(161 days)
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.
The AK 98 Dialysis Machine is a standalone hemodialysis machine intended for use as a single patient dialysis machine to perform HD treatments of patients with renal failure or fluid overload. The Vantive AK 98 Dialysis Machine is intended to be used in a chronic dialysis or hospitale care environment 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 intended to be used on patients with a body weight of 25 kg or more.
To perform hemodialysis therapy, the AK 98 system needs a high purity water source and the appropriate consumables for treatment, including but not limited to: cleaning products, ultrafilters, acid and base dialysate concentrates, bloodlines, and dialyzers.
In hemodialysis therapies, the AK 98 is used to pump the blood through the extracorporeal circuit and to monitor the arterial and venous pressure, but the blood directly contacts only the disposable bloodline and dialyzer, not the monitor itself.
The fluid unit of the AK 98 Dialysis Machine 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 upon the fault, can include actions such as bypassing the dialyzer.
The fluid path of the AK 98 is composed of a variety of different materials, including silicone tubing.
The provided FDA 510(k) clearance letter and summary for the AK 98 Dialysis Machine (K250508) do not contain the details typically associated with Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria for AI/ML-driven medical devices.
The document describes a submission for a dialysis machine, and the key changes and testing detailed focus on physical components and performance attributes of a medical device (e.g., changes in silicone tubing curing process, ultrafiltration accuracy, blood flow rate accuracy). It specifically highlights non-clinical tests rather than clinical studies with human subjects or AI-specific validation.
Therefore, many of the requested categories in the prompt (e.g., sample sizes for test and training sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone AI performance) are not applicable to this type of device and submission as described in the provided text.
The information that can be extracted relates to the device's functional performance and how it maintains equivalence to its predicate.
Here's an attempt to address the prompt based only on the provided text, while noting the limitations:
Acceptance Criteria and Device Performance for AK 98 Dialysis Machine
Based on the provided 510(k) summary for the AK 98 Dialysis Machine (K250508), the device is demonstrated to be substantially equivalent to its predicate device (AK 98 Dialysis Machine, K232467). The assessment of differences focuses on ensuring the proposed device maintains similar performance and safety characteristics despite a material change in its silicone tubing.
1. Table of Acceptance Criteria and Reported Device Performance
The concept of "acceptance criteria" in this context refers to maintaining the performance specifications of the predicate device. The "reported device performance" is implicitly that the proposed device performs identically to the predicate device for all listed features, having passed non-clinical functional testing. The key change evaluated was the transition from peroxide-cured and platinum-cured tubing to solely platinum-cured tubing.
| Feature / Performance Metric | Acceptance Criteria (from Predicate Device K232467) | Reported Device Performance (Proposed Device K250508) |
|---|---|---|
| Intended Use/Indications for Use | Same as predicate (intermittent hemodialysis/isolated ultrafiltration for patients 25 kg+ with renal failure/fluid overload, used by trained operators in chronic care/hospital, not for self-care/home use) | Same |
| Treatment Modalities | Hemodialysis (HD DN/SP, HD SN/SP) | Same |
| Dialysate Conductivity Monitoring | Yes | Same |
| Isolated UF | Yes | Same |
| Ultrafiltration Control | Yes | Same |
| Ultrafiltration Supervision | Yes, in accordance with IEC 60601-2-16, 4th edition | Same |
| Ultrafiltration Accuracy | Between ±50 and ±100 g/h (depending on UF rate); 50 mL or ± 50 mL/h x passed or treatment time (h) or ± 2.5% of accumulated UF volume, whichever is largest. Worst-case accuracy at 4 L/h UF rate is 100 g/h. | Same |
| Air Detector | Yes | Same |
| Blood Leak Detector | Yes | Same |
| Temperature Monitoring | Yes | Same |
| Fail-safe response during power failure | Yes | Same |
| Prescription Profiling | Conductivity profiling (Na, HCO3) | Same |
| Disinfection Programs | Heat, Chemical | Same |
| Anticoagulant Administration Rate | 0 – 10.0 ml/h | Same |
| Anticoagulant Bolus | 0 – 10.0 ml | Same |
| Blood Flow Rate | 20 – 600 ml/min | Same |
| Blood Flow Rate Accuracy | For pre-pump pressure range -200 mmHg to 0 mmHg: ±10 ml/min or ±10% of set point, whichever is largest | Same |
| Dialysate Flow Rate | 300 – 800 ml/min | Same |
| Dialysate Flow Rate Accuracy | ±10% or 50 ml/min, whichever is largest | Same |
| Transmembrane Pressure | -200 – +500 mmHg (calculated value) set of LIMITS | Same |
| Net Fluid Removal Rate | 0 – 4 L/h | Same |
| Dialysate Temperature | 33 – 40 °C | Same |
| Dialysate Conductivity Set Range | 9 – 16 mS/cm | Same |
| Arterial Pressure | -400 - +300 mmHg | Same |
| Venous Pressure | +10 - +500 mmHg | Same |
| Blood Pressure Measurements (BPM) | Yes | Same |
| IT Connectivity | Yes, Integrates with CIS using HL7 protocol | Same |
| Silicone Tubing | Peroxide-cured and Platinum-cured tubing | Platinum-cured tubing |
Note on Silicone Tubing Difference: The crucial "acceptance criteria" here for the tubing change was that "Performance, biocompatibility, and extractables testing demonstrates that the difference in the curing process does not impact the performance or safety of the AK 98 Hemodialysis System." The reported performance is that this testing was successfully conducted, confirming no impact.
