(143 days)
NORMOCARB 25 Sterile Bicarbonate Renal Dialysis Concentrate, after dilution, is indicated for use in Continuous Renal Replacement Therapy (CRRT).
NORMOCARB™ 25 is a clear, sterile, apyrogenic, calcium-free bicarbonate renal dialysis concentrate provided in 240 ml unit-dose vials which, when diluted with water in the required proportions, creates a dialysis solution or dialysate for use in hemodialysis.
This document is a 510(k) premarket notification for a medical device, which seeks to demonstrate substantial equivalence to a legally marketed predicate device. As such, it does not contain a study with acceptance criteria and device performance in the way that an original PMA (Premarket Approval) application or a clinical trial report would. Instead, it argues for substantial equivalence based on material and compositional similarities, and the manufacturing process.
Here's an analysis of what you've provided, mapping it as closely as possible to your requested information, along with explanations for why certain sections cannot be fully populated from this type of document:
1. A table of acceptance criteria and the reported device performance
This document describes a new concentration of an existing product, NORMOCARB™ 25 Sterile Bicarbonate Renal Dialysis Concentrate, and compares it to a legally marketed predicate device, NORMOCARB™ 35. The "acceptance criteria" here are implicitly the characteristics and performance of the predicate device, which the new device aims to be substantially equivalent to, while offering a new, lower bicarbonate concentration.
| Product Characteristic | Acceptance Criteria (Predicate: NORMOCARB™ 35) | Reported Device Performance (Proposed: NORMOCARB™ 25) |
|---|---|---|
| Intended Use | Dialysate concentrate for use in hemodialysis. Specifically for Continuous Renal Replacement Therapy (CRRT) for critically ill patients with renal failure. | Same intended use: Dialysate concentrate for use in hemodialysis. Specifically for CRRT for critically ill patients, offering a lower bicarbonate strength. |
| Raw Materials | All raw materials are tested to, and meet, USP standards. | All raw materials are tested to, and meet, USP standards. |
| Components & Composition (Diluted) | Sodium: 140.0 mEq/L | |
| Magnesium: 1.5 mEq/L | ||
| Chloride: 106.5 mEq/L | ||
| Bicarbonate: 35.0 mEq/L | Sodium: 140.0 mEq/L | |
| Magnesium: 1.5 mEq/L | ||
| Chloride: 116.5 mEq/L | ||
| Bicarbonate: 25.0 mEq/L | ||
| Sterility | Manufactured as a sterile, pyrogen-free product. | Manufactured as a sterile, pyrogen-free product. |
| Container/Closure | Clear, glass serum vials, closed with an elastomeric serum stopper and sealed with an aluminum crimp cap with a polypropylene cover. Single-use 240 mL vials. | Same: Clear, glass serum vials, closed with an elastomeric serum stopper and sealed with an aluminum crimp cap with a polypropylene cover. Single-use 240 mL vials. |
| Diluent | Sterile water - exceeds AAMI standards. | Same: Sterile water - exceeds AAMI standards. |
| Safety (Chloride Level) | N/A (implicit that 106.5 mEq/L is safe) | Increased chloride (116.5 mEq/L) is below the maximum potency (0.8%) allowed for extracorporeal solutions in CDER's Inactive Ingredients Database. |
| Safety (Bicarbonate Level) | N/A (implicit that 35 mEq/L is safe) | Lower bicarbonate (25 mEq/L) alleviates toxicity concerns. |
| Contamination Risk | Low risk (sterile, pyrogen-free, single-use glass vials). | Low risk (sterile, pyrogen-free, single-use glass vials and packaging). |
The study presented here is primarily a comparison of characteristics to demonstrate substantial equivalence, rather than a performance study against specific, quantified acceptance criteria in a clinical setting. The "device performance" is the assertion that it meets the same safety and effectiveness standards as the predicate device due to its similar design and manufacturing.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document does not describe a clinical study with a "test set" in the traditional sense of patient data. It is a comparison of product specifications, raw materials, manufacturing processes, and intended use between a new device and a predicate device. There is no patient data, country of origin, or retrospective/prospective designation relevant to a test set in this 510(k).
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)
Not applicable. As described above, there is no "test set" requiring expert ground truth in this type of submission. The ground truth for the predicate device's safety and effectiveness was established through its prior marketing approval. The ground truth here is based on chemical composition and manufacturing standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no test set or adjudication process described.
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/imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/imaging device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this submission relies on:
- Established USP (United States Pharmacopeia) standards for raw materials.
- Validated manufacturing processes for sterility and pyrogen-free production, consistent with the predicate device.
- Regulatory precedent from the predicate NORMOCARB™ 35, asserting that a similar composition and manufacturing process at a different concentration (with justified adjustments) will yield a safe and effective product for the stated indications.
- Chemical composition analysis to ensure the total concentration of anions and cations is balanced and within acceptable limits for extracorporeal solutions.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/machine learning 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.