(248 days)
2008K@home Hemodialysis Machine 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 (Wet Alert) 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.
The 2008K@home Hemodialysis Machine with Wireless Detector is intended for short term (acute) and long term (chronic) dialysis treatment in a clinical facility and at home. In the home, a trained and qualified person must observe treatment as prescribed by a physician.
The 2008K@home Hemodialysis Machine is designed to provide hemodialysis treatment by controlling and monitoring both the dialysate and extracorporeal blood circuits. In the extracorporeal blood circuit, blood is continuously circulated from the patient through a dialyzer, where toxins are filtered out through a semi-permeable membrane, and returned to the patient. During this process, the extracorporeal blood circuit is monitored for venous and arterial blood pressures, and for the presence of air and blood.
The Wireless Wetness Detector system (branded as WetAlert) is an optional accessory to the 2008K@home. It is a multi-use, battery-powered device capable of detecting fluid leaks (i.e., blood or other conductive fluids). During treatment, the Wireless Wetness Detector transmits radio signals to the corresponding 2008K@home Hemodialysis Machine and will alert the 2008K@home Hemodialysis 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.
Modifications to the previously cleared 2008K@home with Wireless Wetness Detector system include:
- . 2008K@home Hemodialysis Machine- Replace the single receiver system with a dual antenna/receiver configuration for reception durability.
- . Wireless Wetness Detector- Change the Wireless Wetness Detector device body from a solid over-molded enclosure to a hollow, lighter weight, two-part bonded plastic case.
- . Wireless Wetness Detector- Modify the software to enhance the electrostatic immunity of the device.
- 2008K@home WetAlert Home User's Guide- The guide is being separated into a clinical . and a home version. Additional modifications include instructions and descriptions of changes.
The request describes the acceptance criteria and study that proves the device meets them, but the provided text does not contain detailed acceptance criteria or specific study results for quantitative performance metrics. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing exhaustive performance data.
However, based on the information provided, here's what can be extracted and inferred:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly list quantitative acceptance criteria with corresponding performance metrics. Instead, it states that "All testing...met the acceptance criteria." The overall acceptance criterion is based on demonstrating "substantial equivalence" to the predicate device in terms of safety and effectiveness, and functioning "as intended."
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Device functions "as intended" (detect fluid leaks, alarm, stop blood pump, close venous clamp) | "All testing...met the acceptance criteria." (implies successful leak detection and alarm response) |
| Modifications do not affect essential performance | "The performance data...demonstrate that the modified...system is substantially equivalent to the unmodified version..." |
| Wireless verification and performance acceptable | Testing included "wireless verification and performance" and "met the acceptance criteria." |
| Electromagnetic emissions and immunity acceptable | Testing included "electromagnetic emissions and immunity" and "met the acceptance criteria." |
| Mechanical integrity acceptable | Testing included "mechanical testing" and "met the acceptance criteria." |
| Usability for intended users acceptable | "Usability testing was also conducted to assure safe and effective use by the intended users. The results...did not prompt additional changes." |
| Safety and effectiveness comparable to predicate device | "The performance data demonstrate that the...system is as safe and effective, and performs as well as the predicate device." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size for the test set. It mentions "Design verification and validation tests were conducted," but does not provide details on the number of devices or scenarios used in these tests.
The data provenance is not explicitly stated as retrospective or prospective, nor does it mention the country of origin. The testing was conducted "according to existing FMCNA procedures, protocols, declared performance standards and guidelines of the quality system regulation (21 CFR 820)" by the manufacturer (Fresenius Medical Care North America) based in Waltham, MA, USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the use of experts to establish ground truth for testing. The testing appears to be based on engineering and performance validation against predefined specifications and regulatory guidelines rather than expert consensus on subjective data.
