(263 days)
No
The device description and performance studies focus on the chemical composition and proportioning of a liquid acid concentrate for hemodialysis, with no mention of AI or ML technology.
Yes
The device is an acid concentrate used in hemodialysis therapy for acute and chronic renal failure, which is a therapeutic process to filter blood.
No
The device is an acid concentrate used in hemodialysis therapy to prepare dialysate, which filters wastes and toxins from the blood of patients with renal failure. It is a treatment device, not a diagnostic one that identifies or characterizes a disease or condition.
No
The device description clearly states it is comprised of chemical components (sodium chloride, magnesium chloride, etc.) and is a liquid concentrate, indicating it is a physical product, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "acute and chronic hemodialysis" and is used in conjunction with other concentrates to prepare dialysate. This is a therapeutic use, not a diagnostic one.
- Device Description: The device is a component used to create a solution (dialysate) that interacts with the patient's blood outside the body in a hemodialyzer to remove waste and toxins. This is a treatment process, not a diagnostic test performed on a sample of the patient's body.
- Lack of Diagnostic Language: The text does not mention any diagnostic purpose, analyzing patient samples, or providing information about a patient's health status.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or screening purposes. This device is used to create a solution for a therapeutic procedure.
N/A
Intended Use / Indications for Use
For LC+100 Series: This acid concentrate is formulated for use in acute and chronic hemodialysis, and is to be used in conjunction with Nipro MedicaLyte™ bicarbonate concentrate, or an equivalent bicarbonate concentrate of the same composition, in a 36.83X proportioning three-stream hemodialysis machine.
For LC+200 Series: This acid concentrate is formulated for use in acute and chronic hemodialysis, and is to be used in conjunction with Nipro MedicaLyte™ bicarbonate concentrate, or an equivalent bicarbonate concentrate of the same composition, in a 45X proportioning three-stream hemodialysis machine.
Product codes
KPO
Device Description
The Citric Complete™ Liquid Citric Acid Concentrate products are single-use, non-sterile devices intended for use in hemodialysis therapy for acute and chronic renal failure. These products are designed to be used as one (1) component in the preparation of dialysate in a three (3)-stream proportioning hemodialysis machine according to a physician's prescription.
The subject devices are formulated to be compatible with 36.83X proportioning (proposed LC+100 series devices), as well as 45X proportioning (proposed LC+200 series devices) hemodialysis machines, in which bicarbonate concentrate is proportioned into one stream, this Citric Complete™ Liquid Acid Concentrate is proportioned into a second stream, and RO water is proportioned into third stream. These three streams are then mixed by the hemodialysis machine in distinctly specific ratios to prepared hemodialysis solution, or final dialysate.
The Citric Complete™ Liquid Citric Acid Concentrate products are comprised of:
Ø USP grade sodium chloride,
Ø USP grade magnesium chloride,
Ø USP grade calcium chloride,
Ø USP grade potassium chloride,
& USP grade dextrose, and
& USP grade citric acid.
The final dialysate solution is pumped to the dialysis system, known as the dialyzer or hemodialyzer, through which the patient's blood also flows in the opposite direction. The dialysate is separated from the patient's blood by semi-permeable membranes in the hemodialyzer, which passage of waste and toxins from the circulating blood into the hemodialysis solution. The used dialysate is disposed, while the patient blood is recirculated back into the patient with acute and end-stage renal failure can effectively have their blood filtered of wastes and toxins without the proper functioning of his or her kidneys.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing was accomplished by formulating the dialysis liquid concentrate pursuant to the instructions on the device labels and measuring the concentrations of all components to ensure that by following the label instructions, end users can generate a final dialysate consistent with the values as specified on the Citric Acid Concentrate label. All testing was conducted pursuant to ANSI/AAMI/ISO 23500-4:2019. All requirements were met.
All samples from all batches of each device tested were within acceptable limits for that product, as set by ANSI/AAMI/ISO 23500-42019. Therefore, the performance of these devices is considered to be satisfactory, fit for use according to the intended purpose of this device, and as safe, as effective, and performing as well as or better than the legally marketed device K171750.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K160847, K130511, K901471, K171750
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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August 4, 2023
Nipro Renal Solutions USA, Corp. Vincent DeGrandchamp Quality Assurance Manager 509 Fishing Creek Road Lewisberry, Pennsylvania 17339
Re: K223431
Trade/Device Name: Citric Complete™ Liquid Citric Acid Concentrate Regulation Number: 21 CFR 876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: KPO Received: July 7, 2023
Dear Vincent DeGrandchamp:
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
1
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
2
Indications for Use
Submission Number (if known)
Device Name
Citric Complete TM Liquid Citric Acid Concentrate
Indications for Use (Describe)
For LC+100 Series: This acid concentrate is formulated for use in acute and chronic hemodialysis, and is to be used in conjunction with Nipro MedicaLyte™ bicarbonate concentrate, or an equivalent bicarbonate concentrate of the same composition, in a 36.83X proportioning three-stream hemodialysis machine.
For LC+200 Series: This acid concentrate is formulated for use in acute and chronic hemodialysis, and is to be used in conjunction with Nipro MedicaLyte™ bicarbonate concentrate, or an equivalent bicarbonate concentrate of the same composition, in a 45X proportioning three-stream hemodialysis machine.
