2008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, 2008T Hemodialysis Machine

K150708 · Fresenius Medical Care Renal Therapies Group, LLC · KDI · Dec 10, 2015 · Gastroenterology, Urology

Device Facts

• Record ID: K150708
• Device Name: 2008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, 2008T Hemodialysis Machine
• Applicant: Fresenius Medical Care Renal Therapies Group, LLC
• Product Code: KDI · Gastroenterology, Urology
• Decision Date: Dec 10, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The 2008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, and the 2008T Hemodialysis Machine are intended to be used for acute and chronic dialysis therapy.

Device Story

Hemodialysis machines pump blood through extracorporeal circuit with semipermeable membrane; performs diffusion to remove toxins and ultrafiltration to remove excess water. System mixes dialysate concentrates with purified water, heats, degasses, and delivers to dialyzer. Balancing chambers regulate fluid flow. Monitored parameters include venous/arterial blood pressures, air, and blood presence. Used in hospitals or home settings (2008K@home) by clinicians, nurses, or trained/qualified observers. Optional accessories include bibag (bicarbonate delivery), Wireless Wetness Detector (leak detection), and Crit-Line Clip Monitor (CLiC). CLiC provides real-time hematocrit, oxygen saturation, and blood volume data; clinician uses output to adjust fluid removal rates, mitigating complications like nausea, cramping, and vomiting. Benefits include effective toxin/fluid removal and improved patient comfort during treatment.

Clinical Evidence

Bench testing only. No clinical data provided. Verification included electronic functional testing (dialysate air detection), mechanical testing (functional, reliability, regression), and software verification/validation (unit, integration, and system-level testing including simulated dialysis treatment).

Technological Characteristics

Medical electrical system. Materials: PAEK, PEI, PESU, PSU, PET, PUR, PP, PPO, PPS, PPSU, PTFE, PVDF, EPDM, silicone, stainless steel, titanium, tantalum, tungsten, borosilicate glass. Hydraulic system with dialysate circuit. Software-controlled fluid flow, mixing, heating, and alarms. Connectivity: Standalone/networked. Sterilization: Not specified.

Indications for Use

Indicated for acute and chronic dialysis therapy in patients with renal failure. 2008K@home version indicated for home use under observation by a trained/qualified person as prescribed by a physician. Optional bibag system indicated for bicarbonate hemodialysis. Optional Wireless Wetness Detector indicated for blood/water leak detection. Optional Crit-Line Clip Monitor indicated for real-time non-invasive measurement of hematocrit, oxygen saturation, and blood volume change to assist clinicians in fluid removal management.

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

• 2008K Hemodialysis Machine (K994267)
• 2008K@home Hemodialysis Machine (K124035)
• 2008T Hemodialysis Machine (K131908)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. 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 Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 10, 2015

Fresenius Medical Care Renal Therapies Group, LLC Denise Oppermann Senior Director 920 Winter Street Waltham, MA 02451

Re: K150708

> Trade/Device Name: 2008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, and 2008T Hemodialysis Machine Regulation Number: 21 CFR§ 876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: KDI. ONW Dated: October 29, 2015 Received: October 30, 2015

Dear Denise 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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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 and Part 809); 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 and Part 809), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Herbert P. Lerner -S

for 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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# Indications for Use

### 510(k) Number (if known) K150708

### Device Name

2008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, and the 2008T Hemodialysis Machine

# Indications for Use (Describe)

## 2008K Hemodialysis Machines:

The 2008K Hemodialysis Machine is indicated for acute and chronic dialysis therapy.

### 2008K@home Hemodialysis Machine:

The 2008K@home Hemodialysis Machine is indicated for acute and chronic dialysis therapy in an acute or chronic facility. The 2008K@home Hemodialysis Machine is also indicated for hemodialysis in the home and must be observed by a trained and qualified person as prescribed by their physician.

