2008T BlueStar Hemodialysis Machine

K173972 · Fresenius Medical Care Renal Therapies Group, LLC · KDI · May 10, 2018 · Gastroenterology, Urology

Device Facts

• Record ID: K173972
• Device Name: 2008T BlueStar Hemodialysis Machine
• Applicant: Fresenius Medical Care Renal Therapies Group, LLC
• Product Code: KDI · Gastroenterology, Urology
• Decision Date: May 10, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5860
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The 2008T BlueStar Hemodialysis Machine is indicated for acute and chronic dialysis therapy in a healthcare facility. Additional therapy options for patients receiving hemodialysis include: Isolated Ultrafiltration, Sustained Low Efficiency Dialysis (SLED), and low volume hemodialysis (patients weighing ≥ 20 kg and ≤40 kg). This machine accommodates the use of both low flux and high flux dialyzers. The SLED therapy option is not to be used for patients weighing ≤40 kg. The 2008 BlueStar Hemodialysis Machine is not to be used for plasma replacement therapies, for patients weighing less than 20 kg, or for renal therapies using substitution fluid.

Device Story

Electromechanical hemodialysis machine for healthcare facilities; controls/monitors dialysate and extracorporeal blood circuits. Pumps blood through dialyzer; semi-permeable membrane uses diffusion/ultrafiltration to remove toxins/excess water. Mixes dialysate concentrates with purified water; heats/degasses/delivers to dialyzer. Balancing chambers control fluid flow. Monitors venous/arterial pressures, air, and blood presence. Optional modules: bibag (bicarbonate), Crit-Line Clip Monitor (CLiC) (non-invasive hematocrit/oxygen saturation/blood volume), BTM, BVM. Clinician/nurse operates device under physician direction; uses real-time data to adjust fluid removal rates to prevent complications like nausea/cramping. Benefits patient by providing effective, controlled dialysis treatment.

Clinical Evidence

Bench testing only. Included biocompatibility (ISO 10993), electrical safety/EMC (IEC 60601-1-2:2014), software verification/validation (unit, integration, system level), mechanical functional verification, environmental/ship testing, and human factors testing. No clinical trial data presented.

Technological Characteristics

Electromechanical hemodialysis system. Materials: PAEK, PEI, PESU, PSU, PET, PUR, PP, PPO, PPS, PPSU, PTFE, PVDF, EPDM, Silicone, Stainless Steel, Tantalum, Tungsten, Borosilicate Glass. Energy: AC 117V. Connectivity: Patient Card/Reader. Software: Firmware-controlled fluid flow, mixing, heating, alarms. Sterilization: Heat/Chemical disinfection. Standards: IEC 60601-2-16, ANSI/AAMI 13959, 26722, RD62.

Indications for Use

Indicated for acute and chronic dialysis therapy in healthcare facilities. Supports Isolated Ultrafiltration, SLED, and low volume hemodialysis for patients 20-40 kg. Contraindicated for patients <20 kg, plasma replacement therapies, or renal therapies using substitution fluid. SLED contraindicated for patients ≤40 kg.

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

• 2008K2 Hemodialysis Machine (K153449)

Reference Devices

• 2008T Hemodialysis Machine (K150708)
• Diasafe®plus Filter (K070049)
• bibag® (K162716, K121341)
• CDX (K093902)
• CLiC (K121599, K131908)
• BTM (K941460, K080964)
• BVM (K982926, K994267)
• Single Needle System (K080964)
• Bloodlines (K962081, K000451, K001107, K022536, K070049, K120823)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 10, 2018

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

Re: K173972

> Trade/Device Name: 2008T BlueStar Hemodialysis Machine Regulation Number: 21 CFR& 876.5860 Regulation Name: High Permeability Hemodialysis System Regulatory Class: II Product Code: KDI Dated: April 6, 2018 Received: April 10, 2018

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); medical device 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.

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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Joyce M. Whang -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)

### K173972

Device Name 2008T BlueStar Hemodialysis Machine

Indications for Use (Describe) 2008T BlueStar Hemodialysis Machine:

The 2008T BlueStar Hemodialysis Machine is indicated for acute and chronic dialysis therapy in a healthcare facility.

