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

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

bibag System (Optional): The bibag system is used with three stream proportioning Hemodialysis Machines equipped with the bibag module such as the 2008T BlueStar Hemodialysis Machine and is intended for use in bicarbonate hemodialysis for acute and chronic renal failure. The bibag is intended for extracorporeal bicarbonate hemodialysis according to a physician's prescription.

Crit-Line Clip Monitor (CLiC) (Optional): The Crit-Line Clip Monitor is used with the 2008T BlueStar Hemodialysis Machine to non-invasively measure hematocrit, oxygen saturation and percent change in blood volume. The CLiC device measures hematocrit, percent change in blood volume and oxygen saturation in the treatment of dialysis patients with the intended purpose of providing a more effective treatment for both the dialysis patient and the clinician. Based on the data that the monitor provides, the clinician nurse, under physician direction, intervenes (i.e., increases or decreases the rate at which fluid is removed from the blood) in order to remove the maximum amount of fluid from the dialysis patient without the patient experiencing the common complications of dialysis which include nausea, cramping and vomiting.

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.

AI/ML Overview

The provided text describes specific acceptance criteria and the studies conducted to verify the performance of the 2008T BlueStar Hemodialysis Machine.

1. Table of Acceptance Criteria and Reported Device Performance:

Feature	Acceptance Criteria (Specification)	Reported Device Performance (Verification Method)
Blood Flow Rates	8 mm line: 20–600 mL/min (not available with Low Volume feature enabled). Accuracy: ± 10% tested at -200 mmHg. 6.35 mm line: 20–465 mL/min. 4.8 mm line: 10–274 mL/min. 2.6 mm line: 6–86 mL/min.	Verified through functional and performance verification testing, and regression testing. (Implied to meet specification as no deviations are reported).
Dialysate Flow Rates	Selectable increments: (0)/100 /150/200/300/400/500/600/700/800 mL/min. Auto Flow based on Blood Pump rate (Qb) for 1.5x and 2.0x Qd. (Specific Qb-Qd ranges detailed in the table). Adjusts at least 15–20 mL/min Qb. Accuracy: ± 5%.	Verified through functional and performance verification testing, and regression testing. (Implied to meet specification).
Net Fluid Removal	0–4000 mL/hr. Accuracy (on total vol. removed): ± (1% UF rate + 18 mL/hr) for 100 mL/min Qd; ± (1% UF rate + 30 mL/hr) for 500 mL/min Qd; ± (1% UF rate + 48 mL/hr) for 800 mL/min Qd.	Verified through functional and performance verification testing. (Implied to meet specification).
Dialysis Time	0-9:59 hours (adjustable). SLED fixed at 12 hours. Accuracy: ± 1 second per hour.	Verified through functional and performance verification testing. (Implied to meet specification).
Dialysis Fluid Composition	Volumetric, selectable: Acid 130–155 mEq/L Na+, Bicarbonate 20-40 mEq/L. Monitoring conductivity average accuracy: ± 1.5%.	Verified through functional and performance verification testing. (Implied to meet specification).
Dialysis Fluid Temperature	Range 35°C–39°C (alarm window auto-adjusted to 2°C above/below set point, not below 34°C (or 30°C for BTM recirculation) or above 41 °C). Accuracy: ± 0.3°C.	Verified through functional and performance verification testing. (Implied to meet specification). Lower Dialysate Temperature Limit adjusted to 34°C to comply with IEC 60601-2-16:2012.
Heparin Delivery Rate	0 – 9.9 mL/hr. Accuracy: ± 5%.	Verified through functional and performance verification testing. (Implied to meet specification).
Electrical Safety & EMC	In accordance with IEC 60601-1-2:2014.	Evaluated and verified through electrical testing.
Biocompatibility	ISO 10993 requirements for hydraulic components.	Tested via Chemical analysis Simulated-Use Leachable Extraction, Cytotoxicity, Sensitization, Irritation, Material Mediated Pyrogenicity, Hemocompatibility (Indirect Contact), Subchronic toxicity, and Risk assessment.
Software	Effectiveness of software modifications, confirmation of machine operation, essential performance, and safe operation. (Specific unit, integration, and system level verification, regression testing, and code reviews for changes meeting design inputs and good coding practices).	Unit, integration, and system level software verification testing. Functional and performance verification testing. Regression testing. Code reviews.
Mechanical Components	Functional verification for new paint, tubing organizer, Patient Card housing, keyboard, Monitor EMI ground assembly, hook for extended lines, ratio valves, UF pumps, acid and bicarbonate pumps.	Functional verification of mechanical components.
Environmental & Ship	Performs normally in temperature- and humidity-controlled environments. Withstands typical shipping and distribution hazards.	Environmental testing and ship testing.
Human Factors	New features are safe and effective for intended users, uses, and environments (for device modifications impacting usability).	Human Factors testing.
SLED Functionality	Dialysate flow rates: 100, 150, 200, 300 mL/min. Ultrafiltration Rate: 0-1000 mL/hr (10 mL/hr increments). Blood Flow Rates: 0-300 mL/min. Treatment Time: 0-12:00 (hours:minutes). Contraindicated for patients ≤ 40 kg.	Implemented and functionally identical to the predicate device.
Low Volume Hemodialysis	Restricts blood pump segment sizes to < 6.4 mm for patients 20-40 kg. Machine alarm for incorrect segment ID. Ultrafiltration Rate: 0-1000 mL/hr. Blood Flow Rate: 6-465 mL/min (depending on segment ID). Venous Pressure Monitor: -60 to +300 mmHg (± 40, 60, 80 mmHg fixed window). Arterial Pressure Monitor: -260 to +100 mmHg or -60 to +300 mmHg (± 40, 60, 80 mmHg auto-set).	Implemented and functionally identical to the predicate device.
Conductivity Testing Method	Independent Conductivity. Automatically set alarm windows ± 0.5 mS/cm around calculated conductivity (adjustable by user an additional ± 0.5 mS/cm within range). Average Accuracy: ± 1.5%.	Verified (considered substantially equivalent to manual testing).
Reinfusion Method	Assisted Reinfusion.	New mechanism of returning blood introduced (considered substantially equivalent to unassisted reinfusion).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the sample sizes (number of devices or test cases) used for each specific test mentioned (Biocompatibility, Electrical Safety, Software V&V, Mechanical, Environmental, Ship, Human Factors).
The data provenance (country of origin, retrospective/prospective) is not specified. The testing was conducted "according to existing FMCRTG procedures, protocols, declared performance standards, and guidelines of the quality system regulation (21 CFR §820)."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This section is not applicable as the document describes the performance testing of a physical medical device (hemodialysis machine) based on engineering specifications and regulatory standards, not the performance of an AI/ML algorithm that requires expert-established ground truth for a test set. Experts would be involved in the design, testing, and regulatory review processes, but their role isn't in establishing a "ground truth" for an AI model's output in the typical sense.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable for the type of device and testing described. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or for evaluating subjective interpretations, often in the context of AI models. The testing described here is focused on objective engineering performance verification.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. The document describes a hemodialysis machine, which is not an AI-assisted diagnostic or interpretive device that would typically be evaluated with a multi-reader, multi-case study comparing human readers with and without AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. The device is a hemodialysis machine, a physical piece of medical equipment, not an AI algorithm. Its performance is inherent to its mechanical and software functions, which inherently involve human operation as "human-in-the-loop."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For a device like a hemodialysis machine, "ground truth" refers to established engineering specifications, physical laws, and regulatory standards. The performance characteristics (e.g., flow rates, temperatures, pressures, accuracy) are evaluated against these predefined, objective criteria. For instance, the accuracy of blood flow rates is verified against a known, precise measurement reference. The "ground truth" is therefore:

Established engineering specifications and design requirements.
International standards (e.g., ISO 10993 for biocompatibility, IEC 60601-1-2:2014 for EMC, IEC 60601-2-16 for dialysate temperature).
Quality system regulations (21 CFR §820).

8. The sample size for the training set

This is not applicable. The device is a hemodialysis machine, not an AI/ML model that is 'trained' on data.

9. How the ground truth for the training set was established

This is not applicable as there is no "training set" for this type of medical device.

Summary

{0}------------------------------------------------

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

May 10, 2018

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

Re: K173972

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

Dear Denise Oppermann:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.

{1}------------------------------------------------

You must comply with all the Act's requirements. including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Joyce M. Whang -S

for

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known)

K173972

Device Name 2008T BlueStar Hemodialysis Machine

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

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

bibag System (Optional):

The bibag system is used with three stream proportioning Hemodialysis Machines equipped with the bibag module such as the 2008T BlueStar Hemodialysis Machine and is intended for use in bicarbonate hemodialysis for acute and chronic renal failure. The bibag is intended for extracorporeal bicarbonate hemodialysis according to a physician's prescription.

Crit-Line Clip Monitor (CLiC) (Optional):

The Crit-Line Clip Monitor is used with the 2008T BlueStar Hemodialysis Machine to non-invasively measure hematocrit, oxygen saturation and percent change in blood volume. The CLiC device measures hematocrit, percent change in blood volume and oxygen saturation in the treatment of dialysis patients with the intended purpose of providing a more effective treatment for both the dialysis patient and the clinician. Based on the data that the monitor provides, the clinician nurse, under physician direction, intervenes (i.e., increases or decreases the rate at which fluid is removed from the blood) in order to remove the maximum amount of fluid from the dialysis patient without the patient experiencing the common complications of dialysis which include nausea, cramping and vomiting.

