(232 days)
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No
The document describes a water purification system using ion exchange and carbon filtration, with no mention of AI or ML technologies.
No
The device is a water purification system component for hemodialysis, not a therapeutic device itself. It supplies purified water, a necessary component for the procedure, but does not directly treat the patient.
No
The device is a water purification system used in hemodialysis facilities. It purifies water for use in dialysis applications according to AAMI standards. Its purpose is to treat water, not to diagnose a medical condition.
No
The device description clearly states it is comprised of physical components (FRP tanks, resins, carbon, connectors, head, pipe, basket) and is used for water purification, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to supply purified water for use in hemodialysis applications. This is a water treatment system, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is described as tanks filled with resins and carbon for water purification. This aligns with a water treatment system, not an IVD.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples (blood, urine, tissue, etc.). There is no mention of reagents, assays, or any process for detecting or measuring substances in a biological specimen.
- Performance Studies: The performance studies focus on the quality of the treated water (chlorine, chloramine, resistivity, TOC), which is relevant to water purification for medical use, but not to the diagnostic analysis of biological samples.
In summary, the device's purpose is to purify water used in a medical procedure (hemodialysis), not to perform diagnostic tests on patient samples.
N/A
Intended Use / Indications for Use
The Deionizer and Carbon Exchange Service for Hemodialysis are intended to be used in a hemodialysis facility according to AAMI standards to supply purified water for use in hemodialysis applications per the requirements of ANSI/AAMI RD62. The exchange tanks can be used for either primary water purification or to supply emergency backup water purification for dialysis. These exchange tanks are components of a larger water treatment system employing adequate pretreatment and post treatment sections. These tanks are not to be used alone. Upon exhaustion, these tanks will be replaced with other Deionization Tanks containing newly regenerated resin or with new resin altogether, or in the case of Carbon Tanks, with tanks containing fresh virgin carbon.
Product codes (comma separated list FDA assigned to the subject device)
FIP
Device Description
New Aqua LLC Deionizer and Carbon Filter exchange tanks for Dialysis are FRP tanks filled with high purity DI resins for the Deionizers and acid washed carbon for the carbon filters. Union style connectors are used in conjunction with a molded Noryl head, PVC riser pipe and distributor basket. The tanks are designed to supply AAMI standard water for dialysis through ion exchange.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
hemodialysis facility
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A system performance test was run by simulating operational conditions. A system consisting of Carbon, and DI resins was set in place and operated. Quality testing of chlorine, chloramine and resistivity levels were monitored to ensure performance. To qualify performance four (4) water samples were taken for validation purposes. Two samples of the raw feed water were drawn for use as a beginning foundation of the need for treatment. Two samples were taken from the final DI unit to validate performance meeting AAMI RD62 standards. The water samples were sent to two separate labs. To test for AAMI standards a raw water feed sample and a treated water feed sample was sent to AmeriWater. To test for TOC a raw water feed sample and a treated water feed sample was sent to Broward Testing Laboratory, LTD. Analysis results from AmeriWater show AAMI standard performance. Results from Broward Testing Laboratory, LTD show a reduction of TOC to non detectable limits.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo for Aqua Systems. The word "AQUA" is in large, bold, sans-serif font, with three curved lines underneath the "Q" to represent water. Below "AQUA" and slightly to the right, the word "SYSTEMS" is written in a smaller, sans-serif font.
APR - 2 2010
April 2, 2010
510(k) Summary
| 1. Submitter: | New Aqua LLC (dba Aqua Systems)
114 Vista Parkway
Avon, Indiana, 46123 |
|---------------------------|------------------------------------------------------------------------------|
| Contact: | Nevin Rudie
Commercial Industrial Director
Telephone: 317-272-6715 |
| Date Prepared: | March 19, 2010 |
| 2. Device Name: | Deionizer and Carbon Exchange Tanks for Dialysis |
| 3. Device Classification: | Class II Medical Device under 21 CFR §876.56653. |
| 4. Predicate: | AmeriWater Dialysis Deionizer Exchange Tanks |
- New Aqua LLC Deionizer and Carbon Filter exchange tanks 5. Device Description: for Dialysis are FRP tanks filled with high purity DI resins for the Deionizers and acid washed carbon for the carbon filters. Union style connectors are used in conjunction with a molded Noryl head, PVC riser pipe and distributor basket. The tanks are designed to supply AAMI standard water for dialysis through ion exchange. The tanks are based on the AmeriWater Dialysis Deionizer Exchange Tanks K991519.
The Deionizer and Carbon Exchange Service for Hemodialysis 6. Indications for use: are intended to be used in a hemodialysis facility according to AAMI standards to supply purified water for use in hemodialysis applications per the requirements of ANSI/AAMI RD62. The exchange tanks can be used for either primary water purification or to supply emergency backup water purification for dialysis. These exchange tanks are components of a larger water treatment system employing adequate pretreatment and post treatment sections. These tanks are not to be used alone.
Upon exhaustion, these tanks will be replaced with other Deionization Tanks containing newly reqenerated resin or with new resin altogether, or in the case of Carbon Tanks, with tanks . containing fresh virgin carbon.
