(30 days)
No
The summary describes an electromechanical device controlled by software for fluid flow, mixing, heating, and alarms. While it monitors various parameters and includes optional components like the Crit-Line Clip Monitor which provides real-time data for clinician intervention, there is no mention of AI or ML algorithms being used for decision-making, data analysis beyond basic monitoring, or adaptive control. The performance studies focus on functional, safety, and biocompatibility testing, not on the performance of any AI/ML model.
Yes
The device is indicated for "acute and chronic dialysis therapy", which is a therapeutic treatment for renal failure.
No
The device is a hemodialysis machine used for treatment, not diagnosis. While an optional component (Crit-Line Clip Monitor) provides diagnostic-like measurements, the primary device itself is therapeutic.
No
The device is described as an "electromechanical device" and includes descriptions of hardware components and their functions (fluid flow, mixing, heating, pumps, dialyzer, tubing, balancing chambers, sensors). While software controls the machine, it is an integral part of a physical medical device, not a standalone software product.
Based on the provided text, the 2008T BlueStar Hemodialysis Machine itself is not an In Vitro Diagnostic (IVD).
Here's why:
- Definition of IVD: An IVD is a medical device used to perform tests on samples taken from the human body (such as blood, urine, or tissue) to provide information for diagnosis, monitoring, or treatment.
- Function of the 2008T Machine: The description clearly states that the 2008T Machine is an electromechanical device that performs hemodialysis treatment. It controls and monitors the dialysate and extracorporeal blood circuits to remove toxins and excess water from the patient's blood. This is a therapeutic process performed directly on the patient's blood outside the body, not a diagnostic test on a sample.
While the document mentions optional components that could be considered IVDs or related to diagnostic measurements:
- bibag System: This is used for bicarbonate hemodialysis, which is a treatment, not a diagnostic test.
- Crit-Line Clip Monitor (CLiC): This device measures hematocrit, oxygen saturation, and percent change in blood volume. These are measurements taken from the blood, and the information is used to guide treatment. While these measurements are diagnostic in nature and provide information about the patient's condition, the CLiC is described as a monitor used with the hemodialysis machine to improve treatment effectiveness. It's more likely classified as a patient monitoring device rather than a standalone IVD used for diagnosis in vitro.
Therefore, the core device, the 2008T BlueStar Hemodialysis Machine, is a therapeutic device, not an IVD.
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 Ultratiltration, Sustained Low Efficiency Dialysis (SLED), and low volume hemodialysis (patients weighing ≥ 20 kg). This machine accommodates the use of both low flux and high flux dialyzers. The SLED therapy option is not to 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 hurse, under physician direction, intervenes (i.e., increases 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 Machine is an electromechanical device. Software controls the machine during hemodialysis treatment, including fluid flow, mixing, heating, and alarms.
The 2008T 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 through platinum cross-linked silicone tubing. Balancing chambers control the dialysate during treatment. During treatment, the extracorporeal blood circuit is monitored for venous and arterial blood pressures as well as for the presence of air and blood. The 2008T Machine accommodates the following accessory devices and options:
Accessories: DIASAFE®plusus Filter (K182367), Patient Card (K173972), Patient Card Reader (K173972), Bloodlines: 6.35 mm and 8 mm (K962081, K000451, K001107, K022536, K070049, K120823, and K201207), Dialyzers: Any commercially available dialyzer equipped with ISO 8637 standard dialysis connectors, 2008T BlueStar Hemodialysis Machine Field Upgrade Kits (K173972).
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).
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
The 2008T BlueStar Hemodialysis Machine is not to be used for plasma replacement therapies, for patients weighing less than 20 kg.
Intended User / Care Setting
The 2008T BlueStar Hemodialysis Machine is indicated for acute and chronic dialysis therapy in a healthcare facility.
The 2008T Machine is intended for use in healthcare facilities, such as hospitals and dialysis clinics where intermittent dialysis treatment is performed.
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 to support the determination of substantial equivalence of the 2008T Machine is summarized in Table 4.
Functional Tests – Long Term Aging: Verify that the machine hydraulics will not have leaks or failures after seven (7) years of aging when performing cleaning, heat disinfection, or chemical disinfection.