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the Fresenius Medical Care logo. The logo consists of a blue symbol on the left and the text "FRESENIUS MEDICAL CARE" on the right, also in blue. The symbol is made up of three downward-pointing chevrons stacked on top of each other.

ട. 510(K) SUMMARY

This 510(k) Summary is in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990. The content of this 510(k) summary is provided in conformance with 21 CFR §807.92.

5.1. Submitter's Information

Name:	Fresenius Medical Care Renal Therapies Group, LLC
Address:	920 Winter StreetWaltham, MA 02451-1457
Phone:	(781) 699-4479
Fax:	(781) 699-9635
Contact Person:	Denise OppermannSenior Director, Regulatory Affairs – Devices
Preparation Date:	4 May 2018

5.2. Device Name

Trade Name:	2008T BlueStar Hemodialysis Machine
Common Name:	Dialyzer, High Permeability With or WithoutSealed Dialysate System
Classification Name:	High Permeability Hemodialysis System
Regulatory Class:	Class II per 21 CFR §876.5860
Product Code	KDI
Classification Panel:	Gastroenterology/Urology

Legally Marketed Predicate Device 5.3.

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

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

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

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

Device Description 5.4.

5.4.1. Device Identification

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

{4}------------------------------------------------

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

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

ProductCode	Product Code Description	BlueStarFeaturesImplementation
190713	2008T Hemodialysis System with CDX
190766	2008T Hemodialysis System with BIBAG	Field Upgrade
190858	2008T Hemodialysis System w/o CDX	(Standard orPremium)
190895	2008T GEN2 BIBAG without CDX
191124	2008T HD SYS. CDX BLUESTAR
191126	2008T HD SYS. CDX W/BIBAG BLUESTAR	New Production
191128	2008T HD SYS. W/O CDX BLUESTAR
191130	2008T HD SYS. W/O CDX W/BIBAG BLUESTAR

Table 1: BlueStar Hemodialysis Machines and Field Upgrade Machines

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

5.4.2. Device Characteristics

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

5.4.3. Environment of Use

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

5.4.4. Brief Written Description of the Device

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

{5}------------------------------------------------

Image /page/5/Picture/1 description: The image shows the Fresenius Medical Care logo. The logo consists of a blue symbol on the left and the text "FRESENIUS MEDICAL CARE" on the right. The symbol is made up of three downward-pointing chevrons stacked on top of each other. The text is in a bold, sans-serif font, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.

Accessories

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

Options

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

5.4.5. Materials of Use

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

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

{6}------------------------------------------------

Image /page/6/Picture/1 description: The image shows the logo for Fresenius Medical Care. The logo consists of a blue symbol on the left and the text "FRESENIUS MEDICAL CARE" on the right. The symbol is made up of three downward-pointing chevrons, stacked on top of each other. The text is in a bold, sans-serif font, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.

PPS (Polyphenylene Sulfide) -
-PPSU (Polyphenylsulfone)
PTFE (Polytetrafluoroethylene) -
PVDF (Polyvinylidene fluoride) -
EPDM (Ethylene Propylene Diene Monomer Rubber) —
-Silicone
Metals ●
- Stainless Steel -
- Tantalum Tungsten -
- -Tungsten
Glass
- Borosilicate Glass -

The hydraulic lines of the machines are in contact with the dialysate circuit. The dialysate circuit has prolonged, indirect blood contact. Modifications have been made to components of the hydraulic system. Biocompatibility testing was conducted to verify the changes.

Essential Performance Characteristics 5.4.6.

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

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

Table 2 2008T BlueStar Hemodialysis Machine Essential Performance Characteristics

{7}------------------------------------------------

Image /page/7/Picture/1 description: The image contains the Fresenius Medical Care logo. The logo consists of a blue emblem on the left and the text "FRESENIUS MEDICAL CARE" on the right. The emblem is a stylized design with three downward-pointing chevrons stacked on top of each other. The text is in a bold, sans-serif font, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.

2008T BlueStar Hemodialysis Machine Traditional 510(k)

Feature	Specification
	† Sustained Low Efficiency Dialysis (SLED)
	‡ Flow rate requires that the Allow Slow Flow option beselected in Service mode.
	The dialysate flow rates (Qd) for both 1.5x or 2.0x dialysateflow (Auto Flow), based on the Blood Pump rate (Qb).
	Qb w/1.5x Qd Qb w/2.0x Qd Qd 0 – 165* 0 – 150* 300 166 – 215* 151 – 215* 400 216 – 315* 216 – 265* 500 315 and below 265 and below 500 316 – 415 266 – 315 600 416 – 480 316 – 365 700 481 and above 366 and above 800
	Note: All flow rates are approximate. Dialysate flow will notadjust unless the blood pump is adjusted at least 15–20 mL/min.* If Auto Flow Minimum of 300 Qd is set in Service mode** If Auto Flow Minimum of 500 Qd is set in Service mode
Net Fluid Removal	0–4000 mL/hr
	Dialysate flow rate Accuracy (on total vol. removed) 100 mL/min ± (1% UF rate + 18 mL/hr) 500 mL/min ± (1% UF rate + 30 mL/hr) 800 mL/min ± (1% UF rate + 48 mL/hr)
Dialysis Time	Dialysis type Time Dialysis 0-9:59 hours* SLED Fixed at 12 hours
	*Time can be adjusted manuallyAccuracy: ± 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),

{8}------------------------------------------------

Image /page/8/Picture/0 description: The image shows the Fresenius Medical Care logo. The logo consists of a blue symbol on the left and the text "FRESENIUS MEDICAL CARE" on the right. The symbol is made up of three downward-pointing chevrons stacked on top of each other. The text is in a bold, sans-serif font, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.

Feature	Specification
Monitoring conductivity average accuracy: ± 1.5%
Dialysis Fluid Temperature	Range 35°C–39°C with alarm limit window automaticallyadjusted to 2°C above and below set point. Alarm window willnot adjust to below 34°C (or 30°C during BTM recirculationmeasurement) or above 41 °C.
Accuracy: ± 0.3°C
Heparin Delivery Rate	0 – 9.9 mL/hr
Accuracy: ± 5%

ર.ડ. Intended Use

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

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

5.6. Indications for Use

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

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

bibag System (Optional):

Crit-Line Clip Monitor (CLiC) (Optional):

The Crit-Line Clip Monitor is used with the 2008T BlueStar Hemodialysis Machine to noninvasively measure hematocrit, oxygen saturation and percent change in blood volume. The CLiC device measures hematocrit, percent change in blood volume and oxygen saturation in real time for application in the treatment of dialysis patients with the intended purpose of providing a more effective treatment for both the dialysis patient and the clinician. Based on the data that the

{9}------------------------------------------------

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

monitor provides, the clinician/nurse, under physician direction, intervenes (i.e., increases or decreases the rate at which fluid is removed from the blood) in order to remove the maximum amount of fluid from the dialysis patient without the patient experiencing the common complications of dialysis which include nausea, cramping and vomiting

5.7. Comparison of Technological Characteristics with the Predicate Device

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

{10}------------------------------------------------

Image /page/10/Picture/1 description: The image shows the logo for Fresenius Medical Care. The logo consists of a blue symbol on the left and the text "FRESENIUS MEDICAL CARE" on the right, also in blue. The symbol is made up of three chevron-like shapes stacked on top of each other, pointing downwards.

