(272 days)
BiPro Model SDS-CB200 is intended for use in a hemodialysis facility for mixing and distribution of sodium bicarbonate (bicarb) to remote points of use. The bicarb is then mixed with purified water and acid to create the dialysate solution used in hemodialysis.
The Medical Solutions BiPro Models provide semi-automatic mixing of bicarb concentrates and RO water for distribution as a hemodialysis patient stations. A mix tank is used for the mixing of bicarb concentrates and RO water. After mixing the bicarb solution, it is transferred to a loop (day) tank, via the mix pump, where the bicarb solution is distributed to the dialysis machine.
The provided text is a 510(k) summary for the BiPro Model SDS-CB200, a mixing and distribution system for bicarbonate used in dialysis. This document focuses on demonstrating substantial equivalence to an existing device, rather than detailed performance against acceptance criteria in a traditional clinical study. As such, the information typically found in a study proving a device meets acceptance criteria (like specific performance metrics, sample sizes, expert ground truth, MRMC studies, standalone performance, training set details) is not present in this type of submission.
Therefore, many of the requested sections will be marked as "Not Applicable" or "Not Provided" based on the content.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety Requirements | Voluntarily tested to meet ANSI/AAMI RD62: 2001 Water Treatment Equipment for Hemodialysis Applications. |
| Substantial Equivalence | Found to be substantially equivalent in intended use, features, functions, and technological characteristics to the Mar Cor Services, Inc Bicarb System (K003560). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: Not provided. The submission focuses on compliance with a safety standard and functional equivalence, not a clinical test set.
- Data Provenance: Not applicable/Not provided. The "study" mentioned is a voluntary testing against an engineering standard (ANSI/AAMI RD62: 2001), not a study with patient data.
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)
- Number of experts: Not provided.
- Qualifications of experts: Not provided.
- Reason: This type of information is not relevant to a submission based on substantial equivalence and adherence to an engineering standard.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication method: Not applicable/Not provided.
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
- MRMC study done? No.
- Effect size: Not applicable.
- Reason: This device is a mixing and distribution system for bicarbonate, not an AI-powered diagnostic or interpretive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone performance done? Not applicable.
- Reason: This device is a hardware system for mixing and distributing solutions, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of ground truth: Not applicable. The "ground truth" equivalent would be the specifications and performance requirements outlined in the ANSI/AAMI RD62: 2001 standard. The device's performance was compared against these technical specifications, not against medical ground truth from patient data.
8. The sample size for the training set
- Sample size for training set: Not applicable/Not provided. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
- How ground truth was established: Not applicable.
§ 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.