(30 days)
Not Found
No
The summary describes a standard hemodialysis machine with control and monitoring systems, but there is no mention of AI or ML capabilities in the device description, intended use, or performance studies. The CDX PC is explicitly stated to operate independently and not control the machine's operation.
Yes
The device is indicated for acute and chronic dialysis therapy, which is a medical treatment.
No
This device is a hemodialysis machine, which is a treatment device, not a diagnostic one. While it monitors certain physiological parameters during treatment (e.g., blood pressures, presence of air and blood), its primary function is to filter toxins from the blood (therapy), not to diagnose a condition.
No
The device description clearly details a physical hemodialysis machine with various hardware components (control panel, computer, CDX PC board, modules for blood transfer, dialysate management section, etc.). While it includes software, it is an integral part of a larger hardware system.
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 for a patient's condition, not a test performed on a sample taken from the patient to provide diagnostic information.
- Device Description: The description details how the machine controls and monitors blood and dialysate circuits to filter toxins from the patient's blood. This is a therapeutic process, not a diagnostic one.
- Lack of IVD Characteristics: The text does not mention any components or functions related to analyzing biological samples (like blood, urine, etc.) to provide diagnostic information about a disease or condition. IVD devices typically involve reagents, analyzers, or other components used to perform tests on samples.
Therefore, the Fresenius 2008T Hemodialysis Machine is a therapeutic device used for dialysis treatment, not an IVD device.
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)
78 KDI, KDI
Device Description
The Fresenius 2008T Hemodialysis Machine (K111639) 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, the 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.
In the dialysate circuit, the dialysate acid and bicarbonate concentrates are mixed with purified water in predefined ratios, heated, degassed, and delivered to the dialyzer. Balancing chambers ensure that the incoming flow of the dialysate is volumetrically equal to the outgoing flow in order to control ultrafiltration from the patient.
The front of the machine, with three main sections, contains all of the controls the operator needs access to during a hemodialysis treatment.
The top section of the 2008T Hemodialysis Machine contains the control panel and houses the computer, which runs the treatment program and the separate CDX PC board, which provides the platform for users to utilize medical information software of their choice. The CDX PC is physically located in the 2008T machine's cabinet, but operates independently of the 2008T machine with no capacity to either control the operation of the 2008T hemodialysis machine or influence its programming.
The control panel includes the touchscreen display, fold-down keyboard, touchpad and keypad which allow the operator/user to control the operation of machine by aiding the setting of treatment parameters, monitoring treatment and patient status during dialysis.
The center section contains the modules used for the safe transfer of blood to and from the dialyzer. Dialysate management occurs in the bottom section of the 2008T hemodialysis machine, where the acid and bicarbonate concentrates used to make up the dialysate are mixed and pumped to the dialyzer.
Modifications to the previously cleared 2008T Hemodialysis Machine (K111639) include:
-
CDX as an Optional Feature: The existing CDX PC allows the user the convenience of a PC, running a Windows or Linux operating system and a compatible MDDS, within the same cabinet as the 2008T machine. The modifications are made to make the 2008T Hemodialysis Machine configuration without the CDX feature similar to a previous configuration of the 2008T (TUI; K080964) which did not contain the additional PC board. The CDX PC hardware module is removed from the 2008T user interface board to implement this configuration. Software modifications are made to the functional and user interface board to support the proposed machine configuration ("No CDX" option). The CDX feature will be made available as an upgrade with the supporting hardware and software upon customer request. The 2008T Hemodialysis Machine without CDX configuration performs identically to the unmodified device (K111639), except that users will be unable to access the third party MIS systems.
-
Proposed maintenance changes: The following modifications were implemented following a regulatory assessment that the changes 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", FMCNA determined that these modifications did not necessitate a 510(k) submission:
- Fn Lock Keyboard: The existing fold-down compact keyboard used on the 2008T Hemodialysis Machine (K111639) is located directly below the display screen. For added user convenience while navigating their MIS systems, FMCNA added function lock capability to the current 2008T's keyboard. The modification includes repurposing the "Fn" key to a "Fn Lock" key and adding a function lock indicator light. Software and hardware modifications were made to implement this feature, which is only available in 2008T Hemodialysis Machines with activation of the CDX option. The keyboard is also equipped with a new elastomer material with high tear resistant properties.
The 2008T is a high permeability hemodialysis system used for the treatment of patients with acute or chronic failure, fluid overload or toxemic conditions. Therapies include hemodialysis, hemofiltration and hemoconcentration. The 2008T will accommodate the use of both low flux and high flux dialyzers.
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)
Performance, safety and software verification and validation testing 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
- Safety Testing:
- EMC Testing (ESD immunity, emissions)
- Unit Testing (Fn Lock Keyboard)
- Physical Testing (Fn Lock Keyboard):
- High Tear Elastomer: Use Life (Shelf Life)
- High Tear Elastomer: Life cycle
The test results demonstrated that the modified 2008T Hemodialysis Machine functioned as intended and met pre-determined acceptance criteria. Results 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.)
