(1491 days)
Not Found
No
The summary describes a hemodialysis machine with a simplified user interface and a wetness detector. There is no mention of AI, ML, or any related technologies in the device description, intended use, or performance studies. The modifications focus on usability and a simple leak detection mechanism.
Yes
The Fresenius 2008K@home is indicated for acute and chronic dialysis therapy, which is a treatment for kidney failure. The Wireless Wetness Detector is an accessory that aids in the detection of leaks during this therapy.
No
Explanation: The device, the Fresenius 2008K@home, is indicated for dialysis therapy (treatment), and the Wireless Wetness Detector is an accessory that aids in the detection of leaks during this treatment. Neither device is described as being used to diagnose a medical condition.
No
The device description explicitly mentions hardware components: the Fresenius 2008K@home machine (a modified hemodialysis machine) and the Wireless Wetness Detector (a disposable device that transmits radio signals).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "acute and chronic dialysis therapy" and "hemodialysis in the home." This describes a therapeutic treatment, not a diagnostic test performed on in vitro samples (like blood, urine, or tissue).
- Device Description: The device is a "hemodialysis machine" and an accessory "wireless wetness detector." These are devices used to perform a medical procedure (dialysis) and monitor for leaks during that procedure. They do not analyze biological samples to provide diagnostic information.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, reagents, or diagnostic outputs related to a patient's condition based on in vitro testing.
Therefore, the Fresenius 2008K@home and its Wireless Wetness Detector are medical devices used for treatment and monitoring during that treatment, not for in vitro diagnostic purposes.
N/A
Intended Use / Indications for Use
The Fresenius 2008K@home is indicated for acute and chronic dialysis therapy in an acute or chronic facility. The 2008K@home is also indicated for hemodialysis in the home and must be observed by a trained and qualified person as prescribed by a physician.
The Wireless Wetness Detector is indicated for use with the Fresenius 2008K@home hemodialysis machine and is an optional accessory to aid in the detection of blood and water leaks during hemodialysis. Home hemodialysis using the detector must be observed by a trained and qualified person as prescribed by a physician.
Product codes (comma separated list FDA assigned to the subject device)
78 KDI, ONW, ODX
Device Description
The Fresenius 2008K@home machine is a modified version of the 2008K 3stream hemodialysis machine. Modifications to the device interface are designed to improve and simplify the training and process of performing hemodialysis. This modified user interface is intended to make it easier for patients and/or their caregivers to deliver hemodialysis safely and effectively in the home environment.
Additionally, the wireless wetness detector (WetAlert), an optional accessory to the 2008K@home, is a disposable device that detects leaks. During treatment, the WetAlert device transmits radio signals to the corresponding 2008K@home hemodialysis machine and alerts the machine if it detects a blood or water leak. During a wetness alarm, the 2008K@home hemodialysis machine will automatically stop the blood pump, close the venous clamp, and sound an alarm.
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
acute or chronic facility, home
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)
Summary of non-clinical data submitted with the premarket notification of the device
Full system validation and software regression testing was performed to ensure that the modifications to the 2008K@home with Wireless Wetness Detector function as intended and that the modifications did not negatively impact the overall 2008K@home hemodialysis machine system. Testing included:
- Software validation and regression testing
- Electromagnetic compatibility (EMC) testing
- Electrical safety testing
The results from the testing demonstrated that all modifications functioned as intended and met pre-determined acceptance criteria.
Summary of clinical data obtained
FMCNA conducted clinical studies demonstrating that the 2008K@home can be used as safely and effectively at home as in the dialysis clinic. The company collected and evaluated safety data from over 500 incenter and 500 home hemodialysis treatments. Additionally, FMCNA conducted an evaluation of treatment adequacy and safety from 29 subjects who transitioned from in-center to home hemodialysis.
Usability testing also was conducted in the clinic and home settings to confirm the safe and effective use of the modified device.
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
Fresenius Medical Care
FEB - 3 20il
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: | 781-699-9505 |
| Fax: | 781-699-9635 |
| Contact Person: | Randy Quinn, Lead Regulatory Affairs |
| Specialist - Devices | |
| Date of Preparation: | December 1, 2010 |
B. Device Name:
| Trade Name: | 2008K@home with Wireless Wetness
Detector |
|---------------------------------------|-------------------------------------------------------------------|
| Common Name: | Hemodialysis Machine |
| Product
Code/Classification Panel: | 78 KDI / Gastroenterology/Urology |
| Classification Name: | High Permeability Hemodialysis
System, Class II per § 876.5860 |
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KO 70049
Page 2 of 3
C. Legally Marketed Predicate Device (unmodified devices):
The Fresenius 2008K@home with Wireless Wetness Detector is a modified version of the Fresenius 2008K, which was cleared under the following premarket notification:
Fresenius 2008K Dialysate Delivery System
- K994267 (3/10/2000) .
