(132 days)
No
The summary describes an electromechanical device controlled by software for fluid flow, mixing, heating, and alarms. It monitors pressures and the presence of air and blood. There is no mention of AI or ML in the device description, intended use, or performance studies. The Crit-Line Clip Monitor provides data for clinician intervention, not automated decision-making based on AI/ML.
Yes
The device is a hemodialysis machine, which is a medical device used to treat patients with acute and chronic renal failure by removing waste products and excess fluid from their blood, thereby providing therapy.
No
The 2008T BlueStar Hemodialysis Machine is a therapeutic device used for dialysis treatment, not for diagnosing medical conditions. While it can be paired with an optional diagnostic component (Crit-Line Clip Monitor), the primary device itself is for treatment.
No
The device description explicitly states that the 2008T BlueStar Hemodialysis Machine is an "electromechanical device" and describes various hardware components and circuits involved in the hemodialysis process. While software controls the machine, it is an integral part of a physical system, not a standalone software product.
Based on the provided information, the 2008T BlueStar Hemodialysis Machine itself is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Definition of IVD: An IVD device is a medical device intended for use in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to monitor therapeutic measures.
- Function of the 2008T BlueStar Hemodialysis Machine: The description clearly states that the machine is an electromechanical device that performs hemodialysis treatment. This involves pumping blood from the patient, mixing dialysate, and using a dialyzer to remove toxins and excess water. This is a direct treatment of the patient's blood outside the body, but it's a therapeutic process, not an examination of a specimen for diagnostic information.
- Optional Components: While the optional Crit-Line Clip Monitor (CLiC) does measure parameters (hematocrit, oxygen saturation, percent change in blood volume) from the blood, its stated purpose is to provide information to the clinician to guide the dialysis treatment and improve its effectiveness. It's used to monitor the patient's response to the therapy, not to diagnose a condition or provide information about a physiological or pathological state in the traditional sense of an IVD. The bibag system is also a component used in the preparation of the dialysate, not for examining a specimen.
In summary, the core function of the 2008T BlueStar Hemodialysis Machine is a therapeutic intervention (hemodialysis), not an in vitro diagnostic examination of a specimen.
N/A
Intended Use / Indications for 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
KDI
Device Description
The 2008T BlueStar Hemodialysis Machine is an electromechanical device. Software controls the machine during hemodialysis treatment, including fluid flow, mixing, heating, and alarms.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
patients weighing ≥ 20 kg and ≤40 kg
patients weighing less than 20 kg
Intended User / Care Setting
clinician nurse, healthcare facility
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The performance of the modified device described in this submission was evaluated according to existing FMCRTG procedures, protocols, declared performance standards, and guidelines of the quality system regulation (21 CFR §820). Design verification tests confirmed that all design updates were effective, did not affect the essential performance of the device, and that the device functions as intended.
Biocompatibility Testing: The 2008T BlueStar Hemodialysis Machine's hydraulic components were evaluated to ISO 10993 requirements. The Unit Under Test (UUT) included the new hardware components (acid, bicarbonate and UF pumps, extended concentrate lines and ratio valves). The following testing was performed to support the biological safety of the 2008T BlueStar HD Machine's hydraulics:
- Chemical analysis Simulated-Use Leachable Extraction
- Cytotoxicity
- Sensitization
- Irritation
- Material Mediated Pyrogenicity
- Hemocompatibility (Indirect Contact)
- Subchronic toxicity
- Risk assessment of potential toxicity
Electrical Safety and Electromagnetic Compatibility (EMC): The 2008T BlueStar Hemodialysis Machine was evaluated for electromagnetic compatibility (EMC) in accordance with IEC 60601-1-2:2014. Additional electrical testing was conducted to verify new BlueStar hardware.
Software Verification and Validation Testing: Unit, integration, and system level software verification testing was performed to demonstrate the effectiveness of the software modifications and to confirm operation of the machine. The following system level testing was performed:
- Functional and performance verification testing conducted to ensure operational efficacy of software with the upgraded hardware
- Regression testing - conducted on dialysis treatment and key safety measures to ensure the essential performance and safe operation of the system were not adversely impacted
Code reviews were performed for all changes to the code. To ensure that the inputs were met and good coding practices were followed, the code reviews analyzed the following source documents: - Design inputs
- Software Design Specification (SDS)
- "diff files"
Mechanical Testing: Functional verification of mechanical components was conducted to verify the following changes:
- New paint
- Tubing organizer
- Patient Card housing
- Keyboard
- Monitor EMI ground assembly
- Hook for extended lines
- Ratio valves
- UF pumps, acid and bicarbonate pumps
Environmental and Ship Testing: Environmental testing was performed to verify that the machine performs normally (i.e., no nonresettable alarms or unusual behavior) in the temperature- and humidity-controlled operating environment. Ship testing was performed to verify that the machine can withstand hazards associated with the typical shipping and distribution environment. A series of reliability tests were conducted to show that the product met shipping requirements.
