(133 days)
The Pure Water, Inc. Acidified Storage and Distribution system 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.
Pure Water, Inc.'s Acidified Storage and Distribution System 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.
Pure Water, Inc.'s Acidified Storage and Distribution System with optional Remote Fill meets or exceeds all Association for the Advancement of Medical Instrumentation (AAMI) National Standards for Hemodialysis.
This 510(k) summary describes a medical device, the Pure Water, Inc. Acidified Storage and Distribution System, but it is not an AI/ML powered device. Therefore, most of the requested information regarding AI/ML device studies (such as sample sizes for test and training sets, ground truth establishment methods, expert qualifications, adjudication methods, and MRMC studies) is not applicable to this document.
However, based on the provided text, I can infer the following about the device's acceptance criteria and how it aims to meet them:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Meeting or exceeding National Standards for Hemodialysis (specifically AAMI standards) | "Pure Water, Inc.'s Acidified Storage and Distribution System with optional Remote Fill meets or exceeds all Association for the Advancement of Medical Instrumentation (AAMI) National Standards for Hemodialysis." |
| Substantial equivalence to predicate devices (Better Water's K920186 and ZyzaTech Water System, Inc.'s K964539) | The FDA found the device to be "substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." |
| Indication for Use: Storage and distribution of acid concentrate in hemodialysis facilities. | The device 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." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable. This device is an physical medical device (storage and distribution system), not an AI/ML software device that relies on a "test set" of data for performance evaluation. Its performance is demonstrated through adherence to manufacturing standards and functional equivalence to predicate devices.
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):
- Not applicable. Ground truth in the context of AI/ML testing is not relevant for this physical device. The "ground truth" for this device's acceptance is its compliance with established industry standards (AAMI) and functional equivalence to predicate devices, which are assessed through engineering and manufacturing processes, not expert review of a "test set."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This concept relates to resolving discrepancies in ground truth labeling for AI/ML datasets and is not relevant to the evaluation of this 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:
- Not applicable. This device is not an AI-assisted diagnostic or interpretive tool, so MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a physical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- For this physical medical device, the "ground truth" is established by:
- Compliance with recognized national standards: Specifically, the Association for the Advancement of Medical Instrumentation (AAMI) National Standards for Hemodialysis. These standards themselves are developed through expert consensus and industry best practices to ensure safety and efficacy.
- Functional equivalence to predicate devices: The FDA's substantial equivalence determination relies on comparing the new device's technological characteristics and performance to those of legally marketed predicate devices. This implies that the predicate devices' prior approval and safe use serve as a form of "ground truth" for the new device's acceptable performance.
8. The sample size for the training set:
- Not applicable. There is no "training set" for this type of physical device.
9. How the ground truth for the training set was established:
- Not applicable. See 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.