D. Device Description:
The Fresenius 2008K@home machine is a modified version of the 2008K 3stream hemodialysis machine. Modifications to the device interface are designed to improve and simplify the training and process of performing hemodialysis. This modified user interface is intended to make it easier for patients and/or their caregivers to deliver hemodialysis safely and effectively in the home environment.
Additionally, the wireless wetness detector (WetAlert), an optional accessory to the 2008K@home, is a disposable device that detects leaks. During treatment, the WetAlert device transmits radio signals to the corresponding 2008K@home hemodialysis machine and alerts the machine if it detects a blood or water leak. During a wetness alarm, the 2008K@home hemodialysis machine will automatically stop the blood pump, close the venous clamp, and sound an alarm.
Indications for Use: E.
2008K@home Indications for Use:
The Fresenius 2008K@home is indicated for acute and chronic dialysis therapy in an acute or chronic facility. The 2008K@home is also indicated for hemodialysis in the home and must be observed by a trained and qualified person as prescribed by a physician.
Wireless Wetness Detector Indications for Use:
The Wireless Wetness Detector is indicated for use with the Fresenius 2008K@home hemodialysis machine and is an optional accessory to aid in the detection of blood and water leaks during hemodialysis. Home hemodialysis using the detector must be observed by a trained and qualified person as prescribed by a physician.
2
KO70049
Rge 393
F. Technological Characteristics
The Fresenius 2008K@home is a modified version of the Fresenius 2008K Dialysate Delivery System. Modifications were made to the user interface and the Wireless Wetness Detector was added as an optional accessory to facilitate the device's use by home patients. The performance data described below demonstrate that the modified Fresenius 2008K@home with Wireless Wetness Detector is substantially equivalent to the Fresenius 2008K (K994267) Dialysate Delivery System.
Performance Data G.
1. Summary of non-clinical data submitted with the premarket notification of the device
Full system validation and software regression testing was performed to ensure that the modifications to the 2008K@home with Wireless Wetness Detector function as intended and that the modifications did not negatively impact the overall 2008K@home hemodialysis machine system. Testing included:
- · Software validation and regression testing
- Electromagnetic compatibility (EMC) testing .
- · Electrical safety testing
The results from the testing demonstrated that all modifications functioned as intended and met pre-determined acceptance criteria.
Summary of clinical data obtained 2.
FMCNA conducted clinical studies demonstrating that the 2008K@home can be used as safely and effectively at home as in the dialysis clinic. The company collected and evaluated safety data from over 500 incenter and 500 home hemodialysis treatments. Additionally, FMCNA conducted an evaluation of treatment adequacy and safety from 29 subjects who transitioned from in-center to home hemodialysis.
Usability testing also was conducted in the clinic and home settings to confirm the safe and effective use of the modified device.
H. Conclusion
The non-clinical and clinical data demonstrate that the 2008K@home is as safe and effective, and performs as well, as the cleared 2008K.
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
FEB 3 2011
Mr. Randolph Ouinn Lead Regulatory Affairs Specialist Fresenius Medical Care North America 920 Winter Street WALTHAM MA 02451-1457
Re: K070049
Trade/Device Name: Fresenius 2008K@Home with Wireless Wetness Detector Regulation Number: 21 CFR §876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: ONW and ODX Dated: December 10, 2010 Received: December 13, 2010
Dear Mr. Quinn:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related
4
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.
Sincerely vours.
Hubert Lemon 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
5
Indications for Use
510(k) Number (if known): K070049
Device Name:
Fresenius 2008K@home
Indications for Use:
2008K@home Indications for Use:
The Fresenius 2008K@home is indicated for acute and chronic dialysis therapy in an acute or chronic facility. The 2008K@home is also indicated for hemodialysis in the home and must be observed by a trained and qualified person as prescribed by their physician.
Wireless Wetness Detector Indications for Use:
The Wireless Wetness Detector is indicated for use with the Fresenius 2008K@home hemodialysis machine and is an optional accessory to aid in the detection of blood and water leaks during hemodialysis. Home hemodialysis using the detector must be observed by a trained and qualified person as prescribed by their physician.
Prescription Use X (Per 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELQW 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 | K070049 |