(86 days)
The Isopure ACDS with remote fill is intended to be used in Hemodialysis facilities for the storage and distribution of acid concentrate to be used in the treatment of Hemodialysis patients.
The Isopure ACDS (Acidified Concentrate Distribution and Storage) is designed for storage of pre-mixed acidified concentrate in a tank for transfer through a loop to the individual dialysis machines or to fill jugs which then can be transported to the individual dialysis machines when no distribution loop exists. ISOPURE ACDS (Acidified Concentrate Distribution and Storage) with optional remote fill uses "one-piece molded seamless tanks constructed of linear polyethylene" for bulk storage of acidified concentrate. The optional remote fill allows the storage tanks to be filled by the vendor from outside the building. The Isopure ACDS (Acidified Concentrate Distribution and Storage) with optional remote fill meets or exceeds all Association for the Advancement of Medical Instrumentation (AAMI) National Standards for Hemodialysis.
The provided text is a 510(k) summary for the Isopure ACDS (Acidified Concentrate Distribution and Storage) device, which is a medical device used in hemodialysis facilities. The summary focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria in the format typically seen for novel AI/software devices.
Instead, the "acceptance criteria" here refer to the performance and functional equivalence to the previously cleared predicate device (Pure Water Inc.'s Acidified Storage and Distribution System, K993058). The "study" proving this equivalence is the validation protocol VP12-002, which tests the operation of various components of the ACDS system.
Here's an analysis of the provided information, addressing your questions where applicable and noting where information is not present in this type of submission:
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of this 510(k) (seeking substantial equivalence for a device that is essentially a re-branded and re-manufactured version of a previously cleared device), the acceptance criteria are implicitly that the new device operates identically or equivalently to the predicate device, especially regarding functional components. The "performance" is the successful testing of those components.
| Acceptance Criteria (Implicit from Predicate Device) | Reported Device Performance (Validation Protocol VP12-002) |
|---|---|
| ACDS Storage Tank: | |
| - Proper assembly of trim kit. | - A 250-gallon storage tank assembled with the trim kit. |
| - No leaks in trim kit assemblies and connections. | - Tested for leaks in trim kit assemblies and connections to the storage tank. (Implied successful as no failures reported). |
| - Bottom connection provides acidified concentrate. | - When connected to the bottom, provided acidified concentrate to the distribution pump. |
| - Valve allows flow termination. | - Valve allowed flow to be terminated to the distribution pump when closed. |
| Level Floats: | |
| - Low float provides low tank warning. | - Low float tested to ensure proper operation of the remote alarm low-level indicator. (Implied successful). |
| - Low float turns power on for remote fill station. | - Low float tested to ensure proper operation for the optional remote fill station (turns power on). (Implied successful). |
| ACDS Control Box: | |
| - Proper operation of control box. | - Connected to storage tank and remote fill box. Power connected. (Implied successful operation of the control box). |
| - Distribution pump operation. | - Distribution pump tested. (Implied successful). |
| - Low-level alarm operation. | - Low-level alarm tested. (Implied successful). |
| - Optional remote fill station operation. | - Optional remote fill station tested. (Implied successful). |
| Distribution Pump: | |
| - Distribution of acidified concentrate. | - Connected to a 500 ft ½" polyethylene line to test distribution. (Implied successful distribution). |
| - Pressure and flow measurement. | - Pressure gauge and flow meter used to measure flow and pressure on the distribution line. (Measurements taken, implied within acceptable parameters of the predicate device, though specific numbers are not provided). |
| - Flow switch operation validation. | - Flow meter used to verify the operation of the flow switch on the ACDS distribution pump. (Implied successful validation). |
| Remote Fill Station: | |
| - On/off electrical connections to controller. | - Connected to storage tank and controller; tested the on/off electrical connections of the controller in relation to the fill station. (Implied successful). |
| Regulators: | |
| - Regulates excessive pressure (> 5 psig). | - A 0-25 regulator is supplied to regulate pressure at each individual station in the event of excessive pressure (> 5 psig) at the distribution box. (Implied functional as designed, though a specific test scenario for excessive pressure and its regulation is not detailed, it often falls under design verification testing). |
| Overall Equivalence: | - "The Isopure ACDS... is the same device that was manufactured by Pure Water, Inc. under 510(k) 993058." "The only change to the device is the name and manufacturing location. All performance data provided in the original 510(k) remains the same." "Performance testing was undertaken to verify that the device is as safe, as effective and performs as well as or better than the earlier versions of the Pure Water Inc's Acidified Concentrate Distribution and Storage system (K993058)." |
Information Not Applicable or Provided in this 510(k) Summary:
The following questions are typically relevant for AI/software devices performing diagnostic or interpretive tasks, clinical studies, or novel device performance claims. This 510(k) is for a physical medical device (Acidified Concentrate Distribution and Storage System) and focuses on manufacturing transfer and minor changes, demonstrating substantial equivalence to an existing device. Therefore, these categories are mostly Not Applicable (N/A) to this specific submission.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- N/A. The "test set" here refers to the actual physical device components and their integrated system. The testing is a validation protocol on a single prototype/production unit or a representative sample, not a data-based test set for an algorithm. The testing was done at the manufacturer's location (Simpsonville, KY, USA).
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)
- N/A. "Ground truth" in this context would be engineering specifications and functional requirements outlined in the design and AAMI standards, which are verified by engineers or quality control personnel, not clinical experts establishing diagnostic "ground truth."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. Adjudication methods are for human interpretation conflicts in clinical studies, not for the functional testing of a physical device.
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
- N/A. This applies to AI-assisted diagnostic or interpretive devices. The Isopure ACDS is a physical system for storing and distributing hemodialysis concentrate.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- N/A. This applies to AI/software performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- N/A. The "ground truth" for this device's performance is adherence to engineering specifications, functional requirements (e.g., pump distributes fluid, alarm activates), and relevant industry standards (AAMI National Standards for Hemodialysis).
8. The sample size for the training set
- N/A. This device does not use a "training set" in the context of machine learning or algorithms. Its design and manufacturing are based on established engineering principles and the predicate device.
9. How the ground truth for the training set was established
- N/A. As above, no training set. The "ground truth" for its design and performance expectations is based on the previously cleared predicate device and industry standards for hemodialysis equipment.
§ 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.