Parameter	Modified Device – 2008TBlueStar HemodialysisMachine	Primary Predicate Device –2008K2 HemodialysisMachine (K153449)	Reference Device– 2008T HemodialysisMachine (K150708)	Equivalence Discussion
Intended Use	The device is intended foracute and chronic dialysistherapy.	The device is intended foracute and chronic dialysistherapy.	The device is intended foracute and chronic dialysistherapy.	Same
Indications for Use	2008T BlueStar HemodialysisMachine: The 2008T BlueStarHemodialysis Machine isindicated for acute andchronic dialysis therapy in ahealthcare facility.	The 2008K2 HemodialysisMachine is indicated for acuteand chronic hemodialysistherapy in a healthcarefacility.	N/A. Substantial Equivalencediscussion is limited to themodified and primarypredicate devices.	Same
	Additional therapy optionsfor patients receivinghemodialysis include:Isolated Ultrafiltration,Sustained Low EfficiencyDialysis (SLED), and lowvolume hemodialysis(patientsweighing≥ 20 kgand≤ 40 kg). This machineaccommodates the use of bothlow flux and high fluxdialyzers. The SLED therapyoption is not to be used forpatients weighing ≤ 40 kg.The 2008T BlueStarHemodialysis Machine is notto be used for plasmareplacement therapies, forpatients weighing less than20 kg, or for renal therapiesusing substitution fluid	Additional therapy optionsfor patients receivinghemodialysis include:Isolated Ultrafiltration,Sustained Low EfficiencyDialysis (SLED), and lowvolume hemodialysis(patients weighing ≥ 20 kgand ≤ 40 kg). This machineaccommodates the use of bothlow flux and high fluxdialyzers. The SLED therapyoption is not to be used forpatients weighing ≤ 40 kg.The 2008K2 HemodialysisMachine is not to be used forplasma replacement therapies,for patients weighing lessthan 20 kg, or for renaltherapies using substitution fluid		Same
Parameter	Modified Device – 2008TBlueStar HemodialysisMachine	Primary Predicate Device –2008K2 HemodialysisMachine (K153449)	Reference Device– 2008T HemodialysisMachine (K150708)	Equivalence Discussion
bibag System (Optional):The bibag system is used withthree stream proportioningHemodialysis Machinesequipped with the bibagmodule such as the 2008TBlueStar HemodialysisMachine and is intended foruse in bicarbonatehemodialysis for acute andchronic renal failure. Thebibag is intended forextracorporeal bicarbonatehemodialysis according to aphysician's prescription.	Bibag functionality is notavailable on the 2008K2Hemodialysis Machine.		Substantially EquivalentThe Indications for Uselanguage for the optionalbibag system wasleveraged from thecurrently marketed(unmodified) 2008THemodialysis Machine.There were nomodifications made tothe optional bibagsystem with the 2008TBlueStar HemodialysisMachine.
Crit-Line Clip Monitor(CLiC) (Optional):The Crit-Line Clip Monitor isused with the 2008T BlueStarHemodialysis Machine tonon-invasively measurehematocrit, oxygen saturationand percent change in bloodvolume. The CLiC devicemeasures hematocrit, percentchange in blood volume andoxygen saturation in real timefor application in thetreatment of dialysis patientswith the intended purpose ofproviding a more effectivetreatment for both the dialysis	Crit-Line Clip Monitor(CLiC) functionality is notavailable on the 2008K2Hemodialysis Machine.		Substantially EquivalentThe Indications for Uselanguage for the optionalCLiC functionality wasleveraged from thecurrently marketed(unmodified) 2008THemodialysis Machine.There were nomodifications made tothe optional (CLiC)functionality with the2008T BlueStarHemodialysis Machine.
MEDICAL CARE
Parameter	Modified Device – 2008TBlueStar HemodialysisMachine	Primary Predicate Device –2008K2 HemodialysisMachine (K153449)	Reference Device– 2008T HemodialysisMachine (K150708)	Equivalence Discussion
	patient and the clinician.Based on the data that themonitor provides, theclinician/nurse, underphysician direction,intervenes (i.e., increases ordecreases the rate at whichfluid is removed from theblood) in order to remove themaximum amount of fluidfrom the dialysis patientwithout the patientexperiencing the commoncomplications of dialysiswhich include nausea,cramping and vomiting.
Dimensions		N/A. Substantial Equivalencediscussion is limited to themodified and referencedevices.
Floor Space	Approximately 54 cm wideby 63 cm deep		Approximately 54 cm wideby 63 cm deep	Same as the reference(unmodified) 2008T
Height	149 cm		149 cm	device.
OperatingTemperature andHumidity	$60°F – 100°F (15.5°C –38°C)$Relative Humidity 10% to90%, non-condensing	$60°F - 100°F (15.5°C –38°C)$Relative Humidity 10% to90%, non-condensing
Electrical
Power Supply – Main	Single phase AC 117 V ±10% 60 Hz ± 3 Hz; must beconnected to a circuit whichis equipped with a hospitalgrade receptacle and isprotected by circuit breakerand ground fault interrupter(GFI).	Single phase AC 117 V ±10% 60 Hz ± 3 Hz; must beconnected to a circuit whichis equipped with a hospitalgrade receptacle and isprotected by circuit breakerand ground fault interrupter(GFI).	Single phase AC 117 V ±10% 60 Hz ± 3 Hz; must beconnected to a circuit whichis equipped with a hospitalgrade receptacle and isprotected by circuit breakerand ground fault interrupter(GFI).	Same
MEDICAL CARE		Traditional 510(k)
Parameter	Modified Device – 2008TBlueStar HemodialysisMachine	Primary Predicate Device –2008K2 HemodialysisMachine (K153449)	Reference Device– 2008T HemodialysisMachine (K150708)	Equivalence Discussion
	chassis to ground must be< 0.2 ohm.	chassis to ground must be< 0.2 ohm.	chassis to ground must be< 0.2 ohm.
Power Consumption	Does not exceed 12.6 amps	Does not exceed 12.5 amps	Does not exceed 12.5 amps	Substantially Equivalent
Protection AgainstElectric Shock	Type: Safety class I Degree:Type BType CF: Only BPM BloodPressure Cuff	Type: Safety class I Degree:Type BType CF: Only BPM BloodPressure Cuff	Type: Safety class I Degree:Type BType CF: Only BPM BloodPressure Cuff	Same
Materials
Patient-ContactingMaterials	All direct and indirect patient-contacting materials havebeen evaluated forBiocompatibility	All direct and indirect patient-contacting materials havebeen evaluated forBiocompatibility	All direct and indirect patient-contacting materials havebeen evaluated forBiocompatibility	Same
Water
Back Flow Prevention	Integral back flow preventionprovided by external vent toatmosphere in water inletcircuit.	Integral back flow preventionprovided by external vent toatmosphere in water inletcircuit.	Integral back flow preventionprovided by external vent toatmosphere in water inletcircuit.	Same
Water Pressure	Min 20 psi; max 105 psi	Min 20 psi; max 105 psi	Min 20 psi; max 105 psi	Same
Water Temperature	Min 50°F (10°C); max 77°F(25°C)	Min 50°F (10°C); max 77°F(25°C)	Min 50°F (10°C); max 77°F(25°C)	Same
Water Quality	Current national (U.S.)Standards for the Quality ofWater:ANSI/AAMI 13959:2014,Water for hemodialysis andrelated therapiesANSI/AAMI 26722:2014,	Current national (U.S.)Standards for the Quality ofWater:ANSI/AAMI 13959:2014,Water for hemodialysis andrelated therapiesANSI/AAMI 26722:2014,	Current national (U.S.)Standards for the Quality ofWater:ANSI/AAMI 13959:2014,Water for hemodialysis andrelated therapiesANSI/AAMI 26722:2014,	Same
MEDICAL CARE				Traditional 510(k)
Parameter	Modified Device – 2008TBlueStar HemodialysisMachine	Primary Predicate Device -2008K2 HemodialysisMachine (K153449)	Reference Device- 2008T HemodialysisMachine (K150708)	Equivalence Discussion
	for hemodialysis applicationsand related therapies	for hemodialysis applicationsand related therapies	for hemodialysis applicationsand related therapies
	Other related standardsinclude:ANSI/AAMI RD62:2006,Water treatment equipmentfor hemodialysis applicationsand related therapies	Other related standardsinclude:ANSI/AAMI RD62:2006,Water treatment equipmentfor hemodialysis applicationsand related therapies	Other related standardsinclude:ANSI/AAMI RD62:2006,Water treatment equipmentfor hemodialysis applicationsand related therapies
Water ConsumptionRate	470 mL/min, typical**typical treatment conditions:dialysate flow rate500 mL/min, concentrateratio 1:44	470 mL/min, typical**typical treatment conditions:dialysate flow rate500 mL/min, concentrateratio 1:44	470 mL/min, typical**typical treatment conditions:dialysate flow rate500 mL/min, concentrateratio 1:44	Same
Drain	3 feet maximum height. Mustcomply with local codes andmust maintain a free fall airgap between drain hose andbuilding drain.3 meters (approximately 10feet) maximum drain hoselength.	3 feet maximum height. Mustcomply with local codes andmust maintain a free fall airgap between drain hose andbuilding drain.3 meters (approximately 10feet) maximum drain hoselength.	3 feet maximum height. Mustcomply with local codes andmust maintain a free fall airgap between drain hose andbuilding drain.3 meters (approximately 10feet) maximum drain hoselength.	Same
Rinsing	Temperature 37°C. Flow rate620 mL/min. Time between10 and 60 minutes (internallyselectable)	Temperature 37°C. Flow rate620 mL/min. Time between10 and 60 minutes (internallyselectable)	Temperature 37°C. Flow rate620 mL/min. Time between10 and 60 minutes (internallyselectable)	Same
Dialysate
Dialysate FlowAdjustment Range	Dialysate flow rates areselectable in the followingmL/min increments:	Dialysate flow rates areselectable in the followingmL/min increments:	N/A. Substantial Equivalencediscussion is limited to themodified and primarypredicate devices.	Same

Table 3: 2008T BlueStar Hemodialysis Machine Comparison of Technological Characteristics

{11}------------------------------------------------

Image /page/11/Picture/1 description: The image contains the logo for Fresenius Medical Care. On the left side of the logo, there are three blue chevron shapes stacked on top of each other, pointing downwards. To the right of the chevron shapes, the text "FRESENIUS MEDICAL CARE" is written in a bold, blue font. The words "FRESENIUS" and "MEDICAL CARE" are stacked on top of each other.

2008T BlueStar Hemodialysis Machine Traditional 510(k)

{12}------------------------------------------------

Image /page/12/Picture/1 description: The image shows the logo for Fresenius Medical Care. The logo consists of a blue symbol on the left and the words "FRESENIUS MEDICAL CARE" in blue on the right. The symbol is made up of three chevrons pointing downwards.

{13}------------------------------------------------

Image /page/13/Picture/1 description: The image shows the logo for Fresenius Medical Care. The logo consists of a blue abstract symbol on the left and the text "FRESENIUS MEDICAL CARE" on the right. The abstract symbol is made up of three downward-pointing chevrons, stacked on top of each other. The text is in a bold, sans-serif font, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.

{14}------------------------------------------------

Image /page/14/Picture/1 description: The image shows the Fresenius Medical Care logo. The logo consists of a blue geometric shape on the left and the words "FRESENIUS MEDICAL CARE" in blue on the right. The geometric shape is made up of three chevrons pointing downwards.