### bibag System (Optional):

The bibag System is used with three stream proportioning Hemodialysis Machines equipped with the bibag module such as the 2008K@home Hemodialysis Machine and is indicated for use in bicarbonate hemodialysis for acute and chronic renal failure. The bibag System is intended for extracorporeal bicarbonate hemodialysis according to a physician's prescription.

### Wireless Wetness Detector (Wet Alert):

The Wireless Wetness Detector is indicated for use with the 2008K@home Hemodialysis Machine and is an optional accessory to aid in the detection of blood and water leaks during hemodialysis using the detector must be observed by a trained and qualified person as prescribed by their physician.

2008T Hemodialysis Machine:

The 2008T Hemodialysis Machine is indicated for acute and chronic dialysis therapy.

### bibag System (Optional):

The bibag system is used with three stream proportioning Hemodialysis Machines equipped with the bibag module such as the 2008T Hemodialysis Machine and is intended for use in bicarbonate hemodialysis for acute and chronic renal failure. The bibag is intended for extracorporeal bicarbonate hemodialysis according to a physician's prescription.

### Crit-Line Clip Monitor (CLiC) (Optional):

The Crit-Line Clip Monitor is used with the 2008T Hemodialysis Machine to non-invasively measure hematocrit, oxygen saturation and percent change in blood volume. The CLiC device measures hematocrit, percent change in blood volume and oxygen saturation in real time for application in the treatment of dialysis patients with the intended purpose of providing a more effective treatment for both the dialysis patient and the clinician. Based on the data that the monitor provides, the clinician/nurse, under physician direction, intervenes (i.e., increases or decreases the rate at which fluid is removed from the blood) in order to remove the maximum amount of fluid from the dialysis patient experiencing the common complications of dialysis which include nausea, cramping and vomiting

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/4/Picture/0 description: The image contains the logo for Fresenius Medical Care. On the left side of the logo, there are three blue chevron shapes stacked on top of each other, pointing downwards. To the right of the chevrons, the text "FRESENIUS MEDICAL CARE" is written in blue, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.

### 510(K) SUMMARY 5.

This 510(k) Summary is in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990. The content of this 510(k) summary is provided in conformance with 21 CFR § 807.92.

### 5.1. Submitter's Information

| Name: | Fresenius Medical Care Renal Therapies Group, LLC |
|-------------------|---------------------------------------------------|
| Address: | 920 Winter Street |
| | Waltham, MA |
| | 02451-1457 |
| Phone: | [phone] |
| Fax: | [phone] |
| Contact Person: | Denise Oppermann, Senior Director |
| | Regulatory Affairs – Devices |
| Preparation Date: | March 5, 2015 |

### 5.2. Device Name

| Trade Name: | 2008K Hemodialysis Machine,<br>2008K@home Hemodialysis Machine,<br>and the 2008T Hemodialysis Machine |
|----------------------------------------|-------------------------------------------------------------------------------------------------------|
| Common Name: | Accessories, blood circuit, hemodialysi |
| Classification Name : | Hemodialysis system and accessories,<br>Hemodialysis System for Home Use |
| Regulatory Class: | Class II per 21 CFR § |
| Product Code/<br>Classification Panel: | KDI/Gastroenterology-Urology,<br>ONW/Gastroenterology —Urology |

### 5.3. Legally Marketed Predicate Device

| 2008K Hemodialysis Machine | K994267 |
|----------------------------------|---------|
| 2008K @home Hemodialysis Machine | K124035 |
| 2008T Hemodialysis Machine | K131908 |

### Device Description 5.4.

This section includes an explanation of how the devices function, the concepts that form the basis for the devices, and the significant physical and performance characteristics of the devices, such as device design, material used, and physical properties.

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#### 5.4.1. Device Identification:

The 2008K Hemodialysis Machine, the 2008K@home Hemodialysis Machine, and the 2008T Hemodialysis Machine are the subject of this submission. These machines are variations of the same basic mechanisms and design concepts, having different user interfaces and/or mechanical sub-systems. The disposable devices used with these systems are not the subject of this submission.