Human Factors Testing: Human Factors testing was performed on device modifications found to impact usability. FMCRTG concludes that the new features are safe and effective for the intended users, uses, and use environments.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.”
0
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.
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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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 |
| Waltham, MA 02451-1457 | |
| Phone: | (781) 699-4479 |
| Fax: | (781) 699-9635 |
| Contact Person: | Denise Oppermann |
| 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 |
| 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
Code | Product Code Description | BlueStar
Features
Implementation |
|-----------------|----------------------------------------|----------------------------------------|
| 190713 | 2008T Hemodialysis System with CDX | |
| 190766 | 2008T Hemodialysis System with BIBAG | Field Upgrade |
| 190858 | 2008T Hemodialysis System w/o CDX | (Standard or
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 | ||
| Accuracy: ± 10% tested at -200 mmHg | ||
| Dialysate Flow Rates | Dialysate flow rates are selectable on the Home screen in the | |
| following mL/min increments: | ||
| (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 | |||||||||||||||||||||||||
| selected in Service mode. | |||||||||||||||||||||||||
| The dialysate flow rates (Qd) for both 1.5x or 2.0x dialysate | |||||||||||||||||||||||||
| 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 | |||||||||||||||||||||||||
| adjust unless the blood pump is adjusted at least 15– | |||||||||||||||||||||||||
| 20 mL/min. |
- If Auto Flow Minimum of 300 Qd is set in Service mode
** 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
Accuracy: ± 1 second per hour | | | | | | | | | | | | | | | | | | | | | | | | |
| Dialysis Fluid Composition | Volumetric, selectable:
Acid adjustment range: 130–155 mEq/L Na+
Bicarbonate adjustment range: 20-40 mEq/L Bicarbonate
(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 |
| adjusted to 2°C above and below set point. Alarm window will | |
| not adjust to below 34°C (or 30°C during BTM recirculation | |
| 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
9
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.
10
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
BlueStar Hemodialysis
Machine | Primary Predicate Device –
2008K2 Hemodialysis
Machine (K153449) | Reference Device
– 2008T Hemodialysis
Machine (K150708) | Equivalence Discussion |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|
| Intended Use | The device is intended for
acute and chronic dialysis
therapy. | The device is intended for
acute and chronic dialysis
therapy. | The device is intended for
acute and chronic dialysis
therapy. | Same |
| Indications for Use | 2008T BlueStar Hemodialysis
Machine: The 2008T BlueStar
Hemodialysis Machine is
indicated for acute and
chronic dialysis therapy in a
healthcare facility. | The 2008K2 Hemodialysis
Machine is indicated for acute
and chronic hemodialysis
therapy in a healthcare
facility. | N/A. Substantial Equivalence
discussion is limited to the
modified and primary
predicate devices. | Same |
| | Additional therapy options
for patients receiving
hemodialysis include:
Isolated Ultrafiltration,
Sustained Low Efficiency
Dialysis (SLED), and low
volume hemodialysis
(patientsweighing≥ 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 | 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 2008K2 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 | | Same |
| Parameter | Modified Device – 2008T
BlueStar Hemodialysis
Machine | Primary Predicate Device –
2008K2 Hemodialysis
Machine (K153449) | Reference Device
– 2008T Hemodialysis
Machine (K150708) | Equivalence Discussion |
| 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. | Bibag functionality is not
available on the 2008K2
Hemodialysis Machine. | | Substantially Equivalent
The Indications for Use
language for the optional
bibag system was
leveraged from the
currently marketed
(unmodified) 2008T
Hemodialysis Machine.
There were no
modifications made to
the optional bibag
system with the 2008T
BlueStar Hemodialysis
Machine. | |
| 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 real time
for application in the
treatment of dialysis patients
with the intended purpose of
providing a more effective
treatment for both the dialysis | Crit-Line Clip Monitor
(CLiC) functionality is not
available on the 2008K2
Hemodialysis Machine. | | Substantially Equivalent
The Indications for Use
language for the optional
CLiC functionality was
leveraged from the
currently marketed
(unmodified) 2008T
Hemodialysis Machine.
