(472 days)
The USFilter Bicarbonate Mixing and Dispensing (Bicarb) System is intended to be used in a Hemodialysis facility to allow safe and effective delivery of concentrates as well as central mixing and delivery of sodium bicarbonate solution necessary for a hemodialysis treatment.
The consistent mixing and delivery of bicarbonate solution for use in hemodialysis
The provided document is a 510(k) summary for the USFilter Bicarbonate Mixing and Dispensing (Bicarb) System. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a device meets specific acceptance criteria based on performance metrics like sensitivity or specificity.
Therefore, many of the requested categories for a study proving device performance (such as sample size for test sets, number of experts for ground truth, MRMC studies, standalone performance, training set details) are not applicable to this type of submission.
However, I can extract information related to the comparison with the predicate device, which serves as the basis for demonstrating equivalence.
Here's a breakdown of the information that can be extracted and the reasons why other requested categories are not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
Instead of traditional performance metrics like sensitivity/specificity, the "acceptance criteria" here relate to demonstrating that the new device is fundamentally similar and performs comparably to a legally marketed predicate device. The document uses a comparison table to show substantial equivalence in specifications and intended use.
| Acceptance Criteria (Demonstration of Substantial Equivalence to Predicate) | Reported Device Performance (USFilter Bicarb System) | Predicate Device Performance (MAR COR MCB 210) |
|---|---|---|
| Intended Use | The USFilter Bicarbonate Mixing and Dispensing (Bicarb) System is intended to be used in a Hemodialysis facility to allow safe and effective delivery of concentrates as well as central mixing and delivery of sodium bicarbonate solution necessary for a hemodialysis treatment. | The Bicarb Mixing and Distribution System (Bicarb System) designed and manufactured by Mar Cor Services is, safe, reliable and easy to use. This system will reduce staff time by providing consistent bicarb mixing, and through system cleaning and disinfection. |
| Utility Requirements | ||
| Water Feed | RO or DI water produced to AAMI standards for Hemodialysis | RO or DI water produced to AAMI standards for Hemodialysis |
| Electrical requirements | 115 VAC, Single Phase, 20 AMP | 115 VAC, Single Phase, 20 AMP |
| Drain | 1" Minimum | 1" Minimum |
| Physical Dimensions (50 Gallon System) | ||
| Length | 70" | 85" |
| Depth | 27" | 32" |
| Height | 60" | 57" |
| Operating Weight | 1800 LBS | 1300 LBS |
| Physical Dimensions (100 Gallon System) | ||
| Length | 83" | 85" |
| Depth | 35" | 32" |
| Height | 60" | 61" |
| Operating Weight | 2500 LBS | 2050 LBS |
| Dimensional/Operating Room (Common) | ||
| Width | 6' 10" | 6' 10" |
| Depth | 3' 3" | 3' 3" |
| Height | 6' 0" | 6' 0" |
| Installation Piping (Common) | ||
| Feedwater | ½" schedule 80 PVC | ½" schedule 80 PVC |
| Loop Distribution | ¾" schedule 80 PVC | ¾" schedule 80 PVC |
| Loop Return | ¾" schedule 80 PVC | ¾" schedule 80 PVC |
| Drain | 1" schedule 80 PVC | 1" schedule 80 PVC |
| System Floats (Mix Tank) | The mix tank is equipped with a high level float that will close the fill valve if the water in the tank exceeds 100 gallons (50 gallons for 50 gallon systems). The fill valve controller will not reactivate unless the water level is below the float level. | The mix tank is equipped with a high level float that will close the fill valve if the water in the tank exceeds 100 gallons (50 gallons for 50 gallon systems). The fill valve controller will not reactivate unless the water level is below the float level. |
| System Floats (Distribution Tank) | The distribution tank is equipped with a low-level float that lights a warning light if the bicarbonate in the tank drops below 25 gallons. If the distribution tank is allowed to go empty an audible alarm will sound. | The distribution tank is equipped with a low-level float that lights a warning light if the bicarbonate in the tank drops below 25 gallons. If the distribution tank is allowed to go empty an audible alarm will sound. |
| Pumps (Mix Pump) | ½ hp Totally Enclosed Fan Cooled (TEFC) motor | ½ hp Totally Enclosed Fan Cooled (TEFC) motor |
| Pumps (Distribution Pump) | 1/9 hp TEFC motor | 1/8 hp TEFC motor |
| Tank Material | Polyethylene | Polyethylene |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable as this is a device submission for substantial equivalence based on design and technical specifications, not a performance study on a test dataset. The "test set" would effectively be the device itself being compared to the predicate.
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)
This is not applicable. Ground truth, in the context of device performance, typically refers to a gold standard used to evaluate the accuracy of a diagnostic or analytical device. This submission is for a mixing and dispensing system where "ground truth" would not be established by experts in the same way.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods are used in studies where there's disagreement among reviewers establishing ground truth, which is not relevant for this type of device submission.
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
This is not applicable. An MRMC study pertains to the evaluation of diagnostic performance, often with AI assistance for human readers. This device is a bicarbonate mixing and dispensing system, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This question relates to the performance of an algorithm independently of human involvement, which is relevant for AI or diagnostic software. The USFilter Bicarb System is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This is not applicable. As discussed above, "ground truth" in the typical sense of a performance study is not relevant for demonstrating substantial equivalence for this device. The "ground truth" for this submission is the accepted safety and effectiveness of the legally marketed predicate device.
8. The sample size for the training set
This is not applicable. Training sets are used for machine learning algorithms, which are not involved in this device or its submission.
9. How the ground truth for the training set was established
This is not applicable for the reasons mentioned in point 8.
§ 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.