(230 days)
No
The document describes a standard electromechanical hemodialysis machine with software control for fluid flow, mixing, and alarms. There is no mention of AI or ML in the device description, intended use, or performance studies. The optional Crit-Line Clip Monitor provides real-time data for clinician intervention, but it does not describe any AI/ML-driven decision support or automated adjustments.
Yes.
The device is indicated for acute and chronic dialysis therapy, which is a treatment to remove waste products and excess fluid from the blood when the kidneys are unable to do so, thus directly affecting a medical condition.
No
The 2008T BlueStar Hemodialysis Machine is a treatment device, indicated for acute and chronic dialysis therapy. While it monitors various parameters, its primary function is therapeutic (dialysis), not diagnostic. The Crit-Line Clip Monitor (CLiC), an optional component, does measure diagnostic parameters (hematocrit, oxygen saturation, percent change in blood volume), but the question asks about the hemodialysis machine itself which is a treatment device.
No
The device description explicitly states that the 2008T BlueStar Hemodialysis Machine is an "electromechanical device" and describes its hardware components and functions (pumping blood, dialyzer, balancing chambers, monitoring pressures). While software controls the machine, it is an integral part of a physical medical device, not a standalone software product.
Based on the provided information, the 2008T BlueStar Hemodialysis Machine itself is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The primary intended use of the 2008T BlueStar Hemodialysis Machine is for acute and chronic dialysis therapy. This is a treatment, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details an electromechanical device that controls and monitors the process of removing waste products and excess fluid from the blood. This is a therapeutic function.
- Lack of In Vitro Testing: The device does not perform tests on biological samples (like blood, urine, or tissue) outside of the body to diagnose a condition or provide information about a patient's health status.
However, the optional components have different classifications:
- bibag System: The bibag system is a component used with the hemodialysis machine to prepare the dialysate fluid. While it's part of the dialysis process, it's not performing a diagnostic test itself. It's more of a consumable/accessory for the therapy.
- Crit-Line Clip Monitor (CLiC): The CLiC monitor is likely an IVD. Its intended use is to noninvasively measure hematocrit, oxygen saturation, and percent change in blood volume. These are measurements taken from the patient's blood (even if non-invasively) to provide information about their physiological state during dialysis. This fits the definition of an IVD, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
In summary:
- 2008T BlueStar Hemodialysis Machine: Not an IVD (Therapeutic device)
- bibag System: Not an IVD (Accessory for therapy)
- Crit-Line Clip Monitor (CLiC): Likely an IVD (Diagnostic/monitoring device)
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 ≥ 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 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.
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, 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 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, 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
patients weighing ≥ 20 kg and ≤ 40 kg
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, clinician/nurse, physician
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 substantial equivalence, safety, and efficacy of the 2008T BlueStar Hemodialysis Machine.
Biocompatibility Testing: 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" (04 September 2020), the 2008T BlueStar Hemodialysis Machine hydraulics assembly is classified as an externally communicating, indirect blood contact, and prolonged exposure (> 24 hours to 30 days) Class II (Category B) device.
No changes were made to the machine's patient-contacting components. However, new blood pressure cuffs have been added to the blood pressure measurement system. Because the blood pressure cuffs are only intended to contact intact skin for transient use of blood pressure monitoring during hemodialysis treatment, they are classified as a surface, intact skin, limited contact (
§ 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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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
December 6, 2023
Fresenius Medical Care Renal Therapies Group, LLC Denise Oppermann Vice President - Regulatory Affairs 920 Winter Street Waltham, Massachusetts 02451
Re: K231125
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: November 3, 2023 Received: November 3, 2023
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 (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.
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).
1
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 OS 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 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-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 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.
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-device-safety/medical-device-reportingmdr-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/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the
2
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,
Maura
Rooney -S
Digitally signed by Maura
Rooney -S
Date: 2023.12.06 17:56:22
-05'00'
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
3
Indications for Use
510(k) Number (if known)
K231125
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 Ultration, 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 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/4/Picture/0 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 downward-pointing chevron shapes stacked on top of each other, also in blue. The text "FRESENIUS MEDICAL CARE" is written in a bold, sans-serif font, with "FRESENIUS" on top of "MEDICAL CARE".