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.
Not Found
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
DEC 2 1 2011
Image /page/0/Picture/2 description: The image shows the Fresenius Medical Care logo. The logo consists of a symbol above the text "Fresenius Medical Care". The symbol is an inverted triangle with horizontal lines inside.
2008T Hemodialysis Machine Special 510(k) Notification
Section 5 510(k) Summary
This 510(k) Summary is in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990. The content in this 510(k) summary has been provided in conformance with 21 CFR Part 807.92
A. Submitter's Information
| Name: | Fresenius Medical Care North America |
|---|---|
| Address: | 920 Winter Street Waltham, MA 02451-1457 . |
| Phone: | (781) 699-4479 |
| Fax: | (781) 699-9635 |
| Denise Oppermann, Senior Director | |
| Contact Person: | Regulatory Affairs - Devices |
| Renal Therapies Group | |
| Date of Preparation: | 18 November 2011 |
| Name: | Fresenius Medical Care North America |
| Address: | 920 Winter Street Waltham, MA 02451-1457 |
- B. Device Name
| Trade Name: | Fresenius 2008T Hemodialysis Machine |
|---|---|
| Common Name: | High Permeability Hemodialysis System |
| Product Code/Classification Panel: | 78 KDI/Gastroenterology/Urology Panel |
| Classification Name: | Class II per § 876.5860 |
- C. Legally Marketed Predicate Device (Unmodified Device) Fresenius 2008T Hemodialysis Machine (K111639).
D. Device Description
The Fresenius 2008T Hemodialysis Machine (K111639) is indicated for acute and chronic dialysis therapy. It is designed to provide hemodialysis treatment by
1
Image /page/1/Picture/1 description: The image shows the Fresenius Medical Care logo. The logo consists of a stylized triangle shape with horizontal lines inside, resembling a filter or funnel. Below the symbol, the text "Fresenius Medical Care" is written in a simple, sans-serif font.
2008T Hemodialysis Machine Special 510(k) Notification
controlling and monitoring both the dialysate and extracorporeal blood circuits. In the extracorporeal blood circuit, the 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.
In the dialysate circuit, the dialysate acid and bicarbonate concentrates are mixed with purified water in predefined ratios, heated, degassed, and delivered to the dialyzer. Balancing chambers ensure that the incoming flow of the dialysate is volumetrically equal to the outgoing flow in order to control ultrafiltration from the patient.
The front of the machine, with three main sections, contains all of the controls the operator needs access to during a hemodialysis treatment.
The top section of the 2008T Hemodialysis Machine contains the control panel and houses the computer, which runs the treatment program and the separate CDX PC board, which provides the platform for users to utilize medical information software of their choice. The CDX PC is physically located in the 2008T machine's cabinet, but operates independently of the 2008T machine with no capacity to either control the operation of the 2008T hemodialysis machine or influence its programming.
The control panel includes the touchscreen display, fold-down keyboard, touchpad and keypad which allow the operator/user to control the operation of machine by aiding the setting of treatment parameters, monitoring treatment and patient status during dialysis.
The center section contains the modules used for the safe transfer of blood to and from the dialyzer. Dialysate management occurs in the bottom section of the 2008T hemodialysis machine, where the acid and bicarbonate concentrates used to make up the dialysate are mixed and pumped to the dialyzer.
Modifications to the previously cleared 2008T Hemodialysis Machine (K111639) include:
2
: K113427
Image /page/2/Picture/1 description: The image shows the Fresenius Medical Care logo. The logo consists of a stylized image of a filter above the text "Fresenius Medical Care". The filter is depicted as an inverted triangle with horizontal lines inside. The text is in a simple, sans-serif font.
2008T Hemodialysis Machine Special 510(k) Notification
CDX as an Optional Feature 1.
The existing CDX PC allows the user the convenience of a PC, running a Windows or Linux operating system and a compatible MDDS, within the same cabinet as the 2008T machine. The modifications are made to make the 2008T Hemodialysis Machine configuration without the CDX feature similar to a previous configuration of the 2008T (TUI; K080964) which did not contain the additional PC board. The CDX PC hardware module is removed from the 2008T user interface board to implement this configuration. Software modifications are made to the functional and user interface board to support the proposed machine configuration ("No CDX" option). The CDX feature will be made available as an upgrade with the supporting hardware and software upon customer request. The 2008T Hemodialysis Machine without CDX configuration performs identically to the unmodified device (K111639), except that users will be unable to access the third party MIS systems.
2. Proposed maintenance changes
The following modifications were implemented following a regulatory assessment that the changes 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", FMCNA determined that these modifications did not necessitate a 510(k) submission:
Fn Lock Keyboard
The existing fold-down compact keyboard used on the 2008T Hemodialysis Machine (K111639) is located directly below the display screen. The keyboard folds down to allow the operator to enter treatment parameter values, chart with CDX or make selections inside the treatment screen and folds up again to prevent unintentional changes.