{15}------------------------------------------------

Image /page/15/Picture/0 description: The image is completely white and contains no discernible content. There are no objects, shapes, or patterns visible. The image appears to be a blank canvas.

Image: three chevrons	FRESENIUS
	MEDICAL CARE

Modified Device – 2008TBlueStar HemodialysisMachine	Primary Predicate Device –2008K2 HemodialysisMachine (K153449)	Reference Device– 2008T HemodialysisMachine (K150708)	Equivalence Discussion
(0)/100†‡/150†‡/200†‡/300†/400/500/600/700/800†Sustained Low EfficiencyDialysis (SLED)‡Flow rate requires that theAllow Slow Flow option beselected in Service mode.	(0)/100†‡/150†‡/200†‡/300†/400/500/600/700/800†Sustained Low EfficiencyDialysis (SLED)‡Flow rate requires that theAllow Slow Flow option beselected in Service mode.
Dialysate flow rates (Qd) forboth 1.5x or 2.0x dialysateflow (Auto Flow) based onblood flow rate (Qb)	Dialysate flow rates (Qd) forboth 1.5x or 2.0x dialysateflow (Auto Flow) based onblood flow rate (Qb)
Qbw/1.5xQd	Qbw/2.0xQd	Qd	Qbw/1.5xQd	Qbw/2.0xQd	Qd
0 – 165*	0 – 150*	300	0 – 165*	0 – 150*	300
166 –215*	151 –215*	400	166 –215*	151 –215*	400
216 –315*	216 –265*	500	216 –315*	216 –265*	500
315 andbelow**	265 andbelow**	500	315 andbelow**	265 andbelow**	500
316 –415	266 –315	600	316 –415	266 –315	600
416 –480	316 –365	700	416 –480	316 –365	700
481 andabove	366 andabove	800	481 andabove	366 andabove	800
	*If Auto Flow Minimum of300 Qd is set in Service mode		*If Auto Flow Minimum of300 Qd is set in Service mode

{16}------------------------------------------------

Image /page/16/Picture/1 description: The image shows the logo for Fresenius Medical Care. The logo consists of a blue symbol on the left and the words "FRESENIUS MEDICAL CARE" in blue on the right. The symbol is made up of three blue chevrons stacked on top of each other.

