(107 days)
Not Found
No
The document describes standard hemodialysis machine functionality and the integration of a non-invasive monitoring device (CLiC) that measures physiological parameters using light absorption. There is no mention of AI or ML in the intended use, device description, or performance studies. The CLiC's function is described as real-time measurement and calculation based on measured values, not learning or adaptive algorithms.
Yes
The device is indicated for "acute and chronic dialysis therapy" and "extracorporeal bicarbonate hemodialysis," which are treatments for renal failure, thus making it a therapeutic device.
Yes
The Crit-Line Clip Monitor (CLiC), an optional component of the 2008T Hemodialysis Machine, is explicitly stated to "non-invasively measure hematocrit, oxygen saturation and percent change in blood volume" and "provides data that the clinician/nurse, under physician direction, intervenes" to provide a more effective treatment. Measuring these physiological parameters to inform treatment decisions is a diagnostic function.
No
The device is a hemodialysis machine, which is a hardware device. While it includes software components and integrates with optional software/hardware systems (bibag, CLiC), the core device is a physical machine.
Based on the provided text, the 2008T Hemodialysis Machine itself is NOT an In Vitro Diagnostic (IVD) device.
Here's why:
- Definition of IVD: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
- Function of the 2008T Hemodialysis Machine: The primary function of the 2008T Hemodialysis Machine is to perform extracorporeal blood filtration (dialysis) on the patient's blood to remove toxins and excess fluid. This is a treatment process, not a diagnostic test performed on a specimen outside the body.
However, the optional Crit-Line Clip Monitor (CLiC) component has characteristics that are closer to an IVD, but it's still not a traditional IVD:
- CLiC Function: The CLiC measures hematocrit, oxygen saturation, and percent change in blood volume non-invasively on the patient's blood during the hemodialysis treatment. While it's measuring parameters of the blood, it's doing so in vivo (within the body) via a clip, not on a collected specimen in vitro.
The bibag System is also not an IVD. It's a component used to prepare the dialysate solution, which is then used in the dialysis process.
In summary:
- 2008T Hemodialysis Machine: Not an IVD. It's a therapeutic device.
- bibag System: Not an IVD. It's a component for preparing the dialysate.
- Crit-Line Clip Monitor (CLiC): While it measures blood parameters, it does so non-invasively and in vivo during treatment, making it not a traditional IVD. It's more of a monitoring device used during a therapeutic procedure.
Therefore, based on the provided information, the device described (the 2008T Hemodialysis Machine with its optional components) is not an IVD.
N/A
Intended Use / Indications for Use
The 2008T Hemodialysis Machine is indicated for acute and chronic dialysis therapy.
bibag System (Optional):
The bibag system is used with Fresenius three stream proportioning hemodialysis systems equipped with the bibag module such as the 2008T Hemodialysis Machine and is intended for use in bicarbonate hemodialysis for acute and chronic renal failure. The bibag is intended for extracorporeal bicarbonate hemodialysis according to a physician's prescription.
Crit-Line Clip Monitor (CLiC) (Optional):
The Crit-Line Clip Monitor is used with the 2008T Hemodialysis Machine to non-invasively measure hematocrit, oxygen saturation and percent change in blood volume. The CLiC device measures hematocrit, percent change in blood volume and oxygen saturation in real time for application in the treatment of dialysis patients with the intended purpose of providing a more effective treatment for both the dialysis patient and the clinician. Based on the data that the monitor provides, the clinician/nurse, under physician direction, intervenes (i.e., increases or decreases the rate at which fluid is removed from the blood) in order to remove the maximum amount of fluid from the dialysis patient without the patient experiencing the common complications of dialysis which include nausea, cramping and vomiting.
Product codes (comma separated list FDA assigned to the subject device)
78 KDI, KPO
Device Description
The 2008T Hemodialysis Machine is indicated for acute and chronic dialysis therapy. 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. In the dialysate circuit, the dialysate concentrates are mixed with purified water, 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 display screen of the 2008T Hemodialysis Machine is shared between the hemodialysis machine and the CDX PC (optional) running third party MDDS (Medical Device Data Systems). 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 Hemodialysis Machine which includes a keyboard, touchpad and touch-screen, is operational in both the dialysis mode and the CDX mode, whichever is actively displayed.
