(252 days)
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No
The summary describes a traditional hemodialysis system with software control, but there is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies.
Yes
The device is described as a "Hemodialysis system" intended for "intermittent haemodialysis and/or isolated ultrafiltration treatments of patients with chronic or acute renal failure or fluid overload," which directly addresses a medical condition and provides a treatment to alleviate or manage it.
No
The device is a hemodialysis system (AK 98 dialysis machine, U9000 Ultrafilter, C-705 Accessory Expansion Chamber) intended for the treatment of renal failure and fluid overload, not for diagnosis. Its function is to perform intermittent hemodialysis and/or isolated ultrafiltration treatments.
No
The device description clearly states that the proposed device consists of the AK 98 dialysis machine, U9000 (Ultrafilter), and C-705 (Accessory Expansion chamber), all of which are hardware components. While the AK 98 machine is software-controlled, the submission describes a system that includes physical devices for hemodialysis.
Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use of the Baxter AK 98 dialysis machine, U9000 Ultrafilter, and C-705 Accessory Expansion Chamber is for treating patients with renal failure or fluid overload through hemodialysis and/or ultrafiltration. This is a therapeutic treatment performed directly on the patient's blood, not a diagnostic test performed on a sample taken from the body.
- Device Description: The descriptions clearly outline the function of each component in the hemodialysis process, which involves filtering and treating blood outside the body and returning it to the patient.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze a sample (like blood, urine, or tissue) to provide information for the diagnosis, monitoring, or screening of a disease or condition.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body. The Baxter AK 98 system is used in vivo (on the living body) to perform a therapeutic procedure.
N/A
Intended Use / Indications for Use
The Baxter AK 98 dialysis machine is intended to be used for intermittant haemodialysis and/or isolated ultrafiltration treatments of patients with chronic or acute renal failure or fluid overload upon prescription by a physician. The AK 98 dialysis machine is indicated to be used on patients with a body weight of 25 kg or more. The AK 98 dialysis machine is intended to be used by trained operators when prescribed by a physician, in a chronic care dialysis or hospital care environment. The Baxter AK 98 dialysis machine is not intended for Selfcare or Home use.
The U9000 Ultrafilter is indication of incoming water for dialysis fluid as well as purification of dialysis fluid to obtain standard dialysis fluid in accordance with international standards requirements and local regulations. The risk of exposure to bacteria and endotoxins can thereby be minimized. The U9000 Ultrafilter is intended to be used in conjunction with a water treatment system.
C-705 Accessory Expansion Chamber is a single use sterile medical device intended to be used during the delivery of Hemodialysis treatment in Single Needle mode, on patients affected by chronic renal failure. The C-705 Accessory Expansion Chamber is an ancillary device used to allow the conversion from Double Needle to Single Needle administration mode of treatments, after connection to proper Blood Tubing System intended for Haemodialysis treatment in Double Needle mode and to a Dialyzer filter. C-705 Accessory Expansion Chamber shall be used in combination with Blood Tubing System suitable for AK 98 haemodialysis delivery system only. The total extracorporeal blood volume for the extracorporeal circuit including the set, dialyzer and accessories should represent less than 10% of the patient's blood volume.
Product codes (comma separated list FDA assigned to the subject device)
KDI, FIP, FJK
Device Description
The proposed device AK 98 Hemodialysis system, which is subject for this Traditional 510(k) premarket notification, consists of the following:
- AK 98 dialysis machine
- U9000 (Ultrafilter)
- C-705 (Accessory Expansion chamber)
AK 98 is a standalone, software controlled hemodialysis machine intended to be used in a chronic care dialysis or hospital care environment for intermittent hemodialysis and/or isolated ultrafiltration treatments of patients with chronic or acute renal failure or fluid overload. The goal of hemodialysis treatment is to remove waste products and excess fluid from the patient's bloodstream. The AK 98 is to be used with compatible blood lines, liquid A-concentrate, sodium bicarbonate powder (BiCart) or liquid bicarbonate, Ultrafilter (U9000) and dialyzers (e.g. Revaclear, Polyflux). The AK 98 pumps blood from the patient into the compatible bloodline, through the dialyzer (where the blood purification takes place), and then back to patient. The AK 98 handles treatment details, monitors and regulates the pressure and flow on both blood and fluid side, and continually monitors the operation of the dialysis machine. The AK 98 dialysis machine can be divided into the following parts: Fluid unit, Blood unit, Power supply, and Operator's panel. The Operator's panel (User Interface) lets the Operator set Treatment parameters and Alarm limits (where applicable) and it shows limits and measured values, remaining time for Treatment and Disinfection and other information to the Operator. In an alarm situation, the dialysis machine provides audible and visual indications.
The Ultrafilter product family (U9000, and its predicate device Diaclear) are ultrafilters intended for water filtration (removal of pyrogens and microorganisms), and filtration of dialysis fluid. The risk of exposure to bacteria and endotoxins can thereby be minimized. The U9000 is intended to be used in conjunction with an upstream water treatment system. The Ultrafilter U9000 can only be used with Baxter/Gambro/Hospal dialysis machines equipped with a dedicated U9000 filter holder. This places the U9000 ultrafilter in the pre-dialyzer flow-path to filter the fluid before it reaches the dialyzer. On the US market, The U9000 is intended to be used as a required component of the AK 98 Hemodialysis System, to minimize the risk of exposure to bacteria and endotoxins by creating a microbiologically high quality dialysate.
