(30 days)
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No
The document describes chemical cleaning cartridges for a dialysis machine and does not mention any AI or ML capabilities.
No.
Explanation: The CleanCart A and CleanCart C devices are intended for cleaning and maintenance of dialysis machines themselves, not for direct therapeutic treatment of a patient's condition. They are accessories for the dialysis machine's fluid circuit to remove deposits, fats, proteins, calcium, and magnesium. The Baxter AK 98 Dialysis machine is the therapeutic device, but the question is specifically about the CleanCart products.
No
The device, CleanCart A and C cartridges, are intended for the preparation of solutions used for cleaning and maintaining dialysis machines, not for diagnosing medical conditions in patients. The AK 98 Dialysis machine mentioned is for treatment, not diagnosis.
No
The device description clearly states that the CleanCart A and CleanCart C products are cartridges containing physical substances (sodium carbonate powder and citric acid anhydrous powder) intended for use in a dialysis machine. These are hardware components, not software.
Based on the provided text, the CleanCart A and CleanCart C cartridges are not IVD (In Vitro Diagnostic) devices.
Here's why:
- Intended Use: The intended use of the CleanCart cartridges is for the maintenance and cleaning of the dialysis machine's fluid circuit. They are used to remove organic deposits, fats, proteins, calcium, and magnesium precipitation from the machine itself.
- Mechanism of Action: The cartridges prepare chemical solutions (sodium carbonate and citric acid) that are used in conjunction with the machine's heat disinfection program to clean the internal components.
- Patient Connection: The text explicitly states that "the patient is not connected with the hemodialysis machine during this process." IVD devices are used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description reinforces that these are "accessories for the maintenance of the dialysis fluid pathway of hemodialysis machines."
In summary, the CleanCart cartridges are accessories for maintaining the functionality of a medical device (the dialysis machine), not for performing diagnostic tests on patient samples.
N/A
Intended Use / Indications for Use
The CleanCart A cartridge is intended for preparation of a sodium carbonate solution used for removing organic deposits, fats and proteins from the dialysis machine's fluid circuit.
The CleanCart A cartridge must be used in combination with the heat disinfection program of the corresponding dialysis machine.
The CleanCart C cartridge is intended for preparation of a citric acid solution used for removing calcium and magnesium precipitation from the dialysis machine's fluid circuit.
The CleanCart C cartridge must be used in combination with the heat disinfection program of the corresponding dialysis machine
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.
Product codes (comma separated list FDA assigned to the subject device)
KDI
Device Description
CleanCart A and Cleancart C products are accessories for the maintenance of the dialysis fluid pathway of hemodialysis machines equipped with a compatible cartridge holder. CleanCart products are compatible with the BiCart holder of the AK 98 Dialysis Machine (K201809). The AK 98 Dialysis Machine and CleanCart products will be used in chronic care dialysis or hospital care environments. The CleanCart products are used in combination with a heat disinfection cycle; the patient is not connected with the hemodialysis machine during this process.
The CleanCart A cartridge contains 13 grams of anhydrous sodium carbonate powder. The CleanCart A cartridge is intended for the preparation of a sodium carbonate solution used for removing organic deposits, fats and proteins from the dialysis machine's fluid circuit. The diluted solution has a pH of approximately 11.
The CleanCart C cartridge contains 32 grams of citric acid anhydrous powder. The CleanCart C cartridge is intended for preparation of a citric acid solution used for removing calcium and magnesium precipitation from the dialysis machine's fluid circuit. The diluted solution has a pH of approximately 2.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The AK 98 Dialysis Machine is intended to be used by trained operators when prescribed by a physician, in a chronic care dialysis or hospital care environment.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
No design changes were required for CleanCart products to be compatible for use with the AK 98 Dialysis Machine, therefore no additional testing has been performed in support of this change. The data demonstrating that CleanCart and AK 98 products can be used together was part of the AK 98 510(k) submission (K201809). Design reviews were performed to determine if the microbiological disinfection verification and human factors studies submitted in K201809 were relevant to the use of CleanCart products and AK 98. Both reviews determined use of the Heat and CleanCart cycles was covered by existing data, and no additional testing was needed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 876.5860 High permeability hemodialysis system.