Additional therapy options for patients receiving hemodialysis include: Isolated Ultrafiltration, Sustained Low Efficiency Dialysis (SLED), and low volume hemodialysis (patients weighing ≥ 20 kg and ≤40 kg). This machine accommodates the use of both low flux and high flux dialyzers. The SLED therapy option is not to be used for patients weighing ≤40 kg. The 2008 BlueStar Hemodialysis Machine is not to be used for plasma replacement therapies, for patients weighing less than 20 kg, or for renal therapies using substitution fluid.

### bibag System (Optional):

The bibag system is used with three stream proportioning Hemodialysis Machines equipped with the bibag module such as the 2008T BlueStar 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 BlueStar 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 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.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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Image /page/3/Picture/1 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, also in blue. The symbol is made up of three downward-pointing chevrons stacked on top of each other.

### ട. 510(K) SUMMARY

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<br>Waltham, MA 02451-1457 |
| Phone: | [phone] |
| Fax: | [phone] |
| Contact Person: | Denise Oppermann<br>Senior Director, Regulatory Affairs – Devices |
| Preparation Date: | 4 May 2018 |

### 5.2. Device Name

| Trade Name: | 2008T BlueStar Hemodialysis Machine |
|-----------------------|------------------------------------------------------------------------|
| Common Name: | Dialyzer, High Permeability With or Without<br>Sealed Dialysate System |
| Classification Name: | High Permeability Hemodialysis System |
| Regulatory Class: | Class II per 21 CFR §876.5860 |
| Product Code | KDI |
| Classification Panel: | Gastroenterology/Urology |

### Legally Marketed Predicate Device 5.3.

#### 5.3.1. Primary Predicate - 2008K2 Hemodialysis Machine (K153449)

The 2008K2 Hemodialysis Machine (K153449) is the primary predicate for the 2008T BlueStar Hemodialysis Machine.

#### 5.3.2. Reference Device – 2008T Hemodialysis Machine (K150708)

The 2008T Hemodialysis Machine (K150708) is the reference device for the 2008T BlueStar Hemodialysis Machine.

### Device Description 5.4.

#### 5.4.1. Device Identification

The BlueStar features will be implemented on both New Production Machines and 2008T Machines currently on the market (Table 1). New Production 2008T BlueStar Hemodialysis

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Image /page/4/Picture/1 description: The image contains the logo for Fresenius Medical Care. The logo consists of a blue geometric shape on the left, resembling a stylized downward-pointing arrow composed of three chevrons. To the right of the shape is the text "FRESENIUS" in bold, blue letters, with "MEDICAL CARE" in a smaller font size below it, also in bold, blue letters. The background is white.

(HD) Machines will be available in four (4) configurations. Clinics will be given the option to upgrade the 4 current 2008T Hemodialysis Machine configurations with the new BlueStar software and hardware via Upgrade Kits.

| Product<br>Code | Product Code Description | BlueStar<br>Features<br>Implementation |
|-----------------|----------------------------------------|----------------------------------------|
| 190713 | 2008T Hemodialysis System with CDX | |
| 190766 | 2008T Hemodialysis System with BIBAG | Field Upgrade |
| 190858 | 2008T Hemodialysis System w/o CDX | (Standard or<br>Premium) |
| 190895 | 2008T GEN2 BIBAG without CDX | |
| 191124 | 2008T HD SYS. CDX BLUESTAR | |
| 191126 | 2008T HD SYS. CDX W/BIBAG BLUESTAR | New Production |
| 191128 | 2008T HD SYS. W/O CDX BLUESTAR | |
| 191130 | 2008T HD SYS. W/O CDX W/BIBAG BLUESTAR | |

Table 1: BlueStar Hemodialysis Machines and Field Upgrade Machines

Both Standard and Premium Upgrade Kits will be offered to clinics to upgrade current 2008T Hemodialysis Machines to BlueStar software and hardware.

### 5.4.2. Device Characteristics

The 2008T BlueStar Hemodialysis Machine is an electromechanical device. Software controls the machine during hemodialysis treatment, including fluid flow, mixing, heating, and alarms.

### 5.4.3. Environment of Use

The 2008T BlueStar Hemodialysis Machine is to be used in healthcare facilities.