The C-705 Accessory Expansion Chamber is a single use sterile medical device for hemodialysis intended to be connected to compatible bloodlines for hemodialysis that allow the channeling of blood from the body through its circuits into another device that carries out the hemodialysis effect of the treatment. C-705 is intended to be used during the delivery of hemodialysis treatment in Single Needle mode; it allows the conversion from Double Needle to Single Needle administration mode of treatments. C705 intended to be used on patients affected by chronic renal failure in an in-center hemodialysis environment. At this time, AK 98 is the only hemodialysis system compatible with the C705 accessory on the US market.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
The AK 98 dialysis machine is indicated to be used on patients with a body weight of 25 kg or more.
Target Population for C-705: Adult patients with chronic renal failure.
Intended User / Care Setting
The AK 98 dialysis machine is intended to be used by trained operators when prescribed by a physician, in a chronic care dialysis or hospital care environment. The Baxter AK 98 dialysis machine is not intended for Selfcare or Home use.
C-705 Accessory Expansion Chamber is intended to be used in an in-center hemodialysis environment.
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 in accordance with FDA guidance document Guidance for the Content of Premarket Notifications for Hemodialysis Systems was conducted on the AK 98 dialysis machine to evaluate the functional performance of the system. The performance testing confirms AK 98 remain as safe and effective as Phoenix dialysis system and is substantially equivalent.
In summary the AK 98 has successfully implemented performance requirements and subsequent outputs verifying and validating:
- Functional testing demonstrating the AK 98 dialysis machine and its accessories performs as designed and expected.
- The device complies with the latest edition of IEC60601-2-16. Testing was confirmed by TÜV SÜD recognized test laboratory as part of the testing of IEC60601-1 edition 3.1. The testing confirmed the device meets the requirements for Essential Performance according to the particular standard IEC60601-2-16.
- Electrical safety testing according to latest edition of IEC60601-1. The standard includes reports for software, alarms, usability, safety and performance.
- Electromagnetic compatibility compliance in accordance with IEC 60601-1-2:2014.
- Risk assessment and Risk Control Measures. A therapy level, product level and process level hazard analysis confirms the device does not perform in an unexpted or unsafe manner.
- Labeling, software including Cybersecurity, Human Factors requirements have been successfully implemented.
- Biocompatibility testing was performed in accordance with ISO 10993-1.
Performance testing in accordance with FDA guidance document Guidance for Content of Premarket Notifications for Water Purification Components and Systems for Hemodialysis was performed on the U9000 Ultrafilter. The performance testing confirms that the device is safe, effective and is substantially equivalent to the predicate device when used in accordance with the instructions for use.
The following performance testing was conducted to verify the performance of the proposed device: Biocompatibility, Pressure drop, Retention capacity for Bacteria and Endotoxin., Ultrafiltration rate, Dilaysis fluid composition, Filter and membrane integrity, Chemical evaluation. The specifications of the U9000 ultrafilter are provided in accordance with FDA Guidance.
Performance testing in accordance with FDA guidance document Guidance Hemodialysis Tubing Sets- Premarket Notification [510(k)] Submission, was performed on the C-705 Accessory Expansion Chamber indicates that the device is safe, effective and substantially equivalent to the predicate device, when used in accordance with the instructions for use.
The following performance testing were conducted to verify the performance of the proposed device configurations: Biocompatibility testing, Clamp Performance, Tensile Strength of Connections, Priming Volume, Filling of Expansion Chamber, Connector Performance, Structural Integrity testing, Fitting Test, Mechanical Hemolysis test. The specifications, and functionality of components are provided accordance with FDA Guidance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 876.5860 High permeability hemodialysis system.
(a)
Identification. A high permeability hemodialysis system is a device intended for use as an artificial kidney system for the treatment of patients with renal failure, fluid overload, or toxemic conditions by performing such therapies as hemodialysis, hemofiltration, hemoconcentration, and hemodiafiltration. Using a hemodialyzer with a semipermeable membrane that is more permeable to water than the semipermeable membrane of the conventional hemodialysis system (§ 876.5820), the high permeability hemodialysis system removes toxins or excess fluid from the patient's blood using the principles of convection (via a high ultrafiltration rate) and/or diffusion (via a concentration gradient in dialysate). During treatment, blood is circulated from the patient through the hemodialyzer's blood compartment, while the dialysate solution flows countercurrent through the dialysate compartment. In this process, toxins and/or fluid are transferred across the membrane from the blood to the dialysate compartment. The hemodialysis delivery machine controls and monitors the parameters related to this processing, including the rate at which blood and dialysate are pumped through the system, and the rate at which fluid is removed from the patient. The high permeability hemodialysis system consists of the following devices:(1) The hemodialyzer consists of a semipermeable membrane with an in vitro ultrafiltration coefficient (K
uf ) greater than 8 milliliters per hour per conventional millimeter of mercury, as measured with bovine or expired human blood, and is used with either an automated ultrafiltration controller or anther method of ultrafiltration control to prevent fluid imbalance.(2) The hemodialysis delivery machine is similar to the extracorporeal blood system and dialysate delivery system of the hemodialysis system and accessories (§ 876.5820), with the addition of an ultrafiltration controller and mechanisms that monitor and/or control such parameters as fluid balance, dialysate composition, and patient treatment parameters (e.g., blood pressure, hematocrit, urea, etc.).
(3) The high permeability hemodialysis system accessories include, but are not limited to, tubing lines and various treatment related monitors (e.g., dialysate pH, blood pressure, hematocrit, and blood recirculation monitors).
(b)
Classification. Class II. The special controls for this device are FDA's:(1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Device—Part I: Evaluation and Testing,’ ”
(2) “Guidance for the Content of 510(k)s for Conventional and High Permeability Hemodialyzers,”
(3) “Guidance for Industry and CDRH Reviewers on the Content of Premarket Notifications for Hemodialysis Delivery Systems,”
(4) “Guidance for the Content of Premarket Notifications for Water Purification Components and Systems for Hemodialysis,” and
(5) “Guidance for Hemodialyzer Reuse Labeling.”
