(252 days)
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.
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 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 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.
This document is an FDA 510(k) premarket notification for a medical device. It does not describe an AI medical device or a study involving human experts to establish ground truth or assess AI performance. Instead, it details the substantial equivalence of new hemodialysis equipment (AK 98 Dialysis Machine, U9000 Ultrafilter, and C-705 Accessory Expansion Chamber) to previously cleared predicate devices.
Therefore, the requested information regarding acceptance criteria and a study proving an AI device meets those criteria, involving items like sample size, expert adjudication, MRMC studies, standalone performance, and ground truth establishment, cannot be extracted from this document because it pertains to conventional medical devices, not AI/ML-based ones.
The document primarily focuses on:
- Device Identification and Intended Use: Clearly defines what the devices are and what they are used for.
- Predicate Device Comparison: Detailed tables (Table 3, Table 4, Table 5) compare the features, specifications, and performance of the proposed devices to their respective predicate devices. This is the core of a 510(k) submission, demonstrating "substantial equivalence."
- Nonclinical Testing: Summarizes the performance testing conducted to confirm the functional performance, electrical safety, electromagnetic compatibility, risk assessment, and biocompatibility of the devices, all in accordance with relevant FDA guidance and international standards (e.g., IEC 60601 series, ISO 10993-1).
No information related to AI/ML acceptance criteria, expert adjudication, or MRMC studies is present.
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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.
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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 | Predicate510(k) | ClearanceDate |
| AK 98 DialysisMachine | PhoenixHemodialysisDelivery System | Gambro RenalProducts | K103832 | May 2011 |
| U9000 Ultrafilter | Diaclear Ultrafilter | Gambro RenalProducts | K003957 | January 2001 |
| C-705 AccessoryExpansion Chamber | Single NeedleConversion Kit(Gambro CartridgeBlood Set) | Gambro RenalProducts | 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
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| Features | Predicate DevicePhoenix 3.40Cleared under K103832 | Proposed DeviceAK 98 (software version 3.x.x) | Assessment of Differences |
|---|---|---|---|
| Intended use | The Phoenix® Hemodialysisdelivery system is intended to beused to provide high flux andflow flux hemodialysis.hemofiltration and ultrafiltrationon patients weighing 15Kilograms or more. The Phoenixsystem is to be used with eitherhigh or low permeabilitydialyzers. The device is intendedto be used by trained operatorswhen prescribed by a physician,in a chronic care dialysis facilityor acute care unit. | The Baxter AK 98 dialysis machineis intended to be used forintermittent hemodialysis and/orisolated ultrafiltration treatments ofpatients with chronic or acute renalfailure or fluid overload uponprescription by a physician.The AK 98 dialysis machine isindicated to be used on patients witha body weight of 25 kg or more.The AK 98 dialysis machine isintended to be used by trainedoperators when prescribed by aphysician, in a chronic care dialysisor hospital care environment.The Baxter AK 98 dialysis machineis not intended for Selfcare or Homeuse. | AK 98 can be used with both low andhigh flux dialyzers for hemodialysis.Performance of the Phoenix and AK 98machines are equivalent, but the patientweight limit is determined at the systemlevel.Hemofiltration is not supported by AK98. |
| Treatment modalities | Hemodialysis (HD)- HD DN/SP(DoubleNeedle/Single Pump) treatment- HD SN/SP (SingleNeedle/Single Pump) treatmentHemofiltration | Hemodialysis- HD DN/SP treatment- HD SN/SP treatment | Hemofiltration is not supported by AK98. |
| Dialysate conductivity monitoring | Yes | Yes | None |
| Features | Predicate DevicePhoenix 3.40Cleared under K103832 | Proposed DeviceAK 98 (software version 3.x.x) | Assessment of Differences |
| pH sensor | Yes | No | The AK 98 System controls risk bymonitoring the concentrate (pumps'speed. The difference does not impact onsafety and effectiveness |
| Isolated UF | Yes | Yes | None |
| Ultrafiltration control | Yes | Yes | None |
| Ultrafiltration supervision | Yes, monitored by TMP(Transmembrane pressure) | Yes, supervision in accordance withIEC 60601-2-16, 4th edition | Both predicate and proposed devicesupervise Ultrafiltration however due torequirement in IEC 60601-2-16 ed.4; theAK 98 uses separate Ultrafiltrationsupervision as protection instead of TMPas used by Phoenix.(subclause 201.12.4.4.103 NET FLUIDREMOVAL TMP monitoring is notconsidered to be an adequate protectionagainst fluid balancing errors in the caseof high-flux DIALYSERS.). |
