(246 days)
Not Found
No.
The document describes "software controls" and "automation features" but does not mention AI, DNN, or ML, nor does it describe any functionality that implies an AI model (e.g., learning from data, making predictions, or complex pattern recognition beyond what is typically found in embedded control systems).
Yes
The device is indicated for "acute and chronic dialysis therapy" and states it provides "hemodialysis treatment," which are therapeutic interventions for renal failure.
No
The 2008T BlueStar Hemodialysis Machine is a therapeutic device used for acute and chronic dialysis therapy, not for diagnosing conditions. While it can be paired with an optional diagnostic component (Crit-Line Clip Monitor), the core device's function is treatment.
No
The device is described as an "electromechanical device" and processes physical substances (blood, dialysate). While it uses software for control, the primary function and components are hardware-based.
No
The device is a hemodialysis machine, which is an extracorporeal therapeutic device that removes waste products from the blood, not an IVD. While it can be optionally used with a Crit-Line Clip Monitor (CLiC) that measures parameters like hematocrit and oxygen saturation, the primary device itself does not perform in vitro diagnostic testing.
N/A
Intended Use / 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 ≥ 20kg 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 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 real time for application in the treatment of dialysis patients with the intended purpose of providing a more effective treatment for both the dialysis patient and the clinician. Based on the data that the monitor provides, the clinician/nurse, under physician direction, intervenes (i.e., increases or decreases the rate at which fluid is removed from the blood) in order to remove the maximum amount of fluid from the dialysis patient without the patient experiencing the common complications of dialysis which include nausea, cramping and vomiting.
Product codes
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.
The 2008T BlueStar Hemodialysis Machine has automation features (independent internal conductivity testing, auto priming, auto start, CDX auto on, assisted reinfusion) to minimize user workload and improve user experience. The 2008T BlueStar Hemodialysis Machine includes SLED (Sustained Low Efficiency Dialysis), Low Volume, and Isolated Ultrafiltration therapy options. The 2008T BlueStar Hemodialysis Machine also accommodates the use of the Patient Card system, a dialysis treatment information system.
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 ≥ 20kg and ≤ 40 kg (for low volume hemodialysis); SLED therapy option is not to be used for patients weighing ≤ 40 kg; not to be used for patients weighing less than 20 kg.
Intended User / Care Setting
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)
Performance testing was conducted for the 2008T BlueStar Hemodialysis Machine. Results of performance testing support the substantial equivalence, safety, and efficacy of the 2008T BlueStar Hemodialysis Machine.
Biocompatibility testing for the 2008T BlueStar Hemodialysis Machine's patient contacting components was conducted in accordance with ISO 10993-1:2018 and FDA guidance document Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" (08 September 2023). The following endpoints were evaluated to support the biological safety of the 2008T BlueStar Hemodialysis Machine: Cytotoxicity, Sensitization, Irritation, Pyrogenicity (Material Mediated), Hemocompatibility, Chemical Characterization, Toxicological Risk Assessment.
The changes to the 2008T BlueStar Hemodialysis Machine do not impact the usability of the device. Human Factors Validation Testing is not required.
Electromagnetic compatibility (EMC) testing was conducted on the 2008T BlueStar Hemodialysis Machine in accordance with IEC 60601-1-2 (2020) Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic disturbances - Requirements and tests.
There are no changes to the 2008T BlueStar Hemodialysis Machine's software. Software verification and validation testing are not required.
No animal studies were performed for the 2008T BlueStar Hemodialysis Machine.
No clinical studies were performed for the 2008T BlueStar Hemodialysis Machine.
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.
Not Found
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.”
FDA 510(k) Clearance Letter - K243237
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
June 13, 2025
Fresenius Medical Care Renal Therapies Group, LLC
Tara Kenney
Principal Regulatory Affairs Associate
920 Winter Street
Waltham, Maryland 02451
Re: K243237
Trade/Device Name: 2008T HD SYS. CDX BLUESTAR (191124); 2008T HD SYS. CDX W/bibag BLUESTAR (191126); 2008T HD SYS. W/O CDX BLUESTAR (191128); 2008T HD SYS. W/O CDX W/bibag BLUESTAR (191130)
Regulation Number: 21 CFR 876.5860
Regulation Name: High permeability hemodialysis system
Regulatory Class: Class II
Product Code: KDI
Dated: October 10, 2024
Received: May 14, 2025
Dear Tara Kenney:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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K243237 - Tara Kenney
Page 2
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-
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K243237 - Tara Kenney
Page 3
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Maura Rooney -S
Maura Rooney
Assistant Director
DHT3A: Division of Renal, Gastrointestinal,
Obesity, and Transplant Devices
OHT3: Office of Gastrorenal, ObGyn,
General Hospital, and Urology Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
Indications for Use
Submission Number (if known)
K243237
Device Name
2008T HD SYS. CDX BLUESTAR (191124);
2008T HD SYS. CDX W/bibag BLUESTAR (191126);
2008T HD SYS. W/O CDX BLUESTAR (191128);
2008T HD SYS. W/O CDX W/bibag BLUESTAR (191130)
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 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 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 real time for application in the treatment of dialysis patients with the intended purpose of providing a more effective treatment for both the dialysis patient and the clinician. Based on the data that the monitor provides, the clinician/nurse, under physician direction, intervenes (i.e., increases or decreases the rate at which fluid is removed from the blood) in order to remove the maximum amount of fluid from the dialysis patient without the patient experiencing the common complications of dialysis which include nausea, cramping and vomiting.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
Page 5
K243237 510(k) Summary
2008T BlueStar Hemodialysis Machine Traditional 510(k)
1. 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.