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & 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.
March 10, 2021
Baxter Healthcare Corporation Kristen Bozzelli Manager, Regulatory Affairs 25212 W. Illinois Route 120 Round Lake, Illinois 60073
Re: K201809
Trade/Device Name: AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory Regulation Number: 21 CFR 876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: KDI, FIP, FJK Dated: February 5, 2021 Received: February 9, 2021
Dear Kristen Bozzelli:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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 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,
Carolyn Y. Neuland, Ph.D. 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
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Indications for Use
510(k) Number (if known) K201809
Device Name Baxter AK 98 Dialysis Machine
Indications for Use (Describe)
The Baxter AK 98 dialysis machine is intended to be used for intermittant haemodialysis and/or isolated ultrafiltration treatments of patients with chronic or acute renal failure or fluid overload upon prescription by a physician. The AK 98 dialysis machine is indicated to be used on patients with a body weight of 25 kg or more. The AK 98 dialysis machine is intended to be used by trained operators when prescribed by a physician, in a chronic care dialysis or hospital care environment. The Baxter AK 98 dialysis machine is not intended for Selfcare or Home use.
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K201809 (CONTINUED)
Device Name: Baxter C-705 Accessory Expansion Chamber
C-705 Accessory Expansion Chamber is a single use sterile medical device intended to be used during the delivery of Hemodialysis treatment in Single Needle mode, on patients affected by chronic renal failure. The C-705 Accessory Expansion Chamber is an ancillary device used to allow the conversion from Double Needle to Single Needle administration mode of treatments, after connection to proper Blood Tubing System intended for Haemodialysis treatment in Double Needle mode and to a Dialyzer filter. C-705 Accessory Expansion Chamber shall be used in combination with Blood Tubing System suitable for AK 98 haemodialysis delivery system only. The total extracorporeal blood volume for the extracorporeal circuit including the set, dialyzer and accessories should represent less than 10% of the patient's blood volume.
[CONTINUED ON THE NEXT PAGE]
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K201809 (CONTINUED)
Device Name: Baxter U9000 Ultrafilter
The U9000 Ultrafilter is indication of incoming water for dialysis fluid as well as purification of dialysis fluid to obtain standard dialysis fluid in accordance with international standards requirements and local regulations. The risk of exposure to bacteria and endotoxins can thereby be minimized. The U9000 Ultrafilter is intended to be used in conjunction with a water treatment system.
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.
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Section 5. 510(k) Summary
10 March, 2021
OWNER:
Baxter Healthcare Corporation One Baxter Parkway Deerfield, Illinois 60015
CONTACT PERSON:
Kristen Bozzeli Manager, Global Regulatory Affairs 25212W. Illinois Route 120 Round Lake, IL 60073 Telephone: +1.224.948.5585 Fax: 224-270- 4119
IDENTIFICATION OF THE DEVICES:
Common Name: Hemodialysis Delivery System Trade/Device Name: AK 98 Classification Panel: 78 Gastroenterology and Urology Regulation Number: 21 CFR 876.5860 Regulation Name: High Permeability Hemodialysis System Regulatory Class: Class II Product Code: 78KDI
Common Name: Ultrafilter/Water Purification Subsystem Trade/Device Name: U9000 Classification Panel: 78 Gastroenterology and Urology Regulatory Class: Class II Product Code: 78FIP
Common Name: : Set, Tubing, Blood, With and Without Anti-Regurgitation Valve Trade/Device Name: C-705 Classification Panel: 78 Gastroenterology and Urology Regulatory Class: Class II Product Code: 78FJK
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| Product code | Name |
|---|---|
| 955607 | AK 98 Dialysis Machine |
| 112062 | U9000 Ultrafilter |
| 6430771A | C-705 Accessory Expansion Chamber |
Table 1. Product codes in this submission
PREDICATE DEVICES:
| Proposed | Predicates | |||
|---|---|---|---|---|
| Device | Device | 510k submitter | Predicate | |
| 510(k) | Clearance | |||
| Date | ||||
| AK 98 Dialysis | ||||
| Machine | Phoenix | |||
| Hemodialysis | ||||
| Delivery System | Gambro Renal | |||
| Products | K103832 | May 2011 | ||
| U9000 Ultrafilter | Diaclear Ultrafilter | Gambro Renal | ||
| Products | K003957 | January 2001 | ||
| C-705 Accessory | ||||
| Expansion Chamber | Single Needle | |||
| Conversion Kit | ||||
| (Gambro Cartridge | ||||
| Blood Set) | Gambro Renal | |||
| Products | K070414 | October 2007 |
Table 2. Predicate Device(s)
DESCRIPTION OF THE DEVICES:
The proposed device AK 98 Hemodialysis system, which is subject for this Traditional 510(k) premarket notification, consists of the following:
- AK 98 dialysis machine
- U9000 (Ultrafilter)
- C-705 (Accessory Expansion chamber)
AK 98 Dialysis Machine
AK 98 is a standalone, software controlled hemodialysis machine intended to be used in a chronic care dialysis or hospital care environment for intermittent hemodialysis and/or isolated ultrafiltration treatments of patients with chronic or acute renal failure or fluid overload.
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The goal of hemodialysis treatment is to remove waste products and excess fluid from the patient's bloodstream.
The AK 98 is to be used with compatible blood lines, liquid A-concentrate, sodium bicarbonate powder (BiCart) or liquid bicarbonate, Ultrafilter (U9000) and dialyzers (e.g. Revaclear, Polyflux).
The AK 98 pumps blood from the patient into the compatible bloodline, through the dialyzer (where the blood purification takes place), and then back to patient. The AK 98 handles treatment details, monitors and regulates the pressure and flow on both blood and fluid side, and continually monitors the operation of the dialysis machine.
