FRESENIUS 2008K @HOME WITH WIRELESS WETNESS DETECTOR

K070049 · Fresenius Medical Care North America · ONW · Feb 3, 2011 · Gastroenterology, Urology

Device Facts

• Record ID: K070049
• Device Name: FRESENIUS 2008K @HOME WITH WIRELESS WETNESS DETECTOR
• Applicant: Fresenius Medical Care North America
• Product Code: ONW · Gastroenterology, Urology
• Decision Date: Feb 3, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5860
• Device Class: Class 2
• Attributes: Therapeutic, Real-World Evidence

Real-World Evidence

Submission	Device	Sponsor	RWD Sources	RWE Use Summary	Key Tags
K070049 · Feb 3, 2011	FRESENIUS 2008K @HOME WITH WIRELESS WETNESS DETECTOR	Fresenius Medical Care North America	Routine clinical hemodialysis treatment records (in-center and home settings)	The sponsor used retrospective clinical data from existing in-center and home hemodialysis treatments to demonstrate the safety and effectiveness of the 2008K@home system and to support the transition of patients from in-center to home hemodialysis.	Hemodialysis; Home therapy; Safety data; Treatment adequacy

Clinical Evidence

Study Design	Population	Comparator	Key Endpoints
Clinical evaluation of 2008K@home safety and adequacy; Retrospective evaluation of clinical treatment data	Patients undergoing in-center and home hemodialysis; Sample Size: >1000 treatments (500 in-center, 500 home); 29 subjects for transition evaluation	Not applicable for this study	Safety, treatment adequacy

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. 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.

Device Story

Hemodialysis machine for acute/chronic therapy in facilities or home. Modified version of 2008K 3stream system; features simplified user interface for home patients/caregivers. Includes optional wireless disposable 'WetAlert' detector; monitors for blood/water leaks during treatment. Detector transmits radio signals to machine; upon leak detection, machine automatically stops blood pump, closes venous clamp, and triggers alarm. Used by patients/caregivers in home or clinicians in facility. Output provides treatment control and safety monitoring; alerts facilitate immediate intervention to prevent blood loss or fluid leakage. Benefits include safer home hemodialysis and simplified operation.

Clinical Evidence

Clinical data included safety and efficacy evaluation from over 500 in-center and 500 home hemodialysis treatments. Additionally, a study of 29 subjects transitioning from in-center to home hemodialysis evaluated treatment adequacy and safety. Usability testing conducted in clinic and home settings confirmed safe and effective operation.

Technological Characteristics

Modified 2008K hemodialysis system. Features include updated user interface and wireless radio-frequency wetness detector accessory. System performs hemodialysis via standard dialysate delivery. Software includes validation and regression testing. Electrical safety and EMC testing performed.

Indications for Use

Indicated for acute and chronic dialysis therapy in facility or home settings. Requires observation by a trained and qualified person as prescribed by a physician. Wireless Wetness Detector indicated for blood and water leak detection during hemodialysis.

Regulatory Classification

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).

Special Controls

*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.”

Predicate Devices

• Fresenius 2008K Dialysate Delivery System (K994267)

Submission Summary (Full Text)

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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 Street<br>Waltham, MA 02451-1457 |
| Phone: | 781-699-9505 |
| Fax: | 781-699-9635 |
| Contact Person: | Randy Quinn, Lead Regulatory Affairs<br>Specialist - Devices |
| Date of Preparation: | December 1, 2010 |

### B. Device Name:

| Trade Name: | 2008K@home with Wireless Wetness<br>Detector |
|---------------------------------------|-------------------------------------------------------------------|
| Common Name: | Hemodialysis Machine |
| Product<br>Code/Classification Panel: | 78 KDI / Gastroenterology/Urology |
| Classification Name: | High Permeability Hemodialysis<br>System, Class II per § 876.5860 |

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KO 70049

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### 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.

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### 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 [phone] or [phone] 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:

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) |
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| (Division Sign-Off) | |
| Division of Reproductive, Gastro-Renal, and<br>Urological Devices | |
| 510(k) Number | K070049 |