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.

Device Description

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.

AI/ML Overview

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.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 3, 2023

Renal Care Dialysis Solutions, S.A. DE C.V. % Brittany Valdez Nava Head of Quality Healthcare Innovations Catalysts 7811 Montrose Road, Suite 215 Potomac, Maryland 20854

Re: K221652

Trade/Device Name: Nikkicart Regulation Number: 21 CFR 876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: KPO Dated: January 30, 2023 Received: February 1, 2023

Dear Brittany Valdez Nava:

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

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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 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 medical devices and radiation-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, MS 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) K221652

Device Name NIKKICART

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

☒ Transitioning To A STEP-NJ Science Program	☐ For The Current Year In A STEP-NJ Science Program
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|X Prescription Use (Part 21 CFR 801 Subpart D)

__ Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for RCDS Renal Care Dialysis Solutions SA de CV. The logo features a stylized image of two kidneys on the left, followed by the letters RCDS in a sans-serif font. The text "Renal Care Dialysis Solutions SA de CV" is written in a smaller font below the letters RCDS.

510(k) Summary

Company Name, Address: a. RENAL CARE DIALYSIS SOLUTIONS, S.A. DE C.V. Carretera a los Cues K.M. 2.2., Lote 23, Bodegas 5 y 6, Parque Tecnològico Innovaciòn Querètaro El Marquès, Querètaro 76246 Mexico

b. Contact:
Mr. José Enrique Aguirre Valadés General Manager RENAL CARE DIALYSIS SOLUTIONS, S.A. DE C.V. Carretera a los Cues K.M. 2.2., Lote 23, Bodegas 5 y 6, Parque Tecnològico Innovaciòn Querètaro El Marquès, Querètaro 76246 Mexico Email:jeav@rcds.mx Phone: 521-5536558830
Official Correspondent: ﻥ Brittany Valdez Nava Head of Quality Healthcare Innovations Catalysts 7811 Montrose Road, Suite 215 Potomac, Maryland 20854
d. Date prepared June 6, 2022
e. Date revised January 26, 2023
f. Subject Device

Device Name: Device Classification Name: Regulation Number: Common Name: Device Class: Classification Product Code: Regulation Medical Specialty: 510(k) Review Panel:

NikkiCart Hemodialysis system and accessories 21 CFR 876.5820 Sodium Bicarbonate for Hemodialysis Class II KPO Gastroenterology/Urology Gastroenterology/Urology

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Image /page/4/Picture/1 description: The image shows a logo for RCDS Renal Care Dialysis Solutions S.A. de C.V. The logo features a stylized image of two kidneys to the left of the letters "RCDS" in a blue sans-serif font. Below the letters is the text "Renal Care Dialysis Solutions S.A. de C.V." in a smaller font, also in blue. The overall design is clean and professional, suggesting a focus on healthcare and medical solutions.

Predicate Device

The NikkiCart cartridge is substantially equivalent to:

510(k) Number:	K013724
Device Name:	Gambro BiCart®
Applicant:	GAMBRO Renal Products
Device Classification Name:	Dialysate Concentrate For Hemodialysis (Liquid OrPowder)
Regulation Number:	21 CFR 876.5820
Common Name:	Sodium Bicarbonate for Hemodialysis
Device Class:	Class II
Classification Product Code:	KPO
Regulation Medical Specialty:	Gastroenterology/Urology
510(k) Review Panel:	Gastroenterology/Urology

h. Device Description

i. Intended Use
The NikkiCart cartridge is intended for preparation of hemodialysis solutions on theNikkiso dialysis systems. The NikkiCart must always be used with a suitable acid concentrate.

Indications for Use

j. Statement of Substantial Equivalence
The NikkiCart is substantially equivalent to the predicate GAMBRO BiCart® (K013724) regarding the following:
Indications for use
Technological characteristics ●

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Image /page/5/Picture/0 description: The image is a logo for RCDS Renal Care Dialysis Solutions SA de CV. The logo features a stylized image of two kidneys on the left, followed by the letters "RCDS" in a large, sans-serif font. Below the letters is the text "Renal Care Dialysis Solutions SA de CV" in a smaller font.

Chemical composition ●
Materials of construction ●

Table 1 below present a comparison of the NikkiCart cartridge to the predicate BiCart (K013724) cartridge. The only functional difference between BiCart and the NikkiCart is the quantity of sodium bicarbonate contained in each cartridge. The different quantities of sodium bicarbonate provide for different lengths of treatment; the resulting saturated sodium bicarbonate solution is used in the same way.

k. Comparison Table
Table 1: Comparison table between BiCart (K013724) and the NikkiCart