The AK 98 dialysis machine can be divided into the following parts:
- . Fluid unit - is used to produce the dialysis fluid (with the correct temperature, flow, and composition) from reverse osmosis water and concentrates (dry or liquid), and to transport the dialysis fluid through the dialyzer. The fluid unit offers Profiling of Ultrafiltration and/or conductivity, it also offers isolated Ultrafiltration. The fluid unit also includes "Clearance Measurement" (Diascan). The fluid unit maintains the dialysis fluid flow through the dialyzer and controls ultrafiltration. If a fault occurs, the machine enters a patient safe state, which depending on the fault, can include actions such as bypassing the dialyzer.
- Blood unit - is designed to control and supervise the extracorporeal blood circuit. Double needle treatments are most common. Single needle treatments can also be performed with one pump (double clamp function). To prevent coagulation, anticoagulants can be administered by means of the integrated heparin pump. Disposable blood lines are used to transport the blood from the patient to the AK 98 machine and back to the patient.
- . Power supply - The mains voltage is fed to an AC/DC converter within the AK 98, which generates different DC supplies for the machine.
Operator's panel - Both the blood unit and the fluid unit are controlled from the operator's panel. The panel contains a touch screen and a number of hard key buttons to the right of the screen. The screen allows the operator to interact with the dialysis machine by pressing various buttons. The hard-key buttons are language independent. The information in the display can be set to different languages.
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The Operator's panel (User Interface) lets the Operator set Treatment parameters and Alarm limits (where applicable) and it shows limits and measured values, remaining time for Treatment and Disinfection and other information to the Operator. In an alarm situation, the dialysis machine provides audible and visual indications. Additionally, the visual indication is shown on the alarm light bar on top of the dialysis machine.
It is also possible for a Technician to enter Service mode via the User interface sub-system by use of a PIN code.
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Image /page/10/Picture/2 description: The image shows a dialysis machine, which is a medical device used to remove waste products and excess fluid from the blood when the kidneys are not functioning properly. The machine is blue and white and has a variety of tubes and connectors. There is a screen on the top of the machine that displays information about the dialysis treatment. The machine is on wheels, which makes it easy to move around.
Figure 1. Photograph of AK 98 dialysis machine
U9000 Ultrafilter
The Ultrafilter product family (U9000, and its predicate device Diaclear) are ultrafilters intended for water filtration (removal of pyrogens and microorganisms), and filtration of dialysis fluid. The risk of exposure to bacteria and endotoxins can thereby be minimized.
The U9000 is intended to be used in conjunction with an upstream water treatment system. The Ultrafilter U9000 can only be used with Baxter/Gambro/Hospal dialysis
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machines equipped with a dedicated U9000 filter holder. This places the U9000 ultrafilter in the pre-dialyzer flow-path to filter the fluid before it reaches the dialyzer.
On the US market, The U9000 is intended to be used as a required component of the AK 98 Hemodialysis System, to minimize the risk of exposure to bacteria and endotoxins by creating a microbiologically high quality dialysate.
C-705 Accessory Expansion Chamber
The C-705 Accessory Expansion Chamber is a single use sterile medical device for hemodialysis intended to be connected to compatible bloodlines for hemodialysis that allow the channeling of blood from the body through its circuits into another device that carries out the hemodialysis effect of the treatment.
C-705 is intended to be used during the delivery of hemodialysis treatment in Single Needle mode; it allows the conversion from Double Needle to Single Needle administration mode of treatments. C705 intended to be used on patients affected by chronic renal failure in an in-center hemodialysis environment. At this time, AK 98 is the only hemodialysis system compatible with the C705 accessory on the US market.
INDICATIONS FOR USE PROPOSED DEVICES:
AK 98 Dialysis Machine
The Baxter AK 98 dialysis machine is intended to be used for intermittent haemodialysis and/or isolated ultrafiltration treatments of patients with chronic or acute renal failure or fluid overload upon prescription by a physician.
The AK 98 dialysis machine is indicated to be used on patients with a body weight of 25 kg or more. The AK 98 dialysis machine is intended to be used by trained operators when prescribed by a physician, in a chronic care dialysis or hospital care environment.The Baxter AK 98 dialysis machine is not intended for Selfcare or Home use.
U9000 Ultrafilter
The U9000 Ultrafilter is indicated for purification of incoming water for dialysis fluid as well as purification of dialysis fluid to obtain standard dialysis fluid in accordance with international standards requirements and local regulations. The risk of exposure to bacteria and endotoxins can thereby be minimized. The U9000 Ultrafilter is intended to be used in conjunction with a water treatment system.
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C-705 Accessory Expansion Chamber
C-705 Accessory Expansion Chamber is a single use sterile medical device intended to be used during the delivery of Hemodialysis treatment in Single Needle mode, on patients affected by chronic renal failure.
The C-705 Accessory Expansion Chamber is an ancillary device used to allow the conversion from Double Needle to Single Needle administration mode of treatments, after connection to proper Blood Tubing System intended for Haemodialysis treatment in Double Needle mode and to a Dialyzer filter. C-705 Accessory Expansion Chamber shall be used in combination with Blood Tubing System suitable for AK 98 haemodialysis delivery system only. The total extracorporeal blood volume for the extracorporeal circuit including the set, dialyzer, and accessories should represent less than 10% of the patient's blood volume.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE:
AK 98 Dialysis Machine
The differences between the predicate Phoenix machine and the proposed AK 98 dialysis machine as discussed in the AK 98 Device Comparison Table are considered substantially equivalent. See the comparison in Table 3.
Identification of Predicate Device:
- Trade Name: Phoenix Hemodialysis Delivery System
- 510(k) Holder: Gambro Renal Products
- Common Name: Hemodialysis Delivery System.