	MEDICAL CARE		Traditional 510(k)
Parameter	Modified Device – 2008TBlueStar HemodialysisMachine	Primary Predicate Device –2008K2 HemodialysisMachine (K153449)	Reference Device– 2008T HemodialysisMachine (K150708)	Equivalence Discussion
	** If Auto Flow Minimum of500 Qd is set in Service mode	** If Auto Flow Minimum of500 Qd is set in Service mode
Dialysate FlowAdjustment RangeAccuracy	± 5%	± 5%	± 5%	Same
Concentrate Supply
Concentrate Pressure	Max suction height 3 feet;Max supplied pressure 2 psiNote: Max supplied pressureis 10 psi with bibag kitinstalled.	Max suction height 3 feet;Max supplied pressure 2 psi	Max suction height 3 feet;Max supplied pressure 2 psiNote: Max supplied pressureis 10 psi with bibag kitinstalled.	Same as the reference(unmodified) 2008Tdevice.Bibag functionality is
				not available in theprimary predicate2008K2 device.
Proportional Mixing System
Acid	Volumetric1:44	Volumetric, selectable1:341:35.831:441:35.1	Volumetric, selectable1:341:35.831:441:35.1	Substantially Equivalent.The modified devicedoes not support the useof acetate. Theremaining dialysate ratio
Acetate	N/A	1:34	1:34	is 1:44. Thespecification is revisedto reflect the change.
Bicarbonate	Volumetric, selected withassociated acid ratio1:27.461:19.13	Volumetric, selected withassociated acid ratio1:27.461:19.13	Volumetric, selected withassociated acid ratio1:27.461:19.13	Same
	1:25.16	1:25.16	1:25.16
Parameter	Modified Device – 2008TBlueStar HemodialysisMachine	Primary Predicate Device –2008K2 HemodialysisMachine (K153449)	Reference Device– 2008T HemodialysisMachine (K150708)	Equivalence Discussion
	1:27.6	1:27.6	1:27.6
Adjustment Range	130 - 155 mEq/L Na+20 – 40 mEq/L Bicarbonate(post-reaction, after mixingwith acid and purified water).	130 - 155 mEq/L Na+20 - 40 mEq/L Bicarbonate(post-reaction, after mixingwith acid and purified water).	130 - 155 mEq/L Na+20 - 40 mEq/L Bicarbonate(post-reaction, after mixingwith acid and purified water).	Same
Optional bibag DryBicarbonate	Temperature-compensatedconductivity display withautomatically set alarmwindows ± 0.5 mS/cm aroundcalculated conductivity,limited to ± 0.4 mS/cm @24 mEq/L bicarbonate or less.With alarm window set at± 0.5 mS/cm:User can move alarm windowup or down an additional:±0.2 mS/cm @ 36 -40 mEq/L± 0.1 mS/cm @ 30 -35 mEq/Lno adjustment @ 20 -29 mEq/L	N/A. Bibag functionality isnot available on the 2008K2Hemodialysis Machine	Temperature-compensatedconductivity display withautomatically set alarmwindows ± 0.5 mS/cm aroundcalculated conductivity,limited to ± 0.4 mS/cm @24 mEq/L bicarbonate or less.With alarm window set at± 0.5 mS/cm:User can move alarm windowup or down an additional:± 0.2 mS/cm @ 40 mEq/L± 0.1 mS/cm @ 35 mEq/Lno adjustment @ 29 mEq/L	Same as the reference2008T device.The specification isrevised for clarity andremains in compliancewith requirements ofIEC 60601-2-16, clause201.12.4.4.101,Composition of theDIALYSIS FLUID.
Range of Display	10.0 – 17.0 mS/cm at 25°C.Alarm limits will not gobelow 12.5 or above16.0 mS/cm.	10.0 – 17.0 mS/cm at 25°C.Alarm limits will not gobelow 12.5 or above16.0 mS/cm.	10.0 – 17.0 mS/cm at 25°C.Alarm limits will not gobelow 12.5 or above16.0 mS/cm.	Same
Dialysate TemperatureSet Range	35°C – 39°C, selectable in0.1°C steps	35°C – 39°C, selectable in0.1°C steps	35°C – 39°C, selectable in0.1°C steps	Same
Parameter	Modified Device – 2008TBlueStar HemodialysisMachine	Primary Predicate Device –2008K2 HemodialysisMachine (K153449)	Reference Device– 2008T HemodialysisMachine (K150708)	Equivalence Discussion
DisplayedTemperature AverageAccuracy	$\pm$ 0.3°C	$\pm$ 0.3°C	$\pm$ 0.3°C	Same
Temperature Display	Range 35°C – 39°C withalarm limit windowautomatically adjusted to 2°Cabove and below set point.Alarm window will not gobelow 34°C (or 30°C duringBTM recirculationmeasurement) or above 41°C.	Range 35°C - 39°C withalarm limit windowautomatically adjusted to 2°Cabove and below set point.Alarm window will not gobelow 33°C (or 30 °C duringBTM recirculationmeasurement) or above 41°C.	Range 35°C – 39°C withalarm limit windowautomatically adjusted to 2°Cabove and below set point.Alarm window will not gobelow 33°C (or 30 °C duringBTM recirculationmeasurement) or above 41°C.	Substantially EquivalentLower DialysateTemperature Limit fornon-BTM recirculationwas raised from 33°C to34°C to comply withIEC 60601-2-16:2012.
Heat Disinfection
Temperature	83°C $\pm$ 8°C at negativetemperature coefficient(NTC) 3	83°C $\pm$ 8°C at NTC 3	83°C $\pm$ 8°C at NTC 3	Same
Flow Rate	600 mL/minPre-rinse either 10 min @600 mL/min or 20 min @ 300mL/min (user selectable).	600 mL/minPre-rinse either 7 min @600 mL/min or 20 min @300 mL/min (user selectable).10 min @ 600 mL/min forDIASAFE PLUS equippedmachines.	600 mL/minPre-rinse either 7 min @600 mL/min or 20 min @300 mL/min (user selectable).10 min @ 600 mL/min forDIASAFE PLUS equippedmachines.	Substantially EquivalentIn the modified device,DIASAFE PLUS isstandard. Thespecification is revisedaccordingly.
Time	Between 10 and 60 minutes(internally selectable)	Between 10 and 60 minutes(internally selectable)	Between 10 and 60 minutes(internally selectable)	Same
Auto Heat DisinfectPre-Rinse Time	Between 15 and 30 minutes(user selectable) @600 mL/min (standard) or350 mL/min (extended pre-rinse). Note: Heater is offduring pre-rinse.	Between 15 and 30 minutes(user selectable) @600 mL/min (standard) or350 mL/min (extended pre-rinse). Note: Heater is offduring pre-rinse.	Between 15 and 30 minutes(user selectable) @600 mL/min (standard) or350 mL/min (extended pre-rinse). Note: Heater is offduring pre-rinse.	Same
Parameter	Modified Device – 2008TBlueStar HemodialysisMachine	Primary Predicate Device –2008K2 HemodialysisMachine (K153449)	Reference Device– 2008T HemodialysisMachine (K150708)	Equivalence Discussion
Auto Heat DisinfectPressure	25 psi < pressure < 90 psi	25 psi < pressure < 90 psi	25 psi < pressure < 90 psi	Same
Chemical Disinfection
Temperature	37°C (set point applicable)	37°C (set point applicable)	37°C (set point applicable)	Same
Flow Rate	620 mL/min	620 mL/min	620 mL/min	Same
Time	Between 10 and 60 minutes(internally selectable)	Between 10 and 60 minutes(internally selectable)	Between 10 and 60 minutes(internally selectable)	Same
Blood Pump
Blood Flow Rates	Blood line	Blood flow rate	Blood lineBlood flowrate	Same
	8 mm	20-600mL/min	8 mm20-600mL/min
	6.35(displayedas 6.4) mm	20-465mL/min	6.35(displayedas 6.4) mm20-465mL/min
	4.8 mm	10-274mL/min	4.8 mm10-274mL/min
	2.6 mm	6-86 mL/min	2.6 mm6-86 mL/min
Blood Flow RateAccuracy	± 10% tested at -200 mmHg	± 10% tested at -200 mmHg	N/A. Substantial Equivalencediscussion is limited to themodified and primarypredicate devices.	Same
Level Adjust	Up Only	Up Only	Up Only	Same
Power Outage Use	The pump can be manuallyoperated with a hand crank.	The pump can be manuallyoperated with a hand crank.	The pump can be manuallyoperated with a hand crank.	Same
Single Needle System
	MEDICAL CARE		Traditional 510(k)
Parameter	Modified Device – 2008TBlueStar HemodialysisMachine	Primary Predicate Device –2008K2 HemodialysisMachine (K153449)	Reference Device– 2008T HemodialysisMachine (K150708)	Equivalence Discussion
Two Pump Procedure	With two blood pumps,pressure control system withalternating blood pumps.Alarm after 15 or 30 secondswithout an alternation of thepumps.	With two blood pumps,pressure control system withalternating blood pumps.Alarm after 15 or 30 secondswithout an alternation of thepumps.	With two blood pumps,pressure control system withalternating blood pumps.Alarm after 15 or 30 secondswithout an alternation of thepumps.	Same
Heparin Pump
Administration Rate	0 – 9.9 mL/hrAccuracy: ± 5%	0 – 9.9 mL/hrAccuracy: ± 5%	0 – 9.9 mL/hrAccuracy: ± 5%	Same
Monitoring	Monitoring end of stroke	Monitoring end of stroke	Monitoring end of stroke	Same
Bolus	From 0.1 mL – 9.9 mLvolume	From 0.1 mL – 9.9 mLvolume	From 0.1 mL – 9.9 mLvolume	Same
Type of Syringe	10 mL – 12 mL disposablesyringesThe syringes are identifiedwith the Vendor SyringeName and Vendor Code.BD 10 mL Syringe Only,301997BD 10 mL Safety-Lok,305564BD 10 mL Luer-Lok withNeedle, 309642BD 10 mL Syringe & NeedleCombo (WWD-Mexico),309642-20BD 10 mL Luer-Lok, 30960410 mL BD Luer-Lok with 20G x 1 in. needle, 309644	10 mL – 12 mL disposablesyringesThe syringes are identifiedwith the Vendor SyringeName and Vendor Code.BD 10 mL Syringe Only,301997BD 10 mL Safety-Lok,305564BD 10 mL Luer-Lok withNeedle, 309642BD 10 mL Syringe & NeedleCombo (WWD-Mexico),309642-20BD 10 mL Luer-Lok, 30960410 mL BD Luer-Lok with 20G x 1 in. needle, 309644	N/A. Substantial Equivalencediscussion is limited to themodified and primarypredicate devices.	SameAdditional heparinsyringes, initiallyreviewed and clearedwith the predicate2008K2, have beenvalidated for use on themodified 2008Tmachine's heparin pump(Section 18).
MEDICAL CARE		Traditional 510(k)
Parameter	Modified Device – 2008TBlueStar HemodialysisMachine	Primary Predicate Device –2008K2 HemodialysisMachine (K153449)	Reference Device– 2008T HemodialysisMachine (K150708)	Equivalence Discussion
	Covidien/Kendall Monoject12 mL Luer-Lock (relabeledas 10 mL), 1181200777T	Covidien/Kendall Monoject12 mL Luer-Lock (relabeledas 10 mL), 1181200777T
	Covidien/Kendall Monoject12 cc Luer Lock, 1181200777	Covidien/Kendall Monoject12 cc Luer Lock, 1181200777
	Terumo 10 cc Luer Lock TipSyringe without Needle, SS-10L	Terumo 10 cc Luer Lock TipSyringe without Needle, SS-10L
	B. Braun 10 mL Injekt Luer-Lock, 4606728V-02	B. Braun 10 mL Injekt Luer-Lock, 4606728V-02
	B. Braun 10 mL Luer-Lock,4617100V-02	B. Braun 10 mL Luer-Lock,4617100V-02
	Nipro 10 cc Luer-Lockwithout needle, JD+10L-WEI	Nipro 10 cc Luer-Lockwithout needle, JD+10L-WEI
	Nipro 10 cc Luer-Lock,JD+10L2025-WEI	Nipro 10 cc Luer-Lock,JD+10L2025-WEI
	Sol-Care 10 mL Luer-LockSafety Syringe withoutNeedle, 120008IM	Sol-Care 10 mL Luer-LockSafety Syringe withoutNeedle, 120008IM
	SOL-M 10 mL Luer LockSyringe without Needle,180010	SOL-M 10 mL Luer LockSyringe without Needle,180010
Monitoring Elements: Blood Circuit
Arterial PressureMonitor (Standard)	-300 mmHg to +500 mmHgwith 3 automatically set time-delayed alarm window limitvalues (± 60 mmHg, ±80 mmHg, and ± 100 mmHgof actual pressure (SingleNeedle ± 80 mmHg)).	-300 mmHg to +500 mmHgwith 3 automatically set time-delayed alarm window limitvalues (± 60 mmHg, ±80 mmHg, and ± 100 mmHgof actual pressure (SingleNeedle ± 80 mmHg)).	-300 mmHg to +500 mmHgwith 3 automatically set time-delayed alarm window limitvalues (± 60 mmHg, ±80 mmHg, and ± 100 mmHgof actual pressure (SingleNeedle ± 80 mmHg)).	Same
Venous PressureMonitor (Standard)	-80 mmHg to +500 mmHgwith 3 fixed window limit	-80 mmHg to +500 mmHgwith 3 fixed window limit	-80 mmHg to +500 mmHgwith 3 fixed window limit	Same
	MEDICAL CARETraditional 510(k)
Parameter	Modified Device – 2008TBlueStar HemodialysisMachine	Primary Predicate Device -2008K2 HemodialysisMachine (K153449)	Reference Device– 2008T HemodialysisMachine (K150708)	Equivalence Discussion
	values of ± 60 mmHg,± 80 mmHg, and± 100 mmHg of actualpressure. There is also anasymmetric range initially setto ± 80 mmHg whichincreases the lower limit after60 seconds (Single Needle± 80 mmHg).	values of ± 60 mmHg,± 80 mmHg, and± 100 mmHg of actualpressure. There is also anasymmetric range initially setto ± 80 mmHg whichincreases the lower limit after60 seconds (Single Needle± 80 mmHg).	values of ± 60 mmHg,± 80 mmHg, and± 100 mmHg of actualpressure. There is also anasymmetric range initially setto ± 80 mmHg whichincreases the lower limit after60 seconds (Single Needle± 80 mmHg).
Accuracy	± 20 mmHg or ± 10% ofindicated reading, whicheveris greater	± 20 mmHg or ± 10% ofindicated reading, whicheveris greater	± 20 mmHg or ± 10% ofindicated reading, whicheveris greater	Same
TMP Monitor	+60 mmHg to -520 mmHgwith automatically set time-delayed window limit valuesof ± 60 mmHg (conventionaldialysis) and ± 40 mmHg(high flux dialysis).Compensation for upwarddrift.	+60 mmHg to -520 mmHgwith automatically set time-delayed window limit valuesof ± 60 mmHg (conventionaldialysis) and ± 40 mmHg(high flux dialysis).Compensation for upwarddrift.	+60 mmHg to -520 mmHgwith automatically set time-delayed window limit valuesof ± 60 mmHg (conventionaldialysis) and ± 40 mmHg(high flux dialysis).Compensation for upwarddrift.	Same
Level Detector	Ultrasonic impulses detectfluid level in the dripchamber.	Ultrasonic impulses detectfluid level in the dripchamber.	Ultrasonic impulses detectfluid level in the dripchamber.	Same
Optical Sensor	Optical transmission used todetect opaque or non-opaquefluid presence in the bloodtubing.	Optical transmission used todetect opaque or non-opaquefluid presence in the bloodtubing.	Optical transmission used todetect opaque or non-opaquefluid presence in the bloodtubing.	Same
Clamp	Closes with any blood alarm	Closes with any blood alarm	Closes with any blood alarm	Same
Level Adjust	Allows the level in the dripchamber to rise to maintainthe desired fluid level in thedrip chamber	Allows the level in the dripchamber to rise to maintainthe desired fluid level in thedrip chamber	Allows the level in the dripchamber to rise to maintainthe desired fluid level in thedrip chamber	Same
Parameter	Modified Device – 2008TBlueStar HemodialysisMachine	Primary Predicate Device -2008K2 HemodialysisMachine (K153449)	Reference Device- 2008T HemodialysisMachine (K150708)	Equivalence Discussion
Blood Pump speedand direction monitors	Optical speed tachometer,Hall-effect direction sensorAlarm Limits: 30 seconddelay, maximum	Optical speed tachometer,Hall-effect direction sensorAlarm Limits: 30 seconddelay, maximum	Optical speed tachometer,Hall-effect direction sensorAlarm Limits: 30 seconddelay, maximum	Same
Blood Leak Detector	Two color light sourcetransmitter/sensorResolution:minor ≥ 0.35 mL/min ofblood (hematocrit = 25%)alarm ≥ 0.45 mL/min ofblood (hematocrit = 25%)	Two color light sourcetransmitter/sensorResolution:minor ≥ 0.35 mL/min ofblood (hematocrit = 25%)alarm ≥ 0.45 mL/min ofblood (hematocrit = 25%)	Two color light sourcetransmitter/sensorResolution:minor ≥ 0.35 mL/min ofblood (hematocrit = 25%)alarm ≥ 0.45 mL/min ofblood (hematocrit = 25%)	Same
UF Pump VolumeAccuracy	± 1% (for Pdi > -500 mbar)where Pdi = dialysate pressureon the inlet side of thedialyzer	± 1% (for Pdi > -500 mbar)where Pdi = dialysate pressureon the inlet side of thedialyzer	± 1% (for Pdi > -500 mbar)where Pdi = dialysate pressureon the inlet side of thedialyzer	Same
Fluid Removal Ratefrom Patient	0 – 4000 mL/hrDialysate flow rate at100 mL/min: Accuracy (ontotal volume removed): ± (1%UF rate + 18 mL/hr)Dialysate flow rate at500 mL/min: Accuracy (ontotal volume removed): ± (1%UF rate + 30 mL/hr)Dialysate flow rate at800 mL/min: Accuracy (ontotal volume removed): ± (1%UF rate + 48 mL/hr)	0 – 4000 mL/hrDialysate flow rate at100 mL/min: Accuracy (ontotal volume removed): ± (1%UF rate + 18 mL/hr)Dialysate flow rate at500 mL/min: Accuracy (ontotal volume removed): ± (1%UF rate + 30 mL/hr)Dialysate flow rate at800 mL/min: Accuracy (ontotal volume removed): ± (1%UF rate + 48 mL/hr)	0 – 4000 mL/hrDialysate flow rate at100 mL/min: Accuracy (ontotal volume removed): ± (1%UF rate + 18 mL/hr)Dialysate flow rate at500 mL/min: Accuracy (ontotal volume removed): ± (1%UF rate + 30 mL/hr)Dialysate flow rate at800 mL/min: Accuracy (ontotal volume removed): ± (1%UF rate + 48 mL/hr)	Same
Adjustment Range ofUF Rate (Dialysis)	Volumetric Control, Adjustedin 10 mL increments.	Volumetric Control, Adjustedin 10 mL increments.	Volumetric Control, Adjustedin 10 mL increments.	Same
MEDICAL CARE
Parameter	Modified Device – 2008TBlueStar HemodialysisMachine	Primary Predicate Device -2008K2 HemodialysisMachine (K153449)	Reference Device– 2008T HemodialysisMachine (K150708)	Equivalence Discussion
Dialysis	Dialysis: 0 – 4000 mL/hrDialysis settings:1000 mL/hr, 2000 mL/hr,3000 mL/hr, and 4000 mL/hr	Dialysis: 0 - 4000 mL/hrDialysis settings:1000 mL/hr, 2000 mL/hr,3000 mL/hr, and 4000 mL/hr	Dialysis: 0 – 4000 mL/hrDialysis settings:1000 mL/hr, 2000 mL/hr,3000 mL/hr, and 4000 mL/hr
UF Time	Digital Display (0 - 9:59 hrs),selectable in increments of1 min	Digital Display (0 - 9:59 hrs),selectable in increments of1 min	Digital Display (0 - 9:59 hrs),selectable in increments of1 min	Same
UF Goal	Digital Display(0 - 9,990 mL), selectable inincrements of 10 mL	Digital Display(0 - 9,990 mL), selectable inincrements of 10 mL	Digital Display(0 - 9,990 mL), selectable inincrements of 10 mL	Same
UF Profiles	Eight UF profiles areavailable for the removal offluid from the patient. Fourare preset and four may bedefined by the user.	Eight UF profiles areavailable for the removal offluid from the patient. Fourare preset and four may bedefined by the user.	Eight UF profiles areavailable for the removal offluid from the patient. Fourare preset and four may bedefined by the user.	Same
Remaining Time ofDialysis (RTD)	0 – 9:59 hours auto transferfrom UF time, counting downin 1-minute increments. Canadjust manually.	0 – 9:59 hours auto transferfrom UF time, counting downin 1-minute increments. Canadjust manually.	0 – 9:59 hours auto transferfrom UF time, counting downin 1-minute increments. Canadjust manually.	Same
UF Removed Display	Digital display max 9,999 mLcounting in 1 mL increments.	Digital display max 9,999 mLcounting in 1 mL increments.	Digital display max 9,999 mLcounting in 1 mL increments.	Same
Fluid Removal RateMonitoring	Alarm Limit: 300 mL/hrminimum (Diasafe Plusinstalled)Online Pressure Holding testfor hydraulic leak detection(detects leaks in the systemgreater than 300 mL/hr)	Alarm Limit: 300 mL/hrminimum (Diasafe Plusinstalled)Online Pressure Holding testfor hydraulic leak detection(detects leaks in the systemgreater than 300 mL/hr)	Alarm Limit: 300 mL/hrminimum (Diasafe Plusinstalled)Online Pressure Holding testfor hydraulic leak detection(detects leaks in the systemgreater than 300 mL/hr)	Same
Parameter	Modified Device – 2008TBlueStar HemodialysisMachine	Primary Predicate Device –2008K2 HemodialysisMachine (K153449)	Reference Device– 2008T HemodialysisMachine (K150708)	Equivalence Discussion
Additional Monitoring	Alarm in case of powerfailure.Alarm in case of watershortage.	Alarm in case of powerfailure.Alarm in case of watershortage.	Alarm in case of powerfailure.Alarm in case of watershortage.	Same
Functional Options
Access Flow (Qa)(Optional, requiresOnline Clearance(OLC))	Minimum Qa: Will notdetermine the Qa if less thanthe blood pump speed.Maximum Qa: 2000 mL/min	Minimum Qa: Will notdetermine the Qa if less thanthe blood pump speed.Maximum Qa: 2000 mL/min	Minimum Qa: Will notdetermine the Qa if less thanthe blood pump speed.Maximum Qa: 2000 mL/min	Same
Online Clearance(Optional)	Dialysate Flow rate:300 mL/min – 800 mL/min# of online clearance tests: 1– 6 during each treatment	Dialysate Flow rate:300 mL/min – 800 mL/min# of online clearance tests: 1– 6 during each treatment	Dialysate Flow rate:300 mL/min – 800 mL/min# of online clearance tests: 1– 6 during each treatment	Same

