(270 days)
Flier's Quality Water Systems, Inc. systems are primary or temporary devices to provide water for hemodialysis applications per the requirements of ANSI/AAMI RD62:2001. They remove organic and inorganic substances and microbial contaminants from water used to dilute dialysis concentrate to form dialysate, in the reprocessing of hemodialyzers, and equipment rinse and disinfection.
The Acute System #1 consists of two each carbon and mixed bed DI tanks with pre & post filtration. It is intended to be placed on the back of dialysis machine or on a handcart for single patient dialysis. Acute System #2 consists of just carbon tanks and is intended to be used as pretreatment to a single patient RO system.
The Central System #1 and #2 consists of two or more carbon and mixed bed D1 tanks with pre & post filtration. They are used as either a temporary system to feed multiple dialysis machines in normal use, or for a system to feed a biomedical technician service station. For permanent, multiple station dialysis clinics Flier's recommends using central water treatment systems including reverse osmosis.
The Back-up System #1 and #2 consists of two or more mixed bed DI tanks as a component in a "back up" condition when a RO system or major component on a water purification system for hemodialysis is in need of repair. It may also be used in DI polishing mode to remove ions from an RO stream to meet AAMI RD62:2001 requirements.
Upon exhaustion, these tanks will be replaced with other tanks containing newly regenerated resin, or with new resin altogether.
These systems are components of a larger water treatment system employing adequate pre-treatment and post-treatment sections. Flier's systems are not to be used alone.
The systems are primary or temporary devices used to provide water for hemodialysis applications per the requirements of ANSI/AAMI RD62:2001.
The Flier's Quality Water Systems, Inc. systems purify potable feed water through deionization. Deionization is used to remove 99.9% of ions from water. Deionization alone does not remove particulates, organics, bacteria, viruses or endotoxins. The systems require pretreatment and post-treatment. Deionizers are designed in a hemodialysis application to treat RO water or carbon filtered potable water. Improper use can result in the formation of nitrosamines in the effluent of the deionizer.
The purpose of the pretreatment section of the system is to condition that feed water supplying the deionizers. Conditioning the feed water will include: cartridge filters to reduce particulates and sediment and carbon filtration tarks to remove chlorine/chloramine residual.
The purpose of the post-treatment section of the system is to remove bacteria and endotoxins or lower them to acceptable levels as required by AAMI standards. The post-treatment section of the system will include: submicron/ultrafilters after the deionizers, sample ports to check for microbial contamination and to test for comprehensive AAMI analysis, a 1 megohm quality control light at mid tank and a temperature compensated audible and visual resistivity alarm set at 1M ohm or greater for final water quality. A remote alarm will be installed if the deionization system is not located in the patient treatment area. A distribution section of the system is necessary to deliver product water that meets ANSI/AAMI standards to the points of use. During use, continual monitoring of the effluent through the use of the temperature compensated audible and visual resistivity alarm is required. Routine monitoring of the mid tank quality indicator is also required on intervals during the day, at least before and after each patient treatment.
Should final water quality fall at or below 1 megohm, the alarm will sound and all patient treatments must be discontinued. The deionization tanks must be replaced per tank exchange procedure prior to resuming and patient treatment.
Divert to drain option will be provided when necessary per AAMI quidelines. Divert to drain is not supplied for acute systems located in patient room. Monitor and divert to drain not supplied for back-up systems with existing monitor/alarm/divert.
This document is a 510(k) Premarket Notification for the Flier's Quality Water Systems, Inc. line of deionization systems for hemodialysis. It is a submission to the FDA seeking clearance for these medical devices. Unlike a research paper that presents a study to prove a device meets acceptance criteria, this document declares substantial equivalence to a predicate device already on the market. Therefore, the information requested in your prompt regarding acceptance criteria and a study proving performance is largely not present in this type of regulatory submission in the way you're asking.
Here's an analysis based on the provided text, explaining why certain information is not available and what can be inferred:
Acceptance Criteria and Study for Flier's Quality Water Systems, Inc. (K071104)
This 510(k) submission primarily focuses on demonstrating substantial equivalence to a predicate device (USFilter Corporation's/Siemens, K980182) rather than presenting a standalone study with defined acceptance criteria and performance metrics. Therefore, explicit tables of acceptance criteria for the new device and a study proving it meets those criteria are not provided in this document. Instead, the "acceptance criteria" are implicitly met by demonstrating that the new device functions in a manner substantially equivalent to the predicate device, thereby fulfilling the requirements for water purification in hemodialysis as specified by ANSI/AAMI RD62:2001.