- Clearance: K103832 cleared on May 20, 2011.
Identification of Proposed Device:
- Trade Name: AK 98 Dialysis Machine
- 510(k) Holder:: Gambro Lundia AB, Sweden
- Common Name: Hemodialysis Delivery System.
- Clearance: Pending
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U9000 Ultrafilter
The differences between the predicate Diaclear Ultrafilter and the proposed device U9000 Ultrafilter as reflected in the Substantial Equivalence (SE) Table are considered substantially equivalent. See the comparison in Table 4.
Identification of Predicate Device
- Trade Name: Diaclear™ Ultrafilter
- 510(k) Submitter/holder: Gambro Industries, Meyzieu Cedex, France.
- Common name: Ultrafilter/Water Purification Subsystem
- Clearance: K003957
Identification of Proposed Device
- Trade Name: U9000 Ultrafilter
- 510(k) Submitter/holder: Baxter Healthcare Corporation
- Common name: Ultrafilter/Water Purification Subsystem
- Clearance: Pending
C-705 Accessory Expansion Chamber
The differences between the predicate Single Needle Conversion Kit and the proposed device C705 Accessory Expansion Chamber as reflected in the Substantial Equivalence (SE) Table are considered substantially equivalent. See the comparison in Table 5.
Identification of Predicate Device
Trade Name: 510(k) Holder:: Common name: Clearance:
Identification of Proposed Device
- Trade Name: C705 Accessory Expansion Chamber
- 510(k) Submitter/holder: Baxter Healthcare Corporation
- Common name: Clearance: Pending
14
| Features | Predicate Device
Phoenix 3.40
Cleared under K103832 | Proposed Device
AK 98 (software version 3.x.x) | Assessment of Differences |
|--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | The Phoenix® Hemodialysis
delivery system is intended to be
used to provide high flux and
flow flux hemodialysis.
hemofiltration and ultrafiltration
on patients weighing 15
Kilograms or more. The Phoenix
system is to be used with either
high or low permeability
dialyzers. The device is intended
to be used by trained operators
when prescribed by a physician,
in a chronic care dialysis facility
or acute care unit. | The Baxter AK 98 dialysis machine
is intended to be used for
intermittent hemodialysis and/or
isolated ultrafiltration treatments of
patients with chronic or acute renal
failure or fluid overload upon
prescription by a physician.
The AK 98 dialysis machine is
indicated to be used on patients with
a body weight of 25 kg or more.
The AK 98 dialysis machine is
intended to be used by trained
operators when prescribed by a
physician, in a chronic care dialysis
or hospital care environment.
The Baxter AK 98 dialysis machine
is not intended for Selfcare or Home
use. | AK 98 can be used with both low and
high flux dialyzers for hemodialysis.
Performance of the Phoenix and AK 98
machines are equivalent, but the patient
weight limit is determined at the system
level.
Hemofiltration is not supported by AK
98. |
| Treatment modalities | Hemodialysis (HD)
- HD DN/SP(Double
Needle/Single Pump) treatment - HD SN/SP (Single
Needle/Single Pump) treatment
Hemofiltration | Hemodialysis - HD DN/SP treatment
- HD SN/SP treatment | Hemofiltration is not supported by AK
-
|
| Dialysate conductivity monitoring | Yes | Yes | None |
| Features | Predicate Device
Phoenix 3.40
Cleared under K103832 | Proposed Device
AK 98 (software version 3.x.x) | Assessment of Differences |
| pH sensor | Yes | No | The AK 98 System controls risk by
monitoring the concentrate (pumps'
speed. The difference does not impact on
safety and effectiveness |
| Isolated UF | Yes | Yes | None |
| Ultrafiltration control | Yes | Yes | None |
| Ultrafiltration supervision | Yes, monitored by TMP
(Transmembrane pressure) | Yes, supervision in accordance with
IEC 60601-2-16, 4th edition | Both predicate and proposed device
supervise Ultrafiltration however due to
requirement in IEC 60601-2-16 ed.4; the
AK 98 uses separate Ultrafiltration
supervision as protection instead of TMP
as used by Phoenix.
(subclause 201.12.4.4.103 NET FLUID
REMOVAL TMP monitoring is not
considered to be an adequate protection
against fluid balancing errors in the case
of high-flux DIALYSERS.). |
| Ultrafiltration accuracy | Between ±35 and ±160 g/h,
depending on dialysis fluid flow
rate and the ultrafiltration rate.
Note: Ultrafiltration accuracy
calculated per the Phoenix
Operator's Manual a, section
9.2.6 Ultrafiltration system. | Between ±50 and ±100 g/h,
depending on ultrafiltration rate.