1.1. Submitter's Information
Name: Fresenius Medical Care Renal Therapies Group, LLC
Address: 920 Winter Street
Waltham, MA
02451-1457
Contact Person: Tara Kenney, Principal Regulatory Affairs Associate
Phone: (781) 250-7689
Fax: (781) 699-9635
Alternate Contact: Laura Reed, Regulatory Affairs Director
Phone: (781) 491-7581
Preparation Date: 10 October 2024
1.2. Device Name
Trade Name: 2008T BlueStar™ Hemodialysis Machine
Common Name: Hemodialysis Delivery Device
Regulation Name: High Permeability Hemodialysis System
Regulatory Class: Class II per 21 CFR §876.5860
Product Code: KDI
Product Code Name: Dialyzer, high permeability with or without sealed dialysate system
FDA Review Panel: Gastroenterology/Urology
1.3. Legally Marketed Predicate Device
The 2008T BlueStar Hemodialysis Machine (K231125) is the legally marketed predicate device.
1.4. Device Description
1.4.1. Device Identification
The device is identified as the 2008T BlueStar Hemodialysis Machine. The 2008T BlueStar Hemodialysis Machine is available in four (4) configurations (Table 1).
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K243237 510(k) Summary
2008T BlueStar Hemodialysis Machine Traditional 510(k)
Table 1: 2008T BlueStar Hemodialysis Machine Configurations
| Part Number | Part Number Description |
|---|---|
| 191124 | 2008T HD SYS. CDX BLUESTAR |
| 191126 | 2008T HD SYS. CDX W/bibag BLUESTAR |
| 191128 | 2008T HD SYS. W/O CDX BLUESTAR |
| 191130 | 2008T HD SYS. W/O CDX W/bibag BLUESTAR |
1.4.2. 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.
1.4.3. Environment of Use
The 2008T BlueStar Hemodialysis Machine is intended for use in healthcare facilities, such as hospitals and dialysis clinics where intermittent dialysis treatment is performed.
1.4.4. 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 has automation features (independent internal conductivity testing, auto priming, auto start, CDX auto on, assisted reinfusion) to minimize user workload and improve user experience. The 2008T BlueStar Hemodialysis Machine includes SLED (Sustained Low Efficiency Dialysis), Low Volume, and Isolated Ultrafiltration therapy options. The 2008T BlueStar Hemodialysis Machine also accommodates the use of the Patient Card system, a dialysis treatment information system.
The 2008T BlueStar Hemodialysis Machine accommodates the following accessory devices and options:
Accessories
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K243237 510(k) Summary
2008T BlueStar Hemodialysis Machine Traditional 510(k)
- Bloodlines: 6.35 mm and 8 mm (K962081, K000451, K001107, K022536, K120823, K201207, and K213992)
- Dialyzers: Any commercially available dialyzer equipped with ISO 8637 standard dialysis connectors
- 2008T BlueStar Hemodialysis Machine Field Upgrade Kits (K173972, K231125)
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)
1.4.5. Materials of Use
The 2008T BlueStar Hemodialysis Machine hydraulics assembly is classified as an externally communicating, blood path, indirect, long-term contact (>30 days) duration, (Category C) device in accordance with FDA guidance Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (08 September 2023). A list of the hydraulic materials for the machine is provided in Table 2.