#### 5.4.2. Device Characteristics

The machines described in this submission are medical electrical systems. Software controls the functions of the machines, including fluid flow, mixing, heating, and alarms.

#### 5.4.3. Environment of Use

All 2008 Series Hemodialysis Machines are designed to be used in healthcare facilities, including hospitals. The 2008K@Home Hemodialysis Machine is also intended to be used in the home environment. During home use, a trained and qualified person must observe patient treatment as prescribed by a physician.

### 5.4.4. Brief Written Description of the Device

Hemodialysis machines are used for performing dialysis therapy. The machines pump blood from the patient's body through an extracorporeal circuit which contains a semipermeable membrane. This acts as an artificial kidney to transport toxins (diffusion) and excess water (ultrafiltration) from the blood into a separate fluid (dialysate) circuit. During this process, the extracorporeal blood circuit is monitored for venous and arterial blood pressures, and for the presence of air and blood. In the dialysate circuit, the dialysate concentrates are mixed with purified water, heated, degassed, and delivered to the dialyzer. Balancing chambers control the incoming flow and outgoing flow of the dialysate fluid during ultrafiltration.

#### 5.4.5. Materials of Use

The machines' hydraulic systems are composed of the following indirect, prolonged contact, externally communicating materials:

## Plastic/Rubber:

- PAEK (Polyaryletherketone) PEI (Polyetherimide) PESU (Polyethersulfone) PSU (Polysulfone) PET (Polvethylene terephthalate) PUR (Polyurethane) PET (Polyethylene terephthalate) PP (Polypropylene) PPO (Polyphenylene oxide)

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Image /page/6/Picture/0 description: The image shows the Fresenius Medical Care logo. The logo consists of a blue symbol on the left and the text "FRESENIUS MEDICAL CARE" on the right. The symbol is made up of three downward-pointing chevrons of decreasing size. The text is in a bold, sans-serif font, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.

PPS (Polyphenylene Sulfide) PPSU (Polyphenylsulfone) PTFE (Polytetrafluoroethylene) PVDF (Polyvinylidene fluoride)

EPDM (Ethylene Propylene Diene Monomer Rubber) Silicone

# Metals:

Stainless Steel Titanium Tantalum Tungsten

# Glass:

Borosilicate Glass

The hydraulic lines of the machines are in contact with the dialysate circuit. The dialysate circuit has prolonged, indirect blood contact.

### 5.4.6. Key Performance Specifications/Characteristic

The key performance specification of the 2008K Hemodialysis Machine, the 2008K @home Hemodialysis Machine, and the 2008T Hemodialysis Machine remain identical to the predicate devices.

The following non-clinical testing was conducted to verify the modifications do not affect the key performance specifications of the machines:

Hardware Testing

- Electronic Functional Testing
- Circuit Testing ।
- Mechanical Testing
- Mechanical Functional Testing —
- Mechanical Reliability Testing -
- Mechanical Regression Testing —

Software Verification and Validation

- Software Unit and Integration Testing ●
- . Software Functional Verification and Validation Tests (including Simulated Dialysis Treatment Testing)

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Image /page/7/Picture/0 description: The image shows the logo for Fresenius Medical Care. On the left is a blue symbol that looks like three downward-pointing chevrons stacked on top of each other. To the right of the symbol is the text "FRESENIUS MEDICAL CARE" in blue, with "FRESENIUS" on top of "MEDICAL CARE".

### 5.5. Intended Use

The 2008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, and the 2008T Hemodialysis Machine are intended to be used for acute and chronic dialysis therapy.

### Indications for Use 5.6.

The following indication for use statements for each of the Hemodialysis Machines are provided for reference.

### 5.6.1. 2008K Hemodialysis Machine:

The 2008K Hemodialysis Machine is indicated for acute and chronic dialysis therapy.

### 2008K@home Hemodialysis Machine: 5.6.2.

The 2008K @home Hemodialysis Machine is indicated for acute and chronic dialysis therapy in an acute or chronic facility. The 2008K @home Hemodialysis Machine is also indicated for hemodialysis in the home and must be observed by a trained and qualified person as prescribed by their physician.