Residual Disinfectant: Ensure that residuals from chemical disinfection are reduced to an acceptable level.
Inlet and Drain Hose Functional Tests: Ensure that the inlet and drain hoses can be properly connected, withstand pressure and heat, and are the proper size and color.
Shunt Interlock Functional Tests: Verify that the shunt interlock performs as intended and the components do not fail or leak.
Water Inlet Plate Functional Tests: Verify that the water inlet plate performs as intended and withstands expected pressures, temperatures, and chemical exposure.
Disinfection Validation Testing: Ensure that the disinfection cycles preset in the machine properly reduce microorganism populations.
Biocompatibility Testing:
Biocompatibility testing for the 2008T 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" (04 September 2020). The following endpoints were evaluated to support the biological safety of the 2008T Machine:
- Cytotoxicity
- Sensitization, Guinea Pig Maximization
- Intracutaneous Irritation
- Material-Mediated Pyrogenicity
- Genotoxicity
- Bacterial Reverse Mutation (Ames)
- Mouse Lymphoma
- Hemocompatibility, ASTM Hemolysis (Indirect)
- Chemical Characterization
- Toxicological Risk Assessment
Human Factors Validation Testing: The changes to the hydraulics do not impact the usability of the 2008T Machine. Human Factors Validation Testing is not required to support this change to the hydraulics.
Electrical Safety and Electromagnetic Compatibility (EMC): The changes to the hydraulics do not impact the electrical safety or EMC of the 2008T Machine. No new electrical safety or EMC testing is required to support the change.
Software Verification and Validation Testing: No software changes were made as a result of the changes to the hydraulics. No new software verification or validation testing is required to support the change.
Animal Studies: No animal studies were performed on the device.
Clinical Studies: Clinical studies were not performed on the device.
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.”
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October 27, 2022
Fresenius Medical Care Renal Therapies Group, LLC Denise M. Oppermann Sr. Director Regulatory Affairs 920 Winter Street Waltham, Massachusetts 02451
Re: K22952
Trade/Device Name: 2008T BlueStar™ Hemodailysis Machine Regulation Number: 21 CFR 876.5860 Regulation Name: High Permeability Hemodialysis System Regulatory Class: II Product Code: KDI Dated: September 26, 2022 Received: September 27, 2022
Dear Denise Oppermann:
We have reviewed vour 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. 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 located 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.
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
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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,
Gema Gonzalez -S
Gema Gonzalez Acting 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
2
Indications for Use
510(k) Number (if known) K22952
Device Name 2008T BlueStar Hemodialysis Machine
Indications for Use (Describe)
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 Ultratiltration, Sustained Low Efficiency Dialysis (SLED), and low volume hemodialysis (patients weighing ≥ 20 kg). This machine accommodates the use of both low flux and high flux dialyzers. The SLED therapy option is not to 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 hurse, under physician direction, intervenes (i.e., increases 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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K22952
న. 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) 996-9103 |
| Fax: | (781) 699-9635 |
| Contact Person: | Denise Oppermann, Senior Director |
| Preparation Date: | 9 September 2022 |
5.2. 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 |
5.3. Legally Marketed Predicate Devices
The predicate device for the 2008T BlueStar Hemodialysis Machine (hereinafter referred to as the "2008T Machine") is the 2008T BlueStar Hemodialysis Machine cleared under K173972.
5.4. Device Description
5.4.1. Device Identification
The 2008T Machines with updated hydraulics will be implemented on new 2008T Machines. The 2008T Machines are available in four (4) configurations (Table 1).
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
Table 1: 2008T Machine Configuration
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Image /page/4/Picture/0 description: The image contains the logo for Fresenius Medical Care. On the left side of the logo, there are three downward-pointing chevron shapes stacked on top of each other. To the right of the chevrons, the text "FRESENIUS MEDICAL CARE" is written in a bold, sans-serif font. The logo is in blue.
| Part Number | Description |
|---|---|
| 191130 | 2008T HD Sys. W/O CDX W/bibag BLUESTAR |
Device Characteristics 5.4.2.