There were no
modifications made to
the optional (CLiC)
functionality with the
2008T BlueStar
Hemodialysis Machine. | |
| MEDICAL CARE | | | | |
| Parameter | Modified Device – 2008T
BlueStar Hemodialysis
Machine | Primary Predicate Device –
2008K2 Hemodialysis
Machine (K153449) | Reference Device
– 2008T Hemodialysis
Machine (K150708) | Equivalence Discussion |
| | 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. | | | |
| Dimensions | | N/A. Substantial Equivalence
discussion is limited to the
modified and reference
devices. | | |
| Floor Space | Approximately 54 cm wide
by 63 cm deep | | Approximately 54 cm wide
by 63 cm deep | Same as the reference
(unmodified) 2008T |
| Height | 149 cm | | 149 cm | device. |
| Operating
Temperature and
Humidity | $60°F – 100°F (15.5°C –38°C)$
Relative Humidity 10% to
90%, non-condensing | $60°F - 100°F (15.5°C –38°C)$
Relative Humidity 10% to
90%, non-condensing | | |
| Electrical | | | | |
| Power Supply – Main | Single phase AC 117 V ±
10% 60 Hz ± 3 Hz; must be
connected to a circuit which
is equipped with a hospital
grade receptacle and is
protected by circuit breaker
and ground fault interrupter
(GFI). | Single phase AC 117 V ±
10% 60 Hz ± 3 Hz; must be
connected to a circuit which
is equipped with a hospital
grade receptacle and is
protected by circuit breaker
and ground fault interrupter
(GFI). | Single phase AC 117 V ±
10% 60 Hz ± 3 Hz; must be
connected to a circuit which
is equipped with a hospital
grade receptacle and is
protected by circuit breaker
and ground fault interrupter
(GFI). | Same |
| MEDICAL CARE | | Traditional 510(k) | | |
| Parameter | Modified Device – 2008T
BlueStar Hemodialysis
Machine | Primary Predicate Device –
2008K2 Hemodialysis
Machine (K153449) | Reference Device
– 2008T Hemodialysis
Machine (K150708) | Equivalence Discussion |
| | chassis to ground must be
-500 mbar)
where Pdi = dialysate pressure
on the inlet side of the
dialyzer | ± 1% (for Pdi > -500 mbar)
where Pdi = dialysate pressure
on the inlet side of the
dialyzer | ± 1% (for Pdi > -500 mbar)
where Pdi = dialysate pressure
on the inlet side of the
dialyzer | Same |
| Fluid Removal Rate
from Patient | 0 – 4000 mL/hr
Dialysate flow rate at
100 mL/min: Accuracy (on
total volume removed): ± (1%
UF rate + 18 mL/hr)
Dialysate flow rate at
500 mL/min: Accuracy (on
total volume removed): ± (1%
UF rate + 30 mL/hr)
Dialysate flow rate at
800 mL/min: Accuracy (on
total volume removed): ± (1%
UF rate + 48 mL/hr) | 0 – 4000 mL/hr
Dialysate flow rate at
100 mL/min: Accuracy (on
total volume removed): ± (1%
UF rate + 18 mL/hr)
Dialysate flow rate at
500 mL/min: Accuracy (on
total volume removed): ± (1%
UF rate + 30 mL/hr)
Dialysate flow rate at
800 mL/min: Accuracy (on
total volume removed): ± (1%
UF rate + 48 mL/hr) | 0 – 4000 mL/hr
Dialysate flow rate at
100 mL/min: Accuracy (on
total volume removed): ± (1%
UF rate + 18 mL/hr)
Dialysate flow rate at
500 mL/min: Accuracy (on
total volume removed): ± (1%
UF rate + 30 mL/hr)
Dialysate flow rate at
800 mL/min: Accuracy (on
total volume removed): ± (1%
UF rate + 48 mL/hr) | Same |
| Adjustment Range of
UF Rate (Dialysis) | Volumetric Control, Adjusted
in 10 mL increments. | Volumetric Control, Adjusted
in 10 mL increments. | Volumetric Control, Adjusted
in 10 mL increments. | Same |
|
MEDICAL CARE | | | | |
| Parameter | Modified Device – 2008T
BlueStar Hemodialysis
Machine | Primary Predicate Device -
2008K2 Hemodialysis
Machine (K153449) | Reference Device
– 2008T Hemodialysis
Machine (K150708) | Equivalence Discussion |
| Dialysis | Dialysis: 0 – 4000 mL/hr
Dialysis settings:
1000 mL/hr, 2000 mL/hr,
3000 mL/hr, and 4000 mL/hr | Dialysis: 0 - 4000 mL/hr
Dialysis settings:
1000 mL/hr, 2000 mL/hr,
3000 mL/hr, and 4000 mL/hr | Dialysis: 0 – 4000 mL/hr
Dialysis settings:
1000 mL/hr, 2000 mL/hr,
3000 mL/hr, and 4000 mL/hr | |
| UF Time | Digital Display (0 - 9:59 hrs),
selectable in increments of
1 min | Digital Display (0 - 9:59 hrs),
selectable in increments of
1 min | Digital Display (0 - 9:59 hrs),
selectable in increments of
1 min | Same |
| UF Goal | Digital Display
(0 - 9,990 mL), selectable in
increments of 10 mL | Digital Display
(0 - 9,990 mL), selectable in
increments of 10 mL | Digital Display
(0 - 9,990 mL), selectable in
increments of 10 mL | Same |
| UF Profiles | Eight UF profiles are
available for the removal of
fluid from the patient. Four
are preset and four may be
defined by the user. | Eight UF profiles are
available for the removal of
fluid from the patient. Four
are preset and four may be
defined by the user. | Eight UF profiles are
available for the removal of
fluid from the patient. Four
are preset and four may be
defined by the user. | Same |
| Remaining Time of
Dialysis (RTD) | 0 – 9:59 hours auto transfer
from UF time, counting down
in 1-minute increments. Can
adjust manually. | 0 – 9:59 hours auto transfer
from UF time, counting down
in 1-minute increments. Can
adjust manually. | 0 – 9:59 hours auto transfer
from UF time, counting down
in 1-minute increments. Can
adjust manually. | Same |
| UF Removed Display | Digital display max 9,999 mL
counting in 1 mL increments. | Digital display max 9,999 mL
counting in 1 mL increments. | Digital display max 9,999 mL
counting in 1 mL increments. | Same |
| Fluid Removal Rate
Monitoring | Alarm Limit: 300 mL/hr
minimum (Diasafe Plus
installed)
Online Pressure Holding test
for hydraulic leak detection
(detects leaks in the system
greater than 300 mL/hr) | Alarm Limit: 300 mL/hr
minimum (Diasafe Plus
installed)
Online Pressure Holding test
for hydraulic leak detection
(detects leaks in the system
greater than 300 mL/hr) | Alarm Limit: 300 mL/hr
minimum (Diasafe Plus
installed)
Online Pressure Holding test
for hydraulic leak detection
(detects leaks in the system
greater than 300 mL/hr) | Same |
| Parameter | Modified Device – 2008T
BlueStar Hemodialysis
Machine | Primary Predicate Device –
2008K2 Hemodialysis
Machine (K153449) | Reference Device
– 2008T Hemodialysis
Machine (K150708) | Equivalence Discussion |
| Additional Monitoring | Alarm in case of power
failure.
Alarm in case of water
shortage. | Alarm in case of power
failure.
Alarm in case of water
shortage. | Alarm in case of power
failure.
Alarm in case of water
shortage. | Same |
| Functional Options | | | | |
| Access Flow (Qa)
(Optional, requires
Online Clearance
(OLC)) | Minimum Qa: Will not
determine the Qa if less than
the blood pump speed.
Maximum Qa: 2000 mL/min | Minimum Qa: Will not
determine the Qa if less than
the blood pump speed.
Maximum Qa: 2000 mL/min | Minimum Qa: Will not
determine the Qa if less than
the blood pump speed.
Maximum Qa: 2000 mL/min | Same |
| Online Clearance
(Optional) | Dialysate Flow rate:
300 mL/min – 800 mL/min
of online clearance tests: 1
– 6 during each treatment | Dialysate Flow rate:
300 mL/min – 800 mL/min
of online clearance tests: 1
– 6 during each treatment | Dialysate Flow rate:
300 mL/min – 800 mL/min
of online clearance tests: 1
– 6 during each treatment | Same |
17
Image /page/17/Picture/1 description: The image shows the logo for Fresenius Medical Care. The logo consists of a blue symbol on the left and the words "FRESENIUS MEDICAL CARE" in blue on the right. The symbol is made up of three blue chevrons stacked on top of each other.
2008T BlueStar Hemodialysis Machine Traditional 510(k)
18
Image /page/18/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 or chevron. To the right of the shape are the words "FRESENIUS MEDICAL CARE" in bold, blue letters, arranged in two lines. The text is aligned to the left and positioned next to the geometric shape.