{17}------------------------------------------------

Image /page/17/Picture/1 description: The image shows the logo for Fresenius Medical Care. The logo consists of a blue symbol on the left and the words "FRESENIUS MEDICAL CARE" in blue on the right. The symbol is made up of three blue chevrons stacked on top of each other.

2008T BlueStar Hemodialysis Machine Traditional 510(k)

{18}------------------------------------------------

Image /page/18/Picture/1 description: The image contains the logo for Fresenius Medical Care. The logo consists of a blue geometric shape on the left, resembling a stylized downward-pointing arrow or chevron. To the right of the shape are the words "FRESENIUS MEDICAL CARE" in bold, blue letters, arranged in two lines. The text is aligned to the left and positioned next to the geometric shape.

2008T BlueStar Hemodialysis Machine Traditional 510(k)

{19}------------------------------------------------

Image /page/19/Picture/0 description: The image shows the logo for Fresenius Medical Care. The logo consists of a blue symbol on the left and the company name on the right. The symbol is made up of three downward-pointing chevrons, stacked on top of each other. The company name is written in blue, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.

2008T BlueStar Hemodialysis Machine Traditional 510(k)

{20}------------------------------------------------

Image /page/20/Picture/1 description: The image shows the logo for Fresenius Medical Care. The logo consists of a blue symbol on the left and the text "FRESENIUS MEDICAL CARE" on the right. The symbol is made up of three blue chevrons pointing downwards. The text is in a bold, sans-serif font, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.

{21}------------------------------------------------

Image /page/21/Picture/1 description: The image contains the logo for Fresenius Medical Care. The logo consists of a blue emblem on the left and the text "FRESENIUS MEDICAL CARE" on the right, also in blue. The emblem is a stylized design featuring three downward-pointing chevrons stacked on top of each other. The text is arranged in two lines, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.

{22}------------------------------------------------

Image /page/22/Picture/1 description: The image shows the logo for Fresenius Medical Care. The logo consists of a blue geometric shape on the left, resembling three downward-pointing chevrons stacked on top of each other. To the right of the geometric shape, the words "FRESENIUS MEDICAL CARE" are written in blue, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.

{23}------------------------------------------------

Image /page/23/Picture/1 description: The image contains the logo for Fresenius Medical Care. The logo consists of a blue emblem on the left and the company name on the right. The emblem is made up of three chevron shapes stacked on top of each other, pointing downwards.