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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3
| K223431 | ||
|---|---|---|
| 510(k) #: K223431 | 510(k) Summary | Page 1 of 2 |
| Prepared on: 2023-07-07 | ||
| Contact Details | 21 CFR 807.92(a)(1) | |
| Applicant Name | Nipro Renal Solutions USA, Corporation | |
| Applicant Address | 509 Fishing Creek Road Lewisberry PA 17339 United States | |
| Applicant Contact Telephone | 2676784390 | |
| Applicant Contact | Mr. Vincent DeGrandchamp | |
| Applicant Contact Email | VincentG@nipromed.com | |
| Device Name | 21 CFR 807.92(a)(2) | |
| Device Trade Name | Citric Complete™ Liquid Citric Acid Concentrate | |
| Common Name | Hemodialysis system and accessories | |
| Classification Name | Dialysate Concentrate For Hemodialysis (Liquid Or Powder) | |
| Regulation Number | 876.5820 | |
| Product Code | KPO | |
| Legally Marketed Predicate Devices | ||
| 21 CFR 807.92(a)(3) | ||
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
| K160847 | CitraPure® Acid Concentrate | KPO |
| K130511 | CitriSol Acid Concentrate | KPO |
| K901471 | GC-1000 to GC-3005 Acid Concentrate (MedicaPure™ Liquid Ac | KPO |
| K171750 | Citric Complete™ Dry Citric Acid Concentrate | KPO |
Device Description Summary
The Citric Complete™ Liquid Citric Acid Concentrate products are single-use, non-sterile devices intended for use in hemodialysis therapy for acute and chronic renal failure. These products are designed to be used as one (1) component in the preparation of dialysate in a three (3)-stream proportioning hemodialysis machine according to a physician's prescription.
21 CFR 807.92(a)(4)
The subject devices are formulated to be compatible with 36.83X proportioning (proposed LC+100 series devices), as well as 45X proportioning (proposed LC+200 series devices) hemodialysis machines, in which bicarbonate concentrate is proportioned into one stream, this Citric Complete™ Liquid Acid Concentrate is proportioned into a second stream, and RO water is proportioned into third stream. These three streams are then mixed by the hemodialysis machine in distinctly specific ratios to prepared hemodialysis solution, or final dialysate.
The Citric Complete™ Liquid Citric Acid Concentrate products are comprised of:
Ø USP grade sodium chloride,
Ø USP grade magnesium chloride,
Ø USP grade calcium chloride,
Ø USP grade potassium chloride,
4
The final dialysate solution is pumped to the dialysis system, known as the dialyzer or hemodialyzer, through which the patient's blood also flows in the opposite direction. The dialysate is separated from the patient's blood by semi-permeable membranes in the hemodialyzer, which passage of waste and toxins from the circulating blood into the hemodialysis solution. The used dialysate is disposed, while the patient blood is recirculated back into the patient with acute and end-stage renal failure can effectively have their blood filtered of wastes and toxins without the proper functioning of his or her kidneys.
Intended Use/Indications for Use
& USP grade dextrose, and 网 USP grade citric acid.
For LC+100 Series: This acid concentrate is for use in acute and chronic hemodialysis, and is to be used in conjunction with Nipro Medicalyte™ bicarbonate concentrate, or an equivalent bicarbonate concentrate of the same composition, in a 36.83X proportioning three-stream hemodialysis machine.
For LC+200 Series: This acid concentrate is formulated for use in acute and chronic hemodialysis, and is to be used in conjunction with Nipro Medical yte™ bicarbonate concentrate, or an equivalent bicarbonate concentrate of the same composition, in a 45X proportioning three-stream hemodialysis machine.
Indications for Use Comparison
The subject device as well as the predicate and reference devices are all acid concentrates formulated for use in acute and chronic hemodialysis as one component in a three-stream dialysate. There are no significant differences with respect to any of the above presented predicate devices in regard to their indications for use, and no new issues of the subject device.
Technological Comparison
Internal verification and validation testing confirms that the Citric Acid Concentrate meets specifications equivalent in design and technological characteristics to the predicate devices. The subject device complies with all applicable voluntary consensus standards for performance, package integrity and biocompatibility.
There are no significant differences with respect to any of the above presented predicate devices, and therefore a finding of substantial equivalence is deemed appropriate for the proposed Citric Complete™ Liquid Citric Acid Concentrate.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
Testing was accomplished by formulating the dialysis liquid concentrate pursuant to the instructions on the device labels and measuring the concentrations of all components to ensure that by following the label instructions, end users can generate a final dialysate consistent with the values as specified on the Citric Acid Concentrate label. All testing was conducted pursuant to ANSI/AAMI/ISO 23500-4:2019. All requirements were met.
N/A
All samples from all batches of each device tested were within acceptable limits for that product, as set by ANSI/AAMI/ISO 23500-42019. Therefore, the performance of these devices is considered to be satisfactory, fit for use according to the intended purpose of this device, and as safe, as effective, and performing as well as or better than the legally marketed device K171750.
K223431 Page 2 of 2