(156 days)
No
The description focuses on data management software integration and the addition of new concentrate options, with no mention of AI or ML algorithms for decision-making, data analysis beyond basic transfer, or predictive capabilities.
Yes.
The device is used for "acute and chronic dialysis therapy", which is a medical treatment.
No
The device is indicated for "acute and chronic dialysis therapy," which is a treatment, not a diagnostic process. While it has data management capabilities, these are for transferring "treatment data," further supporting its role as a therapeutic device.
No
The device description explicitly states that the software is incorporated into the 2008T hemodialysis machine, which is a hardware device. The software is an "optional modification" that runs on a PC board within the machine and interfaces with the machine's existing hardware (keyboard, display). The performance studies also include full system validation and electrical safety testing, indicating hardware components are part of the device.
Based on the provided text, the Fresenius 2008T device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "acute and chronic dialysis therapy." This is a therapeutic treatment performed on a patient, not a diagnostic test performed on a sample outside the body.
- Device Description: The description focuses on the machine's function in performing hemodialysis, managing treatment data, and using specific acid concentrates. These are all related to the dialysis process itself.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, etc.) to provide diagnostic information about a patient's condition. The device's purpose is to filter the patient's blood.
Therefore, the Fresenius 2008T is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Fresenius 2008T is indicated for acute and chronic dialysis therapy.
Product codes (comma separated list FDA assigned to the subject device)
78 KDI
Device Description
The optional CDX modification incorporates a standard Windows/Linux capable computer (PC board) into the 2008T giving clinics the option to load data management software into the machine. With data management software on the machine the user may then interface with the program, using the machines preexisting alphanumeric keyboard, then transfer treatment data directly from the 2008T machine to their In-center medical information system. Additionally, the selection of Citrasate (K000792) and DRYalvsate (K980659) acid concentrates have been added to the selection of acid concentrates available to our customers on the 2008T hemodialysis machine. The user interface has been changed to allow the user to select Citrasate/DRYalysate from the dialysis screen of the 2008T hemodialysis machine and to display the proper constituents of the concentrate.
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
Operators of the 2008T Hemodialysis machine with CDX option must be trained to administer hemodialysis at the direction of a physician. In addition, the operator should be: Knowledgeable of hemodialysis methodology and relevant physiology. Proficient in healthcare procedures regarding aseptic techniques. Thoroughly familiar with the contents of the Operator's manual. Fully trained and qualified to operate this machine, and able to distinguish between normal and abnormal operation.
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)
Full system validation and software regression testing was performed to ensure that the modifications to the 2008T hemodialysis functions as intended and that the modifications did not negatively impact the overall 2008T hemodialysis machine system. Testing included: Software validation and regression testing, Electromagnetic compatibility (EMC) testing, Electrical safety testing, System performance testing using Citrasate acid concentrate. The results from the testing demonstrated that all modifications functioned as intended and met pre-determined acceptance criteria. Electromagnetic compatibility testing (EMC) was conducted according to the IEC 60601-1-2 (2007) Class A Testing at CKC Laboratories, Inc. The modified 2008T hemodialysis machine, outlined in this submission, met the requirements for IEC 60601-1-2 devices. Electrical safety testing was conducted according to the following standards: UL 60601-1, 1st Edition, 2006-04-26, (Medical Electrical Equipment, Part 1:General Requirements for Safety) CAN/CSA-C22.2 No. 601.1-M90, 2005, (Medical Equipment Electrical Equipment, Part 1: General Requirements for Safety) The modified 2008T hemodialysis machine with was found to comply with the above standards.
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
This 510(k) Summary is in accordance with the requirements of 21CFR Part 807.92
A. Submitter's Information:
MAY 2 7 2010
| Name: | Fresenius Medical Care North America |
|---|---|
| Address: | 920 Winter Street |
| Waltham, MA 02451 | |
| Phone: | 1-781-699-4475 |
| Fax: | (781) 699-9635 |
| Contact Person: | Janet Kay, Director of Regulatory Affairs-Devices |
| Date of Preparation: | December 21, 2009 |
- B. Device Name: Fresenius 2008T Hemodialysis Machine
Common Name: Hemodialysis Machine
Product Code/Classification Panel: 78 KDI / Gastroenterology/Urology
Classification: Class II per § 876.5860
- C. Legally Marketed Predicate Device (unmodified devices); Fresenius 2008T Hemodialysis Machine
D. Device Description:
-
- The optional CDX modification incorporates a standard Windows/Linux capable computer (PC board) into the 2008T giving clinics the option to load data management software into the machine. With data management software on the machine the user may then interface with the program, using the machines preexisting alphanumeric keyboard, then transfer treatment data directly from the 2008T machine to their In-center medical information system.
