(270 days)
Not Found
No
The device description focuses on physical filtration and deionization processes, with monitoring based on resistivity alarms. There is no mention of AI or ML technologies for data analysis, decision-making, or system control.
No
The device is designed to provide purified water for hemodialysis applications, removing contaminants from the water used to dilute dialysis concentrate, not directly treating the patient.
No
This device is designed to purify water for hemodialysis applications, not to diagnose medical conditions in patients. It provides clean water for a medical procedure, but it does not analyze patient data or provide diagnostic information.
No
The device description clearly outlines physical components such as tanks, filters, and alarms, indicating it is a hardware-based system for water purification.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide purified water for hemodialysis applications. This involves treating water that will be used to create dialysate, reprocess hemodialyzers, and for equipment rinse and disinfection. This is a water purification system for a medical procedure, not a device used to perform tests on biological samples in vitro (outside the body).
- Device Description: The description details a water purification process using deionization, filtration, and monitoring of water quality (resistivity). This is consistent with a water treatment system, not an IVD.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing diagnostic information about a patient's health status
- Using reagents or assays for testing
The device is clearly intended to prepare water for use in a medical procedure (hemodialysis), which is a different category of medical device than an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes
FIP
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Dialysis machine / single patient dialysis, feeding multiple dialysis machines in normal use, biomedical technician service station.
Care setting is not explicitly stated but inferred as clinics or patient treatment areas.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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K071104
PAGE 1 OF 3
Image /page/0/Picture/1 description: The image shows the logo for Flier's Quality Water Systems Inc. The logo features the company name in a stylized font, with the words "Quality Water Systems" stacked on top of each other. To the left of the text is a black water droplet, which serves as a visual representation of the company's focus on water systems.
JAN 1 4 2008
510(k) Summary
This 510(k) Summary is provided as part of this Premarket Notification to comply with the provisions of the safe Medical Devices Act of 1990 requiring that either a summary be included in a submission or a statement that a summary is available upon request.
Submitter James B. Flier Flier's Quality Water Systems. Inc. 7425 Clyde Park Ave. SW Byron Center, MI 49315 April 13, 2006
Device Names Acute System #1, Acute System #2 (AS-1, AS-2) Central System #1, Central System #2 (CS-1, CS-2) Back-up System #1, Back-up System #2 (BS-1, BS-2)
Common or usual name Deionization system with pre & post treatment and water distribution components.
Classification name Water purification systems for hemodialysis (21CFR 876.5665)
Predicate Device
The Flier's Quality Water Systems, Inc. systems are substantially equivalent to USFilter Corporation's/Siemens (K980182) predicate marketed water treatment systems for dialysis which use carbon and deionization canisters with pre and post filtration to purify water for hemodialysis.
Device Description
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.
1
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.
Indications for Use
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 DI 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.
Conclusion
In both the case of Flier's systems and the predicate device carbon filtration is utilized to filter out chlorine and chloramines from the water. Both companies use two carbon filters in a series configuration. A minimum empty bed contact time of 10 minutes is incorporated into the designs as recommended by the FDA for chlorine and chloramine removal. Both companies utilize an
2
KC711C4
PAGE 3 OF 3
activated carbon with an lodine number of 900 or greater. Flier's always recommends installing dual carbon tanks in series including single patient systems (Acute System #1, Acute System #2).
In both cases deionization tanks are utilized to remove dissolved solids from the water. Both utilize mixed bed resin, consisting of anion and cation resin, to remove the charged particles from the water. Both utilize parts and materials which are NSF and/or FDA approved.
In summary, the components of Flier's systems and those of the US Filter/Siemens predicate device are very similar to one another. The core water purification components and technology are exactly the same. The predicate device components utilize the exact same water purification principles.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, with three lines extending from the eagle's body.
Public Health Service
JAN 1 4 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. James Flier Quality Committee Flier's Quality Water Systems, Inc. 7425 Clyde Park Ave., S.W., Suite A BYRON CENTER MI 49315
K071104 Re:
Trade/Device Name: Acute Portable Exchange Deionization (PEDI) System Regulation Number: 21 CFR §876.5665 Regulation Name: Water purification system for hemodialysis Regulatory Class: II Product Code: FIP Dated: December 26, 2007 Received: December 26, 2007
Dear Mr. Flier:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
4
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510/k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Flier's
Quality
Water
Systems
inc
Indications for Use
510(k) Number: K071104
Device Name:
Acute System #1, Acute System #2 (AS-1, AS-2) Central System #1, Central System #2 (CS-1, CS-2) Back-up System #1, Back-up System #2 (BS-1, BS-2)
Indications for Use:
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.
| Prescription Use
| (Part 21 CFR 801 Subpart D) | X |
|---|---|
| AND/OR | |
| Over-The-Counter Use | |
| (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Occurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
| 510(k) Number | K071104 |
|---|---|
| --------------- | --------- |