-
- Comparison with Predicate Device: New Aqua LLC exchange tanks for dialysis are substantially equivalent to the currently marketed AmeriWater Dialysis tanks and have not altered the fundamental scientific technologies used in the predicate device. The intended use of the exchange tanks for dialysis is the same as the intended use of the predicate device K991519.
1
Image /page/1/Picture/1 description: The image shows the logo for Aqua Systems. The logo is in black and white and features the word "AQUA" in large, bold letters. Below the word "AQUA" is the word "SYSTEMS" in smaller letters. There are three curved lines that appear to be water waves under the letter Q.
| Tank Parts & Manufacturer | AmeriWater Dialysis Deionizer
Exchange Service | New Aqua LLC Deionizer
Exchange Service |
|---------------------------------------|------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| Tank Type & Manufacturer | FRP tanks manufactured by
Park International * | FRP tanks manufactured by
Park / Pentair |
| Resin Type & Manufacturer | MBD-10 Resin by ResinTech | MBD-15 Resin by ResinTech |
| Carbon Type & Manufacturer | Calgon Centaur | Calgon CPGLF |
| Audio Alarm Type | Resi-Lite 1 megohm
audio/visual alarm positioned
between worker and polisher | Resi-Lite 1 megohm
audio/visual alarm positioned
between worker and polisher |
| Interconnecting Tubing | High purity PVC
interconnecting tubing | High purity PVC
interconnecting tubing |
| Connectors | Widget connectors made of
glass filled Noryl | Union style connectors made
of glass filled Noryl |
| Heads and fill plugs | PVC schedule 80 machined
head with PVC schedule 80 fill
plug | Glass filled Noryl head and fill
plug |
| Stand pipe and distributor
baskets | PVC schedule stand pipe and
distributor basket | PVC schedule stand pipe and
distributor basket |
*Park International is now owned by Pentair Water Treatment. Tanks are sold under the names Structural and Park.
Note: All components used meet or exceed ANSI/AAMI RD62-2006 standards.
-
- Differences: There minor differences between the predicate and New Aqua LLC devices. These differences are within the Resin and Carbon types selected. The predicate device uses ResinTech MBD-10 while the New Aqua LLC device uses MBD-15. The difference between the two is the predicate device uses ResinTech Anion type 1 resin media while the New Aqua LLC device uses ResinTech Anion type 1P resin media. The type 1P has improved cleaning performance allowing greater consistency in cleaning during regeneration providing greater performance and improved consistant gallonage thru put making the type 1P a superior product. The carbon Medias again are from the same manufacturer. The predicate device uses Calgon's Centaur while the New Aqua LLC device uses Calgon's CPGLF. Both medias meet AAMI RD62 2006 standards.
2
9 Performance Testing
A system performance test was run by simulating operational conditions. A system consisting of Carbon, and DI resins was set in place and operated. Quality testing of chlorine, chloramine and resistivity levels were monitored to ensure performance.
To qualify performance four (4) water samples were taken for validation purposes. Two samples of the raw feed water were drawn for use as a beginning foundation of the need for treatment. Two samples were taken from the final DI unit to validate performance meeting AAMI RD62 standards.
The water samples were sent to two separate labs. To test for AAMI standards a raw water feed sample and a treated water feed sample was sent to AmeriWater. To test for TOC a raw water feed sample and a treated water feed sample was sent to Broward Testing Laboratory, LTD.
Analysis results from AmeriWater show AAMI standard performance. Results from Broward Testing Laboratory, LTD show a reduction of TOC to non detectable limits.
Analysis results and testing facility contacts are included in Section 10 of this submittal.
10 Conclusions
Performance testing demonstrates that the exchange tank devices perform to the same standard as that of the predicate devices.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter of the circle. Inside the circle is a stylized image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G60 Silver Spring, MD 20993-0002
Mr. Nevin Rudie Commercial/Industrial Director New Aqua LLC (dba Aqua Systems) 7785 East U.S. Hwy 36 AVON IN 46123
APR - 2 2010
· Re: K092481
Trade/Device Name: Deionizer and Carbon Exchange Service for Hemodialysis Regulation Number: 21 CFR §876.5665 Regulation Name: Water purification system for hemodialysis Regulatory Class: II Product Code: FIP : Dated: March 19, 2010 Received: March 26, 2010
Dear Mr. Rudie:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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); medical device reporting of medical device-related
4
Page 2 -
adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Janine M. Morris
Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(K) Number K092481:
Device Name: Deionizer and Carbon Exchange Service for Hemodialysis
The Deionizer and Carbon Exchange Service for Indications for Use: Hemodialysis are intended to be used in a hemodialysis facility according to AAMI standards to supply purified water for use in hemodialysis applications per the requirements of ANSI/AAMi RD62. The exchange tanks can be used for either primary water purification or to supply emergency backup water purification for dialysis. These exchange tanks are components of a larger water treatment system employing adequate pretreatment and post treatment sections. These tanks are not to be used alone.
Upon exhaustion, these tanks will be replaced with other Deionization Tanks containing newly regenerated resin or with new resin altogether, or in the case of Carbon Tanks, with tanks containing fresh virgin carbon.
Prescription Use _ X
AND/OR Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign Off
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devic
510(k) Number
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