	Predicate Device:BiCart(K013724)	Proposed Device: NikkiCart	Discussion
Fill Weight	720g and 1250g	720g and 900g	SubstantiallyEquivalent
Dimensional/GeometricalMeasurements	Total Height - 236.01mmBODY Nipple Height - 10.27 mmBODY Nipple Diameter – 9.90mmCAP Nipple Height - 10.30mmCAP Nipple Diameter – 9.89mm	Total Height → 235.26mmBODY Nipple Height → 10.04mmBODY Nipple Diameter → 9.98mmCAP Nipple Height → 10.02mmCap Nipple Diameter → 9.82mm	SubstantiallyEquivalent
MachineInterfaceDimensions	No data available	Lower Arm O-ring(interfacewith nipple):● Distance: 8.52mm● Diameter: 9.49mmUpper Arm O-ring (interface withnipple):● Distance to bottom - O-ring: 4.37mm● Diameter 1 (interface withnipple): 9.48mm● Distance: 10.06mmDiameter 2 (Seal Upper /Lowerarea when closed): 16.19mm
Duration of Use	720g:● 500ml/min dialysis flowrate: 6h 45min● 700ml/min dialysis flowrate: 4h 50 min1250g:● 500ml/min dialysis flowrate: 12h 26min● 600ml/min dialysis flowrate: 10h 22min● 700ml/min dialysis flowrate: 8 h 53 min	720g:● 500ml/min dialysis flowrate: 6h 45min● 600ml/min dialysis flowrate: 5h 37 min900g:● 500ml/min dialysis flowrate: 8h 41min● 800ml/min dialysis flowrate: 5h 25min	SubstantiallyEquivalent
Acid DilutionRatio	1:44	1:44	Identical
Final DialysateConductivity	Final dialysate Conductivity13.7mS/cm with Centrisol Acidconcentrate SB-111.	Final dialysate Conductivity13.7mS/cm with Centrisol Acidconcentrate SB-111	Identical
Fill WaterTemperature	33.0°C to 40.0°C	34.0°C to 40.0°C	SubstantiallyEquivalent
CompatibleHemodialysisModels	Baxter Phoenix and AK98hemodialysis models	Nikkiso DBB-06 hemodialysismodel
The variation in the sizes offered does not raise any questions of the safety and effectiveness of our devicebecause these sizes will accommodate the Nephrologist prescription for the patient's hemodialysis treatment,e.g., Treatment time dialysate flow rate and Sodium Bicarbonate.
Indications forUse	To be used in bicarbonatehemodialysis treatment forpatients suffering from acuterenal failure, chronic renalfailure, or acute intoxicationwith dialyzable substances.	To be used in a bicarbonatedialysis treatment for patientssuffering from acuterenalfailure, chronic renal failure, oracute intoxicationwithdialyzable substances.	Identical
Disposable	Yes	Yes	Identical
SodiumBicarbonateGrade	USP & EuropeanPharmacopeia	USP & EuropeanPharmacopeia	Identical
BicarbonateConcentration	38 mEq/L	37 mEq/L	SubstantiallyEquivalent
The difference in the bicarbonate concentration does not raise new issues of safety and effectiveness becausethe dialysis machine Sodium Bicarbonate is prescribed by the Nephrologist to be specific to the patientmedical status.
StorageCondition	Store below +40 °C (+104°F)	Store below +30 °C (+86°F)	SubstantiallyEquivalent
The difference in storage conditions does not raise new issues of safety and effectiveness because the benchtesting data showed that bicarbonates integrity was not compromised.
HousingMaterial	Polypropylene	Polypropylene	Identical

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Image /page/6/Picture/0 description: The image is a logo for RCDS Renal Care Dialysis Solutions S.A. de C.V. The logo features a stylized drawing of two kidneys on the left, followed by the letters "RCDS" in a large, sans-serif font. The words "Renal Care Dialysis Solutions S.A. de C.V." are printed in a smaller font below the letters.

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Image /page/7/Picture/0 description: The image shows the logo for RCDS Renal Care Dialysis Solutions SA de CV. The logo features a stylized image of two kidneys in blue, followed by the letters "RCDS" in a similar blue color. Below the letters, the full name of the company, "Renal Care Dialysis Solutions SA de CV," is written in a smaller font.

Performance Data

The proposed device has been subjected to biocompatibility testing, functional performance testing, and stability testing to support safety and effectiveness. No clinical testing was performed.

The following endpoints were assessed to support the biological safety of the NikkiCart

Cytotoxicity ●
Sensitization ●
Irritation ●
Acute Systemic toxicity ●
Material mediated pyrogenicity ●
Hemocompatibility ●

Stability evaluations were conducted for the NikkiCart in support of the 24-month (2-year) shelf life. The 24-month shelf life is supported by real time stability evaluations.

Additionally, a chemical characterization assessment was conducted to assess the following endpoints to support the biological safety of the NikkiCart:

Chronic systemic toxicity ●
Mutagenicity/Carcinogenicity ●

Shipping and distribution verification testing was performed for the NikkiCart in accordance with ASTM D4169-16, Standard Practice for Performance Testing of Shipping Containers and Systems. Results support that the product's packaging can withstand the distribution environment.

There are no differences between the predicate device (K013724) and the proposed device that raise new issues of safety and effectiveness.

m. Conclusion
The intended use, technological characteristics, chemical composition, and materials of construction of the NikkiCart sodium bicarbonate cartridge are substantially equivalent to the BiCart (K013724) bicarbonate cartridge the predicate device. The non-clinical data support the safety of the NikkiCart and demonstrate the device performs as intended. Differences between the NikkiCart Bicarbonate cartridge and the predicate do not raise new or modified issues of safety or efficacy.

Regulation Number and Section

§ 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.