(211 days)
The bicarbonate mixing and distribution system and its components consisting of; tanks, pumps, piping, and controls, are designed to consistently, safely, and effectively mix and distribute bicarbonate solutions for hemodialysis treatments.
NOTE: Federal Law restricts this device to sale by or on the order of a physician for use as a bicarbonate mixing and distribution system for hemodialysis.
Device is designed to provide the user with a system for consistent and easy to use system by which they may be able to mix and distribute bicarbonate solution for use in a hemodialysis clinic.
The provided text describes a 510(k) submission for the TYPHOON Bicarb Mixing and Distribution System, focusing on its substantial equivalence to a predicate device. However, the document does not contain information on acceptance criteria or a study proving the device meets specific performance criteria in the manner expected for a typical medical device performance study.
Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (USFilter Bicarbonate Mixing and Dispensing System, K031502) by comparing technical specifications and intended use. The rationale is that since the TYPHOON system utilizes similar technology, components, and fluid contact materials as previously cleared devices, it is safe and effective.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
As mentioned, explicit quantitative acceptance criteria and corresponding reported device performance values (e.g., accuracy, sensitivity, specificity) for a clinical or in-vitro performance study are not present in the provided document. The performance is assessed through a comparison of technical specifications and the assertion of similar technology and components to a predicate device.
The table below summarizes the comparison of technical specifications between the TYPHOON device and its predicate, which serves as the basis for demonstrating "performance" in this context of substantial equivalence.
| Technical Specifications and Information | Dialysis Services, Inc. TYPHOON | USFilter BICARB50SYS & BICARB100SYS |
|---|---|---|
| Requirements | ||
| Inlet Water: | RO or DI water which meets AAMI standards for Hemodialysis | RO or DI water which meets AAMI standards for Hemodialysis |
| Drain: | Minimum of 1" | Minimum of 1" |
| Electrical: | 115 vac, Single Phase, 20 amp | 115 vac, Single Phase, 20 amp |
| Piping: | ||
| Water Inlet: | 1" schedule 80 PVC | 1/2" schedule 80 PVC |
| Loop Feed: | 3/4" schedule 80 PVC, or 5/8" polyethylene | 3/4" schedule 80 PVC |
| Loop Return: | 3/4" schedule 80 PVC, or 5/8" polyethylene | 3/4" schedule 80 PVC |
| Drain: | 1 ½" schedule 80 PVC | 1" schedule 80 PVC |
| Level Controls: | ||
| Mix Tank Level Control: | The Dialysis Services TYPHOON gives the user the ability to mix and distribute from both tanks, so there is not a separate Mix and Distribution tank. Because of this, both tanks utilize the same level control sensor and operate the same. The sensor automatically allows the system to fill in 50 gal., 75 gal., and 100 gal. increments (user selected). The level sensor controls the fill valve with these levels. | The mix tank is equipped with a high level float that closes the fill valve if the water in the tank exceeds 100 gals. (50 gals. for a 50 gal. system). The fill valve will not reactivate unless the water level is below float level. |
| Distribution Tank Level Control: | In addition, when the bicarbonate level drops to 10 gallons in the tank being used, it will give an audible and visual alarm and/or automatically switch tanks. (See Operator's Manual for details) | The distribution tank is equipped with a low-level float that lights a warning light if the bicarbonate in the tank drops below 25 gals. if the distribution tank is allowed to go empty, and audible alarm will sound. |
| Pumps: | ||
| Mix Pump: | 1/3 hp Totally Enclosed Fan Cooled (TEFC) motor | 3/4 hp Totally Enclosed Fan Cooled (TEFC) motor |
| Distribution Pumps: | 1/4 hp Totally Enclosed Fan Cooled (TEFC) motor | 1/9 hp Totally Enclosed Fan Cooled (TEFC) motor |
| Material | ||
| Tank Materials: | Polyethylene | Polyethylene |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. The submission does not describe a clinical or performance study with a test set of data points or cases. It relies on a comparison of device specifications to demonstrate substantial equivalence.
- Data Provenance: Not applicable. There is no test set data mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. There was no test set or ground truth established by experts in the context of a performance study for this submission. The device is a physical system for mixing and distributing bicarbonate solution.
4. Adjudication Method for the Test Set
Not applicable, as there was no test set.
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 device is a mechanical system for mixing and distributing solutions; it does not involve AI or human readers for diagnostic interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a mechanical system; it does not have an algorithm for standalone performance evaluation in the usual sense of AI/software devices.
7. The Type of Ground Truth Used
Not applicable. There is no concept of "ground truth" (e.g., pathology, outcomes data) in the context of this 510(k) submission, as it relates to a mechanical system rather than a diagnostic or interpretive device. The "truth" of its performance relies on its physical and functional specifications meeting the intended use and being similar to a predicate.
8. The Sample Size for the Training Set
Not applicable. The device is a mechanical system for which a "training set" in the context of machine learning or AI is not relevant.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set.
Summary of the Study (or lack thereof) Proving Device Meets Acceptance Criteria:
The provided document indicates that the Dialysis Services, Inc. TYPHOON Bicarb Mixing and Distribution System relies on substantial equivalence to a predicate device (USFilter Bicarbonate Mixing and Dispensing System, K031502) rather than a novel performance study with explicit acceptance criteria.
The "study" to prove the device meets acceptance criteria consists of:
- Comparison of Technical Specifications: The submission provides a detailed table comparing the technical specifications and requirements of the TYPHOON system with those of its predicate device, demonstrating functional and material similarity (Section {2}).
- Similar Technology and Intended Use: The submitter explicitly states that both devices utilize "similar technology" and share the same "intended use" to consistently mix and distribute bicarbonate solution for hemodialysis (Sections {1} and {3}).
- Non-Clinical Performance Data: The document states that the TYPHOON system "utilizes similar components and fluid contact materials as other items currently cleared for use in hemodialysis" (Section {3}, 4.12).
- Biocompatibility Testing: The submitter certifies that most materials and components are "identical to those previously cleared and registered with the FDA," with additional testing provided in Section 9.0 (not included in the provided text snippet) (Section {3}, 4.14).
- Absence of Clinical Testing: The submission explicitly states "N/A" for clinical testing, indicating that such a study was not deemed necessary due to the substantial equivalence claim (Section {3}, 4.13).
In conclusion, the acceptance criteria are not quantitative performance metrics from a specific study, but rather the qualitative determination by the FDA that the device is substantially equivalent to a legally marketed predicate device based on its design, materials, and intended use, and therefore meets the safety and effectiveness requirements without the need for a separate clinical or detailed performance study beyond the comparison provided.
§ 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.