What is the FDA product code for AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory?

KDI. It is classified under 21 CFR 876.5860 as a Class 2 device in the Gastroenterology, Urology panel.

What is the regulatory pathway for AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory?

510(k) clearance (submission type: Traditional).

What are the predicate devices for AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory?

Phoenix Hemodialysis Delivery System (K103832); Diaclear Ultrafilter (K003957); Single Needle Conversion Kit (Gambro Cartridge Blood Set) (K070414).

Who can help prepare an FDA 510(k) submission like AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory

Q: Who is the manufacturer of AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory?

Baxter Healthcare Corportation filed the 510(k) submission for AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory (K201809).

K201809 · Baxter Healthcare Corportation · KDI · Mar 10, 2021 · Gastroenterology, Urology

Device Facts

Record ID	K201809
Device Name	AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory
Applicant	Baxter Healthcare Corportation
Product Code	KDI · Gastroenterology, Urology
Decision Date	Mar 10, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 876.5860
Device Class	Class 2
Attributes	Therapeutic, Pediatric

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.

Device Story

AK 98 is a standalone, software-controlled hemodialysis machine for intermittent hemodialysis and isolated ultrafiltration. It pumps blood from patient through bloodlines to a dialyzer for purification, then returns it. The system includes a fluid unit (produces dialysis fluid from RO water and concentrates; manages temperature, flow, composition, and ultrafiltration) and a blood unit (manages extracorporeal circuit, heparin pump for anticoagulation). Operators interact via a touchscreen/hard-key panel to set treatment parameters and alarm limits. The system monitors pressures, flows, and conductivity; provides audible/visual alarms; and enters a safe state (e.g., bypass) upon fault detection. It integrates with clinical information systems via HL7. The U9000 ultrafilter (installed in the pre-dialyzer flow-path) purifies dialysis fluid to minimize bacteria/endotoxin exposure. The C-705 expansion chamber allows conversion from double-needle to single-needle treatment mode. Benefits include waste/fluid removal for renal failure patients.

Clinical Evidence

Bench testing only. Performance verified via functional testing, electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), and adherence to IEC 60601-2-16. Biocompatibility testing per ISO 10993-1. U9000 verified for pressure drop, retention capacity (bacteria/endotoxin), ultrafiltration rate, and membrane integrity. C-705 verified for clamp performance, tensile strength, priming volume, and mechanical hemolysis.

Technological Characteristics

Standalone hemodialysis system. Materials: PVC, M-ABS, PETG, Polycarbonate, Polypropylene, Polyurethane. Sensing: Pressure, conductivity, temperature, blood leak, air detection. Connectivity: HL7 for CIS integration. Software: Version 3.x.x, software-controlled. Sterilization: C-705 (Ethylene Oxide), U9000 (non-sterile, clean room produced, disinfected in-situ). Power: AC/DC converter. Standards: IEC 60601-1, IEC 60601-2-16, ISO 10993.

Indications for Use

Indicated for intermittent hemodialysis and/or isolated ultrafiltration in patients (≥25 kg) with chronic or acute renal failure or fluid overload. Used in chronic care dialysis or hospital settings by trained operators.

Regulatory Classification

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).

Special Controls

*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.”

Predicate Devices

Phoenix Hemodialysis Delivery System (K103832)
Diaclear Ultrafilter (K003957)
Single Needle Conversion Kit (Gambro Cartridge Blood Set) (K070414)

Submission Summary (Full Text)

{0}------------------------------------------------ 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. {1}------------------------------------------------ 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 {2}------------------------------------------------ # 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. [CONTINUED ON THE NEXT PAGE] {3}------------------------------------------------ #### 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] {4}------------------------------------------------ #### 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. {5}------------------------------------------------ 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." {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the word "Baxter" in a bold, sans-serif font. The word is a dark blue color. The letters are slightly slanted to the right, giving the word a dynamic appearance. #### 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 {7}------------------------------------------------ Image /page/7/Picture/1 description: The image shows the word "Baxter" in a bold, blue font. The word is slightly italicized, giving it a sense of movement. The font is sans-serif and the color is a vibrant blue. | 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. {8}------------------------------------------------ Image /page/8/Picture/1 description: The image features the word "Baxter" in a bold, italicized, sans-serif font. The text is a vibrant blue color, which contrasts with the white background. The font style gives the word a dynamic and forward-leaning appearance. 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. {9}------------------------------------------------ Image /page/9/Picture/1 description: The image shows the word "Baxter" in a bold, sans-serif font. The word is a dark blue color. The image is a logo for the company Baxter International. 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. {10}------------------------------------------------ Image /page/10/Picture/0 description: The image shows the text "K201809" on the first line and "Page 5 of 24" on the second line. The text is in a simple, sans-serif font and is aligned to the left. The image appears to be a page number indicator from a larger document. Image /page/10/Picture/1 description: The image shows the word "Baxter" in a bold, blue font. The font appears to be sans-serif and slightly italicized. The word is the primary focus of the image and is positioned horizontally. 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 {11}------------------------------------------------ Image /page/11/Picture/1 description: The image shows the word "Baxter" in a bold, blue font. The word is slightly slanted to the right. The font is sans-serif and the letters are closely spaced together. 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. {12}------------------------------------------------ #### 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 {13}------------------------------------------------ Image /page/13/Picture/1 description: The image shows the word "Baxter" in a bold, blue font. The font is sans-serif and appears to be slightly italicized. The word is the logo for the healthcare company Baxter International. ## 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 98. | | 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…

AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory

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AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory

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