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.

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.

AI/ML Overview

The provided text describes the acceptance criteria and the study that proves the device meets them for the Fresenius 2008K@home with Wireless Wetness Detector.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Tests/Evaluations	Reported Device Performance
Non-clinical Performance	Software validation and regression testing	"all modifications functioned as intended and met pre-determined acceptance criteria."
	Electromagnetic compatibility (EMC) testing	"all modifications functioned as intended and met pre-determined acceptance criteria."
	Electrical safety testing	"all modifications functioned as intended and met pre-determined acceptance criteria."
	Full system validation	Ensured "that the modifications did not negatively impact the overall 2008K@home hemodialysis machine system" and "all modifications functioned as intended and met pre-determined acceptance criteria."
Clinical Performance	Safety Data Collection (in-center and home hemodialysis)	Collected and evaluated safety data from "over 500 in-center and 500 home hemodialysis treatments." Conclusion: "the 2008K@home can be used as safely and effectively at home as in the dialysis clinic."
	Treatment Adequacy and Safety (transitional subjects)	Conducted an evaluation from "29 subjects who transitioned from in-center to home hemodialysis." Implied satisfactory outcome given the conclusion of safety and effectiveness.
	Usability Testing (clinic and home settings)	Conducted to "confirm the safe and effective use of the modified device." Implied satisfactory outcome given the conclusion of safety and effectiveness.
Overall Comparison	Substantial Equivalence to Predicate Device (Fresenius 2008K)	non-clinical and clinical data demonstrate that the 2008K@home is as safe and effective, and performs as well, as the cleared 2008K." The 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...demonstrate that the modified Fresenius 2008K@home with Wireless Wetness Detector is substantially equivalent to the Fresenius 2008K."

2. Sample Size Used for the Test Set and the Data Provenance

Clinical Safety Data: Over 500 in-center and 500 home hemodialysis treatments were evaluated for safety. The provenance (country of origin) is not explicitly stated, but the submission is from "Fresenius Medical Care North America," suggesting the data is likely from North America. The data is retrospective, as it mentions "collected and evaluated safety data."
Clinical Treatment Adequacy and Safety: 29 subjects who transitioned from in-center to home hemodialysis were evaluated. The provenance is not explicitly stated. The study type (retrospective/prospective) is not specified.
Usability Testing: Conducted in "clinic and home settings." The sample size for usability testing is not specified. The provenance is not explicitly stated.
Non-clinical Testing (Software, EMC, Electrical Safety, Full System): The sample size for these tests is not quantified in terms of units tested, but rather refers to the comprehensive nature of the testing. The data provenance is not specified.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

The document does not explicitly state the number of experts used or their specific qualifications for establishing ground truth for any of the clinical or non-clinical studies. The clinical studies evaluated "safety data" and "treatment adequacy," implying clinical assessment by qualified medical professionals, but this is not detailed.

4. Adjudication Method

The adjudication method for any of the test sets (clinical or non-clinical) is not specified in the provided text.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study is mentioned in the provided text, nor is there any discussion of AI assistance or human reader improvement with/without AI. This device is a hemodialysis machine with a wetness detector, not an AI-assisted diagnostic tool.

6. Standalone Performance Study (i.e., algorithm only without human-in-the-loop performance)

The document describes non-clinical performance (software, EMC, electrical safety, full system validation) and clinical performance studies, which involve the device functioning. The Wireless Wetness Detector functions "automatically stop the blood pump, close the venous clamp, and sound an alarm" during a wetness alarm. This indicates a standalone algorithmic function for detection and response.

7. The Type of Ground Truth Used

Non-clinical Data: The ground truth for non-clinical tests (software validation, EMC, electrical safety, full system validation) would be based on engineering specifications, regulatory standards, and pre-determined functional requirements. "Pre-determined acceptance criteria" are explicitly mentioned.
Clinical Safety Data: The ground truth for safety would be based on clinical outcomes, adverse event reporting, and standard medical safety assessments.
Clinical Treatment Adequacy: The ground truth for treatment adequacy would be established by clinical measures of dialysis effectiveness (e.g., clearance rates, patient well-being, lab results), likely compared against established medical standards for hemodialysis.
Usability Testing: The ground truth for usability would be based on observations of user interaction, task completion rates, error rates, and user feedback, evaluated against pre-defined usability criteria for safe and effective operation in both clinic and home environments.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning or AI. The device described does not appear to be an AI/ML-based diagnostic or prognostic tool that would typically involve a separate training set for algorithm development. The "performance data" refers to validation and evaluation of the device as a whole.

9. How the Ground Truth for the Training Set Was Established

As there is no explicit mention of a "training set" for an AI/ML algorithm, this question is not applicable based on the provided text. The ground truth for the device's intended function and performance was established through the various non-clinical and clinical testing methods described above, against pre-determined acceptance criteria and established medical standards for hemodialysis.

Summary

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K070049

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 StreetWaltham, MA 02451-1457
Phone:	781-699-9505
Fax:	781-699-9635
Contact Person:	Randy Quinn, Lead Regulatory AffairsSpecialist - Devices
Date of Preparation:	December 1, 2010

B. Device Name:

Trade Name:	2008K@home with Wireless WetnessDetector
Common Name:	Hemodialysis Machine
ProductCode/Classification Panel:	78 KDI / Gastroenterology/Urology
Classification Name:	High Permeability HemodialysisSystem, 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:

Indications for Use: E.

2008K@home Indications for Use:

Wireless Wetness Detector Indications for Use:

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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.

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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

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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

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Indications for Use

510(k) Number (if known): K070049

Device Name:

Fresenius 2008K@home

Indications for Use:

2008K@home Indications for Use:

Wireless Wetness Detector Indications for Use:

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, andUrological Devices
510(k) Number	K070049

Regulation Number and Section

§ 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.”