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria (Inferred): The primary "acceptance criteria" for the Flier's systems are to achieve water purity levels suitable for hemodialysis applications, specifically by removing 99.9% of ions and effectively reducing particulates, chlorine/chloramine, bacteria, viruses, and endotoxins to acceptable ANSI/AAMI RD62:2001 standards. This is achieved through deionization combined with pre- and post-treatment.
- Specific criteria mentioned:
- Remove 99.9% of ions.
- Remove chlorine/chloramine residual (minimum empty bed contact time of 10 minutes, activated carbon with Iodine number of 900 or greater).
- Submicron/ultrafilters after deionizers to remove bacteria and endotoxins or lower them to acceptable AAMI levels.
- Temperature compensated audible and visual resistivity alarm set at 1M ohm or greater for final water quality.
- Mid-tank quality indicator for routine monitoring.
- Divert to drain option when necessary.
- Specific criteria mentioned:
- Reported Device Performance (Inferred): The document states that "The Flier's Quality Water Systems, Inc. systems purify potable feed water through deionization. Deionization is used to remove 99.9% of ions from water." It also highlights that "The systems require pretreatment and post-treatment" to address other contaminants. The performance is essentially claimed to be equivalent to the predicate device, which also uses carbon and deionization with pre- and post-filtration for water purification in hemodialysis. The conclusion explicitly states: "The core water purification components and technology are exactly the same. The predicate device components utilize the exact same water purification principles."
| Acceptance Criteria (Inferred from Predicate Equivalence & AAMI Standards) | Reported Device Performance (Inferred/Stated) |
|---|---|
| Removal of 99.9% of ions from water | "Deionization is used to remove 99.9% of ions from water." |
| Removal of chlorine and chloramines to AAMI standards | Carbon filtration utilized, two carbon filters in series, minimum 10 min EBCT, Iodine number ≥ 900 |
| Reduction of bacteria and endotoxins to AAMI standards | Post-treatment includes submicron/ultrafilters. |
| Final water quality monitoring and alarm at ≥ 1 M Ohm | Temperature compensated audible and visual resistivity alarm set at 1M ohm or greater. |
| Mid-tank quality indicator for routine monitoring | 1 megohm quality control light at mid-tank. |
| Compliance with ANSI/AAMI RD62:2001 | Systems "are primary or temporary devices used to provide water for hemodialysis applications per the requirements of ANSI/AAMI RD62:2001." |
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 document is a 510(k) premarket notification for substantial equivalence, not a clinical or performance study report. There is no "test set" in the context of clinical trial data or a formal performance evaluation with a specified sample size. The claim of equivalence is based on the technical characteristics and operating principles being the same as a legally marketed predicate device.
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. As there is no "test set" used in the manner of a diagnostic device requiring ground truth establishment by experts, this information is not provided. The "ground truth" here is the established standards for water quality in hemodialysis (ANSI/AAMI RD62:2001) and the demonstrated performance of the predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. This information is relevant to studies involving human interpretation or subjective assessments, which is not the nature of this 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
- Not Applicable. This device is a water purification system, not a diagnostic imaging device or an AI-powered system designed to assist human readers. Therefore, an MRMC study is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device does not involve an algorithm or AI. It is a physical water purification system. Its performance is inherent in its engineering and components, designed to meet physical and chemical purity standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" in this context is the physicochemical requirements for water purity in hemodialysis as defined by established standards, specifically ANSI/AAMI RD62:2001. The performance of the predicate device (K980182) in meeting these standards serves as the benchmark for substantial equivalence.
8. The sample size for the training set
- Not Applicable. This device does not utilize machine learning or AI, and therefore does not have a "training set."
9. How the ground truth for the training set was established
- Not Applicable. As there is no "training set," this question is not relevant.
§ 876.5665 Water purification system for hemodialysis.
(a)
Identification. A water purification system for hemodialysis is a device that is intended for use with a hemodialysis system and that is intended to remove organic and inorganic substances and microbial contaminants from water used to dilute dialysate concentrate to form dialysate. This generic type of device may include a water softener, sediment filter, carbon filter, and water distillation system.(b)
Classification. Class II (special controls). The device, when it is a water purification subsystem disinfectant, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.