CleanCart A, CleanCart C, AK 98 Hemodialysis Machine

K232467 · Baxter Healthcare Corporation · KDI · Sep 14, 2023 · Gastroenterology, Urology

Device Facts

• Record ID: K232467
• Device Name: CleanCart A, CleanCart C, AK 98 Hemodialysis Machine
• Applicant: Baxter Healthcare Corporation
• Product Code: KDI · Gastroenterology, Urology
• Decision Date: Sep 14, 2023
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.5860
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended 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.

Device Story

System comprises AK 98 Dialysis Machine and two cleaning cartridges: CleanCart A (sodium carbonate) and CleanCart C (citric acid). Cartridges are accessories for maintenance of dialysis fluid pathway; they are not present during patient treatment. CleanCart A removes organic deposits, fats, and proteins; CleanCart C removes calcium and magnesium precipitation. Cartridges are inserted into the machine's BiCart holder and used in conjunction with the machine's automated heat disinfection cycle. Machine is operated by trained personnel in chronic care or hospital environments. Output of cleaning process is a disinfected fluid circuit. Machine provides hemodialysis and isolated ultrafiltration; monitors conductivity, pressure, and flow rates; integrates with clinical information systems via HL7. Benefits include maintenance of machine hygiene and performance, ensuring safe treatment delivery for patients with renal failure.

Clinical Evidence

No clinical data. Bench testing only. Substantial equivalence supported by design reviews of previously submitted data (K201809) regarding microbiological disinfection and human factors.

Technological Characteristics

Cartridges: Polypropylene tube/cap, PET net filter, anhydrous sodium carbonate (CleanCart A) or citric acid (CleanCart C). Machine: Hemodialysis delivery system, electromechanical, integrates with CIS via HL7. Disinfection: Heat cycle combined with chemical cartridge. Connectivity: HL7 protocol for clinical information systems.

Indications for Use

Indicated for patients with chronic or acute renal failure or fluid overload requiring intermittent hemodialysis or isolated ultrafiltration. Indicated for patients with body weight ≥ 25 kg. Not for self-care or home use.

Regulatory Classification

Identification

A high permeability hemodialysis system is a device intended for use as an artificial kidney system for the treatment of patients with renal failure, fluid overload, or toxemic conditions by performing such therapies as hemodialysis, hemofiltration, hemoconcentration, and hemodiafiltration. Using a hemodialyzer with a semipermeable membrane that is more permeable to water than the semipermeable membrane of the conventional hemodialysis system (§ 876.5820), the high permeability hemodialysis system removes toxins or excess fluid from the patient's blood using the principles of convection (via a high ultrafiltration rate) and/or diffusion (via a concentration gradient in dialysate). During treatment, blood is circulated from the patient through the hemodialyzer's blood compartment, while the dialysate solution flows countercurrent through the dialysate compartment. In this process, toxins and/or fluid are transferred across the membrane from the blood to the dialysate compartment. The hemodialysis delivery machine controls and monitors the parameters related to this processing, including the rate at which blood and dialysate are pumped through the system, and the rate at which fluid is removed from the patient. The high permeability hemodialysis system consists of the following devices:(1) The hemodialyzer consists of a semipermeable membrane with an in vitro ultrafiltration coefficient (K uf ) greater than 8 milliliters per hour per conventional millimeter of mercury, as measured with bovine or expired human blood, and is used with either an automated ultrafiltration controller or anther method of ultrafiltration control to prevent fluid imbalance.(2) The hemodialysis delivery machine is similar to the extracorporeal blood system and dialysate delivery system of the hemodialysis system and accessories (§ 876.5820), with the addition of an ultrafiltration controller and mechanisms that monitor and/or control such parameters as fluid balance, dialysate composition, and patient treatment parameters (e.g., blood pressure, hematocrit, urea, etc.). (3) The high permeability hemodialysis system accessories include, but are not limited to, tubing lines and various treatment related monitors (e.g., dialysate pH, blood pressure, hematocrit, and blood recirculation monitors).

Special Controls

*Classification.* Class II. The special controls for this device are FDA's:(1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Device—Part I: Evaluation and Testing,’ ” (2) “Guidance for the Content of 510(k)s for Conventional and High Permeability Hemodialyzers,” (3) “Guidance for Industry and CDRH Reviewers on the Content of Premarket Notifications for Hemodialysis Delivery Systems,” (4) “Guidance for the Content of Premarket Notifications for Water Purification Components and Systems for Hemodialysis,” and (5) “Guidance for Hemodialyzer Reuse Labeling.”

Predicate Devices

• CleanCart A Cartridge (K001156)
• CleanCart C Cartridge (K001156)
• AK 98 Dialysis Machine (K201809)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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## 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) | |
|-------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| <div> <span> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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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: [phone] Fax: [phone]