2008T BlueStar Hemodialysis Machine Traditional 510(k)
19
Image /page/19/Picture/0 description: The image shows the logo for Fresenius Medical Care. The logo consists of a blue symbol on the left and the company name on the right. The symbol is made up of three downward-pointing chevrons, stacked on top of each other. The company name is written in blue, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.
2008T BlueStar Hemodialysis Machine Traditional 510(k)
20
Image /page/20/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 blue chevrons pointing downwards. The text is in a bold, sans-serif font, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.
21
Image /page/21/Picture/1 description: The image contains the logo for Fresenius Medical Care. The logo consists of a blue emblem on the left and the text "FRESENIUS MEDICAL CARE" on the right, also in blue. The emblem is a stylized design featuring three downward-pointing chevrons stacked on top of each other. The text is arranged in two lines, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.
22
Image /page/22/Picture/1 description: The image shows the logo for Fresenius Medical Care. The logo consists of a blue geometric shape on the left, resembling three downward-pointing chevrons stacked on top of each other. To the right of the geometric shape, the words "FRESENIUS MEDICAL CARE" are written in blue, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.
23
Image /page/23/Picture/1 description: The image contains the logo for Fresenius Medical Care. The logo consists of a blue emblem on the left and the company name on the right. The emblem is made up of three chevron shapes stacked on top of each other, pointing downwards.
24
Image /page/24/Picture/1 description: The image shows the logo for Fresenius Medical Care. The logo consists of a blue geometric shape on the left and the text "FRESENIUS MEDICAL CARE" on the right. The geometric shape is made up of three chevrons pointing downwards. The text is in a bold, sans-serif font, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.
25
Image /page/25/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.
2008T BlueStar Hemodialysis Machine Traditional 510(k)
SLED Discussion:
The SLED functionality, reviewed and cleared with the 2008K2 Hemodialysis machine (K153449), is being implemented in the modified 2008T Bluestar Hemodialysis machine. Implementation of SLED in the modified to the predicate 2008K2 Hemodialysis machine. As with the 2008K2 device, "SLED" is a selectable treatment option on 'Select Program' screen. The labeling of the modified device reflects that the SLED functionality is contraindicated in patients weighing ≤ 40 kg.
| Dialysate Flow Rates | 100 mL/min, 150 mL/min,
200 mL/min, and
300 mL/min | 100 mL/min, 150 mL/min,
200 mL/min, and
300 mL/min | N/A. Substantial Equivalence
discussion is limited to the
modified and primary
predicate devices. | Same |
|----------------------|---------------------------------------------------------------------------|---------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|------|
| Ultrafiltration Rate | Volumetric Control, adjusted
in 10 mL/hr increments.
0 – 1000 mL/hr | Volumetric Control, adjusted
in 10 mL/hr increments.
0 – 1000 mL/hr | | Same |
| Blood Flow Rates | 0 – 300 mL/min | 0 – 300 mL/min | Same | |
| Treatment Time | 0 - 12:00 (hours : minutes) | 0 - 12:00 (hours : minutes) | Same | |
26
Image /page/26/Picture/1 description: The image contains the logo for Fresenius Medical Care. The logo consists of a blue emblem on the left and the text "FRESENIUS MEDICAL CARE" on the right. The emblem is made up of three chevron shapes stacked on top of each other. The text is in a bold, sans-serif font and is also blue.
2008T BlueStar Hemodialysis Machine
Traditional 510(k)
| Parameter | Modified Device – 2008T
BlueStar Hemodialysis
Machine | Primary Predicate Device –
2008K2 Hemodialysis
Machine (K153449) | Reference Device
– 2008T Hemodialysis
Machine (K150708) | Equivalence Discussion | | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Low Volume Hemodialysis Discussion: | | | | | | |
| Restricts the allowable blood pump segment sizes to less than to 6.4 mm for patients weighing between 20 kg and 40 kg. Reviewed and
cleared with the 2008K2 Hemodialysis machine (K153449), and is being implemented in the modified 2008T Bluestar Hemodialysis
machine. The Low Volume functionality in the modified device is identical to the feature in the predicate 2008K2 device. | | | | | | |
| Ultrafiltration Rate | Volumetric Control, adjusted
in 10 mL/hr increments.
0 – 1000 mL/hr | Volumetric Control, adjusted
in 10 mL/hr increments.