(a)
Identification. A high permeability hemodialysis system is a device intended for use as an artificial kidney system for the treatment of patients with renal failure, fluid overload, or toxemic conditions by performing such therapies as hemodialysis, hemofiltration, hemoconcentration, and hemodiafiltration. Using a hemodialyzer with a semipermeable membrane that is more permeable to water than the semipermeable membrane of the conventional hemodialysis system (§ 876.5820), the high permeability hemodialysis system removes toxins or excess fluid from the patient's blood using the principles of convection (via a high ultrafiltration rate) and/or diffusion (via a concentration gradient in dialysate). During treatment, blood is circulated from the patient through the hemodialyzer's blood compartment, while the dialysate solution flows countercurrent through the dialysate compartment. In this process, toxins and/or fluid are transferred across the membrane from the blood to the dialysate compartment. The hemodialysis delivery machine controls and monitors the parameters related to this processing, including the rate at which blood and dialysate are pumped through the system, and the rate at which fluid is removed from the patient. The high permeability hemodialysis system consists of the following devices:(1) The hemodialyzer consists of a semipermeable membrane with an in vitro ultrafiltration coefficient (K
uf ) greater than 8 milliliters per hour per conventional millimeter of mercury, as measured with bovine or expired human blood, and is used with either an automated ultrafiltration controller or anther method of ultrafiltration control to prevent fluid imbalance.(2) The hemodialysis delivery machine is similar to the extracorporeal blood system and dialysate delivery system of the hemodialysis system and accessories (§ 876.5820), with the addition of an ultrafiltration controller and mechanisms that monitor and/or control such parameters as fluid balance, dialysate composition, and patient treatment parameters (e.g., blood pressure, hematocrit, urea, etc.).
(3) The high permeability hemodialysis system accessories include, but are not limited to, tubing lines and various treatment related monitors (e.g., dialysate pH, blood pressure, hematocrit, and blood recirculation monitors).
(b)
Classification. Class II. The special controls for this device are FDA's:(1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Device—Part I: Evaluation and Testing,’ ”
(2) “Guidance for the Content of 510(k)s for Conventional and High Permeability Hemodialyzers,”
(3) “Guidance for Industry and CDRH Reviewers on the Content of Premarket Notifications for Hemodialysis Delivery Systems,”
(4) “Guidance for the Content of Premarket Notifications for Water Purification Components and Systems for Hemodialysis,” and
(5) “Guidance for Hemodialyzer Reuse Labeling.”
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 14, 2023
Baxter Healthcare Corporation Kristen Bozzelli Senior Manager, Regulatory Affairs 25212 W. Illinois Route 120 Round Lake, Illinois 60073
Re: K232467
Trade/Device Name: CleanCart A, CleanCart C, AK 98 Dialysis Machine Regulation Number: 21 CFR 876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: KDI Received: August 15, 2023
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.
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
1
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-regulatory-information/postmarketing-safety-reportingcombination-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 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 mediation-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,
Gema Gonzalez -S
Gema Gonzalez Acting 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) K232467
Device Name
CleanCart A, CleanCart C and AK 98 Dialysis Machine
Indications for Use (Describe)
The CleanCart A cartridge is intended for preparation of a sodium carbonate solution used for removing organic deposits, fats and proteins from the dialysis machine's fluid circuit.
The CleanCart A cartridge must be used in combination with the heat disinfection program of the corresponding dialysis machine.
The CleanCart C cartridge is intended for preparation of a citric acid solution used for removing calcium and magnesium precipitation from the dialysis machine's fluid circuit.
