federal agencies. You must or any I ouch statules undersgaements, including, but not limited to: registration and listing Configry with an the Not 1-og (21 CFR Part 801); medical device reporting (reporting of medical
6
Page 2 -
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/ReportalProblem/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.
Sincerély yours,
Sincerely yours,
Benjamin K. Evanko
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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Indications for Use Statement
510(k) Number (if known):
Device Name: Fresenius 2008T Hemodialysis Machine
Indications for Use:
Fresenius 2008T Hemodialysis Machine is indicated for acute and chronic dialysis therapy.
20505
XPrescription Use (Per 21 CFR 801 Subpart D)
AND/OR
Over-the-Counter Use (21 CFR 801 Subpart C)
Harles Henry
ision Sign-Off) of Reproductive, Gastro-Renal, and 20.505