## bibag System (Optional):

The bibag System is used with three stream proportioning Hemodialysis Machines equipped with the bibag module such as the 2008K@home Hemodialysis Machine and is indicated for use in bicarbonate hemodialysis for acute and chronic renal failure. The bibag System is intended for extracorporeal bicarbonate hemodialysis according to a physician's prescription.

# Wireless Wetness Detector (Wet Alert):

The Wireless Wetness Detector is indicated for use with the 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.

### 2008T Hemodialysis Machine: 5.6.3.

The 2008T Hemodialysis Machine is indicated for acute and chronic dialysis therapy.

## bibag System (Optional):

The bibag system is used with three stream proportioning Hemodialysis Machines equipped with the bibag module such as the 2008T Hemodialysis Machine and is intended for use in bicarbonate hemodialysis for acute and chronic renal failure. The bibag is intended for extracorporeal bicarbonate hemodialysis according to a physician's prescription.

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Image /page/8/Picture/0 description: The image shows the logo for Fresenius Medical Care. The logo consists of a blue symbol on the left and the text "FRESENIUS MEDICAL CARE" on the right. The symbol is made up of three downward-pointing chevrons stacked on top of each other. The text is in a bold, sans-serif font, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.

# Crit-Line Clip Monitor (CLiC) (Optional):

The Crit-Line Clip Monitor is used with the 2008T Hemodialysis Machine to noninvasively measure hematocrit, oxygen saturation and percent change in blood volume. The CLiC device measures hematocrit, percent change in blood volume and oxygen saturation in real time for application in the treatment of dialysis patients with the intended purpose of providing a more effective treatment for both the dialysis patient and the clinician. Based on the data that the monitor provides, the clinician/nurse, under physician direction, intervenes (i.e., increases or decreases the rate at which fluid is removed from the blood) in order to remove the maximum amount of fluid from the dialysis patient without the patient experiencing the common complications of dialysis which include nausea, cramping and vomiting

### 5.7. Comparison of Technological Characteristics with the Predicate Device

The following technical specifications of the modified devices remain the same as the predicate device:

- Safety system System performance Environmental Requirements Accessories Accuracy and Controls Protection against Mechanical Hazard Protection against Electrical Hazard Protection against excessive temperature or other hazards Transportation and Storage specifications
### 5.8. Performance Data

The performance of the modified devices described in this submission was evaluated according to existing FMC-RTG procedures, protocols, declared performance standards, and guidelines of the quality system regulation (21 CFR Part 820). Design verification tests confirmed that all design updates were effective and did not affect the essential performance of the devices and that the devices function as intended.

### 5.8.1. Hardware - Electronic Functionality Testing

Functional verification evaluations of the electronic circuit consisted of demonstrating effectiveness of the dialysate air detection circuit.

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Image /page/9/Picture/0 description: The image shows the Fresenius Medical Care logo. The logo consists of a blue symbol on the left and the text "FRESENIUS MEDICAL CARE" on the right. The symbol is made up of three downward-pointing chevrons stacked on top of each other. The text is in a bold, sans-serif font and is also blue.

#### 5.8.2. Hardware-Mechanical Testing

The mechanical evaluations consisted of:

- Functional verification testing to demonstrate effectiveness of the hydraulic system.
- System reliability testing to demonstrate appropriate repeated function.
- Regression verification testing to demonstrate (system) functional performance of the machines.

#### 5.8.3. Software Verification and Validation Testing

Software evaluations consisted of:

- Unit level testing to demonstrate unit level software performance met software ● design specifications
- . Integration testing to demonstrate the unit level software interacted as specified in software design specifications
- . System level software verification testing to demonstrate the effectiveness of the software modifications and confirm operation of the machines

### 5.9. Conclusions

Test results demonstrated that the modified 2008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, and 2008T Hemodialysis Machine function as intended and met the acceptance criteria. Results of performance testing do not raise any new concerns with regard to safety or effectiveness.