The CleanCart C cartridge must be used in combination with the heat disinfection program of the corresponding dialysis machine
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) |
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Section 5. 510(k) Summary
15 August 2023
OWNER:
Baxter Healthcare Corporation One Baxter Parkway Deerfield, Illinois 60015
CONTACT PERSON:
Kristen Bozzelli Senior Manager, Global Regulatory Affairs 32650 N Wilson Road Round Lake, IL 60073 Telephone: 1-224-948-5585 Fax: 1-224-270-4119
IDENTIFICATION OF THE DEVICE:
Common Name: Hemodialysis Delivery System Trade/Device Name: CleanCart A, CleanCart C, AK 98 Dialysis Machine
Classification Panel: Gastroenterology/Urology Regulation Number: 21 CFR 876.5860 Regulation Name: High Permeability Hemodialysis System Regulatory Class: Class II Product Code: KDI
| Device Description | Code Number |
|---|---|
| CleanCart A Cartridge (Sodium Carbonate) | 955850 |
| CleanCart C Cartridge (Citric Acid) | 955851 |
| AK 98 Dialysis Machine | 955607 |
Table 1. Device Configurations
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PREDICATE DEVICE:
This Special 510(k) is being submitted to add CleanCart A and CleanCart C as accessories of the AK 98 Machine. CleanCart A and CleanCart C were previously cleared for use with the Phoenix Dialysis System.
| Device | Predicate 510(k) | Clearance Date |
|---|---|---|
| CleanCart A Cartridge (Sodium | ||
| Carbonate) | K001156 | 7 July 2000 |
| CleanCart C Cartridge (Citric Acid) | K001156 | 7 July 2000 |
| AK 98 Dialysis Machine | K201809 | 10 March 2021 |
Table 2. Predicate Device(s)
DESCRIPTION OF THE DEVICE:
CleanCart A and Cleancart C products are accessories for the maintenance of the dialysis fluid pathway of hemodialysis machines equipped with a compatible cartridge holder. CleanCart products are compatible with the BiCart holder of the AK 98 Dialysis Machine (K201809). The AK 98 Dialysis Machine and CleanCart products will be used in chronic care dialysis or hospital care environments. The CleanCart products are used in combination with a heat disinfection cycle; the patient is not connected with the hemodialysis machine during this process.
The CleanCart A cartridge contains 13 grams of anhydrous sodium carbonate powder. The CleanCart A cartridge is intended for the preparation of a sodium carbonate solution used for removing organic deposits, fats and proteins from the dialysis machine's fluid circuit. The diluted solution has a pH of approximately 11.
The CleanCart C cartridge contains 32 grams of citric acid anhydrous powder. The CleanCart C cartridge is intended for preparation of a citric acid solution used for removing calcium and magnesium precipitation from the dialysis machine's fluid circuit. The diluted solution has a pH of approximately 2.
INDICATIONS FOR USE:
The CleanCart A cartridge is intended for preparation of a sodium carbonate solution used for removing organic deposits, fats and proteins from the dialysis machine's fluid circuit. The CleanCart A cartridge must be used in combination with the heat disinfection program of the corresponding dialysis machine.
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The CleanCart C cartridge is intended for preparation of a citric acid solution used for removing calcium and magnesium precipitation from the dialysis machine's fluid circuit.
The CleanCart C cartridge must be used in combination with the heat disinfection program of the corresponding dialysis machine.
And
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.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE:
No design changes were required for CleanCart products to be compatible for use with the AK 98 Dialysis Machine. The technological characteristics are described in the device comparison tables below.
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| Features | Predicate Device
CleanCart A
Cleared under K001156 | Proposed Device
CleanCart A (955850) | Assessment of Differences |
|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use/ Indications for
Use | The CleanCart A product is
intended for preparation of a
sodium carbonate solution used
for removing organic deposits,
fats, and proteins from the dialysis
machine's fluid circuit.
The CleanCart A product must be
in combination with the heat
disinfection program of the
corresponding dialysis machine | The CleanCart A cartridge is intended
for preparation of a sodium carbonate
solution used for removing organic
deposits, fats and proteins from the
dialysis machine's fluid circuit.
