(264 days)
Solcart B Powder Dialysis Concentrate 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). The Solcart B cartridge is designed to fit into cartridge holder adapters affixed to the hemodialysis machine. The 1100g cartridge may only be used with B. Braun hemodialysis machines for which the use of powder bicarbonate cartridges is a stated option and the machine is equipped with a holder for the bicarbonate cartridge.
This document describes the Solcart B Sodium Bicarbonate Powder Dialysis Concentrate, 1100g Cartridge, and its acceptance criteria for market clearance.
Here's the breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Acceptability of packing and shipping configuration | Demonstrated through package and ship tests. |
| Compatibility with B. Braun hemodialysis machines | Demonstrated through performance testing with the proposed Solcart B 1100g cartridge. |
| Product meets defined specifications | Verified through stability testing conducted on the Solcart B 1100g cartridge. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify exact sample sizes for the package/ship tests, performance tests, or stability tests. It generally states that "The proposed device was subjected to package and ship tests" and "performance testing was conducted," and "stability testing conducted."
- Data Provenance: The studies were conducted by B. Braun Avitum AG (Germany) and B. Braun Medical Inc. (USA). The nature of these tests (e.g., in-house testing, third-party validation) typically implies a prospective design for these specific engineering and performance evaluations.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This type of information (number and qualifications of experts) is not typically relevant or disclosed for this type of device (sodium bicarbonate powder for hemodialysis). The "ground truth" for this device's performance would be established by objective measurements against predefined chemical, physical, and functional specifications, rather than expert interpretation of complex data like medical images.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
Adjudication methods like 2+1 or 3+1 are used for studies involving subjective reader interpretations (e.g., medical imaging). For hardware/material testing of a hemodialysis concentrate, such methods are not applicable. The device performance is assessed through direct physical and chemical measurements.
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
No MRMC comparative effectiveness study was conducted or is applicable for this device. This is a material component (sodium bicarbonate powder) for a hemodialysis system, not an AI-powered diagnostic or assistive tool for human readers.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done
This question is not applicable. The device is a physical product (sodium bicarbonate powder cartridge), not an algorithm or software. It does not have a "standalone" or "human-in-the-loop" performance in the context of AI or software.
7. The Type of Ground Truth Used
The ground truth for this device's performance is based on predefined specifications for:
- Chemical composition and purity of sodium bicarbonate.
- Physical properties (e.g., concentration upon dissolution).
- Compatibility with B. Braun hemodialysis machines (functional performance).
- Stability over time.
- Integrity of packaging and shipping.
These specifications would be derived from industry standards (e.g., European Pharmacopoeia, United States Pharmacopoeia, AAMI) and internal product requirements.
8. The Sample Size for the Training Set
This question is not applicable. There is no "training set" in the context of machine learning or AI involved with this device. Performance is validated through standard engineering and pharmacological testing, not through training an algorithm.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable, as there is no training set for this 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.