| Ultrafiltration accuracy | Between ±35 and ±160 g/h,depending on dialysis fluid flowrate and the ultrafiltration rate.Note: Ultrafiltration accuracycalculated per the PhoenixOperator's Manual a, section9.2.6 Ultrafiltration system. | Between ±50 and ±100 g/h,depending on ultrafiltration rate.Note: Ultrafiltration accuracycalculated per section 13.1.6 in theAK 98 Operator's Manual | The difference is considered clinicallyinsignificant for low dialysis fluid flowrate. In a worst case scenario the AK 98has improved accuracycompared to thepredicate device. Therefore Baxterconsiders the ultrafiltration accuracy ofthe proposed device and the predicatedevice to be equivalent. |
| Air detector | Yes | Yes | None |
| Blood leak detector | Yes | Yes | None |
| Features | Predicate DevicePhoenix 3.40Cleared under K103832 | Proposed DeviceAK 98 (software version 3.x.x) | Assessment of Differences |
| Temperature monitoring | Yes | Yes | None |
| Fail-safe response during powerfailure | Yes | Yes | None |
| Prescription profiling | Conductivity profiling (Na) | Conductivity profiling (Na, HCO3) | AK 98 supports profiling of both Na andHCO3. |
| Disinfection programs | HeatChemical | HeatChemical | None |
| Anti coagulant administrationrate: | 0/0.5 – 9.9 ml/h | 0 - 10.0 ml/h | The range difference is negligible andtherefore no impact on safety andeffectiveness. |
| Anti coagulant bolus: | 0/0.5 - 10.0 ml | 0 - 10.0 ml | The range difference is negligible andtherefore no impact on safety andeffectiveness. |
| Blood Flow Rate | 10 - 580 ml/min | 20 -600 ml/min | The range difference is negligible andtherefore no impact on safety andeffectiveness. |
| Blood flow rate accuracy | Accuracy ± 10% if pressurebefore the pump is not lower(more negative) than - 150mmHg | For pre-pump pressure range from -200 mmHg to 0 mmHg:±10 mL/min or ±10% of the setpoint value, whichever is the largest | The accuracy difference is negligible andtherefore no impact on safety andeffectiveness. |
| Dialysate Flow Rate | 350 - 800 ml/min | 300 - 800 ml/min | The range difference is negligible andtherefore no impact on safety andeffectiveness. |
| Features | Predicate DevicePhoenix 3.40Cleared under K103832 | Proposed DeviceAK 98 (software version 3.x.x) | Assessment of Differences |
| Dialysate Flow Rate accuracy | $\pm$ 5% | $\pm$ 10 % or 50 mL/min whichever islargest | The range difference is negligible andtherefore no impact on safety andeffectiveness. |
| Transmembrane Pressure (TMP) | -100 to +450 mmHg (calculatedvalue) ALARM range | -200 - +500 mmHg (calculatedvalue) set of LIMITS | For the proposed device TMP is used fordetecting clotting, unlike the predicatedevice which uses it for Ultrafiltrationsupervision. |
| 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 andtherefore no impact on safety andeffectiveness. |
| Dialysate Conductivity set range | 13-17 mS/cm | 9-16 mS/cm | The range difference is negligible andtherefore no impact on safety andeffectiveness. |
| Arterial pressure | -400 to +150 mmHg | -400 - +300 mmHg | The range difference is not impactingsafety and effectiveness. The range can beset by the user. |
| Venous Pressure | 0 to +450 mmHg | +10 - +500 mmHg | The range difference is negligible andtherefore no impact on safety andeffectiveness. |
| Blood pressure measurements(BPM) | Yes | Yes | None |
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| Features | Predicate DevicePhoenix 3.40Cleared under K103832 | Proposed DeviceAK 98 (software version 3.x.x) | Assessment of Differences |
|---|---|---|---|
| IT connectivity | Yes -Integrates with the EXALISDialysis Management Tool | Yes -Integrates with CIS (clinicalinformation system) using HL7 | None |
| protocol |
| Features | Predicate Device - DiaclearCleared under K003957 | Proposed DeviceU9000 Ultrafilter | Assessment of Differences |
|---|---|---|---|
| Intended Use | The DIACLEAR ultrafilter is intended tobe used only with either HOSPALIntegra or Innova or GAMBRO Phoenixdialysis machines equipped with thefeature for dialysate filtration. | The Ultrafilter U9000 is intended to be used inconjunction with a water treatment system.WARNING! The Ultrafilter U9000 can only beused with Gambro/Baxter/Hospal dialysismachines equipped with U9000 filter holder. | U9000 is to be used on a newgeneration of dialysis machines,including AK 98.Diaclear is not compatible with thenew system. |
| Indications forUse | Ultrafiltration with the DIACLEARultrafilter is indicated for purification ofdialysis fluid to obtain microbiologicallyhigh quality dialysis fluid.The risk of exposure to bacteria andendotoxins can thereby be minimised. | The Ultrafilter U9000 is indicated for purificationof incoming water for dialysis fluid as well aspurification of dialysis fluid to obtain standarddialysis fluid in accordance with internationalstandards requirements and local regulations.The risk of exposure to bacteria and endotoxinscan thereby be minimized. The Ultrafilter U9000is intended to be used in conjunction with a watertreatment system | No significant difference |