### 5.4.4. Brief Written Description of the Device

The 2008T BlueStar Hemodialysis Machine provides hemodialysis treatment by controlling and monitoring both the dialysate circuit and the extracorporeal blood circuit. The machine pumps blood from the patient's body through an extracorporeal circuit, one component of which is the dialyzer. The dialyzer contains a semi-permeable membrane that uses diffusion to transfer toxins and ultrafiltration to transport excess water from the blood into the dialysate circuit. In this separate 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. During hemodialysis, the extracorporeal blood circuit is monitored for venous and arterial blood pressures as well as for the presence of air and blood. The 2008T BlueStar Hemodialysis Machine accommodates the following accessory devices and options:

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Image /page/5/Picture/1 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, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.

### Accessories

- Diasafe®plus Filter (K070049) ●
- Patient Card (subject to review in this 510(k)) ●
- Patient Card Reader (subject to review in this 510(k)) ●
- Bloodlines: 6.35mm and 8mm (K962081. K000451. K001107. K022536. K070049 . and K120823)
- Dialyzers: Any commercially-available dialyzer equipped with ISO 8637 Standard dialysis connectors

## Options

- bibag® – K162716 (stand-alone disposable) and K121341 (bibag disposable cleared with 2008T HD Machine)
- CDX (Clinical Data Exchange) K093902 (CDX cleared with 2008T HD Machine) ●
- CLiC (Crit-Line in a Clip Monitor) K121599 (Stand-alone CLiC) and K131908 ● (CLiC with 2008T HD Machine)
- BTM (Blood Temperature Monitor) K941460 (Stand-alone BTM) and K080964 ● (BTM with 2008T HD Machine)
- BVM (Blood Volume Monitor) – K982926 (Stand-alone BVM) and K994267 (BVM with 2008K HD Machine)
- Single Needle System K080964 (Single Needle with 2008T HD Machine) .

#### 5.4.5. Materials of Use

The 2008T BlueStar Hemodialysis Machine's hydraulic system is composed of the following indirect, prolonged contact, externally communicating materials:

- Plastic/Rubber:
- PAEK (Polyaryletherketone) —
- PEI (Polyetherimide) —
- PESU (Polyethersulfone) -
- PSU (Polysulfone) -
- PET (Polyethylene terephthalate) —
- PUR (Polyurethane) -
- -PET (Polyethylene terephthalate)
- PP (Polypropylene) -
- PPO (Polyphenylene oxide) —

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Image /page/6/Picture/1 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.

- PPS (Polyphenylene Sulfide) -
- -PPSU (Polyphenylsulfone)
- PTFE (Polytetrafluoroethylene) -
- PVDF (Polyvinylidene fluoride) -
- EPDM (Ethylene Propylene Diene Monomer Rubber) —
- -Silicone
- Metals ●
- Stainless Steel -
- Tantalum Tungsten -
- -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. Modifications have been made to components of the hydraulic system. Biocompatibility testing was conducted to verify the changes.

#### Essential Performance Characteristics 5.4.6.

The essential performance characteristics of the 2008T BlueStar Hemodialysis Machine are listed in Table 2. A comparison of its essential performance characteristics with those of the 2008K2 Hemodialysis Machine (K153449) and 2008T Hemodialysis Machine (K150708) is provided in Section 12.

| Feature | Specification | |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|-----------------|
| Blood Flow Rates | Blood line | Blood flow rate |
| | 8 mm | 20–600 mL/min* |
| | 6.35 (displayed as 6.4) mm | 20–465 mL/min |
| | 4.8 mm | 10–274 mL/min |
| | 2.6 mm | 6–86 mL/min |
| | *Not available with the Low Volume feature enabled<br>Accuracy: ± 10% tested at -200 mmHg | |
| Dialysate Flow Rates | Dialysate flow rates are selectable on the Home screen in the<br>following mL/min increments:<br>(0)/100 ‡/150‡/200‡/300†/400/500/600/700/800 | |

### Table 2 2008T BlueStar Hemodialysis Machine Essential Performance Characteristics

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Image /page/7/Picture/1 description: The image contains the Fresenius Medical Care logo. The logo consists of a blue emblem on the left and the text "FRESENIUS MEDICAL CARE" on the right. The emblem is a stylized design with 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.