For added user convenience while navigating their MIS systems, FMCNA added function lock capability to the current 2008T's keyboard. The modification includes repurposing the "Fn" key to a "Fn Lock" key and adding a function lock indicator light to the immediate right of the Caps Lock indicator light. Software and hardware modifications were made to implement this feature is only available in 2008T Hemodialysis Machines with activation of the CDX option. In dialysis mode, the Fn Lock LED will be off and the function lock feature will be off. In addition, the keyboard is now equipped with a new elastomer material with high tear resistant
3
Image /page/3/Picture/1 description: The image shows the Fresenius Medical Care logo. The logo consists of a geometric shape resembling a funnel or inverted pyramid with multiple horizontal lines inside. Below the shape, the text "Fresenius Medical Care" is written in a simple, sans-serif font.
properties as compared to the standard silicon elastomer of the existing keyboard in the unmodified device (K111639).
Treatment modalities for the modified Fresenius 2008T hemodialysis machine remain identical to those for the unmodified 2008T (K111639):
The 2008T is a high permeability hemodialysis system used for the treatment of patients with acute or chronic failure, fluid overload or toxemic conditions. Therapies include hemodialysis, hemofiltration and hemoconcentration. The 2008T will accommodate the use of both low flux and high flux dialyzers.
E. Indications for Use
Fresenius 2008T Hemodialysis Machine is indicated for acute and chronic dialysis therapy.
F. Technological Characteristics
There are no changes in the technological characteristics of the previously cleared Fresenius 2008T Hemodialysis Machine (K111639). The modified Fresenius 2008T hemodialysis machine incorporates changes pertaining only to "Software or Firmware" and reliability for the user interface. All water requirements, module options, functional options, performance limits, control parameters, compatible bloodlines, and language options remain unchanged from the predicate device.
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 for the Fn Lock feature)
- . Hardware and therapy settings
- . Accessories
- . Environmental Design
- . Alarms
- . Accuracy and Controls
- . Protection against Mechanical Hazard
- . Identification, marketing and documentation due to changes
- . Protection against Electrical Hazard
4
Image /page/4/Picture/1 description: The image shows the Fresenius Medical Care logo. The logo consists of a stylized image of a funnel or filter above the text "Fresenius Medical Care". The funnel is made up of several horizontal lines that converge into a point at the bottom.
2008T Hemodialysis Machine Special 510(k) Notification
- . Protection against excessive temperature or other hazards
- . Manufacturing location
- . Manufacturing process (assembly, testing, shipping, installation, and service)
A Risk Analysis has been completed and potential hazards associated with the modifications have been identified and mitigated. Performance and safety testing were conducted to ensure the safety and effectiveness of the device after the proposed modifications. All potential risks were deemed acceptable after mitigation. Mitigations have been verified wherever applicable.
G. Performance Testing
The performance of the 2008T machine with CDX as an optional feature (and all other modifications discussed in the scope of this submission) 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 testing were conducted to ensure that the modifications described in this submission will not impact the essential performance of the device and the device functions as intended.
The following tests were conducted:
1. Software Verification and Validation Testing
- Software Verification (Functional Tests) .
- . Regression
- Safety Systems Verification
- Simulated Dialysis Treatment
- . Production Test Procedure
- . Unstructured and Static Code Verification
Safety Testing 2.
- � EMC Testing (ESD immunity, emissions)
-
- Unit Testing (Fn Lock Keyboard)
-
- Physical Testing (Fn Lock Keyboard)
- High Tear Elastomer: Use Life (Shelf Life) .
- . High Tear Elastomer: Life cycle
5
Image /page/5/Picture/1 description: The image shows the Fresenius Medical Care logo. The logo consists of a stylized image of a dialyzer above the text "Fresenius Medical Care". The dialyzer is depicted as an inverted pyramid with horizontal lines inside.
2008T Hemodialysis Machine Special 510(k) Notification
H. Conclusion
The test results demonstrated that the modified 2008T Hemodialysis Machine functioned as intended and met pre-determined acceptance criteria. Results of functional and software validation, performance testing, risk analysis, and usability evaluation 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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Ms. Denise Oppermann Senior Director, Regulatory Affairs Devices Fresenius Medical Care, North America 920 Winter Street WALTHAM MA. 02451
DEC 2 1 2011
Re: K113427
Trade/Device Name: Fresenius 2008T Hemodialysis Machine Regulation Number: 21 CFR8 876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: KDI Dated: November 18, 2011 Received: November 21, 2011
Dear Ms. Oppermann:
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 regustration, 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
7
Page 2
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.
.fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm142694.htm
Sincerely yours,
Huchard Leuner 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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Section 4 Indications for Use Statement
510(k) Number (if known): KI13427
Device Name:
Fresenius 2008T Hemodialysis Machine
Indications for Use:
Fresenius 2008T Hemodialysis Machine is indicated for acute and chronic dialysis therapy.
X Prescription Use (Per 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)
(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K113427
Vol 1/Page 109