4. Adjudication Method for the Test Set
Not applicable. There is no mention of adjudication methods as the testing described is technical verification and validation, not involving human interpretation of data for ground truth establishment.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The document focuses on the technical performance of the device and its equivalence to a predicate, not on human reader performance with or without AI assistance. The device is a "Wireless Wetness Detector" for fluid leaks, not an AI diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, standalone performance testing of the device was done. The "Wireless Wetness Detector system" is a device that autonomously detects fluid leaks, transmits signals, and triggers alarms and machine responses. The performance data discussed (wireless verification, electromagnetic compatibility, mechanical testing) all relate to the standalone function of the device and its components. The document explicitly states, "The performance of the modified 2008K@home machine and Wireless Wetness Detector (WetAlert) system was evaluated according to existing FMCNA procedures, protocols, declared performance standards and guidelines..." implying autonomous testing.
7. The Type of Ground Truth Used
The ground truth used for testing would be objective, measurable conditions for leak detection and system response. For example:
- Leak Detection: Actual presence or absence of conductive fluid (blood or water) in controlled experimental setups.
- Wireless Performance: Successful transmission and reception of signals under various conditions.
- Electromagnetic Compatibility: Adherence to established standards for emissions and immunity.
- Mechanical Integrity: Resistance to physical stress as per engineering specifications.
These are established by engineering standards and controlled experiments rather than expert consensus on subjective data.
8. The Sample Size for the Training Set
The document does not mention a "training set" in the context of machine learning or AI. This device is an electromechanical system with software for control and signal processing, not a learning-based AI system that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no mention of a training set for an AI/machine learning model.
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510K SUMMARY
K121421
pg. 1 of 3
JAN 1 7 2013
2008K@home Hemodialysis Machine with Wetness Detector System Special 510(k) Notification
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
Submitter's Information:
| Name: | Fresenius Medical Care North America | |
|---|---|---|
| Address: | 920 Winter StreetWaltham, MA 02451-1457 | |
| Phone: | 781-699-4479 | |
| Fax: | 781-699-9635 | |
| Contact Person: | Denise OppermannSenior Director, Regulatory Affairs - Devices | |
| Date of Preparation: | 17 January 2013 | |
| Device Name: | ||
| Trade Name: | 2008K@home Hemodialysis Machine withWireless Wetness Detector | |
| Common Name: | Hemodialysis Machine | |
| Product Code/Classification Panel: | KDI, ONW, ODX / Gastroenterology - Urology | |
| Classification Name: | High Permeability Hemodialysis SystemClass II per §876.5860 |
Legally Marketed Predicate Device (unmodified devices):
The Fresenius 2008K@home Hemodialysis Machine with Wireless Wetness Detector (WetAlert) system (K070049) originally 03 February 2011.
Device Description:
D
The 2008K@home Hemodialysis Machine with Wireless Detector is intended for short term (acute) and long term (chronic) dialysis treatment in a clinical facility and at home. In the home, a trained and qualified person must observe treatment as prescribed by a physician.
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Image /page/1/Picture/0 description: The image shows the logo for Fresenius Medical Care. The logo consists of a stylized 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, with the top two pointing upwards and the bottom one pointing downwards. The text is in a bold, sans-serif font, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.
2008K@home Hemodialysis Machine with Wird Wetness Detector System Special 510(k) Notification
The 2008K@home Hemodialysis Machine is designed to provide hemodialysis treatment by controlling and monitoring both the dialysate and extracorporeal blood circuits. In the extracorporeal blood circuit, blood is continuously circulated from the patient through a dialyzer, where toxins are filtered out through a semi-permeable membrane, and returned to the patient. During this process, the extracorporeal blood circuit is monitored for venous and arterial blood pressures, and for the presence of air and blood.
The Wireless Wetness Detector system (branded as WetAlert) is an optional accessory to the 2008K@home. It is a multi-use, battery-powered device capable of detecting fluid leaks (i.e., blood or other conductive fluids). During treatment, the Wireless Wetness Detector transmits radio signals to the corresponding 2008K@home Hemodialysis Machine and will alert the 2008K@home Hemodialysis 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.
Modifications to the previously cleared 2008K@home with Wireless Wetness Detector system include:
- . 2008K@home Hemodialysis Machine- Replace the single receiver system with a dual antenna/receiver configuration for reception durability.