Bibag System (Optional):
The bibag system is intended for use with Fresenius three stream proportioning hemodialysis systems equipped with the bibag module such as the 2008T Hemodialysis Machine and is intended for use in bicarbonate hemodialysis for acute and chronic renal failure. The bibag is intended for extracorporeal bicarbonate hemodialysis according to a physician's prescription.
The 2008T Hemodialysis Machine with bibag System allows operators the option of preparing a saturated sodium bicarbonate solution online through automated mixing of dialysis grade water and dry sodium bicarbonate powder within the bibag source disposable. The bibag System comprises: (1) the sodium bicarbonate concentrate generator (known as the bibag module); and (2) the bag of dry sodium bicarbonate concentrate. A specialized bibag connector with a door is used to connect the single-use bibag disposable (650g/900g) filled with USP grade dry sodium bicarbonate powder to the bibag connector. The 2008T Hemodialysis Machine draws dialysis grade water into the bibag to produce a saturated solution of sodium bicarbonate online. This online generation of sodium bicarbonate can only be performed using a specially modified 2008T Hemodialysis Machine with bibag System and can only be used with 45x (1:44) dilution.
Modifications to the previously cleared 2008T Hemodialysis Machine (K121341) include:
-
Crit-Line Clip Monitor (CLiC) (Optional): Hardware, software and labeling t modifications to integrate the Crit-Line Clip Monitor (CLiC; K121599) and expansion of the Indications for Use for use of the CLiC with the 2008T Hemodialysis Machine. When integrated with the 2008T Hemodialysis Machine, the CLiC will use the same technology cleared under K121599, except the CLiC will now be hosted by the 2008T Hemodialysis Machine instead of the medical grade computer. When installed, the Crit-Line monitoring feature/user interface will be optional, selectable in Service Mode.
The intended use of the CLiC is as a continuous real-time monitor for non-invasive hematocrit, oxygen saturation, and percent change in blood volume measurement during hemodialysis treatment. The CLiC uses the principle of light absorption and scattering through the blood under test to measure oxygen saturation (O2 Sat) and hematocrit (Hct). The Hct values are then used to calculate the Blood Volume (BV) percentage change relative to the starting BV based on the beginning Hct. -
Software Maintenance: Software maintenance modifications were made to the . 2008T Hemodialysis Machine since the last clearance (K121341).
-
. Additional Labeling Modifications: The 2008T Hemodialysis Machine Operator's Manual contains modifications to warnings concerning Total Buffer which were implemented as part of a Class I recall for Naturalyte/Granuflo Prescribing Information (Recall number Z-1826/Z-1827-2012).
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
clinician/nurse
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 performance of the modified device described in this submission was evaluated according to existing FMC-RTG procedures, protocols, declared performance standards and guidelines of the quality system regulation (21 CFR Part 820). Design verification and validation tests were conducted to ensure that the modifications did not affect the essential performance of the device and the device functions as intended.
The following tests were conducted for the modified device:
- System Verification and Software Validation
- Functional Verification and Software Validation
Software Verification (Functional Tests)
Regression
Safety Systems Verification
Simulated Dialysis Treatment
Production Test Procedure
Unstructured and Static Code Verification
- System Performance
- System Safety
- Electromagnetic Compatibility
- Usability (Formative and Summative)
Test results demonstrated that the modified 2008T Hemodialysis Machine with optional CLiC functions as intended and met pre-determined acceptance criteria. Results of system/software verification/validation testing, safety testing, and summative usability testing do not raise any new concerns with regard to safety or effectiveness.
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
2013
Image /page/0/Picture/1 description: The image shows the Fresenius Medical Care logo. The logo consists of a stylized symbol on the left and the text "FRESENIUS MEDICAL CARE" on the right. The symbol is made up of three downward-pointing chevron shapes stacked on top of each other. The text is in bold, sans-serif font, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.
2008T Hemodialysis Machine Traditional 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 § 807.92.
