(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.
§ 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.”