0 – 1000 mL/hr | N/A. Substantial Equivalence
discussion is limited to the
modified and primary
predicate devices. | Same | | |
| Blood Flow Rate | 6 mL/min – 465 mL/min,
depending on pump
segment ID:
2.6 mm: 6 mL/min –
86 mL/min
4.8 mm: 10 mL/min –
274 mL/min
6.35 mm: 20 mL/min –
465 mL/min | 6 mL/min – 465 mL/min,
depending on pump
segment ID:
2.6 mm: 6 mL/min –
86 mL/min
4.8 mm: 10 mL/min –
274 mL/min
6.35 mm: 20 mL/min –
465 mL/min | | Same | | |
| Inner Diameter (ID)
of pump segment | 40 kg) | Cuff Pressure
Range
0 – 300 mmHg
Initial Cuff
Inflation
180 mmHg or
adjusted by
host
Systolic
Determination
Range
60 – 250
mmHg
MAP
Determination
Range
45 – 220
mmHg
Diastolic
Determination
Range
40 – 200
mmHg
Pulse Rate
Determination 40 – 200 BPM
Range
Cuff Inflation
Rate
5 seconds
Determination 25 – 30
Time Normal seconds
Overpressure
Cut Off
300 mmHg
Transducer
Drift
Auto Zeroing
Leakage Rate
(Max)
3 mmHg/min
in 3 minutes
Pressure Rate
Offset
Auto Zeroing | Cuff Pressure
Range
0 – 300 mmHg
Initial Cuff
Inflation
180 mmHg or
adjusted by
host
Systolic
Determination
Range
60 – 250
mmHg
MAP
Determination
Range
45 – 220
mmHg
Diastolic
Determination
Range
40 – 200
mmHg
Pulse Rate
Determination 40 – 200 BPM
Range
Cuff Inflation
Rate
5 seconds
Determination 25 – 30
Time Normal seconds
Overpressure
Cut Off
300 mmHg
Transducer
Drift
Auto Zeroing
Leakage Rate
(Max)
3 mmHg/min
in 3 minutes
Pressure Rate
Offset
Auto Zeroing | | Same | | |
| Parameter | Modified Device – 2008T
BlueStar Hemodialysis
Machine | Primary Predicate Device –
2008K2 Hemodialysis
Machine (K153449) | Reference Device –
2008T Hemodialysis
Machine (K150708) | Equivalence Discussion | | |
| Alarm Preset Values
for Standard Therapy
(> 40 kg) | Systolic | 200/90 | Systolic | 200/90 | | Same |
| | MAP | 120/70 | MAP | 120/70 | | |
| | Diastolic | 110/50 | Diastolic | 110/50 | | |
| | Pulse | 120/50 | Pulse | 120/50 | | |
| | Inflation
Pressure | Auto | Inflation
Pressure | Auto | | |
| Blood Pressure
Module Performance
limits for Low
Volume therapy
(20 kg - 40 kg) | Cuff Pressure
Range | 0 – 210 mmHg | Cuff Pressure
Range | 0 – 210 mmHg | | Same |
| | Initial Cuff
Inflation | 120 mmHg or
adjusted by
host | Initial Cuff
Inflation | 120 mmHg or
adjusted by
host | | |
| | Systolic
Determination
Range | 60 – 220
mmHg | Systolic
Determination
Range | 60 – 220
mmHg | | |
| | MAP
Determination
Range | 45 – 220
mmHg | MAP
Determination
Range | 45 – 220
mmHg | | |
| | Diastolic
Determination
Range | 40 – 200
mmHg | Diastolic
Determination
Range | 40 – 200
mmHg | | |
| | Pulse Rate
Determination
Range | 40 – 200 BPM | Pulse Rate
Determination
Range | 40 – 200 BPM | | |
| | Cuff Inflation
Rate | 5 seconds | Cuff Inflation
Rate | 5 seconds | | |
| | Determination
Time Normal | Approx. 20
seconds | Determination
Time Normal | Approx. 20
seconds | | |
| | Overpressure
Cut Off | 210 mmHg | Overpressure
Cut Off | 210 mmHg | | |
| | Transducer
Drift | Auto Zeroing | Transducer
Drift | Auto Zeroing | | |
| | Leakage Rate
(Max) | 3 mmHg/min
in 3 minutes | Leakage Rate
(Max) | 3 mmHg/min
in 3 minutes | | |
| MEDICAL CARE | | | Traditional 510(k) | | | |
| Parameter | Modified Device – 2008T
BlueStar Hemodialysis
Machine | | Primary Predicate Device –
2008K2 Hemodialysis
Machine (K153449) | | Reference Device
– 2008T Hemodialysis
Machine (K150708) | Equivalence Discussion |
| | Pressure Rate
Offset | Auto Zeroing | Pressure Rate
Offset | Auto Zeroing | | |
| Alarm Preset Values | Systolic | 160/80 | Systolic | 160/80 | | Same |
| for Low Volume
Therapy (20 kg | MAP | 120/60 | MAP | 120/60 | | |
| – 40 kg) | Diastolic | 100/40 | Diastolic | 100/40 | | |
| | Pulse | 120/50 | Pulse | 120/50 | | |
| | Inflation
Pressure | Auto | Inflation
Pressure | Auto | | |
| Priming the Blood Circuit | | | | | | |
| Priming Method | Available methods enable the
removal of air from the blood
lines and dialyzer by allowing
the sterile saline solution to
flow through them. | | Available methods enable the
removal of air from the blood
lines and dialyzer by allowing
the sterile saline solution to
flow through them. | | Available methods enable the
removal of air from the blood
lines and dialyzer by allowing
the sterile saline solution to
flow through them. | Same |
| Reinfusion | | | | | | |
| Reinfusion Method | Assisted Reinfusion. Assists
the operator in returning all
the patient's blood at the end
of treatment. Button
displayed on 'Test & Options'
screen | | Unassisted Reinfusion. | | Unassisted Reinfusion. | Substantially Equivalent.
