(263 days)
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.
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:
USP grade sodium chloride,
USP grade magnesium chloride,
USP grade calcium chloride,
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.
The provided text describes a medical device called "Citric Complete™ Liquid Citric Acid Concentrate" and its FDA 510(k) clearance (K223431). However, the document is a 510(k) summary and does not contain detailed information about specific acceptance criteria and a study proving those criteria are met for AI/ML devices.
The document states:
"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."
And:
"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 23500-4:2019."
This indicates that the device is a liquid concentrate, not an AI/ML powered device. The "acceptance criteria" and "study" described are chemical and performance specifications for the concentrate itself, and the study involves chemical analysis to ensure the concentrate produces a final dialysate consistent with specifications.
Therefore, most of the information requested in your prompt (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, ground truth types, training set size) is not applicable to this type of device and is not present in the provided text.
Based on the available information from the text, here's what can be inferred:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Final dialysate concentrations (of all components after mixing) consistent with values specified on the Citric Acid Concentrate label. | All samples from all batches were within acceptable limits. |
| Compliance with ANSI/AAMI/ISO 23500-4:2019 standards for dialysis solutions. | All requirements of ANSI/AAMI/ISO 23500-4:2019 were met. |
| Equivalence in design and technological characteristics to predicate devices. | Confirmed through internal verification and validation testing. |
| Performance, package integrity, and biocompatibility compliance with applicable voluntary consensus standards. | Device complies with all applicable standards. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated, but implied to be "All samples from all batches of each device tested". This suggests multiple batches and multiple samples per batch were tested. The exact number of samples is not provided.
- Data Provenance: The testing was "internal verification and validation testing" conducted by the manufacturer, Nipro Renal Solutions USA, Corp. The country of origin of the data is not specified beyond being generated internally by this US-based company. The study is prospective, as it involves testing newly manufactured product batches.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The ground truth is based on chemical specifications (target concentrations of components in the final dialysate) and compliance with international standards (ANSI/AAMI/ISO 23500-4:2019), not expert interpretation of data.
4. Adjudication method for the test set:
- Not applicable. The "ground truth" is determined by established chemical specifications and compliance with standards, not discretionary human judgment requiring adjudication.
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 is not an AI/ML device, nor does it involve human readers or image interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/ML device.
7. The type of ground truth used:
- Chemical specifications (target concentrations of active ingredients in the final dialysate) and compliance with established international standards (ANSI/AAMI/ISO 23500-4:2019).
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable.
§ 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.