{24}------------------------------------------------

Image /page/24/Picture/1 description: The image shows the logo for Fresenius Medical Care. The logo consists of a blue geometric shape on the left and the text "FRESENIUS MEDICAL CARE" on the right. The geometric shape is made up of three chevrons pointing downwards. The text is in a bold, sans-serif font, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.

{25}------------------------------------------------

Image /page/25/Picture/1 description: The image shows the logo for Fresenius Medical Care. The logo consists of a blue symbol on the left and the text "FRESENIUS MEDICAL CARE" on the right. The symbol is made up of three downward-pointing chevrons stacked on top of each other. The text is in a bold, sans-serif font, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.

2008T BlueStar Hemodialysis Machine Traditional 510(k)

SLED Discussion:

The SLED functionality, reviewed and cleared with the 2008K2 Hemodialysis machine (K153449), is being implemented in the modified 2008T Bluestar Hemodialysis machine. Implementation of SLED in the modified to the predicate 2008K2 Hemodialysis machine. As with the 2008K2 device, "SLED" is a selectable treatment option on 'Select Program' screen. The labeling of the modified device reflects that the SLED functionality is contraindicated in patients weighing ≤ 40 kg.

Dialysate Flow Rates	100 mL/min, 150 mL/min,200 mL/min, and300 mL/min	100 mL/min, 150 mL/min,200 mL/min, and300 mL/min	N/A. Substantial Equivalencediscussion is limited to themodified and primarypredicate devices.	Same
Ultrafiltration Rate	Volumetric Control, adjustedin 10 mL/hr increments.0 – 1000 mL/hr	Volumetric Control, adjustedin 10 mL/hr increments.0 – 1000 mL/hr		Same
Blood Flow Rates	0 – 300 mL/min	0 – 300 mL/min	Same
Treatment Time	0 - 12:00 (hours : minutes)	0 - 12:00 (hours : minutes)	Same

{26}------------------------------------------------

Image /page/26/Picture/1 description: The image contains the logo for Fresenius Medical Care. The logo consists of a blue emblem on the left and the text "FRESENIUS MEDICAL CARE" on the right. The emblem is made up of three chevron shapes stacked on top of each other. The text is in a bold, sans-serif font and is also blue.

2008T BlueStar Hemodialysis Machine

Traditional 510(k)

Parameter	Modified Device – 2008TBlueStar HemodialysisMachine	Primary Predicate Device –2008K2 HemodialysisMachine (K153449)	Reference Device– 2008T HemodialysisMachine (K150708)	Equivalence Discussion
Low Volume Hemodialysis Discussion:
Restricts the allowable blood pump segment sizes to less than to 6.4 mm for patients weighing between 20 kg and 40 kg. Reviewed andcleared with the 2008K2 Hemodialysis machine (K153449), and is being implemented in the modified 2008T Bluestar Hemodialysismachine. The Low Volume functionality in the modified device is identical to the feature in the predicate 2008K2 device.
Ultrafiltration Rate	Volumetric Control, adjustedin 10 mL/hr increments.0 – 1000 mL/hr	Volumetric Control, adjustedin 10 mL/hr increments.0 – 1000 mL/hr	N/A. Substantial Equivalencediscussion is limited to themodified and primarypredicate devices.	Same
Blood Flow Rate	6 mL/min – 465 mL/min,depending on pumpsegment ID:2.6 mm: 6 mL/min –86 mL/min4.8 mm: 10 mL/min –274 mL/min6.35 mm: 20 mL/min –465 mL/min	6 mL/min – 465 mL/min,depending on pumpsegment ID:2.6 mm: 6 mL/min –86 mL/min4.8 mm: 10 mL/min –274 mL/min6.35 mm: 20 mL/min –465 mL/min		Same
Inner Diameter (ID)of pump segment	< 6.4 mm	< 6.4 mm		Same
Machine Alarm	A visual and audibleindication to Operatorwill occur when the bloodpump segment internaldiameter of greater than6.4 mm is used and LowVolume is set to On.	A visual and audibleindication to Operatorwill occur when the bloodpump segment internaldiameter of greater than6.4 mm is used and LowVolume is set to On.		Same
	MEDICAL CARE		Traditional 510(k)
Parameter	Modified Device – 2008TBlueStar HemodialysisMachine	Primary Predicate Device –2008K2 HemodialysisMachine (K153449)	Reference Device– 2008T HemodialysisMachine (K150708)	Equivalence Discussion
Venous PressureMonitor	Low Volume: -60 mmHg to+300 mmHg with 3 fixedwindow limit values of± 40 mmHg, ± 60 mmHg, and± 80 mmHg of set pressure.(Single Needle ± 80 mmHg).	Low Volume: -60 mmHg to+300 mmHg with 3 fixedwindow limit values of± 40 mmHg, ± 60 mmHg, and± 80 mmHg of set pressure.(Single Needle ± 80 mmHg).		Same
Arterial PressureMonitor	-260 mmHg to +100 mmHg(Pre Blood Pump) or-60 mmHg to +300 mmHg(Post Blood Pump) with 3automatically set alarm limitwindow widths (± 40, ± 60,and ± 80) mmHg centeredaround set pressure. (SingleNeedle ± 80 mmHg).	-260 mmHg to +100 mmHg(Pre Blood Pump) or-60 mmHg to +300 mmHg(Post Blood Pump) with 3automatically set alarm limitwindow widths (± 40, ± 60,and ± 80) mmHg centeredaround set pressure. (SingleNeedle ± 80 mmHg).		Same
Technique	Measures systolic, diastolicpressures, and heart rate(pulse rate) usingoscillometric method. MAPmeasured.	Measures systolic, diastolicpressures, and heart rate(pulse rate) usingoscillometric method. MAPmeasured.	N/A. Substantial Equivalencediscussion is limited to themodified and primarypredicate devices.	Same
Cuff Deflation	Interactive computercontrolled. Determination forstandard patients requiresapproximately 25 –30 seconds depending onstarting point, heart rate, andmotion artifact.	Interactive computercontrolled. Determination forstandard patients requiresapproximately 25 –30 seconds depending onstarting point, heart rate, andmotion artifact.		Same
Cuff Inflation	Typically 5 – 10 secondsfrom 0 – 250 mmHg	Typically 5 – 10 secondsfrom 0 - 250 mmHg		Same
Parameter	Modified Device – 2008TBlueStar HemodialysisMachine	Primary Predicate Device –2008K2 HemodialysisMachine (K153449)	Reference Device– 2008T HemodialysisMachine (K150708)	Equivalence Discussion
Interval Settings	Interval times: 5 – 60 minutesin increments of 5 minutesClock Time: 5, 10, 15, 20, 30,60 minutes	Interval times: 5 – 60 minutesin increments of 5 minutesClock Time: 5, 10, 15, 20, 30,60 minutes		Same
Blood PressureModule Performancelimits for Standardtherapy (> 40 kg)	Cuff PressureRange0 – 300 mmHgInitial CuffInflation180 mmHg oradjusted byhostSystolicDeterminationRange60 – 250mmHgMAPDeterminationRange45 – 220mmHgDiastolicDeterminationRange40 – 200mmHgPulse RateDetermination 40 – 200 BPMRangeCuff InflationRate5 secondsDetermination 25 – 30Time Normal secondsOverpressureCut Off300 mmHgTransducerDriftAuto ZeroingLeakage Rate(Max)3 mmHg/minin 3 minutesPressure RateOffsetAuto Zeroing	Cuff PressureRange0 – 300 mmHgInitial CuffInflation180 mmHg oradjusted byhostSystolicDeterminationRange60 – 250mmHgMAPDeterminationRange45 – 220mmHgDiastolicDeterminationRange40 – 200mmHgPulse RateDetermination 40 – 200 BPMRangeCuff InflationRate5 secondsDetermination 25 – 30Time Normal secondsOverpressureCut Off300 mmHgTransducerDriftAuto ZeroingLeakage Rate(Max)3 mmHg/minin 3 minutesPressure RateOffsetAuto Zeroing		Same
Parameter	Modified Device – 2008TBlueStar HemodialysisMachine	Primary Predicate Device –2008K2 HemodialysisMachine (K153449)	Reference Device –2008T HemodialysisMachine (K150708)	Equivalence Discussion
Alarm Preset Valuesfor Standard Therapy(> 40 kg)	Systolic	200/90	Systolic	200/90		Same
	MAP	120/70	MAP	120/70
	Diastolic	110/50	Diastolic	110/50
	Pulse	120/50	Pulse	120/50
	InflationPressure	Auto	InflationPressure	Auto
Blood PressureModule Performancelimits for LowVolume therapy(20 kg - 40 kg)	Cuff PressureRange	0 – 210 mmHg	Cuff PressureRange	0 – 210 mmHg		Same
	Initial CuffInflation	120 mmHg oradjusted byhost	Initial CuffInflation	120 mmHg oradjusted byhost
	SystolicDeterminationRange	60 – 220mmHg	SystolicDeterminationRange	60 – 220mmHg
	MAPDeterminationRange	45 – 220mmHg	MAPDeterminationRange	45 – 220mmHg
	DiastolicDeterminationRange	40 – 200mmHg	DiastolicDeterminationRange	40 – 200mmHg
	Pulse RateDeterminationRange	40 – 200 BPM	Pulse RateDeterminationRange	40 – 200 BPM
	Cuff InflationRate	5 seconds	Cuff InflationRate	5 seconds
	DeterminationTime Normal	Approx. 20seconds	DeterminationTime Normal	Approx. 20seconds
	OverpressureCut Off	210 mmHg	OverpressureCut Off	210 mmHg
	TransducerDrift	Auto Zeroing	TransducerDrift	Auto Zeroing
	Leakage Rate(Max)	3 mmHg/minin 3 minutes	Leakage Rate(Max)	3 mmHg/minin 3 minutes
MEDICAL CARE			Traditional 510(k)
Parameter	Modified Device – 2008TBlueStar HemodialysisMachine		Primary Predicate Device –2008K2 HemodialysisMachine (K153449)		Reference Device– 2008T HemodialysisMachine (K150708)	Equivalence Discussion
	Pressure RateOffset	Auto Zeroing	Pressure RateOffset	Auto Zeroing
Alarm Preset Values	Systolic	160/80	Systolic	160/80		Same
for Low VolumeTherapy (20 kg	MAP	120/60	MAP	120/60
– 40 kg)	Diastolic	100/40	Diastolic	100/40
	Pulse	120/50	Pulse	120/50
	InflationPressure	Auto	InflationPressure	Auto
Priming the Blood Circuit
Priming Method	Available methods enable theremoval of air from the bloodlines and dialyzer by allowingthe sterile saline solution toflow through them.		Available methods enable theremoval of air from the bloodlines and dialyzer by allowingthe sterile saline solution toflow through them.		Available methods enable theremoval of air from the bloodlines and dialyzer by allowingthe sterile saline solution toflow through them.	Same
Reinfusion
Reinfusion Method	Assisted Reinfusion. Assiststhe operator in returning allthe patient's blood at the endof treatment. Buttondisplayed on 'Test & Options'screen		Unassisted Reinfusion.		Unassisted Reinfusion.	Substantially Equivalent.All devices provide ameans for returningblood to the patient aftertreatment. The proposeddevice introduces a newmechanism of returningblood.
Conductivity Testing
Monitoring	Temperature compensatedelectronic conductivity meterwith adjustable alarm limits.		Temperature compensatedelectronic conductivity meterwith adjustable alarm limits.		Temperature compensatedelectronic conductivity meterwith adjustable alarm limits.	Same