1
select Citrasate/DRYalysate from the dialysis screen of the 2008T hemodialysis machine and to display the proper constituents of the concentrate.
E. Indications for Use:
The Fresenius 2008T is indicated for acute and chronic dialysis therapy.
Substantial Equivalence Decision Making Process
1. Is the product a device?
YES - The modified Fresenius 2008T Hemodialysis Machine is a device pursuant to 21 CFR §201 [321] (h).
2. Does the new device have the same intended use?
YES - The intended use for the modified 2008T Hemodialysis Machine is identical to that for the unmodified 2008T (K080964) as follows:
Intended Use
The Fresenius 2008T is indicated for acute and chronic hemodialysis
3. Does the device have technological characteristics that raise new types of safety or effectiveness questions?
NO - The Fresenius 2008T with CDX option is a modified version of the Fresenius 2008T Dialysate Delivery System. The performance and technological characteristics of the modified Fresenius 2008T are equivalent to those of the Fresenius 2008T (K080964) Dialysate Delivery System and raise no new types of safety or effectiveness questions.
4. Does descriptive or performance information demonstrate equivalence?
YES - Fresenius Medical Care North America believes the information provided in this submission clearly describes the modified Fresenius 2008T and demonstrates that it is substantially equivalent to the original Fresenius 2008T Dialysate Delivery system.
F. Safety Summary
The Fresenius 2008T hemodialysis machine with CDX option incorporates a standard Windows/Linux capable computer (PC board) into the machine. Additionally, Citrasate/DRYalysate was added to the 2008T's selectable acid concentrates. All water requirements, module options, functional options, performance limits, control parameters, compatible bloodlines.
2
and language options remain unchanged from the predicate device, the 2008T (K080964). A Risk Analysis has been completed and potential hazards associated with the modifications have been identified, mitigated and where applicable mitigations have been verified. All potential risks were deemed acceptable after mitigation.
G. Summary of non-clinical tests submitted with the premarket notification of the device
-
- Full system validation and software regression testing was performed to ensure that the modifications to the 2008T hemodialysis functions as intended and that the modifications did not negatively impact the overall 2008T hemodialysis machine system. Testing included:
- . Software validation and regression testing
- · Electromagnetic compatibility (EMC) testing
- · Electrical safety testing
- · System performance testing using Citrasate® acid concentrate
The results from the testing demonstrated that all modifications functioned as intended and met pre-determined acceptance criteria.
-
- Electromagnetic compatibility testing (EMC) was conducted according to the IEC 60601-1-2 (2007) Class A Testing at CKC Laboratories, Inc. The modified 2008T hemodialysis machine, outlined in this submission, met the requirements for IEC 60601-1-2 devices.
-
- Electrical safety testing was conducted according to the following standards:
- UL 60601-1, 1st Edition, 2006-04-26, (Medical Electrical Equipment, . Part 1:General Requirements for Safety)
CAN/CSA-C22.2 No. 601.1-M90, 2005, (Medical Equipment Electrical . Equipment, Part 1: General Requirements for Safety) The modified 2008T hemodialysis machine with was found to comply with the above standards.
H. General Safety and Effectiveness Concerns
Operators of the 2008T Hemodialysis machine with CDX option must be trained to administer hemodialysis at the direction of a physician. In addition, the operator should be:
- . Knowledgeable of hemodialysis methodology and relevant physiology.
- . Proficient in healthcare procedures regarding aseptic techniques.
3
- Thoroughly familiar with the contents of the Operator's manual.
Fully trained and qualified to operate this machine, and able to distinguish between normal and abnormal operation.
.
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Image /page/4/Picture/1 description: The image shows the seal for the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center . WO66-G6( Silver Spring, MD 20993-0002
Ms. Janet C. Kay Director of Regulatory Affairs Renal Therapies Group Fresenius Medical Care North America 920 Winter Street WALTHAM MA 02451
MAY 2 7 2010
Re: K093902
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: April 27, 2010 Received: April 28, 2010
Dear Ms. Kay:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related
5
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/CDRH0ffices/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,
Janine M. Morris
Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known): K093902
Device Name: Fresenius 2008T Hemodialysis Machine
Indications for Use:
Fresenius 2008T is indicated for acute and chronic dialysis therapy
Prescription Use _ √ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Huld Reum
(Division Sign-Off)
Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
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