(123 days)
Solcart B is intended for use in bicarbonate hemodialysis for acute and chronic renal failure, or acute intoxication with dialyzable substances.
Solcart B consists of a powder concentrate used to prepare bicarbonate concentrate solution for use in hemodialysis. Solcart B is a non-refillable polypropylene cartridge containing dry sodium bicarbonate [in compliance with European Pharmacopoeia (Ph. Eur.) and United States Pharmacopoeia (USP)] for hemodialysis. It must be used together with a suitable acid concentrate and water meeting the requirements of the Association for the Advancement of Medical Instrumentation (AAMI). Solcart B must only be used with B. Braun dialysis machines provided with a holder for powder bicarbonate cartridges.
The provided document is a 510(k) summary for the Solcart B device, which is a powder concentrate for hemodialysis. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of the device's performance against specific acceptance criteria for attributes like accuracy, sensitivity, or specificity, which is typical for diagnostic or AI-based devices.
Therefore, many of the requested elements for describing an acceptance criteria study (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this type of regulatory submission as they are for a medical device that simply replaces a predicate.
However, I can extract information related to the device's performance that was assessed to support its substantial equivalence.
Here's a breakdown of the available information:
Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) for a medical consumable (powder concentrate for hemodialysis), the "acceptance criteria" revolve around demonstrating that the device is as safe and effective as a legally marketed predicate device. The performance criteria are therefore related to its fundamental function and safety characteristics, not diagnostic accuracy.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device | Solcart B has the same intended use and technological characteristics as the Gambro BiCart® cartridges (K013724). No differences were found that raise new issues of safety and effectiveness. |
| Biocompatibility | The proposed device has been subjected to biocompatibility testing. (Specific results or thresholds are not detailed in this summary, but the implication is that it met relevant biocompatibility standards.) |
| Functional Performance (e.g., proper concentration, dissolution) | The proposed device has been subjected to functional performance testing. (Specific results or thresholds are not detailed in this summary, but the implication is that it functions as intended for preparing bicarbonate concentrate solution for hemodialysis and is in compliance with Ph. Eur. and USP standards.) It is also stated that it must be used with a suitable acid concentrate and water meeting AAMI requirements. |
| Stability (e.g., shelf life, integrity) | The proposed device has been subjected to stability testing. (Specific results or thresholds are not detailed in this summary, but the implication is that it maintains its characteristics over time.) |
Study Information (as inferable from the document)
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Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified in this 510(k) summary. Given the nature of a consumable product like a powder concentrate, "sample size" would refer to the number of batches or units tested in functional, biocompatibility, and stability studies. These details are typically in the full submission, not the summary.
- Data Provenance: Not explicitly stated, but typically these tests would be conducted by the manufacturer (B Braun Medizintechnologie GmbH, Germany) or their designated testing facilities in controlled laboratory environments. This would be prospective testing as part of product development and validation.
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Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not Applicable. This device is a consumable, and the "ground truth" relates to its chemical composition, physical properties, and functional performance, not diagnostic interpretations. These are typically assessed through laboratory tests and validated manufacturing processes according to industry standards (e.g., European Pharmacopoeia, United States Pharmacopoeia, AAMI).
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Adjudication Method for the Test Set:
- Not Applicable. Adjudication methods like 2+1 or 3+1 are used for human expert review in diagnostic studies. Here, performance is determined by meeting pre-defined physical, chemical, and biological criteria.
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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:
- Not Applicable. This is not a diagnostic device or an AI-powered system, so an MRMC study is irrelevant.
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If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Not Applicable. This is not an algorithm or an AI device. The device's "standalone" performance would be its inherent functional characteristics, as assessed by the functional, biocompatibility, and stability testing mentioned.
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The Type of Ground Truth Used:
- Technical Specifications and Regulatory Standards: The "ground truth" for Solcart B is its adherence to established chemical and physical specifications (e.g., concentration of sodium bicarbonate, dissolution properties, purity) and compliance with regulatory standards for medical devices and pharmaceuticals (e.g., European Pharmacopoeia, United States Pharmacopoeia, AAMI water quality requirements). Its safety is based on biocompatibility testing, which typically refers to standard biological evaluation of medical devices (ISO 10993 series).
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The Sample Size for the Training Set:
- Not Applicable. This is not an AI/ML device, so there is no training set in the conventional sense. Product development and process validation would involve numerous tests, but these aren't "training sets."
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How the Ground Truth for the Training Set Was Established:
- Not Applicable. As there's no training set, this question is not relevant. The "ground truth" for manufacturing and quality control standards is established through pharmacopeial monographs, international standards, and internal quality systems based on scientific principles and regulatory requirements.
§ 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.