The CleanCart A cartridge must be
used in combination with the heat
disinfection program of the
corresponding dialysis machine. | No significant difference. |
| Sterile | No | Same | N/A |
| Non-Pyrogenic | No | Same | N/A |
| Single Use | Yes | Same | N/A |
| Electromechanical device
compatibility | Compatible with Phoenix | Add Compatibility to AK 98 | The AK and Phoenix machines
incorporate the BiCart holder, which is
compatible with the CleanCart products.
The CleanCart products perform the same
function on both devices. |
| Materials | Neither directly nor indirectly
patient contacting | Same | N/A |
| Sodium Carbonate powder | anhydrous sodium carbonate
powder | Same | N/A |
| Tube | Polypropylene tube | Same | N/A |
| Cap | Polypropylene | Phthalate-free polypropylene | No significant difference |
| Features | Predicate Device
CleanCart A
Cleared under K001156 | Proposed Device
CleanCart A (955850) | Assessment of Differences |
| | PET Net filter | Same | N/A |
| Length | 235mm | 238.3mm | No significant difference |
| Shelf life | 2 years | Same | N/A |
Table 3. Device Comparison CleanCart A
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Table 3. Device Comparison CleanCart A
Table 4. Device Comparison CleanCart C
| Features | Predicate Device
CleanCart C
Cleared under K001156 | Proposed Device
CleanCart C (955851) | Assessment of Differences |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|
| Intended Use/ Indications for
Use | The CleanCart C product is
intended for preparation of a citric
acid solution used for removing
calcium and magnesium
precipitation from the dialysis
machine's fluid circuit.
The CleanCart C product used in
combination with the heat
disinfection program increases the
efficiency of the disinfection
program | The CleanCart C cartridge is intended
for preparation of a citric acid solution
used for removing calcium and
magnesium precipitation from the
dialysis machine's fluid circuit.
The CleanCart cartridge must be used in
combination with the heat disinfection
program of the corresponding dialysis
machine | No significant difference |
| Sterile | No | Same | N/A |
| Non-Pyrogenic | No | Same | N/A |
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| Features | Predicate Device
CleanCart C
Cleared under K001156 | Proposed Device
CleanCart C (955851) | Assessment of Differences |
|-------------------------------------------|----------------------------------------------------------|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Single Use | Yes | Same | N/A |
| Electromechanical device
compatibility | Compatible with Phoenix Dialysis
machine | Compatible with AK 98 Dialysis
machine | The AK and Phoenix machines
incorporate the BiCart holder, which is
compatible with the CleanCart products.
The CleanCart products perform the
same function on both devices |
| Materials | Neither directly nor indirectly
patient-contacting | Same | N/A |
| Citrate | Anhydrous citric acid powder | Same | N/A |
| Tube | Polypropylene | Same | N/A. |
| Cap | Polypropylene | Phthalate free Polypropylene | No significant difference |
| Cap | PET Net Filters | Same | N/A |
| Length | 235mm | 238.3mm | No significant difference |
| Shelf Life | 2 years | Same | N/A |
Table 4. Device Comparison CleanCart C
| Features | Predicate Device
AK 98
Cleared under K201809 | Proposed Device
AK 98 | Assessment of Differences |
|--------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | The Baxter AK 98 dialysis machine is
intended to be used for intermittent
haemodialysis and/or isolated | Same | N/A |
| | Predicate Device
AK 98 | Proposed Device
AK 98 | |
| Features | Cleared under K201809 | | Assessment of Differences |
| | 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
| | |
| | not intended for Selfcare or Home use. | | |
| Treatment modalities | Hemodialysis
- HD DN/SP treatment
- HD SN/SP treatment | Same | N/A |
| Dialysate conductivity
monitoring | Yes | Same | N/A |
| Isolated UF | Yes | Same | N/A |
| Ultrafiltration control | Yes | Same | N/A |
| Ultrafiltration
supervision | Yes, supervision in accordance with