Note: Ultrafiltration accuracy
calculated per section 13.1.6 in the
AK 98 Operator's Manual | The difference is considered clinically
insignificant for low dialysis fluid flow
rate. In a worst case scenario the AK 98
has improved accuracycompared to the
predicate device. Therefore Baxter
considers the ultrafiltration accuracy of
the proposed device and the predicate
device to be equivalent. |
| Air detector | Yes | Yes | None |
| Blood leak detector | Yes | Yes | None |
| Features | Predicate Device
Phoenix 3.40
Cleared under K103832 | Proposed Device
AK 98 (software version 3.x.x) | Assessment of Differences |
| Temperature monitoring | Yes | Yes | None |
| Fail-safe response during power
failure | Yes | Yes | None |
| Prescription profiling | Conductivity profiling (Na) | Conductivity profiling (Na, HCO3) | AK 98 supports profiling of both Na and
HCO3. |
| Disinfection programs | Heat
Chemical | Heat
Chemical | None |
| Anti coagulant administration
rate: | 0/0.5 – 9.9 ml/h | 0 - 10.0 ml/h | The range difference is negligible and
therefore no impact on safety and
effectiveness. |
| Anti coagulant bolus: | 0/0.5 - 10.0 ml | 0 - 10.0 ml | The range difference is negligible and
therefore no impact on safety and
effectiveness. |
| Blood Flow Rate | 10 - 580 ml/min | 20 -600 ml/min | The range difference is negligible and
therefore no impact on safety and
effectiveness. |
| Blood flow rate accuracy | Accuracy ± 10% if pressure
before the pump is not lower
(more negative) than - 150
mmHg | For pre-pump pressure range from -
200 mmHg to 0 mmHg:
±10 mL/min or ±10% of the set
point value, whichever is the largest | The accuracy difference is negligible and
therefore no impact on safety and
effectiveness. |
| Dialysate Flow Rate | 350 - 800 ml/min | 300 - 800 ml/min | The range difference is negligible and
therefore no impact on safety and
effectiveness. |
| Features | Predicate Device
Phoenix 3.40
Cleared under K103832 | Proposed Device
AK 98 (software version 3.x.x) | Assessment of Differences |
| Dialysate Flow Rate accuracy | $\pm$ 5% | $\pm$ 10 % or 50 mL/min whichever is
largest | The range difference is negligible and
therefore no impact on safety and
effectiveness. |
| Transmembrane Pressure (TMP) | -100 to +450 mmHg (calculated
value) ALARM range | -200 - +500 mmHg (calculated
value) set of LIMITS | For the proposed device TMP is used for
detecting clotting, unlike the predicate
device which uses it for Ultrafiltration
supervision. |
| Net Fluid Removal Rate | 0 - 4 kg/h | 0 - 4 L /h | None |
| Dialysate Temperature | 34 - 39.5 °C | 33 - 40 °C | The range difference is negligible and
therefore no impact on safety and
effectiveness. |
| Dialysate Conductivity set range | 13-17 mS/cm | 9-16 mS/cm | The range difference is negligible and
therefore no impact on safety and
effectiveness. |
| Arterial pressure | -400 to +150 mmHg | -400 - +300 mmHg | The range difference is not impacting
safety and effectiveness. The range can be
set by the user. |
| Venous Pressure | 0 to +450 mmHg | +10 - +500 mmHg | The range difference is negligible and
therefore no impact on safety and
effectiveness. |
| Blood pressure measurements
(BPM) | Yes | Yes | None |
15
16
17
18
| Features | Predicate Device
Phoenix 3.40
Cleared under K103832 | Proposed Device
AK 98 (software version 3.x.x) | Assessment of Differences |
|-----------------|-----------------------------------------------------------------|-------------------------------------------------------------------------|---------------------------|
| IT connectivity | Yes -
Integrates with the EXALIS
Dialysis Management Tool | Yes -
Integrates with CIS (clinical
information system) using HL7 | None |
| | | protocol | |
| Features | Predicate Device - Diaclear
Cleared under K003957 | Proposed Device
U9000 Ultrafilter | Assessment of Differences |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The DIACLEAR ultrafilter is intended to
be used only with either HOSPAL
Integra or Innova or GAMBRO Phoenix
dialysis machines equipped with the
feature for dialysate filtration. | The Ultrafilter U9000 is intended to be used in
conjunction with a water treatment system.
WARNING! The Ultrafilter U9000 can only be
used with Gambro/Baxter/Hospal dialysis
machines equipped with U9000 filter holder. | U9000 is to be used on a new
generation of dialysis machines,
including AK 98.
Diaclear is not compatible with the
new system. |
| Indications for
Use | Ultrafiltration with the DIACLEAR
ultrafilter is indicated for purification of
dialysis fluid to obtain microbiologically
high quality dialysis fluid.
The risk of exposure to bacteria and
endotoxins can thereby be minimised. | The Ultrafilter U9000 is indicated for purification
of incoming water for dialysis fluid as well as
purification of dialysis fluid to obtain standard
dialysis fluid in accordance with international
standards requirements and local regulations.
The risk of exposure to bacteria and endotoxins
can thereby be minimized. The Ultrafilter U9000
is intended to be used in conjunction with a water
treatment system | No significant difference |
| Sterile | Yes | No
(Unsterile Device) | The U9000 ultrafilter is produced
in a clean room environment, and
the bioburden level of the product is
|
| Features | Predicate Device – Diaclear
Cleared under K003957 | Proposed Device
U9000 Ultrafilter | Assessment of Differences |
| | | | monitored regularly. The product is
not sterilized after production. It
will be installed in a non-sterile
fluid path and after installation,
disinfection prior to first use as
specified in IFU and OPM is
required to be performed by the AK
98 dialysis system. Therefore, the
U9000 ultrafilter does not need to
be sterile to be substantially
equivalent to the predicate device. |
| Non-Pyrogenic | Yes | No | The U9000 ultrafilter is produced
in a clean room environment, and
the bioburden level of the product is
monitored regularly. The product is
not sterilized after production. It
will be installed in a non-sterile
fluid path and after installation,
disinfection prior to first use as
specified in IFU and OPM is
required to be performed by the AK
98 dialysis system. Therefore, the
U9000 ultrafilter does not need to
be sterile to be substantially
equivalent to the predicate device. |
| Expiration | 3 years | 2 years | Design control activities have been
conducted and confirmed that the
different technological
characteristics of the new device do
not raise different questions of
safety and effectiveness |
19
20
| Features | Predicate Device - Diaclear
Cleared under K003957 | Proposed Device
U9000 Ultrafilter | Assessment of Differences |
|---------------------------------------------------------------------------|-----------------------------------------------------------------|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Single Use | No | No | No Difference |
| Storage
conditions | Between 0°C and 30°C | Below 30°C | Design control activities have been
conducted and confirmed that the
different technological
characteristics of the new device do
not raise different questions of
safety and effectiveness |
| Pump
Compatibility or
Electromechanic
al device
compatibility | HOSPAL Integra or Innova or
GAMBRO Phoenix dialysis machines | AK 98 | The Diaclear and U9000 ultrafilters
perform the same function, the only
interaction with the
electromechanical device is to fit
within the holder. The difference
does not imply risks to the patient
safety or to the treatment
effectiveness. |
21
| Features | Predicate Device – Diaclear
Cleared under K003957 | Proposed Device
U9000 Ultrafilter | Assessment of Differences |
|--------------------------------------|------------------------------------------------------------|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Materials | See below | See below | Differences in Materials are deemed
not relevant.
