(269 days)
The NikkiCart cartridge is indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute renal failure, chronic renal failure, or acute intoxication with dialyzable substances. The NikkiCart cartridge is intended to be used as one component in the preparation of dialysate according to a physician's prescription in a 3-stream proportioning machine on the Nikkiso DBB-06 dialysis system equipped with a compatible bicarbonate cartridge holder.
The NikkiCart is a single use polypropylene (PP) cartridge containing dry sodium bicarbonate powder, which enables on-line preparation of saturated Sodium Bicarbonate solution that, in conjunction with appropriate acid concentrate solution and dialysis water, creates a bicarbonate -based dialysis fluid that meets the Association for the Advancement of Medical Instrumentation (AAMI) guidelines.
When the NikkiCart is attached to the Nikkiso DBB-06 dialysis machine with a compatible bicarbonate cartridge holder, water is drawn by the dialysis machine through the cartridge, producing a saturated solution of sodium bicarbonate. The dialysis machine mixes the sodium bicarbonate solution with water and the acid concentrate to produce a bicarbonate-based dialysis fluid. The acid concentrate must have a dilution ratio of 1:44 also known as 45X to be used with the NikkiCart Sodium Bicarbonate cartridge.
The provided text does not contain typical acceptance criteria and study details for an AI-medical device in the format requested. Instead, it describes a 510(k) submission for a medical device called "Nikkicart," which is a single-use polypropylene cartridge containing dry sodium bicarbonate powder for hemodialysis. The submission focuses on demonstrating substantial equivalence to a predicate device (GAMBRO BiCart®) by comparing their characteristics and performance data.
Therefore, many of the requested fields cannot be directly extracted from the provided document. However, I can summarize the performance data that was presented to support the safety and effectiveness of the Nikkicart, which can be seen as meeting the criteria for device functionality and safety.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly list "acceptance criteria" in a quantitative sense as might be typical for AI performance. Instead, it details various performance data categories that were assessed to support the device's safety and effectiveness and its substantial equivalence to the predicate. The "reported device performance" is a statement that these tests were conducted and their results support the claims.
| Acceptance Criteria Category (Implicit) | Reported Device Performance |
|---|---|
| Biocompatibility (Cytotoxicity) | Assessed to support biological safety of the NikkiCart. |
| Biocompatibility (Sensitization) | Assessed to support biological safety of the NikkiCart. |
| Biocompatibility (Irritation) | Assessed to support biological safety of the NikkiCart. |
| Biocompatibility (Acute Systemic toxicity) | Assessed to support biological safety of the NikkiCart. |
| Biocompatibility (Material mediated pyrogenicity) | Assessed to support biological safety of the NikkiCart. |
| Biocompatibility (Hemocompatibility) | Assessed to support biological safety of the NikkiCart. |
| Stability (Shelf life of 24 months/2 years) | Supported by real-time stability evaluations. |
| Chemical Characterization (Chronic systemic toxicity) | Assessment conducted to support biological safety. |
| Chemical Characterization (Mutagenicity/Carcinogenicity) | Assessment conducted to support biological safety. |
| Shipping and Distribution Verification | Performed in accordance with ASTM D4169-16. Results support that the product's packaging can withstand the distribution environment. |
| Functional Equivalence (Refer to Table 1 Comparison) | Demonstrated through comparison of fill weight, dimensions, duration of use, acid dilution ratio, final dialysate conductivity, fill water temperature, and key attributes. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify sample sizes for the various tests (e.g., how many cartridges were tested for stability or biocompatibility). It also does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective, although stability and shipping tests imply a prospective element.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable and not provided. The Nikkicart is a hardware and chemical product, not an AI-driven diagnostic device requiring expert interpretation for ground truth establishment. The "ground truth" for this device would be established by laboratory measurements and chemical analyses, not expert consensus on medical images or patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided, as the device doesn't involve subjective interpretation that would necessitate an adjudication method.
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
An MRMC study was not done. This is not an AI-assisted device, and the concept of human readers improving with AI assistance is not relevant to this product.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is not an algorithm. Performance tests were conducted on the physical cartridge and its components.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is based on laboratory measurements, chemical analysis, physical testing, and established standards (e.g., AAMI guidelines for dialysate fluid, USP & European Pharmacopeia for sodium bicarbonate grade, ASTM D4169-16 for shipping).
8. The sample size for the training set
This is not applicable. The Nikkicart is not an AI/ML device that requires a "training set."
9. How the ground truth for the training set was established
This is not applicable, as there is no "training set" for this type of medical device.
§ 876.5820 Hemodialysis system and accessories.
(a)
Identification. A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.(1) The extracorporeal blood system and accessories consists of tubing, pumps, pressure monitors, air foam or bubble detectors, and alarms to keep blood moving safely from the blood access device and accessories for hemodialysis (§ 876.5540) to the blood compartment of the dialyzer and back to the patient.
(2) The conventional dialyzer allows a transfer of water and solutes between the blood and the dialysate through the semipermeable membrane. The semipermeable membrane of the conventional dialyzer has a sufficiently low permeability to water that an ultrafiltration controller is not required to prevent excessive loss of water from the patient's blood. This conventional dialyzer does not include hemodialyzers with the disposable inserts (Kiil type) (§ 876.5830) or dialyzers of high permeability (§ 876.5860).
(3) The dialysate delivery system consists of mechanisms that monitor and control the temperature, conductivity, flow rate, and pressure of the dialysate and circulates dialysate through the dialysate compartment of the dialyzer. The dialysate delivery system includes the dialysate concentrate for hemodialysis (liquid or powder) and alarms to indicate abnormal dialysate conditions. This dialysate delivery system does not include the sorbent regenerated dialysate delivery system for hemodialysis (§ 876.5600), the dialysate delivery system of the peritoneal dialysis system and accessories (§ 876.5630), or the controlled dialysate delivery system of the high permeability hemodialysis system § 876.5860).
(4) Remote accessories to the hemodialysis system include the unpowered dialysis chair without a scale, the powered dialysis chair without a scale, the dialyzer holder set, dialysis tie gun and ties, and hemodialysis start/stop tray.
(b)
Classification. (1) Class II (performance standards) for hemodialysis systems and all accessories directly associated with the extracorporeal blood system and the dialysate delivery system.(2) Class I for other accessories of the hemodialysis system remote from the extracorporeal blood system and the dialysate delivery system, such as the unpowered dialysis chair, hemodialysis start/stop tray, dialyzer holder set, and dialysis tie gun and ties. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.