## 2008T BlueStar Hemodialysis Machine Traditional 510(k)

| Feature | Specification | | | | | | | | | | | | | | | | | | | | | | | | |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|
| | † Sustained Low Efficiency Dialysis (SLED) | | | | | | | | | | | | | | | | | | | | | | | | |
| | ‡ Flow rate requires that the Allow Slow Flow option be<br>selected in Service mode. | | | | | | | | | | | | | | | | | | | | | | | | |
| | The dialysate flow rates (Qd) for both 1.5x or 2.0x dialysate<br>flow (Auto Flow), based on the Blood Pump rate (Qb). | | | | | | | | | | | | | | | | | | | | | | | | |
| | Qb w/1.5x Qd Qb w/2.0x Qd Qd 0 – 165* 0 – 150* 300 166 – 215* 151 – 215* 400 216 – 315* 216 – 265* 500 315 and below** 265 and below** 500 316 – 415 266 – 315 600 416 – 480 316 – 365 700 481 and above 366 and above 800 | | | | | | | | | | | | | | | | | | | | | | | | |
| | Note: All flow rates are approximate. Dialysate flow will not<br>adjust unless the blood pump is adjusted at least 15–<br>20 mL/min.<br>* If Auto Flow Minimum of 300 Qd is set in Service mode<br>** If Auto Flow Minimum of 500 Qd is set in Service mode | | | | | | | | | | | | | | | | | | | | | | | | |
| Net Fluid Removal | 0–4000 mL/hr | | | | | | | | | | | | | | | | | | | | | | | | |
| | Dialysate flow rate Accuracy (on total vol. removed) 100 mL/min ± (1% UF rate + 18 mL/hr) 500 mL/min ± (1% UF rate + 30 mL/hr) 800 mL/min ± (1% UF rate + 48 mL/hr) | | | | | | | | | | | | | | | | | | | | | | | | |
| Dialysis Time | Dialysis type Time Dialysis 0-9:59 hours* SLED Fixed at 12 hours | | | | | | | | | | | | | | | | | | | | | | | | |
| | *Time can be adjusted manually<br>Accuracy: ± 1 second per hour | | | | | | | | | | | | | | | | | | | | | | | | |
| Dialysis Fluid Composition | Volumetric, selectable:<br>Acid adjustment range: 130–155 mEq/L Na+<br>Bicarbonate adjustment range: 20-40 mEq/L Bicarbonate<br>(post-reaction, after mixing with the acid and purified water), | | | | | | | | | | | | | | | | | | | | | | | | |

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Image /page/8/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, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.

| Feature | Specification |
|--------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Monitoring conductivity average accuracy: ± 1.5% | |
| Dialysis Fluid Temperature | Range 35°C–39°C with alarm limit window automatically<br>adjusted to 2°C above and below set point. Alarm window will<br>not adjust to below 34°C (or 30°C during BTM recirculation<br>measurement) or above 41 °C. |
| Accuracy: ± 0.3°C | |
| Heparin Delivery Rate | 0 – 9.9 mL/hr |
| Accuracy: ± 5% | |

### ર.ડ. Intended Use

The intended use of the 2008T BlueStar Hemodialysis Machine is identical to the primary and reference devices' intended use.

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

### 5.6. Indications for Use

2008T BlueStar Hemodialysis Machine: The 2008T BlueStar Hemodialysis Machine is indicated for acute and chronic dialysis therapy in a healthcare facility.

Additional therapy options for patients receiving hemodialysis include: Isolated Ultrafiltration, Sustained Low Efficiency Dialysis (SLED), and low volume hemodialysis (patients weighing ≥20 kg and ≤40 kg). This machine accommodates the use of both low flux and high flux dialyzers. The SLED therapy option is not to be used for patients weighing ≤40 kg. The 2008T BlueStar Hemodialysis Machine is not to be used for plasma replacement therapies, for patients weighing less than 20 kg, or for renal therapies using substitution fluid.

## bibag System (Optional):

The bibag system is used with three stream proportioning Hemodialysis Machines equipped with the bibag module such as the 2008T BlueStar 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 BlueStar 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

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Image /page/9/Picture/1 description: The image contains the logo for Fresenius Medical Care. On the left side of the logo is a blue symbol that consists of three downward-pointing chevrons stacked on top of each other. To the right of the symbol, the words "FRESENIUS" and "MEDICAL CARE" are written in blue, with "FRESENIUS" on top of "MEDICAL CARE."

