(267 days)
AcetiCon acid concentrate liquids or powders for bicarbonate dialysis are indicated for used in acute and chronic hemodialysis and are accessories to be used with the appropriate hemodialysis machine in a 3 stream mix in the exact prescribed proportion with ANSUAAMI/ISO 13959 standard water for hemodialysis and with bicarbonate concentrate.
CitriCon acid concentrate liquids or powders for bicarbonate dialysis are indicated for used in acute and chronic hemodialysis and are accessories to be used with the appropriate hemodialysis machine in a 3 stream mix in the exact prescribed proportion with ANSI/AAMI/ISO 13959 standard water for hemodialysis and with bicarbonate concentrate.
BicarboCon bicarbonate concentrate liquids or powders for bicarbonate dialysis are indicated for used in acute and chronic hemodialysis and are accessories to be used with the appropriate hemodialysis machine in the exact proportion with ANSI/AAMI/ISO 13959 standard water for hemodialysis and with acid concentrate.
RenaCon acetate concentrate powders and liquids for acetate dialysis are indicated for use in acute and chronic hemodialysis and are accessories to be used with the appropriate hemodialysis machine in a 2 stream mix in the exact prescribed proportion with ANSI/AAMI/ISO 13959 standard water for hemodialysis.
All liquid and powder acid and bicarbonate concentrates for bicarbonate dialysis presented in this 510(k) Notification are produced in a manner consistence with the predicate devices listed in Section 3 of this 510(k) Summary by adhering to strict cGMP guidelines and in accordance with AAMI/ANSI/ISO 13958:2014 Concentrates for Hemodialysis and Related Therapies and AAMI/ANSI/ISO 13959:2014 Water for Hemodialysis and Related Therapies. CitriCon liquids and powders contain Citric Acid and may contain Sodium Acetate along with various other ingredients (such as sodium chloride, calcium chloride, potassium chloride, magnesium chloride and dextrose, all meeting or exceeding current AAMI standards for purity) are equivalent to currently marketed acid concentrates for bicarbonate dialysis. AcetiCon liquids and powders contain either Acetic Acid or Sodium DiAcetate along with various other ingredients (such as sodium chloride, calcium chloride, potassium chloride, magnesium chloride and dextrose, all meeting or exceeding current AAMI standards for purity) are equivalent to currently marketed acid concentrates for bicarbonate dialysis. BicarboCon liquids and powders contain Sodium Bicarbonate and may contain Sodium Chloride, (both either meeting or exceeding current AAMI standards for purity) are equivalent to currently marketed bicarbonate concentrates for bicarbonate dialysis. These products are not designed and/or formulated for reuse and should be considered as single-use only. These acid and bicarbonate concentrate liquid and powder formulations when proportioned/mixed with pretreated, purified water that meets or exceeds current AAMI standards may be used with conventional and commercially available hemodialysis machines or monitors as a hemodialysis solution. These hemodialysis concentrates are intended to be used in three stream hemodialysis machine in which an acidified concentrate is proportioned into one stream, a bicarbonate concentrate is proportioned into a second stream and a third stream of water that meets or exceeds current AAMI standards. Where these three streams are then mixed to prepare a final proportioned hemodialysis solution.
All liquid and powder acetate concentrates for acetate dialysis presented in this 510(k) Notification are produced in a manner consistence with the predicate devices listed in the Section 3 of this 510(k) Summary by adhering to strict cGMP guidelines and in accordance with AAMI/ANSI/ISO 13958:2014 Concentrates for Hemodialysis and Related Therapies and AAMI/ANSI/ISO 13959:2014 Water for Hemodialysis and Related Therapies. RenaCon liquids and powders contain Sodium Acetate along with various other ingredients (such as sodium chloride, calcium chloride, potassium chloride, magnesium chloride and dextrose, all meeting or exceeding current AAMI standards for purity) are equivalent to currently marketed acetate concentrates for acetate dialysis. These products are not designed and/or formulated for re-use and should be considered as single-use only. These acetate concentrate liquid and powder formulations when proportioned/mixed with pre-treated, purified water that meets or exceeds current AAMI standards may be used with conventional and commercially available hemodialysis machines or monitors as a hemodialysis solution. These hemodialysis concentrate formulas are intended to be used in two stream hemodialysis machine in which an acetate concentrate is proportioned into one stream and a second stream of water that meets or exceeds current AAMI standards. Where these two streams are then mixed to prepare a final proportioned hemodialysis solution.
The provided text describes a 510(k) premarket notification for hemodialysis concentrate solutions (CitriCon, AcetiCon, BicarboCon, and RenaCon). This document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a traditional clinical study with acceptance criteria for a novel device performance.
Therefore, many of the requested categories for acceptance criteria and study details are not directly applicable to this type of submission. The safety and effectiveness are established through adherence to existing standards and comparison to legally marketed predicate devices, not through performance metrics of an AI algorithm or a human reader study.