IEC 60601-2-16, 4th edition | Same | N/A |
| Ultrafiltration accuracy | Between ±50 and ±100 g/h, depending
on ultrafiltration rate. | Same | N/A |
| Features | Predicate Device
AK 98
Cleared under K201809 | Proposed Device
AK 98 | Assessment of Differences |
| | Note: Ultrafiltration accuracy
calculated per section 13.1.6 in the AK
98 Operator's Manual
Ultrafiltration control: | | |
| Air detector | Yes | Same | N/A |
| Blood leak detector | Yes | Same | N/A |
| Temperature
monitoring | Yes | Same | N/A |
| Fail-safe response
during power failure | Yes | Same | N/A |
| Prescription profiling | Conductivity profiling (Na, HCO3) | Same | N/A |
| Disinfection programs | Heat
Chemical | Same with the addition of instructions
to use the Heat and CleanCart
disinfection cycles. These cycles use
heat to disinfect the fluid path, and also
use a CleanCart Cartridge to remove
organic deposits or descale the fluid
path. | The Heat and CleanCart Cycles are
included in the cleared software and were
verified and validated in the same
process. Design reviews were performed
to assure that these cycles are covered by
previously performed microbial
disinfection and human factors testing. |
| Anti coagulant
administration rate: | 0 – 10.0 ml/h | Same | N/A |
| Anti coagulant bolus: | 0 - 10.0 ml | Same | N/A |
| Blood Flow Rate | 20 -600 ml/min | Same | N/A |
| Blood flow rate
accuracy | For pre-pump pressure range from -200
mmHg to 0 mmHg: | Same | N/A |
| | Predicate Device
AK 98 | Proposed Device
AK 98 | Assessment of Differences |
| Features | Cleared under K201809 | | |
| | ±10 mL/min or ±10% of the set point
value, whichever is the largest | | |
| Dialysate Flow Rate | 300 – 800 ml/min | Same | N/A |
| Dialysate Flow Rate
accuracy | ±10 % or 50 mL/min whichever is
largest | Same | N/A |
| Transmembrane
Pressure (TMP) | -200 - +500 mmHg (calculated value)
set of LIMITS | Same | N/A |
| Net Fluid Removal Rate | 0 – 4 L /h | Same | N/A |
| Dialysate Temperature | 33 - 40 °C | Same | N/A |
| Dialysate Conductivity
set range | 9-16 mS/cm | Same | N/A |
| Arterial pressure | -400 - +300 mmHg | Same | N/A |
| Venous Pressure | +10 - +500 mmHg | Same | N/A |
| Blood pressure
measurements (BPM) | Yes | Same | N/A |
| IT connectivity | Yes -
Integrates with CIS (clinical
information system) using HL7
protocol | Same | N/A |
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10
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Image /page/12/Picture/1 description: The image shows the word "Baxter" in a bold, blue font. The font appears to be italicized, with the letters leaning slightly to the right. The word is the logo for the healthcare company Baxter International.
DISCUSSION OF NONCLINICAL TESTS:
No design changes were required for CleanCart products to be compatible for use with the AK 98 Dialysis Machine, therefore no additional testing has been performed in support of this change. The data demonstrating that CleanCart and AK 98 products can be used together was part of the AK 98 510(k) submission (K201809). Design reviews were performed to determine if the microbiological disinfection verification and human factors studies submitted in K201809 were relevant to the use of CleanCart products and AK 98. Both reviews determined use of the Heat and CleanCart cycles was covered by existing data, and no additional testing was needed.
Biocompatibility:
No biocompatibility data is required in support of this submission.
The CleanCart products clean the fluid path of the AK 98 machine and are rinsed away during disinfection cycles. As such, the CleanCart products are not present during dialysis treatments; they neither directly nor indirectly contact the patient.
There are no material changes to the AK 98 Dialysis Machine; the biocompatibility data supporting this product is not changed.
CONCLUSION:
Design reviews of previously submitted data support that the use of CleanCart A and CleanCart C with the AK 98 Dialysis Machine is substantially equivalent to the use of CleanCart A and CleanCart C with the Phoenix Dialysis machine.