## 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<br>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<br>CleanCart A<br>Cleared under K001156 | Proposed Device<br>CleanCart A (955850) | Assessment of Differences |
|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use/ Indications for<br>Use | The CleanCart A product is<br>intended for preparation of a<br>sodium carbonate solution used<br>for removing organic deposits,<br>fats, and proteins from the dialysis<br>machine's fluid circuit.<br>The CleanCart A product must be<br>in combination with the heat<br>disinfection program of the<br>corresponding dialysis machine | The CleanCart A cartridge is intended<br>for preparation of a sodium carbonate<br>solution used for removing organic<br>deposits, fats and proteins from the<br>dialysis machine's fluid circuit.<br>The CleanCart A cartridge must be<br>used in combination with the heat<br>disinfection program of the<br>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<br>compatibility | Compatible with Phoenix | Add Compatibility to AK 98 | The AK and Phoenix machines<br>incorporate the BiCart holder, which is<br>compatible with the CleanCart products.<br>The CleanCart products perform the same<br>function on both devices. |
| Materials | Neither directly nor indirectly<br>patient contacting | Same | N/A |
| Sodium Carbonate powder | anhydrous sodium carbonate<br>powder | Same | N/A |
| Tube | Polypropylene tube | Same | N/A |
| Cap | Polypropylene | Phthalate-free polypropylene | No significant difference |
| Features | Predicate Device<br>CleanCart A<br>Cleared under K001156 | Proposed Device<br>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<br>CleanCart C<br>Cleared under K001156 | Proposed Device<br>CleanCart C (955851) | Assessment of Differences |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|
| Intended Use/ Indications for<br>Use | The CleanCart C product is<br>intended for preparation of a citric<br>acid solution used for removing<br>calcium and magnesium<br>precipitation from the dialysis<br>machine's fluid circuit.<br>The CleanCart C product used in<br>combination with the heat<br>disinfection program increases the<br>efficiency of the disinfection<br>program | The CleanCart C cartridge is intended<br>for preparation of a citric acid solution<br>used for removing calcium and<br>magnesium precipitation from the<br>dialysis machine's fluid circuit.<br>The CleanCart cartridge must be used in<br>combination with the heat disinfection<br>program of the corresponding dialysis<br>machine | No significant difference |
| Sterile | No | Same | N/A |
| Non-Pyrogenic | No | Same | N/A |

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| Features | Predicate Device<br>CleanCart C<br>Cleared under K001156 | Proposed Device<br>CleanCart C (955851) | Assessment of Differences |
|-------------------------------------------|----------------------------------------------------------|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Single Use | Yes | Same | N/A |
| Electromechanical device<br>compatibility | Compatible with Phoenix Dialysis<br>machine | Compatible with AK 98 Dialysis<br>machine | The AK and Phoenix machines<br>incorporate the BiCart holder, which is<br>compatible with the CleanCart products.<br>The CleanCart products perform the<br>same function on both devices |
| Materials | Neither directly nor indirectly<br>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<br>AK 98<br>Cleared under K201809 | Proposed Device<br>AK 98 | Assessment of Differences |
|--------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | The Baxter AK 98 dialysis machine is<br>intended to be used for intermittent<br>haemodialysis and/or isolated | Same | N/A |
| | Predicate Device<br>AK 98 | Proposed Device<br>AK 98 | |
| Features | Cleared under K201809 | | Assessment of Differences |
| | ultrafiltration treatments of patients<br>with chronic or acute renal failure or<br>fluid overload upon prescription by a<br>physician.<br>The AK 98 dialysis machine is<br>indicated to be used on patients with a<br>body weight of 25 kg or more. The AK<br>98 dialysis machine is intended to be<br>used by trained operators when<br>prescribed by a physician, in a chronic<br> | | |
| | not intended for Selfcare or Home use. | | |
| Treatment modalities | Hemodialysis<br>- HD DN/SP treatment<br>- HD SN/SP treatment | Same | N/A |
| Dialysate conductivity<br>monitoring | Yes | Same | N/A |
| Isolated UF | Yes | Same | N/A |
| Ultrafiltration control | Yes | Same | N/A |
| Ultrafiltration<br>supervision | Yes, supervision in accordance with<br>IEC 60601-2-16, 4th edition | Same | N/A |
| Ultrafiltration accuracy | Between ±50 and ±100 g/h, depending<br>on ultrafiltration rate. | Same | N/A |
| Features | Predicate Device<br>AK 98<br>Cleared under K201809 | Proposed Device<br>AK 98 | Assessment of Differences |
| | Note: Ultrafiltration accuracy<br>calculated per section 13.1.6 in the AK<br>98 Operator's Manual<br>Ultrafiltration control: | | |
| Air detector | Yes | Same | N/A |
| Blood leak detector | Yes | Same | N/A |
| Temperature<br>monitoring | Yes | Same | N/A |
| Fail-safe response<br>during power failure | Yes | Same | N/A |
| Prescription profiling | Conductivity profiling (Na, HCO3) | Same | N/A |
| Disinfection programs | Heat<br>Chemical | Same with the addition of instructions<br>to use the Heat and CleanCart<br>disinfection cycles. These cycles use<br>heat to disinfect the fluid path, and also<br>use a CleanCart Cartridge to remove<br>organic deposits or descale the fluid<br>path. | The Heat and CleanCart Cycles are<br>included in the cleared software and were<br>verified and validated in the same<br>process. Design reviews were performed<br>to assure that these cycles are covered by<br>previously performed microbial<br>disinfection and human factors testing. |
| Anti coagulant<br>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<br>accuracy | For pre-pump pressure range from -200<br>mmHg to 0 mmHg: | Same | N/A |
| | Predicate Device<br>AK 98 | Proposed Device<br>AK 98 | Assessment of Differences |
| Features | Cleared under K201809 | | |
| | ±10 mL/min or ±10% of the set point<br>value, whichever is the largest | | |
| Dialysate Flow Rate | 300 – 800 ml/min | Same | N/A |
| Dialysate Flow Rate<br>accuracy | ±10 % or 50 mL/min whichever is<br>largest | Same | N/A |
| Transmembrane<br>Pressure (TMP) | -200 - +500 mmHg (calculated value)<br>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<br>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<br>measurements (BPM) | Yes | Same | N/A |
| IT connectivity | Yes -<br>Integrates with CIS (clinical<br>information system) using HL7<br>protocol | Same | N/A |

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### 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.