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

A comparison of the technological characteristics of the 2008T BlueStar Hemodialysis Machine with the 2008K2 Hemodialysis Machine (primary predicate) and the 2008T Hemodialysis Machine (reference device) is provided in Table 3.

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Image /page/10/Picture/1 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, also in blue. The symbol is made up of three chevron-like shapes stacked on top of each other, pointing downwards.

| Parameter | Modified Device – 2008T<br>BlueStar Hemodialysis<br>Machine | Primary Predicate Device –<br>2008K2 Hemodialysis<br>Machine (K153449) | Reference Device<br>– 2008T Hemodialysis<br>Machine (K150708) | Equivalence Discussion |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|
| Intended Use | The device is intended for<br>acute and chronic dialysis<br>therapy. | The device is intended for<br>acute and chronic dialysis<br>therapy. | The device is intended for<br>acute and chronic dialysis<br>therapy. | Same |
| Indications for Use | 2008T BlueStar Hemodialysis<br>Machine: The 2008T BlueStar<br>Hemodialysis Machine is<br>indicated for acute and<br>chronic dialysis therapy in a<br>healthcare facility. | The 2008K2 Hemodialysis<br>Machine is indicated for acute<br>and chronic hemodialysis<br>therapy in a healthcare<br>facility. | N/A. Substantial Equivalence<br>discussion is limited to the<br>modified and primary<br>predicate devices. | Same |
| | Additional therapy options<br>for patients receiving<br>hemodialysis include:<br>Isolated Ultrafiltration,<br>Sustained Low Efficiency<br>Dialysis (SLED), and low<br>volume hemodialysis<br>(patientsweighing≥ 20 kg<br>and≤ 40 kg). This machine<br>accommodates the use of both<br>low flux and high flux<br>dialyzers. The SLED therapy<br>option is not to be used for<br>patients weighing ≤ 40 kg.<br>The 2008T BlueStar<br>Hemodialysis Machine is not<br>to be used for plasma<br>replacement therapies, for<br>patients weighing less than<br>20 kg, or for renal therapies<br>using substitution fluid | Additional therapy options<br>for patients receiving<br>hemodialysis include:<br>Isolated Ultrafiltration,<br>Sustained Low Efficiency<br>Dialysis (SLED), and low<br>volume hemodialysis<br>(patients weighing ≥ 20 kg<br>and ≤ 40 kg). This machine<br>accommodates the use of both<br>low flux and high flux<br>dialyzers. The SLED therapy<br>option is not to be used for<br>patients weighing ≤ 40 kg.<br>The 2008K2 Hemodialysis<br>Machine is not to be used for<br>plasma replacement therapies,<br>for patients weighing less<br>than 20 kg, or for renal<br>therapies using substitution fluid | | Same |
| Parameter | Modified Device – 2008T<br>BlueStar Hemodialysis<br>Machine | Primary Predicate Device –<br>2008K2 Hemodialysis<br>Machine (K153449) | Reference Device<br>– 2008T Hemodialysis<br>Machine (K150708) | Equivalence Discussion |
| bibag System (Optional):<br>The bibag system is used with<br>three stream proportioning<br>Hemodialysis Machines<br>equipped with the bibag<br>module such as the 2008T<br>BlueStar Hemodialysis<br>Machine and is intended for<br>use in bicarbonate<br>hemodialysis for acute and<br>chronic renal failure. The<br>bibag is intended for<br>extracorporeal bicarbonate<br>hemodialysis according to a<br>physician's prescription. | Bibag functionality is not<br>available on the 2008K2<br>Hemodialysis Machine. | | Substantially Equivalent<br>The Indications for Use<br>language for the optional<br>bibag system was<br>leveraged from the<br>currently marketed<br>(unmodified) 2008T<br>Hemodialysis Machine.<br>There were no<br>modifications made to<br>the optional bibag<br>system with the 2008T<br>BlueStar Hemodialysis<br>Machine. | |
