(377 days)
For DA-100 series: This acid concentrate product is formulated for use in acute and chronic hemodialysis and to be used in conjunction with MedicaLyteTM bicarbonate, or an equivalent bicarbonate labeled for use in acute and chronic hemodialysis and having the same composition as MedicaLyteTM bicarbonate, in a 36.83X three-stream artificial kidney (hemodialysis) machine. -Or- For DA-200 series: This acid concentrate product is formulated for use in acute and to be used in conjunction with Medical yteTM bicarbonate, or an equivalent bicarbonate labeled for use in acute and chronic hemodialysis and having the same composition as MedicalyteTM bicarbonate, in a 45X three-stream artificial kidney (hemodialysis) machine. -Or- For DA-300 series: This acid concentrate product is formulated for use in acute and to be used in conjunction with MedicaLyteTM bicarbonate, or an equivalent bicarbonate labeled for use in acute and chronic hemodialysis and having the same composition as MedicaLyteTM bicarbonate, in a 35X three-stream artificial kidney (hemodialysis) machine.
The Nipro Dry Complete™ dry acid concentrate devices for hemodialysis 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 acetic acid. These products may be used in conventional, commercially available hemodialysis machines or monitors as one of the necessary components of three-component hemodialysis solution, and are formulated for 36.83X (DA-100 series), 45X (DA-200 series), and 35X (DA-300 series) proportioning dialysis machines. The hemodialysis concentrate solutions presented in this 510(k) premarket notification are intended to be used in an appropriately proportioned three-stream hemodialysis machines (36.83X, 45X, or 35X as specified on the device label) in which bicarbonate concentrate is proportioned into one stream, an acid solution prepared from the Nipro Dry Complete™ dry acid concentrate device is proportioned into a second stream, and water is proportioned into the third stream of the hemodialysis machine proportioning system. These three streams are then mixed by the hemodialysis machine to prepare the final proportioned hemodialysis solution. The final hemodialysis solution is separated from the patient's blood by semi-permeable membranes which permit the passage of waste products and toxins contained in the patient's blood circulating through the hemodialyzer, and such waste products and toxins pass through the semi-permeable membranes into the hemodialysis solution and exit the hemodialyzer with the hemodialysis solution. By such treatment, waste products and toxins are removed from the patient's blood during acute and end-stage renal failure.
The provided text is a 510(k) summary for a medical device called "Nipro Dry Complete™ Dry Acid Concentrate for Hemodialysis." It describes the device, its intended use, and the studies conducted to demonstrate its substantial equivalence to predicate devices. However, it does not contain information related to an AI/ML-driven device or human-in-the-loop performance studies.
Therefore, I cannot extract the specific information requested in your prompt regarding acceptance criteria, study details for AI/ML performance, sample sizes for test/training sets, expert qualifications, or adjudication methods for ground truth, as these concepts are not applicable to the traditional medical device described in this document.
The document primarily focuses on:
- Device Description: The chemical composition and intended use of the dry acid concentrate for hemodialysis.
- Substantial Equivalence: Comparing the device to existing predicate devices based on chemical composition, manufacturing materials (bottles, bags), and intended use.
- Performance Testing: Chemical analysis to ensure the final solution meets specifications after mixing according to label instructions, transportation testing, biocompatibility, and endotoxin analysis. This is not a performance study of a diagnostic or AI-driven tool, but rather a quality control and safety assessment of a consumable medical product.
- Shelf Life and Sterilization: Stability testing and package integrity.
Here's an attempt to answer the prompt based on the available information, with the understanding that many requested points cannot be answered as they pertain to AI/ML or diagnostic device studies not covered here:
This document describes the Nipro Dry Complete™ Dry Acid Concentrate for Hemodialysis. This is a chemical concentrate used in hemodialysis machines, not an AI/ML diagnostic or image analysis device. Therefore, many of the requested criteria related to AI/ML performance, human-in-the-loop studies, multi-reader multi-case studies, and expert ground truth establishment are not applicable to this device and its 510(k) submission.
The "acceptance criteria" and "study that proves the device meets the acceptance criteria" for this product are related to its chemical composition, safety, and functionality as a hemodialysis concentrate.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Derived from text) | Reported Device Performance |
|---|---|
| Chemical Composition/Concentration (post-formulation) | "All samples of all batches of each device tested were within acceptable limits as set by ANSI/AAMI/ISO 13958:2014." (Specific component concentrations not detailed, but conformance to standard implies they were within specified ranges). |
| Endotoxin Level | "The standard dialysis fluid generated from the devices was well within the acceptable limits." (Limit: 0.5 endotoxin units/mL or less, per ANSVAAMI/ISO 13958:2014 Section 4.1.2). |
| Transportation Stability/Package Integrity | "The results indicate that the proposed devices can be shipped and transported so that they may be received and used in a safe and effective way." |
| "Results from package integrity testing were analyzed and accepted based on Acceptance Quality Limit (AQL) criteria developed using ISO 2859-1:2011..." | |
| Biocompatibility | Evaluated for low density polyethylene bags and high density polyethylene bottles in accordance with ISO 19003-1 (Implied acceptance based on no concerns raised). |
| Shelf Life/Stability | "All chemistry and bioburden stability testing on aged product was performed to conform to standards as laid out in ANSI/AAMI/ISO 13958:2014..." (Implied acceptance based on no concerns raised regarding aged product meeting specifications and endotoxin limits.) |
2. Sample sized used for the test set and the data provenance
- Sample Size for Performance Testing: "Performance testing was conducted on three batches each of [specific DA-100 series, DA-200 series, and DA-300 series formulations – 15 total formulations listed]."
- Data Provenance: Not explicitly stated, but it's understood to be from internal laboratory testing conducted by or for Nipro Renal Solutions Corporation USA as part of their 510(k) submission for the US market. The document implies these were prospective tests of manufactured product.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This device is a chemical concentrate. "Ground truth" in the context of device performance refers to whether the chemical composition and purity meet defined standards (e.g., ANSI/AAMI/ISO 13958:2014), which are established by scientific consensus and regulatory bodies, not by expert interpretation of data points.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. No human interpretation or adjudication of outputs is described or necessary for this type of chemical product testing.
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 diagnostic or image analysis device, nor does it involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's performance is established by validated analytical chemistry methods confirming the concentrations of components and purity levels (e.g., endotoxin, bioburden) against predefined specifications from relevant consensus standards (e.g., ANSI/AAMI/ISO 13958:2014).
8. The sample size for the training set
- Not applicable. This device does not involve a training set as it is not an AI/ML model.
9. How the ground truth for the training set was established
- Not applicable. As above, no training set information is relevant or provided.
§ 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.