| Sterile | Yes | No(Unsterile Device) | The U9000 ultrafilter is producedin a clean room environment, andthe bioburden level of the product is |
| Features | Predicate Device – DiaclearCleared under K003957 | Proposed DeviceU9000 Ultrafilter | Assessment of Differences |
| monitored regularly. The product isnot sterilized after production. Itwill be installed in a non-sterilefluid path and after installation,disinfection prior to first use asspecified in IFU and OPM isrequired to be performed by the AK98 dialysis system. Therefore, theU9000 ultrafilter does not need tobe sterile to be substantiallyequivalent to the predicate device. | |||
| Non-Pyrogenic | Yes | No | The U9000 ultrafilter is producedin a clean room environment, andthe bioburden level of the product ismonitored regularly. The product isnot sterilized after production. Itwill be installed in a non-sterilefluid path and after installation,disinfection prior to first use asspecified in IFU and OPM isrequired to be performed by the AK98 dialysis system. Therefore, theU9000 ultrafilter does not need tobe sterile to be substantiallyequivalent to the predicate device. |
| Expiration | 3 years | 2 years | Design control activities have beenconducted and confirmed that thedifferent technologicalcharacteristics of the new device donot raise different questions ofsafety and effectiveness |
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| Features | Predicate Device - DiaclearCleared under K003957 | Proposed DeviceU9000 Ultrafilter | Assessment of Differences |
|---|---|---|---|
| Single Use | No | No | No Difference |
| Storageconditions | Between 0°C and 30°C | Below 30°C | Design control activities have beenconducted and confirmed that thedifferent technologicalcharacteristics of the new device donot raise different questions ofsafety and effectiveness |
| PumpCompatibility orElectromechanical devicecompatibility | HOSPAL Integra or Innova orGAMBRO Phoenix dialysis machines | AK 98 | The Diaclear and U9000 ultrafiltersperform the same function, the onlyinteraction with theelectromechanical device is to fitwithin the holder. The differencedoes not imply risks to the patientsafety or to the treatmenteffectiveness. |
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| Features | Predicate Device – DiaclearCleared under K003957 | Proposed DeviceU9000 Ultrafilter | Assessment of Differences |
|---|---|---|---|
| Materials | See below | See below | Differences in Materials are deemednot relevant.Each Ultrafilter Device has verifiedBiocompatibility according to ISO10993 |
| Membrane | Polyaryylethersulfone (PAES)Polyvinylpyrrolidone (PVP) | Same | Not Applicable |
| Housing andHeader | Polycarbonate (PC) | Same | Not Applicable |
| Supporting ring | Not Applicable | PolyPropylene (PP) | The predicate device does not havea Supporting ring. Device controlactivities have been conducted andconfirmed that the differenttechnological characteristics of thenew device do not raise differentquestions of safety andeffectiveness. |
| 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 beenconducted and confirmed that thedifferent technologicalcharacteristics of the new device donot raise different questions ofsafety and effectiveness. |
| Features | Predicate Device – DiaclearCleared under K003957 | Proposed DeviceU9000 Ultrafilter | Assessment of Differences |
| Ultrafiltrate cap | PolyPropylene (PP) | Low Density PolyEthylene (LDPE) | Not Significant |
| Specifications | See below | See below | Differences in ProductSpecifications are deemed notrelevant.Each Ultrafilter Device is designedand validated to fulfill the SystemRequirements specific to the therapysystem they are used with |
| Inner diameter offiber | 215 μm | 190 μm | Not significant |
| Wall thickness offiber | 45 μm | Same | Not significant |
| Efficient surface | 1.30 m² | 2.40 m² | Design control activities havebeen conducted andconfirmed that the differentproduct specifications of thenew device do not raisedifferent questions of safetyand effectiveness. |
| Maximumtransmembranepressure | 500 mmHg | 600 mmHg | Not significant |
| Operating range:QD | 500 - 1000 mL/min | 300-1200 mL/min | Not significant |
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| Features | Predicate Device – DiaclearCleared under K003957 | Proposed DeviceU9000 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 DeviceSingle Needle conversion kit (SNK)Cleared under K070414 | Proposed DeviceC-705 Accessory ExpansionChamber | Assessment of Differences |
|---|---|---|---|
| Intended Use | The Gambro Cartridge Blood Set isintended for single use in ahemodialysis treatmentusing thePhoenix Dialysis Delivery Systems | C-705 Accessory Expansion Chamberis intended for single use in ahemodialysis treatment. | Different wording but same Intended use |