| Crit-Line Clip Monitor<br>(CLiC) (Optional):<br>The Crit-Line Clip Monitor is<br>used with the 2008T BlueStar<br>Hemodialysis Machine to<br>non-invasively measure<br>hematocrit, oxygen saturation<br>and percent change in blood<br>volume. The CLiC device<br>measures hematocrit, percent<br>change in blood volume and<br>oxygen saturation in real time<br>for application in the<br>treatment of dialysis patients<br>with the intended purpose of<br>providing a more effective<br>treatment for both the dialysis | Crit-Line Clip Monitor<br>(CLiC) functionality is not<br>available on the 2008K2<br>Hemodialysis Machine. | | Substantially Equivalent<br>The Indications for Use<br>language for the optional<br>CLiC functionality was<br>leveraged from the<br>currently marketed<br>(unmodified) 2008T<br>Hemodialysis Machine.<br>There were no<br>modifications made to<br>the optional (CLiC)<br>functionality with the<br>2008T BlueStar<br>Hemodialysis Machine. | |
| MEDICAL CARE | | | | |
| Parameter | Modified Device – 2008T<br>BlueStar Hemodialysis<br>Machine | Primary Predicate Device –<br>2008K2 Hemodialysis<br>Machine (K153449) | Reference Device<br>– 2008T Hemodialysis<br>Machine (K150708) | Equivalence Discussion |
| | patient and the clinician.<br>Based on the data that the<br>monitor provides, the<br>clinician/nurse, under<br>physician direction,<br>intervenes (i.e., increases or<br>decreases the rate at which<br>fluid is removed from the<br>blood) in order to remove the<br>maximum amount of fluid<br>from the dialysis patient<br>without the patient<br>experiencing the common<br>complications of dialysis<br>which include nausea,<br>cramping and vomiting. | | | |
| Dimensions | | N/A. Substantial Equivalence<br>discussion is limited to the<br>modified and reference<br>devices. | | |
| Floor Space | Approximately 54 cm wide<br>by 63 cm deep | | Approximately 54 cm wide<br>by 63 cm deep | Same as the reference<br>(unmodified) 2008T |
| Height | 149 cm | | 149 cm | device. |
| Operating<br>Temperature and<br>Humidity | $60°F – 100°F (15.5°C –38°C)$<br>Relative Humidity 10% to<br>90%, non-condensing | $60°F - 100°F (15.5°C –38°C)$<br>Relative Humidity 10% to<br>90%, non-condensing | | |
| Electrical | | | | |
| Power Supply – Main | Single phase AC 117 V ±<br>10% 60 Hz ± 3 Hz; must be<br>connected to a circuit which<br>is equipped with a hospital<br>grade receptacle and is<br>protected by circuit breaker<br>and ground fault interrupter<br>(GFI). | Single phase AC 117 V ±<br>10% 60 Hz ± 3 Hz; must be<br>connected to a circuit which<br>is equipped with a hospital<br>grade receptacle and is<br>protected by circuit breaker<br>and ground fault interrupter<br>(GFI). | Single phase AC 117 V ±<br>10% 60 Hz ± 3 Hz; must be<br>connected to a circuit which<br>is equipped with a hospital<br>grade receptacle and is<br>protected by circuit breaker<br>and ground fault interrupter<br>(GFI). | Same |
| MEDICAL CARE | | Traditional 510(k) | | |
| Parameter | Modified Device – 2008T<br>BlueStar Hemodialysis<br>Machine | Primary Predicate Device –<br>2008K2 Hemodialysis<br>Machine (K153449) | Reference Device<br>– 2008T Hemodialysis<br>Machine (K150708) | Equivalence Discussion |
| | chassis to ground must be<br>< 0.2 ohm. | chassis to ground must be<br>< 0.2 ohm. | chassis to ground must be<br>< 0.2 ohm. | |
| Power Consumption | Does not exceed 12.6 amps | Does not exceed 12.5 amps | Does not exceed 12.5 amps | Substantially Equivalent |
| Protection Against<br>Electric Shock | Type: Safety class I Degree:<br>Type B<br>Type CF: Only BPM Blood<br>Pressure Cuff | Type: Safety class I Degree:<br>Type B<br>Type CF: Only BPM Blood<br>Pressure Cuff | Type: Safety class I Degree:<br>Type B<br>Type CF: Only BPM Blood<br>Pressure Cuff | Same |
| Materials | | | | |
| Patient-Contacting<br>Materials | All direct and indirect patient-<br>contacting materials have<br>been evaluated for<br>Biocompatibility | All direct and indirect patient-<br>contacting materials have<br>been evaluated for<br>Biocompatibility | All direct and indirect patient-<br>contacting materials have<br>been evaluated for<br>Biocompatibility | Same |
| Water | |…