All devices provide a
means for returning
blood to the patient after
treatment. The proposed
device introduces a new
mechanism of returning
blood. |
| Conductivity Testing | | | | | | |
| Monitoring | Temperature compensated
electronic conductivity meter
with adjustable alarm limits. | | Temperature compensated
electronic conductivity meter
with adjustable alarm limits. | | Temperature compensated
electronic conductivity meter
with adjustable alarm limits. | Same |
27
Image /page/27/Picture/1 description: The image contains the logo for Fresenius Medical Care. On the left is a blue symbol that looks like three chevrons stacked on top of each other, pointing downwards. To the right of the symbol is the text "FRESENIUS MEDICAL CARE" in blue, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.
28
Image /page/28/Picture/1 description: The image shows the logo for Fresenius Medical Care. The logo consists of a blue geometric shape on the left and the text "FRESENIUS MEDICAL CARE" on the right. The geometric shape is made up of three chevrons stacked on top of each other.
29
Image /page/29/Picture/1 description: The image contains the logo for Fresenius Medical Care. The logo consists of a blue emblem on the left and the company name in blue text on the right. The emblem is made up of three downward-pointing chevron shapes stacked on top of each other. The text reads "FRESENIUS MEDICAL CARE" in a bold, sans-serif font.
2008T BlueStar Hemodialysis Machine Traditional 510(k)
30
Image /page/30/Picture/1 description: The image shows the logo for Fresenius Medical Care. The logo consists of a blue geometric shape on the left, resembling three downward-pointing chevrons stacked on top of each other. To the right of the shape is the text "FRESENIUS MEDICAL CARE" in blue, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.
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Image /page/31/Picture/1 description: The image shows the Fresenius Medical Care logo. The logo consists of a blue symbol on the left and the words "FRESENIUS MEDICAL CARE" in blue on the right. The symbol is made up of three chevrons pointing downwards.
| MEDICAL CARE | Traditional 510(k) | |||
|---|---|---|---|---|
| Parameter | Modified Device – 2008T | |||
| BlueStar Hemodialysis | ||||
| Machine | Primary Predicate Device – | |||
| 2008K2 Hemodialysis | ||||
| Machine (K153449) | Reference Device | |||
| – 2008T Hemodialysis | ||||
| Machine (K150708) | Equivalence Discussion | |||
| Temperature-compensated | ||||
| conductivity display with | ||||
| automatically set alarm | ||||
| windows ± 0.5 mS/cm around | ||||
| calculated conductivity. User | ||||
| can adjust an additional | ||||
| ± 0.5 mS/cm within this | ||||
| range. | ||||
| Average Accuracy: ± 1.5% | Temperature-compensated | |||
| conductivity display with | ||||
| automatically set alarm | ||||
| windows ± 0.5 mS/cm around | ||||
| calculated conductivity. User | ||||
| can adjust an additional | ||||
| ± 0.5 mS/cm within this | ||||
| range. | ||||
| Average Accuracy: ± 1.5% | Temperature-compensated | |||
| conductivity display with | ||||
| automatically set alarm | ||||
| windows ± 0.5 mS/cm around | ||||
| calculated conductivity. User | ||||
| can adjust an additional | ||||
| ± 0.5 mS/cm within this | ||||
| range. | ||||
| Average Accuracy: ± 1.5% | ||||
| Conductivity Testing | ||||
| Method | Independent Conductivity. | |||
| Reading displayed on | ||||
| 'Dialysate' screen when the | ||||
| dialysate lines are on the | ||||
| shunt interlock | Manual. Operator tests for | |||
| proper conductivity before | ||||
| each dialysis treatment | Manual. Operator tests for | |||
| proper conductivity before | ||||
| each dialysis treatment | Substantially Equivalent. | |||
| All devices provide a | ||||
| means for conductivity | ||||
| testing. The proposed | ||||
| device introduces a new | ||||
| mechanism of measuring | ||||
| conductivity. |
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Image /page/32/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.