The 2008T 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 Machine is intended for use in healthcare facilities, such as hospitals and dialysis clinics where intermittent dialysis treatment is performed.
5.4.4. Brief Written Description of the Device
The 2008T 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 through platinum cross-linked silicone tubing. Balancing chambers control the dialysate during treatment. During treatment, the extracorporeal blood circuit is monitored for venous and arterial blood pressures as well as for the presence of air and blood. The 2008T Machine accommodates the following accessory devices and options:
Accessories
- DIASAFE®plusus Filter (K182367)
- Patient Card (K173972) ●
- Patient Card Reader (K173972) ●
- Bloodlines: 6.35 mm and 8 mm (K962081, K000451, K001107, K022536, K070049, K120823, and K201207)
- Dialyzers: Any commercially available dialyzer equipped with ISO 8637 standard ● dialysis connectors
- 2008T BlueStar Hemodialysis Machine Field Upgrade Kits (K173972)
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)
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Image /page/5/Picture/1 description: The image contains the logo for Fresenius Medical Care. On the left side of the logo is a blue icon that looks like three chevrons stacked on top of each other. To the right of the icon is the text "FRESENIUS MEDICAL CARE" in blue, with "FRESENIUS" on top of "MEDICAL CARE".
- 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) ●
Materials of Use
The 2008T Machine is classified as an externally communicating, blood path, indirect, prolonged contact (> 24 hours to 30 days) duration, (Category B) device in accordance with 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 (04 September 2020). A list of the hydraulic materials for the machine is provided in Table 2.
| Component Material | Material Type |
|---|---|
| Plastic/Rubber | PPE+PS (Polyphenylene ether + polystyrene) |
| Plastic/Rubber | EPDM (Ethylene propylene diene monomer rubber) |
| Plastic/Rubber | PP (Polypropylene) |
| Plastic/Rubber | PVDF (Polyvinylidene fluoride) |
| Plastic/Rubber | PVC (Polyvinyl chloride) |
| Plastic/Rubber | PPSU (Polyphenylsulfone) |
| Plastic/Rubber | PESU (Polyethersulfone) |
| Plastic/Rubber | PPS (Polyphenylene Sulfide) |
| Plastic/Rubber | PTFE (Polytetrafluoroethylene) |
| Plastic/Rubber | PEEK (Polyetheretherketone) |
| Plastic/Rubber | Polyamide (glass fiber reinforced nylon) |
| Plastic/Rubber | Polyester Monofilament |
| Plastic/Rubber | Platinum Cross-linked Silicone |
| Metals | Titanium |
| Metals | Stainless Steel |
| Metals | Tantalum |
| Other | Borosilicate Glass |
| Other | Graphite |
| Other | Ceramic |
Table 2: Machine Hydraulic Materials
Key Performance Specifications/Characteristic 5.4.5.
The key performance specifications and characteristics for the 2008T Machine are outlined in Table 3.
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Image /page/6/Picture/0 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 downward-pointing chevrons stacked on top of each other.
2008T BlueStar Hemodialysis Machine Traditional 510(k) K222952
| 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 | |
| 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 | |
| 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 (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) |
| Feature | Specification/Characteristic |
| Dialysis Time | Hemodialysis: 0 – 9:59 hours, time can be adjusted manually
SLED: Fixed at 12 hours
Accuracy: $\pm$ 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)
Monitoring conductivity average accuracy: $\pm$ 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: $\pm$ 0.3°C |
| Heparin Delivery Rate | 0 – 9.9 mL/hr
Accuracy: $\pm$ 5% |
Table 3: Key Performance Characteristics
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Image /page/7/Picture/1 description: The image contains the logo for Fresenius Medical Care. On the left side of the logo, there are three downward-pointing arrows stacked on top of each other. To the right of the arrows, the text "FRESENIUS" is on the top line, and "MEDICAL CARE" is on the bottom line. The text and arrows are in blue.
Table 3: Key Performance Characteristics
ર.ર. Intended Use
The intended use of the 2008T Machine is identical to the predicate 2008T BlueStar Hemodialysis Machine's intended use.