{27}------------------------------------------------

Image /page/27/Picture/1 description: The image contains the logo for Fresenius Medical Care. On the left is a blue symbol that looks like three chevrons stacked on top of each other, pointing downwards. To the right of the symbol is the text "FRESENIUS MEDICAL CARE" in blue, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.

{28}------------------------------------------------

Image /page/28/Picture/1 description: The image shows the logo for Fresenius Medical Care. The logo consists of a blue geometric shape on the left and the text "FRESENIUS MEDICAL CARE" on the right. The geometric shape is made up of three chevrons stacked on top of each other.

{29}------------------------------------------------

Image /page/29/Picture/1 description: The image contains the logo for Fresenius Medical Care. The logo consists of a blue emblem on the left and the company name in blue text on the right. The emblem is made up of three downward-pointing chevron shapes stacked on top of each other. The text reads "FRESENIUS MEDICAL CARE" in a bold, sans-serif font.

2008T BlueStar Hemodialysis Machine Traditional 510(k)

{30}------------------------------------------------

Image /page/30/Picture/1 description: The image shows the logo for Fresenius Medical Care. The logo consists of a blue geometric shape on the left, resembling three downward-pointing chevrons stacked on top of each other. To the right of the shape is the text "FRESENIUS MEDICAL CARE" in blue, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.

{31}------------------------------------------------

Image /page/31/Picture/1 description: The image shows the Fresenius Medical Care logo. The logo consists of a blue symbol on the left and the words "FRESENIUS MEDICAL CARE" in blue on the right. The symbol is made up of three chevrons pointing downwards.

	MEDICAL CARE	Traditional 510(k)
Parameter	Modified Device – 2008TBlueStar HemodialysisMachine	Primary Predicate Device –2008K2 HemodialysisMachine (K153449)	Reference Device– 2008T HemodialysisMachine (K150708)	Equivalence Discussion
	Temperature-compensatedconductivity display withautomatically set alarmwindows ± 0.5 mS/cm aroundcalculated conductivity. Usercan adjust an additional± 0.5 mS/cm within thisrange.Average Accuracy: ± 1.5%	Temperature-compensatedconductivity display withautomatically set alarmwindows ± 0.5 mS/cm aroundcalculated conductivity. Usercan adjust an additional± 0.5 mS/cm within thisrange.Average Accuracy: ± 1.5%	Temperature-compensatedconductivity display withautomatically set alarmwindows ± 0.5 mS/cm aroundcalculated conductivity. Usercan adjust an additional± 0.5 mS/cm within thisrange.Average Accuracy: ± 1.5%
Conductivity TestingMethod	Independent Conductivity.Reading displayed on'Dialysate' screen when thedialysate lines are on theshunt interlock	Manual. Operator tests forproper conductivity beforeeach dialysis treatment	Manual. Operator tests forproper conductivity beforeeach dialysis treatment	Substantially Equivalent.All devices provide ameans for conductivitytesting. The proposeddevice introduces a newmechanism of measuringconductivity.

{32}------------------------------------------------

Image /page/32/Picture/0 description: The image shows the logo for Fresenius Medical Care. The logo consists of a blue symbol on the left and the text "FRESENIUS MEDICAL CARE" on the right. The symbol is made up of three downward-pointing chevrons stacked on top of each other. The text is in a bold, sans-serif font, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.

K173972 Page 30 of 32

Performance Data 5.8.

The performance of the modified device described in this submission was evaluated according to existing FMCRTG procedures, protocols, declared performance standards, and guidelines of the quality system regulation (21 CFR §820). Design verification tests confirmed that all design updates were effective, did not affect the essential performance of the device, and that the device functions as intended.

Biocompatibility Testing 5.8.1.

The 2008T BlueStar Hemodialysis Machine's hydraulic components were evaluated to ISO 10993 requirements. The Unit Under Test (UUT) included the new hardware components (acid, bicarbonate and UF pumps, extended concentrate lines and ratio valves). The following testing was performed to support the biological safety of the 2008T BlueStar HD Machine's hydraulics:

Chemical analysis Simulated-Use Leachable Extraction ●
Cytotoxicity ●
Sensitization ●
Irritation
Material Mediated Pyrogenicity
Hemocompatibility (Indirect Contact) ●
Subchronic toxicity ●
Risk assessment of potential toxicity ●

Electrical Safety and Electromagnetic Compatibility (EMC) 5.8.2.

The 2008T BlueStar Hemodialysis Machine was evaluated for electromagnetic compatibility (EMC) in accordance with IEC 60601-1-2:2014. Additional electrical testing was conducted to verify new BlueStar hardware.

Software Verification and Validation Testing 5.8.3.

Unit, integration, and system level software verification testing was performed to demonstrate the effectiveness of the software modifications and to confirm operation of the machine.

The following system level testing was performed:

Functional and performance verification testing conducted to ensure operational ● efficacy of software with the upgraded hardware
Regression testing - conducted on dialysis treatment and key safety measures to ensure the essential performance and safe operation of the system were not adversely impacted

{33}------------------------------------------------

Image /page/33/Picture/1 description: The image contains the logo for Fresenius Medical Care. The logo consists of a blue geometric shape on the left, resembling a stylized downward-pointing arrow or chevron. To the right of the shape are the words "FRESENIUS" and "MEDICAL CARE" stacked on top of each other, also in blue. The text is bold and sans-serif.

Code reviews were performed for all changes to the code. To ensure that the inputs were met and good coding practices were followed, the code reviews analyzed the following source documents:

Design inputs
Software Design Specification (SDS)
"diff files"

Mechanical Testing 5.8.4.

Functional verification of mechanical components was conducted to verify the following changes:

New paint ●
Tubing organizer ●
Patient Card housing ●
Keyboard
Monitor EMI ground assembly
Hook for extended lines ●
Ratio valves ●
UF pumps, acid and bicarbonate pumps

5.8.5. Environmental and Ship Testing

Environmental testing was performed to verify that the machine performs normally (i.e., no nonresettable alarms or unusual behavior) in the temperature- and humidity-controlled operating environment.

Ship testing was performed to verify that the machine can withstand hazards associated with the typical shipping and distribution environment. A series of reliability tests were conducted to show that the product met shipping requirements.

5.8.6. Human Factors Testing

Human Factors testing was performed on device modifications found to impact usability. FMCRTG concludes that the new features are safe and effective for the intended users, uses, and use environments.

5.9. Conclusions

The 2008T BlueStar Hemodialysis Machine's indications for use, intended use, and technological characteristics are equivalent to those of the primary predicate and reference devices. Differences between the 2008T BlueStar Hemodialysis Machine and the predicate and reference devices do not raise any new concerns with regard to safety or effectiveness. FMCRTG concludes that the proposed 2008T

{34}------------------------------------------------

Image /page/34/Picture/1 description: The image shows the Fresenius Medical Care logo. The logo consists of a blue symbol on the left and the words "FRESENIUS MEDICAL CARE" in blue on the right. The symbol is made up of three downward-pointing chevrons.

BlueStar Hemodialysis Machine is substantially equivalent to the predicate device, the 2008K2 Hemodialysis Machine (K153449) within the meaning of the Medical Device Amendments Act of 1976.

Regulation Number and Section

§ 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.”