Table 2: Machine Hydraulic Materials
| Component | Material | Material Type |
|---|---|---|
| Plastic/Rubber | PPE+PS (Polyphenylene ether + polystyrene) | |
| EPDM (Ethylene Propylene Diene Monomer Rubber) | ||
| PP (Polypropylene) | ||
| PVDF (Polyvinylidene fluoride) | ||
| PVC (Polyvinyl chloride) | ||
| PPSU (Polyphenylsulfone) | ||
| PESU (Polyethersulfone) | ||
| PPS (Polyphenylene Sulfide) | ||
| PTFE (Polytetrafluoroethylene) | ||
| PEEK (Polyetheretherketone) | ||
| Polyamide (glass fiber reinforced nylon) |
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K243237 510(k) Summary
2008T BlueStar Hemodialysis Machine Traditional 510(k)
Table 2: Machine Hydraulic Materials
| Component Material | Material Type |
|---|---|
| Polyester Monofilament | |
| Silicone | |
| Metals | Titanium |
| Stainless Steel | |
| Tantalum | |
| Other | Borosilicate Glass |
| Graphite | |
| Ceramic |
1.4.6. Key Performance Specifications/Characteristics
The key performance specifications and characteristics for the 2008T BlueStar Hemodialysis Machine are outlined in Table 3.
Table 3: Key Performance Characteristics
| Feature | Specification/Characteristic |
|---|---|
| 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 |
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K243237 510(k) Summary
2008T BlueStar Hemodialysis Machine Traditional 510(k)
Table 3: Key Performance Characteristics
| Feature | Specification/Characteristic |
|---|---|
| Maximum Dialysate Flow Rate | 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 |
| †Sustained Low Efficiency Dialysis (SLED) | |
| ‡ Flow rate requires that the Allow Slow Flow option is selected in Service mode. | |
| 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 (mL/min) - Qb w/2.0x Qd (mL/min) - Qd (mL/min) | |
| 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 | Hemodialysis: 0 – 9:59 hours, time can be adjusted manually |
| SLED: Fixed at 12 hours | |
| Accuracy: + 1 second per hour |
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K243237 510(k) Summary
2008T BlueStar Hemodialysis Machine Traditional 510(k)
Table 3: Key Performance Characteristics
| Feature | Specification/Characteristic |
|---|---|
| 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) | |
| 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% |
1.5. Intended Use
The intended use of the 2008T BlueStar Hemodialysis Machine is identical to the intended use of the predicate device (K231125):
The 2008T Machine is intended for use in acute and chronic hemodialysis therapy.
1.6. 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 ≥ 20kg 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 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 real time for application in the treatment of dialysis patients with the intended purpose of providing a
Page 6
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K243237 510(k) Summary
2008T BlueStar Hemodialysis Machine Traditional 510(k)
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.
1.7. Comparison of Technological Characteristics with the Predicate Device
The following technological characteristics of the 2008T BlueStar Hemodialysis Machine are substantially equivalent to those of the predicate 2008T BlueStar Hemodialysis Machine (K231125):
- Intended Use
- Indications for Use
- Design Specifications
- Technological Characteristics
- Principle of Operation
- Performance Requirements
1.8. Performance Data
Performance testing was conducted for the 2008T BlueStar Hemodialysis Machine. Results of performance testing support the substantial equivalence, safety, and efficacy of the 2008T BlueStar Hemodialysis Machine.
1.8.1. Biocompatibility Testing
Biocompatibility testing for the 2008T BlueStar Hemodialysis Machine's patient contacting components was conducted in accordance with ISO 10993-1:2018 and FDA guidance document Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" (08 September 2023). The following endpoints were evaluated to support the biological safety of the 2008T BlueStar Hemodialysis Machine:
- Cytotoxicity
- Sensitization
- Irritation
- Pyrogenicity (Material Mediated)
- Hemocompatibility
- Chemical Characterization
- Toxicological Risk Assessment
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K243237 510(k) Summary
2008T BlueStar Hemodialysis Machine Traditional 510(k)
1.8.2. Human Factors Validation Testing
The changes to the 2008T BlueStar Hemodialysis Machine do not impact the usability of the device. Human Factors Validation Testing is not required.
1.8.3. Electrical Safety and Electromagnetic Compatibility (EMC)
Electromagnetic compatibility (EMC) testing was conducted on the 2008T BlueStar Hemodialysis Machine in accordance with IEC 60601-1-2 (2020) Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic disturbances - Requirements and tests.
1.8.4. Software Verification and Validation Testing
There are no changes to the 2008T BlueStar Hemodialysis Machine's software. Software verification and validation testing are not required.
1.8.5. Animal Studies
No animal studies were performed for the 2008T BlueStar Hemodialysis Machine.
1.8.6. Clinical Studies
No clinical studies were performed for the 2008T BlueStar Hemodialysis Machine.
1.9. Conclusion
The intended use, design, principle of operation, and technological characteristics of the 2008T BlueStar Hemodialysis Machine are substantially equivalent to those of the predicate device. Differences between the 2008T BlueStar Hemodialysis Machine and the predicate do not raise new concerns with regard to safety or efficacy. FMCRTG concludes that within the meaning of the Medical Device Amendments Act of 1976, the 2008T BlueStar Hemodialysis Machine is safe and effective for its intended use.
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