A. Submitter's Information
| Name: | Fresenius Medical Care Renal Therapies Group, LLC | |
|---|---|---|
| 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: | 25 June 2013 |
B. Device Name Trade Name: 2008T Hemodialysis Machine Common Name: Hemodialysis Delivery System Classification Name: High Permeability Hemodialysis System Classification Number: Class II per 21 CFR § 876.5860 Product Code/Classification Panel: 78 KDI, KPO; Gastroenterology/Urology Panel
C. Legally Marketed Predicate Devices
2008T Hemodialysis Machine (K121341) and Crit-Line Clip Monitor (K121599).
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Image /page/1/Picture/1 description: The image shows the Fresenius Medical Care logo. The logo consists of a stylized symbol on the left and the text "FRESENIUS MEDICAL CARE" on the right. The symbol is made up of three chevron-like shapes stacked on top of each other, pointing downwards. The text is in bold, sans-serif font, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.
2008T Hemodialysis Machine Traditional 510(k) Notification
D. Device Description
The 2008T Hemodialysis Machine is indicated for acute and chronic dialysis therapy. 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. In the dialysate circuit, the dialysate concentrates are mixed with purified water, 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 display screen of the 2008T Hemodialysis Machine is shared between the hemodialysis machine and the CDX PC (optional) running third party MDDS (Medical Device Data Systems). 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 Hemodialysis Machine which includes a keyboard, touchpad and touch-screen, is operational in both the dialysis mode and the CDX mode, whichever is actively displayed.
Bibag System (Optional):
The bibag system is intended for use with Fresenius three stream proportioning hemodialysis systems equipped with the bibag module such as the 2008T Hemodialysis Machine and is intended for use in bicarbonate hemodialysis for acute and chronic renal failure. The bibag is intended for extracorporeal bicarbonate hemodialysis according to a physician's prescription.
The 2008T Hemodialysis Machine with bibag System allows operators the option of preparing a saturated sodium bicarbonate solution online through automated mixing of dialysis grade water and dry sodium bicarbonate powder within the bibag source disposable. The bibag System comprises: (1) the sodium bicarbonate concentrate generator (known as the bibag module); and (2) the bag of dry sodium bicarbonate concentrate. A specialized bibag connector with a door is used to connect the single-use bibag disposable (650g/900g) filled with USP grade dry sodium bicarbonate powder to the bibag connector. The 2008T Hemodialysis Machine draws dialysis grade water into the bibag to produce a saturated solution of sodium bicarbonate online. This online generation of sodium bicarbonate can only be performed using a specially modified 2008T Hemodialysis Machine with bibag System and can only be used with 45x (1:44) dilution.
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Image /page/2/Picture/1 description: The image shows the Fresenius Medical Care logo. The logo consists of a stylized graphic on the left and the text "FRESENIUS MEDICAL CARE" on the right. The graphic is made up of three chevron-like shapes stacked on top of each other, with the top two pointing upwards and the bottom one pointing downwards. The text is in bold, sans-serif font, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.
Modifications to the previously cleared 2008T Hemodialysis Machine (K121341) include:
-
Crit-Line Clip Monitor (CLiC) (Optional): Hardware, software and labeling t modifications to integrate the Crit-Line Clip Monitor (CLiC; K121599) and expansion of the Indications for Use for use of the CLiC with the 2008T Hemodialysis Machine. When integrated with the 2008T Hemodialysis Machine, the CLiC will use the same technology cleared under K121599, except the CLiC will now be hosted by the 2008T Hemodialysis Machine instead of the medical grade computer. When installed, the Crit-Line monitoring feature/user interface will be optional, selectable in Service Mode.
The intended use of the CLiC is as a continuous real-time monitor for non-invasive hematocrit, oxygen saturation, and percent change in blood volume measurement during hemodialysis treatment. The CLiC uses the principle of light absorption and scattering through the blood under test to measure oxygen saturation (O2 Sat) and hematocrit (Hct). The Hct values are then used to calculate the Blood Volume (BV) percentage change relative to the starting BV based on the beginning Hct. -
Software Maintenance: Software maintenance modifications were made to the . 2008T Hemodialysis Machine since the last clearance (K121341).
-
. Additional Labeling Modifications: The 2008T Hemodialysis Machine Operator's Manual contains modifications to warnings concerning Total Buffer which were implemented as part of a Class I recall for Naturalyte/Granuflo Prescribing Information (Recall number Z-1826/Z-1827-2012).