| Indications for Use | The Single Needle Conversion Kit isintended for use with the DialysisDelivery Systemsand a Gambro Cartridge Blood Set.When properly used, the kit will allowthe clinicianto reconfigure a Gambro CartridgeBlood Set to perform a single needledialysis treatment. | C-705 Accessory Expansion Chamberis a single use sterile medical deviceintended to be used during thedelivery of Hemodialysis treatment inSingle Needle mode, on patientsaffected by chronic renal failure.The C-705 Accessory ExpansionChamber is an ancillary device used toallow the conversion from DoubleNeedle to Single Needleadministration mode of treatments,after connection to proper BloodTubing System intended for | Different wording but same Indicationsfor Use |
| Features | Predicate DeviceSingle Needle conversion kit (SNK)Cleared under K070414 | Proposed DeviceC-705 Accessory ExpansionChamber | Assessment of Differences |
| Haemodialysis treatment in DoubleNeedle mode and to a Dialyzer filter.C-705 Accessory Expansion Chambershall be used in combination withBlood Tubing System suitable for AK98 haemodialysis delivery systemonly. The total extracorporeal bloodvolume for the extracorporeal circuitincluding the set, dialyzer andaccessories should represent less than10% of the patient's blood volume. | |||
| Target Population | Adult patients with chronic renalfailure | patients affected by chronic renalfailure | Different wording but same patientpopulation |
| Sterile | Yes | Yes | No differences |
| Sterilization Method | Radiation | Ethilene Oxide | Both devices meet sterilizationandbiocompatibilityrequirements.Thedifferences in sterilization method does notcreate different questions of safety oreffectiveness, |
| Expiration | 3 years | 3 years | No differences |
| Non-Pyrogenic | Yes | Yes | No differences |
| Single Use | Yes | Yes | No differences |
| Pump Compatibility orElectromechanicaldevice compatibility | Phoenix and Centrysystem 3 | AK 98 | The accessory is used on different dialysisdelivery systems. Two accessories performthe same function, the only interactionwith the electromechanical device is to fit |
| Features | Predicate DeviceSingle Needle conversion kit (SNK)Cleared under K070414 | Proposed DeviceC-705 Accessory ExpansionChamber | Assessment of Differences |
| within the holder. The difference does notimply risks to the patient safety or to thetreatment effectiveness. | |||
| Materials | |||
| Tubing(direct contact withblood for transport tubesand indirect contact forservice tube) | PVC | PVC | The PVC material is tested for biocompatibilityand performance in accordance with FDAguidance. No significance to safety oreffectiveness |
| Dialyzer ConnectorBlue (inner Part) | PVC | PVC | No differences |
| Male Locking DialyzerConnector BlueA | M-ABS | M-ABS | No differences |
| Expansion Chamber | PETG | PVC | Rigid PVC-based material is suitable forthe component function and tested forbiocompatibility |
| Female luer connector(indirect contact withblood) | PETG | PETG | No differences |
| Clamps | Pinch | Pinch | No differences |
| Blood Tubing Length | Dialyzer Length (venous) :46 cmDialyzer Length (arterials) :51 cm | Dialyzer Length (venous) :75 cmDialyzer Length (arterials) :8 cm | The accessory is used on different dialysisdelivery systems. The difference does notimply risks to the patient safety or to thetreatment effectiveness. |
| Features | Predicate DeviceSingle Needle conversion kit (SNK)Cleared under K070414 | Proposed DeviceC-705 Accessory ExpansionChamber | Assessment of Differences |
| Blood Pathway | ID: 4.17 mmOD: 6.50 mm | ID: 4.30 mmOD: 6.80 mm | The accessory is used on different dialysisdelivery systems. The difference does notimply risks for patient safety nor treatmenteffectiveness. |
| Connection to dialyzer | ID: 4.17 mmOD: 6.80 mm | ID: 4.30 mmOD: 6.6 mm | The accessory is used on different dialysisdelivery systems. The difference does notimply risks for the patient safety nortreatment effectiveness. |
| Priming Volume | 45 ml | 50 ml | C-705 Accessory Expansion Chamber hasone expansion chamber to be connectedafter the dialyzer filter while CartridgeSingle Needle Conversion Kit has twosmaller expansion chambers to beconnected before and after the dialyzerfilter . Consequence of this difference is ahigher priming volume of the proposeddevice (50 ml) compared to the primingvolume of the predicate device (45 ml). |
| Packaging | Blister | Blister | No differences |
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Table 5. Accessory Comparison
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Table 5. Accessory Comparison
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Table 5. Accessory Comparison
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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.
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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.
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The specifications, and functionality of components are provided accordance with FDA Guidance
§ 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.”