Here's an attempt to extract relevant information, with notations indicating where the requested information is not available in the provided text:
Acceptance Criteria and Reported Device Performance
The acceptance criteria for these hemodialysis concentrates are primarily based on established industry standards for chemical composition and purity. The device performance (i.e., the composition of the concentrates) is demonstrated by ensuring the formulations fall within the defined ranges.
Table of Acceptance Criteria and Reported Device Performance (Concentrate Formulas - Example for AcetiCon):
This table presents the component formula ranges as the acceptance criteria and shows reported specific values for various product codes within those ranges. These specific values represent the "reported device performance" in terms of composition.
| Criteria (Component Formula Range in Final Dialysate) | Reported Device Performance (Specific Formulas Shown for AcetiCon in mEq/L or mg%) - Examples |
|---|---|
| Sodium: 70 – 110 mEq/L | 70.00 - 110.00 (e.g., 79.00, 80.00, 100.00, 103.00, 104.00) |
| Potassium: 0 – 5 mEq/L | 0.00 - 5.00 (e.g., 0.00, 1.00, 2.00, 2.50, 3.00, 4.00, 5.00) |
| Calcium: 0 – 5 mEq/L | 0.00 - 5.00 (e.g., 0.00, 1.00, 1.50, 2.00, 2.20, 2.50, 3.00, 3.25, 3.50, 5.00) |
| Magnesium: 0 – 2 mEq/L | 0.00 - 2.00 (e.g., 0.00, 0.50, 0.70, 0.75, 1.00, 1.50, 2.00) |
| Dextrose: 0 – 350 mg/dl (mg%) | 0.00 - 350.00 (e.g., 0.00, 100.00, 150.00, 200.00, 250.00, 350.00) |
| Acetate from Acetic Acid: 2 – 5 mEq/L | 2.00 - 5.00 (e.g., 2.00, 3.00, 4.00, 5.00) |
| Acetate from Sodium DiAcetate: 4 – 8 mEq/L | 4.00 - 8.00 (e.g., 4.00, 6.00, 8.00) |
| Citric Acid (CitriCon only): 2.4 mEq/L | 2.40 |
| Sodium Acetate (CitriCon only): 0 – 0.3 mEq/L | 0.00 - 0.30 (e.g., 0.00, 0.30) |
| Bicarbonate (BicarboCon only): 30 – 39 mEq/L | 30.00 - 39.00 (e.g., 30.00, 35.00, 37.00, 39.00) |
| Chloride (BicarboCon only): 0 – 20 mEq/L | 0.00 - 20.00 (e.g., 0.00, 20.00) |
| Sodium Acetate (RenaCon only): 33 – 45 mEq/L | 33.00 - 45.00 (e.g., 33.00, 35.00, 36.00, 36.60, 37.00, 38.00, 38.25, 40.00, 41.00, 45.00) |
| Physical State | Liquid or Powder |
| Proportioning Ratios | Specific ratios for each product line (e.g., AcetiCon: 1:34, 1:35.83, 1:44) |
| Endotoxin levels | Well below release limit of 0.5 EU/ml (reported in submission) |
| Microbial count | Well below release limit of 100 CFU/ml (reported in submission for bicarbonate-containing formulations) |
Study Information
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Sample size used for the test set and the data provenance:
- Sample Size: The document mentions "in vitro testing was performed on laboratory prepared formulations which bracket the extremes of each critical component in each product line." It does not specify a numerical sample size for these tests (e.g., number of batches, number of samples per batch).
- Data Provenance: The data is generated from "laboratory prepared formulations." The country of origin is not explicitly stated but implies testing conducted by Global Scientific Technologies, LLC (based in South Carolina, USA). The study is prospective in the sense that these formulations were specifically prepared and tested for this submission.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable as the device is not an AI/diagnostic device that requires expert ground truth. The "ground truth" for chemical composition is established by validated analytical methods, not human expert consensus.
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Adjudication method for the test set:
- This question is not applicable as the device is not an AI/diagnostic device that requires adjudication.
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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:
- This question is not applicable as the device is not an AI-assisted diagnostic device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This question is not applicable as the device is not an AI algorithm. The performance is assessed on the chemical composition of the concentrates.
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The type of ground truth used:
- The "ground truth" for determining the composition and purity of the concentrates is based on validated analytical methods (in vitro testing) and adherence to established industry standards (ANSI/AAMI 13958:2014 and ANSI/AAMI 11663:2014 for chemical composition, endotoxin levels, and microbial counts).
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The sample size for the training set:
- This question is not applicable as there is no mention of a training set, as this is not an AI or machine learning device. The product development relies on chemical formulation within established ranges.
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How the ground truth for the training set was established:
- This question is not applicable as there is no training set for this type of 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.