Each Ultrafilter Device has verified
Biocompatibility according to ISO
10993 |
| Membrane | Polyaryylethersulfone (PAES)
Polyvinylpyrrolidone (PVP) | Same | Not Applicable |
| Housing and
Header | Polycarbonate (PC) | Same | Not Applicable |
| Supporting ring | Not Applicable | PolyPropylene (PP) | The predicate device does not have
a Supporting ring. Device control
activities have been conducted and
confirmed that the different
technological characteristics of the
new device do not raise different
questions of safety and
effectiveness. |
| Gasket material | Silicon | Same | Not Applicable |
| Potting material | Polyurethane (PUR) | Same | Not Applicable |
| Dialysate cap | High Density PolyEthylene (HDPE) | Polypropylene (PP) | Design control activities have been
conducted and confirmed that the
different technological
characteristics of the new device do
not raise different questions of
safety and effectiveness. |
| Features | Predicate Device – Diaclear
Cleared under K003957 | Proposed Device
U9000 Ultrafilter | Assessment of Differences |
| Ultrafiltrate cap | PolyPropylene (PP) | Low Density PolyEthylene (LDPE) | Not Significant |
| Specifications | See below | See below | Differences in Product
Specifications are deemed not
relevant.
Each Ultrafilter Device is designed
and validated to fulfill the System
Requirements specific to the therapy
system they are used with |
| Inner diameter of
fiber | 215 μm | 190 μm | Not significant |
| Wall thickness of
fiber | 45 μm | Same | Not significant |
| Efficient surface | 1.30 m² | 2.40 m² | Design control activities have
been conducted and
confirmed that the different
product specifications of the
new device do not raise
different questions of safety
and effectiveness. |
| Maximum
transmembrane
pressure | 500 mmHg | 600 mmHg | Not significant |
| Operating range:
QD | 500 - 1000 mL/min | 300-1200 mL/min | Not significant |
22
23
| Features | Predicate Device – Diaclear
Cleared under K003957 | | | Proposed Device
U9000 Ultrafilter | | | | Assessment of Differences | | |
|--------------------------|------------------------------------------------------|------------|-------------|--------------------------------------|--------------------|------------|-------------|---------------------------|-------------|-----------------|
| Inlet pressure
(37°C) | QF
(ml/min) | 500 | 750 | 1000 | QF
(ml/min) | 300 | 600 | 900 | 1200 | Not significant |
| | Pressure
(mmHg) | 72
±40% | 108
±40% | 144
±40% | Pressure
(mmHg) | 59
±10% | 117
±10% | 176
±10% | 235
±10% | |
| Table 5. Accessory Comparison | |
|---|---|
| ------------------------------- | -- |
| Features | Predicate Device
Single Needle conversion kit (SNK)
Cleared under K070414 | Proposed Device
C-705 Accessory Expansion
Chamber | Assessment of Differences |
|----------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Gambro Cartridge Blood Set is
intended for single use in a
hemodialysis treatmentusing the
Phoenix Dialysis Delivery Systems | C-705 Accessory Expansion Chamber
is intended for single use in a
hemodialysis treatment. | Different wording but same Intended use |
| Indications for Use | The Single Needle Conversion Kit is
intended for use with the Dialysis
Delivery Systems
and a Gambro Cartridge Blood Set.
When properly used, the kit will allow
the clinician
to reconfigure a Gambro Cartridge
Blood Set to perform a single needle
dialysis treatment. | C-705 Accessory Expansion Chamber
is a single use sterile medical device
intended to be used during the
delivery of Hemodialysis treatment in
Single Needle mode, on patients
affected by chronic renal failure.
The C-705 Accessory Expansion
Chamber is an ancillary device used to
allow the conversion from Double
Needle to Single Needle
administration mode of treatments,
after connection to proper Blood
Tubing System intended for | Different wording but same Indications
for Use |
| Features | Predicate Device
Single Needle conversion kit (SNK)
Cleared under K070414 | Proposed Device
C-705 Accessory Expansion
Chamber | Assessment of Differences |
| | | Haemodialysis treatment in Double
Needle mode and to a Dialyzer filter.
C-705 Accessory Expansion Chamber
shall be used in combination with
Blood Tubing System suitable for AK
98 haemodialysis delivery system
only. The total extracorporeal blood
volume for the extracorporeal circuit
including the set, dialyzer and
accessories should represent less than
10% of the patient's blood volume. | |
| Target Population | Adult patients with chronic renal
failure | patients affected by chronic renal
failure | Different wording but same patient
population |
| Sterile | Yes | Yes | No differences |
| Sterilization Method | Radiation | Ethilene Oxide | Both devices meet sterilization
and
biocompatibility
requirements.
