(30 days)
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.
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.
The provided text describes a 510(k) submission for Baxter Healthcare Corporation's CleanCart A, CleanCart C, and AK 98 Dialysis Machine. The submission aims to add CleanCart A and CleanCart C as accessories to the AK 98 Machine, as they were previously cleared for use with the Phoenix Dialysis System. The information focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study that proves the device meets specific acceptance criteria with performance metrics.
Therefore, many of the requested details about acceptance criteria, extensive study methodologies, sample sizes, expert involvement, and ground truth establishment are not present in this document. The document primarily relies on technical characteristics comparison and design reviews of existing data.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state acceptance criteria in the typical sense of quantitative performance metrics for a new device's function. Instead, it focuses on demonstrating that the proposed device (CleanCart A and C used with AK 98) is substantially equivalent to predicate devices. The "acceptance criteria" here implicitly relate to maintaining the safety and effectiveness characteristics of the predicate devices.
The reported "device performance" is also not in terms of specific numerical outcomes for efficacy or accuracy, but rather a statement of no significant differences in various technical characteristics and intended use.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| CleanCart A / C: Intended Use / Indications for Use (removing organic deposits/fats/proteins, or calcium/magnesium precipitation in combination with heat disinfection). | CleanCart A / C: No significant difference in Intended Use / Indications for Use compared to predicate devices. Functionally, performs the same tasks. |
| CleanCart A / C: Sterile, Non-Pyrogenic, Single Use characteristics maintained. | CleanCart A / C: Same as predicate devices for Sterile, Non-Pyrogenic, Single Use. |
| CleanCart A / C: Electromechanical device compatibility with the AK 98 Dialysis Machine. | CleanCart A / C: Compatible with AK 98. The AK and Phoenix machines incorporate the BiCart holder, which is compatible with CleanCart products. The CleanCart products perform the same function on both devices. |
| CleanCart A / C: Material composition (e.g., anhydrous sodium carbonate, citric acid, polypropylene tube/cap). | CleanCart A / C: Predominantly "Same" as predicate devices. Minor difference for cap material (Phthalate-free polypropylene vs. polypropylene for predicate) assessed as "No significant difference." |
| CleanCart A / C: Physical dimensions (Length). | CleanCart A / C: Minor difference (238.3mm vs. 235mm) assessed as "No significant difference." |
| CleanCart A / C: Shelf life. | CleanCart A / C: Same (2 years) as predicate devices. |
| AK 98: Maintenance of existing intended use (intermittent hemodialysis/isolated ultrafiltration) and other functional specifications (e.g., treatment modalities, conductivity monitoring, UF control, alarms, blood flow rate, dialysate flow rate, etc.). | AK 98: All specified features (Intended Use, Treatment modalities, Dialysate conductivity monitoring, Isolated UF, Ultrafiltration control, Ultrafiltration supervision, Ultrafiltration accuracy, Air detector, Blood leak detector, Temperature monitoring, Fail-safe response during power failure, Prescription profiling, Anticoagulant administration/bolus, Blood Flow Rate/accuracy, Dialysate Flow Rate/accuracy, Transmembrane Pressure, Net Fluid Removal Rate, Dialysate Temperature, Dialysate Conductivity set range, Arterial pressure, Venous Pressure, Blood pressure measurements, IT connectivity) are "Same" as the predicate AK 98. |
| AK 98: Integration and safety of new disinfection programs using CleanCart products. | AK 98: Same disinfection programs with the addition of instructions to use Heat and CleanCart cycles. These cycles are included in the cleared software and were verified and validated in the same process. Design reviews confirmed coverage by previously performed microbial disinfection and human factors testing. |
| CleanCart A / C and AK 98: Bio-compatibility and patient safety. | CleanCart A / C: No biocompatibility data required; products clean the fluid path and are rinsed away, no direct/indirect patient contact. AK 98: No material changes, existing biocompatibility data supports it. |
2. Sample size used for the test set and the data provenance:
The document states: "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)."
This indicates that no new specific test set was used for this particular 510(k) submission to assess the combined use of CleanCart with AK 98. The justification relies on previous testing for the AK 98 (K201809) and the CleanCart products (K001156) individually, and a design review.
Therefore, specific sample sizes and data provenance (country of origin, retrospective/prospective) for a new test set are not provided because such a study was not conducted for this submission. The data provenance would refer back to the original studies for K201809 and K001156, which are not detailed here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided because no new "ground truth" or expert-driven case reviews for device performance are described in this submission. The "evaluation" was a "Design Review" by the manufacturer.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable, as no new test set requiring expert adjudication is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is a medical apparatus (dialysis machine and cleaning cartridges), not an AI-assisted diagnostic or imaging tool involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device does not involve an AI algorithm in the context of diagnostic performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this submission relies on:
- Previously established safety and performance data: From the original 510(k) clearances of the predicate devices (CleanCart A/C under K001156 and AK 98 under K201809).
- Design reviews: Conducted by the manufacturer to ensure that the combined use of CleanCart products with the AK 98 machine is covered by existing data, specifically for microbiological disinfection verification and human factors studies.
There is no mention of expert consensus, pathology, or outcomes data being used to establish a new ground truth for this specific 510(k) submission.
8. The sample size for the training set:
Not applicable. This device does not use machine learning or AI that would require a "training set."
9. How the ground truth for the training set was established:
Not applicable. As above, there is no training set mentioned.