ನ. 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, Vice President |
| Preparation Date: | 19 April 2023 |
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 Device
The 2008T BlueStar Hemodialysis Machine (K173972) is the legally marketed predicate device. This device is not currently subject to a design-related recall.
The 2008T BlueStar Hemodialysis Machine (K222952) is used as a reference device.
5.4. Device Description
5.4.1. Device Identification
The device is identified as the 2008T BlueStar Hemodialysis Machine. The software version 2.5 features will be implemented on new production 2008T BlueStar Hemodialysis Machines, 2008T BlueStar Hemodialysis Machines currently on the market, and 2008T Hemodialysis Machines currently on the market (see Table 1). Clinics will be given the option to upgrade the four (4) current 2008T Hemodialysis Machine configurations and the 4 current 2008T BlueStar Hemodialysis Machine configurations with software version 2.5 via upgrade kits.
5
| Part Number | Part Number Description | Software Version 2.5 Features
Implementation |
|-------------|----------------------------------------|-------------------------------------------------|
| 190713 | 2008T Hemodialysis System with CDX | Field Upgrade |
| 190766 | 2008T Hemodialysis System with bibag | |
| 190858 | 2008T Hemodialysis System w/o CDX | |
| 190895 | 2008T GEN2 bibag without CDX | |
| 191124 | 2008T HD SYS. CDX BLUESTAR | New Production/Field Upgrade |
| 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 | |
Table 1: BlueStar Hemodialysis Machines and Field Upgrade Machines
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, and alarms.
5.4.3. 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.
Brief Written Description of the Device 5.4.4.
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:
Accessories
- DIASAFE®plusus Filter (K182367) ●
- Patient Card (K173972) ●
- Patient Card Reader (K173972)
- Bloodlines: 6.35 mm and 8 mm (K962081, K000451, K001107, K022536, K120823, and ● K201207)
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Image /page/6/Picture/0 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 downward pointing arrows 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".
- 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) ●
5.4.5. Materials of Use
The 2008T BlueStar Hemodialysis Machine hydraulics assembly 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 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) |
| 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) | |
| Polyester Monofilament | |
| Silicone |
Table 2: Machine Hydraulic Materials
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Image /page/7/Picture/0 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 top of "MEDICAL CARE".
| Component Material | Material Type |
|---|---|
| Metals | Titanium |
| Stainless Steel | |
| Tantalum | |
| Other | Borosilicate Glass |
| Graphite | |
| Ceramic |
Table 2: Machine Hydraulic Materials
Key Performance Specifications/Characteristics 5.4.6.
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 8mm 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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Image /page/8/Picture/0 description: The image contains the logo for Fresenius Medical Care. The logo consists of a stylized blue symbol on the left, resembling 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 bold, blue letters, with "FRESENIUS" on top of "MEDICAL CARE."
| 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 | | | | | | | | | | | | | | | | | | | | | | | | |
| 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% | | | | | | | | | | | | | | | | | | | | | | | | |
Table 3: Key Performance Characteristics
9
| Feature | Specification/Characteristic |
|---|---|
| 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: Kev Performance Characteristics
ર.ડ. Intended Use
The intended use of the 2008T BlueStar Hemodialysis Machine is identical to the intended use of the predicate device (K173972):
The 2008T Machine is intended for use in acute and chronic hemodialysis therapy.
Indications for Use 5.6.
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 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.
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5.7. 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 (K173972):
- Intended Use
- Indications for Use
- Design Specifications ●
- Technological Characteristics ●
- Principle of Operation ●
- Performance Requirements ●
5.8. Performance Data
Performance testing was conducted for the 2008T BlueStar Hemodialysis Machine. Results of performance testing support substantial equivalence, safety, and efficacy of the 2008T BlueStar Hemodialysis Machine.
5.8.1. Biocompatibility Testing
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" (04 September 2020), the 2008T BlueStar Hemodialysis Machine hydraulics assembly is classified as an externally communicating, indirect blood contact, and prolonged exposure (> 24 hours to 30 days) Class II (Category B) device.
No changes were made to the machine's patient-contacting components. However, new blood pressure cuffs have been added to the blood pressure measurement system. Because the blood pressure cuffs are only intended to contact intact skin for transient use of blood pressure monitoring during hemodialysis treatment, they are classified as a surface, intact skin, limited contact (