2. Sample Size Used for the Test Set and Data Provenance
The provided document describes non-clinical functional performance testing, biocompatibility testing, and extractables and leachables assessment. It does not mention a "test set" in the context of patient data or clinical trials. Therefore, sample sizes for such data are not applicable here. The data provenance would be laboratory testing results from the manufacturer.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This submission pertains to a physical medical device and primarily relies on engineering and laboratory testing for equivalence, not AI/ML-driven analysis of medical images or patient data requiring expert adjudication. Thus, this information is not applicable.
4. Adjudication Method for the Test Set
As there is no mention of a clinical test set requiring human interpretation or AI output evaluation, an adjudication method is not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC study was not done, as this device is a physical hemodialysis machine, not an AI/ML diagnostic or assistive tool for human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
No, a standalone algorithm performance study was not done, as this device does not contain a discrete AI/ML algorithm whose performance is being evaluated in isolation. Its "performance" refers to the mechanical and fluid dynamic functions of the dialysis machine itself.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance evaluation lies in established engineering standards, device specifications, and the performance characteristics of the legally marketed predicate device. The change in the silicone tubing's curing process required "Performance, biocompatibility, and extractables testing" to demonstrate continued safety and effectiveness. This testing serves as the "ground truth" method for verifying that the new component does not negatively impact the device's adherence to its established specifications.
8. The Sample Size for the Training Set
This concept is not applicable to the submission of this physical medical device. There is no AI/ML model being trained with a dataset.
9. How the Ground Truth for the Training Set was Established
This concept is not applicable as there is no training set for an AI/ML model.
FDA 510(k) Clearance Letter - AK 98 Dialysis Machine
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.08.00
August 1, 2025
Vantive US Healthcare LLC
Kristen Bozzelli
Senior Manager, Regulatory Affairs
One Baxter Parkway, Building 6
Deerfield, IL 60015
Re: K250508
Trade/Device Name: AK 98 Dialysis Machine (955607)
Regulation Number: 21 CFR§ 876.5860
Regulation Name: High permeability hemodialysis system
Regulatory Class: II
Product Code: KDI
Dated: July 3, 2025
Received: July 3, 2025
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 (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Page 2
K250508 - Kristen Bozzelli Page 2
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
Page 3
K250508 - Kristen Bozzelli Page 3
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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,
Gema Gonzalez -S
Maura Rooney
Assistant Director
DHT3A: Division of Renal, Gastrointestinal,
Obesity and Transplant Devices
OHT3: Office of GastroRenal, ObGyn,
General Hospital and Urology Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
Indications for Use
Submission Number (if known)
K250508
Device Name
AK 98 Dialysis Machine (955607)
Indications for Use (Describe)
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.
Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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"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."
Page 5
510(k) Summary
K250508
Page 1 of 7
July 30, 2025
OWNER:
Vantive US Healthcare LLC
One Baxter Parkway
Building 6
Deerfield, IL 60015
CONTACT PERSON:
Kristen Bozzelli
Senior Manager, Regulatory Affairs
Telephone: 1-224-948-5585
Fax: 1-224-948-2111
kristen.bozzelli@vantive.com
IDENTIFICATION OF THE DEVICE:
Common Name: Hemodialysis Delivery System
Trade/Device Name: AK 98 Dialysis Machine (955607)
Classification Panel: Gastroenterology and Urology
Regulation Number: 21 CFR 876.5860
Regulation Name: High Permeability Hemodialysis System
Regulatory Class: Class II
Product Code: KDI
Table 1. Product Codes in this Submission
| Product Code | Name |
|---|---|
| 955607 | AK 98 Dialysis Machine |
Page 6
K250508
Page 2 of 7
PREDICATE DEVICE:
Table 2. Predicate Device
| Proposed Device | Predicate Device | 510(k) Submitter | Predicate 510(k) | Clearance Date |
|---|---|---|---|---|
| AK 98 Dialysis Machine | AK 98 Dialysis Machine | Baxter Healthcare Corporation | K232467 | September 14, 2023 |
DESCRIPTION OF THE DEVICE:
The AK 98 Dialysis Machine is a standalone hemodialysis machine intended for use as a single patient dialysis machine to perform HD treatments of patients with renal failure or fluid overload. The Vantive AK 98 Dialysis Machine is intended to be used in a chronic dialysis or hospitale care environment 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 intended to be used on patients with a body weight of 25 kg or more.