K173972 Page 30 of 32
Performance Data 5.8.
The performance of the modified device described in this submission was evaluated according to existing FMCRTG procedures, protocols, declared performance standards, and guidelines of the quality system regulation (21 CFR §820). Design verification tests confirmed that all design updates were effective, did not affect the essential performance of the device, and that the device functions as intended.
Biocompatibility Testing 5.8.1.
The 2008T BlueStar Hemodialysis Machine's hydraulic components were evaluated to ISO 10993 requirements. The Unit Under Test (UUT) included the new hardware components (acid, bicarbonate and UF pumps, extended concentrate lines and ratio valves). The following testing was performed to support the biological safety of the 2008T BlueStar HD Machine's hydraulics:
- Chemical analysis Simulated-Use Leachable Extraction ●
- Cytotoxicity ●
- Sensitization ●
- Irritation
- Material Mediated Pyrogenicity
- Hemocompatibility (Indirect Contact) ●
- Subchronic toxicity ●
- Risk assessment of potential toxicity ●
Electrical Safety and Electromagnetic Compatibility (EMC) 5.8.2.
The 2008T BlueStar Hemodialysis Machine was evaluated for electromagnetic compatibility (EMC) in accordance with IEC 60601-1-2:2014. Additional electrical testing was conducted to verify new BlueStar hardware.
Software Verification and Validation Testing 5.8.3.
Unit, integration, and system level software verification testing was performed to demonstrate the effectiveness of the software modifications and to confirm operation of the machine.
The following system level testing was performed:
- Functional and performance verification testing conducted to ensure operational ● efficacy of software with the upgraded hardware
- Regression testing - conducted on dialysis treatment and key safety measures to ensure the essential performance and safe operation of the system were not adversely impacted
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Image /page/33/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 or chevron. To the right of the shape are the words "FRESENIUS" and "MEDICAL CARE" stacked on top of each other, also in blue. The text is bold and sans-serif.
Code reviews were performed for all changes to the code. To ensure that the inputs were met and good coding practices were followed, the code reviews analyzed the following source documents:
- Design inputs
- Software Design Specification (SDS)
- "diff files"
Mechanical Testing 5.8.4.
Functional verification of mechanical components was conducted to verify the following changes:
- New paint ●
- Tubing organizer ●
- Patient Card housing ●
- Keyboard
- Monitor EMI ground assembly
- Hook for extended lines ●
- Ratio valves ●
- UF pumps, acid and bicarbonate pumps
5.8.5. Environmental and Ship Testing
Environmental testing was performed to verify that the machine performs normally (i.e., no nonresettable alarms or unusual behavior) in the temperature- and humidity-controlled operating environment.
Ship testing was performed to verify that the machine can withstand hazards associated with the typical shipping and distribution environment. A series of reliability tests were conducted to show that the product met shipping requirements.
5.8.6. Human Factors Testing
Human Factors testing was performed on device modifications found to impact usability. FMCRTG concludes that the new features are safe and effective for the intended users, uses, and use environments.
5.9. Conclusions
The 2008T BlueStar Hemodialysis Machine's indications for use, intended use, and technological characteristics are equivalent to those of the primary predicate and reference devices. Differences between the 2008T BlueStar Hemodialysis Machine and the predicate and reference devices do not raise any new concerns with regard to safety or effectiveness. FMCRTG concludes that the proposed 2008T
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Image /page/34/Picture/1 description: The image shows the Fresenius Medical Care logo. The logo consists of a blue symbol on the left and the words "FRESENIUS MEDICAL CARE" in blue on the right. The symbol is made up of three downward-pointing chevrons.
BlueStar Hemodialysis Machine is substantially equivalent to the predicate device, the 2008K2 Hemodialysis Machine (K153449) within the meaning of the Medical Device Amendments Act of 1976.