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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
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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 (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
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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) | |
|---|---|
| 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 (SodiumCarbonate) | 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 DeviceCleanCart ACleared under K001156 | Proposed DeviceCleanCart A (955850) | Assessment of Differences |
|---|---|---|---|
| Intended Use/ Indications forUse | The CleanCart A product isintended for preparation of asodium carbonate solution usedfor removing organic deposits,fats, and proteins from the dialysismachine's fluid circuit.The CleanCart A product must bein combination with the heatdisinfection program of thecorresponding dialysis machine | The CleanCart A cartridge is intendedfor preparation of a sodium carbonatesolution used for removing organicdeposits, fats and proteins from thedialysis machine's fluid circuit.The CleanCart A cartridge must beused in combination with the heatdisinfection program of thecorresponding dialysis machine. | No significant difference. |
| Sterile | No | Same | N/A |
| Non-Pyrogenic | No | Same | N/A |
| Single Use | Yes | Same | N/A |
| Electromechanical devicecompatibility | Compatible with Phoenix | Add Compatibility to AK 98 | The AK and Phoenix machinesincorporate the BiCart holder, which iscompatible with the CleanCart products.The CleanCart products perform the samefunction on both devices. |
| Materials | Neither directly nor indirectlypatient contacting | Same | N/A |
| Sodium Carbonate powder | anhydrous sodium carbonatepowder | Same | N/A |
| Tube | Polypropylene tube | Same | N/A |
| Cap | Polypropylene | Phthalate-free polypropylene | No significant difference |
| Features | Predicate DeviceCleanCart ACleared under K001156 | Proposed DeviceCleanCart 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 DeviceCleanCart CCleared under K001156 | Proposed DeviceCleanCart C (955851) | Assessment of Differences |
|---|---|---|---|
| Intended Use/ Indications forUse | The CleanCart C product isintended for preparation of a citricacid solution used for removingcalcium and magnesiumprecipitation from the dialysismachine's fluid circuit.The CleanCart C product used incombination with the heatdisinfection program increases theefficiency of the disinfectionprogram | The CleanCart C cartridge is intendedfor preparation of a citric acid solutionused for removing calcium andmagnesium precipitation from thedialysis machine's fluid circuit.The CleanCart cartridge must be used incombination with the heat disinfectionprogram of the corresponding dialysismachine | No significant difference |
| Sterile | No | Same | N/A |
| Non-Pyrogenic | No | Same | N/A |
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| Features | Predicate DeviceCleanCart CCleared under K001156 | Proposed DeviceCleanCart C (955851) | Assessment of Differences |
|---|---|---|---|
| Single Use | Yes | Same | N/A |
| Electromechanical devicecompatibility | Compatible with Phoenix Dialysismachine | Compatible with AK 98 Dialysismachine | The AK and Phoenix machinesincorporate the BiCart holder, which iscompatible with the CleanCart products.The CleanCart products perform thesame function on both devices |
| Materials | Neither directly nor indirectlypatient-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 DeviceAK 98Cleared under K201809 | Proposed DeviceAK 98 | Assessment of Differences |
|---|---|---|---|
| Intended use | The Baxter AK 98 dialysis machine isintended to be used for intermittenthaemodialysis and/or isolated | Same | N/A |
| Predicate DeviceAK 98 | Proposed DeviceAK 98 | ||
| Features | Cleared under K201809 | Assessment of Differences | |
| ultrafiltration treatments of patientswith chronic or acute renal failure orfluid overload upon prescription by aphysician.The AK 98 dialysis machine isindicated to be used on patients with abody weight of 25 kg or more. The AK98 dialysis machine is intended to beused by trained operators whenprescribed 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 conductivitymonitoring | Yes | Same | N/A |
| Isolated UF | Yes | Same | N/A |
| Ultrafiltration control | Yes | Same | N/A |
| Ultrafiltrationsupervision | Yes, supervision in accordance withIEC 60601-2-16, 4th edition | Same | N/A |
| Ultrafiltration accuracy | Between ±50 and ±100 g/h, dependingon ultrafiltration rate. | Same | N/A |
| Features | Predicate DeviceAK 98Cleared under K201809 | Proposed DeviceAK 98 | Assessment of Differences |
| Note: Ultrafiltration accuracycalculated per section 13.1.6 in the AK98 Operator's ManualUltrafiltration control: | |||
| Air detector | Yes | Same | N/A |
| Blood leak detector | Yes | Same | N/A |
| Temperaturemonitoring | Yes | Same | N/A |
| Fail-safe responseduring power failure | Yes | Same | N/A |
| Prescription profiling | Conductivity profiling (Na, HCO3) | Same | N/A |
| Disinfection programs | HeatChemical | Same with the addition of instructionsto use the Heat and CleanCartdisinfection cycles. These cycles useheat to disinfect the fluid path, and alsouse a CleanCart Cartridge to removeorganic deposits or descale the fluidpath. | The Heat and CleanCart Cycles areincluded in the cleared software and wereverified and validated in the sameprocess. Design reviews were performedto assure that these cycles are covered bypreviously performed microbialdisinfection and human factors testing. |
| Anti coagulantadministration 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 rateaccuracy | For pre-pump pressure range from -200mmHg to 0 mmHg: | Same | N/A |
| Predicate DeviceAK 98 | Proposed DeviceAK 98 | Assessment of Differences | |
| Features | Cleared under K201809 | ||
| ±10 mL/min or ±10% of the set pointvalue, whichever is the largest | |||
| Dialysate Flow Rate | 300 – 800 ml/min | Same | N/A |
| Dialysate Flow Rateaccuracy | ±10 % or 50 mL/min whichever islargest | Same | N/A |
| TransmembranePressure (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 Conductivityset 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 pressuremeasurements (BPM) | Yes | Same | N/A |
| IT connectivity | Yes -Integrates with CIS (clinicalinformation system) using HL7protocol | 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.
§ 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.”