To perform hemodialysis therapy, the AK 98 system needs a high purity water source and the appropriate consumables for treatment, including but not limited to: cleaning products, ultrafilters, acid and base dialysate concentrates, bloodlines, and dialyzers.
In hemodialysis therapies, the AK 98 is used to pump the blood through the extracorporeal circuit and to monitor the arterial and venous pressure, but the blood directly contacts only the disposable bloodline and dialyzer, not the monitor itself.
The fluid unit of the AK 98 Dialysis Machine 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 upon the fault, can include actions such as bypassing the dialyzer.
The fluid path of the AK 98 is composed of a variety of different materials, including silicone tubing.
Page 7
K250508
Page 3 of 7
INDICATIONS FOR USE PROPOSED DEVICE:
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.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE:
The differences between the predicate AK 98 dialysis 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.
Page 8
K250508
Page 4 of 7
Table 3. AK 98 Device Comparison
| Features | Predicate Device Cleared under K232467 | Proposed Device AK 98 Hemodialysis System | Assessment of Differences |
|---|---|---|---|
| Intended Use/ Indications for Use | 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. | Same | Not Applicable |
| Treatment modalities | Hemodialysis - HD DN/SP treatment - HD SN/SP treatment | Same | Not Applicable |
| Dialysate conductivity monitoring | Yes | Same | Not Applicable |
| Isolated UF | Yes | Same | Not Applicable |
| Ultrafiltration Control | Yes | Same | Not Applicable |
| Ultrafiltration Supervision | Yes, supervision in accordance with IEC 60601-2-16, 4th edition | Same | Not Applicable |
| Ultrafiltration accuracy | Between ±50 and ±100 g/h, depending on ultrafiltration rate | Same | Not Applicable |
Page 9
K250508
Page 5 of 7
Table 3. AK 98 Device Comparison
| Features | Predicate Device Cleared under K232467 | Proposed Device AK 98 Hemodialysis System | Assessment of Differences |
|---|---|---|---|
| Note: Ultrafiltration accuracy calculated per section 13.1.6 in the AK 98 Operator's Manual Ultrafiltration control: 50 mL or ± 50 mL/h x passed or treatment time (h) or ± 2.5% of the accumulated UF volume, whichever is largest Provided the highest set UF rate (4 L/h), the worst-case accuracy is 100 g/h (based on ± 2.5% of the accumulated UF volume). | |||
| Air detector | Yes | Same | Not Applicable |
| Blood leak detector | Yes | Same | Not Applicable |
| Temperature monitoring | Yes | Same | Not Applicable |
| Fail-safe response during power failure | Yes | Same | Not Applicable |
| Prescription profiling | Conductivity profiling (Na, HCO3) | Same | Not Applicable |
| Disinfection programs | Heat Chemical | Same | Not Applicable |
| Anti coagulant administration rate | 0 – 10.0 ml/h | Same | Not Applicable |
| Anti coagulant bolus | 0 – 10.0 ml | Same | Not Applicable |
| Blood flow rate | 20 – 600 ml/min | Same | Not Applicable |
Page 10
K250508
Page 6 of 7
Table 3. AK 98 Device Comparison
| Features | Predicate Device Cleared under K232467 | Proposed Device AK 98 Hemodialysis System | Assessment of Differences |
|---|---|---|---|
| Blood flow rate accuracy | 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 | Same | Not Applicable |
| Dialysate flow rate | 300 – 800 ml/min | Same | Not Applicable |
| Dialysate flow rate accuracy | ±10% or 50 ml/min whichever is largest | Same | Not Applicable |
| Transmembrane pressure | -200 – +500 mmHg (calculated value) set of LIMITS | Same | Not Applicable |
| Net fluid removal rate | 0 – 4 L/h | Same | Not Applicable |
| Dialysate temperature | 33 – 40 °C | Same | Not Applicable |
| Dialysate conductivity set range | 9 – 16 mS/cm | Same | Not Applicable |
| Arterial pressure | -400 - +300 mmHg | Same | Not Applicable |
| Venous pressure | +10 - +500 mmHg | Same | Not Applicable |
| Blood pressure measurements (BPM) | Yes | Same | Not Applicable |
| IT connectivity | Yes Integrates with CIS (clinical information system) using HL7 protocol | Same | Not Applicable |
| Silicone Tubing | Peroxide-cured and Platinum-cured tubing | Platinum-cured tubing | Performance, biocompatibility, and extractables testing demonstrates that the difference in the curing process does not impact the performance or safety of the AK 98 Hemodialysis System |
Page 11
K250508
Page 7 of 7
DISCUSSION OF NONCLINICAL TESTS:
Functional performance testing, biocompatibility testing, and extractables and leachables assessment was conducted on the AK 98 dialysis machine with the proposed platinum-cured silicone tubing. This testing confirms that the AK 98 dialysis machine remains as safe and effective as the predicate AK 98 dialysis machine and is substantially equivalent.
§ 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.”