- . Wireless Wetness Detector- Change the Wireless Wetness Detector device body from a solid over-molded enclosure to a hollow, lighter weight, two-part bonded plastic case.
- . Wireless Wetness Detector- Modify the software to enhance the electrostatic immunity of the device.
- 2008K@home WetAlert Home User's Guide- The guide is being separated into a clinical . and a home version. Additional modifications include instructions and descriptions of changes.
Indications for Use:
The modified 2008K@home with Wireless Wetness Detector (WetAlert) system has the same indications for use as the unmodified device.
2008K@home Hemodialysis Machine 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 (Wet Alert) 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
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Image /page/2/Picture/0 description: The image shows the logo for Fresenius Medical Care. 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 stacked chevron shapes pointing downwards, with the bottom chevron being the smallest. The text is in bold, sans-serif font, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.
water leaks during hemodialysis. Home hemodialysis using the detector must be observed by a trained and qualified person as prescribed by their physician.
Technological Characteristics:
The modifications to the 2008K@home Hemodialysis Machine and Wireless Wetness Detector do not change the technological characteristics of either device. The principles of operation and the performance specifications remain the same as the unmodified devices. The modifications to the 2008K@home machine are made to enhance the reception from the Wireless Wetness Detector. The modifications to the Wireless Detector are being implemented to enhance durability without reducing battery life. The performance data described below demonstrate that the modified Fresenius 2008K@home with Wireless Wetness Detector (WetAlert) system is substantially equivalent to the unmodified version (K070049)
Performance Data:
The performance of the modified 2008K@home machine and Wireless Wetness Detector (WetAlert) system was evaluated according to existing FMCNA procedures, protocols, declared performance standards and guidelines of the quality system regulation (21 CFR 820). Design verification and validation tests were conducted to ensure that the modifications described in this submission did not affect the essential performance of the devices and the devices function as intended.
Testing included performance, safety, reliability and usability of the 2008K@home machine and the Wireless Wetness Detector. The evaluation involved wireless verification and performance, electromagnetic emissions and immunity and mechanical testing. Usability testing was also conducted to assure safe and effective use by the intended users. The results of the usability testing did not prompt additional changes. All testing of the 2008K@home and the Wireless Wetness also Detector met the acceptance criteria.
Conclusion:
The performance data demonstrate that the 2008K@home with Wireless Wetness Detector (WetAlert) is as safe and effective, and performs as well as the predicate device.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract representation of people or a flowing design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 17, 2013
Fresenius Medical Care North America % Ms. Denise Oppermann Senior Director, Regulatory Affairs - Devices 920 Winter Street WALTHAM MA 02451-1457
Re: K121421
Trade/Device Name: Fresenius 2008@home Hemodialysis Machine Regulation Number: 21 CFR§ 876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: ODX, ONW, KDI Dated: January 15, 2013 Received: January 16, 2013
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 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.
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Page 2 - Ms. Denise Oppermann
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 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Benjamin A. Fisher -S
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/5/Picture/0 description: The image shows the logo for Fresenius Medical Care. The logo consists of three downward-pointing chevrons stacked on top of each other on the left. To the right of the chevrons is the text "FRESENIUS MEDICAL CARE" in bold, sans-serif font. The text is arranged in two lines, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.
510(k) Number (if known):
2008K@home Hemodialysis Machine with Wireless - Wetness Detector System Special 510(k) Notification
Section 4 Indications for Use Statement
ection 4. Indications for Use Stateme
Device Name:
Fresenius 2008K@home Hemodialysis Machine
Indications for Use:
2008K@home Hemodialysis Machine 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 (Wet Alert) 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.
A copy of this 'Indications for Use Statement' is also provided in Appendix 1 Note:
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)
Benjamin R. Fisher -S 2013.01.17 17:48:07 -05'00'
on of Reproductive, Gastro-Renal, and
Volume Page 16
§ 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.”