The device description information included in the submission conforms to the applicable requirements of 21 CFR Section 876.5860(b).
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Image /page/3/Picture/1 description: The image shows the Fresenius Medical Care logo. The logo consists of a stylized downward-pointing chevron symbol on the left. To the right of the symbol, the words "FRESENIUS MEDICAL CARE" are written in bold, sans-serif font, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.
E. Indications for Use
2008T Hemodialysis Machine:
The 2008T Hemodialysis Machine is indicated for acute and chronic dialysis therapy.
bibag System (Optional):
The bibag system is used with Fresenius Medical Care three stream proportioning hemodialysis systems equipped with the bibag module such as the 2008T Hemodialysis Machine and is intended for use in bicarbonate hemodialysis for acute and chronic renal failure. The bibag is intended for extracorporeal bicarbonate hemodialysis according to a physician's prescription.
Crit-Line Clip Monitor (CLiC) (Optional):
The Crit-Line Clip Monitor is used with the 2008T Hemodialysis Machine to non-invasively measure hematocrit, oxygen saturation and percent change in blood volume. The CLiC device measures hematocrit, percent change in blood volume and oxygen saturation in real time for application in the treatment of dialysis patients with the intended purpose of providing a more effective treatment for both the dialysis patient and the clinician. Based on the data that the monitor provides, the clinician/nurse, under physician direction, intervenes (i.e. increases or decreases the rate at which fluid is removed from the blood) in order to remove the maximum amount of fluid from the dialysis patient without the patient experiencing the common complications of dialysis which include nausea, cramping and vomiting.
F. Intended use
The intended use of the modified 2008T Hemodialysis Machine with optional bibag is the same as the unmodified device (K121341). Both devices are intended to be used for acute and chronic dialysis therapy in patients with End Stage Renal Disease.
The intended use of the Crit-Line Clip Monitor when installed and used with the 2008T Hemodialysis Machine is the same as the predicate device (K121599). The CLiC is intended to be used as a non-invasive hematocrit, oxygen saturation and percent change in blood volume monitor during hemodialysis treatment.
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Image /page/4/Picture/1 description: The image shows the Fresenius Medical Care logo. The logo consists of a stylized symbol on the left and the text "FRESENIUS MEDICAL CARE" on the right. The symbol is made up of three chevron-like shapes stacked on top of each other, pointing downwards. The text is in bold, sans-serif font, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.
G. Technological Characteristics
The technological characteristics of the proposed device are summarized in the context of the predicate devices:
2008T Hemodialysis Machine with optional bibag System (K121341)
The modified device has the same operating principle, fundamental scientific technology, and is comparable in key safety, effectiveness and quality assurance features.
All existing 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 predicate device:
- . Safety system
- System performance
- Environmental Requirements G
- . User Interface (except for CLiC features)
- Hardware and therapy settings .
- ♥ Accessories (except for CLiC sensor clip)
- o Alarms (except for additional alerts/warnings associated with the CLiC )
- � Accuracy and Controls
- � Protection against Mechanical Hazard
- Protection against Electrical Hazard �
- Protection against excessive temperature or other hazards
- Transportation and Storage conditions ●
- . Manufacturing Location and manufacturing processes (assembly, fabrication, testing, shipping, installation and service).
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Image /page/5/Picture/1 description: The image shows the Fresenius Medical Care logo. The logo consists of a stylized symbol on the left and the text "FRESENIUS MEDICAL CARE" on the right. The symbol is made up of three horizontal lines that are stacked on top of each other, with the top line being the longest and the bottom line being the shortest.
Crit-Line Clip Monitor (CLiC):
The Crit-Line Clip Monitor (CLiC) proposed for use with the 2008T Hemodialysis Machine is the same device cleared for use with the medical grade computer during hemodialysis treatments under K121599.
The CLiC has the following key similarities to the predicate device (K121599):
-
. Intended Use
. -
Operating Principle ●
-
Fundamental Scientific Technology .
-
Performance Specifications (monitoring parameters) ●
Safety and effectiveness of the 2008T Hemodialysis Machine with optional CLiC is confirmed by system verification and validation testing to verify performance specifications, and user requirements, in conformance with applicable referenced FDA regulations and FDArecognized industry and international standards.