The
differences in sterilization method does not
create different questions of safety or
effectiveness, |
| Expiration | 3 years | 3 years | No differences |
| Non-Pyrogenic | Yes | Yes | No differences |
| Single Use | Yes | Yes | No differences |
| Pump Compatibility or
Electromechanical
device compatibility | Phoenix and Centrysystem 3 | AK 98 | The accessory is used on different dialysis
delivery systems. Two accessories perform
the same function, the only interaction
with the electromechanical device is to fit |
| Features | Predicate Device
Single Needle conversion kit (SNK)
Cleared under K070414 | Proposed Device
C-705 Accessory Expansion
Chamber | Assessment of Differences |
| | | | within the holder. The difference does not
imply risks to the patient safety or to the
treatment effectiveness. |
| Materials | | | |
| Tubing
(direct contact with
blood for transport tubes
and indirect contact for
service tube) | PVC | PVC | The PVC material is tested for biocompatibility
and performance in accordance with FDA
guidance. No significance to safety or
effectiveness |
| Dialyzer Connector
Blue (inner Part) | PVC | PVC | No differences |
| Male Locking Dialyzer
Connector BlueA | M-ABS | M-ABS | No differences |
| Expansion Chamber | PETG | PVC | Rigid PVC-based material is suitable for
the component function and tested for
biocompatibility |
| Female luer connector
(indirect contact with
blood) | PETG | PETG | No differences |
| Clamps | Pinch | Pinch | No differences |
| Blood Tubing Length | Dialyzer Length (venous) :46 cm
Dialyzer Length (arterials) :51 cm | Dialyzer Length (venous) :75 cm
Dialyzer Length (arterials) :8 cm | The accessory is used on different dialysis
delivery systems. The difference does not
imply risks to the patient safety or to the
treatment effectiveness. |
| Features | Predicate Device
Single Needle conversion kit (SNK)
Cleared under K070414 | Proposed Device
C-705 Accessory Expansion
Chamber | Assessment of Differences |
| Blood Pathway | ID: 4.17 mm
OD: 6.50 mm | ID: 4.30 mm
OD: 6.80 mm | The accessory is used on different dialysis
delivery systems. The difference does not
imply risks for patient safety nor treatment
effectiveness. |
| Connection to dialyzer | ID: 4.17 mm
OD: 6.80 mm | ID: 4.30 mm
OD: 6.6 mm | The accessory is used on different dialysis
delivery systems. The difference does not
imply risks for the patient safety nor
treatment effectiveness. |
| Priming Volume | 45 ml | 50 ml | C-705 Accessory Expansion Chamber has
one expansion chamber to be connected
after the dialyzer filter while Cartridge
Single Needle Conversion Kit has two
smaller expansion chambers to be
connected before and after the dialyzer
filter . Consequence of this difference is a
higher priming volume of the proposed
device (50 ml) compared to the priming
volume of the predicate device (45 ml). |
| Packaging | Blister | Blister | No differences |
24
Table 5. Accessory Comparison
25
Table 5. Accessory Comparison
26
Table 5. Accessory Comparison
27
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DISCUSSION OF NONCLINICAL TESTS:
AK 98 Dialysis Machine
Performance testing in accordance with FDA guidance document Guidance for the Content of Premarket Notifications for Hemodialysis Systems was conducted on the AK 98 dialysis machine to evaluate the functional performance of the system. The performance testing confirms AK 98 remain as safe and effective as Phoenix dialysis system and is substantially equivalent.
In summary the AK 98 has successfully implemented performance requirements and subsequent outputs verifying and validating:
- . Functional testing demonstrating the AK 98 dialysis machine and its accessories performs as designed and expected.
- . The device complies with the latest edition of IEC60601-2-16. Testing was confirmed by TÜV SÜD recognized test laboratory as part of the testing of IEC60601-1 edition 3.1. The testing confirmed the device meets the requirements for Essential Performance according to the particular standard IEC60601-2-16.
- . Electrical safety testing according to latest edition of IEC60601-1. The standard includes reports for software, alarms, usability, safety and performance.
- Electromagnetic compatibility compliance in accordance with IEC 60601-1-2:2014.
- . Risk assessment and Risk Control Measures. A therapy level, product level and process level hazard analysis confirms the device does not perform in an unexpted or unsafe manner.
- . Labeling, software including Cybersecurity, Human Factors requirements have been successfully implemented.
- Biocompatibility testing was performed in accordance with ISO 10993-1.
U9000 Ultrafilter
Performance testing in accordance with FDA guidance document Guidance for Content of Premarket Notifications for Water Purification Components and Systems for Hemodialysis was performed on the U9000 Ultrafilter. The performance testing confirms that the device is safe, effective and is substantially equivalent to the predicate device when used in accordance with the instructions for use.
28
Image /page/28/Picture/0 description: The image shows the text "K201809" and "Page 23 of 24" at the top. Below that is the Baxter logo in blue.
The following performance testing was conducted to verify the performance of the proposed device:
- Biocompatibility,
- Pressure drop
- Retention capacity for Bacteria and Endotoxin.
- Ultrafiltration rate
- Dilaysis fluid composition
- Filter and membrane integrity
- Chemical evaluation
The specifications of the U9000 ultrafilter are provided in accordance with FDA Guidance.
C-705 Accessory Expansion Chamber
Performance testing in accordance with FDA guidance document Guidance Hemodialysis Tubing Sets- Premarket Notification [510(k)] Submission, was performed on the C-705 Accessory Expansion Chamber indicates that the device is safe, effective and substantially equivalent to the predicate device, when used in accordance with the instructions for use.
The following performance testing were conducted to verify the performance of the proposed device configurations:
- Biocompatibility testing,
- Clamp Performance,
- Tensile Strength of Connections,
- Priming Volume
- Filling of Expansion Chamber,
- Connector Performance,
- Structural Integrity testing,
- Fitting Test,
- Mechanical Hemolysis test.
29
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The specifications, and functionality of components are provided accordance with FDA Guidance