The 2008T Machine is intended for use in acute and chronic hemodialysis therapy.
5.6. 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 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):
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2008T BlueStar Hemodialysis Machine Traditional 510(k) K222952
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 monitor provides, the clinician/nurse, under physician direction, intervenes (i.e., increases or decreases the rate at which fluid is removed from the blood) in order to remove the maximum amount of fluid from the dialysis patient without the patient experiencing the common complications of dialysis which include nausea, cramping and vomiting.
5.7. Comparison of Technological Characteristics with the Predicate Device
The following technological characteristics of the 2008T Machine are substantially equivalent to those of the predicate 2008T BlueStar Hemodialysis Machine (K173872):
- Intended Use
- Indications for Use ●
- Design Specifications
- Technological Characteristics ●
- Principle of Operation
- Performance Requirements ●
5.8. Disinfection Testing
The 2008T Machine is provided non-sterile. The components are disinfected using either heat disinfection or chemical (bleach) disinfection using the pre-programmed machine disinfection cycle. The machine disinfection cycle has been validated to ensure an appropriate log reduction of bacteria and prevention of biofilm overgrowth in the hydraulics of the machine.
Performance Data 5.9.
Performance testing to support the determination of substantial equivalence of the 2008T Machine is summarized in Table 4.
| Test Conducted | Test Objective |
|---|---|
| Functional Tests – Long Term Aging | Verify that the machine hydraulics will not have leaks or |
| failures after seven (7) years of aging when performing | |
| cleaning, heat disinfection, or chemical disinfection | |
| Residual Disinfectant | Ensure that residuals from chemical disinfection are reduced |
| to an acceptable level |
Table 4: 2008T Machine Performance Testing Summary
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Image /page/9/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.
| Test Conducted | Test Objective |
|---|---|
| Inlet and Drain Hose Functional | |
| Tests | Ensure that the inlet and drain hoses can be properly |
| connected, withstand pressure and heat, and are the proper | |
| size and color | |
| Shunt Interlock Functional Tests | Verify that the shunt interlock performs as intended and the |
| components do not fail or leak | |
| Water Inlet Plate Functional Tests | Verify that the water inlet plate performs as intended and |
| withstands expected pressures, temperatures, and chemical | |
| exposure | |
| Disinfection Validation Testing | Ensure that the disinfection cycles preset in the machine |
| properly reduce microorganism populations |
Table 4: 2008T Machine Performance Testing Summary
5.9.1. Biocompatibility Testing
Biocompatibility testing for the 2008T 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" (04 September 2020). The following endpoints were evaluated to support the biological safety of the 2008T Machine:
- Cytotoxicity
- Sensitization, Guinea Pig Maximization
- Intracutaneous Irritation ●
- Material-Mediated Pyrogenicity
- Genotoxicity
- Bacterial Reverse Mutation (Ames) -
- Mouse Lymphoma -
- Hemocompatibility, ASTM Hemolysis (Indirect)
- Chemical Characterization ●
- Toxicological Risk Assessment ●
Human Factors Validation Testing
The changes to the hydraulics do not impact the usability of the 2008T Machine. Human Factors Validation Testing is not required to support this change to the hydraulics.
5.9.2. Electrical Safety and Electromagnetic Compatibility (EMC)
The changes to the hydraulics do not impact the electrical safety or EMC of the 2008T Machine. No new electrical safety or EMC testing is required to support the change.
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Image /page/10/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 chevrons stacked on top of each other, pointing downwards. The text is in a bold, sans-serif font, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.
5.9.3. Software Verification and Validation Testing
No software changes were made as a result of the changes to the hydraulics. No new software verification or validation testing is required to support the change.
5.9.4. Animal Studies
No animal studies were performed on the device.
Clinical Studies 5.9.5.
Clinical studies were not performed on the device.
Conclusion 5.10.
The Indications for Use, technological characteristics, design, and performance requirements of the 2008T BlueStar Hemodialysis Machine and its components are substantially equivalent to those of the predicate device (K173972). FMCRTG concludes that, within the meaning of the Medical Device Amendments Act of 1976, the 2008T Machine included in this submission is safe and effective for its intended use.