A risk analysis (per ISO 14971) 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.
H. Performance Data
The performance of the modified device described in this submission was evaluated according to existing FMC-RTG procedures, protocols, declared performance standards and guidelines of the quality system regulation (21 CFR Part 820). Design verification and validation tests were conducted to ensure that the modifications did not affect the essential performance of the device and the device functions as intended.
The following tests were conducted for the modified device:
System Verification and Software Validation 1.
- . Functional Verification and Software Validation
-
Software Verification (Functional Tests)
-
Regression
-
Safety Systems Verification
-
Simulated Dialysis Treatment
-
Production Test Procedure
-
Unstructured and Static Code Verification
-
- Svstem Performance .
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Image /page/6/Picture/1 description: The image shows the Fresenius Medical Care logo. The logo consists of a stylized graphic on the left and the text "FRESENIUS MEDICAL CARE" on the right. The graphic is composed of three chevron-like shapes stacked vertically, with the top two pointing upwards and the bottom one pointing downwards. The text is in bold, sans-serif font, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.
2. System Safety
- ◆ Electromagnetic Compatibility
-
- Usability (Formative and Summative)
l. Conclusion
Test results demonstrated that the modified 2008T Hemodialysis Machine with optional CLiC functions as intended and met pre-determined acceptance criteria. Results of system/software verification/validation testing, safety testing, and summative usability testing do not raise any new concerns with regard to safety or effectiveness.
FMC-RTG concludes that, within the meaning of the Medical Device Amendments Act of 1976, the 2008T Hemodialysis Machine with optional CLiC is substantially equivalent to the predicate devices.
7
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The logo also includes the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the caduceus symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring MD 20993-0002
October 11, 2013
Fresenius Medical Care Renal Therapies Group, LLC % Denise Oppermann Senior Director, Regulatory Affairs - Device 920 Winter Street Waltham, MA 02451
Re: K131908
Trade/Device Name: 2008T Hemodialysis Machine Regulation Number: 21 CFR§ 876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: KDI Dated: July 17, 2013 Received: July 19, 2013
Dear Denise 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 registration. Ilsting 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
8
Page 2 - Denise Oppermann
medical 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/MedicaiDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Image /page/8/Picture/7 description: The image shows the name "Benjamin R. Fisher -S" in a bold, sans-serif font. The text is horizontally oriented and appears to be a title or heading. The letters are uniformly sized and spaced, creating a clear and legible presentation of the name.
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
9
Image /page/9/Picture/0 description: The image shows the Fresenius Medical Care logo. On the left is a symbol consisting of three chevrons stacked on top of each other, pointing downwards. To the right of the symbol is the text "FRESENIUS MEDICAL CARE" in bold, sans-serif font, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.
510(k) Number (if known): K 131908 Device Name: 2008T Hemodialysis Machine
Indications for Use:
2008T Hemodialysis Machine:
The 2008T Hemodialysis Machine is indicated for acute and chronic dialysis therapy.
bibag System (Optional):
The bibag system is used with Fresenius three stream proportioning hemodialysis systems equipped with the bibag module such as the 2008T Hemodialysis Machine and is intended for use in bicarbonate hemodialysis for acute and chronic renal failure. The bibag is intended for extracorporeal bicarbonate hemodialysis according to a physician's prescription.
Crit-Line Clip Monitor (CLiC) (Optional):
The Crit-Line Clip Monitor is used with the 2008T Hemodialysis Machine to non-invasively measure hematocrit, oxygen saturation and percent change in blood volume. The CLIC device measures hematocrit, percent change in blood volume and oxygen saturation in real time for application in the treatment of dialysis patients with the intended purpose of providing a more effective treatment for both the dialysis patient and the clinician. Based on the data that the monitor provides, the clinician/nurse, under physician direction, intervenes (i.e., increases or decreases the rate at which fluid is removed from the blood) in order to remove the maximum amount of fluid from the dialysis patient without the patient experiencing the common complications of dialysis which include nausea, cramping and vomiting.
XPrescription Use (Per 21 CFR 801 Subpart D) AND/OR
lover-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)
Beniamin R. 2013.1
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